Pfizer

Flu-like symptom reports

Male, 40 - 59 years

Age Reported Symptoms Notes
40 2020-12-31 headache, fever, chills fever of 100.4 started around 02:30PM until 06:00PM on 1/1/20. Chills and headache.
40 2021-01-03 sweating In December 24th late in the evening I experienced sweats followed by extreme chills for a few hours... Read more
In December 24th late in the evening I experienced sweats followed by extreme chills for a few hours. I also had upset stomach and diarrhea throughout the day. All symptoms only lasted the day after injection.
40 2021-01-03 throat pain Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, thro... Read more
Pt entered observation around 1950. Around 2010, stated that "his body felt warm and tingling, throat was sore, and he had a flush feeling". Denies SOB or chest pain when asked. Continued to remain in observation. Stated that he felt somewhat better around 2015. Still had the same symptoms but they were letting up some. Around 2025, he stated that he felt better and the symptoms had stopped. Pt left observation @ 2027
40 2021-01-04 throat irritation Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Pat... Read more
Pleasant 40-year-old male comes in the emergency room with concern related to allergic reaction. Patient had received his COVID-19 vaccination approximate 60 minutes ago, at approximate 45 minutes after vaccination he developed flank pain left greater than right rated a 3 out of 10 extending down to his thighs he also noted a scratchy type sensation in the back of his throat feeling as if he needed to frequently clear his throat. The symptoms have been ongoing now for the past 15 to 30 minutes with no increasing or change in symptoms. Has never had allergic reaction in the past, unsure of previous Covid 19 infection though he describes in February of last year having upper respiratory illness which time he lost his sense of taste and smell. Currently denies any fevers, chills, nausea or vomiting. Denies any diarrhea. Denies cough or shortness of breath. Denies any swelling of the lips, face, eyes or nose. Denies any rash. Upon presentation emergency room patient was seen, evaluated, treated following standards of care given. Given patient's presenting symptoms and the recent COVID-19 vaccination will treat patient as adverse allergic reaction. Patient was given 50 mg of Benadryl IV, 20 mg of Pepcid IV, 10 mg of Zyrtec p.o. and 125 Solu-Medrol IV. Patient was observed in the emergency room for minimum of 2 hours, with complete resolution of symptoms. Patient was discharged home on Zyrtec to take 10 mg by mouth daily as well as Pepcid 20 mg by mouth twice daily for minimum of next 14 days, prednisone 20 mg 1 by mouth daily x5 days. Patient was given a prescription for EpiPen should his symptoms return or progress, recommend he call 911 and return immediately. Risks and warnings were discussed in detail, all questions were answered, patient verbalized understanding agreement plan of care.
40 2021-01-05 chills, fever Fevers, chills, myalgias
40 2021-01-05 sweating, chills Dizziness Lightheadedness Chills Sweating Hypotensive Monitored for 45 minutes. Placed in Trendel... Read more
Dizziness Lightheadedness Chills Sweating Hypotensive Monitored for 45 minutes. Placed in Trendelenberg position. BP 142/100 EMS was called to evaluated. Patient refused to go with.
40 2021-01-06 chills, sweating, fever, throat pain lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt... Read more
lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899 and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot. Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons. He did not have a fever, but he sweated a lot. He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before. He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-01-06 chills, sleepiness Drowsy, injection site pain, chills, aches/pains, weakness
40 2021-01-07 chills, headache Body aches, chills, headaches, refused MD follow up at time of report
40 2021-01-07 headache, fatigue I had muscle ache everywhere. I was felt fatigue could not stand long. Headache.
40 2021-01-08 fatigue Dizziness Fatigue Narrative: Patient developed vertigo and general fatigue following administration... Read more
Dizziness Fatigue Narrative: Patient developed vertigo and general fatigue following administration of covid vaccine. Resolved as of 1/5/21.
40 2021-01-08 nasopharyngitis Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulati... Read more
Symptoms began on 1/2/21 Self isolating Start of symptoms similar to a cold with mild discombobulation Symptoms are mild with a loss of taste and smell continuing
40 2021-01-09 influenza like illness, chills, headache, fever Approximately 20 hours after I received the second vaccine dose, I developed a fever of 102 F. This ... Read more
Approximately 20 hours after I received the second vaccine dose, I developed a fever of 102 F. This was associated with other moderate-to-severe flu-like symptoms including chills, myalgias, and headache. Within 3 hours, the fever decreased to 99-100 F and remained between 98-99 F throughout the rest of the day. The headache and myalgias persisted, but by the following day (today), nearly all symptoms had resolved. No GI symptoms were experienced.
40 2021-01-10 chills, fatigue, fever, headache ? Fever ? Chills ? Nausea ? Headache ? Fatigue
40 2021-01-10 fatigue, throat pain Fatigue Sore throat, Arm pain-resolved 24hr
40 2021-01-10 fever, chills Fevers, rigors, skin sensitivity, muscle aches. Fever's to 102.5 up to 36 hours after injection. Sym... Read more
Fevers, rigors, skin sensitivity, muscle aches. Fever's to 102.5 up to 36 hours after injection. Symptoms of rigors, fever and muscle aches began 12 hours after injection. Rigor subsided at 18 hours after injection. All symptoms resolved at 48 hours after injection
40 2021-01-11 chills Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen arou... Read more
Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen around the clock. No fevers. Mild localized arm pain. Mild cough.
40 2021-01-11 fatigue, fever severe muscle aches and fatigue. felt feverish
40 2021-01-11 fatigue Severe nausea x 2 days, body aches x 1 day, fatigue, tiredness, moderate soreness at injection site.... Read more
Severe nausea x 2 days, body aches x 1 day, fatigue, tiredness, moderate soreness at injection site. All symptoms started the day after the vaccination. Was administered
40 2021-01-11 headache frontal headache pain score 3/10
40 2021-01-11 malaise, chills, fever Fever, chills, body ache, malaise, arthralgia I started to have these symptoms the night after I rec... Read more
Fever, chills, body ache, malaise, arthralgia I started to have these symptoms the night after I received the second dose of the vaccine. Tylenol and Advil helped. But symptoms recurred after 8 hours.
40 2021-01-12 fatigue GENERALIZED FATIGUE Narrative:
40 2021-01-12 headache, upper-airway cough syndrome Frontal headache lasting about twenty minutes. Later that night, about 4 hours after receiving the ... Read more
Frontal headache lasting about twenty minutes. Later that night, about 4 hours after receiving the vaccine, I experienced mild wheezing for less than 5 minutes, but believe this was likely due to allergies and associated postnasal drip rather than the vaccine. The following day I had mild muscle soreness and injection site pain without swelling or redness.
40 2021-01-12 fever, chills, headache Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability ... Read more
Significant chills for 5 hours, fever, body aches, headache significant enough to impair my ability to work the following day. No reaction occurred after first dose. Reaction began with several hours of chills.
40 2021-01-12 fever, chills Fever up to 102.8F with chills 24 hours after 2nd vaccine and body aches. All Symptoms went away wit... Read more
Fever up to 102.8F with chills 24 hours after 2nd vaccine and body aches. All Symptoms went away within another 24 hours and treatments were OTC medicines including Tylenol and ibuprofen.
40 2021-01-12 fever Fever chills, body aches. Very sore left shoulder at injection site Narrative:
40 2021-01-13 sweating Administration at 2:00pm; At 2:15, patient complained of nausea and became diaphoretic. He was plac... Read more
Administration at 2:00pm; At 2:15, patient complained of nausea and became diaphoretic. He was placed in a supine position and provided a moist cloth for his forehead; vital signs and blood pressure remained stable. He was provided a snack and dishcarge d to home at 2:50pm
40 2021-01-13 malaise, fatigue, headache Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had ... Read more
Per reporter: "I received the COVID vaccine on 12/29/2020 (first dose). The first couple days I had a really sore left arm, but didn?t feel any ?side effects? until about Wednesday, 1/6 (about a week later). I remember waking up to a sore left side of my upper body. The left side of my neck, chest, arm, and lymph node (under my left arm) felt weird. It was until about Saturday night, 1/9, that I felt my left under arm lymph node noticeably swollen. I had a bad headache and loss of energy, and overall feeling unwell. No fever or night sweats to report. I was absent from work on 1/11 and 1/12, as a result. 1/13 was my first day back and feel better. The swollen left lymph node is no longer present, but still slightly tired. I did not seek Medical Care for my symptoms.
40 2021-01-13 fever, headache severe headache, neck stiffness, fever up to 102F, diffuse myalgias; symptoms started ~12 hr after 2... Read more
severe headache, neck stiffness, fever up to 102F, diffuse myalgias; symptoms started ~12 hr after 2nd dose and persisted for another ~48-60hr before resolving
40 2021-01-13 runny nose, cough, influenza like illness he tested positive for COVID-19 / (probably infected by a family member); runny nose; dry cough; flu... Read more
he tested positive for COVID-19 / (probably infected by a family member); runny nose; dry cough; flu-like symptoms; he tested positive for COVID-19 / (probably infected by a family member); he tested positive for COVID-19 / (probably infected by a family member); This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that the next dose is scheduled for the time of the report, however he tested positive for COVID-19 on 05Jan2021 (probably infected by a family member). Representatives at the administration site are not sure if he should get the second dose. The patient reported minor symptoms "flu-like symptoms, runny nose, dry cough, no major symptoms". The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-01-14 fatigue, throat pain, cough, headache Pfizer-BioNTech COVID-19 Vaccine EUA Starting two days after injection: headache, sore throat, coug... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Starting two days after injection: headache, sore throat, cough, exhaustion, some intestinal cramping
40 2021-01-14 fever, headache, chills Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts do... Read more
Headache; blurry vision; fevers; body ache; chills; Second dose on 07Jan2021 (19days) after firts dose on 19Dec2020; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date not provided), via an unspecified route of administration left arm second dose on 07Jan2021 07:45 at singled dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 for covid-19 immunisation (first dose, Anatomical Location: Arm Left and lot number EJ1685). On 07Jan2021, the patient experienced Headache, blurry vision, fevers, chills, body ache. The patient did not received treatment for the events. Second dose on 07Jan2021 (19days) after first dose on 19Dec2020. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior vaccination. Since vaccination patient was not tested for COVID-19.
40 2021-01-14 fever Body aches, low grade temp.
40 2021-01-17 sweating to ed with chest pain, diaphoresis and arms tingling
40 2021-01-17 nasal congestion, malaise, headache, runny nose Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days lat... Read more
Chill, malaise, malaise started that night. Headache/malaise next day. Slight runny nose 2 days later. Nasal congestion starting 4 days later. Diagnosed with active COVID-19 infection 6 days later.
40 2021-01-18 fatigue I was just little tired with the first shot I received; This is a spontaneous report from a contacta... Read more
I was just little tired with the first shot I received; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in the arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included clonazepam. On unspecified date, the patient was just little tired with the first shot he received. The outcome of the event was unknown.
40 2021-01-18 headache, chills Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, heada... Read more
Experienced severe shaking chills, necessitating I leave work. Also experienced mild myalgias, headache. Treated with acetaminophen 1000mg and ibuprofen 400mg.
40 2021-01-18 fever temperature was like between 102.6 and 103.5; back hurts; couldn't even really move; woke up at the ... Read more
temperature was like between 102.6 and 103.5; back hurts; couldn't even really move; woke up at the middle of the night; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the arm on 07Jan2021 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included clonazepam. The patient had historical vaccine first dose of BNT162B2 for COVID-19 immunization and experienced tiredness. On unspecified date, the consumer stated, "I just want to, I didn't have, I was just little tired with the first shot I received. But I am little concerning on the second one like I woke up at the middle of the night, I got it yesterday at about 13:00. I woke up at about 2:00 in the morning on 08Jan2021 nd I couldn't even really move but then I was up for most of the night. My temperature is like between 102.6 and 103.5 and my back hurts really bad. So, I am hoping that these are normal things but I am curious at any point is there something I should watch out for taking on that stuff further. The first shot was not anywhere near to bad which I know is to be expected but the second one being the worse, it's like dramatic, I have had a fever for I don't know like eighteen hours. Is there anything I should just make sure, or like this can be a normal side effect, correct?" The outcome of the events was unknown.
40 2021-01-19 headache 5-10 minutes after dose 1, the patient reported feeling very dizzy and a massive headache. He state... Read more
5-10 minutes after dose 1, the patient reported feeling very dizzy and a massive headache. He stated that he never gets headaches and was on a pain scale of 7-8 at that time. Vitals were taken. BP 135/86, pulse 91, temp 96.4. We dosed the patient with 1000mg of Tylenol at 3:05pm. At 3:15, the patient stated that his headache had increased to a pain scale of 9. He wasn't doing well so the staff laid him down. At this point the staff felt it was a situation that needed more attention. They took the patient to the ER where he was given saline and something for headache. The also drew labs. Not sure what labs they drew.
40 2021-01-19 fever, chills Chills, aching body, fever of 101
40 2021-01-20 fatigue, headache, fever general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse... Read more
general ache/pains, headache woke me up ~3:30am. movement hurt, pain progressed, headaches got worse, never went away. nausea, fever throughout the day, general tiredness and increased join point all day. swollen glands in arm pits. headache pain completely impaired daily activity. Tylenol in the afternoon for fever, dramamine for nausea Effects lasted 24 hours... headaches persisted 5+days
40 2021-01-20 headache, sinus headache Back pain; Headache; Would be sleeping and would wake up in middle of night; Felt like a sinus heada... Read more
Back pain; Headache; Would be sleeping and would wake up in middle of night; Felt like a sinus headache on one side of the head; Neck pain; Could not lift his arm; his neck he could not turn it; Bruised under the arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 21Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history human immunodeficiency virus (HIV), COVID-19 in 2020 (Jun2020 or Jul2020; tested positive for COVID-19 at that time and has 3 tests after that which were all negative) and since then lost weight (2020), and root canal. The patient had no issues with vaccines in the past. There were issues with the tuberculosis (TB) vaccine, because he would be positive to TB, but this is because of his culture, he is from a specific country, and so they cannot take that vaccine. The patient clarified that he did not take the TB vaccine, what he meant was he is aware he can't take it. On 21Dec2020, the patient works in healthcare and had a patient that came in that tested positive for COVID-19 and so because of that, everyone including him that came in contact with the COVID-19 positive patient had to check and get tested. This happened the same day as his first dose of COVID-19 vaccine, the test (Dec2020) came out negative. There were no concomitant medications. The patient had not had any antibody test for COVID-19. The patient asked the doctor, but she never scheduled him for that, until after last month, she talked to him about it, but by that time he told her that he doesn't need it now - it's been almost a year. The patient had the first dose on 21Dec2020 and at that time he did experience symptoms the next day (22Dec2020). At that time after the first dose administration (21Dec2020), he could not lift his arm and it was bruised under the arm. The next day (22Dec2020), he had back pain, with his neck he could not turn it (neck pain), he could not be on his left side where he got the shot on left arm, it was like that for 3 days. Then on Thursday (24Dec2020), he had headache every time he bended his head down, he would be sleeping and would wake up in middle of night because of the headache, it felt like a sinus headache on one side of the head, and when he bend his head down, he would feel it, it stayed this way till 29Dec2020 (Tuesday). The patient has a question trying to find out with his employer. They told them they need to take the vaccine, they pushed them to take the vaccine, he works in healthcare. If they get sick at the job, he asked if they (employer) would pay for it, how would he get paid. The job told him he gets paid sick days and asked how they would do that. The patient asked how long the vaccine was alive in the body and how does it work. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
40 2021-01-20 headache, sleepiness Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both... Read more
Drowsy; Weak; Pain in the knees/pain in his joints/joint pain from his Legs, Arms, and fingers; Both of his eyes feel tired; could not lift arm; bruised under the arm; back pain; neck pain; could not turn neck; headache; Pain with bending head down; This is a spontaneous report from a contactable consumer. A 41-year-old male consumer received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on 11Jan2021 at 07:45 at single dose for COVID-19 immunisation at the age of 40-year-old. Medical history included HIV infection, root canal in Dec2020, COVID-19 in Jun2020 or Jul2020. Concomitant medications were unknown. Vaccination history included first dose of BNT162B2 on 21Dec2020 for COVID-19 immunisation (could not lift arm, bruised under the arm, back pain with his neck he could not turn it, he could not be on his left side where he got the shot on left arm, headache). The patient experienced drowsy, weakness, knee pain, joint pain, could not lift arm, bruised under the arm, back pain, neck pain and could not turn neck, Headache, pain with bending head down, both eyes feel tired. In Jun2020/ Jul2020, the patient resulted positive to SARS-CoV-2 test; then, the patient had 3 negative SARS-CoV-2 test; weight: lost. The outcome of the events was unknown. Information on the lot/batch number has been requested.
40 2021-01-20 fever Developed fever on the 3rd day after injection but only lasted over night then on the 5th day there ... Read more
Developed fever on the 3rd day after injection but only lasted over night then on the 5th day there was a lose of sense of smell and taste that lasted for 3 days. Two covid test results were negative
40 2021-01-21 chills, headache, fatigue CHILLS, BODY ACHES, FATIGUE, HA
40 2021-01-21 headache Shoulder stiffness around 9:00 pm Back pain and neck and shoulder stiffness and headache in the mor... Read more
Shoulder stiffness around 9:00 pm Back pain and neck and shoulder stiffness and headache in the morning when i woke up around 6:00 am
40 2021-01-24 fatigue, respiratory tract congestion positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (hcp). This hcp reported the same events for 2 patients. This is the first of two reports. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 21Dec2020 at a single dose on left deltoid for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient reported to have received the vaccine 3 weeks ago and was scheduled to receive the vaccine yesterday (11Jan2021) but tested positive last Saturday 09Jan2021. He mentioned that he had subsequent symptoms of COVID on 01Jan2021. He and his significant other (S/O) got tested last 05Jan2021. He got a negative result while his S/O got a positive result. He had symptoms throughout the week until he confirmed positive last Saturday. As of this report, he is still in quarantine and is experiencing residual congestion and tiredness. He asked when he should schedule to receive the vaccine. The patient underwent lab tests and procedures which included COVID-19 test: negative on 05Jan2021, and then positive on 09Jan2021. The patient has not recovered from the events.; Sender's Comments: Based on the available information, a causal relationship between event positive "COVID-19 test with symptoms" (coded to coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021030850 same drug/events/reporter, different patients
40 2021-01-25 fatigue, headache, cough, fever Had COVID test/positive test result/Tested positive for COVID-19 after getting the initial dose of t... Read more
Had COVID test/positive test result/Tested positive for COVID-19 after getting the initial dose of the vaccine; I am sick with COVID 19; This is a spontaneous report from a contactable other HCP. A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration in left deltoid/left arm on 05Jan2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed about 7 years ago and ongoing GERD that he had his entire life. There were no concomitant medications. The patient got the first vaccine on 05Jan2021, then tested positive for COVID-19. The patient added that he experienced fever of 103, body aches, headache, cough, fatigue, nausea and vomiting and diarrhea times one week.Had COVID test Friday, 08Jan2021 and positive test result received on Saturday, 09Jan2021. The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
40 2021-01-25 fatigue, fever, chills Body ache, chills diarrhea, fatigue, mild fever, muscle pain, brain foggy
40 2021-01-26 malaise, fever STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT... Read more
STARTED 1/27/2021 5AM WITH GENERAL MALAISE, BODYACHE, NAUSEA, EYE REDNESS, PHOTOPHOBIA, FEVER, LEFT ARM AND AXILLARY PAIN ,
40 2021-01-27 chills, fever Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable... Read more
Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, vomiting, diarrhea, and sore arm on 16Jan2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient was recovering from the events.
40 2021-01-27 fever, chills Fever, chills, body aches, bpm over 100 entire night even while laying in bed
40 2021-01-27 fever Fever, muscle aches, joint pain
40 2021-01-28 runny nose, chills, fatigue, nasal congestion Fatigue/chills/nausea later that day, (Saturday) runny nose on Monday, nasal congestion on Wednesd... Read more
Fatigue/chills/nausea later that day, (Saturday) runny nose on Monday, nasal congestion on Wednesday, tested positive for COVID-19 (PCR) on 1/15/2021
40 2021-01-31 chills, headache 30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he won... Read more
30th January 2021-Am-rash-size od baseball, chills, HA-is this his from his tooth or COVID-19-he wonders, PM-freezing & hot body. 31st January 2021-more of the same-chills, HA, hot body- freezing, rash still present on his left deltoid area 1 February 2021-less chills, moving slowly, Left deltoid less hot, not as freezing Taking Tylenol, motrin. Reminded IF he gets worse-go to the ER. Reminded him-does he need to contact his PCM-do so.
40 2021-01-31 fever, chills, cough, headache Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest co... Read more
Headache, nerves in skin were raw and inflamed, agitated by touch. Fever, chills. Nausea. Chest congestion, cough. Loss of taste and smell (this began on 01/31). All side effects symptoms are still present on 02/01.
40 2021-02-01 fatigue Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency ... Read more
Systemic: Other- Patient said he suffered from confusion, fatigue, and had a hypertensive emergency in which he had to increase his amount of blood pressure medication. Highest reading was 198/116.-Severe; symptoms lasted 2 days
40 2021-02-03 fever, malaise, headache, chills Chill like sensations; Aches; Dyspnea on Exertion; General Malaise; Fever; Persistent headache that ... Read more
Chill like sensations; Aches; Dyspnea on Exertion; General Malaise; Fever; Persistent headache that is not relieved with pain killers; other vaccine same date vaccine date 22Dec2020, dose number 1; other vaccine same date vaccine date 22Dec2020, dose number 1; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date not reported), intramuscular in the right arm on 22Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL IR), vitamin d3, calcium ascorbate (VITAMIN C), vitamin b complex, magnesium, cynara cardunculus extract (ARTICHOKE EXTRACT), and vaccinium macrocarpon (CRANBERRY EXTRACT). On 23Dec2020 07:00, the patient experienced chill like sensations, aches, dyspnea on exertion, general malaise, fever, persistent headache that is not relieved with pain killers. It was also reported that other vaccine with same date vaccine date on 22Dec2020, dose number 1. The patient underwent lab tests and procedures which included salivary sample (SARS-cov-2 test): negative on 01Dec2020 . No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
40 2021-02-04 headache Headache, "Feels like I need to run." pain in back of shoulder blades, anxious
40 2021-02-04 headache Mild headache; injection site swollen and sore. Swollen lymph node on left side of neck with mild te... Read more
Mild headache; injection site swollen and sore. Swollen lymph node on left side of neck with mild tenderness.
40 2021-02-04 fever, chills, headache First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. S... Read more
First day - Cold sweats, Fever, Chills, Headache, Nausea, Diarrhea, Body aches, Extreme back pain. Second day - Back pain, Nausea, No fever
40 2021-02-05 dehydration, headache, fatigue Fatigue, muscle aches, vomiting, headache, dehydration
40 2021-02-07 headache Patient had dizziness, extreme headache and muscle and join pain as well as diarrhea on the second d... Read more
Patient had dizziness, extreme headache and muscle and join pain as well as diarrhea on the second dose of the vaccine. The symptoms about a day and half.
40 2021-02-08 chills, headache Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began t... Read more
Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began to feel hot and very painful and sore to touch which started later in the evening. Sunday all day nausea, headache and sore arm continued with chills and whole body feeling hot. I may have had a fever but did not confirm with thermometer. Treatment included increase hydration with water and rest. I felt like my normal self on Monday morning.
40 2021-02-09 chills, fever All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Re... Read more
All body temperatures taken with the same infra-red thermometer at same site, center of forehead. Regularly Consume approximately 3/4 Gallon of water through the course of a day. 2/08/2021 3:30pm - Injection 4:30pm - Typical sore arm 2/9/2021 8:00am - Slept through the night, very drowsy, some body aches, temp 99.8 9:00am - Body aches growing in intensity, temp 101.1 12:00am - Chills, severe body aches, temp 102.6, went to lay down, fell asleep 6:00pm-11:00pm - Severe body aches continue, temp 103.9 - 104.3, monitored every hour. Went to bed 2/10/2021 Fever has come down, 99.7 at this time Body aches in my back continue, along with random chills. Research suggests not consuming any OTC medications such as NSAIDs, and other pain relievers/fever reducers, and allow the vaccination to run its course, as this may impede the body's immune response to the vaccination. No treatment was sought.
40 2021-02-09 cough, headache, malaise, lethargy, fever Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm ... Read more
Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down. On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F. Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21
40 2021-02-09 malaise, headache, fatigue, chills tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nod... Read more
tiredness; headache; muscle pain; chills; injection site swelling; feeling unwell; swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy); injection site pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection. lot number: EL3249), via an unspecified route of administration on 21Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No vaccines received 4 weeks prior to vaccination. The patient experienced injection site pain on 21Jan2021. On 22Jan2021 (24 hours after vaccination), patient experienced tiredness, headache, muscle pain, chills, injection site swelling, feeling unwell and swollen lymph nodes - moderate-severe (left axillary lymphadenopathy). All occurred for a duration of 24 hours, except for event swollen lymph nodes - Moderate-severe (Left axillary lymphadenopathy) in which reported duration was 48 + hours. The patient was treated with ibuprofen for the events. The patient was not tested for COVID-19 post vaccination. The patient has not recovered from the events.
40 2021-02-12 chills Violent tremors or chills in the middle of the night for half an hour, followed by a burning electri... Read more
Violent tremors or chills in the middle of the night for half an hour, followed by a burning electric feeling in my muscles. Not able to sleep afterwards. Woke up and muscles in body are very tight and tense.
40 2021-02-16 runny nose, headache, fever, chills Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil a... Read more
Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil at 7pm. Advil is cutting the pain.
40 2021-02-17 chills, sweating, headache Chills; sweating; headache; body aches; This is a spontaneous report from a contactable consumer. A ... Read more
Chills; sweating; headache; body aches; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiry date: unknown) via an unspecified route of administration, in the right arm, on 02Feb2021 at 06:45, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) on an unspecified date at 13:30, in the right arm. for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 02Feb2021, at 22:00, the patient experienced chills, sweating, headache and body aches. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-02-17 fatigue, influenza like illness 2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fati... Read more
2 days post vaccine Pt reports that he experienced sever flu like symptoms with the worse being fatigue, tachycardia, and shortness of breath. He reports the symptoms lasted for about 1 day except the tachycardia and shortness of breath. He reports 8 days after onset of adverse symptoms with complaints of continue shortness of breath with walking or going up stairs. At time of visit Patient positive for tachypnea and tachycardia. Wheezes audible throughout lung fields.
40 2021-02-17 headache, runny nose My parents live with my family of four. My father was exposed to COVID when he was in the hospital f... Read more
My parents live with my family of four. My father was exposed to COVID when he was in the hospital from 1/19-1/21 getting his hip replaced. My mother and wife lost their sense of smell on Sunday 1/24. They got rapid and differential PCR tests on Tuesday 2/2. The rapid test came back positive for both of them. I served as primary care provider for all four of them during their illness. I started to experience mild symptoms on 2/13. Symptoms included: reduction in sense of taste and smell (could not smell cinnamon or taste spicy foods), headaches, runny nose, waves of nausea. I went to an medical center on 2/16 to receive the Rapid, PCR, and flu differential tests. My Rapid test came back negative but my PCR test came back positive on 2/17.
40 2021-02-19 headache Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision... Read more
Patient woke up at 4am on Feb. 14th 2021 with extreme headache, nausea, dizziness, and blurry vision. patients wife called 911 and patient was taken to Hospital ER for emergency evaluation. CT scan revealed a brain bleed. patient was rushed to Hospital Neuro ICU for immediate care. patient was at Hospital from Sunday Feb. 14th - Tuesday Feb. 16th. patient blood pressure (which is usually well controlled) had spiked up to dangerous level and caused a rupture to an AVM in the tegmentum region of his brain. hospital treated patient and got his blood pressure regulated. Patient discharged on Tuesday Feb. 16th 2021 with the expectation of making a full recovery after several weeks of rest.
40 2021-02-20 sleepiness, fever, lethargy, sweating, fatigue, chills I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after... Read more
I had practically no side effects from shot #1....shot #2 was different. Starting about 6-8hrs after injection I started to feel lethargic. By 10hrs, I started with varying chills/sweats that lasted all night, injection site soreness, and soreness in left breast area. The next day I was extremely exhausted and had trouble staying awake. Muscle aches in both shoulders and neck. Also had varying fever from 100 up to 104.1 throughout the day. At 36hrs after injection. I took 2 Advil to help with the muscle aches...nothing taken to this point. 48hrs After injection some energy returned, but still lethargic throughout the day, and occasion fever between 100-101. During shower, I noticed swelling under my left armpit, not present on the right side. At 60hrs after injection, fever gone, energy returned...lingering soreness of left shoulder and breast area and swelling under left armpit remains. At no point did I have any breathing or lung issues...but otherwise it felt like I had a bad flu (minus the coughing/wheezing) for 2 days.
40 2021-02-21 headache, chills severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non... Read more
severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number El3248), via an unspecified route of administration at single dose in the left arm on 04Feb2021 07:00 AM for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 14Jan2021 08:00 AM in the left arm for covid-19 immunisation. On 04Feb2021, the patient experienced severe headache 8hours after second shot, chills at 12hours. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
40 2021-02-22 chills, fatigue My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and th... Read more
My arms felt sore soon after the injection I felt a little tired around 9:00 a.m on the 23rd. and then extreme fatigue chills and body aches around 7:00 p.m.
40 2021-02-23 chills Chills, body aches.
40 2021-02-23 fatigue very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the foll... Read more
very sore arm, could not lift it, fatigue hit almost 24 hours exactly after injection, rash the following day over chest and neck
40 2021-02-25 chills, lethargy, headache Lathargic; headache; muscle ache; chills; This is a spontaneous report from a contactable consumer (... Read more
Lathargic; headache; muscle ache; chills; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old male patient received first dose of BNT162B2 (COVID 19, Pfizer/BionTech, Solution for injection, Lot number: EN5318), via an unknown route administration on 26Jan2021 12:00 on left arm at single dose for Covid-19 immunization at Workplace clinic. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products was reported. Concomitant medications the patient received within 2 weeks of vaccination included bupropion (buproprion), buprenorphine hydrochloride (SUBUTEX) and trazodone (trazadone). On 26Jan2021 at 18:00, the patient experienced lathargic, headache, muscle ache, chills. No treatment was received for the events. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Outcome of events at the time of last observation was recovering. Information regarding lot/batch number has been requested.
40 2021-02-25 headache, fatigue, fever, chills Nausea, headache, body/muscle aches, extreme fatigue, fever/chills
40 2021-02-27 body temperature increased, chills, fatigue I started to develop deep chills, fatigue, and generalized muscle soreness at 9 pm. Then I developed... Read more
I started to develop deep chills, fatigue, and generalized muscle soreness at 9 pm. Then I developed a101.6 oral temp on 2/28/21 around 155 am. I took 1 gram of Tylenol at that time. As of this am my temp is 99.4 and I still have the chills,fatigue, and soreness. Thank you.
40 2021-02-27 fatigue, chills Fatigue, body aches, and chills for about 12-18 hours (6 PM Monday evening - 12 PM Tuesday).
40 2021-02-27 fatigue, sleepiness Diarrhea appeared fairly quickly and lasted about 18 hours. Used Pepto Bismol and generic Immodium r... Read more
Diarrhea appeared fairly quickly and lasted about 18 hours. Used Pepto Bismol and generic Immodium roughly 6 hours apart. Second symptom is exhaustion. Still ongoing. I just want to sleep.
40 2021-03-01 headache Dizziness. I was immediately, slightly dizzy after the dose. It seemed mild enough for me to drive h... Read more
Dizziness. I was immediately, slightly dizzy after the dose. It seemed mild enough for me to drive home. After released I had to pull over because I was getting dizzier. I calle fly wife to pick me up to drive me home. We hung up and it seems to get worse. I called emergency services. When they arrived they checked my vitals and said all was normal. I chose not to go to hospital. At home I ate and slept. Still had a headache I to the evening, but feel fine. I still plan to get my second dose
40 2021-03-02 chills, headache Chills; no fever; real bad headache; nausea. Headache and nausea it lasted all the way until the sec... Read more
Chills; no fever; real bad headache; nausea. Headache and nausea it lasted all the way until the second vaccine - January 19, 2021. I was taking Tylenol which didn't really help. The headache and nausea was pretty steady throughout the day and night - rough during the entire day and at night. Doctor's visit on January 25th, 2021 and another one on January 26, 2021.
40 2021-03-02 headache, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to urgent care one day after vaccination with fatigue, chest tightness, back pain, myalgias, headaches, right arm soreness, and decreased concentration. Patient states had COVID-19 illness in October 2020 and current symptoms are similar. Patient denies facial/throat swelling, palpitations, rash, or lesions and reports some symptom improvement with acetaminophen. Vitals within normal ranges except blood pressure 141/84 attributed to white coat syndrome. Advised to continue acetaminophen and discharged to home stable.
40 2021-03-02 headache Headache and nausea - they got a little worse after the second shot; headaches got a little more int... Read more
Headache and nausea - they got a little worse after the second shot; headaches got a little more intense . I still get headaches now. I still get nausea but not as much as before. January 25th, 2021 and another one on January 26, 2021 at the medical center.
40 2021-03-03 fatigue Pfizer-bioNTech Covid-19 Vaccine Sore arm Tired
40 2021-03-03 headache After receiving the vaccine, patient started to feel dizzy, nausea, headaches, and neck pain. @1213... Read more
After receiving the vaccine, patient started to feel dizzy, nausea, headaches, and neck pain. @1213: diphenhydramine 50 mg po x1; lot#202906 exp 9/2023 @1216: HR 69 bpm, SO2 99%, BP 120/98 mmHg. @1227: HR 54, SO2 98%, BP 150/90 mmHg @1238: patient discharged to home. @1349: Called patient at home, arrived safely.
40 2021-03-03 sweating After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbne... Read more
After 5 min of receiving the vaccine, client became diaphoretic, pallor observed and reported numbness to bilateral hands. BP taken using manual cuff at 14:26 hrs and recorded 68/42, HR 51 bpm with O2 saturation of 98 % on RA. LCTA, S1 and S2 audible to L apex 4th intercostal space. Water was provided to the client. EMS was notified; EKG was obtained. Last V/S: BP of 103/68, HR of 79 bpm and RR of 18. Client declined EMS care and declined to go to the hospital. Client was discharged home with wife; ambulated to car with steady gait. Alert/ Oriented x 3.
40 2021-03-04 cough, chills Chills, cough temp 101.9
40 2021-03-04 sweating I got really hot and started sweating a few minutes after my injection and I have been getting hot a... Read more
I got really hot and started sweating a few minutes after my injection and I have been getting hot and sweaty for no reason since. I want to know if it's safe to get the second injection. And if this will go away.
40 2021-03-05 fever, fatigue Feverish, nausea, body aches, pain/swelling and bruising at injection site, hurts from left side of ... Read more
Feverish, nausea, body aches, pain/swelling and bruising at injection site, hurts from left side of face and ears down to wrist and back to shoulder blade on left side, hurts under left arm pit, tired, soreness in whole body
40 2021-03-08 fatigue, fever, dehydration began with dehydration - frequent urination, low fever - up all night due to stomach issues very tir... Read more
began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1
40 2021-03-08 headache Patient received his Covid-19 vaccine almost 3 weeks ago and reported a mild headache post vaccinati... Read more
Patient received his Covid-19 vaccine almost 3 weeks ago and reported a mild headache post vaccination, but the headache only lasted a few days. He then received a Typhoid vaccine about 7 days ago and states he has had headaches daily. He is one who suffers from migraines and these headaches are different. They are not severe or cause impairment.
40 2021-03-09 chills, headache Muscle aches, chills, 100.4 temperature, headache, sore arm. All lasted approximately 12 hours
40 2021-03-13 headache, fever Fever 100 degrees with Tylenol Muscle and body aches Massive headache
40 2021-03-13 sweating Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Syst... Read more
Systemic: Dizziness/ Lightheadness-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient warned immunizer that he was anxious about receiving vaccine because he is scared of needles. Once he received the vaccine, he became nauseous, sweaty, clammy, dizzy and lightheaded. Pt explained to immunizer that he was switched to night shift and had taken his diabetic meds without food soon before his shift at 5:30pm. An EMT was on scene and she proceeded to call more medics. I checked on the pt and he was vomiting and very pale. Medics checked pt vitals and okayed him for work.
40 2021-03-14 fatigue When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The... Read more
When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The pain increased if I moved my arm greater than perpendicular to my body. The worst pain though with with my back. I could not stand up straight without a sharp pain starting in my lower back. I was also extremely tired. So I called into work took some Tylenol and went back to bed. By 1 o?clock that afternoon I had felt fine as if nothing had ever happened.
40 2021-03-14 fatigue Severe fatigue (two days), injection site soreness (two days), dizziness (for several hours after va... Read more
Severe fatigue (two days), injection site soreness (two days), dizziness (for several hours after vaccination).
40 2021-03-15 body temperature increased, headache, chills 103 degree temperature, chills, headache. Took 1000 mg acetaminophen every 6 hours. Fever broke afte... Read more
103 degree temperature, chills, headache. Took 1000 mg acetaminophen every 6 hours. Fever broke after initial dose of Tylenol only to come back after 3 hours.
40 2021-03-16 fatigue, fever, chills The day after vaccination I had chills, body aches and fatigue The next day I started running a feve... Read more
The day after vaccination I had chills, body aches and fatigue The next day I started running a fever as well. The symptoms lasted a week. I was tested for Covid-19 but the test was negative. The fever came and went. I had a two day period with no fever. The fever returned and I started to have signs of Jaundice. My Bilirubin was up to 14. I was hospitalized for five days as a result of the bilirubin level. The physician thought that the vaccine caused an inflammatory response because of medical history. Discharge from hospital was two weeks after vaccine and drain in place for three weeks after.
40 2021-03-16 sweating Pt's significant other called nurse triage line on 3/14, stated that patient had not been eating sin... Read more
Pt's significant other called nurse triage line on 3/14, stated that patient had not been eating since his second dose of the COVID vaccine and was having severe abdominal pain and was "doubled over in a fetal position and sweating profusely." Triage advised them to call EMS. Patient presented at the emergency department an hour later, was diagnosed with acute appendicitis, and was admitted to general surgery. Laparoscopic appendectomy was completed on 3/14 with successful removal of "acute gangrenous, perforated appendix" and patient was discharged home the same day with no complications.
40 2021-03-17 headache, chills, body temperature increased Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hou... Read more
Metallic taste at 6 hours & headache 103 temp at 12 hours with chills and shakes 101 temp at 30 hours
40 2021-03-17 sluggishness, headache, fatigue Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired an... Read more
Headache, Sedation, Myalgia, Diarrhea, Tachycardia, "I feel like my heart is beating fast" "tired and sluggish and slow". Soreness in arm is painful and radiating to neck on left side Narrative: Advised to seek treatment from PCP or Emergency services if symptoms do not improve, worsen, or become severe Other Relevant History:
40 2021-03-18 fatigue Injection site pain, Fatigue Narrative:
40 2021-03-19 fatigue I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting ... Read more
I had difficulty concentrating and focusing on Wednesday evening, a little over a day after getting my first shot. The focusing/concentration issues went away by the next morning when I woke up, however I have been feeling very tired physically since then. I'm yawning all day and have very little energy or interest in doing things I need to be doing. I'm not certain that this is vaccine related, and I'm not super concerned about it yet as I'm on Spring break from school, but I start virtual classes again on Monday and will be concerned if I'm still super tired. If it doesn't go away by next weekend, I will likely resubmit/add on to this report if that is an option. It is not a serious concern yet so I haven't contacted medical professionals yet, but I thought it might be a good idea to at least report that this has been going on to VAERS
40 2021-03-20 cough, body temperature increased, fatigue, nasal congestion cough; nasal congestion; didn't sleep well/He has sleep apnea; blood pressure went up to 121/63; his... Read more
cough; nasal congestion; didn't sleep well/He has sleep apnea; blood pressure went up to 121/63; his temp and it went up; pulse rate was up; very tired; He had COVID test and it came back positive; He had COVID test and it came back positive; This is a spontaneous report from a contactable Nurse (patient's mother). Report 3 of 3. MI filed on report 1 of 3. A 40-year-old-male patient received first dose of BNT162B2 (COVID VACCINE, Pfizer product, Formulation: Solution for injection, Lot: Number: EL3302, NDC number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient's medical history included sleep apnea (he started with CPAP and technically it was a BIPAP machine), bipolar disease (took psychiatric medications), lost weight, blood pressure and liver enzymes. On 17Mar2020, he quit smoking. Concomitant medications were not reported. On 26Jan2021, the patient experienced nasal congestion and cough. He had COVID test and it came back positive. It was reported that, "they were vaccinated on 15Jan2021 with first dose. The Wednesday after which was about 5 days after the vaccine her husband got chills, sneezing, and fatigue. He did not call the doctor and did not get tested. About a week later her son had nasal congestion and cough. This was the third day for that. Called her son's doctor since this was the second person in the house to have symptoms. He had COVID test and it came back positive. Is the COVID vaccine enough to give a positive test. She had symptoms too, but she normally get sinusitis this time of year. No one had a fever. Her son was really congested. Maybe he will develop a fever down the line. She was at a quandary. She had to quarantine in case it was. Could the vaccination cause a positive COVID test result. She thought the symptoms should show up in 1 to 3 days. A week in between her husband and son and it was hard to believe. It should have been her to get it worse since she sleeps with her husband. Praise the Lord she had not. She and her husband had not been tested for COVID. Only her son was COVID tested. Wednesday morning he woke up and he was much more congested. He complained a little on Tuesday. He had sleep apnea and uses CPAP. He might have wanted cough medicine to help him sleep good. He said he did not sleep well. He was very tired and congested. On the evening of 26Jan2021 he was more congested than usual. He was tested yesterday and got positive results this morning. History and Investigations: he was in a lot better shape since living with them because he had lost over 100 pounds. He had sleep apnea. He started with CPAP and technically it was a BIPAP machine. They call it a CPAP. He was 355 pounds and now 228 pounds. Slowly loosing weight. He had bipolar disease and took psychiatric medications. Since he had lost weight he has had to decrease his doses. He was having problems with blood pressure in October. He was starting to feel faint and the doctor stopped his blood pressure medications. He had issues with his liver enzymes and he was not out of the woods yet. He had been a smoker on and off. He quit smoking on 17Mar2020. Caller declined to do provide information about her son's psychiatric medications and blood pressure medications for report. They bought a blood pressure cuff to keep track of his blood pressure. Since he got sick his blood pressure went up to 121/63. It was normally 110 to 114 over 63 to 70. She had also been keeping an eye on his temp and it went up about a degree. His pulse rate was up which you would expect. His pulse rate was usually between 55 and 68. That day it was 83. There was a product complaint. Caller was patient's mother. Vaccinated on 15Jan2021 with first dose. About a week later her son had nasal congestion and cough. This was the third day for that. Called her son's doctor since this was the second person in the house to have symptoms. He had COVID test and it came back positive. Is the COVID vaccine enough to give a positive test. Her son was really congested. Maybe he would develop a fever down the line. Could the vaccination cause a positive COVID test result. On the evening of 26Jan2021 he was more congested than usual. He was tested yesterday and got positive results this morning. Outcome of the events was unknown.
40 2021-03-20 sweating Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: F... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
40 2021-03-21 chills, sweating Lightheadedness Chills Sweating Room spinning
40 2021-03-21 headache Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Severe headache & migraines without relief for approximately 72 hours.
40 2021-03-21 headache Within few minutes, I started feeling high heart rate and dizzy. Notified health care professional a... Read more
Within few minutes, I started feeling high heart rate and dizzy. Notified health care professional and they took me in to observe vitals. Heart rate and blood pressure was higher than normal. EKG looked normal but with higher heart rate. Started feeling better in an hour and went home. The high heart rate recurred the next several days but would go away after few minutes. Occasionally I get a headache and feel resting heart rate is higher than before. Definitely feeling better after two weeks compared to day of the shot.
40 2021-03-24 fatigue, headache Fatigue, headache, tingling feeling, mild vertigo and nausea
40 2021-03-24 fatigue Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelli... Read more
Starting at 8pm on vaccination day I got loopy and disoriented, and had a hard time speaking intelligibly. I also had trouble with balance and fine motor skills. Had some personality changes too: became very moody with erratic mood swings. The next day I slept all day because of exhaustion and aches. When I woke up on Wednesday (36hrs later) I was literally screaming in pain because of how bad my arm and shoulder hurt. It hurt to move it, and hurt not to move it. It was excruciating and ibuprofen didn't seem to help at all. Throughout Wednesday I could hardly move my left arm. Getting dressed or washing my hair was very difficult and very painful. I was also still very uncoordinated. My left armpits lymph nodes were so swollen that (1) it filled in my entire armpit so there was no more pit, just a very soft bulge, and (2) the fluid extended all the way to my chest and it looked like I had one breast and one pec.
40 2021-03-24 fever, chills chills, body aches, uncontrollable shaking, fever, vomiting, night sweats, pain in left arm
40 2021-03-26 cough, fever Fever, aches, cough
40 2021-03-26 fever 8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, ... Read more
8 hours after shot extreme nausea. In one instant, extreme feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour. Afterwards mild headache, fatigue, nausea persisted for 2-3 days.
40 2021-03-27 nasopharyngitis, headache Headache. Hot flashes. Cold flashes. Body aches. Dizzy
40 2021-03-28 headache, malaise I was surprised that I am having any side effects due to the fact that I am so very lucky in that de... Read more
I was surprised that I am having any side effects due to the fact that I am so very lucky in that department, in most cases. The first day, following the shot, I had a bit of soreness at the injection site but it was gone by the following day, Friday, 3/26/21. I had a general feeling of weakness the afternoon and into the night on the day of the shot as well. However, it was about midday or a bit after the following day that I began feeling obvious side effects. These include, primarily, a general feeling of being ill. Headache (but that's not that abnormal & body aches and stiffness similar to a mild version of influenza. It appeared late in the day on Saturday, 3/27/21 and has continued since. (See next page)
40 2021-03-31 fatigue Experienced extreme fatigue for around 36 hours.
40 2021-03-31 headache, fatigue, chills, fever Fever, headache, chills, sore joints, tiredness for approximately 24 hours.
40 2021-04-01 fatigue Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches... Read more
Body ache and difficulty sleeping beginning overnight after shot, increasingly unpleasant body aches, weakness, tiredness throughout following day.
40 2021-04-01 sweating PT LOST CONSCIOUSNESS WITHIN 15 MIN OF ADMIN. PT WAS MILDLY DIAPHORETIC. VITALS WERE NORMAL. BP 124/... Read more
PT LOST CONSCIOUSNESS WITHIN 15 MIN OF ADMIN. PT WAS MILDLY DIAPHORETIC. VITALS WERE NORMAL. BP 124/75 HR 74 NO CPR NO EPI NEEDED. ICE PACKS APPLIED TO COOL PT . 911 CALLED PT WAS TRANSPORTED TO HCF by EMS. PER PT REQUEST.
40 2021-04-02 headache, chills, fever They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescript... Read more
They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; They diagnosed the hives as shingles (which I've never had before) and provided anti-viral prescription.; Headache; Sore neck; Chills; slight fever; This is a spontaneous report from a contactable consumer (reporting for himself). A 40-year-old male patient received first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Mar2021 at 13:00 (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient's medical history included Known allergies: Penicillin. The patient's concomitant medications were not reported. On 19Mar2021 at 03:00, the patient experienced headache, sore neck, chills, slight fever. Friday evening, the patient noticed hives. The patient went to the emergency room (ER) Saturday morning at 3 AM, to be sure hives were not concerning. They diagnosed the hives as shingles (which the patient never had before) and provided anti-viral prescription, Valtrex 1000 mg 3 times per day for 7 days. The outcome of the events was recovering. The patient did not had COVID-19 prior to vaccination and was not tested post vaccination.
40 2021-04-02 lethargy Lethargy, arthralgia (knees, shoulders) Onset 22 hours post-dose, resolved by 36 hours post-dose
40 2021-04-03 headache, fatigue Fatigue, Muscle Ache, Mild nausea and mild headaches persistent for 39 days after vaccine shot.
40 2021-04-03 fever, headache, fatigue Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked u... Read more
Initial symptoms first 48 hours first dose; Headache; Joint pain- hips and below (left knee locked up and could not bare weight on it). Tiredness; Second dose 48 hours; Fever 101.8; Tiredness; Severe headache; Sore Arm; Approximately 1 month after 2nd dose unknown if related. Sudden hearing loss left ear; Tinnitus; Lightheaded.
40 2021-04-04 chills, headache, fever, fatigue Started having swelling to left axillary lymph nodes and pain to left collar bone and left axillary ... Read more
Started having swelling to left axillary lymph nodes and pain to left collar bone and left axillary area (pain and lymph nodes are still swollen) Fever, chills, body aches, fatigue, headache x 4 days
40 2021-04-04 headache Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, so... Read more
Spoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored forSpoke with pt 1/11/2021 at 1615 and he was doing well, speaks clearly, does have a mild headache, sore arm, and dizzy sensation if moves too fast. He was given NFW today and can return in am to fire house/station. ---- EVENT: This employee reports received 2nd shot and about 10 min later he felt nauseated. The nausea progressed to a gagging, which made him vomit, his throat was hoarse constantly trying to clear, had problems exhaling, could speak easily, felt flushed, mild headache, - staff checked vital signs (normal) and given epi. Taken to ER where skin noted bright red all over (torso, face, extremities), but no further n/v/gagging/sob. ER gave IVNS, IV Benadryl, Solu-medrol, Pepcid, and Zofran. Monitored for 2 hours and sent home with coworkers with resolution of all symptoms. 1/15/2021 f/u: advised doing well, no further issues. review as of 4/01/2021 shows he received flu vaccine on 1/22/21 w/o issues.
40 2021-04-04 malaise Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: P... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Additional Details: PHARMACIST GAVE HIM INJECTION ,HE WAS DIZZI,NOT FEELING WELL ,CALLED 911 ,THEY CAME AND CHECKED HIM OUT ,BP WAS NORMAL, THEN HE WALK OUT FROM THE PHCY
40 2021-04-04 fever, chills Employee had a reaction approximately 30 minutes post vaccination. Employee had itching and reporte... Read more
Employee had a reaction approximately 30 minutes post vaccination. Employee had itching and reported having hives. Took 50mg of Benadryl PO. Employee reports having chills and low grade fever the following day.
40 2021-04-05 fatigue, throat pain Mild aches, mild sore throat, fatigue, sore arm at site of injection. Symptoms were first noticed th... Read more
Mild aches, mild sore throat, fatigue, sore arm at site of injection. Symptoms were first noticed the morning following the injection and persisted until the evening (~08:00 pm).
40 2021-04-05 nasopharyngitis Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to... Read more
Patient received first dose Pfizer COVID vaccine and was sitting in observation area. Nurse came to get me and patient was found lying on the floor. Patient was cool, clammy, eyes closed but easy to arouse. Patient's friend states he sometimes has a seizure associated with feeling like this. Patient alert and oriented, able to converse, and states he did not fall but sat down in floor prior to lying down. 1119 VS: 98% RA, pulse 69 and regular, b/p 118/72. Ice pack applied to patient along with fanning of patient. Patient states feeling better and brought to sitting position without difficulty. Patient offered juice which he was able to drink without difficulty. Patient assisted into wheelchair and brought back to observation area. 1128 VS: 98% RA, pulse 79 and regular, b/p 122/72. Patient no longer clammy, able to converse and follow directions without difficulty. Patient states he is feeling much better, able to stand without feeling dizzy or lightheaded. Friends present with patient and will drive patient home. Patient transported to car via wheelchair. Able to transfer into car independently.
40 2021-04-06 fatigue, chills, fever 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump / lymph nodes sev... Read more
2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquetball and area around chin and neck severely swollen. Developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling was administered Percocet, Fentanyl, Ketorolac, and Morphine, 2 COVID test were negative. Due to difficulty breathing issues admitted through ER to hospital critical care unit 9 days post vaccine. Hospital stay 4 days 3/27/21 thru 3/30/21. On 4/7/2021 still have hard swelling in neck and under chin area
40 2021-04-06 fatigue, fever, chills Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2)... Read more
Onset of all symptoms began on March 17, 2021. Symptom (1) Dry mouth: symptoms are still active; (2) Extreme thirst: symptoms are still active; At the minimum, I consume 366 fluid ounces (2.859 gallons) of water per day. (3) Blurry vision: symptoms are still active; (4) Dizzy/lightheadedness: symptoms ongoing; (5) fatigued/tired/muscle fatigue: symptoms ongoing: (6) fever/chills: symptoms no longer present as of April 6, 2021. (7) Extreme weight loss (30 lbs/13.64 kgs); (8) Neuropathy of both left and right hands: symptoms still ongoing; (9) Mental fatigue: symptoms still ongoing.
40 2021-04-06 sweating Patient was witnessed on the ground following his vaccination. He has a loss of consciousness for a... Read more
Patient was witnessed on the ground following his vaccination. He has a loss of consciousness for about 30 seconds. we arrived to find the patient pale diaphoretic with abrasions on his left side of his face and his eye glasses broken. he was placed on the back board and taken to observation area two. He is currently alert and oriented and by 3. BP 133/90, HR 85, Resp 20, oxygen sat 100 on room air. once in the observation area patient removed from the backboard. he is sitting up on the bed and calling his significant other. He was given apple juice and crackers. he states he his feeling better. The medical team at this time is encouraging the patient to be seen in the emergency department due to the the unwitnessed fall from seating position and the fact that he had a positive loss of consciousness. Pt is not wanting to go to the ED due to the fact that he has bad insurance and currently unemployed. 12:50 Bp 138/86 HR 87 Resp18 Oxygen sat 100: on room air patient is feeling better however we are concerned about his LOC and wanting him to be evaluated. His partner arrived BP 133/87 pulse oxygen 100 HR 76. Once he was here he convinced pt to go to the ED. EMS was called and arrived to take patient to the ED at 1343
40 2021-04-06 lethargy, headache, fatigue Arm pain, general muscle pain, body aches, headache, fatigue, nausea, and lethargy.
40 2021-04-06 fever, sweating, headache, fatigue Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; in... Read more
Thrombocytopenia (109,000); elevated D dimer (3960); fatigue; subjective fever; headache; sweats; injection site pain; paresthesias of hand on side of injection; This is a spontaneous report from a contactable physician (reporting for a patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly, administered in arm left on 15Mar2021 (at the age of 40-years-old) as single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 prior to vaccination; patient had no known allergies. Concomitant medication included lisinopril. Patient had no other vaccine in four weeks and the COVID vaccine was received at a Public Health Clinic/Veterans Administration facility. On 15Mar2021, the patient experienced thrombocytopenia (109,000), elevated D dimer (3960), fatigue, subjective fever, headache, sweats, injection site pain and paresthesias of hand on side of injection. The adverse events resulted in emergency room/department or urgent care. The patient was tested for COVID post-vaccination through a nasal swab and Biofire PCR on 22Mar2021 which were both negative. Therapeutic measure taken as a result of the events included IV hydration. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and all reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
40 2021-04-07 fatigue Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of co... Read more
Whole body Numbness and tingling, loss of feeling of lower right arm and lower right leg. Loss of control of lower right arm. Extreme fatigue unable to get up and move at times. Very light headed and on the verge of blacking out.. possibly Loss of consciousness. Extreme tightness in chest. Increase work of breathing. Confusion. Unable to keep eyes open and maintain alertness. Extremely tired Symptoms have gotten a little better throughout the day of april 8th with lots of rest and very little physical activity. I still have slight tightness in chest. Increase work of breathing. Still have tingling throughout body and am lightheaded. When doing any physical activity I become fatigued and lightheaded very fast and must stop after 5-10 minutes. Tongue is still tingling and metallic taste in moutg
40 2021-04-07 headache Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pai... Read more
Sharp headache in that feels like it's "inside his brain." Also had unilateral ear and head/face pain on the left side the evening of the vaccine. H/A is recurrent and has not changed. Has treated with ibuprofen , Sudafed, and Nasacort. Was seen by PCM on 4/7 and diagnosed with Neuritis and given Prednisone 30mg taper.
40 2021-04-08 headache, fever, malaise, chills 24 hours after 2nd dose, I felt fever with chills, moderate headache, malaise for about 12-16 hours.
40 2021-04-08 sweating Became diaphoretic and pale. BP slightly elevated. Assisted to a sitting position on the floor. P... Read more
Became diaphoretic and pale. BP slightly elevated. Assisted to a sitting position on the floor. Provided with water and ice pack. Stayed in vaccination area for an extended period of time for continued monitoring.
40 2021-04-08 lethargy, fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild
40 2021-04-10 fatigue, headache, chills, fever Thursday, March 25th at 3:10pm I received my 2nd dose of the Pfizer vaccine. Thursday, March 25th at... Read more
Thursday, March 25th at 3:10pm I received my 2nd dose of the Pfizer vaccine. Thursday, March 25th at 9pm I had cold chills, headache, low grade fever, diarrhea, and fatigue. These symptoms lasted Thursday night, Friday, Saturday (March 25th - March 28th). Sunday, March 29th at 4am I woke up with severe chest pains, shortness of breath and light headed. At this time I went to the emergency room.
40 2021-04-10 headache, fever Severe soreness all over. Low grade fever (around 101F). Headache. Temperature swings (going from... Read more
Severe soreness all over. Low grade fever (around 101F). Headache. Temperature swings (going from chills to sweats and back for no reason.)
40 2021-04-10 headache Patient states the day of vaccine he developed a headache shortly after the vaccine. He has had hive... Read more
Patient states the day of vaccine he developed a headache shortly after the vaccine. He has had hives reaction/itching all over body, sparing face. Patient with rash on palms of hands and feet as well.
40 2021-04-10 fever, headache, fatigue 4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolve... Read more
4 days of fever, headache, body aches, fatigue, "brain zaps", brain fog. Most symptoms have resolved but fever and brain fog persist as of day 6. Sleeping 14+ hours per day, unable to work due to symptoms.
40 2021-04-11 chills, body temperature increased, headache Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armp... Read more
Left arm soreness lasted several days Flush feeling, chills, temp of 99.5-100.5, headache, left armpit itching, weakness when standing, soreness in upper thighs.
40 2021-04-11 fatigue, body temperature increased temp 102, nausea, no appetite, tired last about three days
40 2021-04-11 fatigue, fever Moderate pain at injection site and throughout upper left arm developing into joint pain, muscle pai... Read more
Moderate pain at injection site and throughout upper left arm developing into joint pain, muscle pain, 101 F fever, chills, body pain, and fatigue, which dissipated 2nd morning after with a lingering low-grade (99-100 F) fever and light fatigue
40 2021-04-11 sweating Nausea, dizziness, sweaty.
40 2021-04-11 fever, chills Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm cau... Read more
Severe upper body muscle cramps, fever and chills, minor nausea. Cramping in chest and diaphragm causing moderate to severe positional pain and some difficulty breathing. Self treated with advil and tylenol. Laid flat on the floor for several hours in a position causing least amount of pain, until cramping subsided. Cramping lasted a total of 10 to 12 hours starting some time overnight after injection.
40 2021-04-11 respiratory tract congestion Post Vaccine COVID. 2/4/21, onset of congestion and funny taste. PCR + 2/5/2021. Had multiple fam... Read more
Post Vaccine COVID. 2/4/21, onset of congestion and funny taste. PCR + 2/5/2021. Had multiple family members in the home +
40 2021-04-12 chills, fever, fatigue shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine ... Read more
shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
40 2021-04-12 fatigue Sore Arm and Overall fatigue the next morning. Strange taste in mouth. Metallic like.
40 2021-04-12 sweating Pt experienced fleeting moment of syncope 5secs while sitting on a chair in the recovery hall. He wa... Read more
Pt experienced fleeting moment of syncope 5secs while sitting on a chair in the recovery hall. He was aroused to consciousness when his name was called and chest rub applied. V/s bp 103/64, res 12, temp 94.8, hr 83, o2 97% RA. He was taken to a cubicle in a wheelchair and made to lay down on a cot for further observation. Pt was noted to be perspiring profusely. 2pkts of small apple juice and a bottle of water were offered, Pt drank all. At 10:15 a m v/s obtained read - bp 116/84, rr14,hr75, temp 96.6, O2 97% RA. Pt. verbalized feeling well, denied any pain. He was advised to see his caregiver for further medical evaluation .He walked away from the room unassisted at 10:28 a m.
40 2021-04-12 sweating 1100 Pt reports increased in nausea and "feels like is going to throw up". Pale and diaphoretic. P... Read more
1100 Pt reports increased in nausea and "feels like is going to throw up". Pale and diaphoretic. Pt reports name and states has hx of vagal with injections/vaccinations and sutures-which occurred 2 years ago. EMS activated. Pt increase with diaphoretic and vomited x 2. EMS assessed and controlled situation. Pt appeared to recover without difficulty after 10-15 minutes. Drank 16.9 oz. bottle water. Ambulated independently without asst to exit. Pt reports he is not driving and he has a ride. Pt instructed to inform medical to lay down prior to 2nd/next injection/vaccination in 3 weeks. Pt verbalized understanding.
40 2021-04-13 cough, throat pain, fatigue, sleepiness I was fine for a while but on the 10th (4/9) day after taking my first shot I started feeling my thr... Read more
I was fine for a while but on the 10th (4/9) day after taking my first shot I started feeling my throat swell up. The next day (4/10), my body shut down. I was in bed and slept most of the day. My throat was sore and swollen and had general fatigue. The third day (4/11), I brought myself to a medical clinic and got a strep test, negative; rapid covid test, negative. I also received the PCR test which turned up negative a few days later. My throat culture results are still pending. 4th & 5th day I was still coughing with a sore throat and fatigue. Day 6 is today and I am still fatigued with a sore throat but I seem to have turned a corner. I am able to get up and walk a little at a time. This may not be related to the shot but it was close enough where I felt the need to report it. I am scheduled to take my 2nd Pfizer shot on 4/20 and am curious if I should push it back or not.
40 2021-04-13 fatigue, fever, sweating Fatigue beginning the following morning (6AM) Fever 99.9 at 6AM treated with Ibuprofen Fever 102.2 a... Read more
Fatigue beginning the following morning (6AM) Fever 99.9 at 6AM treated with Ibuprofen Fever 102.2 at 7PM treated with Ibuprofen Fever 102.8 at 8:30 PM Fever throughout the night accompanied with excessive sweating Consistent Body and Joint aches
40 2021-04-13 fatigue I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual... Read more
I had already completed my menstrual cycle before the vaccine. I started a extremely heavy menstrual flow the day after vaccination and it went on for 8 days. I had body aches on my left side only. Was not able to stay awake an entire hour. Slept 3/4 of the day away for the first 4 days. It was hard to focus or read any information.
40 2021-04-14 headache Significant swelling of feet, hands; Very sore shoulder at injection site; headache.
40 2021-04-15 chills, body temperature increased, headache Woke up with chills and fever of 102. Treated with ibuprofen and acetaminophen. Had fever and musc... Read more
Woke up with chills and fever of 102. Treated with ibuprofen and acetaminophen. Had fever and muscle aches all day Thursday. Woke up this morning with a strange pain in my left eye socket, felt like a headache but inside my eye ball, it goes away when I sit and lie down and comes back when I stand up. Vision in that eye was blurry, but slowly returning. Continue to have muscle aches and fever, but they are lightening.
40 2021-04-15 fatigue Fatigue, beginning about 2 hours after shot, Seems to have gone away by next morning.
40 2021-04-15 headache 4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE ... Read more
4/10/21, Swollen/ sore lymph nodes left arm pit. 4/12/21, Trouble swallowing food. Flare up of EoE 4/13/21, Dizziness, low grade headache, tingling of skin on face and hands. Elevated response to seasonal and food allergies . Ongoing 4/15/21, Swollen/ sore lymph nodes right arm pit.
40 2021-04-15 malaise, sweating On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and cou... Read more
On the evening of March 6, 2021, patient tried to exercise (consistent with regular routine) and couldn't do more than 15 minutes. He was very winded. On March 7, we skipped exercise. On March 8, patient tried to do simple stretching exercise, and couldn't do it. He got winded and shaky. On March 9, he was seen at an urgent care where he was told he had an inverted T wave on his EKG and a very fast heart rate (125 resting pulse). He was told to not exercise and to make an appointment with a cardiologist. On March 9, I called the urgent care clinic to ask questions about monitoring his blood pressure and when to seek more medical care. I spoke with Dr, who prescribed Atenolol. Around 4:30 pm on
40 2021-04-15 fever, malaise, body temperature fluctuation Pain at injection site 6 hours after injection. Woke up at approximately 3 am (roughly 12 hours afte... Read more
Pain at injection site 6 hours after injection. Woke up at approximately 3 am (roughly 12 hours after injection) with feverish symptoms such as dramatic body temperature changes and general malaise. At this same time the entire left side of my body was in pain, which lasted the entire next day. Side effects lasted through the next night and had noticeably subsided by the following morning.
40 2021-04-16 dehydration, chills, fatigue note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was... Read more
note I was moderately anxious prior to getting the vaccine and had a busy day the next day which was worrisome in case of side effects. dizzy first day, chills, fast heart. Everyday so far feel off and on tired, dry mouth off and on, dehydrated? Felt tired within an hour of injection on Tuesday. I don't remember if my stomach was growling on the first night on the day I got injected and I just went to bed. The next morning I woke up really thirsty/hungry and tired. I slowly made myself breakfast. Sat down to eat on a stool and felt dizzy. My heart raced for 30 sec as I carefully made my way to the flow to be safe. I had the chills, a bit shaky for a short period. I called my doc who told me to stay hydrated. The clinic where I got injected DID NOT inform me about dehydration. As of today, I still have off and on a dry mouth, feel more of an empty stomach at meal time, tired off and on, and maybe dehydrated. I work from home so I am not pushing myself. I have not felt dizzy again and am decent at taking in water now.
40 2021-04-16 headache Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within... Read more
Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within two hours
40 2021-04-16 fever, headache Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer (the patient).... Read more
Headache; Fever; Joint pain; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247), via an unspecified route of administration on arm left on 10Feb2021 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported and no known allergies.The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications in 2 weeks. The patient concomitant medications was not reported. the patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 20Jan2021 10:45 AM at single dose for COVID-19 immunization. On 10Feb2021 10:00 PM, the patient experienced headache, fever, joint pain. The patient did not receive any treatment for the events. The outcome of the events was recovered.
40 2021-04-17 dehydration Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a ... Read more
Vivid/lucid dreaming with bright lights; Vivid/lucid dreaming with bright lights; light headiness a feeling that i would pass out or die and tingling and shakimg; tingling and shaking throughout his body; tingling and shaking throughout his body; As he remained in a confused mental state; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; received bnt162b2 first dose on 10Mar2021, second dose on 24Mar2021; nocturnal panic attack with unknown trigger; Occasinally elevated blood pressure; slight markings of dehydration; hangover; This is a spontaneous report from a Contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, brand: Pfizer), second dose via an unspecified route of administration, administered in arm left on 24Mar2021 11:30 at age of 40-year-old (Lot Number: ER8733) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at Facility of Doctor's office/urgent care. Medical history included gout, anxiety, gastrooesophageal reflux disease, 'espoghutis'. The patient did not have allergies to medications, food, or other products. Concomitant medication within 2 weeks of vaccination included omeprazole; allopurinol; escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm left on 10Mar2021 11:30 at age of 40-year-old (Lot Number: En6206) at single dose for COVID-19 immunization. On 02Apr2021, the patient had vivid/lucid dreaming with bright lights and unusual feelings as he initially fell asleep. He was able to wake himself up but remained in between sleep and awake. This was accompanied by light headiness a feeling that he would pass out or die and tingling and shaking throughout his body as he remained in a confused mental state while his wife called an ambulance. In 2021, his vitals were fine with occasionally elevated blood pressure and slight markings of dehydration ( during the day following his second dose he felt like he had a bad hangover). The ER doctor thought the most likely explanation is sometime of nocturnal panic attack with unknown trigger. He had not previously sufferer anything like it. The events were reported as non-serious. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse events which included: drugs to calm, fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events light headiness, tingling and shaking throughout his body, confused mental state, nocturnal panic attack with unknown trigger, vivid/lucid dreaming with bright lights, elevated blood pressure, slight markings of dehydration, hangover were resolving. Information on lot/batch number obtained. Further information is expected.
40 2021-04-17 headache, nasal congestion Congestion, ETD, Tinnitus, Headaches
40 2021-04-18 chills Severe pain at injection site; joint pain; dizziness; nausea; chills; overall severe achiness
40 2021-04-18 fatigue Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. ... Read more
Bruising on upper back and left arm. Blurred Vision. Gastrointestinal issues. Shortness of Breath. Dizziness. Eyes being extremely sore. Fatigue. Difficulty concentrating.
40 2021-04-18 headache, fatigue, fever, influenza like illness 4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhe... Read more
4/10-1945 Caller states patient had flu like symptoms post vaccine. headache fatigue fever diarrhea Cramps. Cramps and Diarrhea has continued and is still every 15 minutes . Advised to seek medically attention diarrhea every 15 minutes for days needs medical attention . 4/11-Patient's spouse returned call, patient continues with diarrhea, not as many bouts as yesterday, started taking Immodium as directed today. Will follow up tomorrow. 4/12-Follow Up: He stated he didn't go to the urgent care he just took Pepto Bismol and Loperimide to help with diarhea (which help tremendously). As of 4/11/21 he stated all his symptoms have subsided (diarrhea, headache, etc) and feels a lot better.
40 2021-04-18 sweating, cough ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16... Read more
ER Nursing Intervention/Reassessment [Charted Location: EMR-Emergency Rm Service] [Authored: 04/16/2021 15:18]- for Visit: 004092726008, Complete, Revised, Signed in Full, General IV: IV Intervention: ? IV IV INTERVENTION/REASSESSMENT ? IV 1 Date 04/16/2021 ? IV 1 Time 14:25 ? IV IV 1 ? IV 1 Size 20G ? IV 1 Type peripheral iv ? IV 1 Inserted By inserted per RN ? IV 1 Side right ? IV 1 Right antecubital ? IV 1 Actions flushes easily labs obtained ? IV 1 Dressing needleless valve placed, catheter secured, transparent dressing applied with date/time/initials transparent semi-permeable dressing applied ? IV 1 Response pt. tolerated well pt instructed to call RN for problems ? IV 1 Total Attempts 1 COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes (1) ? Was this COVID-19 vaccine your: First dose (1) Assessment Date / Time: ? Date/Time 04/16/2021 14:25 History of Present Illness: Chief Complaint: ? History of Present Illness allergic reaction ? Onset Time/Last Seen Normal 04/16/2021 13:15 Skin Assessment: Skin Assessment: ? Skin cool diaphoretic ? Mucous Membranes moist intact COVID Screening Questions: COVID Screening Questions: ? Have you had a COVID-19 vaccine in the last 7 days? Yes ? Was this COVID-19 vaccine your: First dose ER Triage Note: ? Triage Date/Time 04/16/2021 14:21 ? Triage Chief Complaint medical, Allergic Reaction to Covid Vaccine ? Additional Triage Comments Pt states he went home after receiving his Covid Vaccine (Phizer) when he noticed he was itching on his back. Pt arrived to ED with generalized erythema, skin cool and clammy, and wheezing. Pt denies contact with chemicals or anything else. ? Have you been sexually assaulted? no ? Stroke Screening no ? Pregnant/Could be pregnant not applicable ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes ? CDC Early Warning Symptoms None Identified ? CDC Precautions standard precautions mask applied Infectious Disease: Infectious Disease: ? Have you traveled recently? No ? Do you have any of the following symptoms? none Mode of Arrival: ? Mode of Arrival private auto Height/Length - Weight for Calculation: Weight for Med Calculation: ? Height (ft) 6 Feet ? Height (remainder in inches) 0 Inch ? Height (cm) 182.8 cm ? Body Measurements stated ? Weight for Calculation (kg) 108 Kg ? Weight Method stated ? BSA (m2) 2.29 M2 ? BMI (kg/m2) 32.3 kg/m2 Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On room air ? SpO2 (%) 98 % Treatment Prior to Arrival: ? Treatment Prior to Arrival none Allergies: Allergies/Intolerances: Allergies: ?? Pfizer-BioNTech COVID-19 Vaccine: Anaphylaxis ?? tramadol: Hives Home Medications - OMR: Home Medications - OMR: * Patient Currently Takes Medications as of 04/16/2021 15:11 documented in Structured Notes ?? losartan 50 mg oral tablet: None, 1 tab(s) orally once a day, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: ?? Albuterol (Eqv-ProAir HFA) 90 mcg/inh inhalation aerosol: None, 2 puff(s) inhaled every 6 hours, Hx, Status: Active, Quantity: 0, Refills: None, Last Dose Taken: Patient Seen Time: ? Patient Seen Time 04/16/2021 14:21 ? LMP not applicable ? Tetanus <5 years ago ? Immunization up to date yes Triage Vital Signs: ? Temp (degrees F) 97.1 degrees F ? Temp (degrees C) 36.1 degrees C ? Method skin/temporal ? Heart Rate (beats/min) 118 bpm ? Respiration (breaths/min) 18 ? BP Systolic (mm Hg) 156 mm Hg ? BP Diastolic (mm Hg) 103 mm Hg ? Sitting BP right upper arm ? SpO2 Patient On Pulseox: 98 % on RA @ bedside monitor -- normal ? SpO2 (%) 98 % ? Acuity Level 3 Preferred Pain Scale: Preferred Pain Scale Numeric Pain Scale© Numeric Pain Score - Rest© 0 - No Pain Numeric Pain Score - Activity© 0 - No Pain Treatment Prior to Arrival: ? Treatment Prior to Arrival none Nursing Documentation Review: ? Triage Review I have reviewed the above Vital Signs, Nursing Documentation and Triage Assessment. Arrived From: ? Arrived From home home after leaving vaccination clinic HPI: ? HPI CC: rash/itching HPI: history from patient He describes Covid just after receiving the Pfizer vaccine, his initial dose. By the time that he returned home he had opened up a soft drink was having some slight cough, trouble swallowing and had sensation of itching on his back. He asked his mother to check his back and it was discovered that he was starting to have rash over his body. This seemed to be persistent and he returned to ER for further evaluation/treatment. He has not had reaction to vaccination in the past. He does have allergy to tramadol. He denies having any allergy to soap, detergent, or other chemicals. He denies having exposure to any chemical, fume, dust, plant material after receiving the vaccination. He denies having any new foods or drinks recently. He is not having any nausea or vomiting. He has felt somewhat sweaty. Allergy: tramadol H/O LE muscle weakness/atrophy , COPD ROS Const: No fever, chills, sweats. No unusual weakness (he does note "my leg is atrophying" when he is speaking about his LLE) HEENT: No runny nose, congestion, ear ache. Perhaps some odd sensation in the throat due to swollen uvula. CV: No chest pain, palpitations. No unusual shortness of breath. No edema to the ankles / legs. No pain with breathing. Abdom: No nausea, vomiting, diarrhea, or constipation. No abdominal pain. Lymph: No swelling to glands. Physical Exam: ? Physcial Exam A&O, nontoxic. Pleasant. No pain distress. Mild physiologic distress. Appears to be overwt adult with component of chronic illness and with acute allergic reaction/process_. Eyes: EOMI, nonicteric, conjunctiva clear. Throat: Moist mucous membranes. Symmetric rise of palate. No pharynx erythema. Tonsils normal size and without erythema or exudate. His uvula is moderately edematous and elongated. He is managing his secretions well. There is no angioedema of the tongue, soft palate, lips. No stridor. No blood in the oropharynx. No rhinitis/runny nose. Neck: supple, normal ROM, nontender. trachea midline. No cervical or supraclavicular lymphadopathy. Thyroid nontender and normal size. Back: No pain on percussion. No muscle spasm. Nontender palpation. No kyphosis. Lungs: fair to good air movement with quiet, fine primarily inspiratory wheezes in the mid to lower lung fields. nl effort, no rales, crackles, rhonchi. Normal resonance on percussion. Cough clear. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, Pedal pulses 2/4 bilaterally. No ankle or pretibial edema. Skin: cool & dry extermities. cool & moist (not diaphoretic) back skin. Normal turgor. He does have confluent macular rash to the neck, (somewhat on face), arms, back/chest/abdomen. Some mild hyperemia to the legs/ankles. No urticaria. The right deltoid injection site is involved with the hyperemia/macular rash but no urticaria at this location right now Abdom: Bowel sounds present x 4 Quadrants. Normal tympany to percussion. Soft. Non-distended. Nontender. Nonsurgical. Good muscle tone and moves all extremities. He notes he has his chronic weakness in his left lower extremity. Medical Decision Making: ? Discussed with another healthcare provider Discussed case with another healthcare provider ? Consultation Consultation 1, Consultation 2 ? Consultation 1 04/16/2021 15:54 ? Consultation 1 Comments discussed with RPh. He will come to ER to obtain additional information from patient. This is the hospital's first presumptive Pfizer vaccine reaction. ? Consultation 2 04/16/2021 15:41 ? Consultation 2 Comments discussed with Dr. we discuss presentation. he agrees pt will need monitoring with the persisting symptom/findings and the H/O COPD. 1617 Dr has been to ER and completed eval. pt to be placed on 2nd floor med/tele for additional monitoring and treatment. pt did have labs yesterday. ? Decision to Admit Based On 1446 Based on his symptoms and presentation presumptive acute anaphylaxis to component of the Pfizer Covid vaccine. We will begin treatment with 0.3 mg epinephrine IM once as well as dexamethasone, famotidine, diphenhydramine IV. We will continue to monitor with cardiac telemetry and pulse oximetry. He does have slight wheezing but this may be related to his chronic COPD. No respiratory distress at this time, but his symptoms seem to have been mildly progressive over the past hour (per his report). I believe inclusion of the epi to be prudent based on his presentation. Additionally, I will inform the vaccination clinic of this reaction. he agrees pt will benefit from continued monitoring and repeated IV antihistamine and IV steroid treatment. Pt will need IVFluid for hydration as well. Recheck: ? Recheck Recheck 1, Recheck 2, Recheck 3 ? Time 14:55 ? Recheck patient stable patient improving with treatment ? Comments He is improving. His skin is now warm and moist (not sweatty , not diaphoretic). The rash is receeding from the arms. Good coloration to the legs/ankles. Back & torso rash starting to recede. no nausea/vomiting. no difficulty breathing. still with fading macular rash on the torso and upper back. Lungs: improved air movement compared to the initial exam, nl effort, no rales, crackles, rhonchi. He has lower field (only) quiet fine inspiratory wheezes. Normal resonance on percussion. Cough mildly wheeze @ bases, with improved airflow. Cardiac: borderline tachy RRR S1, S2, without murmur or rub. Posterior tibial, pedal pulses 2/4 bilaterally. No ankle or pretibial edema. ? Time #2 15:05 ? Recheck #2 patient stable patient improving with treatment ? Comments #2 man from pharmacy is here and recognizes patient from the vaccination clinic. Patient rash has faded from his extremities fully and appears to have faded from his abdomen still somewhat at the malar area of the cheeks as well as the neck and torso portion of the chest. His pulse is 98?99 continues to have elevated blood pressure. Pulse oximetry 98-100% on room air, normal. Pharmacist will enter the reaction into the CDC/FDA/Pfizer database. Overall pt notes he feels tired (probably related to hydration & benadryl). He notes he has returned to home about 2 weeks ago after spending some time on the road in mountains playing guitar / touring with a small band , playing music. ? Time #3 15:37 ? Recheck #3 patient stable ? Comments #3 He has been resting. No respiratory distress. His blood pressure and pulse and pulse oximetry are reviewed at bedside and they are nonfocal at this time. Overall he is improving. He notes he still has malaise and feels about the same with itching in his back and the sensation in his throat. When I evaluate his back there is hyperemia/some macular rash that is in approximately the distribution of the trapezius muscle of the back this is where he notes he has the itching. Additionally when I evaluate his throat there is still some presence of uvula edema. There is no other angioedema. Perhaps he does have some mild hyperemia to the uvula and soft palate at this time. He is clinically improving but his symptoms have not resolved fully. Skin warm and dry normal turgor. No diaphoresis Lungs initially some coarseness/mucousy breath sounds to the mid lower fields but this clears after he coughs. Good air exchange at this time. No rales rhonchi wheezes or crackles. Cough initially mucousy then clear. managing secretions well. no stridor. no respiratory distress. Critical Care Times: ? Critical Care Time of minutes excluding, separately billable procedures 35 Disposition Summary: Arrival 04/16/2021 14:21 Disposition to be admitted Disposition Decision Date/Time 04/16/2021 15:54 Does an Emergency Medical Condition Exist at the time of D/C? yes Condition at Disposition Stable Alert and Oriented Guarded Emergency Diagnosis: ?? History of COPD (Z87.09): Entered Date: 04/16/2021 15:59, ICD-10: Z87.09 ?? Anaphylaxis due to immunization (T80.52XA): Entered Date: 04/16/2021 15:59, ICD-10: T80.52XA ?? Drug reaction, initial encounter (T50.905A): Entered Date: 04/16/2021 15:59, ICD-10: T50.905A PCP Summary: ? PCP , ? Select Follow-up Physician Follow Up Physician #1 Follow Up Physician #2 ? Follow-Up MD ? Group Name Primary Care ? Specialty ? Follow-Up MD ? Fax Number ? Follow Up In 04 days Instructions: ? Other Instructions Return to ER for worsening symptoms or other concerns ? Additional Instructions Patient has had clinical improvement and stabilization although he is not fully resolved of his symptoms. He is placed into the hospital for further evaluation and management under Dr. Note Complete: Note Complete This document is complete. Affix my electronic signature. Last Updated: 04/16/2021 16:19 by (MD) References: 1. Data Referenced From "ER MD Exam and Disposition" 04/04/2021 17:40 2. Data Referenced From "1. Vital Signs - Adult" 04/16/2021 14:30
40 2021-04-19 sweating "Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweat... Read more
"Administered - 4/19, time unknown Adverse event started - 10:06 Patient had syncope, flushing/sweating. BP 109/53 -- > 114/55, HR 68 -- >64, RR 16 -- >16 , O2 100% -- > 99%, Temp 97.3F. Given PO juice, Graham crackers. Patient stable, released from vaccination site."
40 2021-04-20 cough PT reports chest pain & being dizzy. (More profound then 1st shot) Checked out. High BP. Abnormal ... Read more
PT reports chest pain & being dizzy. (More profound then 1st shot) Checked out. High BP. Abnormal EKG. Persistent cough present. IV administered on right ac. Transported to Hospital.
40 2021-04-20 fatigue, headache Nausea, headache, and fatigue. All side effects gradually disappeared after 24 hrs.
40 2021-04-20 headache, chills Noticeable headache, body aches, uncontrollable chills, rapid heart beat, some nausea.
40 2021-04-20 sweating I was called to see the patient in the vaccine area. He had a mild to moderate vasovagal episode pri... Read more
I was called to see the patient in the vaccine area. He had a mild to moderate vasovagal episode prior to his vaccine without syncope. He was dizzy, diaphoretic, and pale. He was repositioned and orally hydrated. Mild to moderate vasovagal episode without syncope. This was resolved with hydration and repositioning. He was returned home at baseline with a partner as the driver.
40 2021-04-21 chills, fever, headache, sweating Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had... Read more
Ii got he vaccinator on 3/5 and went home. the first night around 9p, I started to feel chills, Had a really big temporal headache. I thought it was a reaction to vaccination, I took Tylenol PM, layer down and woke up in the middle of the night, in a full body sweat. I went strait into chills, changed my clothes. Layed back own and awoke the next morning, with chills and temp of 101. I had body ache but proceeded with my day. I continued to have chills, I went out to my elderly parents, took them food and had dinner. Upon arrival home, had high fever 103...no Tylenol. Awoke still w/ chills and high fever and this was Sunday. Stayed in Sunday then the afternoon, felt like I needed to seek help. I went to get a rapid test at Medical Center and it came back Neg. Went back home, I could now sense that my taste was altered. I then continued to have a high fever but they would only come at night. Body sweat, aches, chills cont'd on Sunday. Monday still had same s/s and Tuesday, I thought that I should seek more medical attention. I went to an Urgent Care 3/9/21. They then did a nose swab and felt that it would come back Neg. I went home and on Thursday 3/11/2021 I got a call that I was positive. Did isolate. But from 3/5 to 3/11 then I lost taste/smell. Came out of isolation 3/20 and on 3/21 my whole left side of fact, shoulder and leg went numb for approx 1hr. Then my wife said that I was talking a little slow in my response. Next morning my left shoulder was hurting and I had pain. The Urgent care provider wanted to r/o TIA so he sent me to ER for full work up and that doctor said he saw nothing. He didi say that it could be Covid related and/or possible TIA. "I am feeling good today" There is no residual but because of the left shoulder pain I did go back to Urgent Care. Got cortisone inject and MRI. My PCP then told me that I had a partial "tear" in my left shoulder but I do exercise every day and could have done it then.
40 2021-04-22 lethargy, fatigue, headache, chills Tinnitus within the hour of shot. Ringing continues in ears indefinitely. Other symptoms that went a... Read more
Tinnitus within the hour of shot. Ringing continues in ears indefinitely. Other symptoms that went away within 48 hours were fatigue, cold chills, lethargy, and head ache.
40 2021-04-23 chills After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well ... Read more
After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine
40 2021-04-23 fatigue, headache Fatigue, body aches, brain fog, loss of muscle tone and headache.
40 2021-04-24 fatigue Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report ... Read more
Irritable; was fatigued; Patient has tenderness at the injection site; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 first dose on 30Mar2021 17:15 (Age at vaccination was 40 Years old) on left arm at single dose for COVID-19 immunization. Medical history included Pencillin Allergy. Concomitant medications in two weeks included SSRI. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has tenderness at the injection site, and was fatigued and irritable beginning approximately 24 hours after vaccination (31Mar202105:00 PM). Symptoms lasted for approximately 12 hours. At the end of that 12 hour period all symptoms ceased. The outcome of the events was recovered in 2021. No treatment for the events. No covid tested post vaccination. No follow up attempts are possible. Information on lot/batch number cannot be obtained.
40 2021-04-24 headache, chills, fatigue Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the n... Read more
Temporary symptoms include headache (gone the next day), sore arm (lasted a few days), chills (the next day only), and tiredness (for a couple days). However, I have experienced tinnitus starting the evening of injection, and it hasn't disappeared or even dampened since.
40 2021-04-24 headache, throat pain, chills, productive cough, fatigue, body temperature increased, malaise, fever deep phlegmy cough/ the phlegm is now green; deep phlegmy cough/ the phlegm is now green; sore throa... Read more
deep phlegmy cough/ the phlegm is now green; deep phlegmy cough/ the phlegm is now green; sore throat; a fever ranging from 100-102; Severe chills; headache; tired; feeling lousy; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 30Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 31Mar2021, the patient experienced a fever ranging from 100-102 F (fever lasting more than a week), severe chills, and headache. In Mar2021, the patient was tired and feeling lousy. On 02Apr2021, the patient developed deep phlegmy cough/ the phlegm was now green, and sore throat. There was no emergency room or physician office visit. Treatment for the events fever, headache, sore throat, tired and feeling lousy included acetaminophen (TYLENOL). There was no treatment for the events chills and phlegmy cough/phlegm was now green. The outcome of the events fever, chills, deep phlegmy cough/phlegm was now green, and sore throat was not recovered. The outcome of the event headache was recovered on 03Apr2021. The outcome of the events tired and feeling lousy was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
40 2021-04-24 influenza like illness Multiple nosebleeds flu like body aches. The multiple nosebleeds were the most concerning and unusua... Read more
Multiple nosebleeds flu like body aches. The multiple nosebleeds were the most concerning and unusual
40 2021-04-24 fever Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - I... Read more
Fever - Unverified by Medical Treatment Facility Dizziness Sitting & Standing Vomiting Psychosis - Inability to Communicate Properly Major Anxiety Allergic Reaction - Unverified by Hospital CT - Scan Not Performed Psychological Evaluation Not Performed
40 2021-04-25 headache, fatigue, fever Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after inj... Read more
Sore arm. Headache, dizziness, fever (treated with Tylenol), fatigue. Sore arm a few hours after injection worsening the next day (not treated). Headache starting about 8am the next morning. Fever starting about 9am. Did not slow down or rest all day. Performed mentally challenging tasks. Drank plenty of fluids. Fatigue hit hard about 8pm.
40 2021-04-25 fever Night of injection pt developed a low grade fever of 101.0. By monday 4/19/21 patient had a rash on ... Read more
Night of injection pt developed a low grade fever of 101.0. By monday 4/19/21 patient had a rash on his arms and torso. it then spread to his legs. Rash began as pink and very itch. It has since become a darker pink and continues to itch.
40 2021-04-26 fatigue, body temperature increased, chills, headache Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to ... Read more
Hit by a train (figuratively), Sore Arm, High Fever (102.1), Vomiting, Diarrhea, Headache, Close to fainting, Shake, Chills, Loss of Appetite (didn't eat for 10 days), Fatigue. Symptoms were intense for 2 days, then were mild for 2 days.
40 2021-04-26 headache, sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small ga... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Fell from chair and hit head on floor - small gash on bridge of nose-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: Within 5 minutes of vaccination, pt fell from sitting position in chair to the ground. Pt hit his head and had small gash on bridge of nose. When I got to him, his eyes openned and he knew what happenned. Called 911. He laid on ground while we had NP check blood pressure, pulse, and O2 levels. Pt was stable and walked out with EMS to be checked out.
40 2021-04-26 headache C/O HA "Like I ate Ice Cream" Requested BP check. "Nothing is wrong"
40 2021-04-26 sweating Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/2... Read more
Patient DOB: 11/18/1980. Received his first dose Pfizer (LOT#: EW0179 EXP: 8/2021) at 1108 on 4/27/21. Patient alerted EMT. Patient stated that she was sweating a lot and felt like his vision went blurry/dark for about 3 minutes. Patient stated that he also felt nervous. EMT alerted PHN. PHN suggested to move patient to zero gravity chair. Patient walked with assistance from EMT to gravity chair. Patient walked over and sat down safely on gravity chair. EMT took patients vital signs. BP: 118/60, pulse: 65, O2: 97%. Patient was given water. PHN recommended that patient stay an extra 30 minutes. Patient agreed. EMT re-assessed patient. Patient stated that he was feeling a lot better and that his vision was completely fine now. Patient left vaccination site unassisted and with a steady gait at 1150.
40 2021-04-27 chills, fever Tactile fever, chills, injection site pain. Feeling better after taking Acetaminophen.
40 2021-04-27 headache constant headaches starting the day after shot was administered; This is a spontaneous report receiv... Read more
constant headaches starting the day after shot was administered; This is a spontaneous report received from a contactable consumer, the patient. This 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 18:30 (at the age of 40-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. Medical history included a head cold the week prior to the vaccination (Mar2021). Concomitant medications included pantoprazole and escitalopram. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 14:00, the patient experienced constant headaches starting the day after shot was administered. No treatment was received for the adverse event. The clinical outcome of the "constant headaches" was not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
40 2021-04-27 headache 2nd, NOTE; Caller Stated the 1st shot he developed a HA 4pm ( 1pm had shot) Called asking what to ... Read more
2nd, NOTE; Caller Stated the 1st shot he developed a HA 4pm ( 1pm had shot) Called asking what to do for the signs and symptoms. PC advised treat symptoms with OTC Medications, Consult His Local Pharmacy and or PCP. Call back PRN
40 2021-04-27 fever, headache, chills Fever (approx. 100 F); Chills; Body aches; Headache; This is a spontaneous report from a contactable... Read more
Fever (approx. 100 F); Chills; Body aches; Headache; This is a spontaneous report from a contactable 40-year-old male consumer (patient) reporting for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration into the left arm on 11Feb2021 09:30 AM (at the age of 40-year-old) as single dose for COVID-19 immunization. No allergies to medications, food, or other products. Concomitant medications included melatonin (1.5 mg/day). The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration into the left arm on 21Jan2021 09:30 AM. The patient medical history was not reported. On 11Feb2021 at about 06:00 PM, the patient had fever (approx. 100 F), chills, body aches, headache which persisted for around 36 hours after the second dose of Covid vaccine. No treatment was received for the adverse events. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19 nor has the patient been tested since the vaccination. On an unspecified date in Feb2021, the outcome was recovered for all the events. Follow-up attempts are completed. No further information is expected.
40 2021-04-27 sinus congestion, sweating, headache, cough, chills, fever, fatigue 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade... Read more
4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
40 2021-04-28 fatigue Fatigue on 2nd day and 9 days later still have Covid arm (dull pain) in right upper arm and deltoids
40 2021-04-28 sweating Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod adminis... Read more
Pt was vaccinated with Pfizer brand of covid vaccine given intramuscular at his left deltiod administered by LVN today 04/29/21 at 3:36 pm. At 03:48 pm I, RN (EOA) noticed pt was pale and diaphoretic, came near to pt and asked how he is doing pt verbalized he is okay, when I was about to move out he eventually stated that he is dizzy and nauseous. I took initial set of vitals at 03:49 pm BP 100/60mmhg, PR 60 bpm, RR20 cpm, Temp 96.1F, Spo2 98% at room air. I called for admin assistance from admin assisted me in monitoring the patient together with another RN. Pt was given water and felt relieved. Ice packs was placed on pt's nape and made him relaxed. Pt had no complaints of chest pain and SOB. Pt had no history of DM, no HTN, no known allergies and had not gotten any flu shot for long time. Pt also verbalized that he hadnt slept well for the past 2 days related to job adjustment and hadnt eaten since yesterday that might have contributed to his complaints of dizziness Reapeat set of vitals were taken at 3:58 pm BP 100/80, PR 64 bpm, RR 18 cpm, SPO2 99% at room air. Pt stated he is back to normal and no more complaints of dizziness or nausea. Pt refused to call 911 as well. at 4:06 pm latest BP 126/88 mmhg. At 4:20 pm pt was assisted by me RN to his car with resolved dizziness and nausea. Pt was advised to have an appointment with primary physician for wellness check and health teaching was given related to side effects of vaccine and when to contact 911. Pt verbalized understanding and is appreciative of the care provided.
40 2021-04-28 sweating Dizziness, pallor, sweating. BPs 74/52 (pulse 128), 118/77 (pulse 87). Given water, orange juice, an... Read more
Dizziness, pallor, sweating. BPs 74/52 (pulse 128), 118/77 (pulse 87). Given water, orange juice, and crackers.
40 2021-04-29 influenza like illness, fever, headache Flu like symptoms Extreme aches and pain full body Headache Fever
40 2021-04-30 fatigue Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, li... Read more
Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, lightheadedness, nausea, joint pains
40 2021-04-30 headache, fatigue Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) app... Read more
Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.
40 2021-04-30 headache Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; L... Read more
Mild headache; overall body soreness, worse in left arm; overall body soreness, worse in left arm; Lack of energy; This is a spontaneous report received from a contactable consumer. A 40-year-old male received received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number EP6955 and expiry date was not reported) via an unspecified route of administration, in the left arm, on 14Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medications included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient had previously received first dose of vaccine on 24Mar2021 at 14:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination included tadalafil, allium sativum bulb (GARLIC EXTRACT), fish oil, colecalciferol (VITAMIN D3) and multi vitamin. Patient did not have covid prior vaccination. Patient did not test covid, post vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. On 15Apr2021 at 09:00, patient experienced mild headache, overall body soreness, worse in left arm and lack of energy. The events were considered non serious. No treatment was received. The outcome of events was recovering. Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer (patient) reported in response to a letter sent which included that: No new information received. No follow-up attempts are needed. No further information is expected.
40 2021-05-01 fatigue Nausea Foggy brain Fatigue
40 2021-05-01 headache, sweating Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was ... Read more
Hit quickly and strongly. Dizziness, nausea, waves of hot and cold, with profuse sweating. This was followed a couple of hours later by body aches, alternate hot and cold spells and headache. Injection site was sore, which started the previous day. Massive headaches from 4/9 to 4/11. NSAIDs somewhat helped symptoms. Began feeling human on 4/12. Was like a bad influenza, but no one else in household had any symptoms subsequently, so assume it was the vaccination.
40 2021-05-02 chills, fever Fever and chills that lasted for four hours, from 2AM the following night until 6AM. Soreness in th... Read more
Fever and chills that lasted for four hours, from 2AM the following night until 6AM. Soreness in the shoulder and upper arm.
40 2021-05-02 fatigue, headache, malaise, fever patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diar... Read more
patient experienced onset of fevers, headache, neck pain, generalized malaise/fatigue/weakness, diarrhea/abd pain, with 2 ED visits ultimately admitted to hospital and diagnosed with MIS-A with elevated bnp, troponin, and inflammatory markers, and treated with dex 6mg x 10 days with complete resolution on follow-up.
40 2021-05-02 sweating Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; n... Read more
Awakened at 2 am 5/1/21 with acute onset of chest pain, SOB, and diaphoresis. No cardiac history; no history of similar episode. Reported that, following his second dose of COVID vaccine, he was ill for 1 day with vomiting. Chest pain continued upon arrival to ER 5/1/21 about 7 am. EKG indicated STEMI. Adm with Acute ST elevation myocardial infarction.
40 2021-05-03 chills, headache, fatigue, cough, nasal congestion, fever, runny nose Fever or Chills Cough Fatigue Muscle or body aches Headache Congestion or running nose
40 2021-05-03 fatigue One day after vaccination, Fatigue. 10 days after vaccine, shortness of breath and pain while breat... Read more
One day after vaccination, Fatigue. 10 days after vaccine, shortness of breath and pain while breathing. This happened both times with both shots. Fatigue the day after, shortness of breath/pain breathing on day 10 lasting 3-4 days.
40 2021-05-04 cough, nasopharyngitis, nasal congestion, fever have cold symptoms; Cough; Fever; Stuffiness/Congestion; This is a spontaneous report from a contact... Read more
have cold symptoms; Cough; Fever; Stuffiness/Congestion; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 15:00 (at the age of 40-years) as single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included jardiance, atorvastatin, unspecified vitamins and some unspecified prebiotics. On 28Jan2021, the patient had cold symptoms, cough, stuffiness/congestion and fever. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
40 2021-05-04 fatigue Severe cramping, diarrhea, vomiting, fatigue like I have never experienced before. This should not b... Read more
Severe cramping, diarrhea, vomiting, fatigue like I have never experienced before. This should not be injected into humans
40 2021-05-04 headache, fatigue Fatigue. Severe headache, frequent migraine
40 2021-05-04 sweating Pt was given the 1st Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol... Read more
Pt was given the 1st Pfizer Covid 19 shot and asked to sit in the lobby for 15 minutes per protocol. After 10-15 minutes, he came to the pharmacy counter stating he felt hot and sweaty. His eyes then rolled backwards and he collapsed on to the floor. He was unresponsive, his head and back arched and he slightly rocked while on the ground. I went to make sure he didn't hit his head and patient became responsive. We tried to have pt stay on the ground, but he refused. Therefore we moved him to a chair and elevated his legs. 911 and store medical assistance were called. After the ER services arrived and examined pt, left on his own and stated he felt fine now.
40 2021-05-05 chills The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both ca... Read more
The morning after the vaccine, I began experiencing chills, injection site pain, and pain in both calves. The chills and injection site pain went away within a couple of days, but the pain in both calves did not go away and continues to the present. It has not affected by ability to walk, but I continue to experience pain, as well as some throbbing and tingling in both calves. There has also been occasionally tingling I my feet. After extensive consultation with several doctors, and a variety of tests, it is suspected that this is a small fiber neuropathy that was caused by the vaccine.
40 2021-05-05 headache, fatigue, chills, fever, malaise ? tiredness ? headache ? muscle pain ? chills ? joint pain ? fever ? nausea ? feeling unwell
40 2021-05-06 fatigue, lethargy Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Se... Read more
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: vivid dreams-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Mild, Additional Details: general feeling of increased inflammation of joint pain
40 2021-05-06 headache Swelling of lymph node, headaches.
40 2021-05-06 headache Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on... Read more
Employee presents today after receiving his second pfizer covid vaccine. Pt. received 1st vaccine on 4/2/21 and 2nd vaccine on 5/7/21 around 1500 pm today. Pt. received 2nd vaccine in left arm. Symptoms started twelve minutes in 1522 pm and in cluded: headache, back of shoulders feel "super tight", soreness to the back of neck, and headache is b etween patient's eyes as well as blurry vision. Pt. states that his shoulder pain is 10/10 and headache is an 8/10 Pt. denies shortness of breath, denies chest pain, denies trouble breathing. Pt. denies numbness, d enies tingling. Instructed patient to go to the Urgent care for evaluation.
40 2021-05-07 sleepiness Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was ad... Read more
Phizer shot 1 of 2 in the left arm on Thursday 5/6. I arrived home 45 minutes after the shot was administered and went to the bedroom as my heart rate continued increasing until it was racing non-stop. As my rate increased, so did my breathing until it became rapid and shallow. It is difficult to describe how fast my heart was beating. The rapid heart rate and shallow breathing reminded me of how my breathing changed when I summited a 5800-meter volcano and there was insufficient oxygen near the peak. As my pulse increased I became weak and fell asleep, or fell unconscious. I awoke at 11:00 PM and my breathing was normal however my heart continued racing for an additional hour until midnight. I have experienced no other side effects except heart rate and breathing.
40 2021-05-08 fever, fatigue Body aches 8 hours Fatigue 4 days Fever blisters on lip ongoing
40 2021-05-09 fatigue, headache Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a conc... Read more
Fatigue, nausea, dizzyness, headache, difficulty concentrating, generally feeling like I have a concussion
40 2021-05-09 headache, chills, fatigue Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and wo... Read more
Chills, dizziness, vax fog (confusion, disorientation), fatigue, headaches. Took a 3 hour nap and woke up with just a headache, which went away in the evening.
40 2021-05-09 fever, chills Within 12 hours, I started to feel achy, and soon after I felt the chills, and had a small fever. T... Read more
Within 12 hours, I started to feel achy, and soon after I felt the chills, and had a small fever. The achiness and fever continued for 36 hours before the symptoms stopped.
40 2021-05-09 fever I was vaccinated on Friday 5/7/2021. I got a low fever on the same night and the day after. On Sunda... Read more
I was vaccinated on Friday 5/7/2021. I got a low fever on the same night and the day after. On Sunday morning 5/9/2021, I feel my inner lap parts are itchy. During the day, I found some rashes here and there over my body. Some rashes are swelling bumps. They are itches. I found my head skin under my hairs are itchy too. It was getting worse throughout the whole day.
40 2021-05-10 cough, nasal congestion COVID-19 virus detected Exposure to viral disease Cough Nasal congestion
40 2021-05-11 chills, headache Severe nausea and vomiting. Headaches. Fever, chills. Widespread body aches (extremely tenderness a... Read more
Severe nausea and vomiting. Headaches. Fever, chills. Widespread body aches (extremely tenderness and soreness).
40 2021-05-11 fatigue, chills, headache Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put o... Read more
Body aches, severe chills/shaking, mild to moderate headache, sleeplessness. I took Advil and put on pants, a sweatshirt, a a beanie and got underneath 3 blankets (for the chills). I fell asleep about 2 hours later. Now, it is 11:23 am on 5/12/2021 and I still feel moderate to severe fatigue, mild chills and my headache is gone. My head does feel a bit foggy though. I took Advil again at 6:45 am. At noon, I'm going to take Aspirin.
40 2021-05-11 headache, fever Pt had 102 Fever with joint aches, nausea and headache severe enough to keep him in bed for 3-4 days
40 2021-05-11 sweating Pt presents w/Dizziness & sweats, AOx4, VS@ 1025 BP 105/41, HR 60, RR 20 O2Sat 98%; VS @1035 BP 141/... Read more
Pt presents w/Dizziness & sweats, AOx4, VS@ 1025 BP 105/41, HR 60, RR 20 O2Sat 98%; VS @1035 BP 141/67, HR 59, RR 20, O2 sat 98%. Provider concerned about orthostatic hypotension, pt called friend to be taken to urgent care
40 2021-05-12 chills, headache Severe Chills; Mild nausea; achy muscles; Severe headache; This is a spontaneous report from a conta... Read more
Severe Chills; Mild nausea; achy muscles; Severe headache; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 10Feb2021 11:30, at 40 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 20Jan2021 at 11:30 AM in left arm. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 21:15 the patient experienced sever chills, mild nausea, achy muscles and severe headache. No treatment was administered. The reported events were resolving at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-05-12 chills, fever, fatigue Fever over 100.3. Chills, Aches, Fatigue, Injection site pain.
40 2021-05-12 malaise not feeling well
40 2021-05-12 fever Mild fever of up to ~101.5F, felt better after 12-18 hours.
40 2021-05-14 fatigue, fever, chills Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks. Have not repor... Read more
Nausea, vomiting, severe fatigue, fever, chills, weakness ongoing for over 2 weeks. Have not reported to doctor because I felt ok before I got the vaccine and I can?t miss work. The first dose didn?t make me feel sick.
40 2021-05-14 fatigue Muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 40-yea... Read more
Muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:45 (Batch/Lot Number: EL3247), age at vaccination of 40-years-old, as single dose, for covid-19 immunisation. Medical history was none; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 12:45 (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient had not received other vaccine in four weeks. The patient experienced muscle aches and fatigue on 13Feb2021 at 05:45 AM (around 16 hours after injection of the second dose). No treatment was administered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021. The patient was not tested for covid prior vaccination. Muscle aches started to feel better as the day progressed. The patient was considered to be recovering from the events.
40 2021-05-16 chills, fever Pt reports approx. 7 days post 2nd dose he developed fever of 101 F and chills. Pt reports the took ... Read more
Pt reports approx. 7 days post 2nd dose he developed fever of 101 F and chills. Pt reports the took Tylenol 3x q5-6 hours yesterday only, this broke his fever.
40 2021-05-17 fatigue, cough HCP indicated tracheitis; Less of a passageway; Fair amount of coughing/Dry cough; Swelling in the n... Read more
HCP indicated tracheitis; Less of a passageway; Fair amount of coughing/Dry cough; Swelling in the neck area; Fatigue; Is there any correlation between the delated anaphylaxis and ingredient?; Throat tightening with difficulty breathing; Throat tightening with difficulty breathing; This is a spontaneous report received from a contactable consumer (reported for himself). A 40-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0164) administered in left deltoid via an unknown route of administration on 16Apr2021 at 12:50 pm as 1st dose single for COVID-19 immunization. It was reported that that he received the vaccine in his left arm, the bicep muscle, or above the bicep. He states the muscle on the shoulder area. Patient states that asthma was in the lungs and chest. He has had mild intermittent asthma and gets it 4 times a year. There was no prior Vaccinations, no adverse events within 4 weeks. Medical history included asthma (patient was diagnosed 30 years ago), allergic to shellfish. The patient's concomitant medications were not reported. On 16Apr2021 patient experienced is there any correlation between the delated anaphylaxis and ingredient, throat tightening with difficulty breathing (Throat tightness and dyspnea), less of a passageway, fair amount of coughing/dry cough swelling in the neck area and fatigue. On 19Apr2021 at 10:15 HCP indicated tracheitis. The patient states that he got the vaccine on 16Apr2021 at 12:50 pm and isn't sure exactly when the swelling started because he got a little fatigued. Patient states that it was about 3-5 hours after and at a certain point he noticed it. It was reported that a half an hour to an hour later patient throat started to tighten, it gets triggered by certain stimuli, steam and vocalization, and rubbing the area. patient states that he could reproduce the issue if he rubs the area, the frequency has decreased, and in that case, it has improved. It was reported that patient was diagnosed with tracheitis on 19Apr2021 at 10:15 and it was still ongoing, or the effects of it are. Patient states that what he feels in the front of his throat near the trachea and up a little further was inflammation. Patient gets the symptoms of the tightening of the throat, and it is inflamed there is less area to breath. Patient states that his understanding of the tightening of the throat and dry cough are all symptoms of the tracheitis. It was reported that the first symptom experienced after the injection (at least 2-3 -4 hours), patient had fatigue first then probably a half an hour to an hour later the swelling started. patient believes the fatigue has gone away, but not 100 percent sure. patient states that there are times he has felt fatigue and is not 100 percent of the cause. patient states that if he does feel fatigue, he assumes it because of the tracheitis. patient states that these events happen when he needs to get area in his throat, and it might cause the fatigue. patient states that the coughing is parallel with the throat tightening, when he wants to open his airway or pass way the coughing seems to occur. Patient states he gets relief or a more open passageway and the coughing reflex or coughing bouts are less, when he gets the tightness of the throat or the inflammation he sort of goes into coughing. The outcome of the event for hcp indicated tracheitis was not recovered and unknown for the other events, whereas the outcome of the event fatigue was recovered. Follow up were needed, further information has been requested. 07May2021: Follow-up spontaneous report received from a contactable consumer. No new information was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524696 Pfizer
40 2021-05-17 fatigue, headache Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb als... Read more
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling. Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor. Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
40 2021-05-18 cough Cough; muscle or body aches.
40 2021-05-18 sweating After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", swe... Read more
After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", sweating hands and face, racing heart rate. Called 911. After EMT arrived, and checked patient for any issues. From EMT, patient had known history of "fear of needles" and had anxiety attack after the vaccine. After about 20 minutes, patient was stabled and got release by EMT.
40 2021-05-19 fatigue, headache Headache, dizziness, fatigue.
40 2021-05-20 headache, fatigue Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain i... Read more
Severe nausea and vomiting for an entire day. Could not keep any fluids down. Severe burning pain in muscles all throughout the body for 3 days. Severe muscle spasms and cramps all throughout the body. Could not stand or walk for 12 hours. Severe burning sensation on the skin all over the body, felt like a sunburn. Severe headache for 3 days. Minor muscle spasms for an additional 5 days after the severe ones diminished. Moderate fatigue for 10 days. Had tested positive for COVID 4 months prior to being vaccinated, but only had minor symptoms for 2 days.
40 2021-05-21 chills, headache, sweating, fever Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the o... Read more
Shortly after I received the shot, I had minor soreness in the spot of the injection. This was the only symptom for about 12 hours. At the twelve hour mark, about, I almost immediately started shivering uncontrollably. I was very cold ad sweating. I wasnt able to think clearly. My wife said I had a fever. Also, I had a headache. This occurred for about 6 hours. I was still cold and sweating, with a headache, for about another 4 hours, but it wasn't as extreme. I was still unable to think well. I had a desire to drink gatorade, not water, at this time. This was unusual. I drank about 2L of gatorade. I began to not feel cold, and only had a minor fever. Not sure how correlated these are. Over the next 10hrs or so, I slowly improved and was able to carryon daily activities.
40 2021-05-21 headache, fatigue Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cel... Read more
Allergic reaction; Allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis); itching; Heavy fatigue; vomiting; diarrhea; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03May2021 at 08:45 AM (Batch/Lot Number: EW0173) at the age of 40-years-old as 2nd dose, single for COVID-19 immunization at a pharmacy or drug store. The patient had no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included complex regional pain syndrome (CRPS) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lamotrigine (LAMICTAL); both taken for unspecified indications, start and stop dates were not reported (received within 2 weeks of vaccination). The patient previously received the first dose of BNT162B2 (Lot number: ER8729) on 15Apr2021 at 02:15 PM in the left arm for COVID-19 immunization. On 03May2021 at 11:00 AM, the patient experienced allergic reaction that developed into a bacterial infection of the lower leg (Cellulitis). There was extreme pain and burning in addition to itching, and the patient also experienced heavy fatigue, vomiting, diarrhea, and headache. The events resulted in doctor or other healthcare professional office/clinic visit and also emergency room/department or urgent care. The patient was treated with antibiotics for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
40 2021-05-22 cough Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.
40 2021-05-23 nasal congestion In the face sensation in my mouth like anesthesia from a dentist difficult to breathe my nose was co... Read more
In the face sensation in my mouth like anesthesia from a dentist difficult to breathe my nose was completely stuffed up I had to go to the emergency room.
40 2021-05-24 headache Blook Glock in the brain cause severe headache
40 2021-05-25 sweating Vasovagal. Patient diaphoretic with decreased responsiveness. Resolved on own. Water and juice given... Read more
Vasovagal. Patient diaphoretic with decreased responsiveness. Resolved on own. Water and juice given. Normal vitals. Observed for 30 minutes and asymptomatic when released. Declined EMS
40 2021-05-26 fatigue, fever, cough SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccinati... Read more
SOB, Fever, fatigue, cough Hypoxia, tachycardia, HTN Admitted 5 days after the 2nd dose of vaccination Dx: Myocarditis and Pneumonitis RX: steroid, Diuretic
40 2021-05-26 head discomfort, headache 50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after... Read more
50% loss of vision; Tingling on one side of body; Experienced Transient Ischemic Attack 1 week after vaccine 2nd dose (April 27, 2021).; Strong pressure in head; loss of ability to support body in RL; Slurred speech; Difficulty in breathing; Cognitive difficulties; Extreme headache; This is a spontaneous report from a contactable consumer (patient) reported for himself that a 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EL7533) via an unspecified route of administration, administered in Arm Left on 20Apr2021 14:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Lot number EL8727) in the Left arm on 29Mar2021 16:00 at the age of 40 years for covid-19 immunisation. No known allergies. No vaccines were received within 4 weeks prior to the COVID vaccine. Healthy and no prior adverse event history. The patient experienced transient ischemic attack 1 week after vaccine 2nd dose, strong pressure in head, loss of ability to support body in RL, slurred speech, difficulty breathing, cognitive difficulties, extreme headache on 27Apr2021 16:30; visited emergency department. 2nd incident 02May2021- 50% loss of vision, tingling on one side of body, slurred speech, cognitive difficulties, extreme headache. The adverse events resulted in emergency room and healthcare professional office visit. Patient was treated with headache medications. It was reported that patient was recovered from events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in 2021. Information on Lot/Batch number was available. Additional information has been requested.
40 2021-05-26 headache, malaise, chills Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; K... Read more
Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose for Covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-05-26 fever fever; body pain; This is a spontaneous report from a contactable consumer (patient's son). A 40-yea... Read more
fever; body pain; This is a spontaneous report from a contactable consumer (patient's son). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0169 and expiration date was reported), via an unspecified route of administration in arm (reported as shoulder), on 18May2021 between 14:00 to 15:00 (at the age of 40 years old) as second dose, single for COVID-19 immunization in the patient's home. The vaccine was not administered in a military facility. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731 and expiration date was reported), via an unspecified route of administration in shoulder, on 26Apr2021 (at the age of 40 years old) as first dose, single for COVID-19 immunization. No other vaccinations was administered within four weeks prior to the first dose of the COVID-19 vaccine. The patient experienced body pain on the night of 18May2021 and fever on 19May2021. The patient events did not require emergency room (ER)/physician's office. The outcome of fever was unknown and body pain was not recovered at the time of report. No follow attempts are possible; no further information is expected.
40 2021-05-27 malaise Patient received Pfizer COVID-19 vaccine on 5/28/21 from Nurse. Felt fine right after the vaccine. H... Read more
Patient received Pfizer COVID-19 vaccine on 5/28/21 from Nurse. Felt fine right after the vaccine. He did tell the nurse that he is afraid of needles. While waiting the 15 minute observation period, patient came to the pick up window and stated " I do not feel well". He then squatted down and felt backwards onto his back. He was non responsive for around 30 seconds then regained consciousness. I proceeded to call ED and ran out to assist the patient. By the time I went out there, he regained consciousness. I instructed him to elevate his legs while lying down. Two fire department members assisted us while we waited for emergency services. Person declined to go to the hospital but emergency services advised him todo so since his blood pressure was low. Patient was taken by ambulance to the hospital
40 2021-05-28 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt's forehead felt cold and sweaty and he tried to lift his legs up and kept his hands high - he described that he faints after a blood taken for a test or after a vaccing, and this might be a mental predisposition to this reaction. we called an embulance, but patient felt better in 5-7 min and requested to cancel embulance. He spent 10-20 min on the chair and felt ok to get up and walk around. He left stating he fill better.
40 2021-05-28 malaise, fatigue Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt li... Read more
Walking to the observation room approximately 2 minutes post shot I felt extreme dizziness. Felt like I could potentially pass out so I waited 30 minutes in the observation room before leaving. After I was fairly confident I would not pass out I left the facility. When I made it outside it felt like the right side of my brain was "not there," like a portion of my brain was dead. While driving home approximately 45 minutes post shot I felt numbness and tingling on the right side of my face. Mental confusion also started. I don't recall the numbness and tingling in my face continuing at this time. Proceeded home, laid down on the couch to relax and about 3 hours post shot felt my heart racing. Checked heart rate with pulse oximeter and heart rate was 120 w/98 oxygen. 5 minutes later the heart rate went down to around 90 but blood oxygen went to 90. I sat up, drank water and pulse/oxygen returned to normal. The next day the mental confusion continued. Approx. 24 hours post shot tingling and numbness felt on right side of face. Couldn't move lips properly, communicate to my facial muscles. This lasted around an hour or two. 30 hrs post shot short term memory loss caused confusion when typing texts, following conversation, etc. Symptoms improved greatly over the next couple of days. Tiredness/general unwell feeling approximately 48hrs post shot but unremarkable. By the time I went to a GP 84hours post shot I felt 95%. Went to a neurologist 108hrs post shot who performed standard tests and all was well. 1 week post shot got into an argument and felt tingling and numbness on right side which lasted approximately 10 seconds.
40 2021-05-31 fatigue Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after sec... Read more
Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs. No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.
40 2021-05-31 sweating Bradycardia, hypotension Diaphoresis, pallor, visual disturbances - Patient treated for hypotension... Read more
Bradycardia, hypotension Diaphoresis, pallor, visual disturbances - Patient treated for hypotension via IV/Fluid administration. - Patient transported to Medical Center
40 2021-06-01 malaise, fever, fatigue, pneumonia Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on... Read more
Immediate nausea, hot flash and heart palpitations at time of injection, soreness for 3 days, and on the 4th day I had a general feeling of malaise, which worsened until I developed a fever. Severe fatigue and constant fever as high as 105 for three days, and finally went to the ER. Immediately treated for sepsis. Full blood panel, blood cultures, x-ray and CT scan. Also ran some additional cultures for respiratory pathogens. The Dr?s had a tough time determining what it was. They saw a very small area which they called pneumonia, however, I?ve had pneumonia and this was not what it was. Final discharge paperwork stated Systemic Inflammatory Response Syndrome.
40 2021-06-02 chills, headache Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of va... Read more
Per Client received COVID 19 in right arm on 5/24/2021, soreness at injection site on same day of vaccine. On 5/25/2021 around 4 am, started having chills and headache. On 5/26-5/27/2021 headache worsened and by Friday on 5/28/2021, along with headache, left sided pain in chest and arm. Per patient was taken to ER by wife and admitted to hospital on 5/28/2021. Per Client, was told first by hospital that he was having a heart attack. Client reported having labs collected, EKG, Catheterization and Ultra Sound. Per Client, later diagnosed with "myocarditis" and is now taking multiple mediations. Per Client was discharged from hospital on 5/29/2021, that evening. Will be following up with PCP in one week.
40 2021-06-02 chills, fever Body pain; Chills; Mild fever; This is a spontaneous report received from a contactable non-healthca... Read more
Body pain; Chills; Mild fever; This is a spontaneous report received from a contactable non-healthcare professional reporting for a patient. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 40-year-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history and concomitant therapies were not reported. The patient experienced chills, mild fever and body pain on 16Mar2021.The patient did not receive treatment for the reported events. The clinical outcome of the chills, fever and general body pain was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
40 2021-06-06 sweating Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of... Read more
Within about 5 minutes of patient of patient receiving the vaccine, he had a seizure in the lobby of the pharmacy. The seizure was not witnessed by any employee, but by his companion and a customer. I immediately had a technician call 911 and ran out with our emergency kit when I heard the patient's companion screaming for help. When I got to the patient he was in a seated position in a chair in the lobby and was coming to. He was disoriented and looking around. I asked if he knew his name and what day it was, he did know. I asked if he knew where he was and he responded correctly. He said he felt week and hot, he appeared sweaty. I checked his blood pressure (100/58) and pulse (50 bpm). His temperature was 97.1. His companion stated he had never had a seizure before when asked. I gave him some water and sat with him until EMS arrived. He remained seated the entire time and said he felt week. A few minutes after EMS arrived, the patient left via stretcher by ambulance, but remained conscience.
40 2021-06-06 fever Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left ... Read more
Loss of appetite, fever (102/103) and night sweats for the first 3 days. my chest pain on the left started the night of the shot around 2 am. The pain kept getting worse and worse each day. I finally had to drive myself to the emergency room (5/4/201) to get it checked out. It felt like something was squeezing my heart. i was super light headed and felt like i was going to drop on the floor dead. They gave me a chest x ray and took blood work. Everything cam back good and the doctor said if i kept getting those chest pain i should return. so they let me go. i still kept getting my chest pain for another week. however i didnt go back to the ER, because i was scared of getting a second bill as im not insured.
40 2021-06-10 cough Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable co... Read more
Insomnia; Cough; his body start jerking; This is a spontaneous report received from a contactable consumer. A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on 03May2021 (at the age of 40 years) and second dose of BNT162B2 on 26May2021, as a single dose for COVID-19 immunization. The patient medical history included Ventricular tachycardia and concomitant medications included Amiodarone used for Ventricular tachycardia on an unknown date. Reporter stated that he took the highest dose in that medicine, yes the highest, I do not know what the highest is that he is taking I know it is the highest since they said they cannot give him anything now". Reporter stated, "My son might be having a reaction to the Pfizer vaccine and he has a test in the morning, but he already been into the emergency room and all these and I need to ask or talk to somebody that can medically give me some advice before his test specifically we do not know he can actually have this test now. Reporter added, "Now do you need to know his side effects that he is having from the vaccine that came from the vaccine. Okay the side effects he is having started right after his first vaccine on 03May2021 he started getting the sleep apnea well not sleep apnea sorry about that he started getting insomnia and he cannot sleep and he ended up getting a cough so when he went back to his second vaccine his insomnia started getting worse, he is like he cannot sleep at all and when he does fall asleep its only for 2 hours and he gets so tried, his body start jerking and makes him wake up. Report-er stated, "They are worsening". The patient underwent laboratory test and procedures which included chest X-ray, Nuclear test on Friday and have not got results for that test. Outcome of events was reported as unknown. Reporter seriousness for Insomnia, Cough, his body start jerking was unspecified.
40 2021-06-16 headache, cough, runny nose, throat pain Symptomatic; cough, runny nose, shortness of breath, sore throat, headache, and burning eyes.
40 2021-06-17 fatigue Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five day... Read more
Sharp chest pain, shortness of breath, Extreme fatigue, pain with deep breath, lasted about five days. Took about 10 to 12 days to feel fully recovered
40 2021-06-19 fatigue, chills, sleepiness, fever, headache Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the... Read more
Chills, severe headache, muscle pain, injection location pain, tight chest, fever, rash/bumps on the arm of the injection site, tiredness, drowsiness, dizziness and difficulty breathing. Symptoms lasted approximately 24-36 hours
40 2021-06-20 chills, fever, headache, fatigue Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third... Read more
Following the vaccination on 2/23/21, Pt had fever, chills, fatigue the first two days. On the third and fourth days, he added diarrhea and headache to those symptoms. He felt awful over the weekend and spoke to his doctor on Monday, 3/1. The doctor began him on steroids and ivermectin. Over the next 24 hours his breathing began to worsen. He entered the hospital on Tuesday, 3/2, for supplemental oxygen. Things continued to get worse. He was intubated and put on a ventilator on 3/6/21 and ultimately spent 13 days in a coma. He was extubated on 3/19/21 but then had seizures on 3/20/21 and had to be reintubated to secure his airway. Pt was taken back off the ventilator on 3/24/21. He suffered vocal cord paralysis and ultimately wound up with both a PEG tube and tracheotomy. He was discharged from the hospital after 43 days and then spent 10 days in an inpatient rehab center. He continues to deal with vocal cord issues, tracheal stenosis, nerve damage in his neck and shoulder, muscle atrophy, and damaged lungs.
40 2021-06-21 headache I had a headache an hour after the shot. Then I had muscle pain in my arm for five days after. Then,... Read more
I had a headache an hour after the shot. Then I had muscle pain in my arm for five days after. Then, in the afternoon, my ears started ringing and it lasted weeks. I saw a doctor who told me he had seen it in other patients who experienced the same. Said it was inflammation.
40 2021-06-21 influenza like illness, headache, fatigue A day later general flu like symptoms had to take a day off from work and then the following day my ... Read more
A day later general flu like symptoms had to take a day off from work and then the following day my symptoms decreased but i still felt tired and headaches.
40 2021-06-22 fatigue Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath si... Read more
Patient reports chest and upper abdominal discomfort, fatigue and difficulty taking a deep breath since receiving 2nd dose of Pfizer Covid vaccine.
40 2021-06-23 fatigue Patient stated he had experienced usual side effects from the vaccines including fatigue, frequent u... Read more
Patient stated he had experienced usual side effects from the vaccines including fatigue, frequent urination (every hour) and blurred vision. Those symptoms only lasted 3 days after his first covid vaccine, but persisted since he received his second dose on 6/8. He denied having shortness of breath, irregular heart rate, hives or any other anaphylaxis reactions. No new medications or health conditions as he was aware of. He will continue monitor more symptoms and he has scheduled an appointment with his primary provider in couple weeks
40 2021-06-23 sweating PATINET FELL FROM CHAIR. BRIEF LOC , HIT RIGHT SIDE AND TOP OF HEAD. DIAPHORETIC. LAYED DOWN OF COT... Read more
PATINET FELL FROM CHAIR. BRIEF LOC , HIT RIGHT SIDE AND TOP OF HEAD. DIAPHORETIC. LAYED DOWN OF COT. ICE PACK TO HEAD. DRANK WATER. SAT ON EDGE OF COT. OBSERVED.
40 2021-06-24 chills Muscle soreness at injection site; Chills; This is a spontaneous report from a non-contactable consu... Read more
Muscle soreness at injection site; Chills; This is a spontaneous report from a non-contactable consumer (patient himself). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EL3247) via an unspecified route of administration in left arm on an unspecified date in Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant drugs were not reported. No known allergies to medications and food. On an unspecified date in Feb2021 patient experienced with Muscle soreness at injection site and chills lasting roughly 6-8 hours starting about 6-8 hours after injection. Treatment received for the events was reported as no. Outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
40 2021-06-24 fever, chills, fatigue, headache, throat pain Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Men... Read more
Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Mental fog and unusual thoughts.
40 2021-06-25 fatigue Extreme fatigue, exhaustion, and overall body pains. Sore arm at injection site.
40 2021-06-25 headache Dizziness. Headache. Sore at injection site.
40 2021-06-30 influenza like illness Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on Apri... Read more
Pt became severely sick with flu-like symptoms and could not work on April 20-22. He worked on April 23. He told people he was sick again on April 24. He was very anxious and committed suicide some time between April 27-28.
40 2021-07-01 fatigue insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffoca... Read more
insomnia started getting worse; he gets so tried; his body start 'jerking'; feels like he is suffocating; it's like somebody is choking him/choking sensation/feels like somebody has his thumb in the middle of his adam's apple and his throat; light headed; This is a spontaneous report from a contactable consumer (patient's mother). A 40-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 26May2021 as the 2ND dose, single for COVID-19 immunization. Medical history included ongoing ventricular tachycardia. Concomitant medication included amiodarone (manufacturer unknown) taken for ventricular tachycardia, start and stop date were not reported, taking the highest dose (as reported). The patient previously received the first dose of bnt162b2 (lot number and expiry date unknown) on 03May2021 for COVID-19 immunization and right after the patient experienced insomnia and cough. When the patient went back to his second vaccine, his insomnia started getting worse. He can't sleep at all and when he does fall asleep it is only for 2 hours and he gets so tired, his body starts 'jerking' and it makes him wake up. Since the second vaccine, the patient said it's like somebody is choking him, he said it feels like he is suffocating and he said it feels like somebody has his thumb in the middle of his adam's apple and his throat and so they send him to the emergency room and they told him to go home and just take sleeping pills. However the reporter stated that the patient can't take the sleeping pills because of his ventricular tachycardia and the medicine that he is on. They were getting the patient setup for his test the following morning from the day of the report and when he woke the morning of the day of the report he experienced the choking sensation and all that kind of stuff but he is light headed and they don't know if he should be taken to that test the following morning but yes the test is really important because of his heart and they don't know if he can take the medication that they are going to give a 'nuclear' medication with having all these side effects like these if it is from the Pfizer vaccine so that was why the patient's mother was reaching out for somebody with medical knowledge about the vaccine and the side effects and if someone could tell them if the patient could continue with his test. They wanted to know how long the side effects will last and if the side effects need treatment. The patient had a lab test (unspecified) and a chest x-ray both on unspecified dates but they did not have the results at the time of the report. The outcome of the events was unknown. Information on lot number/batch number was requested.
40 2021-07-05 throat irritation, headache, influenza like illness Itchy throat, headache,flu like symptoms, pain and weakness on vaccination site(RightArm)
40 2021-07-06 sweating Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additi... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Patient fainted 5 minutes after vaccine administered. Patient came to within a minute. Refused to be sent to the hospital. Patieent was given water and a ice pack. Girlfriend picked up patient.
40 2021-07-08 sweating, fatigue, chills Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat ... Read more
Increased yawn reflex to find air.; Chills immediately after/ cold body; Sweaty hands; Tight throat muscles; Sore upper left arm; Weird feeling in the body; Very slight difficulty breathing; Very slight difficulty articulating some words; Nausea; Difficulty sleeping; Loss of appetite; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EK8727) via an unspecified route of administration in the left arm on 24Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had known allergies to penicillin and amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg once a day for unknown indication and from an unknown date. On 24Mar2021 at 16:45, the patient experienced increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing (but SPO2 ok at 98%), very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests which included oxygen saturation test on an unknown date and the result was SPO2 at 98%. The clinical outcome of events increased yawn reflex to find air, chills immediately after / cold body, sweaty hands, fatigue, tight throat muscles, sore upper left arm, weird feeling in the body, very slight difficulty breathing, very slight difficulty articulating some words, nausea, difficulty sleeping and loss of appetite was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
40 2021-07-11 headache Patient began experiencing symptoms approximately 1 week (7 days) after receiving the 2nd dose of th... Read more
Patient began experiencing symptoms approximately 1 week (7 days) after receiving the 2nd dose of the Pfizer/BioNTech vaccine series. These symptoms included severe weakness/numbness of right hand and right food, moderate headache every day, migraine lasting 3 days resulting in emergency room visit, sharp nerve pain in back and neck. Patient has been undergoing physical therapy for right hand weakness/numbness that is still continuing 30 days later, but improving slowly. Per MRI and diagnosis from neurologist, concluded that patient has nerve inflammation secondary to receiving the vaccine.
40 2021-07-14 fatigue SORE RIGHT ARM, TIREDNESS
40 2021-07-14 headache Headache.
40 2021-07-15 sweating, fatigue Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where ... Read more
Patient came into pharmacy on 7/ 14/21 and described the following: Severe body pain in areas where he has "recent" injuries (vasectomy, back issues). No control over bowel movements. Disoriented/ motor skills severely lacking; couldn't walk down steps or down the hallway. had to call for help to family to do normal tasks. mild hallucinations. mental anguish; things were true in his head but not true in reality; mental dysphoria. Thinking this was the end; was able to recognize it but also very concerning. 3:30 am saturday this started; not all gone yet (7/14). Tension headaches (not prior). Extremely cold, clammy, sweaty; had to change clothes based on the amount of sweat. Not drug user, not alcohol, active military, not 48 hrs prior till recent. no pre workout. no medications. ibuprofen later saturday morning. First vaccine he just had local pain at shot site, some pain to the older issue sites and tiredness but nothing more than 24 hours. No mental illness dx at this time; possible ptsd but never diagnosed, not something he suffers from on a daily basis.
40 2021-07-16 fever, headache I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2... Read more
I was hospitalized on 6/2/2021 due to viral Meningoencephalitis. Althought this was 6 weeks after 2nd shot, was told I should still report it since it was caused by a virus that the hospital was unable to determine after negative tests for other viruses. Had high fever, which led to loss of consciousness and possible seizure. Experienced hallucinations and loss of self-awareness (forgot who I was). Taken to hospital, entered into ICU for 5 days. Spinal tap revealed viral infection. Throat culture revealed strep throat. Given antibiotics and IV fluids for several days. Restored self-awareness and fever disappeared after a few days. Intense headaches persisted for days. Was discharged from hospital on June 7, 2021 after 7 days. Experienced possible repeat seizure 5 days later in public, loss of sensation in legs, slurred speech. Was re-administered into different hospital on June 13, 2021. Spent ~5 days in that hospital, received EEG which showed brain damage on right temporal lobe. Received another spinal tap which showed infection was improving. Discharged on June 16, 2021.
40 2021-07-16 respiratory tract congestion Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. ... Read more
Chest pain persisted for ~3 day. Chest congestion for ~7 days with occassional heartburn-like pain. On 3/31/21, sharp pain in left arm and back.
40 2021-07-17 chills He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he... Read more
He experienced some leg shaking; Can not sleep; His legs started shaking and Friday it got worse; he went from 180 to, when he was at the doctor, they said 175; Nausea; After getting both doses he experienced Chills; Vomiting; Arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, NDC number, Expiry Date of Pfizer Covid-19 Vaccine: Unknown), via an unspecified route of administration on 15Jun2021 at 10:00 AM (vaccinated at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes and reported as patient has had since he was 22 he thinks. He went with his ex-wife on vacation and came back, so probably 22, Caller clarifies that he thinks he is a type 1 diabetic but he is not sure, he takes insulin. Ongoing smoker and reported as I smoke and occasionally drink on the weekend maybe but nothing crazy. He has been smoking since he was 17 he guesses. Ketoacidosis and reported as caller adds that he did have ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year. Caller does not know additional information but states it was prior to receiving the vaccine. The patient doctor a year ago gave some heart medication because patient had high blood pressure. The time before he saw him, he said it was too low and stop taking it. Family medical history reported as nobody has diabetes in his family, and he is the first. His dad had cancer and passed away when he was 58. Concomitant medications included insulin human injection, isophane (NOVOLIN N) and insulin human (NOVOLIN R) both were taken since he was 23 years for diabetes from an unspecified start date and ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: unknown) on 25May2021 for Covid-19 immunization and he got sick, it made him throw up, experienced chills. The first dose appointment was at 9:30 am. The patient states he got the second shot last Wednesday. Then, he went to work on Thursday. Friday on 18Jun2021, his legs started shaking and Friday it got worse. Saturday it got worse. Sunday, they felt a little better. Monday, or actually yesterday, he went to the doctor and the doctor said he has to go see a neurologist because the doctor kept him there for 3 hours looking at his legs and feeling them. They were moving out of control. Caller added as, considering his job, he walks 20-30,000 steps a day and he has never had trouble with his legs but he was diabetic. Caller adds that right now he kind of walks, like his girlfriend and son explained it, like a gimp and when he walks his legs pop. The patient cannot sleep. He slept maybe 6 or 7 hours since last Friday 18Jun2021. On an unspecified date the patient went from 180 to, when he was at the doctor, they said 175. Caller confirms this was new since receiving the vaccine. He has been 180 my whole life. He has not been able to work in a couple of day because he cannot walk. He guesses the weight loss is because of the vaccines. But, he is diabetic too, and was in pretty good health before this. Caller adds he has to pay for doctor appointments, his doctor kept him there for close to 4 hours and he looked at his legs for 45 minutes. He did not understand what was going on, and he sees him all the time for his diabetes. The doctor said that he has to see a neurologist, but none of these symptoms happened in his life until he got the shot. The patient arm of course was a little sore like when you get a shot and it hurts. Caller went to work and was fine, went to work the next day and was fine. This past Friday, his legs started shaking and he does not know. He could not sleep, they would not stop moving. He can control them if he uses muscle and really tries to control them. caller adds this is not going on still, he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Legs shaking, The patient spoke as per attached document in terms of nausea and vomiting. Treatment; cannot not sleep: caller adds he has a pool and when he goes swimming it feels better. If he walks around too much, how can he explain it, it gest worse but he can control it. If he flexes his muscles he can stop it, like flexing his legs that is how he stops it. If he does not, they just shake. He cannot not sleep because they shake so much they wake him up. The patient was diabetic and uses insulin and the same medication he has taken for years. The patient has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. The patient walks a lot and exercises or swims and uses insulins. One was long and one was short acting. Investigations were none, the patient saw a doctor yesterday who was trying to get him into a neurologist. He thinks it has to do with his nerves. He is trying everything he can. Adverse events do not require a visit to emergency room, but the doctor said if he cannot get him in to a neurologist in the next day or two, that he wants him to go to the emergency room. Needs visit to physician office. The patient doctor did not know what to do and just referred him to a neurologist. Caller just wanted to report this because none of these symptoms occurred until the second shot, or, well, it was the first shot that made him throw up and the other things with the second shot. his doctor did not know what to do and just referred him to a neurologist. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. Adverse events following prior vaccinations was none, he has not had a vaccine since he was a kid or teenager he guesses. The patient underwent lab tests and procedures which included weight loss: went from 180 to 175 lbs on an unknown date and reported as He went from 180 pounds to 175 pounds. Outcome of the event cannot sleep and his legs started shaking and Friday it got worse were not resolved and event arm was a little sore was resolved on an unspecified date, and remaining events were unknown. Information about lot/batch number has been requested.
40 2021-07-17 chills He felt like throwing up; After the first shot, he got sick; He reported that after getting both dos... Read more
He felt like throwing up; After the first shot, he got sick; He reported that after getting both doses he experienced CHILLS; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 40-year-old at the time of vaccination), via an unspecified route of administration on 25May2021 at 09:30 as single dose for COVID-19 immunisation. It was reported that patient works at withheld Center and they get stuff from all over the country, out of the country, and they distribute to all withheld. He touches a lot of stuff and is diabetic. He was not wanting to get it but his sister and girlfriend and son told him he should to be safe. He just kind of listened to them. Medical history included diabetes; he has had since he was 22 he thinks, Smoker; he has been smoking since he was 17 he guesses, Occasionally drink on the weekend, ketoacidosis, He had high blood pressure. Family history included his dad had cancer and passed away when he was 58. Concomitant medication(s) included insulin human injection, isophane (NOVOLIN N, patient had been on since he was 23); insulin human (NOVOLIN R, patient had been on since he was 23); insulin (INSULIN) all taken for diabetes mellitus. Reported that he is diabetic and uses insulin and the same medication he has taken for years. He has been fine. His doctor a year ago gave him some heart medication because he had high blood pressure. The time before he saw him he said it was too low and stop taking it. He walks a lot and exercises or swims and uses insulins. One is long and one is short acting, he thinks he is a type 1 diabetic but he is not sure, he takes insulin. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced he felt like throwing up, after the first shot, he got sick, he reported that after getting both doses he experienced chills, arm was a little sore. Reported that Arm was a little sore because he just thinks the pharmacist who gave the shot gave it rough. Also, his job is to walk a lot and lift stuff so that could be contributing to that part. Reporter seriousness for After the first shot, he got sick and it made him throw up, arm was a little sore was unspecified. On an unspecified date in 2020, the patient underwent lab tests and procedures which included blood test and CAT ketoacidosis, Reported that patient had ketoacidosis last year and they did do everything, CAT scans and all the blood work and everything. This was this past year but states it was prior to receiving the vaccine. No treatment received because his doctor did not know what to do and just referred him to a neurologist. The outcome of events (He felt like throwing up, After the first shot, he got sick, He reported that after getting both doses he experienced CHILLS) was recovered on an unspecified date in 2021 and the outcome of event (arm was a little sore) was recovered on an unspecified date in May2021. Information about lot/batch number is requested.
40 2021-07-17 sweating, fatigue Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 40- year-o... Read more
Sweating; Tired; This is a spontaneous report from a contactable consumer, the patient. A 40- year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included allergies to apples. Concomitant medication included atorvastatin calcium (LIPITOR) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021 at 03:00, when patient's 04-year-old daughter woke him up, the patient was sweating. It was not hot in the room. The patient did not take the temperature as the patient was tired and went back to sleep. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events sweating and tiredness was recovered on 05Mar2021. No follow-up attempts are needed. No further information is expected.
40 2021-07-17 nasopharyngitis, sweating, chills, fatigue, cough right eye looks like he has pinkeye; consistant dry cough; He tested positive this week.; He is ill ... Read more
right eye looks like he has pinkeye; consistant dry cough; He tested positive this week.; He is ill with Covid-19; cold; being knocked out; being in bed all day; He is ill with Covid-19; He had chills and sweats; He had chills and sweats; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 40-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6202) via an unspecified route of administration in left deltoid on 26Feb2021 14:06 as dose 1, single (at the age of 40-years-old) and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6206) via an unspecified route of administration in left deltoid on 19Mar2021 for COVID-19 immunization (to protect from the Covid19 disease caused by SARS-2, as reported). He had a PCR 24Jun2021. He received positive results today. Vaccine was not administered at Military Facility. Patient medical history included ongoing pernicious anemia which was diagnosed 6 years ago. The concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) intramuscularly at a dose of 1 ml weekly with daily dosage as 0.143 ml taken for pernicious anemia. Patient received both doses of the vaccine. He had been out of the country since last Saturday (for 5 days) and stated it was not correct that he had been out of town for a few weeks. He had a PCR test last Thursday and it was negative. He started having symptoms on Tuesday and thought it was a cold because he was vaccinated and there were always colds going around. He went to get a decongestant after being knocked out and being in bed all day. The antigen test for Covid was positive and the antigen test was validated by a PCR-24 test yesterday. He stated somehow in the last 7 days he has become Covid positive. He was ill with Covid-19 and was isolated. His flight was tomorrow and he could not come back until he was negative. He stated it was very inconclusive that he may be testing positive, vaccinated or not, for up to 90 days. He stated he cannot afford that. He heard it tossed around on the news that breakthrough cases generally create mild to moderate infections that do not last as long. He spoke with his doctor who said he can test positive for up to a month. In the news they stated that even if people get infected, after the vaccine there is a level of protection. He stated the people he was with did not test positive for Covid. He wanted to know how long it will be until he tests negative. He stated he felt kind of duped with all the masks being removed because clearly there are risks. He understood that it was not 100 percent effective. He stated he felt like he was being hustled because he had been diligent and tried to really believe in science and the federal government that he would be protected. Additionally, he stated there must be research on breakthrough cases of Covid and how long until they test negative if they have already had the vaccine. He felt like he had no resources to understand what you would be looking at with antibodies from the vaccine combined with a Covid infection. He wanted to know if people get infected with Covid after having the Covid vaccine, was the level of protection just from symptoms or is it the length of viral load.He has has had both Covid shots. He went out of the country a few weeks ago and was fine. Then he left and went to #. He cannot come back because he is positive for Covid. He had a PCR 24 last week and was negative. Had symptoms which he thought was a bad cold. He tested positive this week. He went to for a walk to the pharmacy on Wednesday to get a decongestant because he thought he had a cold. He did not go to any meetings because he did not want to get anyone sick. At the pharmacy they were doing antigen tests. He knew that he needed one to travel back to the United States. He took the tested and waited 15 minutes. He received the results which were positive. He did not have a fever. He had chills and sweats but did not have now. Yesterday (01Jul2021) he developed a consistent dry cough. Today (02Jul2021) his right eye looks like he has pink eye. He took some natural cough syrup and it helped. He had a PCR 24Jun2021 with positive results. The events did not result in emergency room or physician office visit. Description of Product Complaint included patient tested positive for Covid after receiving both doses of vaccine (Lot number- EN6206). On an unspecified date in 2021, the outcome of the events chills and sweats was resolved, outcome of the event dry cough was recovering, outcome of the event COVID-19, vaccination failure and pinkeye was not recovered, while that of the other events was unknown. Information on lot/batch number is available. Other information is requested.
40 2021-07-18 headache headache, nausea, body aches, myalgias
40 2021-07-18 sweating The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was in... Read more
The time of the schedule appointment was for 3:00pm at the local Pharmacy). Once the vaccine was injected into my left arm, I was placed into a different seating placement, to be observe for any signs of side-effects that may occur form the injection. This seating area also displayed a digital clock to notify how long each patient must be stationed for (each station is registered for each patient to wait approximately 15 minutes after injection). Once placed in the seating area and the clock was started to examine my treatment, within the six minutes of observation, the following signs occurred: Rapid-Heart Rate, Short and Shallow Breathing, Sweaty Palms including Hot Flashes (lasting 4 seconds).
40 2021-07-18 respiratory tract congestion, runny nose, productive cough SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NA... Read more
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/17/21, most likely done at a . Test came back positive. Case investigation interview conducted and based on case manager documentation on July 19th at 11:15, "Advised of test results. Client stated that symptoms (runny nose, congestion, productive cough) began 7/14 and continue today.
40 2021-07-19 fatigue, headache Diarrhea, sore muscle at injection site, body aches (upper body), headache, fatigue
40 2021-07-19 fatigue, sweating, chills, malaise, fever, upper-airway cough syndrome Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable t... Read more
Blood pressure went up to 160; My heart rate went up to 130/Rapid heart rate; disorienting; unable to eat; post-nasal drip 'dripping' into my lungs; Occasional shortness of breath; Dizzy; Unable to eat and actually zero desire to eat; Sweating/ sleep sweat; sleeping off and on; Was just physically ill/ malaise; Chills; Fever; Extremely tired/ general fatigue; I throw up the water I have been drinking all day; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 13Apr2021 at 08:00 (at the age of 40-years-old) as single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). The patient stated that it was just a standard rescue inhaler 100 mcg. The patient was vaccinated on 13Apr2021 at 08:00 and within 5 minutes his blood pressure went up to 160 and heart rate went up to 130, so they called paramedics over, who were already on site and did pulse check and blood pressure check until they knew what heart rate, blood pressure and oxygenated blood was. They did not allow him to leave for an hour because it was so highly elevated, he felt so dizzy and very disorienting. His friend dropped him home because he could not drive, there was no way he could drive. After an hour the blood pressure got back down to 140 and heart rate was still about 120, it was lower, so he went home and immediately lay down and rest the entire day. He was just physically ill and experienced chills, fever, sleep sweat, extremely tired, strangely no arm soreness at all. He got every other possible side effect and that lasted until 01:30 in the morning, after he throw up, he was finally able to get some sleep. He took rest the entire day, sleeping off and on, unable to eat and actually zero desire to eat, rapid heart rate, sweating, and occasional shortness of breath. He used the rescue inhaler as treatment, that was probably because he laid on his back for so long and also probably just post-nasal drip into lungs. At 01:30 in the morning, he throw up the water he had drank all day and felt a bit better. It was probably because he did not eat all day. He slept until noon and didn't went to work because he felt malaise, general fatigue, his arm didn't hurt. He didn't feel great on the day of reporting, but it was not like the previous day. He had to go to the emergency room, as his mom kept pushing him to go and he was like not going. He had not eaten anything on the day of reporting, so he was looking for something to (incomplete sentence). The patient took 1 gm of Tylenol (over the course of maybe 14 hours) on 13Apr2021 and was advised not to take Advil for whatever reason. The patient underwent blood volume the previous month which was normal and no STDs. He was negative for COVID. That's why he felt okay with vaccine and then before that he did a PCR test which was also negative. The patient have been in 11 countries in the previous year and might have undergone 20 PCR test. He was kind of scared taking the second shot. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
40 2021-07-20 chills, fatigue, headache, fever Body ache; Fever of 100 for 12 hours; Chills; Headache; Fatigue; This is a spontaneous report from a... Read more
Body ache; Fever of 100 for 12 hours; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) received on unspecified date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 01:00, the patient experienced fever of 100 (unspecified units) for 12 hours, chills, headache, body ache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the reported events. The clinical outcome of the event fever was resolved on 26Mar2021 at 13:00 (for 12 hours) while that of the events chills, headache, body ache and fatigue was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
40 2021-07-21 fatigue, headache Vomiting; Massive headache; Incredibly tired; Sore right arm; This is a spontaneous report from a co... Read more
Vomiting; Massive headache; Incredibly tired; Sore right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 31Mar2021 at 14:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, after about 3 hours from the first dose of vaccine, the patient was incredibly tired and slept. The event of incredibly tired was not that bad. The patient woke up for a little while and then went back to sleep again. On 01Apr2021 at around 06:15, the patient woke up with a massive headache. He took a couple of ibuprofen and tried to relax. About fifteen minutes later, at 06:30, the patient could tell he was about to vomit and did. He kept vomiting for about the next 20 minutes or so till there was nothing left. He slowly sipped water for the next hour. After that he had no adverse reactions. The patient stated that, he had not vomited in at least the past 7 years and that episode of vomiting was violent and also stated he could not control that. On the same day, in the evening, the patient only had a slight sore right arm and episode of tiredness. On 02Apr2021, after vomiting the patient slept for the next five or so hours. His arm was still slightly sore but really did not bother him. After around 2 PM (about 24 hours later), he had felt totally fine. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events of tiredness, vomiting and sore right arm. The clinical outcome of the event tiredness, headache, vomiting and sore right arm were resolved in 02Apr2021. No follow-up attempts are needed. No further information is expected.
40 2021-07-21 headache Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and una... Read more
Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.
40 2021-07-22 headache Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and na... Read more
Severe dizziness, headache, loss of balance, heart palpitations, upset stomach, blurry vision and nausea.
40 2021-07-25 cough About 30 minutes after the injection my throat became swollen, and I felt pressure in my ears. I had... Read more
About 30 minutes after the injection my throat became swollen, and I felt pressure in my ears. I had difficulty swallowing, and some pain in my upper longs with coughing.
40 2021-07-27 headache headache; light pain on my right shoulder; This is a spontaneous report from a contactable consumer,... Read more
headache; light pain on my right shoulder; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 04Apr2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 17:00, the patient experienced headache and light pain on right shoulder. It was reported that the patient still had headache and shoulder pain on 05Apr2021, the second day of vaccination. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event headache and shoulder pain was not resolved. No follow-up attempts are possible. No further information is expected.
40 2021-07-29 headache, lethargy Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriat... Read more
Within 3 hours headache.; Within 30 min: Warm sensation from left cheek down left arm.; Inappropriate schedule of vaccine administered; Joint pain; Significant body aches; Lethargy; Dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151), via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient previously took augmentin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 15:30, within 30 min the patient experienced warm sensation from left cheek down left arm. Within 3 hours headache. Within 12-18 hours post: dry mouth, significant body aches, joint pain, headache and lethargy. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events warm sensation from left cheek down left arm, headache, dry mouth, significant body aches, joint pain, headache and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2020-12-31 fever Patient had a fever (T100), severe body aches, and diarrhea one day post immunization. [note; COVID... Read more
Patient had a fever (T100), severe body aches, and diarrhea one day post immunization. [note; COVID recovered April 2020]
41 2021-01-01 headache, runny nose Soreness and weakness of left arm for more than 5 days. Intermittent headaches and runny nose
41 2021-01-02 chills, head discomfort My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on ... Read more
My entire body felt really cold for the whole day on Tuesday. I couldn't get warm and had to put on extra clothing during the day and extra blankets when I went to sleep. I think this is considered to be chills. On both Tuesday and Wednesday, I ran out of energy by the afternoon. On both Tuesday and Wednesday, my head felt heavy.
41 2021-01-03 chills, headache, fever, fatigue Fever chills headaches fatigue muscle ache
41 2021-01-04 fatigue, fever, chills Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a cont... Read more
Fever of 101.0 F; chills with fever; fatigue; night sweats; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration on 20Dec2020 15:00 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history included Scleroderma, interstitial lung disease. There were no Known allergies to medications, food, or other products. Concomitant medication (reported as other medications the patient received within 2 weeks of vaccination) included ibuprofen, ergocalciferol (VITAMIN D), cetirizine hydrochloride (CITIRIZINE), famotidine. There were no other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior vaccination. The patient experienced Fever of 101.0 F, chills with fever, fatigue, night sweats on 21Dec2020 20:00. No treatment received for all reported events. The patient had Covid tested via Nasal Swab post vaccination with PCR result negative on 23Dec2020. The outcome of the events was recovered in Dec2020. This case was assessed as non-serious.
41 2021-01-04 headache headache approximately 4 hours after vaccine , treated with OTC ibuprofen. symptoms resolved
41 2021-01-06 chills, fever, malaise, headache, fatigue injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, w... Read more
injection site pain, triedness, headache, muscles pain, chills, fever, joints pain feeling unwell, weakness.
41 2021-01-06 headache Headache migraine
41 2021-01-07 chills, headache headache/ his head was really pounding; nausea; chills; he had no appetite; This is a spontaneous re... Read more
headache/ his head was really pounding; nausea; chills; he had no appetite; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL1284, Expiry Date: Apr2021), via an unspecified route of administration in the right arm on 31Dec2020 at 14:00 at single dose for COVID-19 immunization as front line health care worker. There were no medical history and no concomitant medications. The patient received the Pfizer COVID 19 vaccine first dose 31Dec2020 at 14:00 in the right arm and then experienced a headache, nausea, and chills on 02Jan2021. He took two days off from work and now felt better, had no more symptoms. He noticed the symptoms on Saturday 02Jan2021, then Sunday he was able to go to work then he took off on Monday because the symptoms got worse. He had no appetite on 02Jan2021. Today he felt great. He was supposed to get the second dose 21Jan2021. He did take Ibuprofen with strength 600 mg oral once on 02Jan2021, because his head was really pounding and then he went to sleep and it was better the next day. He had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations -within 4 weeks. There was no family medical history. He had the COVID 19 test 3 months ago in 2020 and it was negative. The outcome of the events was recovered on 04Jan2021.
41 2021-01-07 fatigue, fever, sweating, influenza like illness, chills Flu like symptoms; Low grade fever; Chills; body aches; sweating; fatigue; This is a spontaneous rep... Read more
Flu like symptoms; Low grade fever; Chills; body aches; sweating; fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old male patient received BNT162B2 (lot ej1685) intramuscular on 29Dec2020 07:15 AM at a single dose on the left arm as COVID-19 vaccine. Medical history and concomitant medications were not reported. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced flu like symptoms, low grade fever, chills, body aches, sweating, fatigue, all on 30Dec2020 12:00. The events were non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the events. He was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Dec2020.
41 2021-01-08 chills, body temperature increased, headache Headache, Myalgia, Chills, temp to 99.9 Narrative:
41 2021-01-08 cough, headache About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, ... Read more
About 12 hours after admin; arm, shoulder, neck pain, progressed to generalized body aches, nausea, severe headaches, cough, mass weakness, diarrhea, joint pain. Symptoms started subsiding about 15 hours after onset. Minor cough still persist with minor shortness of breath.
41 2021-01-08 headache Headache & Diarrhea
41 2021-01-08 headache Headache & Myalgia
41 2021-01-08 headache Headache migraine, red/sore, warm at site of injection,body aches
41 2021-01-08 malaise, chills, fatigue, headache Malaise, fatigue, intense chills, shivering, headache
41 2021-01-08 paranasal sinus discomfort, sweating Some diaphoresis, sinus pressure Narrative:
41 2021-01-08 respiratory tract congestion, fever, cough Nurse working in Emergency Dept, developed first COVID sxm (mild cough) on 03 Jan 2021. On 05 Jan 20... Read more
Nurse working in Emergency Dept, developed first COVID sxm (mild cough) on 03 Jan 2021. On 05 Jan 2021, he received dose #2 of COVID vaccine (Pfizer lot EL1284). On 06 Jan 2021, sxms progressed to include fever, congestion, impaired taste and smell. On 06 Jan 2021, NP swab for PCR was performed and confirmed positive... patient being managed as outpatient.
41 2021-01-10 chills, lethargy 1. Lethargy 2. Intense Migraine 3. Joint pain 4. Foggy Brain 5. Heavy Chest 6. Chills
41 2021-01-10 headache, chills Body aches, chills and headache.
41 2021-01-10 headache, fatigue Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatme... Read more
Symptom: Headache | Treatment: Tylenol | Outcome: No resolution thus far; Symptom: Fatigue | Treatment: Sleep | Outcome: Slight improvement in fatigue; Symptom: Left arm muscle soreness (same arm as injection) | Treatment: Tylenol | Outcome: No resolution thus far; and Symptom: Back pain (upper-left quadrant) | Treatment: Stretching and Tylenol | Outcome: No resolution thus far
41 2021-01-10 headache, fever 2nd vaccine in Friday morning. At night and Saturday whole day staff having bodyache, headache, fev... Read more
2nd vaccine in Friday morning. At night and Saturday whole day staff having bodyache, headache, fever 100.5. Sunday morning a lot better but found a lump in armpit. This morning feeling better no symptom except the lump in armpit which is almost gone but feeling another lump in neck. All lumps happen to be in left side. Got shot on left arm. Called to advise nurse and told to call PCP, which he hasn't called yet.
41 2021-01-10 headache Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swe... Read more
Approximately 15 minutes after receipt of the vaccine, I experienced tachycardia and mild throat swelling. I was placed in the Immunizations Clinic treatment room, had my airway assessed, and vital signs taken. My initial vital signs at 0950 were BP 197/99, HR 106, O2 sat 99%, temp 98.3 F, and 0/10 pain. Over the course of the next 2 hours, I repeatedly had my vital signs taken, was monitored, was provided with water, and remained hypertensive and tachycardic, although down-trending. I also experienced cottonmouth and bilateral blurred vision/dry eye. At the end of the 2 hour monitoring, the throat swelling seemed to subside, my systolic BP in the mid 140s and diastolic BP was in the mid 90s. At time of release from monitoring, I felt better, but dry eyes and dry mouth continued without difficulty swallowing. I was instructed to report to the ER if my symptoms worsened and to consult by primary care manager about the incident. Upon walking back to my office, I realized I was experiencing dizziness as well and a mild headache. I attempted to submit this form online but I received an error message, so I completed the fillable version to upload, in case a partial duplicate record appears.
41 2021-01-10 sweating, throat irritation, headache, fatigue Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed ti... Read more
Patient received first vaccine 12/29/2020. While in waiting period post-vaccination, he developed tinnitus and was hot, flushed, and diaphoretic. He felt very cold and "wobbly" after other symptoms subsided. He had sharp pains in the joints on the side of injection which continued through 1/1/21 later that day. He was tired and had a minor headache 12/29/2020-12/31/2020. Patient had a bout of severe depression and "not caring about anything" beginning 12/29/2020 and lasting about 16 hours. He has no history of depression. He awoke 1/1/2021 and the depression was gone. Patient states all these symptoms disappeared when his arm pain resolved. He developed a "strained" throat on 1/1/2021 which is the only symptom that has continued to the day of this report.
41 2021-01-11 chills, body temperature increased, fatigue Woke up with Chills and body aches at 3am, measured temp at the time was 97.5F by IR forehead thermo... Read more
Woke up with Chills and body aches at 3am, measured temp at the time was 97.5F by IR forehead thermometer. By 7am temperature was up to 101.7F. Tylenol taken and fever began to break within an hour. Lots of fatigue for the rest of the day.
41 2021-01-11 chills, fatigue, fever 3AM I woke up with chills and muscle aches. Temp by IR forehead thermometer was 97.5F. By 7AM temp w... Read more
3AM I woke up with chills and muscle aches. Temp by IR forehead thermometer was 97.5F. By 7AM temp was 101.7F. Took TYLENOL and fever began to break within an hour. Fatigue for the rest of the day. Felt bad enough to call in sick. Resolved by the next day.
41 2021-01-11 fatigue, headache Muscle and joint pain/aches, mild headache, fatigue - lasted approximately 24 hours
41 2021-01-11 fatigue, fever, chills Fever, chills, and fatigue. Fever and chills resolved with use the of Ibuprofen. Mild fatigue conti... Read more
Fever, chills, and fatigue. Fever and chills resolved with use the of Ibuprofen. Mild fatigue continues
41 2021-01-11 lethargy, headache Lethargic not hungry Headache Weak Cloudy head
41 2021-01-11 fever Fever, shortness of breath, nausea
41 2021-01-12 chills, headache, lethargy, fever High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills a... Read more
High Fever 101.6 F, lethargy, Confusion, Muscle/Joint aches and pains, headache, Tiredness, Chills all started about 17 hours after the shot(vaccine) Fever finally broke after taking 1000mg Tylenol. About 40 hours after the vaccine I felt normal again with just a mild aches and pains in joints.
41 2021-01-12 chills, headache, fever 13.5 hrs after infection chills began. Fever developed and lasted about 9-10 hrs. Headache started... Read more
13.5 hrs after infection chills began. Fever developed and lasted about 9-10 hrs. Headache started after fever started and lasted about 20 hrs
41 2021-01-12 cough 2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain per... Read more
2 days later I developed pain in my chest, back, lats, and entire arm. I have sharp numbing pain periodically from my armpit to my pinky finger. This pain has only grown worse since onset despite my doctor prescribing oral steroids and pain meds. Painful to sneeze, cough and laugh
41 2021-01-12 fatigue, fever, chills, influenza like illness Moderate fatigue starting 12 hours after vaccine. Severe myalgias, fever, chills, rigors, neck stif... Read more
Moderate fatigue starting 12 hours after vaccine. Severe myalgias, fever, chills, rigors, neck stiffness, joint pain, flu-like symptoms
41 2021-01-12 fatigue Had slight injection site soreness and slight fatigue the day of treatment. The following 12 to 24 h... Read more
Had slight injection site soreness and slight fatigue the day of treatment. The following 12 to 24 hours I presented with sever fatigue and severe body and joint aches. I was negative for a fever the entire time. 24 to 36 hours after vaccination symptoms went away.
41 2021-01-12 headache, fatigue, fever, nasal congestion, chills, malaise Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fal... Read more
Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
41 2021-01-12 headache Headache started around 1pm the day after the injection, 1/8. The headache persistent until I went ... Read more
Headache started around 1pm the day after the injection, 1/8. The headache persistent until I went to bed 1/9. It was gone in the morning 1/10.
41 2021-01-12 fever, sweating, chills Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever b... Read more
Sweating, Chills, Extreme Body Aches, Wheezing(never in life before), Dryness of Mouth, 99.8 Fever but fealth much worse, Heart burn, felt like my inside of body was swelled up, slight Gas, Hallusinations, Nightmare, Extreme Back pain not able to stay still, but I had slight back pain before this was 1000 times worse. I thought its coming to an end. This is exactly what happened to me when I had peak of COVID except the wheezing, I though I had COVID all over again. I took Vitamin C, Vitamin D, Zinx, Tums, Ibuprofen and fell asleep around 2 AM. I woke up at 7 AM in a pool of sweat had to remove the blankets to washer. I had no fever and nothing else it seemed like a switch is turned off and everything went away. Injection site was hurting allot during this time, but when I woke up nothing even injection site was not hurting either. It was a horrible night but seemed that nothing happened in AM.
41 2021-01-13 headache Mildly sore injection site for 24 hrs post. Pressure headache with sore neck for up to 24 hrs post i... Read more
Mildly sore injection site for 24 hrs post. Pressure headache with sore neck for up to 24 hrs post inj.
41 2021-01-13 headache " 15mins after vaccine I felt dizzy with Pounding head" VS monitored 150/99 HR 80 o2 sat 97% RR 15... Read more
" 15mins after vaccine I felt dizzy with Pounding head" VS monitored 150/99 HR 80 o2 sat 97% RR 15. Seen by Dr. EKG done repeat VS148/96 HR 83 O2 Sat 97% RR18
41 2021-01-13 sweating, fever, fatigue Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved.... Read more
Fever 103.8 Perspiration Generalized fatigue and weakness Mild dyspnea without cough- now resolved. Soreness at injection site right arm.
41 2021-01-13 fever, chills Slight fever, cold sweats, chills
41 2021-01-13 fever, fatigue 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue... Read more
99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012. Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today). Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
41 2021-01-14 chills, fever, sweating High fever; chills; sweats; This is a spontaneous report from a contactable Other HCP (patient). A 4... Read more
High fever; chills; sweats; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old male patient received the second dose of BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 08Jan2021 at single dose in the left arm for an unspecified indication. Medical history included high blood pressure and allergy to coconut. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. Historical vaccine includes BNT162B2 received via intramuscular on 11Dec2020 14:00 ("also reported as 12Dec2020 14:00) at single dose (first dose) in the left arm for COVID-19 immunization. On 09Jan2021 07:00, the patient experienced high fever, chills and sweats. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the events was not recovered. Information regarding lot/batch number has been requested.
41 2021-01-14 headache severe headaches, nausea, a few days after, vomiting, diarrhea, and body aches. improved with Tyleno... Read more
severe headaches, nausea, a few days after, vomiting, diarrhea, and body aches. improved with Tylenol, Advil, and Imodium.
41 2021-01-14 fever, fatigue pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had... Read more
pins and needles throughout body. started 3 days post vaccination and continues 1 week after. had low grade fever and fatigue in 24hrs post.
41 2021-01-15 fatigue, headache The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 head... Read more
The day after had myalgias and fatigue and arm pain. But on 1/10/21 began developing mild 2/10 headaches. On 1/11/21 the headache worsened to 4/10 and was associated with myalgias and neck stiffness. After a jog, I was in the shower and noticed a rash all over my body that had been pruritic. I went to the ER that night where I tested negative for flu A/B and also tested negative for covid (Antigen then PCR). Got a CMP, CBC, and coags to rule out ITP. everything was normal. The symptoms were so bad I stayed home from work on 1/12/21. Over the next few days the rash improved and the headache slowly went away
41 2021-01-18 chills, fever, headache, fatigue fever/Temperature taken 100 degrees Fahrenheit; chills; overall fatigue; headache; This is a spontan... Read more
fever/Temperature taken 100 degrees Fahrenheit; chills; overall fatigue; headache; This is a spontaneous report from two contactable physicians. A 41-year-old male patient received second dose of bnt162b2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After taking his 2nd dose of the vaccine on 09Jan2021, the patient experienced a headache on 09Jan2021, then on 10Jan2021, also included a fever and chills and overall fatigue throughout the day on 10Jan2021. Although these were consistent with the educational pamphlet on the vaccine, we still wanted to report it. Patient was taking ibuprofen and paracetamol (TYLENOL) as needed. Temperature taken 100 degrees Fahrenheit. Event took place after use of product. The outcome of all the events was unknown. Information about the lot/batch number has been requested.
41 2021-01-18 chills, fever, headache, fatigue Moderate injection site pain began the day of the injection and lasted for 2 more days, Chills occur... Read more
Moderate injection site pain began the day of the injection and lasted for 2 more days, Chills occurred multiple times with first occurrence roughly 13 hours after the injection and last occurrence roughly 60 hours after injection. Mild body aches/pains occurred 1 day after injection and lasted for the entire day. Fever (greater than 100 degrees F with a max of 101.0) was measured 1 day after injection and lasted into the second day after injection. Tiredness began 1 day after injection and lasted till 3 days after the injection. Headaches occurred on the second, third, and fourth days after injection.
41 2021-01-18 fatigue, headache headache, fatigue, nausea
41 2021-01-18 headache, fatigue body aches, fatigue and headache
41 2021-01-18 headache Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, li... Read more
Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, lightheadedness, dizziness, palpitations, high blood pressure.
41 2021-01-19 chills, sweating Chills, stiff joints, insomnia, excessive sweating while sleeping, pain to injection site
41 2021-01-19 fatigue, chills Body aches, chills, general exhaustion lasting 20 hours so far.
41 2021-01-19 headache, fatigue Stiff neck Headache Very tired
41 2021-01-20 fatigue, headache Persistent headache and tiredness for 24 hours after the first dose of the vaccine.
41 2021-01-20 fatigue After taking the second dose of the pfizer covid19 shot on 1/19/21. that evening I started to feel a... Read more
After taking the second dose of the pfizer covid19 shot on 1/19/21. that evening I started to feel a little bit fatigued. After waking up for work on 1/20/21 at 4:30 i was extremely fatigued, also felt some aches in my shoulders. I took 650mg of Tylenol and went to work. During my shift i was fatigued and started feeling chills. at 11:00 am i took 1000mg of Tylenol. I went to the hospital nurse and was sent home. 1/21/21. woke for work and am still feeling fatigued but i do feel like its lessening and I'm getting better.
41 2021-01-20 headache, fatigue As I woke the following day- I experienced a sore arm at shot site. I had a headache which I took Ty... Read more
As I woke the following day- I experienced a sore arm at shot site. I had a headache which I took Tylenol for. I also had body aches. Later in the day I felt more tired than usual and feel asleep on and off.
41 2021-01-20 headache After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with loca... Read more
After 1st Pfizer shot I experienced the worst headache of my life 4-6 hours after the shot with localized pulsation in my right temporal region prior to the headache. The headache persisted through the night and I could not sleep and did not decrease with over the counter medication, my pain was rated 9/10 to 10/10 in the same area the pulsation happened. This headache continued for 4-6 hours at a severe level than for another 6-8 hours at a moderate to severe level. I ended up checking in at the Emergency department that I worked at after my shift and got labs and CT scan, this was after my symptoms resolved. I thought that I might have had a head bleed and wish I would have gotten my CT earlier when experiencing the symptoms. I was not provided a vaccine disclosure sheet or any information on what to do if experience severe symptoms or what symptoms to expect. I am upset that I was not provided guidance about what to expect and how to manage post vaccine symptoms, I would have gone into ED sooner with this information and feel I may have missed possible diagnosis due to lack of disclosure and guidance.
41 2021-01-20 sweating My ears were ringing, I was sweating, I felt a little faint, and I became light headed.
41 2021-01-21 fever, headache, chills Sore arm at injection site. Chills, headache, and fever of 100-101F. .. on third day of fever
41 2021-01-22 headache On 12/26 (Sat), heart rate increased to 170 and then calmed down. On Sun and Mon - vomiting, nausea ... Read more
On 12/26 (Sat), heart rate increased to 170 and then calmed down. On Sun and Mon - vomiting, nausea and HA on and off. On Mon heart rate increased again. Went to Urgent Care and tested covid negative. On Wed 12/30, BP at 180/105. Went to ED and BP eventually went down to 145/95. Dr is speculating that since patient had high antibodies from covid infection in August and still high antibodies in October that all of this is a wild immune reaction triggered by the vaccine.
41 2021-01-22 sweating client became dizzy, lightheaded and sweaty; while in 15 minutes waiting area; client states he only... Read more
client became dizzy, lightheaded and sweaty; while in 15 minutes waiting area; client states he only had 2 cups of coffee and trail mix for breakfast; treated with , 1 cup water,1 cup apple juice and granola bar; VS 136/76, pulse 74 and regular, respirations easy; client observed for 30 minutes; symptoms resolved with nourishment.
41 2021-01-23 fever, fatigue, headache Fever, Headache, Fatigue, Muscle Aches
41 2021-01-24 lethargy, headache Lethargy at 12 hours post injection - resolved by 24 hours post injection Headache at 12 hours post ... Read more
Lethargy at 12 hours post injection - resolved by 24 hours post injection Headache at 12 hours post injection - resolved by 24 hours post injection
41 2021-01-25 chills, fever fever of 101/chills, body aches, and nausea
41 2021-01-25 fever, headache, fatigue About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms pr... Read more
About 4 hours after receiving the vaccine, began with headache and nausea/upset stomach. Symptoms progressively worsened to create low grade temperature body / joint achiness. Notable extreme fatigue. Prevented from going to work.
41 2021-01-26 chills Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other loc... Read more
Feeling weak; Muscle pain; Chills; Not been able to work for last 3-4 days; Please specify other location: Right shoulder; Shortness of breath; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231, Expiry Date: 30Apr2021) via an unspecified route of administration in right shoulder on 30Dec2020 20:30 at single dose for COVID-19 immunisation. The medical history was not reported. There were no concomitant medications. The patient previously took influenza vaccine on 2020 for immunization 2-3 months before this BNT162B2 vaccine, previously took flu shot in the past for immunization and got sick from it. That was about 3 years ago (2018). The patient went and got the Pfizer BioNTech about 2 weeks ago. Wants to know if side effects can start then after the vaccine. He has had chills, muscle pain, shortness of breath, and dizziness. Got this at hospital and has not been able to go to work on Jan2021 that last 3-4 days due to feeling weak. Received the vaccine on 30Dec2020 and the dizziness and shortness of breath kind of started days after that on Dec2020. The chills started a couple of days ago, about 3 days ago (Jan2021) and has been off and on. The muscle pains started today (13Jan2021). Just got a text message about getting the second dose next Wednesday. He did not get any other vaccines that day or 4 weeks prior. He got the shot to protect himself from the virus, but feels like he has the virus or something. The events did not require a visit to emergency room, but may go to be seen tomorrow. Events outcome of chills, muscle pain, shortness of breath, dizziness, and not been able to go to work that last 3-4 days due to feeling weak was not recovered.
41 2021-01-26 headache, fatigue, chills, fever Head ache / aches pain feaver chills / fatique
41 2021-01-26 malaise Generalized malaise and anorexia for about a day and a half. Took a Tylenol, doing better now
41 2021-01-27 fatigue, chills, headache Body aches, chills, headache and fatigue.
41 2021-01-27 fatigue, headache, chills Extreme fatigue Severe joint pain Muscle aches Headache Chills
41 2021-01-27 headache Body ache, Headache
41 2021-01-27 headache Headache, Myalgia, NauseaVomiting, weakness, sore arm Narrative:
41 2021-01-28 fatigue, fever, chills 2 hours later - fever 101.5; aches; chills; a little bit of fatigue (not as bad as the fever) - cont... Read more
2 hours later - fever 101.5; aches; chills; a little bit of fatigue (not as bad as the fever) - continued 2 days for fever; fatigue was 4 or 5 days (of not feeling good). 28th and 29th - body aches returned On the 30th, I woke up with a fever. I went in to get COVID test and it was positive for COVID. Didn't get second one because I was still symptomatic from COVID infection.
41 2021-01-28 fatigue 22 Jan 2021-Friday-Tired,SOB 23 Jan 2021-Saturday-Tired 24th Jan 2021-Sunday-folding laundry-winded ... Read more
22 Jan 2021-Friday-Tired,SOB 23 Jan 2021-Saturday-Tired 24th Jan 2021-Sunday-folding laundry-winded & tired 25th Jan 2021-Monday-winded, tired-climbing stairs 26th Jan 2021-tired & winded, 27th same, 28th Tired & winded 29th Today January-2021-Tired & winded-Reminded patient to GO to ER if his SOB get worse, or see his PCM Took naproxen for his tiredness
41 2021-01-29 sweating, body temperature increased 12 hours later woke up Sweating 101.5- 103, muscle ache back, joint pain finger pain, SOB fatigue. ... Read more
12 hours later woke up Sweating 101.5- 103, muscle ache back, joint pain finger pain, SOB fatigue. Lasted about 17hours.
41 2021-01-31 headache, lethargy, chills, fever, sweating chills; aches; headache; fever & bed sweats; fever & bed sweats; lethargy; This is a spontaneous rep... Read more
chills; aches; headache; fever & bed sweats; fever & bed sweats; lethargy; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 17Jan2021 12:00 PM at left arm at single dose for COVID-19 immunization. Medical history was none. No Known allergies. Other medications in two weeks included vitamin c [ascorbic acid], Zinc, Escitalopram 10 MG, Levocentrine. No other vaccine in four weeks. Patient experienced chills, aches, headache, fever & bed sweats, lethargy on 17Jan2021 05:00 PM. No covid prior vaccination. No covid tested post vaccination. It was unknown if treatment was received for the events. Patient was not recovered from the events. Information about lot/batch number has been requested.
41 2021-01-31 headache, fever 01/19/2021 14:00 Headache all evening. Low grade fever. No treatment provided. Resolved next day. Fe... Read more
01/19/2021 14:00 Headache all evening. Low grade fever. No treatment provided. Resolved next day. Feeling well at moment.
41 2021-01-31 headache Myalgias; Neck stiffness; Diffuse pruritic rash over my whole body; Mild headaches/Headaches worsene... Read more
Myalgias; Neck stiffness; Diffuse pruritic rash over my whole body; Mild headaches/Headaches worsened to about 4/10; This is a spontaneous report from a contactable physician (patient himself). A 41-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer/BioNTech, lot EH9899), via an unspecified route of administration in the right arm on 28Dec2020 11:45 at SINGLE DOSE for Covid-19 immunisation. Medical history included OSA (obstructive sleep apnea) and PFO (patent foramen ovale). He had no known drug allergy. No other vaccine in four weeks. Concomitant medication included aspirin [acetylsalicylic acid]. On 10Jan2021, he began having mild headaches. On 11Jan2021 the headaches worsened to about 4/10 associated with myalgias, neck stiffness and a diffuse pruritic rash over his whole body. To return to work he had to go get tested so he went to the ER, got Flu A/B test, Covid antigen, then PCR test, a CBC, CMP, and coags (to rule out ITP). All tests were normal, Nasal Swab was negative. Treatment given was Normal saline bolus and ketorolac 30mg IV. The outcome of events was recovered.; Sender's Comments: ~~~
41 2021-01-31 fever, chills, headache 17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headac... Read more
17h post the second dose of vaccination I have experience fever 38.1 C (100.6 F), persistent headaches, chills, muscle pain, low energy and lost of appetite. Fever does not respond well with Tylenol (1000mg) and is persistent.
41 2021-02-02 runny nose, fatigue 12/29 vaccination wife had runny nose on the 1st. 1/3/2021 runny nose, fatigue. 1/4/2021 COVID; ... Read more
12/29 vaccination wife had runny nose on the 1st. 1/3/2021 runny nose, fatigue. 1/4/2021 COVID; neg 1/8/2021 - found out on 1/12th COVID; Pos 1/14 cleared from isolation cleared for 2nd vaccine; 1/15th
41 2021-02-03 headache, sneezing sneezing, throbbing headache, thick tongue
41 2021-02-03 sweating Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was abo... Read more
Syncopal event after shot given . Clammy and diaphoretic , ashen appearance and announced he was about to pass out before he passed out . Has had between 15-20 similar episodes describable and recallable in his lifetime . Awoke after a brief 10 sec loss of consciousness. Felt immediately better and no different than any other episode that occurred after seeing needles and getting shots. Drank some water and dc home after observation . Drove himself home . No sequelae.
41 2021-02-04 fatigue, fever, headache Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient... Read more
Headache; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable physician (patient). A 41-year-old male patient received second dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer), batch/lot no. and expiration date not provided, via an unspecified route of administration (vaccination location: left arm) on 21Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included sinus tachycardia and Pvc (premature ventricular contractions). He had no allergies to medications, food, or other products. Concomitant medication included atenolol. Historical vaccine included first dose of bnt162b2 (reported as: product=COVID 19, brand=Pfizer) for covid-19 immunization on 31Dec2020 09:15 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered at a hospital. The patient experienced headache 24-36 hours, fever at 36 hours, fatigue, and nausea on 21Jan2021 05:00 PM. No treatment received for the adverse events. All events were assessed as non-serious (did not result to death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, and no congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
41 2021-02-05 sweating Patient became syncopal within 1-2 minutes of administration. He was lowered to the ground and evalu... Read more
Patient became syncopal within 1-2 minutes of administration. He was lowered to the ground and evaluated by medical team. When repositioned to seated position he again became syncopal, he was again lowered to the ground and placed in a recovery position. EMS assisted him to stretcher and he was transported to medical treatment area at the vaccination site, ECG and VS performed, patient was hypotensive, diaphoretic, and pale. He was ultimately transported to ED
41 2021-02-06 chills, fever Fever (101), night sweats, chills, sore arm
41 2021-02-07 sweating Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions t... Read more
Patient screened for first dose of Pfizer vaccine. He checked no history of allergies or reactions to medications or vaccines. In the initial screening he informed me he had a phobia of needles but this is usually with blood draws. He reported he should be fine with vaccinations. I inquired on previous reactions and he denied any allergic reaction just that he does not like them. I asked him how I can help give the vaccine. We had him look away and to think of a different situation. I asked him if he would like to know when I am administering or just use distraction. He chose to be informed when he would feel a slight poke. Vaccine was administered with no issues. Within the minute following the vaccine patient started to feel dizzy. Hung his head a bit but was responsive. I requested staff assistance to help the situation including RN to prevent any episodes of syncope. We provided water which he was able to drink. He was still seated and we suggested putting head between legs. This was not comfortable for him so we moved him to the floor. About 3-4 min in he began to sweat a bit more and appeared Pale. We obtained a BP and pulse. BP was 112/60 and pulse around 60. When he felt hot, sweaty and appeared pale we all decided to call EMS to be cautious. He maintained BP, no SOB, did not lose conscious. EMS evaluated him, med list provided and vitals. He was on medications for anxiety. They released him after about 30min and reported a panic attack and not related to the vaccine. Patient walked out of the clinic with his partner and was stable. He is requesting 2nd dose of the vaccine. I informed him nurse would review and would have a plan for future injection.
41 2021-02-07 fever Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and m... Read more
Shooting pain down left arm, Swollen Lymph node in neck, slight fever, hand pain between ring and middle fingers, Tylenol , appointment with PCP
41 2021-02-09 chills, headache teeth are extra sensitive to cold and sugar; headache; some chill; This is a spontaneous report from... Read more
teeth are extra sensitive to cold and sugar; headache; some chill; This is a spontaneous report from a contactable consumer reporting for himself. A 41-year-old male patient received bnt162b2 (BNT162B2, Lot no: EN5318), via intramuscularly on an unspecified date at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient stated: "my teeth are extra sensitive to cold and sugar a day or two after my vaccine. Otherwise just a headache and some chill, but those went away after 12 hours. Tooth sensitivity persisted 48 hours after vaccine." No treatment was received for the events. The outcome of sensitivity of teeth was not recovered, headache and chills was recovered on an unspecified date.
41 2021-02-09 headache, chills, fever low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started b... Read more
low grade fever, chills, muscle aches in shoulders/neck, headache, light headed. Symptoms started becoming persistent during commute to work beginning at approximately 0630. Symptoms were significant enough to hinder productive work by 1100, went home early. Napped from 1200-1500. Symptoms subsided by 1800.
41 2021-02-09 fever, chills, fatigue Pain in the injection site 15 after the shot was given. At 1pm fever of 101 started with chill. Arou... Read more
Pain in the injection site 15 after the shot was given. At 1pm fever of 101 started with chill. Around 3pm muscle weakness and tiredness started.
41 2021-02-09 fever, sneezing, chills, runny nose Chills, Subjective fever, Sneezing, Runny Nose. Chills became severe towards evening. Fever broke... Read more
Chills, Subjective fever, Sneezing, Runny Nose. Chills became severe towards evening. Fever broke during night while asleep. Resolved the following morning.
41 2021-02-10 fever, headache, malaise, chills Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was ve... Read more
Within our injection shot sore. No other adverse effects until 5:00 a.m. Woke up because body was very hot similar to being in a sauna. Removing for changing the blanket to a thinner one resulted in extreme chills within one minute. Covering with blanket resulted in extreme hot within 10 minutes. Repeated this cycle for several hours until fall asleep. High discomfort throughout body. Woke up at 10:00 a.m. with mild grade fever of 99.5° (average resting temperature is 96.5). Felt extreme cold and chills shivering body aches headache until 6:00 p.m. felt hungry and okay enough to eat. Main concern is the extreme hot to extreme cold cycle in early morning. It felt as though the body was not in sync. During fever throughout day/afternoon body's reaction was normal - fever meant chills and shivering, putting on a blanket meant comfortable warmth (after long periods of time). But in early morning no no fever yet body burning hot almost suffocating sauna heat insider body, and removing the blanket a immediate and severe chills with uncontrollable shaking, instead of relief from heat... Concerned if vaccine affects body's heart regulation system (hypothalamus, thyroid, etc). General malaise during this period is an understatement... It was not a single spot or feeling pain it was the whole body wanting to twist itself and feeling 'deprssed' and very 'ill' all over all at once.
41 2021-02-11 malaise, fatigue Again fatigue and just feels awful but also leg numbness which is new.
41 2021-02-12 fatigue, fever Fever (102.6 while on ibuprofen) about 18 hours, Fatigue about 36 hours, Severe joint pain head to t... Read more
Fever (102.6 while on ibuprofen) about 18 hours, Fatigue about 36 hours, Severe joint pain head to toe about 24 hours.
41 2021-02-12 headache, chills, fatigue, fever Fever, chills, headache, muscle ache, fatigue, dizziness
41 2021-02-14 chills, influenza like illness Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep;... Read more
Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
41 2021-02-17 chills, headache head ache; Chills; body ache; This is a spontaneous report from a non-contactable consumer (patient)... Read more
head ache; Chills; body ache; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills, body ache, headache. No treatment was received for the events. Outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-02-18 throat pain, fever Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurr... Read more
Initial adverse events: night sweats, fever, body aches, muscle aches (Back pain). These all occurred about 12 hours after the second shot and subsided around 36 hours after the second shot. 8.5 days after the second shot I had throat and chest pain. This pain then continued and got worse to the point I went to the ER and was evaluated for potential heart attack. After testing - results were that I did not have a heart attack. I was still experiencing this pain, so the ER took a strep test. This was also negative. The diagnosis was "pulled chest muscle". I've had pulled muscles, I know what those feel like and it sure didn't feel like what I experienced on the night of the 16th and the day of the 17th of Feb. 2021.
41 2021-02-19 sweating Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiet... Read more
Flushing/sweating, right-sided warmth (right arm at injection site). Patient has a history of anxiety and hypertension. Initial BP 161/102 (pulse 102); final BP 132/88 (pulse 95).
41 2021-02-21 chills, headache, fever, fatigue 3 hours after vax Injection site soreness 15 hours after vax Fatigue 17 hours after vax elevated tem... Read more
3 hours after vax Injection site soreness 15 hours after vax Fatigue 17 hours after vax elevated temp 99 degrees 21 hours after vax fever 100.3 degrees 24 hours after vax fever 101.0 degrees, chills 24 hours after vax took Tylenol 25 hours after vax fever down to 100.3 degrees (went to sleep) 34 hours after vax woke up and temp back to normal at 97.9 degrees 43 hours after vax slight headache and elevated temp to 99 degrees (went to sleep) 57 hours after vax woke up and temp back to normal at 97.7 degrees No further side effects
41 2021-02-22 chills, fever After I went to bed, I started running a fever, had chills, and body aches. All my joints were sore ... Read more
After I went to bed, I started running a fever, had chills, and body aches. All my joints were sore the next day as well.
41 2021-02-22 fever, chills, headache, lethargy Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches
41 2021-02-24 chills, fever Fever, chills, body aches. Started 24 hours after first dose. It lasted for about 20 hours.
41 2021-02-24 headache, chills, fever Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of... Read more
Full body aches all night long, then fever of a 102.3 followed by chills, also headaches, feeling of low energy
41 2021-02-24 headache, fatigue, sleepiness, lethargy 95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, ... Read more
95.4 body temp, grogginess, confusion, fatigue, headaches, confusion, irritation, lack of appetite, lethargic
41 2021-02-25 chills Pt felt the chills shortly after receiving his first Pfizer dose. Pt had no other symptoms. I explai... Read more
Pt felt the chills shortly after receiving his first Pfizer dose. Pt had no other symptoms. I explained that chills are a common side effect after the vaccine. Pt felt well enough to sign out. We discussed options for worsening symptoms. Pt verbalized understanding importance of reporting worsening symptoms to PCP and me as well as going to the ED for life threatening symptoms. Pt came back at 4:30PM after signing out and asked to stay in observation. During this time, his symptoms worsened from chills to body aches and dizziness. Gait with assist was unsteady. I brought him down to the ED at 4:50.
41 2021-02-26 fever, headache Mid-grade fever (topped out at 102 F), severe body aches, joint pain, headache and nausea. Symptoms... Read more
Mid-grade fever (topped out at 102 F), severe body aches, joint pain, headache and nausea. Symptoms lasted for roughly 36 hours; they were very intense for the first 24 hours from the time of onset.
41 2021-02-27 fever I woke up around 1 am with a fever, skin pain, joint pain and muscle pain
41 2021-02-27 sleepiness Feb 17, 2021 woke up with slight case of covid arm. Feb 18, 2021 covid arm symptoms increased slight... Read more
Feb 17, 2021 woke up with slight case of covid arm. Feb 18, 2021 covid arm symptoms increased slightly and red patch on shoulder grew in size. Feb 19, 2021 soreness decreased, itchiness increased and the red patch at injection site had doubled in size. Feb 20, 2021 unknowingly slept through alarm, slept 16 hours straight and woke up feeling groggy. Covid arm symptoms started to dissipate, redness and swelling started to dissipate. Feb 21, 2021 no symptoms.
41 2021-03-03 runny nose, cough cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report fro... Read more
cough; runny nose; fuzzy headed/scatter brained; not sleeping good; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: WEN5318), via an unspecified route of administration on left arm on 28Jan2021 (at the age of 41years) at single dose for covid-19 immunization. Medical history included scratchy throat the day before the vaccine (27Jan2021). The patient had no concomitant medications and no investigation assessment. The patient got first dose of vaccine 28Jan2021 and was debating whether to get Covid test because of symptoms. The patient had a cough and runny nose on 29Jan2021 and fuzzy headed, scatter brained and not sleeping good in 2021. The patient considered the events as non-serious. Asked if these symptoms were from the vaccine and if getting the vaccine cause a false positive on the Covid test. Stated Friday had cough and runny nose. He stated that it felt like he had a pretty bad head cold and would not think about getting tested but since Covid was around. Wanted to know if these were common side effects of the vaccine or if he needed to get tested. The patient just moved houses and it was a stressful process. Sometimes when one gets stressed that one gets sick and may have contributed to his condition. Later clarified that this was for the Pfizer Covid 19 vaccine. The patient stated that the cough and runny nose worsened over the weekend and was a little better now and took alpha lipoic acid;minerals nos;quercetrin;vitamins nos (EMERGEN-C). The outcome of the events cough and rhinorrhea was recovering while unknown for the remaining events.
41 2021-03-07 fatigue swollen and painful axillary lymph node, joint pains fatigue and under arm pain
41 2021-03-09 headache, chills, fever High fever (102 Fahrenheit); body aches; chills; severe headache; nausea; This is a spontaneous repo... Read more
High fever (102 Fahrenheit); body aches; chills; severe headache; nausea; This is a spontaneous report from a contactable consumer (patient himself). A 41-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (at age of 41-year-old) (Lot number: EL3247, expiry: May2021), at single dose in Left arm for COVID-19 immunization. The patient medical history reported as none and no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Feb2021 10:15 AM (at age of 41-year-old) (Lot number: EL3247, expiry: May2021), at single dose in Left arm for COVID-19 immunization and experienced Body aches, joint pain, and intermittent nausea. These symptoms started approximately 8 hours after the shot and persisted for 48 hours. The patient experienced high fever (102 fahrenheit), body aches, chills, severe headache, nausea on 25Feb2021 22:00. These intense symptoms began approximately 12 hours after the 2nd shot and are currently on-going. These events did not result in emergency room visit or physician office visit. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 25Feb2021. No treatment received for the adverse events. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213613 same reporter/patient/drug, different time/event
41 2021-03-10 chills Experienced extreme chills from 11PM until about 1AM.
41 2021-03-10 fatigue Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes afte... Read more
Tingling/itching sensation over right side of face and scalp, starting approximately 10 minutes after vaccination and lasting approximately 20 minutes. Resolved without treatment Intermittent, then sustained muscle soreness in the right arm starting approximately 6 hours after vaccination and lasting until approximately 48 hours after. Resolved without treatment. Fatigue the day following vaccination, and the day following that, but not on the day of vaccination. Resolved without treatment.
41 2021-03-10 headache Severe pain in the left eustacean tube from the ear to the throat, including jaw. Feels like intense... Read more
Severe pain in the left eustacean tube from the ear to the throat, including jaw. Feels like intense pressure/blockage, but still able to voluntarily open the tube (pop your ears) and no increase in mucus discharge or congestion. No swollen lymph nodes in the neck. Pain got up to a level 6/10. Took Extra Strength Tylenol and went to bed early. Following day it still aches some, about the same as the arm area of the shot. Not sharp pain any longer but sore.
41 2021-03-11 sweating nausea and sweating. Evaluated by EMS-Cleared
41 2021-03-11 sweating Patient felt light headed and faint as if patient was going to pass out. Felt sweaty and dizzy howev... Read more
Patient felt light headed and faint as if patient was going to pass out. Felt sweaty and dizzy however no intervention was needed and patient felt fine after some time once paramedics arrived.
41 2021-03-11 malaise, sweating 20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied... Read more
20 minutes of monitored and recorded tachycardia (peak heart rate of 188) while at rest. Accompanied with perspiration, flushing, myalgia and malaise. Tachycardia resolved, other symptoms persisted for 12+ hours.
41 2021-03-13 chills Severe chills lasting approximately 2 hours.
41 2021-03-14 cough, chills, fatigue, throat pain, fever My husband developed a low-grade fever, chills, sore throat, Mild cough, and extreme fatigue. He a... Read more
My husband developed a low-grade fever, chills, sore throat, Mild cough, and extreme fatigue. He also tested positive for COVID. He had COVID test a day prior to vaccine and tested negative.
41 2021-03-14 fatigue, headache Mild headache; mild upset stomach; tiredness; This is a spontaneous report from a contactable consum... Read more
Mild headache; mild upset stomach; tiredness; This is a spontaneous report from a contactable consumer(patient). The 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild headache, mild upset stomach, and tiredness, all on an unspecified date(Feb2021) with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-03-14 fever, cough, fatigue, productive cough Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and F... Read more
Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and Flue and Claritin - D 12 hrs. Lasted 24 hr. Started Saturday Night and ended Monday Morning. Feeling exhausted after the events.
41 2021-03-17 chills, headache Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination... Read more
Second Pfizer COVID vaccine given 2/12/2021. Developed symptoms one day after 2nd Pfizer vaccination with headache, body aches, chills, followed by abdominal pain, vomiting and diarrhea over the next 3 days, then became confused per wife so he came to ED for evaluation on 3/16/2021 and evaluated by me. Also had black stools and vomiting blood. Diagnoses: Septic shock, Gastrointestinal Bleeding with severe blood loss, Hepatitis with Hepatic Encephalopathy, Liver cirrhosis. Admitted to hospital 2/16/2021-discharged 2/21/2021. Since symptoms developed day after vaccination, I am compelled to report.
41 2021-03-17 fever Myalgia, Arthralgia, Fever, INJECTION SITE PAIN Narrative:
41 2021-03-18 headache For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debili... Read more
For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches. I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to a neurologist (April 1st appointment).
41 2021-03-18 headache Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn li... Read more
Sunburn like feeling starting on stomach, forearms and but cheeks. Head pain on left side Sunburn like feeling now in armpits and neck pain running down thru back
41 2021-03-21 fever Pt's wife reports "he had a fever and swollen lymph nodes in his jaw and elbow. the injection site ... Read more
Pt's wife reports "he had a fever and swollen lymph nodes in his jaw and elbow. the injection site arm was tender to touch"
41 2021-03-22 fever, headache, chills Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptom... Read more
Headache, nausea, fever, chills, soreness in right arm, and insomnia. No treatment provided. Symptoms ongoing as of 9:45am 03/23/2021
41 2021-03-22 fever, headache Headache, Myalgia, Fever, INJECTION SITE PAIN Narrative:
41 2021-03-23 fatigue The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE ... Read more
The patient is a 41 yo male with a history of seasonal allergic rhinitis who experienced DVT and PE temporally related to Pfizer BioNTech COVID vaccine dose #2 receipt. He is a Service Member and reported high levels of baseline activity, including running 10 miles each Saturday. He received vaccine #1 25 JAN 21 (EN5318) without AE. He received dose #2 on 16 FEB 21, (EN6200). He experienced no immediate symptoms suggestive of IgE event. On day 1 he reports feeling cold, mild fatigue but no other symptoms. On day 2 he was baseline. On day 3 he noted numbness, tightness and discomfort to his right calf. On day 4 (Saturday), his usual long run day, he experienced dyspnea and lightheadedness after running 20-30 feet. He states he noted tightness in his calf and instead walked the track while his wife completed her run. He rested day 5. Day 6 he noted significant edema to his calf, which he describes as double normal in size, and iced it. Day 7, he tried to schedule with PCP and based on triage was sent to ER. ER diagnosed R DVT and bilateral PE's. He was admitted overnight, started anticoagulation therapy. He saw hematology, and the workup was negative for other causes.
41 2021-03-23 headache Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started abou... Read more
Soreness in arm, started about 1/2 hrs lost injection, lasted about 24 hours. Headache, started about 6/7 hrs post injection. Increased in severity the next day. Non-issue as of 3/24
41 2021-03-23 sweating woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is... Read more
woke up warm/sweaty; mild general body aches/stiffness; Mild arm soreness; trouble sleeping; This is a spontaneous report from a contactable healthcare professional (patient). This 41-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 18Feb2021 at 09:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriasis for which he received guselkumab (TREMFYA) injections every 2 months. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. The patient did not receive any concomitant medications. The patient did not have any allergies to medications, food, or other products. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 01:30 as a single dose in the right arm for COVID-19. On 19Feb2021 at 00:00 after dose 2 of BNT162B2 the patient experienced mild arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of mid arm soreness, woke up warm/sweaty, had trouble sleeping, and mild general body aches/stiffness were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
41 2021-03-24 chills suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report... Read more
suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
41 2021-03-26 sweating Shortly after being vaccinated patient started to excessively sweat. No other complaints. EMS observ... Read more
Shortly after being vaccinated patient started to excessively sweat. No other complaints. EMS observed patient and released patient to go home.
41 2021-03-26 sweating low blood pressure and dizziness, diaphoresis. Taken to medical observation BP 110/60 At 0954 AM BP ... Read more
low blood pressure and dizziness, diaphoresis. Taken to medical observation BP 110/60 At 0954 AM BP was 120/70 Patient stable. Discharged to exit via wheelchair.
41 2021-03-27 throat irritation Patient c/o tightness in face, itching in back of throat, and rash on face and back of neck was note... Read more
Patient c/o tightness in face, itching in back of throat, and rash on face and back of neck was noted.
41 2021-03-28 chills, fatigue Pain at injection site. Intermittent chills lasting ~90 minutes. Joint pain, general fatigue.
41 2021-03-28 chills Light head and dizziness, chills, slightly elevated heart rate
41 2021-03-28 fatigue Dull pain in calf, cramping legs , tired , warm sensation
41 2021-03-28 headache, fatigue, chills, sleepiness, fever Fever with chills that didn't come down easily even under the administration of Acetaminophen 500mg ... Read more
Fever with chills that didn't come down easily even under the administration of Acetaminophen 500mg every 4 hours (strangely temperature was only 37 C), throbbing head ache, body ache, drowsiness and fatigue, loss of apetite, nausea, heartburn, constipation.
41 2021-03-28 headache, fever Patient received vaccine on Thursday. Did not start experiencing adverse reactions until Sunday morn... Read more
Patient received vaccine on Thursday. Did not start experiencing adverse reactions until Sunday morning. Patient had swollen lymph nodes from neck to ear canal with fever and pain. He also had hives above the left eye on the eyelid and eye was red and itchy. He also experienced a headache and low grade fever. These reactions have not resolved (as of Monday), however, they are slightly improving.
41 2021-03-28 headache Mild body aches, mild headaches, numbness and tingling down the arm injected, little light headed
41 2021-03-29 fatigue, headache I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car ... Read more
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated and was not warned about the dangers of driving after the vaccine. Please call me. I need help
41 2021-03-29 fatigue, fever low grade fever; tiredness; pain around injection site; This is a spontaneous report from a contacta... Read more
low grade fever; tiredness; pain around injection site; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified dates, the patient experienced low grade fever, tiredness, and pain around injection site. The events were reported as non-serious and did not require hospitalization. The events were treated with ibuprofen. The clinical outcomes of low-grade fever, tiredness, and pain around injection site were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.
41 2021-03-30 chills, fever, nasal congestion, headache, fatigue Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Di... Read more
Low grade fever (100.9); Tiredness; headaches; muscle pain; chills; joint pain; nasal congestion; Dizziness/Weakness; Dizziness/Weakness; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 29Jan2021 14:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that since Saturday at 10AM. Low grade fever (100.9). Tiredness, headaches, muscle pain, chills, joint pain, nasal congestion, Dizziness/Weakness. Scale of 1-10, 10 being the worst= Level 9 on 30Jan2021 at 10:00 AM. The patient not received treatment for the events. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The report considered as a non serious. The outcome of the events was reported as not recovered.
41 2021-03-30 cough, chills, productive cough, throat pain, headache Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the follow... Read more
Sudden dizziness and then vomiting. Specifically within hours of food being eaten. Nausea the following 2 days, March 28, 29, specifically after eating. March 30th, woke up with chills, sore throat, headache, body aches lasting all day. Diarrhea. No longer nauseated. March 31st, all symptoms subsiding except for a minor headache and sore throat with mild cough and phlegm.
41 2021-03-30 fever, fatigue, chills Fatigue, chills, soreness, fever for 48 hours
41 2021-03-31 chills, headache, fever Day of injection (29th), I had injection site soreness by the evening. Took a dose of Tylenol 500 mg... Read more
Day of injection (29th), I had injection site soreness by the evening. Took a dose of Tylenol 500 mg x 2 tablets. Following day (30th), I had the following: Overall muscle soreness; Joint pain in neck, lower back, hips, and knees; Chills; Low grade fever to 101F; Injection site pain. Continued Tylenol throughout the day. added 1 dose ibuprofen 200mg x 2 tablets in the evening. Following day (31st), I only had headache, lasted all day. Took only 1 dose of ibuprofen 200mg x 2 tablets in the evening. Following day (Apr 1st), No more issues.
41 2021-03-31 chills Aches in my arms and shoulders began a few days before the second vaccination in the series. After ... Read more
Aches in my arms and shoulders began a few days before the second vaccination in the series. After receiving the second vaccination, the aches progressed to full upper body aches. They have since progressed to full body aches. I also had major chills 2 nights ago.
41 2021-04-01 fatigue, malaise 3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized ... Read more
3/30-Adverse events experienced and are they still occurring now: Caller c/o fatigue & generalized "feeling sick" since receiving 2nd vaccine on 3/25/2021. C/o shortness of breath beginning on Sunday 3/28/2021, called out of work yesterday and today, stayed in bed both days due to "feeling exhausted", no distress while on phone. Reports taking tylenol/ibuprofen as needed as well as using rescue inhaler for asthma as needed. Advised to follow up with PCP or Urgent Care due to SOB and asthma history. 4/1-Follow up call by Patient feeling better than yesterday, no longer feeling shortness of breath. Recommended to follow up with physician if symptoms worsen.
41 2021-04-01 headache 03/31/21 10:31 am 1 minute after the first dose, metal taste in my mouth (like a mouthful of nickels... Read more
03/31/21 10:31 am 1 minute after the first dose, metal taste in my mouth (like a mouthful of nickels) that lasted about 5 hours. 04/02/21 08:00 am small headache when I woke up and whistling in ears feels like a small hangover but i haven't been drinking anything for weeks
41 2021-04-01 lethargy, malaise Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noti... Read more
Patient got their Pfizer covid-19 vaccine and during the 15 minute post vaccination waiting was noticed to be lethargic and just didn't feel right. Upon checking vitals it was determined that the patient's blood pressure was a little high, but all other vitals were fine. Patient still said that he didn't feel right so EMS was called and the patient was transported to Hospital for further evaluation.
41 2021-04-01 fever, headache, chills, sweating chills, sweats, fever, headache. Lasted approximately 36 hr. starting the evening I received the se... Read more
chills, sweats, fever, headache. Lasted approximately 36 hr. starting the evening I received the second vaccine.
41 2021-04-01 fever, lethargy, chills Fever, serious lethargy - I slept for 8 hours at a time and woke only to eat and went straight back... Read more
Fever, serious lethargy - I slept for 8 hours at a time and woke only to eat and went straight back to bed. Had fever of 101 and chills. Body aches. All sx x 48 hours and then gone.
41 2021-04-01 fever, malaise, headache Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the s... Read more
Within 5 mins of the shot, I got dizzy but I sat down and that feeling went over. After dinner the same day, I had vertigo and had to vomit. Since then there has been nausea and headache, and I have trouble sleeping in. I feel some more discomfort after eating food. I have intermittent fever also. It has been about 10 days today since I got my COVID Pfizer shot and I still don't feel physically well. I just wanted to report this, as the impression from documentation I read is that symptoms should go away in 3-4 days.
41 2021-04-02 fatigue, headache Day after the vaccine I was very tired with muscle aches and a headache. Two days after my right ea... Read more
Day after the vaccine I was very tired with muscle aches and a headache. Two days after my right ear has been ringing and wont stop.
41 2021-04-02 headache, fatigue Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 2... Read more
Dose 1: Severe headache for the next day, minor pain and moderate stiffness of R arm over the next 24 hours. I am *not* submitting this report for the first dose. Dose 2: Moderate headache over next day, mild fatigue over next day, moderate joint pain over next day, same discomfort/stiffness of R arm. The one thing I wanted to report was my L shoulder. I had pulled/torn it around Wednesday of the week and it hurt quite a bit when I put it in the wrong position, but it was otherwise fine. However, post-second Pfizer shot, the pain in my L shoulder easily double or tripped for some reason as a reaction to the vaccine. Basically, Friday before the shot, my should hurt a little bit but had been getting progressively better. But post-second Pfizer shot, the same area that had mild pain before now felt like I had been stabbed in the shoulder or that I had re-torn the muscle and had done so in a significantly worse way. It's not a big thing, but you may want to start asking people if they've recently had any muscle injuries prior to vaccination. I'm now ~30 hours post vaccine and it is decreasing in pain, but the shot obviously had some type of impact on what bruising/swelling/tearing of my L shoulder that I had. (Note that both vaccine shots were to the R arm and the L should was not related to that in any way.)
41 2021-04-03 headache, chills 6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bo... Read more
6pm April 2 - began feeling nauseous and chilled, began shivering. 8pm April 2 - began vomiting...bouts of vomiting every 1.5 hours from 8 pm April 2 until 12 noon on April 3. An acute stomach ache followed and continued until the morning of April 4th. After vomiting stopped, I laid in bed from about 3pm on April 3 until 9 am on the 4th...I would sleep for 45 minutes at a time and wake in a cold sweat...I physically felt very cold, but was drenched in sweat. The chills and cold sweats stopped on the morning of the 4th and gave way to a lingering but persistent headache and dull stomach ache which are continuing now (3pm on April 4), but seem to be slowly fading.
41 2021-04-03 headache, fatigue Headache, fatigue, muscle aches
41 2021-04-04 headache, fever, fatigue, chills Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling t... Read more
Headache - 4 days and still comes and goes sometimes being very extreme. Fatigue - Started feeling tired around 5:00pm the day of the vaccine and I have continued to feel tired after 4 days. Muscle/Joint pain - Started getting sore arm first a couple hours after shot then progressively getting worse on my entire body for 3 days. On day two is was almost unbearable with my lower back being the most painful. I could not sleep because of the pain with no position that would relief it. Chills - Started getting chills on the evening of the vaccine. They came and went for 3 days. On the second day it was uncontrollable shakes no matter how many blankets I used. Fever - Started the night of my vaccine increasing to 102.4 and reaching the highest on the second day at 103.5. I took ibuprofen every 6 hours for two days straight with it staying steady at above 100. Nausea - Started the evening of the vaccine and got very severe. It has continued for 4 days. Fast Heartbeat - It has stayed consistently above 110 and sometime getting up to 130 while laying in bed shivering.
41 2021-04-06 fatigue Extreme fatigue, extreme weakness, extreme soreness.
41 2021-04-07 headache, fever, chills Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of fee... Read more
Starting 12 hours after dose: Rotating between fever and chills Fever of 103+ Numbness / loss of feeling in tips of fingers / thumb Tinnitus Lower back pain Lack of focus / irritable Overall random shots of pain through body Diarrhea legs and feet turned purple Constant frontal headache Lack of appetite/ nausea Some foods taste metallic
41 2021-04-07 headache, fever Nausea, diarrhea, head and body pain, fever.
41 2021-04-07 sweating Post vaccination, while patient seated in monitoring area, patient fell out of chair and hit right s... Read more
Post vaccination, while patient seated in monitoring area, patient fell out of chair and hit right side and reportedly caught himself and did not hit his head. EMT witnessed event, patient did not loose consciousness. EMT evaluated Vitals HR 45, RR 24, BP 90/57, temp 98.1, +diaphoretic, AAOx3, blood sugar 132. Pt was given orange juice. Vitals remained unchanged for 10-15 minutes. Vitals measured q4 min, patient remained AAOX3 and answered all questions appropriately. At 12:22 Vitals HR 70, RR 20, BP 138/95, Temp 98, no longer diaphoretic. Pt stood without dizziness. Patient denied transfer to ER and was escorted to car at 12:30 reporting to EMT he feels back to baseline.
41 2021-04-07 sweating After administering the vaccine, the patient experienced a severe vasovagal response approximately 5... Read more
After administering the vaccine, the patient experienced a severe vasovagal response approximately 5 minutes after receiving the vaccine. Diaphoresis was treated with ice packs. PulseOx was normal, blood pressure and heart rate were stable.
41 2021-04-07 sweating started to sweat and felt "not right" post injection a few minutes, states has happened several time... Read more
started to sweat and felt "not right" post injection a few minutes, states has happened several times in past when getting injections. staff assisted to floor and states did lose consciousness for a moment. felt better once in obs, 1517 bp 119/68 hr 83 rr 20 sats 98% on ra. 1530 bp 138/72 hr 67 rr 17 sats 98% on ra. states s/s resolved, stood up with no issues, escorted to personal vehicle with no issues.
41 2021-04-08 fatigue Woke up with cold sweat, nausea and vomiting, fatigue.
41 2021-04-08 headache, fever Headache, stiffness, body aches, diarrhea, heartburn, fever 101.4 , feel extremely weak!!!
41 2021-04-08 fever, fatigue Fever, body aches, and tiredness throughout the day on 4/7/21. No medical treatment, only ibuprofen.... Read more
Fever, body aches, and tiredness throughout the day on 4/7/21. No medical treatment, only ibuprofen. Tiredness only on 4/8/21.
41 2021-04-08 throat irritation, sweating Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild,... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: patient felt like his throat was itchy and felt flushed and sweating. he had no other apparent symptoms, we gave him a benadryl and he appeared to be fine
41 2021-04-09 fever, headache Same day had shooting pains down arm all the way down wrist. Later in the week had joint swelling i... Read more
Same day had shooting pains down arm all the way down wrist. Later in the week had joint swelling in left wrist, left hand, left elbow. The following week had swelling in left ankle. Lower back pain about one week later. Swelling will not go down with any treatments - ice/heat, epsom salt soaks, ibuprofen, creams. Did have a fever and headache the night after vaccine but I did expect that.
41 2021-04-10 chills Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under le... Read more
Severe muscle aches and joint pain; shakes and chills; intense night sweats; and large mass under left arm (injection arm). All started the morning after the second dose, and lasted until the following morning. The mass in my armpit is still present and is slightly sore to the touch.
41 2021-04-10 fatigue Dizziness, swollen lymph node right neck with moderate/severe pain (opposite side), lasting fatigue
41 2021-04-10 malaise on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having c... Read more
on 4/11/2021 approximately 1pm , just left home from lunch and went back to work. started having chest tightness, chest pain, called wife -- he felt clammy and all around not feeling well and above symptoms. Advised him to come home- stayed on phone with him til he arrived home. took his blood pressure with wrist bp machine while sitting at dining table and it was 171/85 and pulse was 85 so called EMS.
41 2021-04-11 fatigue, chills, fever After the second shot I had symptoms of chills, fever, and fatigue. Four days later I began experi... Read more
After the second shot I had symptoms of chills, fever, and fatigue. Four days later I began experiencing dizziness and spinning. I visited a doctor and he told me I have vertigo (BPPV). The symptoms match vertigo, but I?ve never experienced it before in my life. It seems like it?s possible that it is a result of the second shot. I?ve read online there are many other people getting similar symptoms.
41 2021-04-11 throat irritation Pt recieved his second dose of Pfizer vaccine at 1120am stated at 1130am that he felt like is throat... Read more
Pt recieved his second dose of Pfizer vaccine at 1120am stated at 1130am that he felt like is throat was feeling itchy and swollen also stated he has a history of severe anxiety then further stated it may not be swollen but i just feel like its very itchy. Nurse evaluated the patient noted O2 sats of 97% pulse was 80 no visible signs of distress were noted on the patient. nurse was noting signs of anxiety with figiting and constant movement to the patients limbs. Benadryl 25mg liquid was administered PO patient was able to swallow the medication without any visible difficulties. Nurse frequently checked on patient with no changes at 1208pm patient stated he was feeling better. Nurse released the patient from high observation area with mother driving and patient in the passenger seat.
41 2021-04-12 headache, fatigue Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injecti... Read more
Headache, diarehhia, fatigue, muscle and joint pain, swollen lymph nodes (arm pit on side of injection), chest pain
41 2021-04-12 sweating pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, ... Read more
pt began feeling "hot" nad was sweating moments after reviewing vaccine. Vitals BP 161/97, HR 110, O2 sat 99%. Pt's entire body began shaking. Pt was unable to walk. EMS called, transported to hospital.
41 2021-04-12 fever, headache Headache developed day after shot. Persisted one week later. Fever developed 5 days later with no ... Read more
Headache developed day after shot. Persisted one week later. Fever developed 5 days later with no other obvious cause.
41 2021-04-13 fatigue Soreness in arm for first 2-3 days Fatigue for 1 week so far, still ongoing
41 2021-04-13 fever mild myocarditis with fevers +constitutional symptoms, trop and BNP elevation (without other cause),... Read more
mild myocarditis with fevers +constitutional symptoms, trop and BNP elevation (without other cause), ekg abnormalities, EF wl
41 2021-04-14 headache Headache for about 3 days continuously after.
41 2021-04-15 fatigue Major symptom experienced is severe swelling and pain in right armpit, i.e. lymphedema. Lymphnoid is... Read more
Major symptom experienced is severe swelling and pain in right armpit, i.e. lymphedema. Lymphnoid is swollen and painful for 5-7 days shot. Fatigue and overall achiness.
41 2021-04-15 headache, chills Cold chills, sore body and muscles, debilitating headache.
41 2021-04-16 fatigue Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightenin... Read more
Vaccine on the 6th Sore arm that day. That night before bed dizzy, tired, back muscles tightening. 7th. Dizzy , tight muscles, sore arm, that late afternoon i sneezed. My back went out. Severe spasms and pain from The 7th-16th. Late night on the 16th. Chest neck and shoulder pain. Heart flutters, tachycardia, oxygen levels dropping to 89. Hovering around 95. Severe nausea. Abdomen pain. Tight painful muscles in legs Same and worse today on the 17th , had ER visit Been taking Valium and Tylenol for pain and spasms per my PCP since April 15
41 2021-04-16 headache, fatigue, fever, sweating, body temperature increased, chills Symptoms: Fatigue, headache, nausea, joint pain, elevated temp 100.4F, chills, sweating, difficulty... Read more
Symptoms: Fatigue, headache, nausea, joint pain, elevated temp 100.4F, chills, sweating, difficulty breathing. Treatment: Tylenol, water, anti-nausea, sleep. Duration: 18hrs
41 2021-04-16 headache Continued headache one week later. Has not gone away since 2nd vaccine.; This is a spontaneous repor... Read more
Continued headache one week later. Has not gone away since 2nd vaccine.; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:30 as SINGLE DOSE for covid-19 immunization. Medical history included dust allergy, asthma, anaemia vitamin b12 deficiency. Concomitant medications included levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR). The patient previously took bnt162b2 for covid-19 immunization, had past drug therapy with aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. It was reported that, on 15Feb2021 at 17:00, patient experienced continued headache one week later and has not gone away since 2nd vaccine. As a therapeutic measure, Tylenol Advil were provided to patient. The outcome of the event not recovered.
41 2021-04-16 headache Slight dizziness and headache
41 2021-04-17 headache, fatigue, chills Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after ... Read more
Sore arm starting 12 hours after shot Body aches, chills, fatigue, headache starting 26 hours after shot and lasting for 6 to 8 hours
41 2021-04-17 headache, malaise, sleepiness, fatigue Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic v... Read more
Sleep for a few minutes, I didn't pass out but it was similar; Was pulled over "for minor traffic violation." He was told "to get out of the car and had a field sobriety test, and I looked intoxicated."; Felt heavy and tired/Run down; Had a headache; Upset stomach; sleep for a few minutes, I didn't pass out but it was similar/crashed for 4-5 hours in the middle of the day which I never do; aching; Over all weakness; Started feeling sick again at dinner; Woke up feeling really bad; Bad diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Allergic to sulfa, PCN and amoxicillin. The patients concomitant medications were not reported. On an unspecified date the patient experienced sleep for a few minutes, I didnt pass out but it was similar, was pulled over for minor traffic violation. He was told to get out of the car and had a field sobriety test, and I looked intoxicated, felt heavy and tired/run down, had a headache, bad diarrhea, upset stomach, sleep for a few minutes, I didnt pass out but it was similar, crashed for 4 to 5 hours in the middle of the day which I never do, aching, overall weakness, started feeling sick again at dinner, he went to the bathroom a few times, woke up feeling really bad. The patient was worried because everything was coming to a head right now. The caller got the first shot, he waited for 15 minutes and felt fine. As the caller walked to his car he began feeling heavy, had severe diarrhea, headache, aching, it was almost like he passed out, it felt like he went to sleep. The patient got home and crashed 4 to 5 hours in the middle of the day and woke up feeling really bad. The patient went to a very important dinner meeting that night. While the patient was at the meeting he went to the bathroom a few times and then excused himself because he felt so bad. The patient did not even finish one cocktail with dinner. The caller got pulled over for a minor traffic stop, cutting the corner and crossing the line or something small. The officers believed the caller was driving under the influence and started making him do a sobriety test with 40 degree wind gusts, the patient was miserable. The caller told the officers that he needed to seek medical attention but they ignored him. The officers forced the caller to do the urine test. It has been 5 days since his vaccination and he is just now feeling better. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
41 2021-04-17 headache, fever fever, body ache, headache
41 2021-04-17 fever, chills, headache very bad headache, body aches and soreness from over night aching. chills over night but no noticea... Read more
very bad headache, body aches and soreness from over night aching. chills over night but no noticeable fever. tylenol helped with the severity of the aches. took tylenol again before bed and had a much better nights sleep. still a slight headache the second day afterwards.
41 2021-04-17 fever, headache Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; w... Read more
Covid test result Positive; Covid test result Positive; Steadily increasing headache; Muscle ache; weakness; feverish; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN- reported as misplace/discarded), dose 1 via an unspecified route of administration, administered in left arm (at the age of 40 years) on 21Dec2020 at 12:15 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. There was no patient medical history. The patient had no known allergies to medications, food, or other products. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 21Dec2020 at 14:30, 2.5 hours after the vaccine, the patient had steadily increasing headache, muscle ache, weakness and feverish. He took 250mg Tylenol. At 5.5 hours after the vaccine, his headache was so severe that he went to the Emergency Department of the facility he works in. Treatment for the adverse event included 1gram Tylenol, IV with saline and another drug (unspecified). The patient did not have COVID-19 prior to vaccination. On 24Mar2021, post vaccination, he was tested for COVID-19 via nasal swab with a positive result. The outcome of headache, muscle ache, weakness and feverish was recovered. The outcome of COVID-19 was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
41 2021-04-17 fever complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a c... Read more
complete body went paralyzed; lost vision; throwing up; fever; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6207), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 08:30 as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient started throwing up, fever, complete body went paralyzed and lost vision all it the ER on 05Apr2021 13:00. The events were resulted in emergency room /department or urgent care. There is some treatment (saline and ondansetron) for the events. The patient did not have covid prior vaccination, did not test covid post vaccination. The patient received Covid test post vaccination via Nasal Swab on 05Apr2021, covid test result was negative. There is no known allergies, no other medical history, no other vaccine in four week, no other medications in two weeks. The outcome of the events was resloving.
41 2021-04-18 chills, fatigue, headache Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fin... Read more
Metal taste in mouth within 30 minutes of injection., similar to injection 1. I otherwise felt fine and had a normal day of moderate physical activity. I awoke in the middle of the night with chills and body aches and a strong feeling of anxiety. I was able to fall back asleep and woke up as normal a few hours later. I had a very strong head ache centered behind my sinuses, body aches in my pelvis and legs, and hot flashes mixed with chills. Aches were manageable with Tylenol. As the day progressed those continued and I was very fatigued. I went to bed earlier than normal and after a full night's sleep symptoms subsided.
41 2021-04-18 headache, fatigue, fever 24 hrs of continuous fever between 99.86 and 101.5 (aprox). Moderate to intense muscle / bone pain m... Read more
24 hrs of continuous fever between 99.86 and 101.5 (aprox). Moderate to intense muscle / bone pain mostly in lower extremities (similar to the flu). Tiredness / inability to move (mostly due to muscle pain). Mild to moderate headache.
41 2021-04-18 fever, fatigue, influenza like illness Diarrhea, throwing up, dizziness, tiredness, trouble breathing, fever,- flu like symptoms
41 2021-04-19 fever, headache A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next mo... Read more
A few hours after my 2nd shot I got dizzy then a headache. My arm hurt too, quite a bit. The next morning I woke up with a fever of 101.5 and kept that fever for 2 more days. I felt weak, dizzy, but the physical pain was the worst. My head was pounding, my neck, back, and legs all hurt. That passed after a day except the headache. 3 days later I still have a low fever, headache, but mostly dizziness. I've never been seriously ill in my life. Ive never been sick enough to get antibiotics prescribed. I eat healthy, don't drink or smoke. This vaccine floored me though. Like getting run over by a truck.
41 2021-04-20 fatigue lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; ... Read more
lost hearing in right ear; everything sounds muffled; constant buzzing; felt foggy, like brain fog; tired, really tired; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41-years, at single dose in left upper arm on 16Mar2021 at 12:00 (Lot Number: EP6955) for covid-19 immunisation. The patient medical history was none. Weight was 99.79 kg and Height was 191 cm. There were no concomitant medications. The patient previously received tetanus vaccine for immunisation when he was a kid. The patient reported that he had his first shot and was scheduled to take second shot today (on 06Apr2021). He stated that two days after the first shot, on 18Mar2021, he didn't have any arm pain, nausea, vomiting, or headaches. He lost hearing out of right ear. He already went to the physician about it. He was scheduled to go to Ear Nose and Throat doctor on 12Apr2021. He stated they checked his ear and everything. The hearing loss was not related to any kind of ear wax or anything. He went to urgent care, so they were limited to what they can do, and he was referred out to Ear Nose and Throat. He said everything sounded muffled and liked a constant buzzing in that ear. He had never had this problem. That doctor was going to check his ears and would do a hearing test on 12Apr2021. He confirmed that the hearing loss started on 18Mar2021. He also confirmed that the hearing loss was still ongoing and it was about the same, or persisting. The patient also reported that after the first one he didn't have the side effects that they claim to have. He hadn't died from it. He was just tired really tired, two to three hours after the shot, he got the shot at 12 noon, so about 2 to 3 o'clock. He laid down to rest and went to sleep. He woke up the next morning, went to work and was fine. He stated that other than that no headache, no arm pain, no diarrhea, no vomiting. He just felt foggy like brain fog the following morning after the vaccine till about mid-day and it went away. It only lasted four or five hours. He confirmed that was on 17Mar2021, as well as, that he had recovered completely. The patient received treatment and included that prescription medication for ear: Ofloxacin 0.3%. Instill five drops in the right ear two times a day for seven days. There was no additional vaccine administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event outcome for Hearing loss, Muffled hearing in both ears and Ear buzzing was not recovered, while for Tiredness and Foggy feeling in head was recovered on 17Mar2021.
41 2021-04-20 sweating Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "... Read more
Pt was vaccinated with Pfizer-BioNTech COVID-19 vaccine EUA and told the vaccinating nurse that he "always faints around needles." Pt was vaccinated and moved to post-vac area; he then began complaining of feeling "sweaty and hot." Pt chose to lie on the floor. Pt's vitals were within normal limits. Pt denied any chest pain, SOB, or other discomfort. Pt lied on the floor for approximately 15 minutes and then stated that he was feeling better. Pt was able to stand without assistance or dizziness and ambulate with a steady gait. Pt left clinic in care of his wife and stated that he felt "back to normal." Pt was advised to seek medical assistance if he began experiencing the same feelings again.
41 2021-04-20 throat pain, sleepiness Sore throat Pain in the injection site (moderate) Sleepiness
41 2021-04-20 fever, headache fevers from 101-104F and squeezing headache that started on 4/19/21.
41 2021-04-21 headache, fatigue, cough, fever Headache, fatigue, sore muscles, lungs burning, fever, cough and I was all ways hungry
41 2021-04-22 chills, headache, fever Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: No... Read more
Day 1 after vaccination: Fever, chills, aches, headache, nausea; all day Day 2 after vaccination: None Day 3 after vaccination: Woke up in the middle of the night with dizziness, or head "swimming" sensation, and body aches. Managed to get back to sleep after about an hour, but woke up at normal time still feeling a "swimming" sensation in the head where it's not dizzy, but similar, and still minor body aches. Submitting this report while I'm still in Day 3
41 2021-04-22 chills, sweating, headache Extreme Tinnitus, Severe Vertigo, Headaches, Nausea, Chills, Sweating
41 2021-04-22 fatigue, influenza like illness Flu like. Severe fatigue, joint and muscle pain
41 2021-04-22 headache Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs... Read more
Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs a few times a day. Not impacting day to day life. Headache - lasted for 5 days.
41 2021-04-22 headache Headache, continued dizziness (similar to vertigo), nausea
41 2021-04-22 fever Fever 99.5 F
41 2021-04-23 chills, fatigue Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after va... Read more
Sore arm, whole body muscle soreness, dizziness, fatigue, chills. Symptoms started 6 hours after vaccine shot and lasted 2 days.
41 2021-04-23 fever, cough Fever , body pains and cough cant stand or walk because of fever , body temperature went upto 100.7
41 2021-04-23 fever Fever - over 102 Aches and pains
41 2021-04-24 cough, malaise, fatigue He tested positive for Covid on 30Mar2021; bad cough; severe fatigue; lost his sense of taste; loss ... Read more
He tested positive for Covid on 30Mar2021; bad cough; severe fatigue; lost his sense of taste; loss of appetite; everything tasted like metal; Lost 15 pounds in 2 weeks; feeling sick; inflammation; This is a spontaneous report from contactable consumer (patient's mother) via Pfizer sponsored program. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination 41 years), Solution for injection) via unknown route of administration, in the left arm on 23Mar2021 at single dose for COVID-19 immunization. Medical history included asthma, the reported stated that it was quite scary. Concomitant medications were not reported. On 24Mar2021, the patient had bad cough couldn't stop coughing for 2 weeks, it was awful and the patient was a nonsmoker and he sounded like someone who had been smoking for 70 years. It was a deep horrible cough. He was afraid to get the second shot, and she doesn't want him to be afraid if the symptoms weren't from a reaction and the patient went to the emergency room and they sent him back. She almost lost the patient as an infant with aspiration pneumonia and had severe fatigue which had gone better just in the last day or 2. The reporter had minor symptoms, but her son's symptoms progressed to the point where they told him he had to get a COVID test. The patient was not feeling right beyond 48 hours and was still thinking it was a reaction from the shot. On 30Mar2021, the patient tested positive for COVID. On an unknown date in 2021, the patient started loss of appetite almost right away a couple days after he got the vaccine. He must have had COVID at the same time. Patient was gaining his appetite back. Patient had lost his sense of taste too. Patient had also lost her sense of taste and her sense of smell. He just said that everything tasted like metal. Nothing tastes normal it was the same for her as well. His appetite was coming back, and his cough was subsiding. The patient had inflammation, which was treated with steroids and inhaler and the patient was little overweight and lost 15 pounds in 2 weeks, feeling sick. The reporter asked 4 different doctors and got 4 different answers. Her son was exposed to COVID through his children from school. They had closed the classroom because the teacher had COVID. No one else in the house was positive. On 08Apr2021, (Yesterday), the patient felt a little better which was a blessing. She thinks he was getting better due to the medicine from the pulmonologist. He got a pulmonologist to have a virtual visit and they gave him steroids and an inhaler which has helped and just starting to get a little better. The patient was due for his second dose of the vaccine on 13Apr2021, but she doesn't know if it was okay for him to get it now. The patient had chest X-ray was negative and the patient did not have pneumonia. The outcome of the event cough, fatigue, ageusia, decreased appetite, dysgeusia, was recovering and the other events COVID-19, weight decreased, malaise was unknown. No follow-up attempts are possible. Information about batch/lot number could not be requested
41 2021-04-24 fatigue, chills Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetami... Read more
Day 1: Symptom a) Severe Abdominal and Back Muscle pain for two to three hours before taking acetaminophen. Pain consisted of sharp pain wrapped around my torso. Symptom b) Nausea. Symptom c) Tiredness Day 2: Mild chills in the evening and night sweats Day 3: Mild chills in the evening and night sweats Day 4: Abdominal and Back pain for approximately one hour (pain reduced after taking acetaminophen. Pain continued overnight. Day 5: Tiredness Day 6: Felt great Day 7: Severe Abdominal and back pain wrapped around my torso and burning sensation in my back
41 2021-04-24 fatigue, headache Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symp... Read more
Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction
41 2021-04-24 fatigue collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneou... Read more
collapsed; weak/weakness; muscle pain; Confusion; Fatigue; Shortness of breath; This is a spontaneous report from a contactable physician. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on 04Apr2021 at a single dose for covid-19 immunization. Medical history included G72.3 periodic paralysis. Concomitant medication included diclofenamide (KEVEYIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The physician stated that the patient received the Pfizer vaccine on Sunday 04Apr2021. The patient collapsed about an hour and half later and, has felt very weak and was experiencing muscle pain since then - all experienced on 04Apr2021. The patient has also been experiencing weakness, confusion, fatigue, and shortness of breath all since Sunday 04Apr2021. The physician reported that there were two different kinds of potassium in the vaccine which he felt was contributing to this. It was informed that the patient has been currently resting and will follow-up if his symptoms don't improve. The outcome of the adverse events was unknown. It was unknown if treatment was received for the adverse events. It was unknown if the patient was tested for covid post-vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role between BNT162B2 vaccine and the reported events can not be excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
41 2021-04-24 headache, chills, fever irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/a... Read more
irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
41 2021-04-24 headache, fatigue, fever Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache... Read more
Swollen Lymph node (under right armpit); Fever (up to at least 102); Muscle Aches; Fatigue; Headache (mild); This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 11:30 (Lot Number: EP-6955) at SINGLE DOSE in Arm Right for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of bnt162b2 in Arm Right on 18Mar2021 11:00 (Lot Number: EP-6955) as SINGLE DOSE for covid-19 immunisation. The patient experienced Fever (up to at least 102), Muscle Aches, Fatigue, Headache (mild), Swollen Lymph node (under right armpit) from 06Apr2021 11:45 PM. The outcome was Recovering. No treatment received. No covid prior vaccination. No covid tested post vaccination. The events were assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
41 2021-04-24 headache, sleepiness Strong headache and drowsiness
41 2021-04-24 fever, fatigue very high fever (~104) starting 12-14 hours after vaccination, moderate fever (~101) for two additio... Read more
very high fever (~104) starting 12-14 hours after vaccination, moderate fever (~101) for two additional days, low fever for period of a few more days; heavy fatigue and general muscle weakness (throughout body) accompanied the high and moderate fevers
41 2021-04-26 headache, fatigue Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle f... Read more
Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness
41 2021-04-27 headache, fatigue, nasal congestion, sinusitis 24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus... Read more
24 hours later dizziness, fatigue, headache bleeding nose, sinuses swollen and plugged, bloody mucus, bloody gums/tongue the next morning(heavy). Sinuses went down, bloody nose stopped in 3 hrs, and teeth stopped bleeding a few hours later. No more bleeding now, but still have a little headache.
41 2021-04-27 headache, fever Pt called call center. Pt c/o fever since 04/22/2021 and headache since 04/23/2021.Also c/o rapid he... Read more
Pt called call center. Pt c/o fever since 04/22/2021 and headache since 04/23/2021.Also c/o rapid heartbeat. Stated sometimes not able to feel heartbeat on left side,sometimes very rapid. Pt concerned stated might be possible s/e from covid vaccine Pfizer he got on 04/19/2021This writer recommended pt to go to nearest ED/Express care for further evaluation as experiencing rapid heartbeat. Pt assure understanding s
41 2021-04-27 sinusitis, head discomfort, fatigue 3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However ac... Read more
3/26 @ 3:15pm ? Got the first dose of Pfizer COVID-19 vaccine for the 1:10pm appointment. However actual time received was around 3:15pm. No vaccine reaction was observed and drove back home. However did not eat or drink much from morning till 4:30pm due to the long line at the vaccination center 4/4 @ 9:00pm ? Experienced first sign of near-syncope at the dinner table upon picking up a glass of milk 4/6 @ 8:45am ? Experienced brain fog, to be exact head felt like it was filled with cotton candy, at the back and top of the head. Felt this way the entire day. Went to work as usual. Logged out at around 5:30pm 4/7 @ 9:00am ? dizziness started getting worse. Started feeling imbalance and started losing depth perception which climbing down staircase 4/8 @ 10:00am ? started to get easily startled by any unexpected trigger. Whole body would ?twitch? or ?startle? upon slightest unexpected event. For e.g., sound, touch, taste (hot/cold) 4/10 @ 12:00pm ? Went to ER. ER ordered series of book tests, EKG, chest x-ray. Everything came out normal. ER doctor said to wait it out and after a week symptom may go away. ER doctor felt body?s immune response was over-working due to the vaccine immune response and possibly pollen allergy I may have experienced right after getting the vaccine. No prescription meds give. Advised to take Meclizine 25mg and Zyrtec. Below are the symptoms experienced on 4/10: ? Lightheadedness/Sudden Jerking body movements when triggered/passing out momentarily for a second when taking strain/not in my elements ? Feeling extremely fatigued. Did not sleep well at night on 4/8 and 4/9 ? Head feels Intoxicated, foggy, lightheaded, as if stuffed with cotton candy. Startled when unexpected things happen like a sudden jerking movement along with momentary passing out while anything unexpected happens. E.g., when I am pushing myself on the sofa to re-position, I feel my whole body is turning off for a second. Simply does not feel normal ? Rubbery legs ? Worsens after shower. I feel like I need to lay down as the foggy feeling worsens after shower ? Lightheadedness. Losing control sometimes. ? I am easily startled when climbing down the stairs - no Depth perception. ? Don?t have the strength to blow nose or cough. Feels like momentary fainting when doing these activities ? Dis-equilibrium. Whole body is twitching when something unexpected happens to my senses. ? Unable to control while laughing feels like momentary faint. I have felt like this when I was down with a fever. Tickled easily ? Difficulty pulling myself out of bed. Felt like muscle was giving away ? Tingling feeling in the right abdomen area ? Difficulty staying alert or focused and random rather unpleasant thoughts constantly coming to mind. Felt a bit of panic attack. 4/11 ? Went to PCP. Body weakness and fatigue got worse. PCP did blood sugar test and flushed out the left ear. Ordered Brain MRI to see if structurally anything was wrong. Brain MRI came out OK as well however noticed minor sinusitis. Prescribed Amoxicillin antibiotics and nasal spray. Referred me to Neurologist and Head and Neck Specialist. 4/11 ? 4/15 - Above symptoms progressively got worse. Especially weakness in the arms and shoulders. Arms quivered every time trying to stand up and felt like fainting. Hand-eye coordination progressively got worse. For e.g., could not pick up water bottle, hands were quivering badly 4/15 ? Neurologist conducted certain diagnostic tests and concluded that there are no neurological issues. Said with rest and plenty of fluids it should get better. Spinal tap was not recommended and said if symptoms got worse a spinal tap can be done during the next visit. Follow up visit with neurologist scheduled on 4/27 4/15 ? 4/27 ? Weakness in arms got better. Arm strength and coordination has improved however it?s still not back to normal. Brain fog and dizziness still persists with no improvement. Left limb and arms are stronger than the left. Difficulty climbing up and down stairs. Dizziness worsens after shower. Not feeling myself. In addition, not able to multitask - getting startled and need to be deliberate about having to do everyday chores need to just focus on one task 100% completely and if something else comes up then my body just goes into a momentary shock. Mostly I can feel my head feeling heavy and my eyelids shutting down when something shocking happens ? a feeling like body is ?turning off?, almost a fainting or passing out feeling. Sometimes when I turn to one side and sleep, I can feel a flickering sensation in the ear. Still always feeling woozy and as if there is something in my head ? a medicated or intoxicated feeling in the head 4/27 ? Neurologist said she sees a lot of improvement and reiterated again that I don?t have any neurological issues. She said I can go back to work starting 5/1. She said I may have Conversion Disorder / Disequilibrium. It?s hard for me to fathom why she would diagnose me with Conversion Disorder when so many people are reporting very similar symptoms that I am facing on the below forum: https://www.drugdiscoverytrends.com/dizziness-among-common-covid-19-vaccine-side-effects/ 4/30 ? Next appointment with Head and Neck / Audiology
41 2021-04-28 fatigue, fever Adverse effect started 24hrs after injection beginning on 24 April 2021. Trended normal resting hea... Read more
Adverse effect started 24hrs after injection beginning on 24 April 2021. Trended normal resting heart rate range is 55-66bpm; Noted elevated resting heart rate of 104bpm began at 12:00pm 24 April; experienced expected side effects of fatigue, soreness, feverish feeling concurrent to elevated resting heart rate. Heart rate remained high ranging from 88-103BPM throughout the day; took a nap from 430 - 530pm; at 5:20-5:30 heart rate measured 174 BPM. 6:00pm - 10:00pm heart rate ranged from 75-88 BPM; after 10:00pm heart rate returned to normal range. 25 April No side effects experienced Measured Heart rate range for the day was 56-73 BPM
41 2021-04-29 fatigue Tiredness, mild upper body aches, soreness at injection site
41 2021-04-29 headache, fatigue Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, fel... Read more
Felt extremely tired around 7:30pm. Went to bed. Woke up at 6:00am to get kids ready for school, felt intense headache joint pain, and intense cold feeling to the point of shaking. Went to bed again around 7:45 am. Slept most of the day with headache getting worse. Next day symptoms lessened slightly still bad headache and brain fog which I still have as of today but getting better.
41 2021-04-29 sweating At the medical facility, within minutes of taken the shot, my left eye vision started to get blurry.... Read more
At the medical facility, within minutes of taken the shot, my left eye vision started to get blurry. I started to sweat. Medical personnel took my blood pressure and said it was high. They had me rest on a bed for 10 minutes. They gave me water and juice. After 2 days of the vaccine, I feel strange heart palpitations every 1 or 2 hours. My blood pressure reading is at 147/88.
41 2021-04-29 sweating Patient had nausea, flushing and sweats approximately 5 minutes after vaccination
41 2021-04-29 fever, headache 10-12 hours after receiving 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, acute body aches were ... Read more
10-12 hours after receiving 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, acute body aches were experienced. Discomfort was experienced in the lower back and joints with mild headache. At about 18-24 hours after injection, a fever of 101 degrees Fahrenheit was experienced. Body aches and fever subsided at about 48 hours after injection. After acute discomforts and fever subsided, injection site discomfort persisted to about 7 days after injection. Treatment included generic ibuprofen (400 mg) at 12 hours after injection. 400 mg of ibuprofen was ingested at 24 hours after injection. 220mg of naproxin was ingested at 36 hours after injection. Most of 24-48 hours was also resting (little activity).
41 2021-05-02 chills, fever, sweating, headache, fatigue fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fat... Read more
fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache
41 2021-05-02 cough, sneezing, respiratory tract congestion Tested positive for COVID. Had a dry cough, congestion, and sneezing on 5/1/2021.
41 2021-05-02 nasal congestion, throat pain, fever On 4/25/21 he began experiencing congestion, sore throat, fevers, loss of taste and smell. He recent... Read more
On 4/25/21 he began experiencing congestion, sore throat, fevers, loss of taste and smell. He recently returned from travelling and tested negative for COVID on 4/23/21.
41 2021-05-04 body temperature increased, sweating, fever, fatigue, headache, chills Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home... Read more
Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off. Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak. I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches. The fever responded well to Ibuprofen. I hydrated with water and Gatorade. It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
41 2021-05-04 fatigue, headache positive COVID-19 test with symptoms; headache; tiredness; This is a spontaneous report from a conta... Read more
positive COVID-19 test with symptoms; headache; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8730), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included "maybe" was exposed to COVID-19 in Apr2021. Concomitant medications were none. There were no other vaccines administered on the same date or within 4 weeks of BNT162B2. Within a couple of days of the first vaccination dose (Apr2021), the patient went for a trip and "maybe" was exposed to COVID-19. On Apr2021, the patient felt some kind of tiredness and headache. The patient took ibuprofen (ADVIL) and paracetamol (TYLENOL) for the tiredness and headache. The patient reported that he drove a lot of distance and did a lot of things during the trip, so these were not COVID-19 symptoms. On 05Apr2021, the patient tested positive for COVID-19 via a nasal COVID-19 test and experienced COVID-19 symptoms. On an unspecified date, the patient had some cough, so he went to the emergency room and was given azithromycin and a cough tablet and cough syrup. The patient queried when he can receive his second dose as he had already completed his 2-week isolation period and had no more symptoms. The clinical outcome of "positive COVID-19 test with symptoms", headache and tiredness was resolved on Apr2021.
41 2021-05-04 fever, fatigue, chills, headache, malaise First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like ... Read more
First day after vaccine (4/30/21): 102 fever, chills, severe nausea, vomiting, aches, migraine-like headache pain, malaise, and fatigue (took Tylenol with minimal effect). Second day after vaccine (5/1/21): aches, shakiness, fatigue, mild nausea, medium-intensity headache, diarrhea, malaise (took Tylenol, which helped with headache pain). Third day after vaccine (5/2/21): aches, mild nausea, shakiness, mild fatigue, mild headache, and mild malaise. Fourth day after vaccine (5/3/21): mild nausea, shakiness, mild headache, and mild fatigue. Fifth day after vaccine (5/4/21): mild nausea, mild headache. Sixth day after vaccine (today 5/5/21): mild nausea, mild headache.
41 2021-05-05 cough, headache, fatigue, fever Fever, Fatigue, Headache, Generalized Body Aches, Cough Can honey and honey tea as needed. Can use ... Read more
Fever, Fatigue, Headache, Generalized Body Aches, Cough Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort. Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night. COVID monoclonal antibodies
41 2021-05-07 fatigue, chills, fever Sudden extreme chills lasting ~4 hours followed by ~101-F fever lasting for ~16 hours. Generalized ... Read more
Sudden extreme chills lasting ~4 hours followed by ~101-F fever lasting for ~16 hours. Generalized fatigue with episodes of dizziness continued for ~3 days. Reduced fitness for walking more than 15-minute intervals for ~1 week.
41 2021-05-08 chills Chills, body aches, loss of sense of taste
41 2021-05-09 chills On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was ... Read more
On April 18 and 19, following my 2nd injection, I had very bad chills and could not get warm. I was nauseous although I did not vomit. On April 22, I began having severe sharp stabbing pains just to the right of my belly button. It felt like I was being stabbed with a very hot knife, and after about 15-90 seconds, it would go away. Anytime I reached for something, bent over, twisted, turned or tried to hug someone, I would get this same pain and it would double me over in pain. On Monday April 26 at 7pm, I finally checked into the Emergency Room at the direction of my Primary Doctor. They did a bunch of blood work on me and sent me for a CT Scan of my abdomen. All of the blood work came back in normal ranges, and the CT Scan showed my appendix was "borderline" according to the surgeon. They consulted with Dr and decided to admit me for a surgical consult and further examination. They gave me fluids and morphine through an IV for the first 24 - 36 hrs, and then switched to Norco by mouth. I continued having pain throughout my stay. On Thursday, April 29, they took me to surgery for "exploratory surgery" with the intention of removing my appendix and looking around to see if anything else stood out to them that would cause me this pain. They stated my appendix had scar tissue on it and they removed it, but said they did not know if this would stop the pain I was having. On Friday April 30, I was released from the hospital at approximately 6pm. By 9pm on Friday, I began having those same sharp, stabbing, burning pains in my abdomen again, now to the right of my belly button again and further towards my right side. I also had sharp burning pain in the inside of my upper right arm, between my bicep and tricep muscles. This pain continued on through the weekend occurring more frequently and more severe. On Monday morning at about 1:30am, I woke up with severe abdominal pains all over and went into the bathroom. I had diarrhea and nausea and felt like I was going to vomit. Between 1:30am and 7:30am, I went to the bathroom 6 times. I went to work on Monday and continued having abdominal pains and diarrhea all day and night. On Tuesday, I went to the bathroom a total of 17 times. On Wednesday, I saw my primary Dr., who examined my abdomen and pains. He suggested I take immodium for the diarrhea and a supplement for muscle pain, as he felt this was the cause of my pain. On Wednesday, I went to the bathroom 21 times and was very nauseaus. I started the Imodium and it had no effect on me whatsoever. On Thursday, I had to call off work because I couldn't stop using the bathroom. By 4pm, I had been to the bathroom 18 times. I returned to the ER. They took a stool sample and did an ultrasound in the ER. They decided to admit me again for surgical consult and pain management. On Friday, Dr ordered another ultrasound of my abdomen, specifically my gallbladder, kidney, and liver. He also sent me for a CT Scan with contrast. They completed a total lab workup of my blood. All of these results came back normal, and nothing on the images showed anything wrong with my organs. On Saturday May 8, Dr came to the hospital to examine me. He stated everything related to my GI was fine. He asked if I have back pain, which I told him I do. At this time, I was in extreme pain and I couldn't even touch my skin. Dr attempted to examine my abdomen, and just by placing his hand on my stomach, I screamed in pain. He then put his hand behind my back and pushed a little, and it cause extreme pain in my abdomen. At this time, Dr suggested that maybe the pain is caused by something going on in my back. Maybe a pinched nerve or something. He ordered an X-ray of my upper and lower spine. Later that day, the results of the X-ray came back and showed there was nothing wrong with my spine. With these results, Dr then ordered an MRI of my lumbar and thoracic spine. On Sunday May 9 at 1030am, I was taken to radiology for an MRI. The initial report shows that I do not have any pinched nerves and nothing notable that would cause this type of pain in my body. As of now, no diagnosis or explanation for the pain I am experiencing. The pain is gradually getting worse and at times I am unable to move at all without extreme severe pain in my body. At times, my right groin hurts and I am unable to stand on my feet, as it feels as if I have pulled a groin muscle. The pain in my abdomen takes my breath away and feels like I am being set on fire in that area of my body. The pain no longer goes away and is constant, but moves throughout my right side from my groin to my shoulder only. I am not able to put my right arm behind my back because I get this pain in the back of my shoulder area. This pain is only on my right side at this time. So far, there is no explanation for this pain. I never had anything like this until I got the vaccine.
41 2021-05-10 fatigue, headache Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site:... Read more
Nausea: 1hr Palpitations: 24hr Restlessness: 8hr Insomnia: 8hr Fatigue: 36hr Pain at injection site: 5hr Headache: 12hr
41 2021-05-10 throat pain, fatigue ? Fatigue ? Sore Throat
41 2021-05-11 fatigue, chills, headache, fever Chills. Slight fatigue, headache, and fever
41 2021-05-11 runny nose, sneezing Started feeling sick on Sunday 5/9/21. Stated his wife had similar symptoms for a week prior. He rep... Read more
Started feeling sick on Sunday 5/9/21. Stated his wife had similar symptoms for a week prior. He reported having rhinorrhea, body aches and sneezing for two days. Both he and his wife are fully vaccinated as of February 2/4/21 with the Pfizer vaccine. He is taking Cold-Eeze for symptoms.
41 2021-05-12 headache, paranasal sinus discomfort, chills, runny nose, throat pain, fever, cough, fatigue, nasal congestion, sinus pain Cough, shortness of breath fatigue, headaches, congestion or runny nose, lightheaded and sore throat... Read more
Cough, shortness of breath fatigue, headaches, congestion or runny nose, lightheaded and sore throat, chills, fever, sinus pressure, sinus pain, diarrhea and nausea, back pain and myalgias
41 2021-05-14 throat pain, chills, fatigue, headache Joint aches Dry mouth Soar throat Bump under armpits (right side) Back pain Shivering Tiredness... Read more
Joint aches Dry mouth Soar throat Bump under armpits (right side) Back pain Shivering Tiredness Hedache
41 2021-05-15 fatigue, fever, headache Contant 102°F fever, body ache, fatigue, severe headache for about 36 hours started 12 hours after ... Read more
Contant 102°F fever, body ache, fatigue, severe headache for about 36 hours started 12 hours after the vaccine shot.
41 2021-05-16 fever, headache Low Grade Fever and Headache; 1 500mg tablet of Acetaminophen (Tylenol) consumed with water on 16th ... Read more
Low Grade Fever and Headache; 1 500mg tablet of Acetaminophen (Tylenol) consumed with water on 16th May at 7 PM. Felt better after taking Tylenol. Temperature became normal and headache also reduced.
41 2021-05-17 fever Fever, body aches and Swollen lips and face for 3 days after the vaccine.
41 2021-05-18 fever, headache Patient presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA... Read more
Patient presented to ER with flu sx that began after vaccine. Pt reports a constant fever (102 F PTA), constant generalized myalgias and a constant HA that all began on onset. He also reports multiple intermittent diarrhea episodes since onset. Pt c/o constant and non-radiating left foot pain with associated swelling that began yesterday. Left foot pain noted to be gout in ER.
41 2021-05-19 chills, influenza like illness Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at ... Read more
Arm soreness started on May 18 @ 3:30pm. Went to sleep with same arm soreness at 11pm. Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills. At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing. After calming down enough to sit, i sat on couch to sleep. Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am. As day progresses am experiencing flu type symptoms.
41 2021-05-19 fatigue, respiratory tract congestion, fever 41 yo male patient with history of renal transplant on immunosuppressive therapy, diabetes, CAD, CHF... Read more
41 yo male patient with history of renal transplant on immunosuppressive therapy, diabetes, CAD, CHF, HTN, HLD, OSA presents with a 9 day history of fatigue, congestion and a 2 day history of nausea/vomiting and intermittent fevers, but no respiratory symptoms. Pt received Pfizer COVID-19 vaccination: first dose 3/18 and second dose 4/8. Pt tests positive for COVID on 4/24; CXR on 4/30 showed no acute findings. Admitted for additional hyponatremia, AKI, and hyperkalemia. Pt remained on room air. Received 2 doses of remdesivir while inpatient and felt significantly improved afterwards. He was set up for outpatient COVID follow ups via telehealth and given a COVID home monitoring kit.
41 2021-05-21 chills, fatigue Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 ... Read more
Shortness of breath weakness tired chills achey heart palpitations headache dizzy confused lasted 2 weeks
41 2021-05-21 fever, fatigue, cough Cough, fever, swollen lymph nodes, pain at injection site. Tiredness,
41 2021-05-22 fatigue, lethargy Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe
41 2021-05-22 headache, fatigue Felt a minor headache, and tiredness directly afterwards. At 7:30 pm 12 hrs later I went through 3 h... Read more
Felt a minor headache, and tiredness directly afterwards. At 7:30 pm 12 hrs later I went through 3 hrs. of violently shaking along with feeling very chilly. Woke up with every muscle aching and a pounding headache, after 3-4 hrs. I started to feel better. The 3 hrs. of violently shaking is what I'm reporting.
41 2021-05-22 malaise Male 41 year old complaining of feeling his heart racing. His stated feeling quizzy.
41 2021-05-23 chills, fatigue, malaise, headache Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me... Read more
Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise; Night sweat about 36 hours after first dose; Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose. Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.
41 2021-05-23 headache, chills, fatigue Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migr... Read more
Sever chills, headache, extreme fatigue, sore arm, worse migraine ever suffered and never had a migraine before, nausea, exhaustion. All of these lasted 48 hours and the migraine did not occur until 72 hours later.
41 2021-05-24 fever 5 days of fever, anorexia oral and nasal desquamation/sores
41 2021-05-25 fever, chills, fatigue He had his 2nd pfizer vaccine on 5/3/21 The next day he felt tired 2 days later (on 5/5) he started ... Read more
He had his 2nd pfizer vaccine on 5/3/21 The next day he felt tired 2 days later (on 5/5) he started with fever, chills and body aches He then started with abdominal pain --hurt to take a breath in, he could not lay flat He went to Hospital and was dx with myocarditis He was started on ibuprofen (changed to naproxen for discharge), colchicine and protonix
41 2021-05-25 fever, chills Had expected fevers and chills day following vaccine. Started approximately 12 hours after shot and ... Read more
Had expected fevers and chills day following vaccine. Started approximately 12 hours after shot and abated approximately 36 hours later. Of note, had a fever and chills when falling asleep night of 5/28 On 5/29 woke with specific chest pain localized to heart area. Waited approximately one hour to see if symptoms abated, then proceeded to ER to get checked out. EKG showed left branch block. Administration of Nitro and asprin alleviated chest pain. Was admitted to hospital for observation and testing to ensure heart functioning properly.
41 2021-05-25 throat irritation Biopsy confirmed leukocytoclastic vasculitis on legs; scratchy throat; This is a spontaneous report ... Read more
Biopsy confirmed leukocytoclastic vasculitis on legs; scratchy throat; This is a spontaneous report from a contactable physician. A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 14Jan2021 for covid-19 immunisation. It was reported that biopsy confirmed leukocytoclastic vasculitis on legs which started on 01Mar2021, two weeks after the second Covid vaccine dose. No other systemic cause of vasculitis found on workup in rheumatology. Prednisone started and transient improvement. An antibiotic (Augmentin) was added because the patient also had a scratchy throat. A second tapering prednisone course was restarted for a few weeks. Vasculitis totally improved by early May and prednisone was discontinued. The patient recovered from the events on an unspecified date. Information on the lot/ batch number has been requested.; Sender's Comments: Based on current information available, the event leukocytoclastic vasculitis on legs and throat irritation mostly represented intercurrent condition in this patient, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
41 2021-05-27 fatigue, fever, chills, lethargy, headache appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable... Read more
appendicitis; Sunday morning: wake with mild stomach pain; pain increasing consistently/considerable and unbearable pain; Vomiting; Saturday: largely symptom free, though tired and lethargic; Saturday: largely symptom free, though tired and lethargic; moderate headache; Wednesday morning: developed mild to moderate fever and chills; Wednesday morning: developed mild to moderate fever and chills; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 17:45 at the age of 41-years-old (Batch/Lot Number: FIL30161) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Surgery for pinned broken thumb. surgical repair of achilles tendon. The patient previously took erythromycin and experienced known allergies: Erythromycin (Nausea). The patient received first dose of BNT162B2 administered in Arm Left on 03Apr2021 04:00 PM at the age of 41-years-old (Batch/Lot Number: ER8737) for covid-19 immunisation. The patient did not take other vaccine in four weeks. Other medications in two weeks included only post-surgery pain meds after vaccine. The patient did not get covid prior vaccination. On Tuesday evening 27Apr2021, Pfizer second dose administered. On Wednesday morning 28Apr2021 10:30 AM: developed mild to moderate fever and chills. On Thursday 29Apr2021: mild to moderate fever and chills continue, new symptoms include a moderate headache. On Friday 30Apr2021: fever and chills begin to subside, headache remained. On Saturday 01May2021: largely symptom free, though tired and lethargic. On Sunday morning 02May2021: wake with mild stomach pain. On Sunday noon 02May2021: pain increasing consistently. On Sunday early afternoon 02May2021: considerable and unbearable pain. Vomiting. The patient was transport to Urgent Care. Urgent Care recommended Emergency Room. On Sunday early evening 02May2021: admitted to ER, administered pain medication. Vomiting ensues. CT Scan administered and showed positive for appendicitis. On Sunday Evening 02May2021: transported to surgical center, prepped for surgery. On Sunday Night 02May2021: emergency surgery performed, appendectomy. Overnight hospital stay was required. On Monday morning 03May2021: discharged from hospital. The adverse events appendicitis, stomach pain, pain and Vomiting resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment received included Pain medications and Surgery (appendectomy). The patient underwent lab tests and procedures which included computerised tomogram: positive for appendicitis on 02May2021, CT Scan administered and shows positive for appendicitis, Nasal Swab: negative on 02May2021. The outcome of the events was resolving. The case was reported as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage.
41 2021-05-27 headache, fever, malaise, fatigue Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, n... Read more
Short-term (24-36 hours after both shots): Extreme fatigue, muscle pain/soreness, headache, fever, nausea. Worst I've ever felt in my adult life, like my whole body was rebelling against me. Long-term (for roughly 10 days after both shots): Serious shortness of breath, irregular and very high heartbeat, extreme fatigue. Couldn't do any physical activity without immediately becoming out of breath (normally very healthy and active). Heart would race unpredictably, reaching 120 bpm (normal resting for me is 60-70). General malaise. Felt more like 80 years old than 40. Was unable to do normal physical activity and work for weeks. Feeling better overall, but still sometimes feel like I get tired unusually easily and heart behaves strangely now and then.
41 2021-05-28 chills, fever had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack... Read more
had diarrhea; a fever of 103*F; He was shivering due to lack of energy; He was shivering due to lack of energy; lost his voice; threw up; sleeping for 48 hours; terrible pain in his stomach which made him scream to the point where he lost his voice; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 23Apr2021 14:15 (Batch/Lot Number: EW0171, not sure if the 0 is a O or a 0) as single dose at the age of 41-year-old for covid-19 immunisation, administered not at a military facility. Medical history included ongoing Hashimoto's disease diagnosed about 10 years ago, ongoing vitamin D deficiency diagnosed about 8 years ago, ongoing vitamin b12 deficiency diagnosed about 8 years ago, lung neoplasm malignant. Family history included: dad had lung cancer, mother had thyroid issues and Alzheimer's. The patient's concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient experienced terrible pain in his stomach which made him scream to the point where he lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, metallic taste in the mouth on 23Apr2021 with outcome of recovered on 24Apr2021, had diarrhea on 24Apr2021 with outcome of recovered on 26Apr2021, a fever of 103°F on 24Apr2021 with outcome of recovered on 26Apr2021, he was shivering due to lack of energy on 24Apr2021 with outcome of recovered on 27Apr2021, lost his voice on 24Apr2021 with outcome of recovered on 27Apr2021, threw up on 24Apr2021 with outcome of recovered on 27Apr2021, sleeping for 48 hours on 24Apr2021 with outcome of recovered on 27Apr2021. The patient underwent lab tests and procedures which included body mass index: 37 on an unknown date, body temperature: 103 Fahrenheit on 24Apr2021. Therapeutic measures were taken as a result of terrible pain in his stomach which made him scream to the point where he lost his voice, had diarrhea, threw up. The course of events was as follows: Within the 1st 24 hours, he mentioned that he was fine and easy but had a metallic taste in the mouth for 24 hours. He mentioned that the next 72 hours were really bad for him. On 24Apr2021, that night, he started to feel terrible pain in his stomach which made him scream to the point where he lost his voice. It was like knives cutting his stomach. He threw up everything he ate, had diarrhea for 2 days along with a fever of 103 degree F for 2 days. He would try to go to the bathroom and he was shivering due to lack of energy that he could not go to the bathroom. He slept for 48 hours after the 1st 24 hours after vaccination due to the side effects. By Monday afternoon, 26Apr2021, he noticed that his side effects were subsiding and by Tuesday, 27Apr2021, he was a different person and was like nothing happened, he was able to resume a normal life and go back to work. The events did not require a visit to Emergency Room or physician Office. He did not go he was taking orange juice and ibuprofen to treat himself. No relevant tests. He asked if this was contraindicated with him to get the 2nd dose. He has not spoken to his doctor yet. He queried if he should get the second dose or is it contraindicated. Patient mentioned he is very large at 6'6" and 320 lbs. He is wondering if he should have a different dose because he is so big. This report is not related to a study or program. Information on Lot/Batch number was available. No further information is expected.
41 2021-05-28 fatigue, nasopharyngitis, headache Diarrhea; Headache; Bodyaches; Cold; Nauseous; Very, very, very tired; This is a spontaneous report ... Read more
Diarrhea; Headache; Bodyaches; Cold; Nauseous; Very, very, very tired; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 20Feb2021 around 3:10 pm (Batch/Lot Number: JSV6H-KD7BK) as 2nd dose, single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks, the patient had Flu shot but thinks that was a couple of months before the COVID shot. The patient previously took first dose bnt162b2 for covid-19 immunization and flu vaccine. On 21Feb2021 the patient experienced headache, bodyaches, cold, nauseous, very, very, very tired, and on 01Mar2021, diarrhea. The patient received second COVID shot 11 days ago. He was still feeling symptoms. Received second COVID shot on 20Feb2021 and was perfectly fine. Woke up the next day, 21Feb2021 and was sick. From what he has seen, most people are sick for a day or two. The patient clarified it was just what he has seen on the news. Was it normal to be sick for longer than a couple days. Stated the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021.Yesterday, 01Mar2021, started having diarrhea. The patient stated that the body aches got better, but he was still tired and still has a headache. Has been going on since 21Feb2021. The patient had called his doctor, but has not heard back. When querying address for vaccination facility, patient stated his brain was not working. Outcome of the events headache, nauseous, very tired were not recovered, outcome of bodyaches was recovering and outcome of cold and diarrhea was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
41 2021-05-31 headache severe headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old m... Read more
severe headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm, on 15May2021 12:00 PM (at the age of 41-years-old) at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and/or any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 on 24Apr2021 (at the age of 41-years-old) administered in left arm for COVID-19 immunisation. After four days from taking a second shot, on 20May2021 at 16:00 (as reported), the patient started feeling severe headache, it was getting worse until the reporting day (25May2021). The event was reported as serious due to life-threatening event and 2 days of hospitalization from May2021 to May2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included COVID test, nasal swab on 22May2021: negative. Therapeutic measures were taken as a result of the event and included treatment with blood thinner medicine injected. The patient had not recovered from the event. Information on the lot/batch number has been requested.
41 2021-05-31 throat pain, fatigue Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka ... Read more
Rare Diagnosis of Ramsay Hunt Syndrome (Shingles in the inner & outer of the left ear & throat) aka Herpes Zoster Oticus. Bedridden, Extreme fatigue, weight loss, weakness, body aches, pain in throat & ear, lymphodema, severe virtigo, tonsillitis, and permanent hearing lose.
41 2021-06-01 headache, chills Chills, body ache, headache; Chills, body ache, headache; Chills, body ache, headache; This is a spo... Read more
Chills, body ache, headache; Chills, body ache, headache; Chills, body ache, headache; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 11:00 (at the age of 41-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in Arm right on 14Mar2021 at 15:30 (at the age of 41-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Apr2021, the patient experienced chills, body ache and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was resolved on an unspecified date in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
41 2021-06-01 sweating I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started f... Read more
I felt completely fine for the first 5 minutes. I left the store. After 5 more minutes I started feeling bad (I was seated). My whole body was sweating and my vision was affected (everything was bright). I was able to return to the store but was close to passing out. I sat down for about 10-15 minutes while the symptoms persisted and I was not able to see well. After that time the sweating stopped and my sight was no longer affected. This was not anxiety and I have no history of fainting with shots. This was a reaction to the shot. After about an hour I felt fine except for muscle soreness at the injection sight. If the reaction was any worse I would have passed out or asked for help. I am hesitant to get a second dose out of concern that the reaction could be worse.
41 2021-06-01 fever, headache About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrib... Read more
About 8 hours after the 2nd dose my husband became very ill. Uncontrollably shaking, fever, terrible headache, nausea, etc. for 24 hours.
41 2021-06-05 chills, fever I received the first vaccine without a single side effect. However, the evening after receiving my s... Read more
I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.
41 2021-06-06 fatigue, fever, chills, headache Fever, Chills, Fatigue, Headaches for approximately 48hrs.
41 2021-06-06 headache, productive cough Client states that 24 hrs following his 1st dose Pfizer COVID vaccine (LOT EW0173 Expiration date 08... Read more
Client states that 24 hrs following his 1st dose Pfizer COVID vaccine (LOT EW0173 Expiration date 08/31/2021) received on 04/29/2021 he experienced a tight throat, difficulty swallowing, headache, mild diarrhea and increase of mucus production in his throat that required frequent spitting up. He denied any chest pain, facial swelling or difficulty breathing. He stated the symptoms lasted 2 days and then resolved on their own. He reported taking 1x 300 mg Advil for the headache with little relief. Client denied reporting the symptoms to his primary care provider due to being in between insurances and in between providers. He also stated because the symptoms self resolved he figured they were normal side effects to the vaccine. Client denied any other significant medical history and medication use.
41 2021-06-07 sweating Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Myocarditis, STEMI Patient received Pfizer COVID vaccines on 4/15/21 and 5/6/21. Patient presented to ED on 5/9/21 with complaints of acute onset substernal chest pain that woke him from sleep. Patient also endorses left arm pain, diaphoresis and nausea. No significant past medical history or family history of heart disease. ECG demonstrated inferior ST elevations. Patient was taken to cath lab and found to have no angiographic evidence of CAD. Patient discharged on aspirin 81 mg QD, Clopidogrel 75 mg QD, Metoprolol 12.5 mg BID, Rosuvastatin 5 mg QD.
41 2021-06-08 chills chills; This is a spontaneous report from a contactable consumer or other non hcp. Consumer reported... Read more
chills; This is a spontaneous report from a contactable consumer or other non hcp. Consumer reported for himself that a 41-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not had any medical history. Concomitant medication(s) included collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM); ascorbic acid, euterpe oleracea fruit (ACAI BERRY [ASCORBIC ACID;EUTERPE OLERACEA FRUIT]); vitamin c [ascorbic acid] and vitamin b complex. Patient had no known allergies. On 10Mar2021 07:00, the patient experienced chills. Patient did not received any treatment. It was reported that patient started getting chills almost 24 hrs after getting the first dose, they have lasted for the past 10 hrs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.
41 2021-06-10 fever, chills 104F fever; Vomiting; Aches; Chills; This is a spontaneous report from a contactable consumer. A 41-... Read more
104F fever; Vomiting; Aches; Chills; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route, administered in Left Arm on 14Apr2021 at 14:30 (at the age of 41-years) as single dose for COVID-19 immunization. The patient's medical history included allergy to cephalosporins and chronic hives of unknown origin. The patient had no other known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication(s) included cetirizine and methylphenidate. The patient previously received first dose of BNT162B2 (Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 at 19:15 (at the age of 14-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021 at 16:00, the patient experienced 104F fever, vomiting, aches, chills. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 104F fever. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr 2021. No follow-up attempts are needed. No further information was expected.
41 2021-06-13 respiratory tract congestion 2nd dose of vaccine given 4/19/21. Developed URI symptoms (congestion) shortly after which coincided... Read more
2nd dose of vaccine given 4/19/21. Developed URI symptoms (congestion) shortly after which coincided with young kids having URI as well. On or around 5/10/21 he began noticing exertional chest pain and tightness. Symptoms progressed to occurring with less exertion. Admitted 6/2/21 with late-presentation anterior STEMI, underwent emergent angioplasty of multiple lesions.
41 2021-06-14 headache, fever 1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pai... Read more
1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.
41 2021-06-14 sweating 3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room... Read more
3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours. He was given IV fluids, antibiotics, then admitted to the hospital. He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.
41 2021-06-14 malaise On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gon... Read more
On May 18, 2021, Patient said he was experiencing severe back pain and that both of his arms had gone numb and he had vomited. Patient called his mother to come help him with the baby because he wasn't feeling well. When she got there 30 minutes later he was not breathing. They were not able to revive him. He died of a blood clot in the front of his heart.
41 2021-06-15 sweating Shortness of breath, gas, tighten chest, sweats
41 2021-06-16 chills, headache, fatigue 24hours after vaccine:headache, chill, muscle pain, tireness 48 hours after vaccine: Slow heart rate... Read more
24hours after vaccine:headache, chill, muscle pain, tireness 48 hours after vaccine: Slow heart rate below 50, chest pain, tightness of heart area from 7am-1pm
41 2021-06-16 malaise PATIENT STATED THAT HE RECEIVED THE VACCINE ON FRIDAY, AT THE END OF THE DAY ON SATURDAY, HIS CHEST ... Read more
PATIENT STATED THAT HE RECEIVED THE VACCINE ON FRIDAY, AT THE END OF THE DAY ON SATURDAY, HIS CHEST STARTED TO FEEL HEAVY AND HE HAS LABOR BREATHING. HE WOKE UP SUNDAY AND DIDN'T FEEL WELL. HE TOOK A NAP AT AROUND 4PM ,THEN WOKE UP AND COULDN'T BREATH WITH HEART PALPITATIONS. HE WAS ABLE TO ARRIVE TO THE EMERGENCY ROOM AND TRIED TO WALK HIMSELF IN. HE COLLAPSED ON THEIR YARD.
41 2021-06-17 fatigue Severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes; Severe fatigu... Read more
Severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes; Severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0176, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 15May2021 17:30 (at the age of 41-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0170, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 24Apr2021 17:15 (at the age of 41-years-old) for COVID-19 immunisation. The patient experienced severe fatigue on 16May2021 07:00 and severe swelling of lymph node in left arm pit and minor swelling in other lymph nodes on 17May2021 07:00. The events were assessed as non-serious. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.
41 2021-06-19 sweating After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute aft... Read more
After about 15 Minutes after the injection, My Hands and Feet broke into a sweat, about 1 minute after that the top of my head started to tingle ( like pins and needles) after about another minute it felt like I had to keep breathing on purpose. ( what I mean by that is I was aware of my breathing and had to knowingly take breaths it was like I had been under water and just come up for air) I don't remember the exact time maybe another minute or so, my heart started to race. This All went on for about 45 Minutes. When this first happened the Pharmacist told me that what was happening was common with vaccinations and had nothing to do with the covid 19 vaccination, I asked for the nurse that had provided the vaccine to me and was told she went to lunch. So there was no healthcare professional there to help me. The pharmacist just had me sit in a chair and told me to sit there until I felt better. This happened for both injections. I have never experienced this type of reaction with any other vaccine in my life.
41 2021-06-19 malaise I don?t know if it?s caused by the vaccine or not as the timing is so apart, but it is crazy to have... Read more
I don?t know if it?s caused by the vaccine or not as the timing is so apart, but it is crazy to have something rare like pericarditis all of a sudden so I thought it best to submit to VAERS to let you review in case it was related or coincidental. I?ve had multiple covid tests that are negative but the current theory is this was from a virus I caught while traveling 6/14-6/16. Staring feeling ill 6/17, went to hospital with chest discomfort 6/19, admitted and run through a battery of tests to make sure I wasn?t having a heart attack.
41 2021-06-21 chills, headache headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, ... Read more
headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea
41 2021-06-23 headache I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing ... Read more
I have had NONSTOP ringing in my left ear since April 19th. I have sporadically experienced ringing in my Right ear as well but not nearly to the extent I have in my left ear. I also experienced frequent, daily headaches for about the first month or so after the shot. I also experienced neck/right shoulder stiffness for about 3 weeks following the shot. I continue to wake up on a daily basis with a feeling in my head and ears like I've been listening to loud music or been in a loud sporting event for several hours (on top of the still nonstop/constant ringing in my left ear that will not go away). I have also experienced swelling in my feet and ankles anytime i'm active for an extended period of time
41 2021-06-23 sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
41 2021-06-24 headache, malaise, fatigue About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has conti... Read more
About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination. Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.
41 2021-06-24 sweating As soon as the vaccine was completed and the bandaid was put on, the patient started having what loo... Read more
As soon as the vaccine was completed and the bandaid was put on, the patient started having what looked like seizures. He arched his back and reached his arms out to either side, lifted his head and started making a noise. He was sweating profusely. I held him and kept him from falling out of the chair and called for my technician to call 911. Once he called the patient came to after about 2 minutes. His breathing was not hindered so I felt it was not an allergic response. I checked his pulse and started asking him questions such as if he knew who he was and what was going on. I gave him some water and kept checking his pulse. I laid him on the ground while we waited for EMTs to arrive. Once they arrived they took over and checked his pulse and heart rhythm. His pulse was low (in the 40s and 50s) and his pressure was low. He denied going on the ambulance and his brother came and picked him up and took him to the hospital. Total time from beginning to end was about an hour.
41 2021-06-26 chills, fatigue, fever, malaise The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, f... Read more
The 2nd dose of Pfizer vaccine was injected on May 3rd, 2021 at a clinic. Minor arm ache, fatigue, fever/chills felt for approx. ~1day post vaccination and then felt back to normal. Around day 3 post vaccination felt sudden, sharp, stabbing pain within chest cavity which forced me to take shallow, rapid breaths to avoid triggering pain. Lasted a few minutes before subsiding. Following day or so pain returned as a dull, diffused pain and was felt intermittently for several weeks. Generally I run fairly often for fitness, however activity level was reduced due the ongoing chest pain. Wanted to resume normal activity levels, but decided to consult a Doctor for peace of mind due to pain taking so long to resolve. Scheduled virtual appointment (06/24/21) who advised an ER visit due to it being a potentially risky chest issue, and the fact that they could run the appropriate tests to diagnose it relatively quickly. Walked over to a nearby ER that afternoon and was hospitalized for 1 night, who diagnosed an "Unprovoked VTE" with a "Pulmonary Embolism" in Right lung. Was treated with Lovenox injections at hospital and currently taking Eliquis medication. As a side note: my brother (43yrs old) who lives in another country, was administered the 1st dose of the AstraZeneca vaccine on 05/24/2021 and subsequently fell ill, went to the ER twice and was eventually diagnosed with VTE/Bilateral PE. He is also currently taking Eliquis medication.
41 2021-06-26 sweating vaccine was administered and patient lost consciousness. he began to turn red and did not breathe fo... Read more
vaccine was administered and patient lost consciousness. he began to turn red and did not breathe for several seconds at which we were about to administer an EpiPen. He then took a breath and started to convulse. he regained consciousness and was not coherent at first. He was sweaty and pale. Pt became alert and oriented and stayed in the room while we waited for the emt to arrive. He declined to be taken to the hospital. He moved to the waiting room and was monitored for 30 minutes before leaving
41 2021-06-27 headache after 2nd dose, severe flu like symptoms for 24-48 hours. After that long lasting issue of knee infl... Read more
after 2nd dose, severe flu like symptoms for 24-48 hours. After that long lasting issue of knee inflammation and temple region vain inflammation. CRP level is was high in recent blood work.
41 2021-06-28 fatigue Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randoml... Read more
Fatigue, ache, Extreme swelling of the lips. 4 occurrences so far covering all 4 quadrants randomly. Numbness, tingling, itchy sensation. Last episode involved swelling of the cheek and eye on same side as lip. Chest and back tightness
41 2021-06-28 fatigue Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccin... Read more
Pt reports lymph node swelling to left side of neck began 5 days after initial dose of Pfizer vaccine (3/25/2021); reports node was firm and "Pistachio size, swelling to a Pecan size." Pt reports muscle pain, and bilateral lower extremities "extremely hot and sweaty." "extreme fatigue and weakness." Pt was seen by his primary provider at local HCF and was prescribed "2 rounds of antibiotics, Zithromycin and steroid." Dr. also had an ultrasound at another HCF which he reports showed lymph note "reactive and inflamed." Pt continued to follow up with medical provider and waited 3 months to received Pfizer booster vaccine (6/23/2021), which he did receive and subsequently reports reaction is "worse." He reports left side of neck lymph node swelled to "Pecan size" and this time left under arm lymph node palpable "pea size" and he became "loopy;" "not fully present" described it as driving as in a fog "dissociated." Extreme fatigue and weakness continue. Pt reports he then again saw his primary medical provider and was prescribed more antibiotics (Rocefin I.M.) and steroids. He is being referred to an ENT MD and infectious disease MD for follow up. Pt reports he tested multiple times in the past for COVID-19 via rapid testing (No PCR confirmatory test done), he reports he never tested positive for COVID-19 but reports he had all the symptoms including loss of taste and smell back in July 2020.
41 2021-06-29 fatigue Upset stomach; heartburn; Gas; diarrhea - for around 48 hours. Fatigue also - maybe longer - about 6... Read more
Upset stomach; heartburn; Gas; diarrhea - for around 48 hours. Fatigue also - maybe longer - about 60 hours. Tried to keep hydrated. Didn't see the doctor.
41 2021-06-29 headache Pain in neck; Pain in head; This is a spontaneous report received from a contactable consumer, the p... Read more
Pain in neck; Pain in head; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old male patient received first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN; Lot Number: unknown) as solution for injection on the left arm, on 20Mar2021 at 1245 for COVID-19 immunisation at public health clinic/ veterans administration facility. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not tested positive for COVID-19 since having the vaccine. On 22Mar2021 at 13:45, the patient experienced neck pain and head pain (patient had felt that his head was swollen and foggy. Patient was not feeling dizzy). The clinical outcome for neck pain and head pain was not resolved at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
41 2021-06-30 headache RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS ... Read more
RAPID HEART RATE - MULTIPLE VISITS TO ER WITH EKG AND BLOOD TESTS -RESULTS NEGETIVE LIGHT-HEADINESS SEVER HEADACHE'S TROUBLE SLEEPING ANXIETY
41 2021-07-01 chills, fever, fatigue arm soreness; fatigue; fever (100 degrees); chills; This is a spontaneous report received from a con... Read more
arm soreness; fatigue; fever (100 degrees); chills; This is a spontaneous report received from a contactable consumer, the patient. A 41-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route administration on 24Mar2021 at 10:00, (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration on 01Mar2021, (at the age of 41-years-old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 21:00 (11 hours after the dose), the patient had very predictable response to the 2nd dose as he experienced severe arm soreness, fatigue, mild fever (100 degrees, units unspecified), chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as result of events and included the treatment with Tylenol and slept. It was reported that, one day after vaccination only mild arm soreness remained. The clinical outcome of the event arm soreness was not resolved and for events fatigue, fever (100 degrees) and chills were recovering at the time of this report. No follow-up attempts are needed. No further information was expected.
41 2021-07-04 fatigue On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Su... Read more
On Saturday July 3rd I noticed tightness in my chest, lightheadedness, and ringing in my ears. On Sunday, July 4th, I still had the lightheadedness, tightness in my chest, rapid heartbeat, and it was more difficult to breath unless I was sitting a certain way. On Monday, July 5th I had severe chest pain, difficulty breathing, fluttering and pounding heart, when I took a deep breath I would feel my heart pounding but at a much slower rate and then it would go back to normal beats, severe ringing in the ears, extreme tiredness. This lasted for about 1.5 hours and I went back to bed and when I awoke 4 hours later my heart seemed to beat fine. Chest pain lightened up a bit, but breathing is still difficult. I?m very healthy and have not had any health issues. The heart issue this morning was so bad that I?m not sure if I should get the second dose. If things worsen, I will contact my doctor. I?m hoping that it goes away soon and this will be alleviated on its own, but I?m really worried about getting the second dose even though I want it.
41 2021-07-05 chills waking up at 4am with aches and some nausea; waking up at 4am with aches and some nausea; experienci... Read more
waking up at 4am with aches and some nausea; waking up at 4am with aches and some nausea; experiencing some chills; This is a spontaneous report received from a contactable consumer. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 12:00 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 04:00, the patient woke up with aches, some nausea and experiencing some chills. It was unknown if the patient received any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events aches, nausea and chills were resolved on an unspecified date. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Event ache, nausea description updated to waking up at 4am with aches and some nausea, Event chills description updated to experiencing some chills, Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-05 headache Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Pa... Read more
Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.
41 2021-07-06 sweating The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as f... Read more
The night of July 3rd, I started getting severe chest pain, that was worse than before. As well as full body nerve pain, obsessive sweating, shaking, my back was twitching, which led to uncontrollable shaking that went into my legs like they were vibrating. It went all over my body, hands, feet, legs, arms, all over. When I tried to stand up I could barely walk, I went to the ER. They took at CT Scan, blood tests, and just sent me home to get checked by a Neurologist. Since then I continue to have these symptoms. Such as trimmers, in my hands and feet. Heat on my skin all over my body at random times of the day. As well as the sensation that I have water or sweat on random parts of my body. I go to the Neurologist, July 15th to do further testing.
41 2021-07-07 cough, sinus congestion, throat pain Breakthrough COVID-19 case despite vaccination in Jan 2021. Current symptoms began July 6,2021. Expo... Read more
Breakthrough COVID-19 case despite vaccination in Jan 2021. Current symptoms began July 6,2021. Exposure to unvaccinated individuals over the July 4 weekend. Symptoms are mild consisting of cough, sinus congestion, sore throat. No fevers, shortness of breath, diarrhea. SARS-CoV-2 nasopharyngeal PCR test positive on 7/7.
41 2021-07-08 fatigue, fever, chills 104 degree fever; chills; body soreness; fatigue; This is a spontaneous report from a contactable co... Read more
104 degree fever; chills; body soreness; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin. The patient did not receive concomitant medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 01:45, the patient experienced 104-degree fever, chills, body soreness, and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive treatment for the reported events 104-degree fever, chills, body soreness, and fatigue. The clinical outcomes of the events 104-degree fever, chills, body soreness, and fatigue were recovered with sequelae (reported as recovered with lasting effects) on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-08 headache Headache; Sore around injection area; Hard around injection site; This is a spontaneous report from ... Read more
Headache; Sore around injection area; Hard around injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, obesity and bicuspid aortic valve. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 16:00, the patient experienced headache, sore around injection area and hard around injection site. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache, vaccination site pain, vaccination site reaction was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
41 2021-07-11 headache, chills, fever Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills... Read more
Patient reported that his heart rate has increased to 150 pm since the shot, also had shaking chills and 103 fever, severe headache for 3 days
41 2021-07-15 fever, chills, fatigue, headache, sweating, lethargy Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), vi... Read more
Day 1-2 post injection: Severe body aches (whole body - hurt to even try to pick up cell phone), visibly swollen left armpit painful to touch and with arm movement, severe rigors, fever ~101, rapid temperature changes (burning up to freezing), sweating, headache, nauseousness, dizziness, exhaustion/low energy, no appetite, brain fog Day 3: above started to slowly subside Majority of symptoms have gone away. Still get nauseous and dizzy at some point every day. Low energy, lethargic still, no real appetite, still have brain fog.
41 2021-07-17 fatigue, headache (MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to vaccination, the patien... Read more
(MANUFACTURER UNKNOWN) in the past and experienced vaccine allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021, the patient experienced facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness. No therapeutic measures were taken as the result of adverse events. The adverse event resulted in visit to the doctors or other healthcare professional office/clinic visit. The clinical outcomes of the events facial flushing, fatigue, dizziness, mild headaches and nausea with dizziness were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
41 2021-07-17 fatigue Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male pa... Read more
Tiredness; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Mar2021 12:30 (Lot Number: ER8730) as dose 1, single for COVID-19 immunization at the age of 41-year-old. The vaccine was administered at pharmacy/drug store. Medical history included smoking from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had SARS-CoV-2 test (nasal swab) on 14Apr2021 and result was negative. The patient experienced tiredness on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021778305 Same patient/drug, different dose/event.
41 2021-07-17 fever 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swellin... Read more
10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; 10 days after the second dose experienced high fever, hives and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night.; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0196), second dose via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant medical history and concurrent conditions. No known allergies were reported. The patient's concomitant medications were not reported. Historical vaccine given to patient was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), first dose via an unspecified route of administration, administered in left arm on an unspecified date in May2021 at 09:30 (at the age of 41-year-old), as a single for COVID-19 immunisation at pharmacy or drug store. No relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Reported Event: 10 days after the second dose on 27Jun2021 at 02:00 the patient experienced high fever, hives, and angioedema according to pcp. swelling was in my face and salivary glands, fever much worse at night. No treatment was received for the event. The events had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. The reporter reported events as non-serious. Adverse events result in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Jun2021 (Nasal Swab). The outcome of events was reported as resolving and outcome of the event high fever was reported as not resolved. No follow-up attempts are possible. No further information is expected.
41 2021-07-18 fatigue, fever Exhaustion, mild fever, and mild diarrhea
41 2021-07-25 fatigue wife called on 7/26 stating her husband quickly felt arm pain and fatigue on 7/24. At 9pm pt was un... Read more
wife called on 7/26 stating her husband quickly felt arm pain and fatigue on 7/24. At 9pm pt was unable to speak and taken to the hospital. CT scan was performed and while that was happening patient lost feeling in arms and legs. Ct scan ruled out acute stroke. Pt must have been well enough to be discharged b/c wife then mentioned she was still concerned and brought him to hospital. He was admitted and as of this morning was waiting for the MRI results.
41 2021-07-26 fever, malaise, cough 42 yo male with history of congenital kidney disease s/p renal transplant in 1990; stable on myforti... Read more
42 yo male with history of congenital kidney disease s/p renal transplant in 1990; stable on myfortic, Neoral, and prednisone. He developed COVID symptoms on 7/15 and tested positive that day with cough, fevers, but no hypoxia or work of breathing. He completed his full Pfizer COVID-19 vaccination:first dose 2/18/21, second dose 3/11/21. He presented and was admitted to the hospital on 7/20 for abdomen tenderness and AKI. Due to his immunocompromised state, he was started on remdesivir for COVID-19.
41 2021-07-27 chills, headache A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizz... Read more
A small triangular patch was still swollen under my left eye; a racing heart; severe headache.; Dizzy moments,; feelings of clumsiness; Chills; pain in right knee; pain in left shoulder; mouth and left side of face felt numb; mouth and left side of face started swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8737) via an unspecified route of administration in the arm left on 03Apr2021 at 09:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and general allergies. Patient had birch allergy (as child) and had reactions (fever) after vaccines as a young child. The patient did not have any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 09:45, the patient experienced numbness, swelling face, dizziness, clumsiness, chills, pain in knee and pain in shoulder and at 3:00 he experienced severe headache. On 04Apr2021, the patient experienced a racing heart and on 05Apr2021, the patient experienced eye swelling. 30 minutes after the vaccine, the patient noticed his mouth and left side of face felt numb and started to swell as he was driving. The sensation felt similar to dental work. It seemed to improve after 1-2 hours (went for a walk and started to do yard work). General numbness and swelling lasted all day. On day 2, a small triangular patch was still swollen under his left eye. In the night (of day1) he woke up at 3:00 with a racing heart and severe headache and had a restless night thereafter (which is highly uncommon). Heart beat went back to normal after waking up and walking outside. Other less severe and persistent symptoms included dizzy moments, feelings of clumsiness (fell playing sports with son, missed a stair), chills, pain in right knee, pain in left shoulder, The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, dizziness, clumsiness, chills, pain in knee, pain in shoulder and eye swelling was recovering at the time of this report. The clinical outcome of the event numbness and swelling face was recovered on 03Apr2021 and racing heart recovered on 04Apr2021. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 fatigue Loss of taste and smell, resolved within 2 weeks. Fatigue, intermitant dull pain left side chest. W... Read more
Loss of taste and smell, resolved within 2 weeks. Fatigue, intermitant dull pain left side chest. Worse at night laying down. Not as noticeable during the day. Fatigue and chest pain are ongoing.
41 2021-07-27 headache Terrible headache; Severe bone pain; This is a spontaneous report from a contactable consumer, the p... Read more
Terrible headache; Severe bone pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the arm left on 02Apr2021 at 14:00(at the age of 41-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included levothyroxine (L-THYROXINE) started on an unknown date for an unknown indication. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced terrible headache, severe bone pain. The bone pain went away the second day; however, still have headaches. The headache was not severe, but had it constantly. On 26Apr2021, lab test included salvia test and the result was negative. The clinical outcome of the event severe bone pain was recovered on 03Apr2021; and that of the event terrible headache was not recovered. No follow-up attempts are needed. No further information is expected.
41 2021-07-27 fever little fever; This is a spontaneous report from a contactable consumer (patient himself). A 41-years... Read more
little fever; This is a spontaneous report from a contactable consumer (patient himself). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 12Jul2021 17:30 (at the age of 41-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Blood pressure high. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No prior vaccinations. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 12Jul2021 17:30 as dose 1, single for COVID-19 immunisation and experienced no adverse event. Concomitant medication included ramipril (RAMIPRIL) taken for hypertension, started three years ago. On 13Jul2021, the patient experienced little fever. He wanted to know the temperature range of the body after receiving dose of the vaccine. Caller stated he know having this little bit of fever is kind of normal. Patient asked, what was the normal range of temperature. Stated the fever began a couple of hours ago today, 13Jul2021. He did not feel bad, just took his temperature and it was 100.5. The patient underwent lab tests and procedures which included temperature: 100.5 on unspecified date. No vaccine administered at Military Facility. The clinical outcome of event was unknown.
41 2021-07-28 headache, fever Persistent headache; 100 degree fever; This is a spontaneous report from a contactable other healthc... Read more
Persistent headache; 100 degree fever; This is a spontaneous report from a contactable other healthcare professional, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included atorvastatin calcium (LIPITOR) 10 mg from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient experienced persistent headache and 100-degree fever. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events persistent headache and fever was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
41 2021-07-28 headache Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizzines... Read more
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
41 2021-07-28 throat pain, runny nose VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/05/21pfizer,Lot#EL3246 2nd dose: 01/26/21,Pfizer,Lot# EL9262 Diagnosed covid positive:07/21/21 symptoms started: 07/19/21 Exposure:Community exposure Symptoms:sore throat,diarrhea,runny nose
42 2021-01-03 headache, fever, chills Day 12.. still have chills, headache and fever of 101.5 every night.
42 2021-01-04 chills Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after... Read more
Red rash at injection site (left shoulder) and red rash on left, middle and right neck 9 hours after administration, also weakness, flushed, hot and cold chills without fever 26 hours later. Red rash disappeared within 1.5 hours after taking ibuprofen.
42 2021-01-04 headache, chills Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want... Read more
Muscle ache; Chills; Headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work; Left arm is too sore way it was administered; This is a spontaneous report from a contactable consumer who reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 23Dec2020 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Concomitant medications were reported as none. On an unspecified date ("roughly" 6 hours after the vaccine was administered) the patient experienced "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" and "left arm is too sore way it was administered". The patient reported that he called "because he took the COVID-19 vaccine last night and he had been having reactions from last time till this time" (as reported). The patient stated that there was no doctor that prescribed the medication, it was administered to him because he was a healthcare worker (certified nursing assistant). He stated that he had been having "muscle ache, chills and severe headache, the headache is so severe, the most disturbing one." He reported that one of the Tylenol doses was administered to him by the nurse that administered the vaccine. He reported that he took some Tylenol and ibuprofen but this time it was not helping. He stated that he received the vaccine about 24 hours ago and started to experience muscle ache, chills and severe headache roughly about 6 hours after the administration. He reported that "I could hang in, but it was getting too bad, my head wanted to fall off, so I am driving home now so I could not work." When the patient was asked about the vaccine dose and route he stated "I believe normal dose I believe, I cannot remember I cannot recap anything, but I know it was administered in my left arm, my left arm is too sore the way it was administered." He stated that he received the vaccination for prevention and to be on the safe side. The patient stated that he did lab work with his doctor a few months ago, probably around 6 or 7 months ago. The clinical outcome of the events "muscle ache", "chills", "headache is so severe most disturbing one; it was getting too bad, my head want to fall off, I could not work" were all not recovered/not resolved, while the clinical outcome of the event "left arm is too sore way it was administered" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
42 2021-01-04 headache Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. A... Read more
Empoyee received his 1st dose of Covid-19 vaccine around 1535 on 12/17 at our vaccination clinic. Around 1545, while being monitored by a registered nurse, he leaned over and grabbed his head. The nurse asked if he was okay and he reported, "no". He stated that he felt nauseated. V/S obtained: B/P 158/80; pulse 99; resp 24; O2 sat 99% on RA; FSBS 267. Pupils were slow to react. Skin was flushed and red. Dr. was notified and assessed the employee. At 1558, the Dr. ordered Benadryl 50mg IM. This was given to employee in Left Deltoid IM at 1558 by RN. At 1559, patient complained of heache, chest tightness, being cold. At 1606, O2 sat was 99% on RA; B/P was 126/90. He reported that his headache was going away at that time and that the chest tightness was going away as well. Headache at that time was a 4/5 on pain scale. Recommended that he be checked at the ER. Between 1620-1625, first responders on site. At 1630, employee was transported to ER for evaluation. Status at time of transfer: Alert and Oriented; headache better, nausea getting better.
42 2021-01-05 headache Diarrhea and Headache starting 3 hours after first dose.
42 2021-01-06 fever, chills, fatigue Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigu... Read more
Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,
42 2021-01-06 fever, chills Fever, body aches, chills, dizzyness
42 2021-01-07 chills, fatigue, dehydration Went to ED 6 days after vaccination. "42yoM with a hx of covid-19 infection in 3/2020 with sequelae... Read more
Went to ED 6 days after vaccination. "42yoM with a hx of covid-19 infection in 3/2020 with sequelae of chest pain, insomnia, SIBO, and distant hx of testicular malignancy who presents with chest pain and chest palpitations.  Pt received COVID vaccine on Monday, then started to have symptoms reminiscent of his original covid infection on Wednesday, including chills, myalgias, substernal chest pain, heart palpitations, and fatigue. Denies any fevers recorded at home. He feels like he has extra beats intermittently. Also reports some nausea, but denies vomiting or diarrhea. He has maintained good PO intake since symptoms started, but is worried he may be a bit dehydrated because he had a small AKI when he had covid back in March?. Etiology of chest pains unclear, but given all of the above workup, unlikely to be due to an acute cardiac or pulmonary etiology." He continued to have palpitations for the next week and had further EKG's don thru urgent care.
42 2021-01-07 fatigue, fever, chills Fever (100.6) chills, very bad body aches, fatigue, dizziness Lasted for about 18 hours. Woke up th... Read more
Fever (100.6) chills, very bad body aches, fatigue, dizziness Lasted for about 18 hours. Woke up the next day feeling fine.
42 2021-01-07 headache complaints of a headache, right side face swelling and numbness, and right sided chest pain
42 2021-01-08 chills, fever Fever, uncontrolled rigors, extreme/uncomfortable aching of the feet and hands that awoke from sleep
42 2021-01-08 fatigue, headache, chills fatigue, muscle soreness (all over), chills, slight headache
42 2021-01-08 fever No reaction to first dose 12/16. I turned positive and recovered on 12/28 with only mild symptoms an... Read more
No reaction to first dose 12/16. I turned positive and recovered on 12/28 with only mild symptoms and received my second dose on 1/08. About 12 hours after started having rapidly evolving myalgia, high fever ( 104f) HR: 105 ( my baseline is 50-60) and RR 22 with SPO2 of 98-100%.
42 2021-01-09 headache, fatigue Headache fatigue, disorientation, loss of interest Narrative:
42 2021-01-09 nasopharyngitis, fever, runny nose, fatigue, headache, malaise Start to not feel well around 4:00 pm. Had a headache and runny nose and a fever of 99.8. At est 8:... Read more
Start to not feel well around 4:00 pm. Had a headache and runny nose and a fever of 99.8. At est 8:45, fever was 100.2, still headache and runny nose and little body aches Felt like a head cold. Was tired also. I took ibuprofen and fell asleep shortly afterwards. Woke up at approx 10:30 pm to go to bed. Fever was at 99.0, with no headache. Woke up next morning felling much better, with no fever and no headache.
42 2021-01-10 fatigue Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gro... Read more
Immediate weird taste in his mouth ("like licking a kitty litter box and made his snickers taste gross"), dizziness, and nausea after getting the vaccine. Brain fog, dizziness, and nausea continued for the rest of the shift. 5 hours after the vaccine (10pm) he was very fatigued. When he woke up the next morning his arm felt like it "was in a vice" and he is still hazy.
42 2021-01-10 sweating, fever slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and bre... Read more
slight fever sweatiness after 15-30 minutes throat started to close up, difficult to swallow and breath tingly and numb around nose this lasted for about an hour
42 2021-01-10 fever Fever to 104.2 F. Abated with APAP and Ibuprofen.
42 2021-01-10 fever 104.2 degree F fever. Abated with time, APAP and Ibuprofen.
42 2021-01-10 respiratory tract congestion, cough, headache, influenza like illness, nasal congestion, fever, chills chills, fever, cough, chest congestion, nasal congestion, HA, nausea, fatigue, body aches. Feel like... Read more
chills, fever, cough, chest congestion, nasal congestion, HA, nausea, fatigue, body aches. Feel like I have the flu. Ibuprofen with mild improvement.
42 2021-01-11 cough, respiratory tract congestion CoughWheeze cough, congestion
42 2021-01-11 headache Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onse... Read more
Approximately 30 minutes after receiving his 2nd dose of the Pfizer COVID vaccine he had sudden onset of dizziness, nausea, and feeling flushed. He went to Emergency Department for treatment. He was discharged from the Emergency Department to home. On 1/12/21 he states nausea and dizziness gone. Slight headache. Feels better.
42 2021-01-12 chills, fatigue DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINC... Read more
DEVELOPED DIZZINESS, EXTREME FATIGUE, CHILLS, WEAKNESS, NIGHTMARES AND ELEVATED BLOOD PRESSURES SINCE 1/12/2021 AT NIGHT. UNABLE TO GO TO WORK.
42 2021-01-12 chills, headache, fever a fever of 103 degrees; second dose on 05Jan2021; Strong headache on the left side/Strong headache b... Read more
a fever of 103 degrees; second dose on 05Jan2021; Strong headache on the left side/Strong headache but stronger on the forehead area; chills; overall body aches; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 at a single dose, and then second dose (lot number: EL3246, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. On 18Dec2020, the patient had a strong headache on the left side, chills and overall body aches. On 05Jan2021, the patient had a strong headache but stronger on the forehead area, body aches, chills and on 05Jan2021, a fever of 103 degrees. This time the patient could not go to work due to these symptoms. No therapeutic measure was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 103 on 05Jan2021, sars-cov-2 test: positive on 2020 prior to vaccination. Clinical outcome of chills and pain was recovered on an unspecified date while for the other events was recovering.
42 2021-01-12 fatigue, headache sore shoulder, headache, exhausted, tired, back and neck pain, sore muscles
42 2021-01-12 headache, fever Fever, aches, severe headache approximately 15 hrs in duration. Fever range: 99.2 to 202.6 F. Onse... Read more
Fever, aches, severe headache approximately 15 hrs in duration. Fever range: 99.2 to 202.6 F. Onset of signs/symptoms approx. 15 hrs after Phizer vaccine dose #2.
42 2021-01-12 lethargy, chills, fever Muscle aches, lethargic, slight fever and chills for six hours
42 2021-01-12 fever, chills, headache Headache, Arthralgia, Fever, chills, injection site pain Narrative:
42 2021-01-13 fever, chills In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, sh... Read more
In the afternoon - pain in right shoulder; within a couple of days: lost of taste, fever, chills, shortness of breath, diarrhea . Tested for Covid 27th of December and was positive. Was on steroids and antibiotics and vitamins; and still on steriods and breathing treatments and still haven't gone back to work.
42 2021-01-14 chills Chills, muscle pain, body aches, nausea, loss of appetite, diarrhea, tenesmus.
42 2021-01-14 headache, fatigue Headache Fatigue
42 2021-01-14 headache, fever fever, headache, nausea. called in sick to work.
42 2021-01-14 headache I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 af... Read more
I was vaccinated on 1/2/2021 and developed oral parasthesias the day of the vaccination. On day 3 after the vaccine, I developed a severe headache with ?brain fog,? confusion, and hyperacusis. The headache has now persisted for 10 days and was severe enough that I missed several days of work this week as I was unable to carry out my clinical duties. I was seen in ED this past weekend and ultimately followed up with neurology after the headache had persisted for 7+ days. The working theory is that I may have developed aseptic meningitis as a side effect of the vaccine and I am currently on a steroid taper which has resulting in partial but significant improvement in my symptoms. I am back at work but still experiencing a mild headache and facial parasthesias. I did request a Covid test in ED 1 on 1/10/21 and tested negative.
42 2021-01-16 chills The day after the vaccine i started to feel this sharp pain in the right side of my lower back in th... Read more
The day after the vaccine i started to feel this sharp pain in the right side of my lower back in the area of the right kidney and today being 12:49 am on 01/17/2021 the pain is located in both sides of my back in the kidney are but is going to the front of my stomach and giving me chills every now and then i have muscle pain from my back al the way to the legs no fever or problems to breath
42 2021-01-16 influenza like illness Flu like body aches, injection site pain, swollen lymph node left armpit
42 2021-01-17 fever, headache, chills Fever Chills Headache Body aches
42 2021-01-17 fever Itching; Rash/all over the body, face, neck and back; Fever; This is a spontaneous report from a con... Read more
Itching; Rash/all over the body, face, neck and back; Fever; This is a spontaneous report from a contactable consumer reported for himself. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 08Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included diabetes. Concomitant medication included varicella zoster vaccine (VARICELLA VACCINE). He noticed a rash on Saturday 09Jan2021 all over the body, face, neck and back; and he had fever. Did not take his temperature. Now today the rash is itching and getting worse. He is planning to get the next injection in 21 days. Mentions he showed the rash to the nurse who gave him this number to call. Information on the Lot/Batch number has been requested. Outcome of event fever was recovered, of others was not recovered.
42 2021-01-19 fatigue, fever, throat pain, headache The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore... Read more
The evening of receiving the vaccine developed body aches, chills, fever, fatigue, headache and sore throat. tested on 12/24/20 for covid results negative. After 10 days developed full body tremors, now improving and then after 2.5 weeks had difficulty walking and leg pain/discomfort. Blood work on 1/13 revealed CPK of 934
42 2021-01-20 fever, headache Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon ... Read more
Fever, body aches, and headache as expected starting about 9 pm on 1/17. On 1/18 in late afternoon developed severe cramping in stomach, chest and upper back. Did not eat after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.
42 2021-01-20 upper-airway cough syndrome, fatigue, headache 01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the ... Read more
01/20/2021: Headache and light headedness 10 mins after receiving vaccine. Waited and completed the 30 mins observation period before returning to work, then took ibuprofen for the headache. About an hour later post nasal drip started, lasted about 2-3 hours or so. Around 4-5pm headache returned, left arm soreness increased (felt like the arm was swung on by a bat), persisted all night. Took ibuprofen around 11 pm before going to bed. 01/21/2021: Woken up at 5 am with a headache and joints were sore especially my troubled joints (knees and lower back). Generalized fatigue experienced as well. Took Ibuprofen at 08:20 for the headache, joint soreness and fatigue still present.
42 2021-01-21 chills, fever, headache Severe chills, shaking, pain in right hip, ribs, headache, fever 101.3, body aches
42 2021-01-21 fatigue, sweating, sleepiness About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I h... Read more
About 3 minutes after receiving the shot, I became dizzy. After 15 minutes, I was still dizzy. I had a little shortness of breath and it felt like my heart was beating faster but this only lasted a few minutes. They had me wait an additional 10 minutes and the dizziness was better but not gone completely. I drove myself home and tried to work from home but was feeling confused. I took the rest of the day off. The next day (yesterday) I woke up exhausted. I took a sick day and slept until noon, which was about 14 hours in total. When I woke up, I felt okay but had no appetite and did not get out of bed for 5 hours. When I finally got up, I still felt dizzy. I ate dinner, watched some TV and went to bed. I woke up this morning without the fatigue but started to feel dizzy in the shower to the point where I almost lost by balance twice. I'm trying to work from home today but feel very dizzy and confused. I couldn't remember my office's phone number. I'm sweating but my temperature is 97.5.
42 2021-01-21 headache, chills, fever for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, ... Read more
for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, right kidney pain
42 2021-01-21 headache, fever, chills, fatigue 01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/1... Read more
01/13:BODY ACHES, HEADACHE,FATIGUE, 01/14: FEVER AND CHILLS, 01/15: HIGH BLOOD PRESSURE,NAUSEA 01/16: HEADACHE AND MINDGRAINE
42 2021-01-21 headache HAD HEADACHE AND BODY ACHES THROUGHOUT THE NIGHT WHICH IMPROVED IN THE MORNING.
42 2021-01-23 headache, fatigue Injection site pain. Lymph node pain same-side. Headache. Fatigue
42 2021-01-24 cough Soreness at the injection site for about a day or so and then might have been exposed during the hol... Read more
Soreness at the injection site for about a day or so and then might have been exposed during the holidays 12/25 or 12/26. Started symptoms on 12/29 - extreme cough, was tested on 12/30 - positive and then after that symptoms worsened, cough, myalgia, no fever.
42 2021-01-24 headache Stomach discomfort and headache
42 2021-01-24 sweating, chills About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking o... Read more
About 72 hours after receiving the vaccination i was shivering uncontrollably on and off, breaking out in sweats on and off. Once i would start to feel better after sleeping 4-6 hours. I get out of bed thinking I was better, then another hour or so later the symptoms were back, so I would go back to bed shivering uncontrollably off and on again, sweating and uncomfortable until falling back to sleep.. This lasted for about 48 hours, which started 72 after receiving my vaccination. No adverse symptoms the first 2 days following the vaccination. I got vaccinated on Tuesday, 1/19/21 - symptoms started Friday, 1/22/21 - Saturday, 1/23/21. Sunday, 1/24/21 I finally felt normal again.
42 2021-01-27 headache Headache, Diarrhea started @ 1am. felt better the following day
42 2021-01-28 fatigue Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in b... Read more
Tingling hands, Feeling weak and tired Patient alert and oriented noted with tingling sensation in both hands at around 5:35 pm, 6 minutes after being vaccinated for 1st dose of PFizer CoviD 19 vaccine. Vitals signs taken BP 156/96, HR 115, RR 20, T 98, O2 sat 98% RA. Patient offered beverage and tolerated well. Patient was monitored, Vitals re checked as Follows: BP 129/80, HR 105, RR 18, O2 sat 99% RA. At around 6:05 PM Patient verbalized that tingling was gone, monitoring continues, pt. noted anxious at all times. Patient states that he is taking Citalopram 30 mg For 2 years. Vitals rechecked at 7 PM BP 148/88, P 134, RR 20 MD evaluated pt with recommendation to send pt to ER For Further (monitor) evaluation. EMS arrived at 7:22 pm and take over the pt. Patient left Ambulating with Wife and EMS.
42 2021-01-29 chills, headache Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Lef... Read more
Woke up at 1:30am with stomach pain, then chills followed by uncontrollable shaking - No fever - Left arm pain and constant head ache for 36hrs after second vaccine - No reaction after the first round of vaccine
42 2021-01-31 fever, headache Tested positive symptomatic COVID-19 on 04Jan2021.; Tested positive symptomatic COVID-19 on 04Jan202... Read more
Tested positive symptomatic COVID-19 on 04Jan2021.; Tested positive symptomatic COVID-19 on 04Jan2021.; High grade fever up to 104F after booster dose on first 24 hours with headache; High grade fever up to 104F after booster dose on first 24 hours with headache; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EK5730), intramuscularly on left arm on 23Dec2020 at 08:45 AM at single dose for COVID-19 immunization. Medical history included hyperuricaemia and hypertriglyceridaemia. Concomitant medication included fenofibrate and febuxostat. The patient was tested positive symptomatic COVID- 19 on 04Jan2021. Symptoms started 01Jan2021: recovered at home. High grade fever up to 104F after booster dose on first 24 hours in Dec2020 with headache. The patient received other vaccine same date (reported as) on 13Jan2021 as second dose on IM left. The patient did not receive any treatment from events. The outcome of events was recovered on unknown date.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
42 2021-02-01 fatigue, chills, lethargy, fever Fever of 101 after fever reducing meds, chills, aches and extreme lethargy for 8 hrs. Low grade feve... Read more
Fever of 101 after fever reducing meds, chills, aches and extreme lethargy for 8 hrs. Low grade fever, chills, aches and fatigue for subsequent 24 hrs. Intense pain and bruising at vaccination site.
42 2021-02-03 body temperature increased Extreme nausea and vomiting for 3 days, muscle pain, 100.9 temperature
42 2021-02-04 chills I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurti... Read more
I didn't have any symptoms all day, then I woke up at 1:30AM with my left arm (injection site) hurting and swollen and I was violently shaking. Hypothermia. Couldn't get warm. It's like my body forgot how to regulate temperature. I've only ever experienced similar coming out of anesthesia after surgery. Took wearing multiple layers of clothes AND multiple blankets just to stabilize my body temp. It lasted for around 2-3 hours. This wasn't normal "chills". This was whole-body shaking hypothermia. Entire body sore afterwards from the involuntary shaking. Unfortunately, I didn't get an actual reading as anything to measure body temp was downstairs and I didn't want to risk falling.
42 2021-02-04 chills Muscle pain, body aches, nausea, chills
42 2021-02-05 sinus congestion, chills On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullne... Read more
On January 18, two days after getting the first dose of the vaccine I woke up with a sense of fullness or pressure in my left ear, mild sinus congestion, and chills. The congestion and chills ended after one day, but the feeling of fullness in the ear has persisted to this day. Then, on January 29, I had a bout of positional vertigo and vomiting that lasted two to three hours. I also experienced ringing or roaring in my left ear. Ever since, I have a bout of vertigo approximately every 24 hours, and the ringing and sense of fullness in the ear ebb and flow on 24 hours cycles as well. This experience has been debilitating and affected my ability to work. My doctor has diagnosed Meniere's disease and says he has been seeing similar symptoms apparently linked to the COVID vaccines. I started taking prednisone on doctor's orders yesterday (February 5), which has stopped the vertigo. Ringing and occasional fullness in the ears persist.
42 2021-02-06 chills, fatigue, fever Chills, low grade fever, fatigue
42 2021-02-06 fever, influenza like illness Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following mo... Read more
Flu-like symptoms. Aches, fever, chills. Began the morning after the shot. Ended the following morning.
42 2021-02-07 fatigue Approximately 10 days following the vaccine, I began to feel mild weakness in my right hand and wris... Read more
Approximately 10 days following the vaccine, I began to feel mild weakness in my right hand and wrist. The vaccine had been administered in my right arm. Over the next two to three weeks I have noticed some additional weakness in both my right and left arms and also my neck muscles. It is currently mild in nature, but a few days ago I had a little difficulty lifting myself out of bed. I also notice the weakness after driving in the car for a while when my arms are in a somewhat horizontal position holding the steering wheel. The weakness in my neck muscles is particularly noticeable in the evening and has caused some fatigue. I have not noticed any significant weakness in the lower body nor have I experienced any additional symptoms. Notably, I was scheduled to receive the second dose of the Pfizer COVID19 vaccine on February 5, 2021, but have delayed it and rescheduled it to February 11, 2021
42 2021-02-07 fever, chills Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night s... Read more
Increased soreness at injection site. Followed by nausea. For next two days: nausea, chills, night sweats, fever, Diarrhea
42 2021-02-07 throat irritation, fatigue, headache Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his ... Read more
Prior to vaccination, patient admitted to taking 25MG of benadryl PO. 3:30 PM: patient received his 2nd dose of the Pfizer COVID-19 vaccine. 3:48 PM: Onset of throat itching and tingling sensation of the right lower extremity. 3:48 PM vitals: BP 137/76, spO2 100%, HR 108, T 98.3F 3:48 PM: Benadryl 25MG IM was given in the left deltoid. 4:03 PM vitals: BP 116/67, spO2 98%, HR 95, T 98.4F. Patient said that he felt a headache that was 2/10 on the pain scale, reported less tingling in his his leg that was mostly felt in his R big toe, and felt some tingling left in his throat but says that "it's nothing." 4:50 PM: Patient's hands felt cold compared to his arms. Patient reported feeling cold in his arms and very tired. 4:55 PM: Patient was transported to the emergency department for further evaluation.
42 2021-02-09 fatigue, fever, headache Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-conta... Read more
Muscle pain; fatigue; Headache; diarrhea; Fever 101.5; This is a spontaneous report from a non-contactable pharmacist reporting for himself. A 42-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 20Jan2021 02:00 PM at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm at 42 years old on Dec2020 03:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient experienced muscle pain, fatigue, headache, diarrhea, fever 101.5; all on 20Jan2021 06:00 PM. The patient required 12 hours in bed to recover. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Covid test post_vaccination (Nasal Swab,Bi naxNow) on 23Jan2021 with negative result. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-02-09 sweating Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in... Read more
Pt sitting up in chair became pale, pasty, diaphoretic, states he isn't thinkin straight. Pt laid in floor, legs elevated. EMS activated, evaluated by paramedics, orthostatics negative, patient allowed to rest for until 1635. Patient color returned, states he felt better, ambulated out of clinic independently. Wife at side.
42 2021-02-09 fever, fatigue Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the inj... Read more
Minor swollen lymph nodes were first observed on day 3 pm at the patient?s neck same side as the injection (left arm). Since then severe swollen lymph nodes have been developing on multiple areas from shoulder, along the neck, to face/back of ear, same side (left) of the shot. Sizes of some areas are more than 1 square inch. Other symptoms including, migrate, mild fever and fatigue.
42 2021-02-09 fever fever. called in sick to work.
42 2021-02-10 headache Since my VAERS report # 228036 on January 8, 2021- I am still getting headaches - they come and go.... Read more
Since my VAERS report # 228036 on January 8, 2021- I am still getting headaches - they come and go. Usually it's in the morning when I wake up. I take Tylenol and an hour or two they will be gone.
42 2021-02-11 fever, headache, chills Temperature of 103, vomiting, chills, body aches, joint pain, head ache, joint swelling. Tylenol an... Read more
Temperature of 103, vomiting, chills, body aches, joint pain, head ache, joint swelling. Tylenol and fluids. It lasted approximately 48 hours.
42 2021-02-15 chills, malaise, headache Headache, Body Aches, Chills, Feeling ill
42 2021-02-17 fatigue Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty se... Read more
Day of the shot (in the afternoon) I felt began feeling ?off?. Day after the shot I had pretty severe body aches and exhaustion that lasted for two full days and lingered for a third day although not as severe. It?s now a week since the last vaccination shot and I went for my first run since the vaccination. I regularly run about 5 miles 3x a week in the mornings. On this run,; which was at about 75% of my normal pace, my lungs felt very heavy with very labored breathing, having to stop and catch my breath periodically. I eventually had to stop at mile 3.
42 2021-02-18 throat pain 1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (... Read more
1. That night I had an elevated blood pressure (around 140/100) but it did return to normal levels (typically 125/80) the next day. 2. Also that night, I had significant body aches (joints and muscle) that was strong enough to effect my sleep. 3. I developed a sore throat 3 days post vaccine that persisted approximately 2-3 days.
42 2021-02-21 headache, fever Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-ras... Read more
Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today
42 2021-02-22 chills, fatigue Patient states that the following morning he began to experience side effects of Chills, Fatigue, Bo... Read more
Patient states that the following morning he began to experience side effects of Chills, Fatigue, Body Aches, and Dizziness. After 5 days with no relief, he proceeded to urgent care and spoke with his PCP. They have tested him with both a Rapid and a regular COVID test and both were negative. He has never had a fever. They have tried various treatments, but he is still having these symptoms.
42 2021-02-23 malaise, headache, fatigue Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2n... Read more
Felt immediate headache, followed by extreme exhaustion, fatigue, body aches (the same day as the 2nd dose) within about 10 minutes after it; and for the next two days. Felt better by 02/14/2021. Began feeling ill again on 02/17/2021, body aches, extreme fatigue, feeling very hot but not having a fever, nausea. It seemed to get better on about 02/21/2021, but then on 02/22/2021, all of the same feelings and symptoms came back and are still present today. I have reached out to my primary doctor to let him know and he suggested that I submit this information here as well.
42 2021-02-24 chills, body temperature increased I was tachycardia at 105/110, hypertensive at 180/110 , riggers and a temp at 102.4
42 2021-02-24 sweating Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi admin... Read more
Patient became diaphoretic, reported tingling on tongue, hoarse voice. Hx. of allergies. Epi administered on site. Patinet transferred to ED and discharged with prednisone.
42 2021-02-25 sweating Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium,... Read more
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild
42 2021-02-28 sweating He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored ever... Read more
He first reported feeling dizzy and that his lips were tingling. His vital signs were monitored every 5 minutes, and he was given 20 mL (50 mg) liquid Diphenhydramine. At 11:50 A.M., his heart rate dropped from 99 to 51, and he experienced a brief loss of consciousness for about 3 seconds. He also became diaphoretic and very pale at the same time. His pulse was weak but present, and his eyes rolled back in his head. 911 was immediately called, and a sternal rub was provided to help patient regain consciousness. EMS arrived at 11:56 A.M. and transported patient to the hospital for further evaluation. Patient was alert and talking upon transport.
42 2021-03-02 cough Coughing; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a cont... Read more
Coughing; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable consumer (reporting for himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3302, expiration date unknown) via an unspecified route of administration in the left arm on 25Jan2021 (at 42 years old) at a SINGLE DOSE for COVID-19 immunization. The patient received the vaccine at a Hospital, reported as "Military Base." The patient had no medical history and had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID since the vaccination. On 26Jan2021, the patient experienced coughing, loss of taste and smell. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient treatment for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.
42 2021-03-02 dehydration, headache Dizziness; high blood pressure; dehydration; severe headache; This is a spontaneous report from a no... Read more
Dizziness; high blood pressure; dehydration; severe headache; This is a spontaneous report from a non-contactable 42-year-old male consumer reported for himself. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6201), via an unspecified route of administration in Arm Left on 13Feb2021 12:30 at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no allergies to medications, food, or other products. Medical history included high bp, fatty liver. Concomitant medication included lisinopril (LISINOPRIL), hctz (HCTZ). The patient experienced dizziness, high blood pressure, dehydration, severe headache all on 14Feb2021 with outcome of recovering. The events were reported as non-serious. No treatment was received. No follow-up attempts are possible. No further information is expected.
42 2021-03-02 headache Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A ... Read more
Shortly after receiving shot in left shoulder, I began to feel sensitivity/tingling in left jaw. A few minutes later, the left side of my face felt heavy/full/numb/tingling. This persisted throughout the remainder of the day along with feeling woozy and having a bad headache. Headache and wooziness were gone by next day but left facial heaviness, fullness, numbness and tingling persisted and is still present today. Not as bad today but still under left eye, along left jaw and mouth, and parts of left cheek. Had teledoc visit with doctor the evening of the shot and he diagnosed as Bell's Palsy.
42 2021-03-02 throat pain, nasal congestion Nasal congestion; sore throat; This is a spontaneous report from a contactable consumer (reported fo... Read more
Nasal congestion; sore throat; This is a spontaneous report from a contactable consumer (reported for himself). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 08:30 at a single dose in the left arm for covid-19 immunization. Medical history included diabetic and traumatic brain injury, both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient experienced nasal congestion and sore throat. No treatment received for the adverse events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The events were reported as not recovered. Information on the lot/batch number has been requested.
42 2021-03-02 fever, headache, influenza like illness random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; ... Read more
random heart-racing; random dizziness; occasional headaches; Temperature between 100-102 for 30hrs; flu-like symptoms; extreme burning resulting in fainting; extreme burning; This 42-year-old male patient contactable consumer (reported for himself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot EN5318,; expiration not provided), via an unspecified route of administration, on 14Feb2021, 12:00 PM (at the age of 42-year-old) as a single dose for COVID-19 immunization, in Left arm. The facility where COVID-19 vaccine was administered was at a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2 (Lot number: el8982) intramuscularly on 24Jan2021 at 09:00 am for COVID-19 immunization on left arm. The patient did not have any other vaccine within four weeks prior to the vaccination. No relevant medical history reported. Concomitant medication included: Levothyroxine 125 "mg", once a day. On 14Feb2021 at 12:15pm, the patient experienced extreme burning resulting in fainting. Ekg normal in ER. Day-2 flu-like symptoms, temp between 100-102 for 30hrs. Day-2 and now day-3, random dizziness, feeling of heart beat, random heart-racing, occasional headaches, no current fever. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events extreme burning resulting in fainting, flu-like symptoms, temp between 100-102 for 30hrs, random dizziness, random heart-racing, occasional headaches, was unknown. It was reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
42 2021-03-03 fatigue, fever, headache Headache, body ache, fatigue, high temp but not fever level, sore arm.
42 2021-03-03 fatigue soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the poin... Read more
soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.
42 2021-03-03 headache On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at... Read more
On Monday I had the COVID vaccination. I noticed no side effects on Tuesday other than tenderness at the injection site. On Wednesday, I noticed light bruising up and down my arms. Thursday morning around 10 AM, I started to have side effect - some so severe they must be documented. At 10 AM, I felt lightheaded and had brain fog. By noon my head was pounding with a headache followed by an upset stomach. At 2 PM things started getting bad and continued to worse. It was not the headache or stomach that need to be noted but a sudden and severe onset of depression and anxiety. - Depression like I have not felt in years when I was at my worst. Throughout the day the depression worsened and by 7 PM, I was unable to stop crying and was overwhelmed with anxiety and PTSD panic attacks. While I have the training to understand this is temporary, - I am very worried about what I?m feeling , because there was no warning or mention of this side effect. I have the resources needed for this but people that are more fragile need to prepare for the sudden o set of critical/ debilitating depression.
42 2021-03-06 headache, chills, fever Severe headaches, fever, chills, muscle aches in legs
42 2021-03-06 throat pain, throat irritation After the first vaccination I had a scratchy and sore throat. 42 hours after the second vaccination,... Read more
After the first vaccination I had a scratchy and sore throat. 42 hours after the second vaccination, I developed hives all over my chest, neck, and back and my tongue swole and became numb. I went to urgent care and the symptoms began to diminish, but the doctor prescribed prednisone and antihistamine.
42 2021-03-07 sweating Pre syncopal , dizzy, flushing, diaphoretic. Evaluated by EMS-Cleared
42 2021-03-08 chills, fever Patient states 6days after injection patient had very painful back pain when breathing in. Patient a... Read more
Patient states 6days after injection patient had very painful back pain when breathing in. Patient also states chills and fever of 102.0.
42 2021-03-11 chills, headache, sweating After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting get... Read more
After about 12 hours, I was woken up from sleeping with extreme body aches/headache and starting getting the chills and shaking. I lost all energy and struggled to get out of bed and walk. Laid in bed all day, took Tylenol, slept off and on. Didn't subside until 6:00pm the next evening when I broke out in a sweat and got some energy back.
42 2021-03-11 chills, fever, malaise Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in be... Read more
Stomach tightness upon waking at 6am. At 12pm felt cold and like was about to get sick. By 1pm in bed with multiple layers of clothes, under multiple blankets with heat cranking. Uncontrollable chills, shivering and teeth chattering. Hands white and lost sensation in fingers. 105 fever. Chills lasted a couple of hours, fever lasted 3 full days. Day 1: 105; Day 2: 102; Day 3: 100; Day 4: No fever. Stomach tightness remains.
42 2021-03-11 sweating lightheaded, nausea, vomiting, sweating, trouble breathing All for about 1 hour
42 2021-03-11 malaise, chills, fatigue, influenza like illness Flu-like symptoms, chills, body aches, fatigue, general malaise
42 2021-03-12 chills, body temperature increased Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp ... Read more
Excessive swelling at injection site (golf ball sized knot) with tenderness to the touch 103.8 temp started 12hrs after injection and lasted for 48hrs Blurred vision during onset of Temp. Muscle pain/ fatigue during onset of Temp. Full body aches during onset of Temp. Chills with moderate spells of hands shaking during onset of Temp Loss of appetite during onset of Temp.
42 2021-03-12 fever, chills Fever chills aches. Heart rate went into tachycardia with a heart rate up to 200BPM. Rush to the ER ... Read more
Fever chills aches. Heart rate went into tachycardia with a heart rate up to 200BPM. Rush to the ER by ambulance. Treated and sent home with a heart rate of 95-100BPM
42 2021-03-12 fever, headache Fever, body aches, headache, dizzy, no appetite, arm pain
42 2021-03-14 fever, chills, fatigue Had severe chills, body fatigue, and fever for approximately 8 hours
42 2021-03-17 chills, fever, fatigue Fever, chills, diarrhea, exhaustion
42 2021-03-17 cough Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; ... Read more
Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; This is a spontaneous report from a contactable consumer reported for himself that a 42-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 25Jan2021 12:00 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies, various surgeries. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Deep itching dry cough in lungs and chest tightness, heaviness, shortness of breath for 4 days after, events start date provided as 07Feb2021 04:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. The patient received the second dose of BNT162 on 13Feb2021 11:30 AM via an unspecified route of administration at Right arm for covid-19 immunization. Information on the lot/batch number has been requested.
42 2021-03-17 sweating He was wearing many layers of clothes due to working in a cold environment prior to receiving vaccin... Read more
He was wearing many layers of clothes due to working in a cold environment prior to receiving vaccine. He was also sweating a lot. About 5 minutes after he was vaccinated, he began to drift in and out of consciousness. His blood pressure was high (165 systolic), but glucose was normal. EMS was called and it was determined to be related to blood pressure and a reaction due to the Pfizer Covid vaccine. Patient was released from hospital.
42 2021-03-18 sweating Client received vaccine at 13:50. Client immediately felt faint and presented with pallor and diapho... Read more
Client received vaccine at 13:50. Client immediately felt faint and presented with pallor and diaphoresis. Client lost consciousness and began to wheeze. Epi administered at 13:53 to right leg. Client then laid to floor and feet were elevated. Client soon recovered and transferred to hospital per protocol for post epinephrine injection. Client coherent, stable and able to independently ambulate.
42 2021-03-19 headache, fatigue Headache, nausea, fatigue
42 2021-03-20 paranasal sinus discomfort Pressure in ears / nose; similar to when flying" NKDA. 130/92, HR 83, talking, 99%
42 2021-03-21 throat pain Trouble swallowing, throat pain
42 2021-03-21 fever, fatigue, chills Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subs... Read more
Intense flu symptoms for three days, to include fever chills, aches, swelling of face and neck. Subsequent to flu, low oxygen rates of 82-91, low resting heart rate of 48-54, extreme exhaustion, swelling of face and neck. General weakness.
42 2021-03-23 sweating Description of event: Patient received vaccine in his LUE and was instructed to wait in line to sche... Read more
Description of event: Patient received vaccine in his LUE and was instructed to wait in line to schedule next dose. While standing in line, patient was witnessed falling to the floor. He appeared to land on his hands, denies injury at this time. Patient responded verbally when asked if he was okay. Vitals recorded while patient sitting on floor 1500. Patient stated he was ok to sit in chair. Upon sitting in chair for approximately 30 seconds his head fell forward and he was unresponsive. Patient began agonal breathing, eyes were open with fixed pupils, pulse was weak. Staff assisted patient to floor where he regained consciousness after approximately one minute. Patient appeared diaphoretic and pale, but was responding appropriately. An ambulance was called during this time. The patient was able to give contact information for his wife. The patient personally spoke to her on the phone. Meanwhile patient was resting supine on the floor. Vitals at 1552 146/94 P 70, R 20, 98% RA. Approximately 15 min later patient returned to the chair and has been resting since. BP at 1615 119/65. He refused treatment from EMS and is currently calling his wife to pick him up as staff has advised him not to drive. Patient currently eating a snack and drinking water, states he is feeling better.
42 2021-03-24 chills, pneumonia, fever 3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but stil... Read more
3/4 Moderate stomach cramps day after vaccine. Much less arm pain then following first dose but still present. 3/9 Work up with terrible thoracic back pain with every breath. Went to ER and received shot of Toradol and chest x-ray (negative). Shortly thereafter, had chills and low grade fever. Alternated naproxen and tylenol for the next two days as fever persisted. 3/11 Moderate chest pressure when breathing. Went back to ER. Received COVID test (negative). No fever or chills. 3/12 Light headedness, racing heartbeat and chills early afternoon. Went back to ER. Received Flu test (negative). Blood work showed positive d-dimer test. CT scan showed small pneumonia in lower left lung. Started Amoxicillin and Z-pack. Symptoms improved over course of following 7 days.
42 2021-03-24 sleepiness The medicine made me extremely drowsy, as if I had taken NyQuil or even some sort of pain pill.
42 2021-03-25 sweating Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and c... Read more
Diaphoretic, felt weak. Vitals wnl. Did not eat as usual in the morning. Offered water, juice, and crackers.
42 2021-03-25 malaise, sweating After receiving vaccine patient complaints of feeling unwell, diaphoretic, nausea, increased heart r... Read more
After receiving vaccine patient complaints of feeling unwell, diaphoretic, nausea, increased heart rate. BP elevated at 226/107 HR 140. Patient assisted to stretcher given oral fluids and reassessed. patient states he does have a history of SVT, which he takes diltazem and lisinopril for.
42 2021-03-28 chills, headache Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night... Read more
Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night of injection until today, which is Monday, 3/29/2021. On Saturday night (3/27) I experienced overwhelming stomach pain and nearly passed out on my toilet multiple times during a bout of diarrhea.
42 2021-03-29 fatigue Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours afte... Read more
Patient states he received 2nd Pfizer shot 3/26 at approximately 10:40am, approximately 2 hours after developed fatigue. At approximately 2:00pm on 3/29 developed chest pain and shortness of breath. Patient was referred to local emergency room for further evaluation.
42 2021-03-29 throat pain Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP ... Read more
Very anxious before vaccine; BP at home 154/90. Felt like "punched in face"/foggy; lightheaded. BP 148/98; pulse 88; p ox 98%; gave water. Continued monitoring; after about 30 minutes, then noted chest "heaviness"; "sore throat"--no tightness, no vision changes. Rapid response evaluated; Patient refused ED; continued monitoring for 10-15. VSS; chest heaviness resolved. Accompanied to hospital entrance; had ride home.
42 2021-03-29 fever 100.5° F fever, body aches, joint pain, tenderness at injection site.. Took two Tylenol Cold+Flu Se... Read more
100.5° F fever, body aches, joint pain, tenderness at injection site.. Took two Tylenol Cold+Flu Severe OTC the next morning Monday. Recovered Tuesday morning. no further symptoms except for injection site tenderness,
42 2021-03-30 chills, fever, fatigue 30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., b... Read more
30-35 minutes after injection, while I was driving home, I felt some minor difficulty swallowing., but no impediment to breathing or speaking. I rerouted to a plaza with a grocery store and urgent care clinic, and bought some Benadryl and took it at about 2:55PM. I waited 20 minutes in the parking lot before deciding I was safe to drive home. When I read about the possibility of a biphasic reaction, where my throat could close up again later, I went to a Clinic (5:40PM walk-in appointment with NP), and they could not treat me, and advised me to go to the Emergency Room. I initially decided to just go home, but went to the Emergency Room out of an abundance of caution at around 7PM. Dr. gave me a prescription for an epi pen and prednisone, just in case symptoms worsened. They did not, and I did not use either drug. The throat swelling started around 2:45PM and worsened for about half an hour. It remained steady (no airway constriction, no difficulty taking pills or drinking water) without getting worse, and started to subside around 5PM. By the time I woke up this morning (3/31), I don't think there is any lingering swelling. I can feel a very slight lump in my throat, but I can't tell if that is a very small amount of residual swelling or just hyper-vigilance based on yesterday's experience. Note: This swelling feeling is identical to my memory of what I felt when I was diagnosed as allergic to penicillin in 2000 or 2001. Back then, the only "treatment" was to immediately stop taking penicillin (and to never take it again), based on a phone call with my doctor's office. I did have a strong immune response after that (102° fever, chills, fatigue, muscle pain), but I don't consider that an adverse reaction. This report is focused on what appeared to be a mild anaphylactic reaction.
42 2021-03-30 dehydration, sweating, influenza like illness, chills Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. N... Read more
Flu like symptoms next day. Vomiting and diarrhea. Body aches. Hot and cold sweats and chills. Night cold sweats during brief sleeping periods. Third day was the same. Loss of appetite and dehydrated. Severe itching on my back. Today is the fourth day and I broke out with a rash on my back. Cortisone has relieved it thus far. My appetite is back. I did not vomit but still experiencing diarrhea.
42 2021-03-30 dehydration Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncon... Read more
Loss of hearing to last less than 5 min. followed by ringing ears through the following day. Uncontrolled palsy for head and neck intermittently through the injection day. I lost my voice and had spasms in my larynx. For several hours I had a hard time choosing my words and speaking which was the scariest. I could not focus enough to even wash my hands on injection day and had to be driven home from work. I got dehydrated because water tasted horrible. The next morning I am better on all fronts except the ringing in my ears wont stop
42 2021-03-30 headache pt. c/o - headaches, dizziness after Pfizer vaccines was given. pt. symptoms was resolved and pt. w... Read more
pt. c/o - headaches, dizziness after Pfizer vaccines was given. pt. symptoms was resolved and pt. went home
42 2021-03-30 sweating Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint a... Read more
Felt a large amount of sensation in my injection arm 1-2 minutes after shot. Started to feel faint and light-headed 3-4 minutes after shot. Passed out about 5 minutes after shot. Felt sweaty, disoriented, spacey, and nauseated shortly after coming back to consciousness. Went to hospital in an ambulance and released a couple hours later.
42 2021-03-30 sweating Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was not... Read more
Shortly after injection, the pt developed dizziness and tingling/numbness in extremities. He was noted to be diaphoretic. HR 70, SP02:99%, BP 110/70. Symptoms resolved after appx. 15 minnutes. The pt was feeling completely back to normal before he departed. Family drove him home.
42 2021-03-30 malaise Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing... Read more
Equatable to the description of Alzheimer's or dementia patients; disorientation; confusion; Knowing your doing something wrong and unable to correct it; Motor skills slowed; Fuzzy tongue; generally out of sorts feeling; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 42-years, via an unspecified route of administration in left arm at 12:15 AM on 16Mar2021 at single dose for COVID-19 immunisation, in Public Health Clinic. Medical history was reported as none. No other vaccine in four weeks. No COVID-19 prior vaccination. No known allergies. Concomitant medications were not reported. At 08:30 AM on 17Feb2021, the patient had periods of disorientation, confusion. Equatable to the description of Alzheimer's or dementia patients. Knowing you doing something wrong and unable to correct it. Motor skills slowed. Fuzzy tongue, and generally out of sorts feeling. Punctuated by periods of lucidity. No treatment received. Outcome of the events was recovering. No Covid-19 tested post vaccination.
42 2021-03-30 fever, fatigue Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a... Read more
Fatigue/More fatigue; slight dizziness; slight nausea; slight fever; hot and cold flashes; This is a spontaneous report from a contactable consumer(patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN5318), first dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 09:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02Feb2021, the patient experienced Fatigue, slight dizziness, slight nausea, slight fever, hot and cold flashes. More fatigue then anything. The patient's lab tests included body temperature: slight fever on 02Feb2021. The outcome of the event was recovering for Fatigue, unknown for Dizziness, Nausea, Pyrexia, Hot flush.
42 2021-03-30 fever, headache, fatigue Fatigue, fever, chest pressure and pain, headache
42 2021-03-31 chills, headache, fever fever (over 101), chills, muscle aches, swelling in left armpit, headaches lasted about 2 days. swel... Read more
fever (over 101), chills, muscle aches, swelling in left armpit, headaches lasted about 2 days. swelling in armpit and headaches lasted another day
42 2021-03-31 fatigue, headache, fever, sweating Headache began 12 hours after shot. Fever Hot/cold sweats Severe nausea Body aches Extreme fatigue
42 2021-03-31 nasal congestion Developed Metallic taste in mouth for several hours almost immediately and slight stuffy nose
42 2021-03-31 fever, chills Chills, fever, body ache
42 2021-03-31 fever, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Tiredness, soreness at injection site, body aches, tingling, fever up to 101 degrees
42 2021-03-31 throat irritation Patient began to fill itchy at injection site, on lower back, and left wrist. His throat also felt i... Read more
Patient began to fill itchy at injection site, on lower back, and left wrist. His throat also felt itchy. His shot was at 10:55AM. Patient alerted us to symptoms at 11:15AM. Patient given 50mg diphenhyramine IM at 11:20AM in left deltoid. His blood pressure at 11:30AM was 144/92, which patient said wasn't abnormal for him. His symptoms did not progress and he was feeling fine other than mild itchiness when he left pharmacy at 11:45AM.
42 2021-04-01 fatigue, fever Lymph node in neck became swollen and painful. Mild fever for at least 2 days. Injection site became... Read more
Lymph node in neck became swollen and painful. Mild fever for at least 2 days. Injection site became a red knot that hurt to touch. Injection site was swollen and turned to a large bruise. Lymph node under left arm swollen. Fatigue.
42 2021-04-01 headache, malaise, fatigue Injections site pain, tiredness, headache, muscle pain, and feeling unwell.
42 2021-04-01 headache 1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I ha... Read more
1 ? I had really bad headaches the night the vaccination was administered. 2 ? The next morning I had a REALLY bad ocular migraine when I woke up. The duration was 24-36 hours.
42 2021-04-02 influenza like illness, fatigue Flu like symptoms Sore muscles. Sore joints. Fatigue. Exhaustion. Loose stools. Lack of thirst, eve... Read more
Flu like symptoms Sore muscles. Sore joints. Fatigue. Exhaustion. Loose stools. Lack of thirst, even when dehydrated.
42 2021-04-04 sweating Patient suddenly became diaphoretic eyes rolled back in head, almost passed out . Onsite EMS was cal... Read more
Patient suddenly became diaphoretic eyes rolled back in head, almost passed out . Onsite EMS was called vitals HR 42 BP 95/59 98% O2 refused glucose check. Patient felt better and reluctantly was transported to local hospital. No reaction to 1st vaccine on 3/12/21
42 2021-04-04 lethargy Vaccine 1st dose in right arm. 2 hours after soreness in arm at site, aching throughout body. 8 hou... Read more
Vaccine 1st dose in right arm. 2 hours after soreness in arm at site, aching throughout body. 8 hours after injection ... itchy all over body. Wheezing accompanied the inching. I took Benadryl just to be safe. Itching and wheezing went away within 1 and a half hours. Following day aching, lethargic all day and diarrhea for 2 days now.
42 2021-04-04 fever, chills, headache fever/chills, headache, myalgia, knee joint pain, lower back pain.
42 2021-04-04 fever, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, joint pain, fever (mild), nause... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, joint pain, fever (mild), nausea
42 2021-04-05 sweating 3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS... Read more
3-5 MIN POST INJECTION, PT EXPERIENCED CHEST TIGHTTHROAT AND TONGUE TINGLING.hE DESCRIBED FEELING AS IF HE COULD NOT GET AIR. nO STRIDOR OR WHEEZING NOTED. PT.SPEAKING WITHOUT DIFFICULTY. PLACED ON STRETCHER, PALE, DIAPHOREETIC. EPI PEN INJECTED TO LEFT QUAD. BP 147/100sat 100% ON ROOM AIR HR 92. MD AT BEDSIDE AND PATIENT TRANSFERRED TO ER FOR EVALUATION.
42 2021-04-05 sweating Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects an... Read more
Patient was given first dose of Pfizer COVID-19 vaccine. I counseled the patient on side effects and asked him to wait 15 minutes afterwards in our waiting area. After about 5 minutes, the patient starting complaining of feeling dizzy. We asked him to sit back in the chair and brought him a bottle of water. I asked the patient if he had eaten today and he replied no. I offered a snack and also a glucose tablet to help with shakiness. As I went to get a bottle of glucose tablets off the shelf, the patient fainted and fell out of his chair. I immediately ran to get an Epipen while my technicians called for a Code White and 911. I was about to inject the patient with the Epipen when he came to about 10 seconds later. He said he was really hot, sweaty, dizzy, and nauseous. Paramedics and AP arrived to evaluate him and take a statement. Patient left on his own will and received a ride home from his mother-in-law, who is an associate at our store.
42 2021-04-07 headache For two days after receiving the shot I had an extremely bad headache. It subsided once I took both... Read more
For two days after receiving the shot I had an extremely bad headache. It subsided once I took both Acetaminophen and Naproxen.
42 2021-04-08 fatigue I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. ... Read more
I had a strange feeling in the left side of my face that I wasn't sure if it was a reaction or not. It happened within the first 15 minutes but did not last more than 30 minutes. I did not experience anything else until the first evening when my arm was very sore. The next day my arm was more sore and I had a mild circular red mark around the injection site and the arm was much harder on that side. I also felt a little in my back and neck. By the second day in the evening the only thing I felt was pain in the arm which eventually traveled into my armpit by day 3. It wasn't until day 5 that all the pain was completely gone. I may have experienced fatigue the first two days also.
42 2021-04-08 fatigue Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care (UC) reporting six days of vomiting, fatigue, shortness of breath, dizziness, constipation, and polyuria starting one day after receiving vaccination. Initial vital signs blood pressure 127/96 mmHg, heart rate 119 beats per minute, temperature 35.9 degrees Celsius, respiratory rate 18 breaths per minute, oxygen saturation 97% on room air. Patient diagnosed with new adult-onset diabetes, diabetic ketoacidosis, and acute kidney injury and admitted to the hospital. Administered intravenous fluids and insulin with improvement in symptoms and lab values. Currently hospitalized.
42 2021-04-08 fever, chills Mild urticaria & itching developed about 12 hours after receiving the vaccine. Fever of 102, chil... Read more
Mild urticaria & itching developed about 12 hours after receiving the vaccine. Fever of 102, chills, and body aches are also present.
42 2021-04-09 fatigue, cough Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generaliz... Read more
Experienced normal soreness the evening of 4/9/2021. At 2:30 pm on 4/10/21, started having generalized soreness. Temp at that point was 98.6. Within ten minutes, started having congestion in chest (rattles). This caused strong bouts of coughing with pain radiation through my lungs. I then started vomiting (x3). I started feeling fatigued so I went to lie down, when I had a cold chill. At 3:00 pm, my temp was 102 F. At 3:15, it was 102.5 F, and then crested at 103 F at 3:30. In the past five hours, the only symptom to subside was vomiting; all the others are still present with my current temp 102.1 F at 8:41 pm.
42 2021-04-09 headache, sleepiness Dizziness, bad headaches, severe soreness in arm, blurred vision, drowsiness.
42 2021-04-09 pneumonia, chills, fever small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when... Read more
small pneumonia in lower left lung; Light headedness; racing heartbeat; Moderate chest pressure when breathing; work up with terrible thoracic back pain with every breath; chills; low grade fever; Moderate stomach cramps; Much less arm pain then following first dose but still present; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via an unspecified route of administration in left arm on 03Mar2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) on 10Feb2021 at 11:30 am in left arm for Covid-19 immunisation. There were no other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had 3/4 moderate stomach cramps day after vaccine on 04Mar2021. Much less arm pain then following first dose but still present on 04Mar2021. The patient 3/9 worked up with terrible thoracic back pain on 09Mar2021 with every breath and went to emergency room and received shot of Toradol and performed chest x-ray which was negative. Shortly thereafter, the patient had chills and low grade fever on 09Mar2021. Alternated naproxen and tylenol for the next two days as fever persisted. The patient had 3/11 moderate chest pressure when breathing and went back to emergency room on 11Mar2021. There was no fever or chills but had 3/12 light headedness, racing heartbeat and chills early afternoon on 12Mar2021. The patient went back to emergency room. The patient's symptoms improved over course of following 7 days. The patient underwent lab test and procedure which included flu test and resulted negative; blood work which showed positive D-dimer test on an unknown date and CT scan showed small pneumonia in lower left lung on 12Mar2021. The patient started to receive amoxicillin and Z-pack. Since the vaccination, the patient had been tested for COVID-19 by nasal swab on 11Mar2021 and tested negative. Events resulted in emergency room/department or urgent care. The outcome of event pneumonia was unknown; for other events was recovering. No follow-up attempts are possible. No further information is expected.
42 2021-04-09 fever, chills High fever, chills, body aches, extremely sore arm, heart racing.
42 2021-04-10 chills, sinusitis, fever, headache On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of th... Read more
On 3/31/21 pt reports feeling "achy, like a wet blanket", headache, Restless and up every hour of the night. "I felt like a freight train ran over me. " Treated for a sinus infection with Z-Pak. Notified he was covid (+) on 4/2/21. Fever, chills, dyspnea.
42 2021-04-10 chills severe trembling and chills (rigors) for minutes in 3 waves.
42 2021-04-10 sweating Individual felt pre-syncopal. Left obs area after 8 minutes to get fresh air. Sat down on grassy are... Read more
Individual felt pre-syncopal. Left obs area after 8 minutes to get fresh air. Sat down on grassy area and was found down, pale and diaphoretic. Suspect LOC. Recovered spontaneously. Normal mental status after event. Treated with oral rehydration. Declined further evaluation. Sent home by POV.
42 2021-04-11 chills, sweating Soreness in shoulder. Chills/sweating/body aches. Swollen lymph node in left arm.
42 2021-04-11 fatigue felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vac... Read more
felt tiredness on 3/28; sore arm showed up on 3/29 and disappeared in about 2 days. However, the vaccine arm pain comes back on 4/11, 2 weeks after the vaccine. it is occasional sharp pain around the injection area. still have ongoing pain.
42 2021-04-11 fever, throat pain Sore throat and dizziness the first 2 days. Sore throat the second day. Currently have a fever of 99... Read more
Sore throat and dizziness the first 2 days. Sore throat the second day. Currently have a fever of 99.8 and had a fever since 4/9/2021
42 2021-04-12 headache, sweating, chills Muscle and bone aches all over the body, chills, sweats, lasting 5-6 hours. Headache.
42 2021-04-12 sweating PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AN... Read more
PATIENT REPORTED FEELING SWEATY, CALMMY, AND FELT LIKE HE WAS GOING TO PASS OUT. HE WAS LAID DOWN AND FEET ELEVATED. NO C/O PAIN OR DISCOMFORT. VITAL SIGNS AS FOLLOWS: 14:15 HR- 68 RESP 18 BP 138/85 O2 @ 96% RA 14:20 HR- 69 RESP 18 BP 138/82 O2 @ 97% RA 14:25 HR- 75 RESP- 18 BP- 132/82 O2 @ 98% RA. 14:30 HR- 71 RESP- 18 BP- 139/81 O2 @ 97% RA. PATIENT WITH NO C/O PAIN OR DISCOMFORT. RELEASED BYSELF TO HOME.
42 2021-04-14 headache, fatigue 7:30 PM- headache, took Tylenol 325 mg x 2 + Benadryl 50mg + 1 packet of Emergen-C next day, 5AM: f... Read more
7:30 PM- headache, took Tylenol 325 mg x 2 + Benadryl 50mg + 1 packet of Emergen-C next day, 5AM: felt tired, headache persisting throughout the day, when got home at 8PM, took Tylenol 325 mg x 2 + Benadryl 50mg 5AM, woke up and noticed rash on chest while in the shower. Took Benadryl 50mg. 11AM: noticed lump on L arm on the injection site. Took Tylenol 325 mg x2 + Benadryl 50mg and it resolved the next day. As of today, 4/15/21: headache still persisting but nowhere near as bad, "not enough to take a Tylenol"
42 2021-04-15 headache, fatigue, chills Moderate chills and aches 8 hours after injection, fatigue, and light headache. Duration of all sym... Read more
Moderate chills and aches 8 hours after injection, fatigue, and light headache. Duration of all symptoms lasted for two hours.
42 2021-04-15 headache, malaise Dizziness severe, headache, aches and pains all over, feeling "sick", taken to bed for 16 hrs.
42 2021-04-15 sweating Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Swe... Read more
Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
42 2021-04-16 fatigue, headache Fatigue, head and body aches
42 2021-04-17 chills, headache, fever Chills, fever, body aches, headache, pain at site of injection. Symptoms managed by using NSAID (Adv... Read more
Chills, fever, body aches, headache, pain at site of injection. Symptoms managed by using NSAID (Advil)
42 2021-04-18 chills, fever Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unabl... Read more
Patient started 2 days after vaccine with shortness of breath and fever/chills. He says he was unable to get out of bed for 24 hours. He said the rest of the week he didn't feel quite right. A week after the vaccine he started with red capillary veins popping up all over his legs. By Saturday his legs were purple and swollen. He has multiple tests run at the hospital. They doctor believes it is vasculitis that has resulted from patient getting the covid vaccine.
42 2021-04-18 influenza like illness Sore left shoulder 24 hours; Flu like symptoms beginning 24 hours after second injection
42 2021-04-18 nasal congestion Head congestion, especially clogged right ear
42 2021-04-21 influenza like illness, fatigue Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left ar... Read more
Flu-like symptoms. Weakness of muscles, soreness, tired. Missed work. Mental confusion. Sore left arm where shot was received.
42 2021-04-22 fatigue, chills, fever Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomni... Read more
Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ), fatigue, insomnia, fever, chills, brain fog
42 2021-04-22 fatigue All symptoms ongoing and have not stopped Bi-lateral tinnitus (high pitched ringing) Ear Ache both ... Read more
All symptoms ongoing and have not stopped Bi-lateral tinnitus (high pitched ringing) Ear Ache both ears Swollen Lymph glands in neck Fatigue Body Aches
42 2021-04-22 headache Severe headaches Almost every day taking Excedrin migraine
42 2021-04-22 sweating, headache Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightnes... Read more
Patient got vaccinated at 10:22 a.m. At 10:35 a.m., patient reported severe headache, chest tightness, difficulty breathing, feeling lightheaded. Patient noted to be diaphoretic, less responsive, and having left eye deviation. Patient assessed/examined by Dr. and Medics on site. Vital signs taken: at 10: 38 a.m., BP 177/126, HR 118; at 10:39 a.m., BP 172/120, HR 110, O2saturation 96% on room Air; at 10:41 a.m., BP 173/123, BG: 333, sinus rhythm on cardiac monitor. At 10:47 a.m., BP 158/78 (with manual cuff). Fire Metro Paramedics called; Patient transported to Hospital at 11 a.m.
42 2021-04-22 sweating, malaise 42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. P... Read more
42 y/o male, past medical history of Anxiety, who presents with possible seizure post vaccination. Patient notified one of the observation nurses that he was not feeling well. The NP was assisting another patient but saw that the patient with his head back and pale. As soon as the NP was at the patient side, it was noted that the patient?s eyes were rolling back, his face was pale, and his lips were blue. The NP attempted a sternal rub with no response from patient. NP instructed police to please call Fire Rescue to transport patient to the ER. Patients left upper extremity was flexed at the elbow and stiff. At that time the patient was placed on the floor by several nurses and the paramedic and patient legs were elevated. Within 10-15 mins patient immediately sat up but was instructed to lay down. Patient was placed on 3L of O2 by nasal cannula and vitals were taken. Patient initial vitals 166/94 L Arm, 98% 3L O2, 84 Pulse and EKG was NSR. Patient no longer with pallor and lips were pink. Patient states that he isn?t feeling well and feels a nervousness throughout his body. Patient placed on stretcher in Trendelenburg. Vitals retaken, 137/97 BP, 98% 3L O2, 80 P. Patient pulses were thready and patient became diaphoretic. Fire Rescue arrive to site and transported patient to the ER. CNO and PM present during event and aware that patient transported to the ER for further evaluation
42 2021-04-22 fever, headache Woke up to a splitting headache, mild fever, minor body aches at around 6:00 AM on April 22. Took Ty... Read more
Woke up to a splitting headache, mild fever, minor body aches at around 6:00 AM on April 22. Took Tylenol to help with the symptoms. By 7:30PM, the symptoms had gone away.
42 2021-04-24 headache headache; Sore arm where the shot was administered; This is a spontaneous report from a contactable ... Read more
headache; Sore arm where the shot was administered; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 42-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unknown route of administration on an unknown date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications included Colecalciferol, Echinacea. The patient experienced headache and sore arm where the shot was administered. The outcome of the events was unknown. No follow-up attempts were needed. No further information was expected.
42 2021-04-24 headache debilitating headache; Pressure in both ears; Tinnitus, a constant ringing in his ears; the pressure... Read more
debilitating headache; Pressure in both ears; Tinnitus, a constant ringing in his ears; the pressure was so painful in one of his ears/felt like it was physically painful; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732 and expiration date not provided), via an unspecified route of administration, in arm left, on 01Apr2021 14:00 (at the age of 42-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. Medical history and concomitant medications were reported as "no". No relevant family medical history. The patient experienced pressure in both ears on 01Apr2021; tinnitus, a constant ringing in his ears on 01Apr2021; the pressure was so painful in one of his ears/felt like it was physically painful on 01Apr2021; and debilitating headache on 06Apr2021. The patient had the vaccine on 01Apr2021 (reported as "last Thursday"), and the same night, he developed pressure in his ears and tinnitus, basically a constant ringing in his ears. The pressure was so painful in one of his ears that it felt like it was physically painful. He compared it to a child having their first ear ache- it was maybe something like that combined with a really bad headache. He clarified he had a debilitating headache, and it was probably so bad that he considered for a moment going to go to the hospital but he did not, instead he took three ibuprofen (ADVIL) and that helped. Patient had not been to the doctor yet in regards to his symptoms, and stated he had a scheduled appointment Friday with an ENT doctor. Patient didn't have pressure in ears before the vaccine. He had constant ringing in his ears that doesn't subside. There's a link between his symptoms and the vaccine. He was in completely normal shape before he decided to get the vaccine. Patient's weight was 225-230 lbs (unknown date). The outcome of the events "pressure in both ears", "tinnitus, a constant ringing in his ears" was not recovered, of other events was unknown.
42 2021-04-24 nasopharyngitis Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after ... Read more
Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.
42 2021-04-24 fever, fatigue THe vanishpoint syringe retracted early. Could not tell if half of the vaccine was injected in the l... Read more
THe vanishpoint syringe retracted early. Could not tell if half of the vaccine was injected in the left arm. explained to patientin that case we sould inject again and he agreed. another dose was injected into the right arm. Patient had nausea, fatigue and fever that night but felt better on Saturday 04/24/21.
42 2021-04-25 fatigue, headache, cough, runny nose, sneezing Headache. Neck Pain. Drowsy. Fatigue. Lump under right arm pit. Consistent Coughing. Runny Nose. Sne... Read more
Headache. Neck Pain. Drowsy. Fatigue. Lump under right arm pit. Consistent Coughing. Runny Nose. Sneezing.
42 2021-04-25 fatigue, fever Fever to 38.8C, moderate muscle pain, severe fatigue Slight soreness at injection site
42 2021-04-25 fatigue Fatigue, sore injection site.
42 2021-04-26 chills, fever Had a fever and chills for two days. Less than 72 hours after the vaccine, he started to get a small... Read more
Had a fever and chills for two days. Less than 72 hours after the vaccine, he started to get a small rash on a few different areas of his body. He took medicine to try to help, but by Sunday morning (the next morning) he had to go to the ER because the rash had spread over 90% of his body. Also, he had some chest pain.
42 2021-04-28 fatigue 3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a... Read more
3 hours after injection, felt like hands, arms, and legs were swelling (but they weren't), and had a total brain fog, felt like I was either on drugs or had alzheimers. Paced around my house and backyard in a fog, confused, not clear of thought. Had a hard time spelling words in emails. Symptoms went away within 45-60 minutes and did not return. Since that time felt a little tired but nothing serious. Today I feel completely normal.
42 2021-04-28 headache, nasal congestion initially began as what felt like jolts to my chest area from inside my chest over five days beginni... Read more
initially began as what felt like jolts to my chest area from inside my chest over five days beginning on March 31, 21 @ 1:20am; next on April 01, 2021 @ 12:02am; then April 02, 2021 @1:02am; then April 03, 2021 @ 1:36am; and on April 04, 2021 @ 2:46am. I ended up in the emergency room the afternoon of Sunday March 04, 2021 with severe chest, abdominal, and intestinal pain. I followed up with doctors on April 05, 2021; April 09, 2021; and April 28, 2021 with continued painful symptoms described below. All they has done so far is 1) took a chest X-ray, 2) taken blood, and 3) referred me to a sleep laboratory. The X-ray and blood work came back negative per ER. Symptoms: 1. Inability to sleep. most nights feels as if I just drank five cups of coffee before bed. When I am able to fall asleep, pain and/or jolts coming from inside my trunk/core area wake me up within about an hour. 2. Constant pain coming from my chest, abdomen, and intestines. Intestinal and abdominal pain (gut wrenching, pain/burning sensation, cramps). At times feels like radiation or waves/currents are passing through my intestines/trunk. I wake up with intestines feeling sore. I also have discomfort when I eat or drink something the following morning. Also, my trunk/core area feels tight all day and night. I constantly feel a burning sensation in my chest and gut areas. The discomfort in my chest area (tightness, burning sensation) with occasional burst of pain the size of a nickel that comes from the left side of my chest and underneath my rib cage. 3. Limbs twitch/jerk on their own (both hands, both feet, neck, both shoulders, both legs, fingers) during the day and during the night. tingling sensations in legs. 4. ringing in the ears with headaches. 5. Woke up from sleep due to both nostrils getting clogged while I slept; woke up gasping for air. 6. Penis no longer has the same sensation and difficulty with erection.
42 2021-04-28 throat pain, headache, sinus pain Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and ting... Read more
Severe insomnia, severe brain fog, sinus pain, sore throat, shortness of breath, body aches and tingling, eye irritation, blurred vision, headaches, stomach discomfort.
42 2021-04-29 headache, chills, fever Spiking fever, strong chills with muscle cramping all over body and headache.
42 2021-04-30 fatigue, headache Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I... Read more
Personality changes; headaches; extreme fatigue; Also, I was unaware on conversations that I had.; I had high blood pressure and insomnia.; I had high blood pressure and insomnia.; It would seem that I had cerebritis from the shot; This is a spontaneous report from a contactable physician (patient). A 42-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL1284, expiry date not reported), via an unspecified route of administration, administered in right arm (at the age of 42 years old) on 08Jan2021 14:30 as a single dose for covid-19 immunisation. There were no medical history (reported as none) and no concomitant medications. The patient had no known allergies. The patient had no covid prior vaccination. The patient received the first dose of bnt162b2 (brand as Pfizer) for Covid-19 immunisation on 18Dec2020 (at the age of 42 years old) at 03:30 PM administered on the right arm. The vaccine was administered on a hospital. The patient had no other vaccine in four weeks and no other medications in two weeks. On 08Jan2021 11:00 PM, the patient experienced personality changes, headaches, and extreme fatigue, and also was unaware on conversations that he had. The symptoms lasted about 24 hours acutely, but for the 3 weeks afterwards, patient had high blood pressure and insomnia (2021). It would seem that patient had cerebritis from the shot since an unspecified date in 2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There were no treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events was recovered with lasting effects.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available clinical data, the event encephalitis most likely represented an intercurrent medical condition not related to vaccination with BNT162B2. This case will be re-assessed when relevant follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
42 2021-04-30 fatigue, fever Fever and fatigue for 12 hours.
42 2021-04-30 lethargy, fever, chills, headache 100.3 fever; Minor lethargy; Occasional chills; Minor headache; This is a spontaneous report from a ... Read more
100.3 fever; Minor lethargy; Occasional chills; Minor headache; This is a spontaneous report from a contactable consumer (Patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), dose 2 via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history was not reported. Concomitant medication included finasteride, 1mg daily for several years. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. On 13Apr2021 the patient experienced 100.3 F fever, occasional chills, minor headache, and minor lethargy after 2nd dose of Pfizer vaccination. symptoms started approximately 20 hrs after vaccination. Patient stated that it was just his body immune response. He no underlying conditions, borderline obese and no significant allergies. No follow-up attempts are needed. No further information is expected.
42 2021-05-01 fatigue, influenza like illness, headache Flu like symptoms (very achy and cold) 12 hours post injection. Headache, neck pain, achy ness beg... Read more
Flu like symptoms (very achy and cold) 12 hours post injection. Headache, neck pain, achy ness began 24 hours post injection. Significant tiredness and weakness throughout at least 48 hours post injection. Still have mild neck pain 48 hours post injection.
42 2021-05-01 headache I had the second shot on April 30th 2021, and then 9 hours later I had mild headache. The day after ... Read more
I had the second shot on April 30th 2021, and then 9 hours later I had mild headache. The day after on May 1st 2021, I started feeling body/muscle aches on around 11:00am. After 6 hours around 5pm the intensity increased. Took 1gr of Tylenol in total each of 500mg which relieved symptoms a little bit. Around 2am on May 2nd 2021, I woke up with severe body ache and feeling of 'electricity' throughout my body with skin sensitivity. Note that the symptoms from the first Pfizer vaccine did not completely disappeared even 3 weeks after administration. The symptoms and reactions were submitted in separate form from this one.
42 2021-05-01 fever, fatigue, headache moderate headache, fever, arm pain, fatigue, body pains for last approximately 2 days and continuing
42 2021-05-02 fever, chills On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chi... Read more
On 25 April I woke up and felt fine and then at 10:30 am I started to feel weak. I had fever and chills and couldn't get out of the bed until 4:00pm that day. I was dizzy and drove to the hospital. They did blood work and did two Covid 19 tests. They released me and the next day I developed Heavy pains. On 27 April I woke up and went back to the hospital. They said I had elevated enzyme levels when they drew blood and they started three iv?s. They said I was having a non emergency heart attack. They had me transferred by ambulance to the another Hospital. They drew more blood and did elf?s and ultra sounds. The next day they said they were going to put a stint in my heart. The next day I was prepped for the procedure and they went in and said my heart didn?t need it. The surgeon said I had Myocarditis and at 7:00 pm that night I was released. My nose broke out with acne bumps and it feels like I have a chest cold and cough.
42 2021-05-02 fever Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency depart... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) with myalgias, nausea, and fever. Denies chest pain, diarrhea, weakness, and shortness of breath. Oxygen saturation 88% on room air, rest of vital signs within normal ranges including temperature of 36.4 degress Celsius. Administered intravenous fluids, oxygen, antiemetics, acetaminophen, and NSAIDs. Patient's symptoms improved, oxygen saturation maintained within normal range on room air, and patient discharged to home stable.
42 2021-05-02 fever Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the... Read more
Pt had some pain in his right arm and fever after taking the vax. Next day he woke up, went to the wash room and then had a seizure. His father gave him a cold compress and provided him with water and extra seizure medicine. His father called the Neurologist. He was told to give him some Tylenol for his fever and extra seizure meds if needed and to FU w/ an office appt if he has another seizure. It had been more than a year since he has had a seizure but had one on 4/14/21 that was 3 days after taking the 1st Covid Vax.
42 2021-05-03 fatigue, fever On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature com... Read more
On 30 Apr, 2nd day after vaccination, I an episode of heart palpitations ("ventricular premature complexes in a pattern of bigeminy"). These were captured on an EKG during a VA disability exam, and started shortly after providing a blood sample (I'm nervous with needles). Previous day (1st day after vaccination) I had a fever of 101.5 F and was fatigued. Suspect the stress of the fever, immune response, and then blood sample caused a stress event that triggered an abnormal heart rhythm. Palpitations not accompanied by light headedness or shortness of breath, so no immediate medical care directed. Episodes of palpitations continued for 4 days, but have mostly disappeared since.
42 2021-05-03 malaise Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was not feeling well, pharmacist saw patient slumped over in chair, we lowered patient to floor, flat on back, and pulled his knees up. Blood pressure was monitored. 911 was called, paramedics monitored pt and advised him to go to hospital. Patient refused to go to hospital. Pt was lucid, was given saltines/water, was monitored for 30-45 min longer, and was driven home by female companion.
42 2021-05-04 sweating About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat dow... Read more
About 90 seconds after my technician gave the COVID19 second dose the patient felt dizzy and sat down in the lobby immediately. He began to drip sweat and his hands looked clammy. Patient said his hands were numb. He seemed to be breathing fine and when I asked if he felt tightness in his airway or chest he said no. I observed the patient and called down the street to urgent care to see if they could see him. I did no suspect an allergy so I did not use the epi pen, but I thought it could be an adverse reaction. The patient returned after urgent care and said since it was less then a minutes when it happened the provider thought it was actually a panic attack and not an adverse reaction, but I thought it deserved a report just in case.
42 2021-05-04 influenza like illness Flu like symptoms followed by 4 episodes of orthostatic syncope
42 2021-05-05 nasal congestion, headache Patient tested positive for COVID despite 2 doses of vaccine. Symptoms started 4/27/2021. Patient... Read more
Patient tested positive for COVID despite 2 doses of vaccine. Symptoms started 4/27/2021. Patient reported body aches, headache, and nasal congestion.
42 2021-05-06 fatigue, body temperature increased, chills, influenza like illness, headache Dizzy, headache, full body muscle aches, chills (over 36 hours), elevated temperate, tightness in th... Read more
Dizzy, headache, full body muscle aches, chills (over 36 hours), elevated temperate, tightness in the chest, fatigue. Symptoms started mild and by 12 hours after the shot full flu like symptoms last for over 48 hours. Did not subside until the Friday after the shot (60 hours after the shot). No treatment except rest and drinking plenty of fluids.
42 2021-05-06 sinus congestion, fever, headache, fatigue Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and f... Read more
Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. His PCP sent him to the ED for evaluation. He was evaluated by neuro consult on 4/4, had an LP. THe LP only showed some elevated protein (somewhat traumatic tap based on 10 RBC in tube 4). MRI brain, cervical/thoracic spine was unremarkable. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Got covid vaccine, had 2nd dose on March 3rd. Had about 2 days of fevers, aches, night sweats and fatigue. About 1 1/2 weeks after the dose, he started to get significant fatigue. He started to sleep poorly. He developed arthralgias described as bilateral, distal joints (hip down, wrists mainly). He developed tingling sensations in his arms and legs. He has had mental fog. He had some HA and eye pain. He was dx w/ possible post-infectious polyneurophathy, and suggested f/u w/ neuro clinic for further eval. Pt reports his paresthesias lasted 2 days and has since resolved. He has not been seen by outpatient neuro clinic yet. He did have a post LP HA which he returned to the ED for. He reports that the HA has resolved. In the past 2-3 days he has had felt less fatigue. He still has arthralgias, continuous. They do not seem to be worse in AM or PM. He can do most activities and just tired working out this week. Activity does not seem to make it better or worse. The joints are not red or swollen but feel "tight". He has not noticed any fevers but gets occasional nightsweats or sometimes feels flush and measures only a low grade temp that does not last (<100F). He has had slight decrease in wt but no change in appetite. No n/v/d. NO cough, sob, CT/CP, wheezes. No rash. He does have some sinus sx's which he thinks could be c/w seasonal allergies. Now experiencing substantial disruption of the ability to conduct normal life functions, including the ability to work.
42 2021-05-09 nasal congestion, headache nasal congestion and headache.
42 2021-05-10 sweating Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air... Read more
Patient became diaphoretic, weak and pale. Blood sugar 254, B/P-134/85, P-62, O2 SAT-96% on room air. Assisted patient to floor and elevated legs. Patient stated, "I'm ok." Wife present and stated, "He has done this before but he didn't do this with his first shot." Patient vomited once. Staff called EMS. Patient refused to go to the hospital. Wife drove patient home.
42 2021-05-11 fatigue Pain and soreness in my arm around the injection site; Body aches and tiredness; Body aches and tir... Read more
Pain and soreness in my arm around the injection site; Body aches and tiredness; Body aches and tiredness; Pain and stiffness in ankle joint where I had a previous injury.; Pain and stiffness in ankle joint where I had a previous injury; This is a spontaneous report from a contactable Nurse. A 42-year male patient received (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3247; Expiry Date: Unknown) dose 1, on an unspecified date on 01Mar2021 at 15:00 (at the age of 42-years-old) into Arm left as a single dose for COVID-19 immunization. Medical history included Amoxicillin for allergy and Pain and stiffness in ankle joint where I had a previous injury. It was reported that the patient had no allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not received list of any other medications the patient received within 2 weeks of vaccination. On 01Mar2021 18:00 patient experienced pain and soreness in his arm around the injection site, body aches and tiredness, pain and stiffness in ankle joint where he had a previous injury. The patient did not receive any treatment for adverse event. The outcome of the events were recovering. No follow-up attempts are needed. No further information is expected.
42 2021-05-11 sweating Pt experienced flushing/sweating and light headedness 5 minutes post vaccination. BP 102/57; HR 55;... Read more
Pt experienced flushing/sweating and light headedness 5 minutes post vaccination. BP 102/57; HR 55; RR 20; O2 Sat 100%. 10 minuts later BP improved to 119/76; HR 71. Pt was stable and released from vaccination site
42 2021-05-11 fever 103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 2... Read more
103* F fever, weakness, dizziness, and a severe rash/welts/hives all over the body. I began taking 20mg of Cetrizine HCl daily in the evening of 3/27 for the rash/hives and it cleared up in 2 days. I visited the Emergency Room on 4/1 for the remaining symptoms. I was prescribed a 5 day dose of Azithromycin and I do not know what else I was administered through my IV.
42 2021-05-12 fever Hives on arm (resolved with benadryl), fever, aches, swollen lymph nodes in left armpit.
42 2021-05-13 fever, chills Fever and chills: Night of 6May thru mid day 8 May Body Aches: 7May thru 8May Headache: 7May thru 8M... Read more
Fever and chills: Night of 6May thru mid day 8 May Body Aches: 7May thru 8May Headache: 7May thru 8May Chest tightness: 9May - still ongoing)
42 2021-05-15 headache, fever, chills Injection site pain started on 5/14. Woke up on 5/15 with the additional symptoms: Low grade fever ... Read more
Injection site pain started on 5/14. Woke up on 5/15 with the additional symptoms: Low grade fever Body aches Chills Headache Lasted thru most of the day, subsiding in afternoon. Feeling much better on 5/16.
42 2021-05-18 fatigue, headache Whole body muscle aches; headache; fatigue; This is a spontaneous report received from a contactabl... Read more
Whole body muscle aches; headache; fatigue; This is a spontaneous report received from a contactable other health professional. A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3247 and expiration date was not reported) via an unspecified route of administration in left arm on 10Feb2021 at 11:00 AM (42 years at the age vaccination time) as a 2nd single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was never diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and expiry date was not reported) via an unspecified route of administration in left arm on 20Jan2021 at 11 AM as a 1st single dose for covid-19 immunisation. The patient's concomitant medications included diazepam 5 mg on 08Feb2021, (pseudoephedrine hydrochloride) SUDAFED 30 mg on 06Feb2021 (received within 2 weeks of vaccination). On 11Feb2021 at 02:00 AM, the patient experienced whole body muscle aches, headache and fatigue. The events were lasted for approximately 24 hours. The patient did not receive any treatment for the events. The outcome of the events was recovered in Feb2021. Follow-up attempts are completed. No further information is expected. .
42 2021-05-18 fever, headache body aches; headache; low fever; This is a spontaneous report from a contactable consumer (patient) ... Read more
body aches; headache; low fever; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 42-year-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 16:45 pm (age at vaccination was 42 years) as UNKNOWN, SINGLE dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. On 12Feb2021, the patient experienced body aches, headache and low fever. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events as non-serious. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
42 2021-05-19 chills, sweating Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later ... Read more
Within 10 minutes i felt clammy and light headed. I passed out in my chair. I awoke moments later to fellow patients and staff tending to me. They attempted to move me to a place to lay down. I immediately passed out again trying to stand. I woke up covered in sweat lying flat on the concrete. Staff and customers did not let me fall so no trauma. They called an ambulance. My bp dropped fo 88/50 in the ambulance with a pulse as low as 36bpm. Chills and uncontrollable shivers started about 30 minutes in and lasted for 2 hours. By 3pm I felt better. 2 bags of IV, chest x-ray, and blood work showed everything normal. Home now and will update my report if anything changes. Feeling much better as of 7pm. I belive they called it normal Sinus rhythm with sinus arrythmia
42 2021-05-19 cough, fatigue, headache, nasal congestion 4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and prog... Read more
4/22--HA, vomiting, fatigue, sinus congestion, nonproductive cough; symptoms started mildly and progressively got worse i.e. sinus congestion and cough then HA, and finally vomiting. Symptoms resolved 4/24 5/13--severe myalgia, arthralgia, fatigue, slight sinus congestion; 5/15--severe radiating left arm pain; 5/16--myalgia and arthralgia improved; severe left arm pain continues today APAP and ibuprofen tried for pain without improvement in symptoms.
42 2021-05-19 sweating About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZ... Read more
About 5 minutes AFTER RECIEVING THE PFIZER VACCINE 1ST DOSE, THE PATIENT STARTED TO SWEAT, FELT DIZZY AS HE SAT IN HIS CHAIR & PASSED OUT FOR 5-10 SECONDS... CAME BACK GAIN CONSCIENCE AS THE PERSON NEAR BY TAP HIM HIS SHOULDER & ASK IF HE WAS OK. SHE CAME TO GET ME & I GAVE THE PATIENT SOME WATER TO SIP A LITTLE WATER. HE SAID HE FEELS BETTER THAT HE'S OK, HAD NO SHORTNESS OF BREATH. I TOLD HIM I WILL CHECK ON HIM IN A FEW MINUTES AGAIN. A FEW MINUTES LATER, HE DECIDED TO GET UP SUDDENLY FELL TO THE FLOOR. 911 WAS CALLED & FRONT STORE SUPERVISER & I MONITOR UNTIL AMBULANCE CAME FOR HIM. PT JUST FELT WEAK, BUT O SHORTNESS OR BREATH . I HAD THE PATIENT STAYED LYING DOWN ON ONE SIDE, SO AIRWAY IS NOT BLOCKED. A CUSTOMER HELP TALK TO HIM TO MAKE SURE HE STAY CONSCIENCE UNTIL AMBULNACE ARRIVED & TOOK OVER.
42 2021-05-19 fever Fever, tightness in chest, loss of energy, difficulty breathing
42 2021-05-20 fatigue, fever, lethargy Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild na... Read more
Within 3-5 minutes developed dizziness, tingling in feet and hands, elevated blood pressure, mild nausea. Within an hour started having trouble with focusing his vision. Was given IV fluids at hospital in ER 5 hours after the injection, while leaving the hospital developed a slight limp on right leg Felt feverish when he got home, took Tylenol when he got home. Noted extreme fatigue. The next morning was lethargic, dizzy and right side of face felt heavy, around 11 am. Called for a telemedicine visit around 12:30p. Became weak and unable to use right side of body, upper and lower extremities and right side of face was drooping, visible to wife. Wife had support of right side of body to move around. Went to urgent care around 2p. During urgent care evaluation, his vision became more impaired and speech became unclear, had to really focus to speak. Transferred to ER. Lost ability to write name, couldn't respond when asked for SSN. Admitted as a "stroke 4". Had CT scan, CT angiogram, MRI, blood labs, cognitive tests, neurologic tests. Neurology consult. Had lost sensation to heat and pressure. All imaging and labs were normal. After MRI, had convulsions. Wasn't dx'd as a seizure. Neck felt tight afterwards. Admitted to hospital x 1 week. Had a burning, red, rash on hands, feet. No bumps, hives, but just a "splotchy" red discoloration on surface of skin that would burn and itch, often flaring at night. Rx'd ativan. Checked for autoimmune disease, Bell's palsy, followed by neurologists, repeat MRI normal. Started to improve, discharged after one week with no clear diagnosis. Discharged to rehab facility. Patient preferred to transfer care to outpatient rehab service closer to home with more social support. Repeat hospitalized 3 weeks later, less extreme, went back to ER, stroke eval neg. Developed more aphasia. Called back to ER for further evaluation of C-spine due to mild abnormality on first scan. On further evaluation not thought to be connected to symptoms. EEG report pending. +Right hemiplegia, aphasia persists. +Rash, itching, burning persist.
42 2021-05-20 fatigue Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, ches... Read more
Having long covid since May 2020, my lingering symptoms have been fatigue, shortness of breath, chest pain, loss of taste. All were subsiding and have come back since the first injection and have not abated for 2 weeks. Fatigue is particularly intense in the morning, loss of taste is now constant.
42 2021-05-21 influenza like illness no longer could get an erection; Flu like symptoms; This is a spontaneous report from a contactable ... Read more
no longer could get an erection; Flu like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:15 (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021, the patient experienced flu like symptoms. After 48 hours (on 26Apr2021) and when flu like symptoms went away, the patient immediately noticed something else; he no longer could get an erection. He had never had an issue ever in life until 48 hours after his second injection and still 2 weeks later, he could not get an erection, which was considered serious as it resulted in disability. The adverse events (AEs) did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the AEs. The patient recovered from the event "flu like symptoms" on 26Apr2021, while he was not recovered from the event "no longer could get an erection." No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
42 2021-05-22 cough I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, ... Read more
I woke up from sleeping with one big cough. I felt chest pressure and some pain, trouble breathing, nausea but did not vomit. My wife called 911 and I was admitted to the hospital.
42 2021-05-22 fatigue, headache, influenza like illness, fever ? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm s... Read more
? Wednesday, May 19, 2021: ? 14:00 EDT - Patient got 2nd Pfizer vaccine. ? 17:00 EDT - arm started to get sore. ? 17:30 EDT - dizzy after sparring class. Blood pressure 107/71. Pulse 59 BPM. Burping. Gassy. A bit nauseous. Watermelon smelled like cut grass (awful). Forcing myself to drink orange juice. Tastes terrible, like Sweet Tarts (My wife says it's just me). ? 20:30 EDT. Found antidote. Antidote is pie. Cherry pie. After kimchi chicken and smokra. Update: Feelin' fine. ? Thursday, May 20, 2021: ? ~ 05:00 - hard relapse. Arm very sore (8/10). Fairly nauseous. Almost regurgitation level. At the same time I do feel hunger so I know it's not real nausea, yet I still can't eat. Bad headache (7/10). Muscle stiffness up the back and up to the neck, getting worse the higher you go; the neck is particularly bad. ? By 9:40, temperature up to 99.6. ? 11:57 temperature 100.7, blood pressure 125/66, pulse 79 ? 2:50 temperature 99.7 ? 3:30 temperature 99.6 ? Friday, May 21, 2021: ? Update about yesterday (Thursday): I ended up spending the entire day in bed. Very nauseous. Couldn't eat. Spiked a high fever (my baseline is around 97.5° F). Blood pressure fluctuated. High pulse (mine is usually around 50 bpm). Sore muscles on entire torso; pain in my lower back (above pelvis) makes it too uncomfortable to sit up. Except for not vomiting or coughing, it felt like the flu. ? Head still hurts (4/10). Weak. Tired. Arm still pretty sore (3/10). Was able to eat kimchi chicken for lunch and shawarma for dinner, but still not completely over the nausea. ? Saturday, May 22, 2021: ? Left arm still sore in a 2" radius from injection site (2/10), but the rest of the arm is fine. Still have the headache (2/10). ? Sunday, May 23, 2021: ? About mid-afternoon, the headache finally receded. Left arm still sore in a 1/2" radius from the injection site (1/10).
42 2021-05-22 fatigue, headache, fever First series of symptoms started 7 hours after the 2nd vaccine shot, including intense fatigue, very... Read more
First series of symptoms started 7 hours after the 2nd vaccine shot, including intense fatigue, very strong headache (different from any headache I have experienced before), feverish (although no high temperature). Symptoms lasted about 30 hours. Second series of symptoms started 5-6 days after the 2d shot, including intense fatigue, burning feet, pain in right leg, then left leg (location of pain changed but mostly behind the leg). Pain felt similar to the beginning of a cramp. Headache for over 48 hours again, feverish with some temperature from 99.5 to 100.5. Since then, pain in the leg has been on and off. Headache is gone, and fatigue is not as intense although still not back to normal.
42 2021-05-23 chills, fatigue, fever At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started ... Read more
At about noon on 01/28/21, I started to experience some fatigue. At about 9:30-10:00 PM, I started to experience fever, chills, and I was very weak and fatigued. This lasted for about 3 days. I took 800 mg ibuprofen every 6 hours to manage the fever and chills. The left arm was very sore from the shot. The symptoms reminded me of what I had experienced when I had COVID in 4/2020, so I went to the doctor on 1/29/2021. I went urgent care at about 10 AM. The doctor told me to not be alarmed, because the symptoms were normal effects of the vaccine. He advised me to keep taking the ibuprofen and to possibly also take Tylenol and to monitor the symptoms. On the third day, I woke up feeling better. I didn't have chills or fever anymore. This was on 1/31/2021.
42 2021-05-23 fever 3 weeks of fever, night sweats and ABN LFT otherwise unexplained.
42 2021-05-25 fatigue Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started ha... Read more
Most, if not all, of my pain from my lower back surgery was gone. 1 week after the shot I started having pain in my left sciatic nerve again. It isn't as bad as it was but definitely painful. The upper back pain has came back and isn't terrible painful but is uncomfortable. Pain in most of my joints: knees, elbow, fingers... Most noticeable in my knees. (I weigh 150 pounds). I have been tired a lot. I did not have any issues with the bells palsy in my face. I received allergy shots for years and stopped getting them when I had surgery. After the surgery, I started getting the allergy shots again, it made me swell and my back pains were increased because of it. So I stopped getting them. So the issue may be that the COVID shot is making me swell.
42 2021-05-25 head discomfort 3 weeks after second dose of Pfizer, woke up with vertigo/dizziness. Almost fell as I left the bed. ... Read more
3 weeks after second dose of Pfizer, woke up with vertigo/dizziness. Almost fell as I left the bed. Felt ok on and off - but in the evening felt moderate vertigo multiple times. Went to ER and physician judged either BPPV or vestibular neuritis or something similar. No prior vestibular history or tinnitus experience. It seemed to resolve after 2-3 days of meclizine. Then again on May 22, it started and continues where on adn off vertigo and dizziness persists. Meclizine is not very effective. Hoping I feel better soon. Have an appt with PCP on Friday. Feel some neck ache occasionally. and a bit of full ear
42 2021-05-25 headache 3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his... Read more
3 pulmonary embolisms; he started having really bad headaches; he was complaining of the back of his leg hurting; his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0172, Expiration Date 31Aug2021) via an unspecified route of administration, on 28Apr2021 at 09:00 (at the age of 42-years-old) as a single dose in the left "shoulder" for COVID-19 immunization. The patient's medical history and concomitant medications were denied (reported as "He has no medical conditions and does not take any regular medications"). The patient did not receive any other vaccinations within four weeks prior to the vaccine. The reporter says she is reporting on behalf of her husband with regard to the Pfizer COVID vaccination. She just wanted to report that her husband got the first shot 28Apr2021 and Friday 07May2021 he was admitted to the hospital with 3 pulmonary embolisms. When asked when the pulmonary embolism began she says the week before the hospitalization, so the week he actually got the first dose, he was complaining of the back of his leg hurting, in the upper calf area. She says it was either the day after the shot or the next day that he said his leg hurt but he did not think too much about it and it resolved after a couple days and then Wednesday, 05 May 2021 he started getting discomfort in his left upper quadrant, she clarifies his abdomen and rib cage area, and he started having really bad headaches Thursday that continued and during the night Thursday night his left shoulder started bothering him and it was radiating from his shoulder up to his chin as well as he had the severe headache so the doctor told him to go to the ER. The patient experienced three pulmonary embolisms on an unspecified date with outcome of not recovered. The patient was hospitalized for 3 pulmonary embolisms from 07May2021 to 08May2021. He also started having really bad headaches on an unspecified date with outcome of unknown and he was complaining of the back of his leg hurting on an unspecified date with outcome of recovered, his left shoulder started bothering him and it was radiating from his shoulder up to his chin on an unspecified date with outcome of unknown. The reporter commented that she and her husband wanted to report this because of the timing of getting the shot and they are waiting now to go see his primary care they are supposed to be calling to set up an appointment because he is supposed to be having the second dose 19May2021 so they do not know what is going to happen. Therapeutic measures were taken as a result of pulmonary embolism and included Eliquis which he would be on for at least 3 months.
42 2021-05-25 headache Headache; Stomach discomfort; Diziness; This is a spontaneous report from a contactable consumer. A... Read more
Headache; Stomach discomfort; Diziness; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: unknown), via intramuscular, administered in left arm on 13apr2021 at 15.30 (at the age of 42-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not undergo COVID-19 test prior to vaccination and Since the vaccination the patient has not been tested for COVID-19. On 13apr2021, 04:00, the patient experienced Headache, dizziness and a little stomach discomfort. The reporter assessed all events as non-serious. The outcome of the events Headache, dizziness and a little stomach discomfort was not recovered. No follow-up attempts possible. No further information expected.
42 2021-05-26 headache, fever, chills, fatigue pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restl... Read more
pain at injection site 24 hours later; Fever; chills/shakes; joint pain; muscle pain; fatique; restlessness; difficulty concentrating; gas; extreme thirst; headache; shakes; This is a spontaneous report from a non-contactable other hcp (health care professional). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262) via intramuscular route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 42-year-old), at a single dose for covid-19 immunization in doctor's office/urgent care. The patient had no allergies and medical history. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3246) via intramuscular route of administration, administered in left arm on 11Jan2021 at 11:45, at a single dose for covid-19 immunization and received Influenza vaccine (within 4 weeks of vaccine) on an unknown date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 19:00, after receiving the second dose of vaccine the patient experienced fever, chills, joint pain, muscle pain, fatigue, restlessness, difficulty concentrating, gas, extreme thirst, headache, shakes and on 03Feb2021 (24 hours later), the patient experienced pain at injection site. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
42 2021-05-26 sweating, malaise, chills Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms an... Read more
Weakness began after first dose and was accompanied by malaise. Second dose intensified symptoms and progressed to body aches, loss of taste and smell, episodes of sweating, shivering and brain fog.
42 2021-05-27 fatigue, headache 1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, e... Read more
1st day - very sore arm of injection, dizziness, and fatigue. 2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm. At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce. I was unable to sleep well for the first 3 days after the vaccine. 3rd day - sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous. 4th day - fatigued and somewhat dizzy from time to time.
42 2021-05-27 headache, fatigue He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped ou... Read more
He got his vaccine, his arm was a little bit sore. The next day he was unbelievably tired, wiped out at around 1:00 He also had a headache and also his blood sugar was elevated quite a bit, in the high 200's. Normal BS's are from 35-150. This lasted for approximately 8-9 hours after that, and was back to his normal self by 9-10:00 PM. He has done well since.
42 2021-05-27 headache I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was ... Read more
I almost immediately started getting soar in my arm. After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy. Headaches were present most of the first day. That night, around supper time I felt nauseous and then had some severe stomach cramps. I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head. Most of the symptoms were gone after 48 hrs.
42 2021-05-28 fever Fever 103.4
42 2021-05-29 head discomfort, paranasal sinus discomfort Head pressure began 4 days after 2nd dose and continue to persist today (45 days) after 2nd dose. Th... Read more
Head pressure began 4 days after 2nd dose and continue to persist today (45 days) after 2nd dose. The head pressure causes dizziness. The head pressure sometimes is mostly on the left side and shifts to sinus pressure and left ear pressure. When the head pressure shifts to sinus and ear pressure, dizziness subsides. The head pressure almost everyday but there were a few days where the the pressure subsided. Took zyrtec for 4 weeks but had no effect. Took flonase for 1 week and had no effect. Sudafed sometimes helps relieve pressure for a few minutes but it persists soon after.
42 2021-05-31 cough Wheezing, coughing; Shortness of breath; Nausea; Lightheadedness.
42 2021-05-31 fatigue Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patien... Read more
Patient received vaccine at 14 days after first dose rather than at 21 days after first dose. Patient reported that he experienced left sided body muscle aches/spasms, fatigue, neck pain and visual disturbances on 5/29/21. Stated his heart felt like it was racing for a short time but it may also have been anxiety because he knew his dose was given early. Symptoms resolved by 5/30/21.
42 2021-06-01 fatigue, headache, chills lot of pain at the shot location; body aches; headache; Chills; muscle aches; tiredness; nausea; dia... Read more
lot of pain at the shot location; body aches; headache; Chills; muscle aches; tiredness; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in left arm on 22May2021 at 15:45 (at the age of 42-years-old) as 2nd dose, single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient had penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), dose 1, administered in left arm on 01May2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. on 23May2021 at 00:00, the patient experienced lot of pain at the shot location, body aches, headache, chills, muscle aches, tiredness, nausea and diarrhea. The patient did not receive treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
42 2021-06-01 fatigue After injecting the second dose, on the 5th day I was getting to work, I went up some stairs and I n... Read more
After injecting the second dose, on the 5th day I was getting to work, I went up some stairs and I noticed a mild pain in the middle of my chest and a bit of fatigue. After eight days the pain has decreased, although it goes from the right side to the left side and towards the middle of my back. I am no longer tired but from time to time I feel a burning or discomfort in my chest and I have not gone to a doctor to examine it, since the pain is mild I would like you to tell me if this is a case of normal mild side effects or if I require urgent medical attention.
42 2021-06-01 runny nose, nasal congestion, headache, fever stuffy/runny nose; stuffy/runny nose; headaches; fever; congestion; This is a spontaneous report fro... Read more
stuffy/runny nose; stuffy/runny nose; headaches; fever; congestion; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a 42-year-old male consumer patient (reporter's father) that, A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing blood pressure measurement, ongoing diabetes mellitus, ongoing hypersensitivity. It was reported that patient took medication for blood pressure, diabetes, and allergies. She does not have information with her. No further information provided. There is unknown Other Products and Patient History ware reported. No Investigation Assessment. It was reported that patient received his first Pfizer Covid vaccine dose on 20May2021. He has been experiencing a stuffy/runny nose, headaches, fever, and congestion. It was reported that patient got Pfizer vaccine first one 4 days ago on Thursday, 20 May2021. Patient having some side effects, stuffy runny nose, almost always clear liquid. Having headaches. Fever. Wants to know if there is something he can take or recommend. Having congestion as well. Going on for 4 days. Events started day of vaccination. Patient took Pfizer Covid Vaccine because he Wanted to be safe from virus, other family members got it. It was reported that patient has not done anything Treatment for event. Reporter seriousness for Stuffy runny nose, almost always clear liquid was unspecified. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
42 2021-06-02 fever, chills, headache, lethargy, malaise Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chi... Read more
Skin began to ache and became sensitive about 11 hours after vaccine was received. Began having chills, lethargy, body aches (it felt like both inside of body and outside of skin), nausea, and high fever. Took Tylenol and Advil to attempt to alleviate symptoms. Could not get to sleep until about 12:30 a.m. and woke up at 2:30 a.m. with headache, extreme chilling, and intense body aches. I didn't know if I could walk. I put a sweatshirt and a coat on, and my teeth were chattering uncontrollably. I can't remember the last time that I was that sick. I contemplated going to the ER but didn't think I could drive. The entire day was a headache, nausea and lethargy. When at the clinic, I stated that I had heard that there could be some minor side effects with the 2nd shot and was told, "Nah, people make things up." I'm so glad that I'm vaccinated, but people need to be forewarned of those kinds of side effects. They have to be aware because that was dangerously sick and was totally unprepared to combat it. 103+ degree fever and this kinds of symptoms aren't things that a person should have to try to make it through alone.
42 2021-06-03 headache, chills, fever Pfizer-BioNTech COVID-10 Vaccine EUA Fever (spiked up to 101.6 three times), chills, headache, body... Read more
Pfizer-BioNTech COVID-10 Vaccine EUA Fever (spiked up to 101.6 three times), chills, headache, body ache, some nausea from 6/2/2021 12:30 PM through 6/4/2021 7:00 AM.
42 2021-06-07 malaise decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass;... Read more
decline in muscle function; sick; aches and pains all over his body; did not feel well; muscle mass; scared; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; he really thinks the biologics in the Humira he takes and the biologics in the vaccine are counter acting each other and putting him into a major flare; generalized aches and pains; This is a spontaneous report from a contactable other HCP (patient's mother). This other HCP reported for patient (reporter's son). A 42-year-old male received (age at vaccination: 42 year) first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0169 and expiry date was reported), via an unspecified route of administration, in Arm Right, on 22Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included spinal muscular atrophy, osteoporosis, and ankylosing spondylitis. Concomitant medications included adalimumab (HUMIRA) which was started about a year and a half ago for ankylosing spondylitis, denosumab (PROLIA) which started about a year ago for osteoporotic bones and Evrysdi: (Start: Dec 2020 Stop: Ongoing). This female consumer reported her son/patient received his first injection of the Pfizer covid-19 vaccine on 22Apr2021. The patient has been taking Evrysdi over the past year and experienced some gains in muscle function. After receiving the Pfizer covid-19 vaccine, the patient began experiencing a decline in muscle function described further as losing all the muscle function he had gained while taking Evrysdi. The reporter/mother said her son has been sick ever since receiving the Pfizer covid-19 vaccine and was experiencing flare-up and been prescribed prednisone as treatment. The reporter stated that since their son got the vaccine, he had gone downhill and clarified he had generalized aches and pains all over his body since the vaccine, mostly in the spinal and sacral area, but they were also in his arms, elbows, everything ached, he really did not feel well and could not do anything he used to do after the vaccine. He was starting to gain muscle mass and everything and since the vaccine all that was gone. The reporter stated they took him to both doctors, and they have been zooming with him and want him to get the second dose. He really thinks the biologics in the Humira he took and the biologics in the vaccine were counter acting each other and putting him into a major flare. The patient was treating symptoms with a dose pack of prednisone, getting a little better but did not have strength back at all. The reporter also stated that prior to this vaccine, the doctors were saying was an anomaly, the newer medication he was on was supposed to stop the progression of muscular dystrophy and he was doing so well on the medication until he got the vaccine. The patient was scared he was going to get worse; they were looking for information about getting the second dose, stated their doctors did not have a lot of information. The reporter asked could the Pfizer COVID-19 vaccine reverse the progress our son made in his muscles while taking Evrysdi for spinal muscular atrophy and should her son get the second dose after what has happened after the first dose of the Pfizer covid-19 vaccine. Also asked how long you could wait to get the second dose of the Pfizer covid-19 vaccine and was there an interaction with Humira. The reporter got response that spoke per FAQ and referred to HCP. Outcome of the event generalized aches and pains was not recovered and for all other events, it was unknown. Additional information has been requested and will be provided as it becomes available.
42 2021-06-08 fever I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in ... Read more
I was in the hospital I couldn't breathe and I was running a fever. I was shacking . While being in the hospital I am now on oxygen and I also got rhino virus while at the facility.
42 2021-06-09 fever, influenza like illness, chills Fever/ chills / sore muscles / sore injection site / flu like symptoms / no treatment
42 2021-06-12 chills, fatigue, fever Rapid resting heart beat, low O2 level, fever, chills, body aches and fatigue from 1 am to ongoing.
42 2021-06-12 chills, sweating, fever, sleepiness Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy.... Read more
Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.
42 2021-06-13 headache, sinus congestion Slow swelling of lymph nodes in neck following by sinus congestion, headaches, and TMJ. Ears became... Read more
Slow swelling of lymph nodes in neck following by sinus congestion, headaches, and TMJ. Ears became full with fluid and pressure then extreme tinnitus developed. My regular doctor prescribed 2 different antibiotics which had zero effect on tinnitus. It is almost 12 weeks after the tinnitus began and I still have ringing in the ears. It has reduced to 50% over the 3 months. I have never experienced this symptom previously and it has become the worst health event in my life. I have not been exposed to any loud sounds. I have been to see 2 ENTs and they believe the condition is permanent. I had a CT scan completed and it shows there are no issues. I am hoping it is inflammation and will go away over time. I am currently taking Prednisone and hoping it reduces any possible inflammation. The ringing and popping noises in my ears need to stop ASAP.
42 2021-06-13 headache Two weeks after the first dose started having sudden dizziness, lightheadedness and some headaches. ... Read more
Two weeks after the first dose started having sudden dizziness, lightheadedness and some headaches. Another big spike one week after the second dose. Sometimes gets better, sometimes worse, but never completely went away
42 2021-06-15 chills, fever, headache Dizziness, feeling weak and feverish, chills, headache, numb hands and fingers, and pain in right sh... Read more
Dizziness, feeling weak and feverish, chills, headache, numb hands and fingers, and pain in right shoulder at administration site, especially when lifting my right arm.
42 2021-06-15 headache headache, bodyaches
42 2021-06-17 fatigue, runny nose, sinus congestion Patient tested positive for Covid on 6/17/21. Pt became symptomatic with the following symptoms: sin... Read more
Patient tested positive for Covid on 6/17/21. Pt became symptomatic with the following symptoms: sinus congestions, rhinorrhea, and fatigue. Symptom onset was 6/17/21.
42 2021-06-17 headache, fatigue I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Bod... Read more
I had elevated level. I get feedback term but it appeared that my liver that is been stressed.; Body aches in my legs and more over back; Body aches in my legs and more over back; Body aches in my legs and more over back; Prolonged headache for about 2 weeks; Fatigue of head; Sore arm at the injection site; At my second ER visit they told me I had something called the bell's palsy; after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension; I have history of hypertension but it was under control prior to the taking vaccination."; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Right on 29May2021 14:00 as (At the age of 42-years) 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension. It was reported that patient had history of hypertension, but it was under control prior to the taking vaccination. Concomitant medication included hydrochlorothiazide taken at a dose of 50 mg once per day for hypertension; amlodipine taken at a dose of 5 mg once per day for High blood pressure. Patient did not take any vaccination 4 weeks prior to covid-19 vaccine. It was reported that patient have experienced side effects after taking the first covid vaccination and he visited the ER two times. Reportedly, after taking the first vaccination on 29May2021 at 2 PM, the next day patient had stage 3 hypertension. He had a prolonged headache for about 2 weeks. Patient experienced fatigue of head, body aches in his legs and more over back. He had sore arm at the injection site and at his second ER visit they said that he had something called the bell's palsy. It was reported that when he went to ER they perform blood tests and COVID test which tested negative. It was reported that he visited his doctor, primary care physician, he ran another lab and he had elevated level. He got feedback term, but it appeared that his liver that was been stressed. It was reported that patient was not treated for liver, he was only treated for the hypertension, for the headache and body ache he was taking ibuprofen over the counter, ibuprofen and the hospital prescribed for the bell's palsy, there are three different medication here valacyclovir, its 1-gram tablet and he take 3 per day. Prednisone, its 20 mg tablet 3 times per day, Erythromycin. The patient underwent lab tests and procedures which included blood test, covid-19: negative, liver function test increased: elevated level on unspecified date. Reporter seriousness for the events was Unspecified. Patient did not got his vaccination card yet as he was not fully vaccinated. The outcome of events was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.
42 2021-06-22 fatigue, sweating The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. withou... Read more
The pharmacist carelessly gave me the second shot of my Pfizer.Some dribbled out of the arm.. without asking my permission he gave me a second dose Basically overdosing me. My tongue felt strange my lips sweated. The injection site hurt for 7 days and is still uncomfortable. My lungs have been extra congested with mucus. I missed 3 days of work due to the inability to use my left arm (sore) and general fatigue. Experienced strange twitching of the left arm muscle at injection site on the third day.
42 2021-06-22 headache, chills, fever chills, fever, muscle pain, swollen lymph nodes, head ache, arm pain
42 2021-06-22 influenza like illness About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling i... Read more
About 24 hours after receiving my second COVID-19 vaccination (Pfizer) on 4/30/21, I began feeling intense pain in my lower back. It was so painful that I could not even sit down or lie down without intense discomfort. I was unable to sit for periods longer than 10 minutes. I did not do anything physically demanding after getting the vaccine, so I'm convinced the vacccine caused the pain. I have had lower back soreness for several years and two doctors have diagnosed it as a possible torn disk. It took a full 30 days for the pain to subside. I also got severe flu-like symptoms from the shot beginning 12 hours after the second shot. These cleared up after about 8 hours. I also began feeling heart burn about 10 days after my first shot. It intensified after my second shot. I've never had heart burn before. I had to go on Omeprazole prescribed by my physisican. Abo
42 2021-06-22 respiratory tract congestion I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little ... Read more
I was giving my second dose of the Pfizer at the drug store, the shot was administered and a little dribbled out so the pharmacist gave me a double dose. I don't believe this was necessary and could have been avoided if the pharmacist would have followed better protocol administering the due to the poor quality of the administration of the shot I missed three days of work. My arm was unusable for 3 days.. I had some mucus buildup in my lungs.. but luckily after 5 days of good rest I'm okay.
42 2021-06-23 fatigue, headache Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two d... Read more
Heart rate speed up to over 180 beats a minute. Fatigue. Out of breath. Felt horrible for two days prior to ending up in hospital for heart.
42 2021-06-23 fatigue Strong muscle pain around the injection site. Slight dizziness. Strong feeling of fatigue, which ca... Read more
Strong muscle pain around the injection site. Slight dizziness. Strong feeling of fatigue, which caused me to rest for at least 6 hours on bed. Feeling a pain around my left armpit around 30 to 40 hours after injection.
42 2021-06-24 chills, headache, influenza like illness, fever flu-like symptoms; body aches; chills; slight fever; listlessness; headaches; This is a spontaneous ... Read more
flu-like symptoms; body aches; chills; slight fever; listlessness; headaches; This is a spontaneous report from a contactable consumer(patient). A 42-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: Not available) via unspecified route of administration on 02Feb2021 07:30 as single dose in left arm for Covid-19 immunisation in hospital. No other vaccine in four weeks was reported. Medical history reported was HIV+. Concomitant medications reported was bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and clarithromycin (CLARITIN), both as 1 a day. No Known allergies were reported. Patient was not tested positive covid prior vaccination nor covid tested post vaccination. Patient wanted to report that he had flu-like symptoms yesterday (04Feb21), he felt better today, but he did experience, body aches, chills, slight fever, and listlessness. He felt a little better today but truly felt like he was hit by a bus yesterday. He will continue to monitor symptoms as he felt much better today, but wanted to make aware of what he experienced. It started on 03Feb2021 with headaches. Patient did not receive any treatment in response to the events. Outcome of all the events was recovering. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
42 2021-06-24 fatigue, sleepiness, fever Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with... Read more
Pt states 04/11/2021 groggy, fatigued. May 5th high grade fever for 3 days continuing, ER visit with Negative Covid-19 test. Antibiotic prescribed and sent home. 04/17/2021 HBP, high pulse rate, A-fib, 06/11/2021 admitted into ICU for a week with palpations. Discharged 06/16/2021. Sent home with recommendation for follow up with Cardiologist. Currently in A-fib, July 7th appt. set to decide how to correct heart A-fibrillation.
42 2021-06-24 malaise, chills, headache For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I... Read more
For 1st vaccine- I experienced first vaccine- one week later I got sick for 15 days, symptoms like I had Covid, body aches, chills. For 2nd vaccine- after one week I experienced had excruciating headaches and shakiness that do not go away. I take Tylenol for pain and as a result have upset stomach. I went to see my PCP who performed exams, lab work, x-rays, CT scan of the head, CT scan of the abdomen and my doctor does not find anything wrong for me. To this day I continue wit the headaches that do not go away. I do not feel well to do my daily living activities and I get anxiety. I feel very tense and frustrated due to my symptoms. I do not have the lot # for my vaccines to provide.
42 2021-06-28 fatigue Diarrhea, Chest Discomfort, Tiredness
42 2021-06-28 sweating, fever Approximately 7.5 hours after the fist dose, at a basketball game, I began to sweat profusely, my vi... Read more
Approximately 7.5 hours after the fist dose, at a basketball game, I began to sweat profusely, my vision blurred, and became extremely nauseated. My partner had to help me out of the venue and drive us home as I sincerely thought that I might lose consciousness at any moment and was unable to operate a vehicle. By the time we reached home, my fever had spiked to 103.1 and I was vomiting. I was severely ill for the next 48 hours. Since the having the vaccine I my vision is still blurry for things closer than about 18 inches from my face. I have never required reading glasses before, but now do.
42 2021-06-29 headache, fatigue, cough, nasal congestion PATIENT BECAME INFECTED WITH COVID AFTER BEING FULLY VACCINATED. SYMPTOMS STARTED 6/28/21 WITH COUG... Read more
PATIENT BECAME INFECTED WITH COVID AFTER BEING FULLY VACCINATED. SYMPTOMS STARTED 6/28/21 WITH COUGH, FATIGUE, MUSCLE ACHES, HEADACHE, AND NASAL CONGESTION. DIAGNOSED WITH COVID ON 6/29/2021.
42 2021-07-01 headache, fever, fatigue fever of 102, fever was getting higher as 102.6; fatigue; headaches; This is a spontaneous report fr... Read more
fever of 102, fever was getting higher as 102.6; fatigue; headaches; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program COVAX US Support. This 42-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 27May2021 at 14:00, at patient age of 46-year-old, as single dose (Lot number EW0178, Expiry Date: Aug 2021) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no other medical history and no known allergies. The patient's concomitant medications included gabapentin, quetiapine fumarate (SEROQUEL), chloroquine. The patient had no past drug reaction. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced the adverse events from 01Jun2021. The patient got a high fever of 102 which had lasted a week and it was not getting any better. The patient also experienced headache and fatigue. The patient went to the emergency room on 07Jun2021, where they did blood work and a chest X-ray and a CT scan. Everything came back normal and they can not figure out why he had this persistent high fever. The patient wanted to know how long this is going to last or what was going on. On 08Jun2021, the patient reported fever was getting higher as 102.6. It was going up little more everyday. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Covid test post vaccination included Rapid test on 05Jun2021 showed negative (Nasal Swab); Non rapid test on 07Jun2021 showed negative (Nasal Swab). The patient received treatment including paracetamol (ACETAMINOPHEN), ibuprofen (MOTRIN), Ibuprofen. The outcome of the events was not resolved.
42 2021-07-01 malaise, headache generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness s... Read more
generally feeling unwell with weakness, body aches, headache since 2nd vaccine on 6/9/21 dizziness started 7/1/21. presented to ED on 7/2/21 and found to have low Hgb, elevated liver enzymes
42 2021-07-01 nasopharyngitis, fatigue Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he... Read more
Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at airforce base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered. Information on the lot/ batch number has been requested.
42 2021-07-05 sweating Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: T... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: 10 minutes after receiving vaccine patient experienced shakiness, tingling, weakness, sweating and appeared pale. Checked blood pressure initial reading 96/68. Second BP taken 15 minutes later BP 107/72. Pulse stable at 68 BPM. Patient stayed 35min for oberservation and seemed to feel much better when he left. Water provided to patient.
42 2021-07-05 throat pain Diagnosed w/ Thyroid Cancer 1 week after vaccine, started with sore throat, shooting pain into ear w... Read more
Diagnosed w/ Thyroid Cancer 1 week after vaccine, started with sore throat, shooting pain into ear whenever you swallow. No issues before the second dose, and then things suddenly manifested. Thyroid has since been removed, plan is to start chemotherapy soon (iodine treatment, has not begun yet). Hospitalized for several days
42 2021-07-09 headache, fatigue Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from d... Read more
Rather intense headache and fatigue night of vaccination, but that was expected. Since then (from day 2 up till now), persistent headache (dull at the back of the head), neck and shoulder ache. Very annoying and makes it difficult to think and/or concentrate. Also having strange inflammation (both in the head and cardiac) and erratic heartbeat, likely contributing to increased blood pressure.
42 2021-07-17 chills, fatigue fatigues; Chill; This is a spontaneous report from a non-contactable consumer, patient. A 42-year-ol... Read more
fatigues; Chill; This is a spontaneous report from a non-contactable consumer, patient. A 42-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203), via an unspecified route of administration on 23Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, patient had experienced chills and fatigue. The clinical outcome of the event chills and fatigue were unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
42 2021-07-17 fever, headache About 2 months after the second dose of the Pfizer COVID-19 vaccine series, the patient developed fe... Read more
About 2 months after the second dose of the Pfizer COVID-19 vaccine series, the patient developed fevers and headache around late June 2021. The fevers and headache have remained persistent. One week after the fevers, he developed bilateral lower extremity weakness and decreased sensation around July 14, 2021. Due to sudden acute weakness, he was admitted to the Hospital for evaluation on July 14th, 2021. The weakness was ascending and also began to include his bilateral arms.
42 2021-07-17 fever Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a conta... Read more
Myocarditis; Chest pain; high fever; Inflamed lymph nodes; This is a spontaneous report from a contactable other hcp.A male patient of 43 years old received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 26Jan2021 13:00 (Batch/Lot Number: EL3249) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included splenectomy from 1995 to an unknown date, mildly high cholesterol.He gets the Pneumovax because he is immunocompromised and gets kind of sick feeling. He gets it every 5 years and does get a fever afterwards; he got the Flu vaccine in Sep2020 or early Oct2020.he got the Flu vaccine in Sep2020 or early Oct2020.The patient's concomitant medications were not reported. Patient previously received the first dose of bnt162b2 on 05Jan2021 for covid-19 immunization. The patient experienced myocarditis in Mar2021 with outcome of recovered, high fever on 27Jan2021 with outcome of recovered, inflamed lymph nodes on 27Jan2021 with outcome of recovering, chest pain in Mar2021 with outcome of unknown. Stated that he received his 2nd dose on 26Jan2021 and had really inflamed lymph nodes and a very high fever. He didn't have chest pain until 4-6 weeks later; around Mar2021. Stated that his lymph nodes were really inflamed for about 2 months after the 2nd dose. They were so inflamed that he said he had a hard time turning his head. States that the other day he was saying that his lymph nodes were still inflamed. He had a very high fever for about 2 days. States this was concerning because they were told that if he had a high fever he would need antibiotics right away because of his splenectomy. He was having chest pain every night when he laid down, but then it got severe, and normally he doesn't complain of anything. He went to the doctor the next day and had an EKG and blood work. Caller states that she doesn't remember the date this occurred, only that it was probably sometime in Mar2021. States that they weren't worried about anything on the EKG, and he had mildly high cholesterol. His doctor put him on Lipitor and Prilosec OTC, but now they are questioning whether he needs to be on them. Stated that about a month later it came out that myocarditis was a side effect of the vaccine. When they read the symptoms they realized that's what he had because every symptom matched, but at the time the doctor didn't know to be looking for that.Stated that the symptoms have gradually gone away. The patient underwent lab tests and procedures which included blood test: unknown, electrocardiogram: unknown. Therapeutic measures were taken as a result of myocarditis, chest pain. The causality between BNT162B2 and Inflamed lymph nodes, high fever was related.
42 2021-07-18 headache, cough Patient returned from vacation and subsequently developed headache, cough, dyspnea. He was found to ... Read more
Patient returned from vacation and subsequently developed headache, cough, dyspnea. He was found to be COVID+ on 7/12. He was admitted to the hospital on 7/15 due to worsening dyspnea, where he is currently on high-flow nasal cannula.
42 2021-07-18 fever, headache, chills Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutter... Read more
Headache, body aches, fever/chills, injection site soreness, muscle aches, joint pain, heart flutters/palpitations .
42 2021-07-20 fatigue, fever Body aches; Sore arm; Tiredness; Tingling all over; Slight fever up to 101 degrees; This is a sponta... Read more
Body aches; Sore arm; Tiredness; Tingling all over; Slight fever up to 101 degrees; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7543) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198) via an unspecified route of administration in the left arm on 05Mar2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 27Mar2021 at 11:00, the patient had sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees. The clinical outcomes of the events sore arm, tiredness, body aches, tingling all over and slight fever up to 101 degrees were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
42 2021-07-20 fatigue 4 days after the vaccine, severe muscle aches, fatigue, and nausea. Also had gastrointestinal bloat... Read more
4 days after the vaccine, severe muscle aches, fatigue, and nausea. Also had gastrointestinal bloating and nausea. These symptoms were severe for 3-4 days.
42 2021-07-20 headache Headache and rash (right wrist, right chest, left hip) began approximately 1 week after first Pfizer... Read more
Headache and rash (right wrist, right chest, left hip) began approximately 1 week after first Pfizer vaccine administered. Presented to PCP 2 weeks after symptoms began. Treated with naproxen 500mg BID and Benadryl 25mg BID x7 days. Patient returned to clinic with symptoms unimproved. Patient denied further treatment recommendations and prefers to try CBD and acupuncture.
42 2021-07-21 fatigue, headache Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour af... Read more
Dizziness from 20 minutes after vaccination to 6 hours after vaccination. Headache started 1 hour after vaccination and lasted 3 days. Sore arm for 3 days. Fatigue starting 1 day after vaccination and ended 4 days later Body aches and pains for 6 days after vaccination Rash on head, shoulders, and neck that started on day 3 after vaccination and lasted 5 days.
42 2021-07-21 fatigue Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exac... Read more
Have not yet sought out medical attention, joint pain, fatigue (had these issues, but they were exacerbated). Pain in knees, back, and hands (marked increase in pain). Depression has been getting much worse, have sought therapy (father died recently, so can't point to vaccine specifically, may be a coincidence).
42 2021-07-21 headache, sneezing, nasal discomfort I experienced minor sneezing, diarrhea , headaches, nostrils discomfort, lower right leg felt weird,... Read more
I experienced minor sneezing, diarrhea , headaches, nostrils discomfort, lower right leg felt weird, back of my ears started itching and general bodily itches. All the symptoms have subsided except mild headaches and mild itches.
42 2021-07-21 headache Severe headache, had to take off work 2 days
42 2021-07-22 chills, influenza like illness Body aches; Chills; Dizzy; Felt like the flu was coming on; Felt very hot; Very blurry eyes; This is... Read more
Body aches; Chills; Dizzy; Felt like the flu was coming on; Felt very hot; Very blurry eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, depression and COVID-19. Concomitant medications included clonazepam (KLONOPIN) 10 milligram (mg) and testosterone (MANUFACTURER UNKNOWN) 200 mg. The patient did not have any known allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, immediately after vaccination, the patient experienced very blurry eyes. On the same day at 17:00, about 3 hours later, the patient experienced chills, dizzy and felt like the flu was coming on and all the night, the patient felt very hot with chills. Next day, on 04Apr2021, the patient had chills and body aches. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches. The clinical outcomes of the events very blurry eyes, chills, dizzy, felt like the flu, felt very hot and body aches were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
42 2021-07-23 headache Headache, swollen eyelids, itchy eyes, eye discharge, blurred vision
42 2021-07-24 fever The first was the Janssen on 3/19/21 in which I felt fever-like symptoms that was mainly an achy, we... Read more
The first was the Janssen on 3/19/21 in which I felt fever-like symptoms that was mainly an achy, weak body that begin about 12 hours since the shot and lasted for 36 hours. This was the most sever experience. The second was the Pfizer on 6/30/21 in which I felt fever-like symptoms again in the same way as above 12 hours after getting the shot, which lasted for about a day. The third was the second Pfizer on 7/21//21 in which I felt the same as above except it began 6 hours after the shot and, though less sever than the previous two, it lingered for 2 and a half days.
42 2021-07-25 sneezing, cough, fever, headache Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3... Read more
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/24/21). Patient was doing well until his return. Which he developed subjective fevers, sneezing, headache and cough on 7/7 and tested positive for SARS-COV-2 on 7/12. On 7/13 he presented to ED for SOB and was D/C'd home on levofloxacin. On 7/15 he returned to ED for worsening SOB and was started on remdesivir on 7/17, tocilizumab, dexamethasone, enoxaparin and antibiotics. On 7/18 respiratory requirements increased requiring NRB and transfer to Hospital with admission to ICU. In hospital, patient completed two more days of remdesivir for a total of 5 day course (ending 7/21) and was continued on dexamethasone until 7/25 to complete a 10 day course. Today patient remains intubated with improving oxygenation with proning.
42 2021-07-27 fatigue New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a ... Read more
New onset atrial fibrillation; Myocarditis/inflammation of the heart; pericardial effusion/he had a significant amount of inflammation and fluid around the heart; pericarditis; Tightness of chest; He went in for difficulty breathing; very tired; chest pain; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 42 years on an unspecified date (Batch/Lot number was not reported) at 14:00 as single dose for covid-19 immunisation. Medical history was none. No family medical history relevant to AEs. There were no concomitant medications. The patient experienced new onset atrial fibrillation (AFib) since 27Apr2021 and hospitalized form 29Apr2021, myocarditis/ Inflammation of heart (2021), pericarditis (2021), and pericardial effusion (2021) after receiving second dose of the Pfizer BioNTech Covid-19 Vaccine. Patient sought medical treatment and was hospitalized twice, the first time being 29Apr2021. The patient was still dealing with issues and went into hospital 27Apr2021 (as reported). Since then, he has been going back and forth to hospital and was admitted twice for the same issues. He was diagnosed with Afib and inflammation of the heart. Reporter just wanted to know who needs to talk to because it seemed to be vaccine related. Patient has had to take time off of work and reporter has had to take time off work to take care of him. Patient stayed a week for the first AFib hospitalization. He got out of the hospital (2021) and was at home for a week. That Friday, he went back and was hospitalized for another week (2021). That admission was for both AFib and inflammation of the heart. They saw the inflammation the first time, but it was not a lot and said it was probably normal because of the AFib. When he went back for follow up, he had a significant amount of inflammation and fluid around the heart (2021). He was still dealing with it. He had another issue with going to ER and this was Friday before last. He went in for difficulty breathing (2021) and was told he had more fluid around the heart. He was not admitted for that one. They gave him more medication to control the fluid. Reporter later stated it was prednisone and she did not have a dose, lot or expiration. She then said the dose was increased after he went for follow up and had more fluid. The first time patient was taken to the emergency they could not find anything and the next day, she (reporter) called 911 from her home and saw that he was experiencing some cardiac issues and saw that he was admitted and told he had AFIB. When she called 911 from her home, they transported by ambulance to (#) Hospital in (#), (#) and that was when he admitted and diagnosed with AFIB. Since # was out of their network, he was transferred to # that same evening or day to # and he was there about a week. Then he was released after a week and still had a hard time breathing and walking a few steps with trying to catch his breath and had chest pain and was very tired (2021). Then he went to a follow up that Friday after being released. Unknown doctor in (#) and then he was readmitted at the follow up appointment to #. He was in the hospital for a week that time as well. He was discharged and they prescribed him medication and then he came back home on medication and he has been on several medications. The one to reduce inflammation, starts with a P and she cannot remember name. He finished it and went to a follow up. After he finished medication, he was experiencing side effects (2021) such as chest pain, difficulty breathing and tightness of chest. She then remembered it was Prednisone that he was on, unknown dose, and it is in pharmacy vial with no lot or expiration. There was no seal, and count size is unknown. He no longer has any left. He went to the ER in (#) because he was experiencing the same symptoms. They saw more fluid collecting and put him on the same medication but a higher dosage of Prednisone. This dose is 10mg, 4 tablets by mouth daily. It was also in a pharmacy vial with no lot or expiration. This was where he was now. He has been out of work and so has reporter. The patient had MRI, XRays, Echo, Blood Test and was still doing blood test (in 2021). He has to go back this week. Everything came back as unknown for what caused this. The outcome of events myocarditis/ Inflammation of heart and AFib was recovered/resolved with sequel in 2021, of other events was unknown. Information on the lot/ batch number has been requested.
42 2021-07-27 fatigue Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a ... Read more
Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 as dose 1, 0.3 ml single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. It was reported that the patient got some kind of side effect that's why he was calling to record. He was in bed and he could feel his heartbeat was pumping (on06May2021) after that day in the evening until Saturday night between 08May2021 and 09May2021. On 10May2021 in the morning he felt normal. . After the first dose, for two days he was so tired (on 07May2021). He saw that it was one of the side effects. The patient also experienced not wheezing but breathing fast on 07May2021 after his first dose. The patient asked if he could take the second dose or not. Someone in his family was a doctor and he said to call that number to see if anyone had the symptoms. The patient did not want medication, he wanted to know if he should move to second dose or not. On 10May2021, the events were resolved. No follow up attempts are needed. No further information is expected.
42 2021-07-27 influenza like illness, cough Several days with flu like symptoms.; Developed a cough that took about a week to go away.; This is ... Read more
Several days with flu like symptoms.; Developed a cough that took about a week to go away.; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP75533), via an unspecified route of administration in the right arm on 07Apr2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included landau-kleffner syndrome and gene mutation. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced flu like symptoms for several days and had developed a cough. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date, the patient underwent COVID-19 antibody blood test and the result was negative. The clinical outcome of the events cough was resolved on 15Apr2021 (took about a week to go away) and flu like symptoms was resolved in Apr2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169), via an unspecified route of administration in the left arm on 28Apr2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
42 2021-07-27 lethargy, fatigue All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and le... Read more
All issues are still present to this day: Fatigue, lethargic, Brain fog, mild Vertigo, hands and leg numbness (feels like they are asleep), out of breath, can't think of simple words or statements, forgetting what I am doing in the middle of a process (simple stuff), heart arrhythmia.
42 2021-07-27 throat pain swollen throat; Bad taste in mouth; sore throat; This is a spontaneous report received from a non-co... Read more
swollen throat; Bad taste in mouth; sore throat; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 11:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, the patient experienced throat swelling, sore throat and bad taste in the mouth. The adverse event resulted in emergency room or department or urgent care. The patient was tested for COVID-19 post-vaccination. The patient underwent a SARS-CoV-2 nasal swab test on 04Apr2021, and the result was negative. The patient received pain medicine as the treatment for the adverse events. The clinical outcome of the events throat swelling, sore throat and bad taste in mouth were not recovered at the time of the report. No follow-up attempts are possible; information about the lot number cannot be obtained.
42 2021-07-28 fever, chills, headache Fever; Chills; Body aches; Headache; An other vaccine was received on same date 28Apr2021; This is a... Read more
Fever; Chills; Body aches; Headache; An other vaccine was received on same date 28Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 28Apr2021 (at the age of 42-year-old) at single dose for COVID-19 immunisation. An other vaccine was received on same date 28Apr2021. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient experienced fever, chills, body aches and headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was unknown. This report was reported as non-serious by reporter. Information about lot/batch number cannot be obtained. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: event Product use for unapproved combination added since 'An other vaccine was received on same date 28Apr2021'.
42 2021-07-29 headache Diagnosed with Bell's Palsy. My face paralyzed and droops on the left side . My eye, mouth, and al... Read more
Diagnosed with Bell's Palsy. My face paralyzed and droops on the left side . My eye, mouth, and all facial muscles on the left side are weak and won't move. My tongue felt numb and and I have no sense of taste. I have a hard time talking because the left side of my mouth doesn't move. My eye is watering a lot and I can't shut my left eyelid all the way. I have headaches and jaw pain. I went to the ER and then to my primary doctor and was given an antiviral medicine and prednisone. I am still currently having all of these symptoms and the jaw pain is worse.
43 2021-01-01 lethargy Severe muscle pain inability to move arm has continued for 4 days and still going Swelling at injec... Read more
Severe muscle pain inability to move arm has continued for 4 days and still going Swelling at injection site Lethargy
43 2021-01-03 fatigue, fever, headache 10 min after injection, my mouth started getting hot, then it moved down my throat and it was diffic... Read more
10 min after injection, my mouth started getting hot, then it moved down my throat and it was difficult and painful to swallow. I got quite dizzy. They initiated rapid response, when they came they simply monitored symptoms and Vitals. Blood pressure and Heart rate were elevated. after about 10 min the symptoms eased, but swallowing was still difficult and slightly painful. then a second wave of dizziness hit me and I nearly passed out. my heart rate was elevated once again and had ringing in ears. these symptoms lasted another 5-10 min then eased. I then had a headache. The symptoms didn't return, just a headache and fatigue the rest of the day. i was then given option to go to ED, which i didn't feel at that time I needed, so I left. The next day, i had some standard symptoms of pain in left arm from injection, and fatigue, but then toward the evening i developed a fever of 101 deg F than continued for a couple of hours. I used ibuprofen and Tylenol rotating to keep the fever down. On day 3 only mild fatigue.
43 2021-01-04 chills, throat pain, headache Headache, Muscle pain, sore throat, chills.
43 2021-01-04 chills, productive cough, headache, cough Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nause... Read more
Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.
43 2021-01-04 chills, fever, headache Body chills; fever; headache; This is a spontaneous report from a contactable other healthcare profe... Read more
Body chills; fever; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), via an unspecified route of administration (left arm) on 29Dec2020 08:15 at single dose for Covid-19 immunization. The patient's medical history included hypertension (HTN) and high cholesterol. Concomitant medications included losartan, atorvastatin, and amlodipine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced body chills, fever, and headache on 29Dec2020 22:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
43 2021-01-04 fatigue, fever, chills Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-10... Read more
Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation. The most recent COVID-19 vaccine was administered at Hospital. Medical history was none. No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.
43 2021-01-04 headache Chronic headache and stuff neck, sore shoulder
43 2021-01-04 headache Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and... Read more
Client started c/o headache, tightness in chest, and was anxious. He was helped out of his truck and taken to triage where they administer o2 4Liters via nasal cannula. He self administered his albuterol inhaler. He admits to having anxiety issues. He was monitored for 20 mins and no other problems arose and he felt better after that. He has had no other problems related to the vaccine since that occasion. He did not contact his doctor.
43 2021-01-04 fever, fatigue Fatigue and fever on day 5 after vaccination
43 2021-01-05 fatigue, chills, headache, fever Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is... Read more
Pain at injection site; headache; muscle pain; chills; joint pain; tiredness; fever; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via intramuscular route of administration, on 28Dec2020 at 09:15 AM (at the age of 43 years old) as a single dose in the right arm for COVID-19 immunization. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Concomitant medication were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, at 11:30 PM, the patient experienced pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. No treatment was received for the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea. The outcome of the events pain at injection site, headache, muscle pain, chills, joint pain, fever, tiredness and nausea was recovered on an unspecified date in Dec2020. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
43 2021-01-05 fatigue Sudden fatigue lasting 3 hours then gradually went away.
43 2021-01-05 throat pain, headache Nausea, Diarrhea, Sore throat, headache and congestion. Started an hour after receiving the vaccinat... Read more
Nausea, Diarrhea, Sore throat, headache and congestion. Started an hour after receiving the vaccination. Symptoms increased the following day.
43 2021-01-06 chills, fever, headache Experienced these side effects: headache - aspirin did not help, but excedrin worked okay; muscle pa... Read more
Experienced these side effects: headache - aspirin did not help, but excedrin worked okay; muscle pain, chills, mild fever.
43 2021-01-06 sweating, headache SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. ... Read more
SWEATING ANXIETY, HEADACHE, NAUSEA, SWEATING AT APPROXIMATELY 1410. HR 100-105. OBSERVED 5 MINUTES. DENIED SOB. NO TACHYPNEA, RASH OR ORAL SWELLING. NO AUDIBLE WHEEZING OR STRIDOR. SENT TO ER AT 2:19 FOR OBSERVATION. OBSERVED 1 HOUR.
43 2021-01-06 fever, chills 1/5/2021 vaccination. Similar to first vaccine reaction. 'Worst body chills'. Seven hours; feverish.... Read more
1/5/2021 vaccination. Similar to first vaccine reaction. 'Worst body chills'. Seven hours; feverish. Tylenol, Advil. 1/6 morning - feverish, body aches No new lesions
43 2021-01-06 fever, fatigue 12/17/2020 Vaccine L shoulder. 12/18 muscle aches, feverish, fatigue. @ night because itchy locatio... Read more
12/17/2020 Vaccine L shoulder. 12/18 muscle aches, feverish, fatigue. @ night because itchy location on back; reddish and inflamed. 12/19 morning ecstatic 12/20 numbness on penis 12/21 lesions on gland penis; spots pigmented Referred to dermatology; prescribed topical steroid cream. Lesion numbness and itching subsided.
43 2021-01-07 fever, chills, headache, fatigue AT 3AM STARTED WITH FEVER AND CHILLS , HEADACHE, SEVERE BODYACHE, LOWER BACK PAIN AND FATIGUE TAKING... Read more
AT 3AM STARTED WITH FEVER AND CHILLS , HEADACHE, SEVERE BODYACHE, LOWER BACK PAIN AND FATIGUE TAKING TYLENOL EVER 4 HRS SINCE 3AM 1/8/2021
43 2021-01-07 fever 100.6 Fever, body aches and mental fogginess
43 2021-01-07 fever fever, muscle aches, joint pain staying home
43 2021-01-07 fever Fever, body aches, Mental fogginess
43 2021-01-07 fever 100.6 Fever, body aches, mental fogginess
43 2021-01-09 fatigue body ache, fatigue, soreness, at injection site Narrative:
43 2021-01-09 headache About 12 hours after vaccine #2: - Hives on left back, arm, face. Resolved with Benadryl within 4 ho... Read more
About 12 hours after vaccine #2: - Hives on left back, arm, face. Resolved with Benadryl within 4 hours. - Headache for about 30 hours - body aches for about 30 hours
43 2021-01-09 malaise, chills, fever Fevers, chills, myalgias, body aches, malaise
43 2021-01-10 chills, fever Body ache, chills, fever lasted about 8 hours.
43 2021-01-10 fatigue, fever, chills Pfizer-BioNTech COVID-19 Vaccine EUA 1 episode of Diarrhea 3 hours after 2nd dose Sudden onset of f... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 1 episode of Diarrhea 3 hours after 2nd dose Sudden onset of fatigue and chills approximately 12 hours after 2nd dose Fever of 102.5 to 103 F and body aches approximately 18 hours after 2nd dose Symptoms all gone after approximately 36 hours
43 2021-01-10 fatigue, fever, headache, throat pain In the first 2 days (probably a couple of hours after the shot) I felt achiness, and it got worse bo... Read more
In the first 2 days (probably a couple of hours after the shot) I felt achiness, and it got worse body pains, joint pains and fatigue. Almost a week after I started getting sick, aches, shore throat, headache and fever (101.5F) that is when I went to the ED and it lasted about 2 days and then it went away. At the ED they did COVID and strep tests both negative. This was with my first dose and my second one the same thing happened.
43 2021-01-10 headache Headache, Myalgia, Left arm soreness, headaches, decreased appetite Narrative:
43 2021-01-10 sluggishness Vaccine recipient experienced nausea and vomiting after receiving the vaccine. At the end of the obs... Read more
Vaccine recipient experienced nausea and vomiting after receiving the vaccine. At the end of the observation period of 15 minutes he developed nausea and vomited once. After he vomited, the symptoms resolved. He was sent to the ED for follow-up and observation. Vaccine recipient stated that they drank a lot of juice. He improved and was subsequently discharged. The next day vaccine recipient reported that they felt sluggish and had arm pain around the site of injection. On a follow-up call today 1/11/2021; he reported that his symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
43 2021-01-11 fatigue, headache, chills Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day ... Read more
Around 8pm I began having chills, body aches and SOB that lasted throughout the night. The next day I felt a little better earlier but got very fatigued, had a headache, chills and a large swollen lymph node developed under my left arm and its still there today. And my arm is sore at the injection site.
43 2021-01-11 fatigue Fatigue; Vertigo; Arm pain; This is a spontaneous report from a contactable other HCP (patient). A 4... Read more
Fatigue; Vertigo; Arm pain; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old male patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fatigue and vertigo, arm pain on 22Dec2020 20:00. It was unknown if treatment received for the adverse event. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.
43 2021-01-11 headache, fatigue 12/23 I woke up around 3am in the morning with a headache, body ache, fatigues, no fever or cough. ... Read more
12/23 I woke up around 3am in the morning with a headache, body ache, fatigues, no fever or cough. 12/26 went to an Urgent Care for COVID-19 and got results 12/27 I was positive for COVID. On 12/27 I lost my taste and smell and started experiencing SOB which lasted for the next couple days.
43 2021-01-11 headache, fever fever, head ache, body aches, dizzy, slight nausea
43 2021-01-11 headache headache (approximately 13 hours later) , shoulder pain (8 hours later) , slight blistering from ban... Read more
headache (approximately 13 hours later) , shoulder pain (8 hours later) , slight blistering from band aid adhesive (~10 hours)
43 2021-01-12 fatigue Pain at the injection site and fatigue Narrative:
43 2021-01-12 headache, fatigue, chills, fever Fever/chills, headache, tired, mild pain at injection site
43 2021-01-12 headache, fever Headache, Arthralgia & Fever Narrative:
43 2021-01-12 headache Headache and muscle aches. Resolved with Tylenol and sleep.
43 2021-01-12 runny nose, fatigue, malaise 2 hours post vaccine runny nose, next day myalsia, back pain injection site discomfort, fatigue thro... Read more
2 hours post vaccine runny nose, next day myalsia, back pain injection site discomfort, fatigue through Friday and Saturday I felt better and Sunday I lost sense of smell Monday I tested positive for covid, the rest of that week I felt sick and slowly symptoms resolved , I took one tylenol on 22nd
43 2021-01-13 chills, cough, sneezing, fatigue, runny nose, headache, throat pain Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, a... Read more
Sore throat, chills, headache, body aches, cough, sneezing, runny nose, fatigue, mental fogginess, and soreness at the injection site.
43 2021-01-13 chills, fever, malaise, fatigue Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from ... Read more
Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from a contactable Physician (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 18Dec2020 at 02:00 PM (at the age of 43 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0130/expiration date: unknown), via unknown route of administration, on 06Jan2021 at 03:45 PM (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension (HTN) and GERD. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Metoprolol, Hydrochloride, Acetylsalicylic acid (ASPIRIN), Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 12:00 PM, the patient experienced low-grade fever 99-100's, muscle aches, fatigue, chills, malaise. Treatment was received for the events low grade fever 99-100's, muscle aches, fatigue, chills, malaise included ibuprofen (ADVIL), acetaminophen (TYLENOL), rest and fluid. The outcome of the events fever 99-100's, muscle aches, fatigue, chills, malaise was recovering. Patient underwent COVID-19 PCR test which was pending result. Since the vaccination, the patient had not been tested for COVID-19.
43 2021-01-13 fever, headache HEADACHE,FEVER,DIZZINESS,IRRITATE EYES.
43 2021-01-14 headache, fever FEVER OF 102 (1/12-1/14), BODY ACHES, PAIN AT INJECTION SITE, JOINT PAIN (LOCKED UP), HEADACHE, NECK... Read more
FEVER OF 102 (1/12-1/14), BODY ACHES, PAIN AT INJECTION SITE, JOINT PAIN (LOCKED UP), HEADACHE, NECK PAIN
43 2021-01-14 fever, headache 101 degree fever, headache
43 2021-01-15 chills, fever started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was adminis... Read more
started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was administered. Tylenol taken on 1.15.21
43 2021-01-17 chills, fever The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/... Read more
The day after receiving the second vaccination, I began to have mild intermittent abdominal pain2-3/10. The pain gradually increased, became more intense, and more constant. Mild fever and chills started happening, and I took Ibuprofen. By about 4 days after the vaccine, the abdominal pain was severe enough that I had some difficulty walking and I couldn?t sleep at night. Pain was 6-8/10. I went to the ER, and CT scan with IV contrast showed 18 mm appendicitis. I underwent laparoscopic surgery and it was found to be perforated. It was removed. I am currently recovering in the hospital. I received the vaccine as a health care provider at my hospital, specifically I am a practicing pediatrician physician for over 10 years.
43 2021-01-17 fever, chills, fatigue 72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am an... Read more
72 hours of body aches, fatigue, uncontrollable chills, fever and night sweats. Got vaccine 8am and symptoms appeared at 4am next morning.
43 2021-01-17 fever, headache, chills Fever of 104.3. Chills. Severe body aches and headache. Nausea. Vomiting. Dizziness. Lasting more th... Read more
Fever of 104.3. Chills. Severe body aches and headache. Nausea. Vomiting. Dizziness. Lasting more than 36 hours
43 2021-01-18 fever, chills, headache Nauseous headache chills fever All lasted about 18 hours
43 2021-01-19 chills, fever i developed fever, chills, body aches and nausea. it has been present for greater than 24 hours now
43 2021-01-19 fatigue A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i ... Read more
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen. After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy. If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate. The heart rate beat felt heavy. I went to bed early and slept through the night. I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated. no fever, no headache. i tried to take a shower but symptoms got worse. i was unable to go to work that day. I took a few naps during the day and by late afternoon most symptoms where going away. the last symptom was the issue with the hands and feet. Heart rate returned to normal. The next day i was able to return to work.
43 2021-01-19 fever, headache Muscle pain and stiffness, more on the left side where I received vaccine. Fever 1/18/21@2100hrs-101... Read more
Muscle pain and stiffness, more on the left side where I received vaccine. Fever 1/18/21@2100hrs-101.4/1/19-20/21@ throughout evening Headache
43 2021-01-19 fever Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms... Read more
Soon after the injection he noted a slight fever, body pain, migraine, slight nausea. These symptoms lasted for 2 days
43 2021-01-20 cough After the required wait period of 15 minutes I started to drive back home which is 77 miles from the... Read more
After the required wait period of 15 minutes I started to drive back home which is 77 miles from the hospital that administered the vaccination. Around 15 minutes down the road I started feeling like something was caught in my throat and was coughing a little. At that time I decided to turn around and go back to the hospital. I took an oral Benadryl 25mg and decided to wait in my car and see if it was something else. After 30-45 minutes I took a drink of water and realized I was having trouble swallowing. I then preceded into the ER and was admitted immediately. In the ER, they started an IV, administered Benadryl, methylprednisolone and a bag of saline. The physician discussed with me and we agreed to hold the Epinephrine to see how I reacted to the previous medications. I was then monitored for a couple hours then released with a prescription of Prednisone 60mg for 5 days and an EpiPen. One day out, no new symptoms besides injection site pain.
43 2021-01-20 headache, chills Body aches, headache, chills
43 2021-01-20 fever Fever/as high as 102.6 tympanic/temperature was 101; This is a spontaneous report from a contactable... Read more
Fever/as high as 102.6 tympanic/temperature was 101; This is a spontaneous report from a contactable other HCP. A 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El3246), intramuscular in left arm on 12Jan2021 09:00 at a single dose for covid-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, rosuvastatin, acyclovir [aciclovir] (ACYCLOVIR), lisinopril, and fenofibrate. The patient previously received the first dose of bnt162b2 on 22Dec2020 09:00 intramuscular in left arm. The patient experienced fever that started at 8pm to 9pm on 12Jan2021. The fever reached as high as 102.6 tympanic. On 14Jan2021 at 7am, temperature was 101. The outcome of the event was not recovered. No treatment was received for the event. This was assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
43 2021-01-20 fever Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a co... Read more
Severe right tibialis anterior muscle cramp; low level fever; This is a spontaneous report from a contactable physician (patient). This 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiry date unknown, vaccine location: left arm), intramuscular on 05Jan2021 08:00 at a single dose for COVID-19 immunization. Medical history included hypertension. The patient has no known allergies. Concomitant medication included valsartan and loratadine (other medications in two weeks include valsartan and loratadine). The patient took the first dose of bnt162b2 on 16Dec2020 01:00 PM (lot number: EH9899) intramuscular, vaccine location: left arm. The patient experienced severe right tibialis anterior muscle cramp on 06Jan2021 12:00 PM, 30 hours after second injection (as reported) with onset of low level fever. The fever resolved within 2 hours. Muscle cramping persisted for 30 hours with complete resolution. No treatment was received. Outcome of the event low level fever was recovered on 06Jan2021 14:00 and of the event muscle severe right tibialis anterior muscle cramp was recovered on 07Jan2021 18:00. The patient had no COVID prior to vaccination. The patient was not tested for COVID post-vaccination. The patient had no other vaccine in four weeks.
43 2021-01-20 throat irritation Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to... Read more
Continued left arm injection site pain, left sided neck neuropathy, and feeling of very mild ache to the anterior throat (feeling of swelling) but not having short of breath or trouble talking.
43 2021-01-21 cough coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contac... Read more
coughing quite a bit; seizure; his whole body feels sore; This is a spontaneous report from a contactable consumer (patient's mother). A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3248) in right deltoid, on 11Jan2021 around 10:30, for COVID-19 immunisation. The patient was in high risk group, was living in senior facility and was disabled. Medical history included also ongoing hydrocephalus diagnosed when he was less than a year old, ongoing shunt (the first one when he was 11 months old, has had multiple revisions since then, the last in 2017), vagal nerve stimulator implantation ongoing from 2003 (for epilepsy; has had multiple since then, last one in 2015), ongoing hemiparesis since he was a baby and epilepsy (he was taking epilepsy drugs but it was well controlled). Concomitant medications included oxcarbazepine (TRILEPTAL) ongoing from 2000, at 1800 mg daily (600 mg in the morning and 1200 mg at night), for epilepsy and levetiracetam (KEPPRA XR) ongoing from 2000, at 1500 mg twice daily (in the morning and at night), for epilepsy. He was on prior medications to these, since he was young. Over the years he has changed to newer and better medications. On 11Jan2021 around 8-9 PM the patient experienced seizure. The patient has not had a grand mal seizure in over 5 years. On an unspecified date in Jan2021, after the vaccine, his whole body felt sore. He was unsure if it was from the seizure or the vaccine. The reporter also noticed that the patient had been coughing quite a bit on 12Jan2021 morning. Events outcomes were unknown.
43 2021-01-21 fatigue, chills, influenza like illness, headache Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of slee... Read more
Woke up 0230 with severe chills but skin was hot (according to my wife). After several hours of sleep I got out of bed around 0600 and noticed severe body and joint ache and a headache. Once I began moving around I also noticed I would fatigue very quickly. Reminded me of how one feels when they get a good case of the Flu. As the day progressed all symptoms lessened in severity and I went to bed at about 20% of what I felt that morning. I woke the following morning and felt no residual symptoms.
43 2021-01-21 fatigue Body aches, tired, hard time catching my breath, mind foggy
43 2021-01-22 chills Arm pain that lasted 3 days, chills and diarrhea that lasted 24 hours, I didn't take any treatment.
43 2021-01-22 cough Patient received vaccine on 1/2 (Sat) and today went to the ED 1/5. On Sunday am began vomiting and ... Read more
Patient received vaccine on 1/2 (Sat) and today went to the ED 1/5. On Sunday am began vomiting and diarrhea with no blood in stool or emesis. Denies fever. States he only coughs post vomiting and it is un productive. Pt has been urinating and has been able to keep food and fluids down. Noted with skin warm and dry/resps, NAD and color WNL. Pt denies any abdo pain except post vomiting. SARs CoV2 RNA test negative.
43 2021-01-24 chills, headache, fever 1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headac... Read more
1/14, 2200 - chills 1/14, 2300 - onset of fever 1/15, 0100 - tremors, chills, fever, onset of headache 1/15, 0300 - peak fever @ 100.7 F (baseline is 96.5) 1/15, 1000 - fever resolved 1/15, 1200 - chills resolved 1/15, 2000 - headache resolved
43 2021-01-24 throat irritation Metallic taste in mouth and unusual sensation in posterior pharynx (1st and 2nd vaccination courses)... Read more
Metallic taste in mouth and unusual sensation in posterior pharynx (1st and 2nd vaccination courses)within 15 minutes post IM injection. Approximately 4.5 hours post IM injection (2nd vaccination) again unusual taste in mouth with swelling of posterior pharynx. Swelling not relieved by 20 mg prednisone X , Benadryl 50 mg and Pepcid 40 mg. Second dose of prednison 20 mg alleviated throat symptoms. Approximately 24 hour post IM injection (2nd vaccination), subject felt itchy, especially the eyes. Subsequant dose of Zyrtec and Pepcid alleviated symptoms within one hour.
43 2021-01-25 chills The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I ... Read more
The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and heartburn/indigestion remain; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 43-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number and exp date not reported), intramuscular (vaccine location: left arm) on 28Dec2020 for COVID-19 immunization. Facility type vaccine: Nursing Home/Senior Living Facility. Medical history included gastric sleeve and surgery. The patient had no known allergies. Patient did not have Covid prior vaccination. There was no other medical history. There were no concomitant medications. There were no other vaccine/s within four weeks. No other medications in two weeks. The day after patient received the vaccine, she got the common side effects on Jan2021: chills, loose stool, and nausea. She also began having heartburn/indigestion (Jan2021). It had been 16 days since the first dose, and the loose stool and heartburn/indigestion remain. Not sure if it's because of having the gastric sleeve done years ago, or not, as the surgery changed her metabolism and the like. No treatment was provided. Nasal Swab on 11Jan2021 was negative. The outcome of the events was not recovered. Information about lot/batch number has been requested.
43 2021-01-25 fever, chills arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hou... Read more
arm pain for 3 days at injection site. Shivers and chills in first 24 hours. Mild fever first 24 hours Ongoing persistent lymph node inflammation in neck for 7 days and counting
43 2021-01-26 fatigue, malaise, fever 10-12 hours post administration experienced severe malaise, fatigue, body aches, and mild fever ~101... Read more
10-12 hours post administration experienced severe malaise, fatigue, body aches, and mild fever ~101.5 fahrenheit. No respiratory symptoms. Symptoms persisted through the next day and began to ease ca 24 hours after beginning. Now almost 48 hours from onset, mild symptoms persist.
43 2021-01-26 headache, malaise, fever Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have res... Read more
Malaise, nausea, headache, mild fever, arm pain. took one dose of acetaminophin,. Symptoms. have resolved 01/23/2021
43 2021-01-26 headache Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after va... Read more
Blurred vision/ loss of peripheral vision/ Optical migraine followed by headache 45 minutes after vaccine. Some tingling on face and left had Resting to see if it goes away.
43 2021-01-26 fever, chills Fever Chills Narrative:
43 2021-01-31 chills, fatigue 1/20/2021 @ 08:25 AM: Chills, body ache and fatigue. Symptoms for one day, next day was feeling well... Read more
1/20/2021 @ 08:25 AM: Chills, body ache and fatigue. Symptoms for one day, next day was feeling well. Verbalized he is recovered.
43 2021-01-31 headache 5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for... Read more
5 hours after vaccination: body aches and light headache, left arm soreness, cramps and numbness for 2 days. Feeling well and resolved except arm numbness.
43 2021-02-01 fatigue Arm sore at injections site and experienced fatigue.
43 2021-02-01 headache, fever, chills Fever, chills, whole body ache, nausea, headache. Symptoms lasted about 24 hours, controlled with ov... Read more
Fever, chills, whole body ache, nausea, headache. Symptoms lasted about 24 hours, controlled with over the counter NSAIDs.
43 2021-02-02 headache Headache & arthralgia Narrative:
43 2021-02-02 fever, chills Sore arm, body weakness, fever, chills
43 2021-02-04 body temperature increased Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness... Read more
Left arm at injection site felt cold after five minutes after injection. Lasted a minute. Dizziness. Has lasted so far four hours Jaw bones hurt Running temperature. Started three hours after injection. Current temp is 100.2. taken orally at 4:15pm PST I called in sick for work, stating it's vaccine related for my shift on 2/5/2021. My shift would have started at 11:00pm.
43 2021-02-04 sweating Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal respo... Read more
Patient had vasovagal syncopal event. This event was not a vaccine side effect but a vasovagal response (previous history of syncope with vaccinations/procedures). Patient received 1st dose of Pfizer vaccine around 11am today. Within 2 minutes of receiving the vaccine, he started to feel dizzy and passed out for around 45 secs. He had cold extremities, looked pale and was sweating. He was immediately transferred from chair to floor and his legs were raised. Cold towel was placed on his head. He regained consciousness but was confused for less than a 1min. Vitals were checked and his BP was 95/50's and HR was around 56. Pulse O2 was 99% during entire event. He was able to converse well after that and was oriented. He informed having anxiety/panic attacks, had taken his medication that morning. He reported similar syncopal episodes in the past. He was monitored in same posture. He was gently hydrated orally with water and soda. He was given sublingual zofran due to nausea and retching. He did not vomit. We continued to monitor his BP on regular intervals. He had slow improvement in BP and after 2 hrs while sitting his BP was 104/65, pulse 56/min (reports being an athlete and previous records show baseline bradycardia). He denied any symptoms and was awake, alert, oriented. As he was not accompanied by anyone, his wife was contacted who came to clinic in 10mins and helped to drive him home. He was transported by wheelchair till entrance of clinic. He reported feeling better and thanked for helping. He does not have any contraindications to receive 2nd dose of vaccine.
43 2021-02-04 fever, chills chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axi... Read more
chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axilla has become very swollen and painful; fluid accumulation in the subcutaneous tissue; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL3247; expiration date: unknown), via an unspecified route of administration left arm on 17Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included known penicillin allergies. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were none. The patient previously took sulfamethoxazole-trimethoprim (BACTRIM) but had allergies. The patient historically vaccine included first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL0140; expiration date: unknown) at the age of 43-year-old via an unspecified route of administration right arm on 29Dec2020 10:00 AM at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the vaccine in a hospital but 36 hours after the vaccine (18Jan2021), the patient developed chills, body aches and low-grade temperature. Then 48 hours later, her left axilla has become very swollen and painful. The pain has subsided but remains mild and swelling persists. The area seems to show fluid accumulation in the subcutaneous tissue but no erythema or e/o [evidence of (pending confirmation)] abscess infection noted. It's now been present for 4 days. The patient received treatment which included NSAIDs. The patient had not been COVID tested post vaccination. The outcome of the events was not recovered.
43 2021-02-05 headache Extreme headache.
43 2021-02-05 sweating Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This ... Read more
Patient felt warm, off balance, disoriented, and was sweating profusely after his vaccination. This reaction started less than 5 minutes after administration of the Pfizer vaccine. EMS took the patient's blood pressure. The first reading was 80/50 mmHg and the second reading was 104/66 mmHg. After having water and sitting for 30 minutes the patient felt fine.
43 2021-02-06 malaise, chills, body temperature increased 11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that ... Read more
11/17/20 J&J Ad26.CoV2.S vaccination. The next morning patient began mild achiness & fatigue that lasted 48 hours and mild arm pain that lasted 72 hours. severity: Gr 1 1/5/21 Pfizer #1. Sudden onset at 10 hours of shaking chills, temperature 103+, severe myalgias and malaise. Severe for 36 hours. 80% better at 48 hrs; at baseline by 72 hours. 1/26/21 Pfizer #2. 10 hours later again noted shaking chills, temperature >103, severe myalgias and malaise. 1/27 could not work. Worked 1/29 & 1/29 at half capability. 1/30 & 1/31 felt worse with temperature >103 both days. 2/1 had to leave work early; noted multiple aphthous ulcers on palate and tongue. Continued to have myalgias and temperature 102-3 through 2/3; tempera
43 2021-02-08 chills, fatigue Vial had been removed from Deep Freezer to cooler & kept in cooler beyond recommended time frame; wa... Read more
Vial had been removed from Deep Freezer to cooler & kept in cooler beyond recommended time frame; was not noted until after administered to employee (patient). Patient experience expected side effects of chilling, body aches and fatigue next day,
43 2021-02-08 fatigue Nausea and tiredness ( heavy tiredness)
43 2021-02-08 sweating Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating,... Read more
Approx 10-15 minutes after the shot client started c/o severe nausea and did vomit. He was sweating, and c/o throat tightening, was pale and still nauseated. Benadryl 50 mg Im given. His brother in law was called to drive him home. After he was stable, and no longer c/o any symptoms he was release to his brother-in=law. He says he went home and slept 3 hours and then slept til noon the next day which is not normal for him.
43 2021-02-10 head discomfort s/p first injection c/o feeling faint, dizzy, and pressure above eyes
43 2021-02-11 fatigue, chills, headache Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approxima... Read more
Headache (severe), muscle aches (mild), chills (mild), and fatigue (mild). Symptoms lasted approximately 48 hours after onset. Could not work/bedridden for approximately 36 hours. Tylenol did nothing to help, ibuprofen effective to lessen the headache so I could sleep.
43 2021-02-11 throat pain Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 mi... Read more
Woke up the next morning feeling a little weak, muscle soreness, and slight sore throat. About 30 minutes after waking up I passed out and fell while taking a shower. I have no history of passing out for any reason and have had no side effects with any other prior vaccinations.
43 2021-02-15 headache HEADACHE, VOMITING, DIZZY
43 2021-02-16 headache, sleepiness hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth;... Read more
hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
43 2021-02-18 throat irritation, fatigue, headache, fever, throat pain Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sor... Read more
Fever, headache, pain in arm; feeling better by 2/16/21, but still dizzy and fatigued. Now has a sore and itchy throat and pain has returned. Symptoms are "off and on."
43 2021-02-19 fever Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102... Read more
Entire body rash for 7 days, started at my neck and then to involve my entire body. Fever 101.8-102.9 for 3 days with 1 gram Tylenol and Benadryl. Weakness for a week, unable to work.
43 2021-02-20 fatigue, headache Headache, soreness on the injection site, overall fatigue, body ache.
43 2021-02-21 fatigue, sleepiness 7 day post-shot still experiencing pain in arm focused at site of injection. Waves of extreme fatig... Read more
7 day post-shot still experiencing pain in arm focused at site of injection. Waves of extreme fatigue requiring me to sit down and overwhelming desire to sleep (unusually) three times day. First dose.
43 2021-02-22 headache, fatigue headache, nausea, fatigue, shortness of breath- started two days after vaccine and lasted about 5 da... Read more
headache, nausea, fatigue, shortness of breath- started two days after vaccine and lasted about 5 days. Was tested for COVID19- results were negative
43 2021-02-23 nasopharyngitis, headache Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased t... Read more
Woke up at 4 am on 01/31/2021 with muffled hearing and numbness on left side of body. BP increased to 150/100. Vomiting and diarrhea. Went to ER on 02/01/2021 and had MRI of the brain to check for stroke/TIA. Had an EKG and carotid artery scan. All tests came back normal. Continued to have neuropathy only on the left side of the body since 01/31/21. Pain travels from nerve to nerve. Occasional HA with pain only on the left side of the head. Cold tightness in chest. Seen PCP numerous times and had bloodwork done, Symptoms have continued since onset on 01/31/21 with no increase or decrease in severity. PCP has referred him to a neurologist.
43 2021-02-25 sweating Pt reported increased HR, anxiety, and sweaty.
43 2021-02-25 fever, chills, headache Chills/shivers (first day); Mild fever (first day); Lymph node inflammation in neck (on and off sinc... Read more
Chills/shivers (first day); Mild fever (first day); Lymph node inflammation in neck (on and off since the vaccine); Headache; Arm pain at injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 13:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included cannabis. The patient experienced chills/shivers (first day), mild fever (first day), lymph node inflammation in neck (on and off since the vaccine), headache, and arm pain at injection on 19Jan2021 16:00. No treatment was received for these events. Outcome of the events was unknown.
43 2021-03-02 fatigue Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off thro... Read more
Day after second vaccine dose, patient began having extreme fatigue, overall body chills on/off throughout every day, joint aches in fingers and ankles, bilateral calf pain, wheezing, heart burn, brain fog, cold feeling in feet. These occur throughout every day, on and off. We are now at week 5.
43 2021-03-02 sweating Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know w... Read more
Patient found on ground by bystander. Patient responsive, alert and oriented. States does not know what happened. Patient stood and sat in chair. A few seconds later patient had syncopal episode and nursing staff assisted him to the ground. BLS provided, airway maintained. Patient pale, diaphoretic and clammy. BP 110/60, P 51, O2 98%, T 96.3. Monitored until EMS arrived. Paramedics on scene. Vitals BP 89/60, P 67, O2 100%, Blood sugar 81. Patient taken to hospital via ambulance.
43 2021-03-02 malaise, head discomfort felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure buildi... Read more
felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination Information on the lot/batch number has been requested.
43 2021-03-02 throat irritation After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensati... Read more
After about 10 minutes I started feeling weird. I became light headed. Then I felt a burning sensation done both arms and my tounge. My heart was beating fast and I was struggling to get my breathing under control. My throat also got tight or warm and that feeling seem to go down through my chest. The monitor told me to take off my mask and gave me water. Shortly after I started to gag and almost vomited. The monitor checked my blood pressure and it was 180 over 120. I was admitted to the ER. I stayed there for about an 90 minutes as was released as the symptoms seemed to leave. While driving home many of the symptoms resurfaced. When I returned home I took a zyrtec and an anxiety medication. A day after I am light headed and a little nautilus but otherwise ok.
43 2021-03-04 chills, fatigue, fever fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second sh... Read more
fatigue, low grade fever and chills began ~24 hours after the second shot. ~36 hours after second shot right armpit lymph node was visibly swollen and very tender. Swelling went down over the course of 24 hours and was unnoticeable within 48 hours of appearing.
43 2021-03-04 fatigue Fatigue Narrative:
43 2021-03-04 fever, paranasal sinus discomfort, fatigue Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a sponta... Read more
Fever up to 100.9 F; Sinus pressure; Body aches; Tiredness; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm on 27Jan2021 at 16:30 at the age of 43 years old at a single dose for COVID-19 Immunization at health clinic/ administration facility. The patient's medical history included mild asthma, CT contrast agent allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) at the age of 43 years old on 07Jan2021 at 12:30 pm in the left arm for COVID-19 Immunization. The patient's concomitant medication included montelukast, albuterol (Salbutamol) and beclomethasone. The patient experienced fever up to 100.9 F, sinus pressure, body aches, tiredness, pain at injection site on 28Jan2021 at 6:00 AM. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
43 2021-03-05 fatigue Light headed followed by losing consciousness for about a minute. Then nausea and throwing up. Fat... Read more
Light headed followed by losing consciousness for about a minute. Then nausea and throwing up. Fatigue rest of the day.
43 2021-03-06 cough Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and... Read more
Threw up foam and saliva in middle of night. Felt like I was choking, woke from a sleep coughing and spit up foaming mucus. Right leg was tingling as well.
43 2021-03-08 lethargy, fever Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all ... Read more
Bloody diarrhea. Blood dripping from anus. Fever. Lethargic. Sleeping constantly. Body aches all over. Extreme abdominal pain.
43 2021-03-09 fatigue, headache, throat pain Soar throat, fatigue, headache.
43 2021-03-09 headache, runny nose, fatigue Patient reported symptoms of fatigue, headache, muscle/body aches, and runny nose that lasted longer... Read more
Patient reported symptoms of fatigue, headache, muscle/body aches, and runny nose that lasted longer than 72 hours.
43 2021-03-09 headache Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in l... Read more
Headache in back/right of head began on 3/5/2021, on 3/7/21 began experiencing facial paralysis in lips which progressed to the rest of right side of face. Went to Emergency Department that evening. CT scan was "unremarkable" and blood work was normal. Was diagnosed with Bells Palsy. Prescribed Valtrex and Prednisone. 3/10/2021 still experiencing partial facial paralysis and headache in same location.
43 2021-03-10 dehydration Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation ... Read more
Narrative: As written per ED notes dated 3/9/2021: This 42-year-old female is here for evaluation of increasing nausea and vomiting. The patient has gotten worse the past 24 hours. She got her second COVID-19 shot yesterday here at the VA Medical Center. She is complaining of consistent nausea and vomiting and can't keep any fluids down. She is here for evaluation of possible dehydration and weakness. The patient feels markedly improved after oral Zofran. I counseled her at length about this is a possible intolerance to the second Covid 19 immunization. She will be discharged home with Zofran 4 mg tablets 3 times a day as needed for nausea #20, increase fluids and rest, no work until Thursday, March 11, 2021. First covid19 vaccine: 2/15/2021, no adverse events Second covid19 vaccine 3/18/2021: presented to ED
43 2021-03-10 lethargy, fatigue, sinus congestion Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue,... Read more
Patient experiencing shortness of breath, on Friday 3/5 heart beating real hard, felt weak, fatigue, lasted about 15 minutes, called ems went to ed, was given prednisone, calmed down, helped with inflammation but still lethargic, chest pressure, and pain, stomach pain, feels like a weight and pressure in chest, feels like sinus infection in head, mucus in them morning was red and thick, also having night sweats
43 2021-03-11 headache Almost continuous head ache and sharp ear pain approximately 40% of time since receiving vaccine.
43 2021-03-11 sweating Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. ... Read more
Pt. looked pale & sweating, RN asked if he was okay, stated he felt like he was going to pass out. Pt clampy and sweating. HR 47, Osat 97%. Pt had difficulty breathing with conversation. @1354 Lowered to the floor to lay flat. 1355 BP 101/62, HR 78, O2Sat 98%. @ 1403 BP 100/68, O2Sat 96%, HR 79, pt sitting. @ 1405 pt states "feels ok now" Sitting on the floor 1410 HR 85, O2Sat 94%, Pt remained talkative, alert & oriented sitting on the floor until 14:32. Pt standing 1433 "feels fine" alert and oriented x 3. Pt discharged 14:42. HR 82, Osat 98%
43 2021-03-15 headache Adverse affects after 2nd shot , 3/9/21 - ongoing undulating headaches at back of skull/ears. Heada... Read more
Adverse affects after 2nd shot , 3/9/21 - ongoing undulating headaches at back of skull/ears. Headache pain 3 to 5 out of 10. Tightness in upper neck. Occasional nausea. Headache usually stronger early waking hours and late afternoon. Scheduled Doctor appointment Tues 3/16/21 with health care provider. Taking 325 mg aspirin to help manage pain - only slightly effective. Side effects have gone well past average 72 hrs reported as normal.
43 2021-03-16 chills, influenza like illness, headache, fever Flu Luke symptoms. Chills, fever exceeding 104, body aches and soreness, head ache.
43 2021-03-17 chills, sweating @ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was dia... Read more
@ 0830, Mr. Started complained of feeling chills, and burry vision. Upon assessment, patient was diaphoresis, minimum tremors, AO x 4 time, place, date and situation. VS taken @ 0830 BP 56/38, HR 65, O2 sat 98%. Patient was offered water to drink and wet towel was applied to front head. Another set of VS was taken @ 0837 with BP 92/50. 911 was called @ 0850 and AMR (department #338) arrived @ 0855. Patient was assessed by medic, 12 leads EKG was done NSR. Patient denied transfer to the hospital. Medic left @0900 after explaining to the patient the risks and need to go to the hospital. Patient called his wife. Wife came at 0903. Patient was assessed, no complains of dizziness, was able to walk steadily, before leaving with wife @ 0905.
43 2021-03-17 headache About an hour after getting my first shot i started to have back and leg pain, a headache was develo... Read more
About an hour after getting my first shot i started to have back and leg pain, a headache was developing. about an two and a half hours I started feeling weak. It was hard for me to lift and carry things, I was getting winded walking across the building and the i would feel a little nauseous but that would go away after standing still for a few minutes.
43 2021-03-18 chills, fever Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and di... Read more
Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and diagnosed with Peripheral Vertigo. Follow ups with ENT, Neuro and PCP have continued with Vestibular Rehabilitation. While in ER, the MRI, MRA, CT, CT with Contrast was done, showed no signs of anything that could have caused this. Ironically tracking back, I received my 2nd Dose of the Pfyzer Vaccine on January 6, 2021 at 8:45 a.m. and this occurred on February 13th at 2:15 a.m. I have not had any other issues before this nor any signs of damage to the nerve or ear that regularly affects Vertigo Patients per my Neuro and ENT. The incident took place 4 weeks and 2 days after the 2nd vaccine. 2 days after the 2nd dose, I experienced Low grade fever, chills, and body aches that lasted only 12 hours, but nothing with the 1st vaccine nor anything after the 2nd dose issue until the Vertigo. I am unable to drive, conduct my job, which requires me to go to emergency calls and carry a Taser (CEW). I have been off work since this occurred and still not eligible to go back to work.
43 2021-03-19 fatigue, fever, headache, chills Body aches, fever (+/- 101°), back ache, chills, severe headache, slightly elevated heart rate, fat... Read more
Body aches, fever (+/- 101°), back ache, chills, severe headache, slightly elevated heart rate, fatigue. Symptoms lasted approximately 24+ hours. Moderate to severe arm soreness at site of vaccination for >36 hours and continuing
43 2021-03-21 throat pain Very sore throat, swollen neck. No fever or other symptoms. Started 2 days ago and has not improved.
43 2021-03-22 headache Diarrhea the following day and Mild to Moderate Headache for the entire 2 days following the shot.
43 2021-03-22 fever, dehydration Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22... Read more
Day 1 none 3/21/21 at approx 8pm Dizziness Nausea Joint pain Light fever Dehydrated Insomnia 3/22/21 all day Joint pain Dizziness Nausea Vertigo Foot pain Insomnia
43 2021-03-23 headache, chills, fatigue Approximately 6 hours after the injection (3pm local time) I became fatigue, tired, and had a minor ... Read more
Approximately 6 hours after the injection (3pm local time) I became fatigue, tired, and had a minor headache. At approximately 8pm, 11 hours after injection, I began to experience a sore body and muscles. Lastly, throughout the night I had sore muscles, joints, and minor chills. These symptoms were moderate; however, I did not take any prescribed or over-the-counter medications to treat the symptoms as I did not want to interfere with the vaccine. All symptoms subsided by mid-morning the next day.
43 2021-03-24 fatigue, chills, fever High Fever (102 versus normal of 96), high heart rate (135 to 150 for 12 hours at rest including sle... Read more
High Fever (102 versus normal of 96), high heart rate (135 to 150 for 12 hours at rest including sleeping), chills, and tiredness. I went to the emergency room to get it checked out. Received Toradol for headache, ice pack and IV fluids. Heart rate reduced to 100 and temperature down to 97. HR elevated throughout Sunday (80 to 100 at rest) I was symptom free from AS with Enbrel treatment, but after adverse event severe inflammation in chest and upper left quadrant. Restarted enbrel use but flair up worse than anything seen throughout 8 week cessation of Enbrel usage.
43 2021-03-24 headache experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Pal... Read more
experiencing facial paralysis in lips which progressed to the rest of right side of face; Bell's Palsy; Headache in right back portion of head; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EN6202) via an unspecified route of administration, in the right arm on 02Mar2021 at 14:30 PM (at the age of 43 years). Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included hydrochlorothiazid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took ibuprofen and experienced hypersensitivity. It was reported that the patient experienced headache in right back portion of head which started in PM on 05Mar2021. On 07Mar2021 the patient began experiencing facial paralysis in lips which progressed to the rest of right side of face. The patient went to the hospital emergency department. Bloodwork was normal. Computerized tomogram (CT) scan was noted as "unremarkable". He was diagnosed with Bell's Palsy and prescribed Valtrex and Prednisone. On 10Mar2021 he was still experiencing facial paralysis and headache. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
43 2021-03-24 sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patie... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced syncope briefly he thinks due to sudden drop in blood pressure but recovered within minutes.
43 2021-03-25 fever, headache, fatigue That evening had tachycardia symptoms and trichina symptoms (about 12 hours after vaccine). I had fa... Read more
That evening had tachycardia symptoms and trichina symptoms (about 12 hours after vaccine). I had fatigue and headache the following morning. Severe myalgias - in the epigastric cisternal area and in the back of my shoulder blades. 36 hours later - low grade temperature. At 48 hours I felt normal. Eye - 10 days later (vaccine) - I noticed a visual deficit in the left eye along with a line and the following day - on the 17th, I saw my ophthalmologist - left branch retinal vein occlusion. Since then I've had an Forestine Angiogram: and a video of my retina - branch retina arterial occlusion - so they are having trouble telling the difference between the two. I still am being followed for my eye. They did a carotid ultrasound - my carotids are fine. I am due to get an echo cardiogram. I am taking baby aspirin mg for now - not sure if it's helping or not. It takes a year and a half to go away.
43 2021-03-27 fatigue, sweating, chills Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. L... Read more
Extreme fatigue starting day following the vaccination. Slept for three days nearly continuously. Loss of appetite. Did not eat for three days. Decreased cognitive functions. Sweats and chills (sometimes simultaneously)
43 2021-03-28 fatigue, chills, headache, sweating, throat pain 3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEA... Read more
3/13/21 - 3:00 PM. LEFT EAR ACHE 5:00 PM. ARM HURT WHERE I GOT THE SHOT. TOOK 2 ADVIL 9:00 PM. HEAD AND THROAT ACHE 10:00 PM. CHILLS AND SWEATS 12:00 PM. EYES WATERING 3/14/21 THROUGHOUT THE DAY. SWEATS AND CHILLS, WATERING EYES, HEADACHE, FATIGUE TOOK 2 TYLENOL EVERY 4 HOURS 3/15/21 8:00 AM - SLIGHT WATERY EYES. 9:00 AM - UPPER LIP BEGAN TO SWELL, TOOK TWO ALEVE 10:00 AM. UPPER LIP COMPLETLY SWOLLEN AND ON FIRE. TOOK 2 BENADRYL 11:00 AM. FATIGUE 12:00 PM. CHEST BEGAN TO TIGHTEN AND SHORTNESS OF BREATHE, TOOK 2 BENADRYL 4:00 PM. TIGHTNESS OF CHEST AND BREATHING WORSENED 4:30 PM. WENT TO EMERGENCY ROOM. 3/16/21 - 3/20/21. FATIGUE, SWELLING OF UPPER LIP, TIGHTNESS OF CHEST, SHORTNESS OF BREATHE 3/22/21 - PRESENT. TIGHTNESS OF CHEST, SHORNESS OF BREATHE
43 2021-03-28 fever, headache, chills Chills, fever, nausea, headache,
43 2021-03-29 chills, throat pain Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears. It's sometimes ... Read more
Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears. It's sometimes louder than other times. It is piercingly loud when exposed to loud noises. It started the day after the vaccine injection. Other events are: - Frequent headaches (every 2 or 3 days). They started the day of the injection and are current. - Sore throat. It started 2 days after the injection and has decreased in the last few days. - Dry throat and chills. They started a week after the injection and are current. - Soreness in the arm where injected. This has gone away. I visited my healthcare professional about this. No treatment was given. The healthcare professional decided that we'll have to monitor the symptoms for any changes. If the tinnitus gets worse or persists after a month, then it is suggested that I see an ENT (Ear, Nose, & Throat) doctor.
43 2021-03-29 sweating Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Syncope-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Bradycardia
43 2021-03-30 fatigue, chills, pneumonia, fever, malaise pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Ve... Read more
pneumonia; had an infection; getting really sick; Night sweats to chills; Night sweats to chills; Very fatigued; I was running 102-103 fever/very high fever; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer vaccine and ended up getting really sick and going into the hospital. They determined he had an infection and pneumonia. Things spiraled in the wrong direction. In the afternoon then by the next morning the patient was quite ill. He was sick for like 15 days. Temps for 102-103F. Night sweats to chills. Very fatigued. He would get better, then sick again, then better again and then ended up in the hospital. The events started on 20Feb2021. The patient was hospitalized for the events pneumonia, infection, and getting really sick from 07Mar2021 to 10Mar2021. The patient underwent lab tests and procedures which included body temperature: 102-103 fahrenheit on an unspecified date, investigation: unknown result on an unspecified date. Therapeutic measures were taken as a result of pneumonia, had an infection, getting really sick, i was quite ill, temps for 102-103f, night sweats to chills, night sweats to chills, very fatigued, i was running 102-103 fever/very high fever. Treatment for severe infection and Pneumonia : the patient had "a lot of injection going in his arm, they gave him fluids they gave medications, they tried to bring the Fever Down, they tried to bring the infection down to help clear out the Pneumonia." The outcome of the events was recovering. Information on the lot/batch number has been requested.
43 2021-03-30 fatigue, malaise Patient reports he has noticed over the past week increased shortness of breath on exertion--at base... Read more
Patient reports he has noticed over the past week increased shortness of breath on exertion--at baseline able to exercise with walking 45-60 minutes without dyspnea, however noticed over the last week getting some shortness of breath even walking to the garage. No chest pain, no fevers, chills, cough. He saw his PCP for these symptoms who ordered EKG and CXR 1 day PTA which per patient were normal--plan was for referral to cardiologist. However on the morning on presentation around 6:45 AM after taking an elevator for work he began feeling lightheaded and lost consciousness, awakening on the floor. He went home as he was not feeling well however proceeded to have another 2-3 episodes of loss of consciousness at home witnessed by his girlfriend--the later 2 occurred while lying down and were not clearly associated with any presyncopal symptoms.
43 2021-03-30 fatigue Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a cont... Read more
Fatigue Soreness in left arm; Fatigue Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 02Feb2021 at 06:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient experienced fatigue soreness in left arm. The patient did not receive any treatment for the events. The outcome of the events was recovering.
43 2021-03-30 sweating, cough 3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination s... Read more
3/31/2021: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, he experienced an adverse reaction with the following symptoms: Tingling and swelling of face and throat. Tightening sensation to the face including mouth. Sweating, with redness to the face. Mild nonproductive cough. Assessment : Time of assessment 0932am. Alert and oriented. Nurse assessed lung sounds, VS monitored for 30 minutes. Actions taken: assessment of face and mouth, no swelling seen, face is red and he has sweating forehead. Vitals sign taken at 0932 with BP- 185/131, P- 89. R-17 O2- 98% , Benadryl 12.5 mg liquid given po x 1, VS rechecked at 0937, BP - 190/134, P- 84, T- 98.4. R- 18, O2- 98%, Benadryl 12.5 liquid given PO at 0927. EMS on site due to another issue, assessed pts lung sounds and assessed for auditory stridor to neck, patient with slight cough, voices that he is feeling some better, he remains sitting in wheelchair. VS at 0947 , BP- 166/127, P- 82. O2- 98%, VS at 1002- BP_ 154/110, P- 85, O2- 96%. Medications administered: Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: 0932 and 0937. Administered by RN. Disposition:Reports swelling to face and mouth has improved, he is advised to follow up with PCP for elevated BP AND SYMPTOMS ASSOCIATED WITH VACCINE/ Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 3/31/2021 9:08 AM 0.3 mL 12/11/2020 Intramuscular
43 2021-03-30 fever Fever; light-headedness; joint pain (specifically, I could really feel pain 1/2 up my humerus, where... Read more
Fever; light-headedness; joint pain (specifically, I could really feel pain 1/2 up my humerus, where my bicep tendon is now attached by a screw); This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9809), via an unspecified route of administration on Left arm on 05Feb2021 12: 30, and then first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EU3248), via an unspecified route of administration on Left arm on 22Jan2021 12: 30 at single dose for covid-19 immunisation administered at workplace clinic. Medical history included Elevated cholesterol. The patient's concomitant medications in two weeks included Ibuprofen (Strength: 400 mg) at 400 mg[occassionally] and Vitamin D supp. On 06Feb2021 08:00, the patient experienced, Fever, light-headedness, joint pain (specifically, I could really feel pain 1/2 up my humerus, where my bicep tendon is now attached by a screw). No treatment was given. No Covid prior to vaccination. No Covid tested post vaccination. No Allergies reported. The seriousness was reported as non-serious. The outcome of the events was resolving. Information on the lot/batch number has been requested.
43 2021-03-31 fatigue, headache Asthma Attack, Muscle and Joint Pain, Headache, Fatigue
43 2021-03-31 fatigue, headache Shaking - cold, Nauseated, Headache, fatigue
43 2021-03-31 fatigue Approximately 4 hours after second dose, light nausea coupled with body aches and fatigue. Symptoms ... Read more
Approximately 4 hours after second dose, light nausea coupled with body aches and fatigue. Symptoms persisted for 6 hours, at that point nausea subsided. 22 hours after shot, fatigue and body aches persisted.
43 2021-03-31 lethargy, influenza like illness, malaise I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. M... Read more
I had soreness in the left arm initially. The morning after the vaccine, I woke up feeling sick. My body was achey and I felt lethargic and flu-like. I did not have fever. This largely cleared up by the evening.
43 2021-03-31 malaise, fatigue hot and cold, restless sleep the night of vaccination. Next day felt fatigue, sick
43 2021-03-31 fever, chills, headache 102 FEVER, HEADACHE, CHILLS, ARM SORENESS, BODY ACHES FOR 30 HOURS
43 2021-04-01 fatigue SORE ARM, PAIN IN THE LEG, ARMPIT, FATIGUE
43 2021-04-01 headache, sweating, fatigue Fatigue, sweating, headaches
43 2021-04-01 headache, fever, sweating, chills Muscle aches, joint aches, chills, fever, sweats, nausea, headache, lightheaded - 40 Hours
43 2021-04-01 headache I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem w... Read more
I got a severe headache/migraine soon after the shot and it lasted for about 72 hours. It did seem worse than usual and lasted longer than is typical, but it might have been a coincidence since I do get frequent headaches or might have something to do with the vaccine.
43 2021-04-01 sweating Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persis... Read more
Starting at approximately 08:45PM on the night of the shot 03/29 (6 hours after the shot) and persisting until about 03/31 between 2am and 4am, I had muscle aches and joint aches with occasional shooting pain in the elbow joints. My arm was also sore. The effect cleared up while sleeping. I had sweated enough to dampen my clothes and sheets. Upon waking, I felt fine.
43 2021-04-01 influenza like illness flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient... Read more
flu like symptoms; Severe Vertigo; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (Batch/Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included High Cholesterol and allergies: Latex from an unknown date and unknown if ongoing. The patient has no Covid prior vaccination. The patient was vaccinated in a hospital. It was reported that there was no other vaccine in four weeks. The patient previously received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via unspecified route of administration (lot number: EK5750) on 18Dec2020 09:30 AM at the Left arm for COVID-19 immunization. Concomitant medication included (also reported as Other medications in two weeks) omeprazole; lisinopril; and fenofibrate; all taken for an unspecified indication, start and stop date were not reported. It was reported that "3 days after 2nd shot I had flu like symptoms 4 weeks after 2nd shot, I developed Severe Vertigo while on duty, taken to ER and am still off duty because of it (5 weeks as of this report). I have followed up with PCP, ENT & Neurologist, all show no signs of ear infection or any trauma or damage that would set this off." The events were reported to occurred on 13Feb2021 at 02:15 am. The outcome of the events was not recovered. The events resulted in: Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care; Disability or permanent damage. Treatment was initiated which includes: MRI, MRA, CT, CT with Contrast, Vestibular Rehabil. The patient was tested for covid post vaccination (nasal swab) on 13Feb2021 with negative result.
43 2021-04-01 malaise, headache, sweating Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to n... Read more
Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles". Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.). A loud noise was heard and participant was observed laying out prone on the floor. Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands. After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down. Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby. Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak. Offered water to sip and by now lip no longer bleeding. When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well. Reported a h/o HTN but did not take his medication today...other history is unremarkable. Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility. Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
43 2021-04-02 fatigue At approximately 12:30 pm, I became dizzy while walking. I had to stop and steady myself from fallin... Read more
At approximately 12:30 pm, I became dizzy while walking. I had to stop and steady myself from falling. The event lasted approximately 5 minutes. After this event, I felt very fatigued for the rest of the day.
43 2021-04-02 headache Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all ... Read more
Severe arm pain, pain level 6, otc pain meds taken (muscle relaxer, Vicodin, Tylenol, ibuprofen all tried) Going on 2 weeks Pain spans from bicep, up to base of skull, down left side of mid back
43 2021-04-02 nasal congestion, fever, headache After a few hours of getting the second shot some fever minor headaches and a stuffy nose feel with ... Read more
After a few hours of getting the second shot some fever minor headaches and a stuffy nose feel with no mu us present, pain and swollen area of shot and also all my left side from head to toe started to hurt significantly to the point that a walk to the bathtroom was difficult. A few of the symptoms fade away after a few days but the left side swollen area on my leg still an issue not letting me continue my workouts, went to my doctor got a sonogram doppler no clots were found and they sent me home. Told me to rest and elevate my legs been doing that nothing has changed and a few minor headaches have made a comeback.
43 2021-04-03 fever, chills Fever with chills and body aches
43 2021-04-04 fatigue A phone call was made to the patient a couple days after his second vaccination and he reported that... Read more
A phone call was made to the patient a couple days after his second vaccination and he reported that he had experienced feeling hot, nausea and fatigue starting the night of his vaccination.
43 2021-04-04 sweating Very fast heartbeat. Sweating hands And a light dizziness
43 2021-04-04 fever Severe joint pain, fever sustained near 103, dry eyes throat, back pain.
43 2021-04-05 dehydration Client became dizzy and lightheaded in the observation area, "he was seeing stars". On exam, no evid... Read more
Client became dizzy and lightheaded in the observation area, "he was seeing stars". On exam, no evidence or symptoms of an allergic reaction. BP 70/50, O2 sat= 80%, Pulse=50. Skin= pasty gray. EMS was called due to low O2 sat and hypotension but client was not transported. No chest pain was reported. After 20 minutes, he felt better and BP responded to hydration with water. Skin color returned to normal. Wife drove client home. Client disclosed he recently lost 10lbs and though he was dehydrated. Advised to eat salty foods and drink lost of fluids. Assessment: vasovagal reaction secondary to vaccination, worsened by dehydration prior to clinic.
43 2021-04-05 fever, chills intense fever, chills, nose bleeds, dizziness going on 4 days
43 2021-04-06 fatigue Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tend... Read more
Next day fatigue, and brain fog. Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot). Swelling about the the size of a fist. 7 days later swelling remains, but reduced by 1/2 the size. Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot). Swelling is minimal, but collar bone discomfort. 6 days later since onset and collar bone discomfort remains.
43 2021-04-06 headache, fever fever of 102 and 103 even after 48hrs of the shot. and severe headache. Advil has no effect on headc... Read more
fever of 102 and 103 even after 48hrs of the shot. and severe headache. Advil has no effect on headche, temp is breaking down after taking meds. but keeps coming back.
43 2021-04-07 chills, fatigue, fever chills, fever, nausea, vomiting, fatigue
43 2021-04-07 chills, fever, fatigue Muscle/Joint Pain, Tiredness, Chills, Fever 100.5
43 2021-04-07 fatigue, headache Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth s... Read more
Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.
43 2021-04-07 headache, sweating Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache ... Read more
Reported onset of frontal headache before leaving vaccination observation area on 5 April; headache later resolved after taking Naproxen and has not returned. Patient also experienced feeling sweaty and clammy evening of vaccine receipt; did not measure temperature; no chills; symptoms did not interfere with sleep and were resolved upon awakening on 6 Apr.. On evening of 5 Apr and on 6 Apr, patient reported generalized achiness diminished after taking Naproxen; aching did not change much between 5 and 6 Apr (no worsening); no joint swelling, warmth, or redness. Also noted "rash" within 2-3 hours of vaccine receipt - not pruritic and only located in antecubital area of left (vaccinated) arm (review of photo showed round/oval, erythematous patch about 3x3, possibly Herald patch); no significant local vaccination site reaction of left upper extremity or axillary tenderness and swelling. Denied symptoms c/w immediate allergic reaction [any hypersensitivity-related signs or symptoms consistent with urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration On 8 Apr, patient reports all symptoms gone except red area on left antecubital, which seems to be getting better
43 2021-04-07 headache, fever, influenza like illness I woke up at 2am, with a fever, flu like symptoms, and a bad headache. I took a nap from 8-10am tha... Read more
I woke up at 2am, with a fever, flu like symptoms, and a bad headache. I took a nap from 8-10am that morning and woke up at 10am with repeating, recurring chest pain every 2-3 minutes, the pain would only last a second then go away. My BP and pulse were very high. This all continued through out the day. I went to a walk-in urgent care clinic around 4PM, and then to the ER around 6PM.
43 2021-04-07 sweating Flush, faint, sweaty and pale
43 2021-04-09 fatigue, influenza like illness, headache Severe headache, started about four hours after vaccination and continued for 72 hours. Including se... Read more
Severe headache, started about four hours after vaccination and continued for 72 hours. Including sensitivity to light and sound (with no history of migraines or head injury) Flu-like symptoms with body aches and extreme fatigue for 72 hours after vaccination. Currently scheduled for an abdominal ultrasound after recent blood work in April 2021 showed elevated renal values (no history of renal problems)
43 2021-04-09 headache Below and above normal temperature, headache, lower back ache, general body ache, nausea, insomnia.
43 2021-04-09 headache 44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension... Read more
44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min. Pt has hypertension and DM2. BP 178/96, HR 105, o2 98% RA BP 156/85, HR 100, 02 98% RA Pt states he feels better and ready to go.
43 2021-04-10 body temperature increased The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days la... Read more
The adverse event that led me to fill out this form: Temperature of 99.4, in the evening two days later; I measure my temperature daily in the evening and it's usually in the range 97.2-98.3. Temperature was normal the first two evenings. I also checked the following morning (today) and it's normal again. Other adverse events: Ache, soreness, etc in left arm, for about two days. Ache in left wrist, right after the vaccination; I'd had pain there the previous week. Muscle spasms in my left flank, not uncomfortable, just weird; intermittently for the rest of the day.
43 2021-04-10 headache, fever, chills Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection... Read more
Fever 100.5, chills, shortness of breath, severe muscle and joint aches, weakness. Pain at injection site.Headache.
43 2021-04-11 fatigue Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain... Read more
Shortness of breath, tight chest, burning sensation in the eyes, significant fatigue, and joint pain in all fingers, hands, knees, toes and neck.
43 2021-04-11 headache, fever, chills, sweating Headache. Nausea. Body aches. Low fever. Chills. Sweats
43 2021-04-11 sweating Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, ... Read more
Patient received dose at 1:19pm walked to OBs area, sat in chair. Started texting, noted weakness, c/o sweaty feeling, alerted staff. Placed in WC, back to Med Eval tent where he was diaphoretic, pale. Did not lose consciousness. Patient admits to not eating or drinking today at all, very stressed about vaccine. Drank a bottle of water, and gatorade, fan for air circulation. Patient recovered well on cot in supine position, walked out without incident. Likely vasovagal response without syncope. NP
43 2021-04-12 fatigue, headache, chills Severe exhaustion, headache, body aches, nauseous, chills. Everything but the nausea lasting for at... Read more
Severe exhaustion, headache, body aches, nauseous, chills. Everything but the nausea lasting for at least 5 days.
43 2021-04-12 fatigue, headache Sore arm, headache, very tired. No treatment. Started approximately 18 hrs after vaccination.
43 2021-04-12 throat pain, fever, headache, runny nose, fatigue, cough, chills At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor ... Read more
At around 10 pm on the day of vaccination, I started to develop a sore throat, runny nose and minor headaches. The following day, April 8, I had more severe symptoms. I had a pounding headache, body aches, chills, fatigue, low grade fever, sore throat, and a runny nose. I spent the day in bed and could not go to work. Towards the end of the day, my low grade fever had subsided, and my sore throat as well. Now I had a slight cough but still had minor chills, fatigue, headache, and body aches. I was able to sleep mostly, and by the following morning, April 9, I was only suffering from body aches, a cough, and a runny nose. I was able to attend work remotely but found my desire to engage in almost any activity very minimal. By that night, most evertything was returning to normal, though a runny nose was still present.
43 2021-04-12 throat irritation Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minut... Read more
Within 5 min of getting the shot my face became flush. That lasted for about 30 seconds. A few minutes later my neck became very itchy. This lasted for maybe a minute or two.. about an hour later my legs became very itchy. This lasted maybe a minute and was immediately followed by my face getting flush again. This also lasted about a minute. Maybe 15 minutes later the same two events repeated in the same order. Both again lasted maybe a minute. During this time there was a little bit of tingling around my lips. This came and went for a few hours. 15 or so minutes after the 2nd round of itchy legs/face flush, my throat became itchy for a couple of minutes. I did go to the urgent care and while was told by that doctor that as all of these had come and gone within a minute or so and that my breathing had not become an issue that I didn't need an epi shot and that I could just go home. I didn't experience any further allergic reactions, just the expected ones.
43 2021-04-13 chills, fever, headache Woke up ~14 hours post injection to moderate fever (101 F) , severe chills, and very severe aches ... Read more
Woke up ~14 hours post injection to moderate fever (101 F) , severe chills, and very severe aches and pains in joints and muscles. Struggled to get up and down a set of stairs and had to go one at a time including holding the handrail (~43 year old male in very good shape, lifts heavy weights and runs 2-3 miles 3-4 times per week) . Managed to fall back asleep and woke up ~2.5 hours later with the same symptoms , plus higher fever (102 F) and additionally mild nausea and a very bad headache. Took Tylenol and upon another 2-3 hour sleep had the fever more managed but dealt with the nausea, headache and aches/pains for the next 24 hours after that. Symptoms resolved after about 36-48 hours , although I did not feel 100% back to normal until about 72-96 hours after this 2nd dose.
43 2021-04-13 cough PFIZER-BIONTECH COVID-19 Vaccine EUA PFizer 2nd dose taken on 4/13 12:30 PM 4/14 around 11 AM had sh... Read more
PFIZER-BIONTECH COVID-19 Vaccine EUA PFizer 2nd dose taken on 4/13 12:30 PM 4/14 around 11 AM had shortness of breath / cough for 5-10 minutes 4/14 around 11:30 AM started seeing swelling on both left /right top Eye lids like a big sty.
43 2021-04-13 fatigue, chills, fever Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny tas... Read more
Nausea, vomiting, muscle aches, high fever, severe fatigue, chills, night sweats, shaking, funny taste, weird feeling lips
43 2021-04-13 headache, chills Initial soreness at injection site. Approximately 18 hours after injection, nausea, chills, severe h... Read more
Initial soreness at injection site. Approximately 18 hours after injection, nausea, chills, severe headache. No fever. Chills and nausea decreased in severity throughout the next 12 hours but body aches and severe headache persisted. Nothing taken to treat symptoms (no ibuprofen or acetaminophen) In conclusion: initial reaction began 18 hours after injection and lasted approximately 12 hours.
43 2021-04-13 headache, fatigue, chills, fever Fever, chills, fatigue & headache
43 2021-04-13 headache, fatigue Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarr... Read more
Hot Flashes, Cold Flashes, Fatigue, Muscles Aches, Headache/sharp pain down to right shoulder, diarrhea
43 2021-04-13 headache, fever Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness thr... Read more
Vivid Dreams Body felt like I was hit by a truck. Had trouble getting around. Pain and stiffness throughout body. This was at 3am At 6am when I woke up, I felt like there was a band around my right calf, and there was shooting pains through my left foot / ankle The second night, I woke up at 3am in a night sweat and feverish. Headache and vivid dreams.
43 2021-04-13 sweating Nurse was called to check on a patient in the vaccination area. Patient was given his first dose of ... Read more
Nurse was called to check on a patient in the vaccination area. Patient was given his first dose of Covid vaccine . He immediately stated he needed to lay on the floor. Patient was diaphoretic and pale. P. McGrath RN obtained vitals: 112/68, HR 62, pulse ox 97% room air. Patient's wife stated he has these episodes all the time. Patient stated he felt fine and wanted to get up. Patient was assisted up. VS rechecked 112/80, HR 66, 98%. Patient was given water and escorted to the monitoring area. Patient was monitored for an additional 30 minutes without further incident
43 2021-04-13 sweating Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with ... Read more
Cold sweats starting Thursday evening, Friday sweating at night, and Saturday morning ~6:00 am with chest pain and sweats. Pain intensified and brought to Urgent Care at 8 am where an EKG was completed and showed signs of a heart attack. Was rushed to Hospital Emergency room. Admitted and examined. Completed an angiogram and noted that there was a blood clot that appeared to dissolve. Troponin levels were high showing damage to the left artery. Spent the night in the hospital. Prescribed medication for cholesterol, blood thinners, and seeing a cardiologist.
43 2021-04-13 influenza like illness, fatigue Injection site pain (lasted for 6 days) Extreme fatigue (lasted for 2 days) Flu-like symptoms/body a... Read more
Injection site pain (lasted for 6 days) Extreme fatigue (lasted for 2 days) Flu-like symptoms/body aches ( lasted 4 days)
43 2021-04-14 headache Body aches, joint pain, bone pain, headaches, soreness at injection site
43 2021-04-14 sweating Dizziness, Lightheaded, Diaphoretic
43 2021-04-14 malaise, fever, sinus congestion Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waki... Read more
Malaise, sinus congestion, dizziness, mild fever (99.4 degrees F), increasing in severity since waking at 5:45 am April 15 Sore left arm, including some tingling along left forearm and back of left hand (diminished within a few minutes of waking)
43 2021-04-15 chills, fatigue Chills, Arm Pain, Fatigue, Muscle Soreness
43 2021-04-15 fever, chills, headache Fever 102-103F; chills; headache; pain on joints; dizziness; This is a spontaneous report from a con... Read more
Fever 102-103F; chills; headache; pain on joints; dizziness; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3245), via an unspecified route of administration at arm left on 11Feb2021 at 12:45 as single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at arm left on 21Jan2021 02:15 as single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL) for an unspecified indication. On 12Feb2021 the patient experienced fever 102-103f 12:30, chills, headache, pain on joints and dizziness. The patient underwent lab tests and procedures which included body temperature was 102-103 Fahrenheit. The outcome of the events was recovering.
43 2021-04-15 fever Fainting. It was sudden onset, I felt fine for 24h after the injection (and had no side effects to t... Read more
Fainting. It was sudden onset, I felt fine for 24h after the injection (and had no side effects to the first dose), then felt very suddenly dizzy and lightheaded, then passed out for a few seconds. After I came to, I was able to quickly catch my breath and recover with no additional episodes. Beyond this, I had a mild fever but no other serious adverse effects.
43 2021-04-16 sweating, fatigue One minute following the shot, began to experience rapidly increased heat and pressure from my chest... Read more
One minute following the shot, began to experience rapidly increased heat and pressure from my chest/breastbone area. Akin to having a heart attack with a feeling of a die pumped from a CAT scan. Sweating, dizziness, and rapid heart beat. Paramedics on site measured my vitals within 3 minutes and reported pulse over 100, BP at 160/100. This feeling gradually subsided over the next 15 minutes but the chest felt as if it was punched. Day 2 and day 3. Extreme fatigue and uncontrolled Heartburn. Was unable to quench heartburn that radiated through my neck, face, whole chest. Took 4000 mg of tums and Pepsid 20mg . Heartburn feeling persisted for 5-7 hours both days.
43 2021-04-16 throat pain, fever, fatigue, headache Headache, fever, painful joints, painful teeth, sore dry throat, brain fog, fatigue
43 2021-04-17 chills, headache, throat pain Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) i... Read more
Eustachian tube dysfunction; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears/ It was sometimes louder than other times/ It becomes piercingly loud and painful when exposed to other loud noises; Soreness at the injection site; Frequent headaches (every 2 or 3 days); Sore throat started 2 days after injection; Dry throat and chills started a week after injection and current; Dry throat and chills started a week after injection; This is spontaneous report received from a contactable consumer (patient himself). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration in left arm on 20Mar2021 at 16:00 (at the age of 43-year-old) as a single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Eustachian tube dysfunction and tinnitus (constant high pitch squeal) in both ears on 21Mar2021. It was sometimes louder than other times. It becomes piercingly loud and painful when exposed to other loud noises, started the day after the vaccine injection. Frequent headaches (every 2 or 3 days) started the day of the injection (20Mar2021) and current. Sore throat started 2 days after injection (on an unspecified date in Mar2021) and has decreased in the last few days. Dry throat and chills started a week after injection (on an unspecified date in Mar2021) and current. Soreness at the injection site on 21Mar2021 that went away after a few days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the event soreness at the injection site was recovered on an unspecified date in 2021, recovering for the event sore throat and not recovered for the other events. No follow-up attempts are needed. No further information is expected.
43 2021-04-17 headache, fatigue, dehydration, fever Fever of 103.5 Fatigue Headache Dehydration Diarrhea Foggy brain Itchiness
43 2021-04-17 fever, fatigue, chills Fever, Chills, Fatigue.
43 2021-04-18 fatigue, fever, chills Fever, chills, fatigue, fuzzy vision
43 2021-04-18 sweating Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer COVID-19 vaccine, pt complained of being dizzy and faint. Pt broke out in a sweat and complained of tingling down his left arm (site of administration was left deltoid) and into his fingers. Pt was instructed to lay down on his side and was given an ice pack to apply to his wrist for the sweating. He was also offered water and to call EMS, which was refused. At this time his blood pressure was checked reading, 102/63 pulse 62. Pt continued to be closely monitored for 30 minutes. During this time he was able verbalize symptoms and continued to complain of dizziness and generalized weakness. After 30 minutes pt sat up and waited an additional 15 minutes before he decided to stand up and at that time decided he was fit to leave. Another blood pressure reading was taken 110/64 pulse 67. He stated that a normal blood pressure reading for him was around 135mmHg systolic.
43 2021-04-18 influenza like illness, fever Intense flu like symptoms. Fever, body aches....enhancement of tinnitus.
43 2021-04-19 fatigue The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my... Read more
The same day, I was exhausted. It lasted 2 days. After that, on the 2nd or 3rd day after my shot, my right calf began to hurt. I knew it was connected to the vaccine, but I figured it would go away. Once the information came out about blood clots and my calf still hurt and didn't get better, I decided to go and get it checked out.
43 2021-04-19 sweating 1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched ... Read more
1110: Alerted that we had a medical patient. 1111: At patient side to find the patient wa slouched over and having snoring respiration?s. The patient appeared pale and diaphoretic. 1112: Contacted Safety Supervisor and also contacting 911. 1113: The patient was seated upright to open airway and asked if he could wake up. Patient was breathing on his own, eyes open, but not tracking. The patient was not responding to painful stimuli. 2 person lift assist to get the patient off the chair and laying on the floor. The patient then had seizure like activity, arms clenched at his side. 10 second passed by, the patient having minimal postictal phase, and the patient immediately sat upright, asking what happened. The patient informed mobile crew that he started to feel hot and dizzy before he started to dream. Vitals taken: BP: 110/54, HR: 40, R: 18, SPO2: 99%, CBG: 108. 1116: Patient care transferred to paramedic unit to transport to closest hospital.
43 2021-04-19 influenza like illness, chills No side effects with the exception of minor irritation at injection site, until 96 hours later, seve... Read more
No side effects with the exception of minor irritation at injection site, until 96 hours later, sever flu like symptoms, chills, nausea - which lasted around 1 day. Feeling much better at this point but the delayed response was unexpected. I'm fairly sure there wasn't another event that prompted the symptoms but anything's possible.
43 2021-04-19 fever, headache he developed fever and headache 1 day after vaccination, he was unable to move his hands and legs fo... Read more
he developed fever and headache 1 day after vaccination, he was unable to move his hands and legs for 1 day.
43 2021-04-20 fatigue, headache Day 1 - diarrhea x 2, Stomach upset, Headache, fatigue, short of breath with ambulation only, rash o... Read more
Day 1 - diarrhea x 2, Stomach upset, Headache, fatigue, short of breath with ambulation only, rash on left hand - dorsal aspect - pink - pinpoint - non itchy. Did not work (called in sick) Day 7 - Rash is less but present - itchy on day 6 and 7. Fatigue and headache continue. Shortness of breath with ambulation - subsides with sitting. Sleep is normal. Attending work as usual - other than days 1 and 6 - went home after 4 hours of work on day 6. Eating normal - bowels and bladder normal. Denies fever and chills.
43 2021-04-20 head discomfort, fatigue, headache extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where va... Read more
extreme fatigue; joint pain; muscle pain; nerve pain; hives; large red skin blotches on arm where vaccinated; Swelling in limbs; Headache; head pressure; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW6208), in left arm on 18Mar2021 04:30 PM (at the age of 43-year-old) at single dose for COVID-19 immunization. The patient's medical history included post-traumatic stress disorder (PTSD) and seborrhea. No allergies to medications, food, or other products were reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported, no other medications were received by the patient within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 18Mar2021 06:30 PM the patient experienced extreme fatigue, joint pain, muscle pain, nerve pain, hives, large red skin blotches on arm where vaccinated, swelling in limbs, headache and head pressure. The events were reported as serious since resulted in disability or permanent damage. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event as steroid pills, ibuprofen, aspercreme rubs and ice pack. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
43 2021-04-20 sweating, body temperature increased passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure an... Read more
passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure and ECG went low; This is a spontaneous report received via COVAES from a non-contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose via an unspecified route of administration, administered in right arm on 01Apr2021 10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin. Concomitant medication(s) included diphenhydramine hcl. Side effects started about 4 minutes after getting the shot. At first, the body temperature rose fast, and patient started sweating. Then, patient passed out, and both blood pressure and ECG went low. Patient was sent to the emergency room and released a few hours later. AE resulted in Emergency room/department or urgent care. Treatment included fluids. No Covid prior vaccination. No Covid tested post vaccination. The event outcome for events was recovered. No follow-up attempts are possible. No further information is expected.
43 2021-04-20 sweating Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded ... Read more
Patient while sitting in the post-vaccination area for 15 minutes, started experiencing lightheaded and faint when he got up. I instructed the patient to sit back down and he complied. I went to grab the patient water and calm him because he seemed a little anxious and then he started shaking, so we immediately called 911. I tapped him to see if he was okay, and he said yes was okay but really faint and the patient was sweating. I asked if he was having trouble breathing, but he denied. He drank the water and had chocolate and I kept conversing with him to assess for any physical/mental status changes, and during the conversation the patient said he usually feels faint and anxious when he gets blood drawn but did not mention it during the screening because he never has when receiving vaccinations. The patient was appearing to improve, less anxiousness, less sweating, and getting more color back to his face. When the EMS arrived within 5-10 mins, they assessed his vitals which were all normal and the patient requested not to be taken to the hospital. The EMT personnel felt the patient was doing okay and left. I had the patient stay for another 30 minutes to make sure he was remaining okay before he left.
43 2021-04-20 malaise, chills 8-10 hours of chills, body aches, and severe malaise. treated with tylenol.
43 2021-04-21 headache I had trouble after the shot, with a chronic headache that started a couple hours after the shot and... Read more
I had trouble after the shot, with a chronic headache that started a couple hours after the shot and wouldn?t break no matter what I took or did. I also had chest soreness and a reduced heart rate that started about 4 days after the second shot, which was similar to what I felt when I thought I had COVID in 2020 (my doctor denied my request to be tested and told me to just quarantine until my symptoms were gone for 48 hours). I tried everything to resolve my symptoms. I could get my heart rate up with vigorous exercise (mountain biking), and it would recover just fine, but the chest soreness and headache persisted. After a week, I called my doctor?s office to get in for an evaluation, thinking my thyroid medication needed adjustment. The doctor who saw me sent me to the ER because she had no answers as to the headache and very low heart rate, which kept dropping into the 30?s... normal is around 50 for me. She thought I could be having a heart attack. After 4 hours and a couple tests, the ER released me with no trouble found. I still had the headache, and slow heartrate with mild chest soreness. The headache subsided about 4 days later, and my heart rate returned to normal. The chest soreness continued for 4 weeks, and is still present, but slowly improving I think.
43 2021-04-21 malaise, chills, fatigue, influenza like illness, lethargy I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shiveri... Read more
I awoke at approximately 02:00 of the morning following the second dose, in a cold sweat and shivering so hard that I could not move (locked in a fetal position). This lasted about 30 minutes, after which I fell back asleep, exhausted. The next time that I woke up, I was walking into wall between the bedroom and the bathroom (I have no history of sleepwalking). For much of the remainder of the night I experienced multiple episodes of somnambulance, each time awakening when I ran into some object (bathroom counter, television, bookcase). The last time that I woke up, at approximately 07:00, I must have been standing and simply fell over; my head bouncing off the ground is what caused me to wake up. For the entirety of the day after vaccination (04/12/21) I felt as if I had the flu: chills (though no/very mild fever < 99 F) accompanied by shivering, sometimes convulsive; sore muscles; hyperalgesia (light touch perceived as painful); lethargic; strong sense of malaise; loss of appetite. As stated, this lasted for the entire day, through the time that I went to sleep for the night (2300). The next day, 04/13/21 I felt completely back to normal with the exception that some muscles were slightly sore, possibly due to the exercise of an entire day spent shivering.
43 2021-04-22 fatigue The next day after the second shot, my right foot got acute pain. I had some fatigue on my left fo... Read more
The next day after the second shot, my right foot got acute pain. I had some fatigue on my left foot on the day I took vaccine and I had got it examined by the doctor, He did. To find any issue on my left foot and suggested it might be a regular sprain. He also examined throughly the right foot and it was perfectly fine in the day time of vaccinations. The pain on right foot joints got so acute that I could not move out of my bed. I waited for two days hoping that the vaccine effect will go in couple of days.but it became unbearable. I saw my pcp and the blood work showed erratic inflammatory markers and unusable high glucose very low platelets and I was given steroid for six days. The inflammation was coming down when I was on med and bed rest, last Saturday my right heel started showing a new and sharp throbbing pain. I went the ortho and they found that possibly my burssaties sack is inflameated. The pain is so unbearable that I am, prescribed some opioid based pain killers, the PCP and hematologists had a discussion , I was told that I may be developing auto immune disorder. I never had a history of ITP. I am still hopi g it is a shock and body will calm down soon but I am on so much in pain and in a small place to get an immediate medical attention is so hard.
43 2021-04-22 headache, chills, fever Muscle/joint pain, fever, chills, nausea, shortness of breath, headache
43 2021-04-22 malaise, fever Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 da... Read more
Fever 101-103.4 / fever chills every day for 6 days. Neck pain with swollen neck lymph nodes x 9 days, Ringing in ears interrupted sleep for 1 month, had decreased some although continues to this day. Malays for 2 weeks. Vomiting for the first 4 days.
43 2021-04-23 fatigue, chills, headache Headache, fatigue, chills, general aches and pains
43 2021-04-23 fever, chills, fatigue Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swoll... Read more
Injection site pain Extreme fatigue Muscle and joint pain Earache Fever Chills Nausea Weakness Swollen lymph nodes 24 hours of moderate symptoms followed by mild lingering symptoms
43 2021-04-23 fever Fever overnight following the second injection. Lymph node swelling on left side of head and neck wa... Read more
Fever overnight following the second injection. Lymph node swelling on left side of head and neck was noticed the first morning along with a burning sensation along the scalp on the left side of head. Lumps formed under hair line on left side of head by second morning after the shot. Lymph nodes still swollen on left side of head and neck. Lumps on left side of head became tender to the touch by third morning after the shot. Sought help at "On Demand Care" on 10th day after Vaccine was given due to pain. The following issue was addressed by CNP: Herpes zoster without complication. Prescribed: acetaminophen, capsaicin and valACYclovir on April 23, 2021.
43 2021-04-23 runny nose At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to h... Read more
At first, my nose hairs were itchy, then I got runny nose. I sprayed Flonase, which didn't seem to help that much except to dry out my nasal passage. Then, I started feeling lightheaded in the same evening and somewhat disconnected from my body. Then, the next morning, and all day, I've been clumsy and uncoordinated.
43 2021-04-24 sweating, headache Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespons... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
43 2021-04-24 fever, fatigue Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in ... Read more
Fever, chills, body aches, fatigue, tiredness, injection site soreness, lump feeling like bruise in armpit.
43 2021-04-25 chills, fatigue Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my sec... Read more
Had minimum side effects during my first shot on 2/9/21 (lot # EL-9261). About 3 hours after my second shot on 3/2/21, the room was spinning wildly to the point I could not look at the ceiling, I may have started to have "brain fog" that night as well. 3/3/21 I had chills, no fever. 3/4/21 while talking to a coworker I experienced a "neurological event", I felt like I received a flash software upgrade to my brain, and things "paused" for a short amount of time. Later on 3/4/21 brain fog was significantly impacting me and it was hard to complete sentences and communicate effectively. From 3/2/21 to 3/ 3/7/21 I experienced brain fog, fatigue, dizziness, and chills (no fever). I was fine on 3/8/21. All 4 side effects came back on 3/24/21. I was having chills, no fever, early in the day then led a meeting in the early afternoon and could barely finish my briefing. I was having issues with fatigue, some dizziness, and brain fog. From 3/24/21 to 4/19/21 the side effects that mainly bothered me was dizziness/vertigo and some brain fog. Majority of time throughout this period the side effects were sporadic. I was able to function at 100% then wham, I was out of commission for 2-3 hours, then back to normal again for a multi-hour window. Hydrochlorothiazide worked well. I also took Meclizine with limited impacts. Also took a prednisone pack that took the edge off.
43 2021-04-25 fatigue Typical and expected side effects were fatigue for ~24 hours and soreness at the site of injection f... Read more
Typical and expected side effects were fatigue for ~24 hours and soreness at the site of injection for ~48 hours. In addition, the morning after the injection I woke up with a bright red face rash and draining on the left nostril, the left eye crusted shut with yellowish drainage, a red blister-like spot on the left lower eyelid, bloodshot eye, and swelling from the eyelid and down into the cheek. The swelling got worse after a couple of days, leading to medical treatment with eye drops and an antibiotic.
43 2021-04-25 fever, headache, chills 3 bouts of vomiting 99.8 degree fever Chills Headache All symptoms subsided around 8pm on Saturday
43 2021-04-26 chills, fever, runny nose, cough, fatigue Fever Bodyaches Chills Cough Runny nose Fatigue
43 2021-04-26 sweating Patient vaccine was administered approximately 1:50pm 4/27/21 and patient was asked to wait around f... Read more
Patient vaccine was administered approximately 1:50pm 4/27/21 and patient was asked to wait around for 15 minutes post vaccination. At approximately 1pm the patient's wife indicated he was not doing well. I went out into the waiting area to assess the patient and determined he was sweating and feeling light headed as though he may faint. After a few moments I had my technician call 911 to send an ambulance. While waiting for the ambulance the patient requested some orange juice and I did provide that. He did drink some of the juice. Patient never did faint or pass out and was conscious the entire time until EMS arrived and as they took him away to the hospital. Patient appeared to be feeling a bit better as time went on.
43 2021-04-27 nasal congestion, throat pain PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt report... Read more
PT called call center 4/28/2021. Verified pt with 2 identifiers. Pt denies emergency s/sx. Pt reports he got 1st vaccine Pfizer 4/14/2021 and ili symptoms; sore throat, nasal congestion, left back(pressure pain but not chest pain or SOB per pt) and both legs pain(weakness but pt is able to walk around in his house without difficulties per pt) since Sunday evening 4/25/20201. Pt said his temperature 99F at noon 4/28/21. Pt is taking tylenol, lozenges and resting a lot and it's helpful. Pt scheduled at 8:45 am 4/29/2021 @ urgent care for evaluation. Pt is educated covid vaccine side effect and flu. Pt agreed and verbalized understanding.
43 2021-04-28 chills, fever, fatigue Fatigue Fever Chills Dizziness when standing
43 2021-04-28 cough, throat pain, fever, respiratory tract congestion, runny nose, chills, headache Fever or Chills Cough Muscle or body aches Headache Sore throat Congestion or running nose
43 2021-04-28 fatigue, headache Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night afte... Read more
Mental and physical fatigue, headache, pain in both jaws and at injection site, sleepless night after shot due to headache and inability to get comfortable
43 2021-04-28 runny nose, nasal congestion Pt tested positive for COVID after full 2 dose vaccination series. Presented with symptoms of runny... Read more
Pt tested positive for COVID after full 2 dose vaccination series. Presented with symptoms of runny nose/nasal congestion. Exposed to children who tested positive for COVID.
43 2021-04-29 fever, chills, fatigue chills, fever, nausea, fatigue, body ache
43 2021-04-30 chills body aches and chills; body aches and chills; dizziness and nausea; dizziness and nausea; This is a ... Read more
body aches and chills; body aches and chills; dizziness and nausea; dizziness and nausea; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced body aches, chills, dizziness and nausea on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-04-30 headache, fever, lethargy Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a... Read more
Pain at injection site; Fever; Body aches; Headache; Weakness/lethargy; Weakness/lethargy; This is a spontaneous report received from a contactable consumer (patient). This 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8729) on 11Apr2021 14:15 in left arm at single dose for COVID-19 immunization. Medical history included high cholesterol, high blood pressure. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8727) in Mar2021 14:30 in left arm at single dose for COVID-19 immunization and after the first dose, experienced strong soreness at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After second dose, starting 12 hours after injection, on 12Apr2021 15:00, patient experienced pain at injection site, fever, body aches, headache, weakness/lethargy. Symptoms fully resolved 48 hours after injection. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on 13Apr2021. No follow-up attempts are needed. No further information is expected.
43 2021-04-30 fever, malaise Rash all over his body; Fever; Didn't feel good; itching; This is a spontaneous report from a contac... Read more
Rash all over his body; Fever; Didn't feel good; itching; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of bnt162b2 (Pfizer COVID vaccine, Formulation: Solution for injection, Batch/Lot Number: ER8734) via Intramuscular in Arm Left on 08Apr2021 13:00 as single dose for covid-19 immunisation. Patient medical history was not reported. The patient received first dose of historical vaccine, bnt162b2 (Lot: EN6204) in left arm on 18Mar2021 for Covid-19 Immunisation. The patient concomitant medications were not reported. Patient received second dose last Thursday. Next day, on 09Apr2021, got typical fever and did not feel good. Was fine on Saturday. Last night, Sunday evening, he woke up and had a rash all over his body. Feels fine otherwise. No fever now. Just has the rash. Had no fever since 10Apr2021. Rash was began on 11Apr2021 in the evening. He woke up and was wondering why he was itching on an unspecified date in Apr2021. He put some steroid stuff on and took Benadryl so the itching was not too bad after that. Confirmed the Benadryl and steroid stuff helped. Rash was from his neck down and on both sides, but not on his hands or feet. Was on pretty much the rest of his body, but not his feet, hands, neck, or face. The Clinical outcome of the event, itching was unknown, for events, fever, did not feel good was Recovered on 10Apr2021 and event Rash was Not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
43 2021-05-01 cough, fatigue, headache, respiratory tract congestion, fever Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on le... Read more
Extreme Tiredness, Headache, Muscle pain everywhere, Cold and Hot Flashes, Fever, Nausea, pain on left arm, congestion, coughing up mucus, and coughing.
43 2021-05-02 body temperature increased About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and fa... Read more
About 10 minutes after first dose (lot EN 6202, 2/25/21), briefly felt very flush in the face and faint. That passed quickly. Then had extreme burning sensation near injection site for about a minute. Did not report this at the time or before the second vaccine for fear of not being given the second injection. About 10 minutes after second dose, suddenly realized it was difficult to breathe. Removed mask. Started to feel better after a few minutes, replaced bottom, more breathable mask (did not report to observers). Was urged to leave vaccination site due to backlog of patients, so walked back to car. Began to feel pretty out of it (faint again, plus heart racing) on the way back to the car. Considered getting the shuttle back to the injection site, but instead sat in the car until it passed. About 25 minutes after the vaccine, started feeling very hot all over. 30-40 minutes after the vaccine, all reactions seemed to have passed and drove home without incident.
43 2021-05-02 fatigue, influenza like illness Extreme fatigue, flu like symptoms, bad rash almost like hives
43 2021-05-02 fever, chills Severe chills, high fever of 104 Aches and pains
43 2021-05-02 upper respiratory tract infection URI
43 2021-05-03 fatigue, headache, runny nose On the day of the injection, within a few hours I had some mild symptoms like light-headedness (head... Read more
On the day of the injection, within a few hours I had some mild symptoms like light-headedness (head rush when I stood up), and slight fatigue. It was the next day, more than 24 hours after the injection that symptoms became more intense. At that point I developed a bad headache with moderate nausea, as well as significant fatigue, and a little bit of runny nose. Now it is over 40 hours since the injection and my headache is not as bad, but I still do have a headache and mild fatigue.
43 2021-05-03 headache, body temperature increased I woke up with bodily/head aches and a strip thermometer indicates a positive reading for 102.5 Deg... Read more
I woke up with bodily/head aches and a strip thermometer indicates a positive reading for 102.5 Degrees fahrenheit.
43 2021-05-03 sweating Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, H... Read more
Pt had sudden onset of diaphoresis, pallor to face, left hand tingling and nausea @ 1135.BP 99/69, HR 78, RR 16, temp 97.8. Pt provided bottled water and consumed 2 bottles, tolerated well. Color returned to normal and no longer diaphoretic. Patient nausea and left hand tingling resolved.
43 2021-05-03 respiratory tract congestion, cough, runny nose, headache, throat pain Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where... Read more
Day of 2nd dose of vaccine received: mild soreness in shoulder, neck and back, around the area where the shot was given. Day after vaccine: lower than normal energy, but otherwise fine. Two days after vaccine: low energy, body aching, occasional cough. Three days after vaccine: similar symptoms of the previous day. Four days after vaccine: lower energy, body aches, coughing, persistent headache, eyes feeling tired and burning, and congestion starting in my chest, all worsened in the evening. Five days after vaccine: congestion in chest, regular cough, sore throat, runny nose, eyes feeling dry and burning, shortness of breath. Was tested for Covid on the fifth day after the vaccine. Six days after vaccine, chest congestion, coughing, sore throat, runny nose, shortness of breath, and still low energy. Covid test result came back as negative.
43 2021-05-04 cough cough
43 2021-05-04 influenza like illness Lymph node swelling in right armpit; Also experienced flu like symptoms; This is a spontaneous repor... Read more
Lymph node swelling in right armpit; Also experienced flu like symptoms; This is a spontaneous report from a contactable consumer reported for himself. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 08:45 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and allergy to eggs, fish and tree nuts. Concomitant medication was received (patient received other medications within 2 weeks). The patient experienced lymph node swelling in right armpit. It was about the size of a half-dollar four days after vaccination. Also experienced flu like symptoms. The events onset on 30Jan2021 at 7:00. No treatment was received. Outcome of the events was not resolved. This case was reported as non-serious. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
43 2021-05-05 headache, chills, fever Fever ranging from 99 to 103 degrees F onset 2 days after vaccination shot and last for 4 days, chil... Read more
Fever ranging from 99 to 103 degrees F onset 2 days after vaccination shot and last for 4 days, chills, muscle aches, headache, nausea, constipation
43 2021-05-06 fatigue, fever Fatigue, body aches, fever of 103, intermittent dizziness starting 5/6 am, all of which are signific... Read more
Fatigue, body aches, fever of 103, intermittent dizziness starting 5/6 am, all of which are significantly improved today, 5/7. By the evening of 5/6 he began having gross hematuria, which is still present. Mild bilateral CVA tenderness on exam.
43 2021-05-06 fever, chills Fever 102f for 13 hours and chills.
43 2021-05-07 headache, fever, fatigue The night after getting the vaccination I had extreme pain in the joints and muscles as well as head... Read more
The night after getting the vaccination I had extreme pain in the joints and muscles as well as headache and fatigue. The pain kept me from sleeping, and woke me up at night for several nights in a row. The joint pain didn?t completely subside for over two weeks. I was also very fatigued, sleeping 10 to 12 hours a night for two weeks. I normally sleep 7 to 8 hours a night. My muscles also felt weak and sore for over a week. Shot one messed me up bad. The first night I also had clammy feeling skin and a slight feverish feeling, although I didn?t take my temperature.
43 2021-05-07 fever Fever, muscular and all over body aches, worst symptoms I felt in the last 20 years.
43 2021-05-09 headache, fatigue No issues day of shot as far as headache, tiredness, etc. and nothing since shot. However, five days... Read more
No issues day of shot as far as headache, tiredness, etc. and nothing since shot. However, five days after shot began to develop a rash/hives. Started around front of neck and moved to chest, both upper arms, back, stomach. Have some on upper thigh and temples also. Has never itched. Contacted Dr. and sent pictures. Suggested cancel 2nd shot on 5/15. Being still have hives 10 days later and Benadryl did not help take them away went to Urgent Care. Was given Prednisone.
43 2021-05-09 malaise, headache client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client ... Read more
client received of 1st dose Pfizer Covid Vaccine approximately 1400. Ancillary signaled PHN client was not feeling good. Client sitting in chair, pale, stated feeling dizzy and seeing blurry. EMT began taking vitals at 1405: blood pressure 142/110, pulse 75, oxygen 98%. Per client had just received vaccine. Client able to transfer self to anti-gravity chair at 1407. Client asked for water, PHN advised to take small sips. Vitals 1410: blood pressure 140/110, pulse 77, oxygen 99%. Per client vision slightly better, dizziness same, new onset of headache and nausea. PHN gave client emesis bag. Per client no pertinent medical history, no current medication and no history of allergies. Per client does not know if he has hypertension, does not regularly follow up with provider. No history of vision problems. Vitals at 1415: blood pressure 138/110, pulse 75, oxygen 98%. Client stated feeling the "room was spinning", nausea. Vitals at 1420: blood pressure 138/108, pulse 77, oxygen 97%. Per client dizziness, nausea same, vision improving slightly. PHN asked client if someone would be able to pick him up, per client no one, he would drive home. Vitals at 1425: blood pressure 140/106, pulse 74, oxygen 97%. Client stated headache to temporal and occipital area. 1430 client stated feeling eyesight heavy. Client alert and oriented. Vitals at 1431: blood pressure 134/108, pulse 75, oxygen 97%. Per client when he moves head quickly is when dizziness worsens. Client denied history of vertigo. 1434 PHN offered client paramedics so client could be further evaluated, client denied. Vitals at 1435: blood pressure: 132/103, pulse 73, oxygen 97%. Per client blurry vision, nausea and dizziness same. Per client wanted to leave facility and go home. PHN advised client to stay longer in observation as symptoms had not resolved and he wanted to drive home. Client declined, stated he felt well enough to drive. PHN asked client to stand by chair to see check dizziness and if client could walk without complaints. Client was able to stand and take steps without assistance. PHN gave client ER precautions, asked client if he wanted to anyone else to pick him up and he declined. Client left facility with steady gait at 1441 against medical advise, symptoms had not resolved.
43 2021-05-09 fever Ear pain and ear ringing started the day after the shot, lasted the weekend (Sat/Sun) and went away ... Read more
Ear pain and ear ringing started the day after the shot, lasted the weekend (Sat/Sun) and went away for the most part during the week. However it returned 5/8-5/10. I also have a fever of 99.8 this past weekend. I don't know if I had a fever previously because I didn't check.
43 2021-05-10 fatigue Moderate fatigue and body aches started at about 10 AM the day after the shot and lasted about 2-3 h... Read more
Moderate fatigue and body aches started at about 10 AM the day after the shot and lasted about 2-3 hours
43 2021-05-10 headache Patient drinking beer prior to vaccination earlier in the day. Didn't eat. Felt dizzy with headach... Read more
Patient drinking beer prior to vaccination earlier in the day. Didn't eat. Felt dizzy with headache and noticed slurred speech. No other symptoms. Monitored and felt better < 20 minutes. Ambulating independently and had a ride home, able to leave after monitoring.
43 2021-05-10 malaise Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patie... Read more
Per patient: Patient received vaccine around noon on the 12 of March 2021 at Community Church. Patient states about 10 -12 hrs later, began an adverse cardiac event. Patient states the day before he injured his knee at work and went to ED from an injury the day before. At the ED they gave Fentanyl and he got sick and told the nurse that he was experience chest pain. Felt burning or falling asleep sensation in arm and chest. Told the nurse he felt like he was having a heart attack. They came in ED with crash cart and confirmed that he was having a heart attack while in ED. Transported from church to hospital.
43 2021-05-12 influenza like illness Severe Flu Like Symptoms
43 2021-05-12 malaise, fatigue Nausea, fatigue, sore arm, diarrhea, malaise
43 2021-05-14 lethargy Pt states they were "fine" prior to vaccine administration. Pt was given vaccination and then began ... Read more
Pt states they were "fine" prior to vaccine administration. Pt was given vaccination and then began to experience immediate partial hearing loss, dizziness and lethargy. Reaction went to assess pt and brought pt water. Pt transported to MO1 on wheelchair. MO1 received 2 sets of VS and both sets were appropriate for pt age and current state. Last vitals taken @ 1655: P: 76, R, 20, BP: 143/84, SpO2: 100%.
43 2021-05-15 sneezing Swollen & itchy eyes Sneezing
43 2021-05-16 fever, fatigue, headache received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon... Read more
received the first dose of Pfizer COVID-19 (Lot#: EN6207) in the left deltoid in the early afternoon of March 24, 2021. He immediately felt left hand tingling/numbness at his left thumb and first finger that has intermittently worsened with flexing his arm. There was no local reaction. The next morning, he experienced severe fatigue, headache, muscle aches/soreness, fever and mild chest congestion that resolved after 5 days. He also developed itching and hives that occurred from his chin downward on his neck, bilateral shoulders, back, chest and abdomen with no hives below his waist. He had photo showing erythematous blotchy rash scattered over this neck, anterior shoulders, chest and upper abdomen. The hives continued daily despite Claritin 10 mg daily and have gradually subsided. There was no nausea, vomiting, diarrhea, abdominal pain, dysphagia, swelling, cough, wheeze or shortness of breath. HIs last hives was 2 days ago and no hives today. Prior to the vaccine he was well without colds or flu-like symptoms in his usual state of health. He had not taken NSAIDs or other medications or supplements.
43 2021-05-16 fever, headache, chills Fever (100.7°) Chills Headache Joint Ache Light-headed I was instructed to report any side effects... Read more
Fever (100.7°) Chills Headache Joint Ache Light-headed I was instructed to report any side effects to this address. That's why I'm reporting these symptoms, which I know are expected side effects of the vaccine.
43 2021-05-17 malaise, chills, fever Fever; chills; malaise; vomiting; This is a spontaneous report from a contactable consumer (patient)... Read more
Fever; chills; malaise; vomiting; This is a spontaneous report from a contactable consumer (patient) via company representative. A 43-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 at the age of 43 years old (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation. It was reported that after Second dose of BNT162b2 vaccine (week of 12Apr2021), patient experienced fever, chills, malaise and vomiting on 12Apr2021 for 24 hours and symptoms resolved. Events took place after use of product. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
43 2021-05-18 cough, runny nose Severe cough, runny nose, hot flashes, pain in chest
43 2021-05-18 fatigue Body & joint aches, fatigue, swollen muscle under right arm pit.
43 2021-05-19 fatigue, headache Swollen armpit, headache, muscle fatigue and tired.
43 2021-05-19 head discomfort Migraines 5 days after 1st dose Head Pressure Tinnitus Headaches Brain Fog Eye Floaters
43 2021-05-20 malaise, chills, headache I had an extremely sore body and couldn?t lift my left arm over my head (I have some should problems... Read more
I had an extremely sore body and couldn?t lift my left arm over my head (I have some should problems anyway, but it made it worse). I had a slight headache, but it wasn?t too bad at that point (maybe about 9:30pm). By 12:30am I was feeling pretty crummy in a general sense and decided to go back to bed (I work nights and normally stay up, even on my nights off). I ended up with severe chills and shivering and shuddering by 1:30am. My legs were so restless and I was shuddering so hard I gave myself charlie horses. By 2:30am I started to warm up but because especially nauseated as I got warmer and warmer. I tried to sleep off and on, but ended up in a chair sitting up and dozing with a bucket in case of getting sick. I was panting heavily for some reason. It felt like it was making the nausea less severe (I also sipped on an Alka-Seltzer and took a meclizine). For three hours I was panting and trying not to vomit. Then I kind of settled down and got an hour or two of sleep, still extremely sore and by this time my head was pounding severely. I got up at 6:30am to take my Mirilax in orange juice (I forgot to mention I take a magnesium supplement and senna on a semiregular basis, as well). The combination of Mg, senna, and OJ didn?t sit well. By about 7:30am I began to get the chills again, but it only lasted about a half hour. Again, an episode of nausea after, but more Alka-Seltzer. I tried to eat small amounts of plain salty tortilla chips, but it didn?t help. It?s now 8:20am and the nausea seems to have passed.
43 2021-05-22 headache, cough, fever Difficulty injecting vaccine into muscle (person giving shot seemed to be having some issues). 16 ho... Read more
Difficulty injecting vaccine into muscle (person giving shot seemed to be having some issues). 16 hours after - moderate headache, pulsing and especially painful when bending over or moving quickly 24 hoyrs after- tightness, muscle spasms spreading from left lower back to right diaphragm. 40 hours after- fever (at first 99.8; 100.6 at 10:00 PM on 5/19, 101.7 at 10:00 PM on 5/20, 102.4 at 10:00 PM on 5/21, 103.2 at 10:00 PM on 5/22. 60 hours after - slight (mostly unproductive) cough with occasional faint bubbling/buzzing when laying down and breathing. From 30 hours later to 60 hours later- Ibuprofen 400 mg 5 times daily - some relief in fever, but very temporary After appointment with clinic: Acetaminophen 1 mg 3 times daily. Just started on 5/22- has not helped yet.
43 2021-05-22 fever, headache, chills Diarrhea within 5 hours, arm sore at 8 hours, fever (100.2), headache and chills and body aches at 1... Read more
Diarrhea within 5 hours, arm sore at 8 hours, fever (100.2), headache and chills and body aches at 18 hours. The fever kept increasing from 100.2 to 103.5 from hours 18- 36. At hour 36 the fever dropped to 100.7. I'm still fevering with a headache and body ache. It's now 53 hours after the shot. I also had covid badly for 28 days straight. It turned into pneumonia and bronchitis. My bout with covid and did 33 days before my vaccination.
43 2021-05-24 fever Presented to ER 5/9/21 with chest pain for 2 days. Noted fever day one and two after 2nd Covid Vacc... Read more
Presented to ER 5/9/21 with chest pain for 2 days. Noted fever day one and two after 2nd Covid Vaccine 5/4/2021. T max 102. Abnormal EKG with inferior and lateral TWI. Elevated Troponin, peak 9.69 ng/ml. Cardiac catheterization -Normal coronaries, mild hypokinesis anterolateral wall. Echocardiogram - normal. Diagnosis - Myocarditis
43 2021-05-25 fatigue Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in f... Read more
Pt. Had glucose level drops. Down into 60's with no previous issue with hypoglycemia, pale skin in face. Severe fatigue, low blood pressure readings of 112/60 and 110/90. Hot flashes and nausea. Non-coherent with glassy eyes with no awareness. Fluctuations in symptoms and slept for Three days in and out. Pt. Took approx. Three days to feel back to himself.
43 2021-05-25 sweating Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling i... Read more
Within 10 min after receiving the first dose of Pfizer Vaccine. Patient started sweating, tingling in his hands. His BP was low (98/60) Temp: 96.6.
43 2021-05-26 headache, fever Mild fever 100.2; headache; This is a spontaneous report from a contactable consumer or other non hc... Read more
Mild fever 100.2; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:45 as 2nd DOSE, SINGLE for covid-19 immunization at work-place clinic (43 year at the time of vaccination). It was reported that previously on 20Jan2021 the pa-tient had her BNT162B2 (Solution for injection, Lot number unspecified) via an unspeci-fied route at 1st DOSE, SINGLE for covid-19 immunization. The patient was healthy before the vaccination. The patient medical history was not reported. Concomitant medication included centrum vita-mints (biotin, calcium pantothenate, chromic chloride, colecalciferol, cyanocobalamin, dl-alpha to-copheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 05:00AM, the patient had his body temperature checked and results show mild fever 100.2 along with headache. The patient did not receive any treatment for the events. The patient also reported that since the vaccination the patient had not been tested for COVID-19. The outcome of the events was reported as recovered on an unknown date at the time of report. No follow-up attempts are possible. No further information is expected.
43 2021-05-26 sweating PATIENT STATES ABOUT FIVE MINUTES AFTER HE RECEIVED HIS VACCINE HE STARTED TO FEEL LIKE HE WAS GOING... Read more
PATIENT STATES ABOUT FIVE MINUTES AFTER HE RECEIVED HIS VACCINE HE STARTED TO FEEL LIKE HE WAS GOING TO PASS OUT. HE BECAME NAUSEOUS, DIZZY AND EXTREMELY DIAPHORETIC. HE DID NOT PASS OUT. HE JUST HAD SYMPTOMS. WE GAVE HIM SOME APPLE JUICE AND GRAHAM CRACKERS. HE WAS FEELING BETTER ALMOST IMMEDIATELY.
43 2021-05-28 headache The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swe... Read more
The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.
43 2021-05-30 sweating client had reported effects after 1st dose and medical team had approved for client to receive 2nd d... Read more
client had reported effects after 1st dose and medical team had approved for client to receive 2nd dose today. Baseline vitals: blood pressure 162/90, pulse 94, oxygen 97%. Within 5 minutes of receiving vaccine client reported feeling dizzy, nausea, and blurry vision. Upon arrival client sitting in anti-gravity chair, pale, with mild diaphoresis. Client alert and oriented x4. RN took vitals at 1610: blood pressure 140/80, pulse 85, oxygen 97%. 1613 client reported blurry vision had resolved. Vitals at 1615: blood pressure 150/85, pulse 82, oxygen 97%. Per client dizziness and nausea had also resolved, skin color normal for ethnicity. Client denied chest pain, shortness of breath, headache, palpitations. Per client history of hypertension but provider had removed medication years ago as it resolved. No allergies. Client reported not following up with provider after first dose or for regular check-ups. Vitals at 1620: blood pressure 170/110, pulse 79, oxygen 97%. Retake blood pressure 172/110. Per client "feels fine". Vitals 1625: blood pressure 168/118, pulse 84, oxygen 95%. Per client no symptoms at this time. PHN advised client to follow up with provider regarding blood pressure. ER precautions given. Per client would make appointment with primary. Last vitals at 1653: blood pressure 160/110, pulse 80, oxygen 97%. Client able to stand with no complaints of dizziness, blurry vision, or nausea. Client denied chest pain, palpitations, headache, blurry vision at this time. Client stated drove alone and felt fine to drive. Client left facility with steady gait at 1640.
43 2021-05-31 fever Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg... Read more
Pericarditis. Pressure in upper chest, trouble breathing, slight fever, rapid heartbeat. Given 800mg Ibuprofen 3 times a day for 5 days and doing much better.
43 2021-06-01 headache chest pain made him go to the emergency room because it was too much, it was multiple throughout the... Read more
chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time; his penis sensations are a lot different; has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen; when he falls asleep he wakes up in an hour; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; getting shocked in the middle of the night when he is sleeping- in his chest and intestines; limbs twitch; This is a spontaneous report from a contactable consumer. A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021), 1ST DOSE SINGLE via an unspecified route of administration, administered in Arm Left on 27Mar2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chest pain made him go to the emergency room because it was too much, it was multiple throughout the day not just one time, has had a bad headache where it feels like he has vibrating inside of his head, in his chest and on 31Mar2021, when he falls asleep he wakes up in an hour 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, getting shocked in the middle of the night when he is sleeping- in his chest and intestines on 31Mar2021, limbs twitch on 31Mar2021, his penis sensations are a lot different. It was reported that 5 days after he got the first dose of the COVID vaccine he started getting pains and the major thing is at night. If he falls asleep, he wakes up in an hour and that has been every night for a month and a half. That is the main thing that is pissing him off. He confirms that he is having issues with his chest and his intestines like he mentioned previously and he has started keeping track and has kept a journal of the pains. This stuff is new. He has never experienced this before and it has been happening every day starting 5 days after when he got the COVID vaccine. He had the COVID vaccine on 27Mar2021 and on 31Mar2021 he got the first shock in his chest at 0120 in the morning when he was sleeping. Then that went on for a week, he had it on 31Mar2021, 01Apr2021, 02Apr2021, 03Apr2021 and 04Apr2021 where he was getting shocked in the middle of the night when he is sleeping. On 04Apr2021 he had to go to the emergency room and have them look at him. But since 31Mar2021 he has been getting up every hour after he falls asleep. This was all worse when it first started because he has never experienced anything like this. The first shock he had was a hard feeling in his chest and then he couldn't go back to sleep. It is so bad. After he went to the emergency room, that is when it started being not as much of a shock pain that woke him up but he was still waking up every hour. The pains are in his upper chest and in his intestines. Also his limbs twitch and he has had a bad headache where it feels like he has vibrating inside of his head, in his chest and in his abdomen. He confirmed that these also began on 31Mar2021 and have been happening whenever they want and he has never experienced all of that before. Never. Everything has all stayed the same. The sad part is that he just thinks that he is getting used to this "new normal" because he is now going on the second month of this and his body is adapting but this is not normal. Also, he guesses that he shouldn't be shy now but the last thing is that his penis sensations are a lot different and he didn't notice until the first time that he was having relations with his wife after the COVID vaccine and it is all different. He noticed and she did too as far as whenever they were trying to have relations. It has been more than once, it has been every time they have tried afterwards. He says his doctor is going to send him to a sleep lab but he wasn't expecting that. He thought that maybe he would need to go somewhere else. But there he will go to sleep and be hooked up and they will read his whole body and tell the reason why he is waking up every hour. The outcome of the event headache, sleep disorder, chest discomfort, muscle twitching was not recovered and penis order, headache was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-06-06 fever, sweating, lethargy, fatigue, headache, chills Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, S... Read more
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
43 2021-06-07 headache, throat pain, chills, fever Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever;... Read more
Dryness in his throat/ extremely, extremely sore and dry throat; Headaches; Feeling terrible; Fever; Chills; Chest pain; Oppression in his chest that does not allow him to breathe normally/ pressure in his chest not letting him breathe normally; Sore throat/ extremely, extremely sore and dry throat; Chest pain is like a pressure; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 43-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 09:00 as 2nd dose, single dose (at the age of 43-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Patient mentions that yesterday (27May2021) he got the second dose of the Pfizer covid vaccine at 9 am and since then he had fever, chills, sore throat, chest pain like a pressure in his chest, oppression in his chest that does not allow him to breathe normally. On 28Feb2021, experienced dryness in his throat (extremely sore and dry throat), headache, feeling terrible. He wants to report the situation. Patient what should he do, does he need to go to a hospital. Communication included Advising patient to seek medical attention or the care of a doctor. The outcome of the events was unknown. No further information is provided or obtained. Information on lot/Batch number has been requested.
43 2021-06-09 sweating, headache, fever, chills Left chest pain similar to pericarditis in my medical history from 2005/06. Additionally, experience... Read more
Left chest pain similar to pericarditis in my medical history from 2005/06. Additionally, experienced body aches, headache, chills, fever and sweating episodes for several days.
43 2021-06-09 malaise, cough, chills, fever Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobil... Read more
Developed right neck swelling/adenopathy which spread to the left. Significant to impair neck mobility. Developed high fevers roughly 12 hours later with rigors. Was seen in the emergency department. Found to be febrile, significantly tachycardic (sinus) . Was given vancomycin, ceftriaxone empirically. Felt ill for the next 48 hours afterwards with weakness, slow to resolve tachycardia and cough. Neck swelling subsided however, right neck lymphadenopathy persisted for well over a month. Was sent home from ED with Bactrim and keflex for coverage of possible neck cellulitis. However, I do not believe it was a cellulitis. Neck was not tender, not indurated nor erythematous. I am a hospitalist and had colleagues take a look as well.
43 2021-06-09 paranasal sinus discomfort, headache Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued t... Read more
Quick onset photo and sound sensitivity, nausea, vomiting on 4/16 from 4/16 through 6/5, continued tinnitus and migraine symptoms (photo sensitivity and sound sensitivity, sinus pressure, intermittent headaches)
43 2021-06-09 fever 99 degree fever; This is a spontaneous report from a contactable consumer or other non-health care p... Read more
99 degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient. A 43-year-old male patient received BNT162B2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, lot number: En6204), Dose: 1 on the left arm via an unspecified route of administration on 16Mar2021 at 12:45 PM (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 3:15 PM, the patient experienced 99 degrees fever. As a therapeutic measure took Tylenol at home Prior to vaccination. The clinical outcome of 99-degree fever was recovering at time of reporting. No follow-up attempts are needed. No further information is expected
43 2021-06-12 influenza like illness, fever, sweating, headache, fatigue, chills Started out as strong flu-like symptoms for several days starting about 54hrs after first Pfizer inj... Read more
Started out as strong flu-like symptoms for several days starting about 54hrs after first Pfizer injection 5/26. Fever 101+, body termperature regulation out of whack (intense chills or sweating) body aches and soreness intense headaches and sharp pains in head. Aceteminophin and Ibuprofen alternated and symptoms would subside for a couple hours at a time. Into the second week still had more mild flu-like symptoms that have persisted to today, 18 days after shot. These include headahce, low-grade fever (99-100), continuous tiredness and fatigue, strong aches in lower back, and occasional sharp pains in head, aching behind eyes and occasional chest pain.
43 2021-06-13 headache, paranasal sinus discomfort Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure,... Read more
Vertigo, dizziness, on-a-boat feeling, headache, sinus pressure, brain fog, elevated blood pressure, elevated pulse. Most symptoms lasted for 6-9 weeks. Dizziness, on-a-boat feeling, occasional headaches continue still (3 month after)
43 2021-06-13 throat irritation Pt presented with an itchy throat and forearms approx 15 min post vaccination. Pt was given 25mg iv ... Read more
Pt presented with an itchy throat and forearms approx 15 min post vaccination. Pt was given 25mg iv benadryl. Pt stated that the benadryl helped but did not completely resolve the issue. Pt remained for approx. 30 minutes. Pt complained of chest discomfort. 911 was called. EKG was normal along with vitals. Pt refused transport and treatment. PT was advised to follow up with his PCP before his next shot.
43 2021-06-14 fever Chest tightness, shakiness, OFF balance (almost fell when trying to go to bathroom), Fever <100F,.
43 2021-06-18 chills I have suddenly started experiencing chills. No fever but consistent chills. Not sure why. It could ... Read more
I have suddenly started experiencing chills. No fever but consistent chills. Not sure why. It could be unrelated to vaccine but I have no way to know.
43 2021-06-21 sweating, chills, fever After 2nd dose following events occur deteriorating overall health. I don't have any preexisting hea... Read more
After 2nd dose following events occur deteriorating overall health. I don't have any preexisting health conditions. 1. On May 24th at around 12.15 am, I started experiencing 100 degree fever followed by chills. The blood pressure shot up to 165-95 and heart rate was around 140. Was feeling breathless and sweaty and was being rushed to ER . 2. On 30th May again experienced BP at 165-90 and pulse was at 150 and rushed to ER 3.Again on May 31st, BP shoot up to 170-90 and pulse 145 and ER visit. 4. Consulted cardiologist and on Metoprolol medicine 5. Always feeling dizzy and lightheaded with unprovoked rise in BP and pulse. 6.Unable to resume regular day to day activities including office work. 7. Daily fluctuation in BP and pulse observed till now since 2nd dose of vaccine.
43 2021-06-22 fever Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at ... Read more
Developed mild pain in the chest the day following the first vaccine dose, painful muscle cramps at arm/injection site, muscle cramps in feet, and very painful colon inflammation which made it difficult to move around. Also felt feverish for two nights after the injection but did not take temperature to confirm. All other symptoms and body inflammation appeared to have resolved with the exception of painful inflammation in the knees which appeared after all other inflammation symptoms at various other body sites dimminished.
43 2021-06-23 throat pain, upper respiratory tract infection UPPER RESPATORY, SORE THROAT, SWELLING IN THE BACK OF NECK, THRASH ANTIBIOTICS STEROIDS (PREDNAZONR)... Read more
UPPER RESPATORY, SORE THROAT, SWELLING IN THE BACK OF NECK, THRASH ANTIBIOTICS STEROIDS (PREDNAZONR), AUGMENTEN
43 2021-06-23 fever, pneumonia Fever, severe chest pain/throbbing of the chest area, heart arrhythmia. Fever began Thursday 5/13, w... Read more
Fever, severe chest pain/throbbing of the chest area, heart arrhythmia. Fever began Thursday 5/13, with the chest pain, throbbing and arrhythmia following early morning on Friday 5/14. 911 was called Saturday afternoon, 5/15. Was taken by ambulance to hospital, after which several tests were administered including a chest X-ray, blood tests, heart stress test, as well as an ultrasound of the heart/chest area. Stayed in hospital for from Saturday 5/15 to Monday, 5/17. Was released 5/17 at approximately 6:00 pm. Further treatments included prescriptions of Amoxicillin, Atenolol, and Ibuprofen.
43 2021-06-24 fatigue Fatigued; Lymph nodes swollen under arm pit; This is a spontaneous report received from a contactabl... Read more
Fatigued; Lymph nodes swollen under arm pit; This is a spontaneous report received from a contactable other health care professional. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 11Jan2020 in the Left arm for COVID-19 immunisation. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced extremely fatigued and lymph nodes swollen under arm pit. No treatment was received for the events. The outcome of the events was reported as recovering. Information about lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
43 2021-06-24 malaise shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feel... Read more
shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
43 2021-06-28 headache, fatigue tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stingi... Read more
tired / fatigue; headache; soreness; chest had a weird feeling like pressure, along with some stinging sensations localized; chest had a weird feeling like pressure, along with some stinging sensations localized; passed out while he was sitting and hit his head that left a bloody scrape; felt dizzy, hot, clammy; felt dizzy, hot, clammy; felt dizzy, hot, clammy; heart rate increased; felt anxious; passed out while he was sitting and hit his head that left a bloody scrape; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Lot Number: EW0178), dose 1 via an unspecified route of administration, administered in arm right on 11Jun2021 15:00 (at the age of 43-year-old) as single dose for covid-19 immunisation. Medical history included slight heart myopia, high tryglicerides that medicine was keeping at normal levels. No past drug history. Concomitant medication included atorvastatin and fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within 5 minutes of the injection (11Jun2021 15:05), the patient felt dizzy, hot, clammy, his heart rate increased and felt anxious, then he passed out while he was sitting and hit his head that left a bloody scrape. Then it took about 45 minutes to feel a little better. Then 24 hours later (12Jun2021) the patient really was tired, headache, fatigue, soreness, and his chest had a weird feeling like pressure, along with some stinging sensations localized. The outcome of events felt dizzy, hot, clammy, heart rate increased, felt anxious, passed out while he was sitting and hit his head that left a bloody scrape were recovering, the rest of events were unknown. No follow-up attempts are possible. No further information is expected.
43 2021-06-29 sleepiness, fever, fatigue Extremely tired; Extremely sleepy; Fever; Nauseous; This is a spontaneous report received from a con... Read more
Extremely tired; Extremely sleepy; Fever; Nauseous; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 43 years old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient previously experienced allergies to food, medications, or other products which is unspecified. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extremely tired, extremely sleepy, fever and nauseous on 20Mar2021 at 12:00. The patient did not receive any treatment for the reported events. The clinical outcome of extremely tired, extremely sleepy, fever and nauseous was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
43 2021-07-01 chills, body temperature increased Body aches; Chills; 101.9 temp; This is a spontaneous report received from a contactable consumer, t... Read more
Body aches; Chills; 101.9 temp; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine 5 mg (MANUFACTURER UNKNOWN) and valsartan 80 mg (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 14:00, the patient experienced chills, body aches and had 101.9 temp. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chills, body aches and 101.9 temp. The clinical outcomes of the events chills, body aches and 101.9 temp were unknown. No follow-up attempts are needed. No further information is expected.
43 2021-07-03 headache, chills Insomnia, chills, body aches, headache (next day, following sleepless night)
43 2021-07-08 nasal congestion, cough, throat pain, runny nose, cough, throat pain, nasal congestion, runny nose Symptomatic, started on 7/6/2021 with cough, runny nose, sore throat, & nasal congestion.
43 2021-07-10 fatigue, chills, headache I didn't have near the change in stamina after second shot; A hint of chill; Hint of a muscle ache; ... Read more
I didn't have near the change in stamina after second shot; A hint of chill; Hint of a muscle ache; Headache; The blurriness seemed to snap back once he got his second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0183) via an unspecified route of administration on 15May2021 as dose 2, single (age at vaccination 43-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0158) 1st dose on 24Apr2021 (age at vaccination 43-year-old), administered on left shoulder, for COVID-19 immunization. The patient experienced I didn't have near the change in stamina after second shot, a hint of chill, hint of a muscle ache, headache, the blurriness seemed to snap back once he got his second shot on an unspecified date. Caller is a consumer (43 years old, male) who is inquiring about additional information for revaccination following getting a complete 2-dose series of the Pfizer covid-19 vaccine. Caller reports when he received his first dose of the Pfizer Covid-19 vaccine, the needle was longer and then with the second shot, the needle was shorter. Caller reports with the first shot I could feel a very deep tissue injection. In my arm was deep tissue sore from my elbow to my shoulder and it hurt to move, but what took me aback was the vision issue. My energy level was depleted to negative levels, walking felt like my feet were stuck in cinderblocks, walking down the hallway took me 20 minutes to get down the hallway. I remember being on the text meeting for work and I'm telling them I'm at 35 percent now and if people say the second is worse than I need to take days off. My thinking was cloudy, felt unbalanced, legs felt weird like my feet were in someone else's shoes, no stamina, wanted to sleep, no energy. I was still quite tired with low energy the next day. A couple days after the shot I had a significant change in vision, was pretty much unable to read anything. If it was a certain point size I couldn't see it. I could see objects, driving wasn't an issue, but reading emails and newspaper were difficult. Thank goodness for the expandable screen on the iPhone. But then, my vision almost snapped right back to 90 to 85 % normal after second shot. It was definitely a shorter needle. Felt superficial, didn't hurt near as bad, effects more mild and were sort of spread out over a longer time. The first shot was compressed into 4 to 5 days. I was on my back for 5-7 days. I didn't have near the change in stamina after second shot. Just a couple days ago I started to feel like I can work out again. I had light symptoms: a hint of chill, hint of a muscle ache, headache, my vision popped back into place, they were a hint and then disappeared over a week and a half and now I'm feeling like I normally had been, but I am turning 44 next week so that might have something to do with. Caller states so it felt thicker with the longer needle, thought it was different substance deeper into the muscle. Caller states I didn't know if that was part of some instruction of which would come first or why it would be at different depths. Why would it feel thicker and feel deeper the second time enquired. The number on my card are different than other people's. I had the opposite side effects than other people had. I just want to make sure what they're doing is correct. Caller states again, I just want to make sure it was safe or if there was some other element I should know. Blurriness: His first shot was administered on 24Apr2021. Around the 27Apr2021, it was not immediate he had a Saturday appointment. This shot had him flat on his back, negative ability to do anything. The blurriness seemed to snap back once. He got his second shot. Ever since he hit 42. He doesn't if it was natural or it has do to with the thing. He was unable to see really up-close it could be he was getting older. Treatment: He was going to see an optometrist Feet could hardly move: Start: The evening of the 24Apr2021 around 11 o'clock. gone away to the real heaviness stopped around 29th the sluggishness and depleted amount of energy until the 07May2021.The patient underwent lab tests and procedures which included chest x-ray: clear on an unknown date, pulmonary function test: unknown on an unknown date. The clinical outcome for all events was unknown. Follow-up attempts are needed. Further information is expected.
43 2021-07-11 fatigue, fever, productive cough Fever, coughing up mucus, extreme fatigue, chest pain trouble breathing/respiratory infection
43 2021-07-11 fever, headache On July 1 traveling back from another state, developed headache and back ache on 7/3 developed fever... Read more
On July 1 traveling back from another state, developed headache and back ache on 7/3 developed fever 102. + test for COVID-19. Symptoms resolved by Mon 7/5
43 2021-07-12 headache swollen right armpit; redness around injection site which the skin was hot to the touch; headache; b... Read more
swollen right armpit; redness around injection site which the skin was hot to the touch; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the right arm on 25Mar2021 at 13:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the right arm on 04Mar2021 at 11:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 18:00, after the second dose, the patient experienced headache and body aches which started by the evening. On 27Mar2021, the patient experienced swollen right armpit and redness around injection site which the skin was hot to the touch. The patient continued to feel body aches. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body aches, swollen right armpit and redness around injection site were resolved on 28Mar2021. No follow-up attempts are needed. No further information is expected.
43 2021-07-12 sweating, headache Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything li... Read more
Kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/Suddenly all stuff fell off on floor, started reacting very bad; Blood pressure went down; Suddenly he started sweating/sweat the entire body; He started shaking his body head, hands and feet; Dizzy/Kind of fainted because he was not able to say anything; Slight headache on and off; Weakness; This is a spontaneous report from a contactable consumer (wife of the patient). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Apr2021, at 12:30, as dose 1, single (age at the time of vaccination: 43 years), for covid-19 immunization. Medical history was not reported. The patient concomitant medication included multivitamins (he just takes multivitamin) taken for an unspecified indication, start and stop date were not reported. The patient experienced kind of fainted because he was not able to say anything/severe pass out and couldn't see anything like everything was black/suddenly all stuff fell off on floor, started reacting very bad, blood pressure went down, suddenly he started sweating/sweat the entire body on 27Apr2021 12:45, he started shaking his body head, hands and feet, dizzy/kind of fainted because he was not able to say anything, slight headache on and off, weakness on 27Apr2021. The wife stated that, her husband took covid19 vaccination and it was his first dose. When he had his vaccine he came out and was sitting on the chair, as was asked to stay for 15 minutes. After 5 minutes of chitchat, he was just kind of holding some stuff, the paper they gave and water bottle and some stuff in his hands and suddenly all of the stuff fell off on the floor and he started reacting very bad to the vaccination and he started shaking his body head, hands and feet. Reportedly, the pharmacist was there and he came and asked the patient whether he need water or juice something and after few seconds he responded that he would have juice, but then again like second time the patient could not see anything like everything was black and got dizzy and kind of fainted because he was not able to say anything. Reportedly, within 5-10 minutes of vaccine, at 12:45 PM, the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body. The pharmacist was really not sure what to do for that. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Upon further inquiry, it has been reported that the patient was just having the normal side effects like slight headache on and off and some weakness. Reportedly, no other lab tests were done. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The seriousness criteria was reported as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: went down on 27Apr2021 within 5-10 min. severe pass out, Blood pressure went down. Treatment was reported as Monitoring of all the body in the hospital for the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body and no treatment was received for the rest of the events. The outcome of the events: the patient had a severe pass out and his blood pressure went down and suddenly he started sweating and sweat the entire body was recovered and recovering for the rest of the events.
43 2021-07-13 fever Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm... Read more
Patient called in stating his arm and top of shoulder are swollen and "bruised" from vaccine, no arm/back pain, felt like his blood pressure was raised and slight fever. Just discovered today that his back looks "bruised". Denied emergency symptoms, but states wants to be seen in person. Offered urgent care provider appointment 5/30/21, but declined, wants to go to emergency room to be seen in person.
43 2021-07-16 nasal congestion, chills, fever, runny nose Rash on chest and stomach. chills, night sweats, runny nose, stuffy nose, body aches, fever
43 2021-07-17 headache Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contacta... Read more
Mild headache; Mild nausea; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever. The patient was allergic to tree nuts. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the right arm on 02Mar2021 at 11:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 06:00, approximately 24 hours after second shot, the patient woke up with mild headache, mild nausea and sore arm at injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea and sore arm at injection site was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
43 2021-07-17 fever Body aching; slight fever; This is a spontaneous report received from a non-contactable consumer (pa... Read more
Body aching; slight fever; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7532, Expiration date: Unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 43-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The medical history was not reported. The patient concomitant medications included Paroxetine (PAXIL), start and stop dates were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198, Expiration date: Unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 43-years-old), as 1ST DOSE, SINGLE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 02:00, the patient had experienced body aching and slight fever. The patient received treatment with TYLENOL for the reported events. The clinical outcome of the events body aching and slight fever were recovering at the time of this report. No follow-up attempts are needed. No further information is expected. Follow-up (29Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information: country added in patient information, patient's details added, concomitant medication Paxil was recoded, allowed to contact hcp was updated as no, age and age unit was added in historical vaccine and lead and final sentence (Since provided allowed to contact as No) in narrative was updated. No follow-up attempts are needed. No further information is expected.
43 2021-07-19 headache Headache; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 43-y... Read more
Headache; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 31Mar2021 at 10:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm left on 10Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021 at 06:00 the patient experienced headache and joint aches. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not received any treatment for the adverse events. The clinical outcome of the adverse events headache and joint aches were resolving. No follow-up attempts are needed. No further information is expected.
43 2021-07-19 throat pain, fatigue, cough cough, sore throat, fatigue
43 2021-07-21 fatigue, fever On Saturday and Sunday I had extreme fatigue with a low fever. I had a swollen arm and some minor jo... Read more
On Saturday and Sunday I had extreme fatigue with a low fever. I had a swollen arm and some minor joint pains. Since then I have suffer from fatigueness everyday with some shoulder pains.
43 2021-07-22 headache Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in;... Read more
Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in; Felt a consistent heaviness orpressure in my lungs; Occasional shortness of breath.; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:30, the patient felt a consistent heaviness or pressure in lungs, occasional shortness of breath and minor nausea which was present at times. On the same day at 10:45, within 15 minutes of receiving the vaccine, the patient felt a pain in chest each time the patient breathed in which lasted for an hour. On 01Apr2021 and 02Apr2021, the patient had bad intermittent headache resembling a migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event felt a pain in chest each time the patient breathed in was resolved on 26Mar2021 in about one hour. The clinical outcome of the events occasional shortness of breath, minor nausea, bad intermittent headache resembling a migraine, and consistent heaviness or pressure in lungs were not resolved at the time of this report No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-26 chills, sweating Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old... Read more
Dizzy, rapid heart beat, nausea, ended of having a ?zombie like episode? according to my 10 year old daughter who was with me. Apparently I fainted but she described me as twitching and having my hands up and my head to the side with my eyes closed. I can remember a repetitive loop that I was experiencing. It was an image that was distorted and I could not control it and I could not get out of it I could hear my daughter but not control my actions. After I came to a few moments later my legs felt tingly and tired and were shaking like they had the chills. Was advised to go to hospital by EMS Still having very achy joints all over my body. Diarrhea, sweats/chills
43 2021-07-26 headache Patient experience headache after receving vaccine on 7/21/21. Took pain med (Tylenol alternating Ib... Read more
Patient experience headache after receving vaccine on 7/21/21. Took pain med (Tylenol alternating Ibuprofen 2 days after with no relief). 7 days later still have ache on right side of head along with pain in right side of eye and ear.
43 2021-07-26 sweating Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Med... Read more
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Patient received vaccine and 10 minutes later, he fainted. We sat with patient until emergency services arrived. Patient reporst history of fainting for the past 10 years and takes no medication. Patient was breathing normally and regained consciousness fully AxO x3 after recovering from fainting. Patient drank water. After emergency services arrived, patient began vomiting under their care. Patient ended up leaving with the emergency crew.
43 2021-07-27 fever, fatigue, chills, malaise, headache Fever,; Chilis/shivering; tiredness; headache; feeling unwel; hot flashes; muscle pain; This is a sp... Read more
Fever,; Chilis/shivering; tiredness; headache; feeling unwel; hot flashes; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the arm right on 31Mar2021 at 10:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included vitamin c [abscorbic acid] (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00 the patient experienced fever, chills, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain for 5 days with those symptoms. On 04Apr2021, the patient underwent a COVID-19 rapid test (Nasal Swab) and the result was Pending. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events Fever, Chilis, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain was recovering at the time of the report. No follow-up attempts are possible. No further information is expected.
43 2021-07-28 headache Hedheac (headache); This is a spontaneous report from a contactable consumer, the patient. A 43 year... Read more
Hedheac (headache); This is a spontaneous report from a contactable consumer, the patient. A 43 year old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 12:00(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 13:15 the patient experienced headache. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event headache was not recovered. Amendment: This follow-up report is being submitted to amend previously reported information: 1. Slider#2 reporter was removed since same as 1st reporter 2. in slide#1 reporter, State format updated 3. patient address added in patient tab 4. Vaccine Facility Information added No follow-up attempts are needed; information about lot/batch number cannot be obtained.
43 2021-07-28 malaise, sweating At around 1330 a few minutes after pt received 1st dose of Pfizer COVID vaccine he stated that he ne... Read more
At around 1330 a few minutes after pt received 1st dose of Pfizer COVID vaccine he stated that he needed to take off his mask for a little bit because he did not feel well. Pt states that he was having a tingling and numbing sensation on his lips and tongue. Pt denies having any SOB or difficulty breathing. He states that he has never had a bad reaction to a vaccine before. PT is diaphoretic and speech does sound slurred. PT denies any dizziness or faint feeling. He states that he is a little bit light headed. Pt is ok to sit in the chair. Dr. notified of reaction and came to immunizations clinic to assess. PT continued to have tingling sensation in his lips and continues to not feel good. PT was transferred to the ER via wheelchair at around 1355 pt was alert when transferred
43 2021-07-28 respiratory tract congestion C/O CONGESTION
44 2021-01-02 fever, chills, fatigue, headache Headache-dull/ site pain - at 12 hrs post injection Chills 18 hrs post injection Fever 38C - 30 hrs ... Read more
Headache-dull/ site pain - at 12 hrs post injection Chills 18 hrs post injection Fever 38C - 30 hrs post Injection Significant fatigue
44 2021-01-05 fatigue nausea, fatigue, disorientation
44 2021-01-05 headache, sinus disorder Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, si... Read more
Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; Back of Left eye hurts, sinus near left eye feels swollen, mild headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient started to receive BNT162B2 (also reported as " Pfizer COVID-19 Vaccine"), Lot number: EL0142, via an unspecified route of administration on 27Dec2020 18:45 at single dose (dose 1) in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Medical history included food allergies: shrimp. Concomitant medication included guaifenesin (MUCINEX). On 28Dec2020 06:00, the patient experienced back of left eye hurts, sinus near left eye feels swollen and mild headache. The outcome of the events was not recovered.
44 2021-01-06 body temperature increased, fatigue Started to feel tired the next day at or around 9 AM. At or around 1230, took temp for the first ti... Read more
Started to feel tired the next day at or around 9 AM. At or around 1230, took temp for the first time and it was 100.2 . Took again in two hours, the same. Took IBUPROFEN. At 430, took temp again, 99.6. Then took IBUPROFEN again 4 hours after 430. Went to sleep, slept through the night. Woke up and took temp, it was normal and was not elevated. No current concerns to note.
44 2021-01-06 malaise, nasal congestion, fever, cough General malaise, body ache, fever 38.1 C, mild cough, nasal congestion.
44 2021-01-06 fever Fever - 100.7
44 2021-01-07 fatigue, chills, headache, fever Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; v... Read more
Injection site soreness only first 24hrs.; fatigue; chills; fever of 99.8 F; body aches; headache; vomiting; Diarrhea; This is a spontaneous report from a contactable other health professional (patient). A 44-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose at right arm for COVID-19 immunization. Medical history included Asthma, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), omeprazole. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that injection site soreness only first 24hrs. At 30 hrs, fatigue, chills, fever of 99.8 Fahrenheit (F), body aches, headache, vomiting and diarrhea. These lasted for 24hrs. Diarrhea persisted for 48 hrs. To the best of his knowledge he had not ever been exposed to Covid. The events onset date reported as 23Dec2020 23:00 (pending clarification). Treatment received for the adverse event reported as "Called nurse line". The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.
44 2021-01-07 headache, fever Posterior headache, nape and upper back pain Low grade fever for about 18 hrs Armpit tenderness on... Read more
Posterior headache, nape and upper back pain Low grade fever for about 18 hrs Armpit tenderness on the side of injection
44 2021-01-07 headache, fever Headache, Myalgia, Fever, NauseaVomiting, Hand erythema and swelling Narrative:
44 2021-01-07 headache Headache, Myalgia, sore arm at injection site Narrative: phone call
44 2021-01-07 fever, fatigue fever 100.3, fatigue
44 2021-01-07 fever fever, flu symptoms
44 2021-01-08 body temperature increased INCREASE IN TEMPERATURE 2HR AFTER VACCINE ADMINISTERED. TEMP 100F AS OF 1100. PT WAS ADVISED TO GO T... Read more
INCREASE IN TEMPERATURE 2HR AFTER VACCINE ADMINISTERED. TEMP 100F AS OF 1100. PT WAS ADVISED TO GO TO ER IF SYMPTOMS WORSEN OR PERSIST. PT DIRECTED TO CALL CLINIC IN THE MORNING WITH AN UPDATE
44 2021-01-08 chills, fatigue, headache, sweating Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side ... Read more
Achey joints & muscles, fatigue, diarrhea, chills, sweats, headaches, sore left arm (injection side more sore than rest of sore body), pain & edema at injection site limiting shoulder range of motion for two days.
44 2021-01-08 headache Headache Narrative:
44 2021-01-09 chills, fever, fatigue Myalgia, Arthralgia, Fever, NauseaVomiting, chills, fatigue, , pain arm Narrative:
44 2021-01-10 nasal congestion Pt was observed for 15 minutes after immunization and reported no immediate symptoms. That night, th... Read more
Pt was observed for 15 minutes after immunization and reported no immediate symptoms. That night, the patient ate salmon and mashed pototaes at 630pm. He reports arund 930pm, he developed stomach ache and one episode of diarrhea. Patient reports subsequent mild constriction in his throat and acute nasal congestion. Patient also reported acute onset of wheezing. He initially took his albuterol inhaler and took a puff of of Dulera without symptom improvement. He administered epinephrine IM at that point with immediate symptom improvement. He reports nasal congestion and wheezing resolved. Patient monitored symptoms at home. He did not seek medical attention. Unsure if reaction was related to salmon or COVID 19 vaccine. Patient will be assessed in clinci for a formal salmon oral challenge in the clinic. Patient will receive the 2nd shot COVID 19 vaccine and will bring epi pen with him to the clinic.
44 2021-01-10 fever, headache Fever 100.3 Body aches Head aches Nausea Treatment: Naproxen and Tylenol
44 2021-01-11 headache Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved with... Read more
Dizziness-10 min post injection resolved within 60 min, headache-10 min post injection resolved within 60 min Rash, neck and chest area 50 min post injection resolved with 30 mg Claritin reditabs 90 mins post injection Body ache- few hours post injection resolved in 24 hrs Injection site/arm pain 20 min post injection resolved in 3 days Blood pressure increased to 170/100 30 min post injection resolved 60-90 min
44 2021-01-11 malaise extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple lin... Read more
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
44 2021-01-12 chills, headache, fever Headache, Myalgia, Chills/rigors, fevers (subjective), myalgia, headache for 8-10 hours, then less s... Read more
Headache, Myalgia, Chills/rigors, fevers (subjective), myalgia, headache for 8-10 hours, then less severe feeling feverish, chills, myalgias for 48 hours total
44 2021-01-12 fatigue onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/... Read more
onset of body aches, fatigue, tachyccardia a few hours after receiving his second vaccine dose on 1/8/21. onset of and L3 dermatome shingles on 1/10/21 pulse was 138 on presentation for evaluation 1/13/21. Hypertensive 170/80
44 2021-01-12 sweating Mild Tachycardia, small SOB, diaphoretic for 5 min, digits tingly , very dizzy
44 2021-01-12 influenza like illness, fatigue, fever, head discomfort Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next da... Read more
Arm soreness 1st day, 3pm next day body aches, weakness and fatigue, heavy head, fever 102. Next day, still experiencing fatigue and body aches but not as much. 1/12/21 feeling flu type symptoms again body aches, muscle, nausea, chills, severe sweating during night sleeping awoke several times . 1/13/2021 feeling flushed and sweating again while working, stomach cramps, nausea and then vomited x1. Tiredness and extreme fatigue, almost hard to walk, heavy head, chills, fever 100. Has taken Tylenol some relief
44 2021-01-12 fever, malaise, chills Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vom... Read more
Severe epigastric abdominal pain (cramping/boring, radiating to back) with associated nausea and vomiting - 4 hours Fever, chills, myalgia, malaise - 12 hours (treated with acetaminophen)
44 2021-01-12 fever Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 d... Read more
Fluid collection and discomfort of left axilla, no erythema, hematoma starting approximately 1.5 days after injection and ongoing. Also had low grade temp and dizziness that was self-limiting.
44 2021-01-13 chills Shivers, cold sweats, and body ache. Treatment: none. Outcome: mild improvement
44 2021-01-13 fatigue, headache, chills, fever Ache, chills, fatigue, headache. Fever of 101 at 7pm on 1/12/2021. Fever resolved by 11pm that nigh... Read more
Ache, chills, fatigue, headache. Fever of 101 at 7pm on 1/12/2021. Fever resolved by 11pm that nighr.
44 2021-01-13 headache Starting having headaches 2 hrs after 1st vaccination. Took Tylenol and it helped but headaches cont... Read more
Starting having headaches 2 hrs after 1st vaccination. Took Tylenol and it helped but headaches continued till 7-8pm.
44 2021-01-13 sweating Sedation diaphoresis Per ER report, effects were most likely not due to his vaccine, other causes.
44 2021-01-14 chills, lethargy Chills; aches; lethargy; This is a spontaneous report from a contactable other healthcare profession... Read more
Chills; aches; lethargy; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL0142 ), intramuscular in the left arm on 07Jan2021 18:15 at a single dose for covid-19 immunization. The patient had no medical history included. Patient has no allergies to medications, food, or other products. There were no concomitant medications. On 08Jan2021, the patient experienced chills, aches and lethargy. The outcome of the events was recovering on 08Jan2021 at 11:00. The patient was vaccinated in a hospital. Patient has no other medications received within 2 weeks of vaccination. Patient has not been diagnosed with COVID-19 prior to vaccination and has not been been tested for COVID-19 since vaccination.
44 2021-01-14 chills Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he ha... Read more
Symptoms - ? EE reports he woke up with chills and cold sweats, EE reports he didn?t feel like he had a fever, but no thermometer at his house. EE reports he bought a thermometer later in the day and temp was 98.7. Friday am, feelings of generalized achiness. Last day of work and shift - ? Monday Home remedies? - rest Any improvement? - mild Recommendation? EE encouraged to take ibuprofen as outlined in the Medical Directive. EE encouraged to continue to monitor his symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports he is not feeling well and is scheduled to work today. EE educated to manage his RTW according to the Illness in the Workplace policy. EE verbalized back understanding and denied further questions at this time.
44 2021-01-18 headache, chills Dizziness, severe headache, chills, nausea.
44 2021-01-21 fatigue About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate ... Read more
About 5 minutes after getting the vaccine injection my heart rate suddenly increased (My heart rate went back down to normal about 2 or 3 minutes after it initially increased), I was short of breath, and slightly dizzy. The night of and the next morning after the injection, I have been tired, my left arm of the injection site, left shoulder, and lower back have been aching. The next day after the shot, I have been unusually tired, also.
44 2021-01-21 fever, sweating 10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side ... Read more
10 min after vaccine-twitch in left calf, quad twitching, bicep, glute--only twitching on left side for first 30 min following vaccination Then after 30 minutes it switched to right side twitching (twitching not painful) Employee also had trouble breathing at that moment and was diaphoretic--Rapid Response Called VSS--employee returned to work Two hours later employee experienced diaphoresis, presyncope--went to Emergency Dept at this time--all labs and tests came back WNL 1/7: Fever 100, twitching continues (superficial) 1/7-14-superficial twitching throughout body 1/14-1/15?twitching seems to go deeper--in intestine, deep in LRQ 1/22 still having these twitches (not painful, just disturbing/odd)--Employee estimates these twitches happen 20x an hour
44 2021-01-22 fatigue, fever s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up t... Read more
s/p vaccination with 2nd Covid Vaccine dose, developed low grade viral type illness with fevers up to 102 with myalgias, fatigue. Began to recover, teh awoke in the morning of 1/16/20 wtih crushing, substernal chest pain. Presented to the emergency department. Was admitted to he hospital - diagnosed with myopericarditis. Stayed in the hospital one night, and discharged the next day.
44 2021-01-23 fatigue, chills, headache Injection site soreness, tiredness, headache, muscle soreness, chills, joint soreness.
44 2021-01-23 headache, malaise Received 2nd dose of the vaccine around 9:15AM and started to notice headaches and malaise in late a... Read more
Received 2nd dose of the vaccine around 9:15AM and started to notice headaches and malaise in late afternoon/early evening. The symptoms continued overnight and started to improve the next morning.
44 2021-01-25 chills As soon as I received the shot and went into the waiting area, I experienced a tingling sensation do... Read more
As soon as I received the shot and went into the waiting area, I experienced a tingling sensation down my right arm where the injection was administered. Throughout the 15 minutes the sensation began to radiate throughout my body and extremities. I waited about 20 minutes before deciding to leave the facility and proceed with my afternoon. Once I got home, I experienced chills, which I read on the pamphlet was an expected side effect. Both hands and feet were cold and I put on additional layers and lied on the couch and rested. During that time I began to notice the tingling sensation/paresthesia predominantly in the injected (right) arm, but also sporadically in other parts of my body including thigh (front/back), left arm, elbow, back, torso, neck, head, wrists, buttocks, etc. This sensation continued as I prepared for bed and continues as of this writing. It's difficult to say whether the sensation is getting better or worse, but it is consistent best described as someone pricking you every so often.
44 2021-01-25 fatigue After dose 2, extreme fatigue and muscle ache ongoing since the day after. Also, nausea for about a ... Read more
After dose 2, extreme fatigue and muscle ache ongoing since the day after. Also, nausea for about a week after the second dose.
44 2021-01-25 headache, fever Fever 100.5; myalgia; headache; nausea; This is a spontaneous report from a contactable physician (p... Read more
Fever 100.5; myalgia; headache; nausea; This is a spontaneous report from a contactable physician (patient). A 44-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:30 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) in the left arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 11Jan2021 19:00, the patient experienced fever 100.5, myalgia, headache and nausea. No treatment was received for the adverse events. Clinical outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
44 2021-01-25 respiratory tract congestion, headache Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing... Read more
Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing in am
44 2021-01-27 chills, lethargy, fever, fatigue At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excess... Read more
At approximately 2 AM, the next day, I started to have uncontrollable chills which results in excessive chattering of my teeth. I had trouble getting warm and had to utilize multiple blankets to gain heat, which is not normal. I was very warm and most likely developed a fever. I did not eat until 2 PM that day and the started feeling better later that night. I was forced to miss work to recover. I returned to work today, 1/28 but I remain tired and a little lethargic.
44 2021-01-27 sweating, fever Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestin... Read more
Little muscle twitches; felt muscle twitches really deep in his abdomen, almost like in the intestines; Low grade fever; Muscle soreness; Muscle tiredness; Hands were a little shaky; Very diaphoretic; This is a spontaneous report from a contactable other Nurse. This 44-year-old Nurse (Patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) at single dose for vaccination in Jan2021 around 9:45am. Relevant medical history included ongoing Mild shrimp allergy and ongoing Hypertension. Relevant concomitant drugs included amlodipine at 10 mg once daily for Hypertension since Feb2020 and ongoing. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to AE(s) was None. The patient was administered the COVID Vaccine around 9:45am; about 10 minutes later he had onset of little muscle twitches on the left side of his body that started in the calf then the glute, then the quadricep, then the bicep and then just started bouncing around everywhere on left side. Approximately a half an hour after that those little muscle twitches started on the right side of his body. Now the little muscle twitches are just everywhere; his hand, his heel, right now as he is speaking he is having the little muscle twitches in his heel; This event has been ongoing since onset; but changed today around 5:00am when he felt muscle twitches really deep in his abdomen, almost like in the intestines which is probably impossible, but it feels like it is not just muscular now, like it is happening in his intestines which concerns him. The little muscle twitches do not hurt, he thinks that is probably why he has waited a week to call; but the fact that they are ongoing and changed today, worsened is unsettling. He reported since that first dose of COVID Vaccine was administered he has also had low grade fever; muscle soreness; muscle tiredness. He reported that a rapid response team was called immediately because of the initial reaction he had. Later that day his hands were a little shaky, he got very diaphoretic and the nurses on the unit of the hospital said he almost fell which he does not recall at all; in response to those events he was taken to the emergency department where they did a complete workup including labs: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), checked his heart and everything was fine; no notable results from any of those tests. The patient was not admitted to the hospital; under observation in emergency room only. Outcome of events Little muscle twitches, Low grade fever, Muscle soreness and Muscle soreness was not resolved, outcome of other events was unknown. Information about lot/batch number has been requested.
44 2021-01-27 sweating Pt became pale, diaphoretic, dizzy and light headed. Pt moved to recovery area and laid on cot, vita... Read more
Pt became pale, diaphoretic, dizzy and light headed. Pt moved to recovery area and laid on cot, vitals done Pt after 15 minutes states he fell fine and left the area on his own power.
44 2021-01-28 chills, throat pain, malaise, headache significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 h... Read more
significant sore arm 48 hours body chills lasted 12 hours muscle pain lasted 48 hours headache 24 hours sore throat- 3+ days (still experiencing) generalized malaise for 3+ days (still experiencing)
44 2021-01-28 fever, fatigue Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wake... Read more
Fever/a temp of 101; feels something is different; intermittent minimal pain especially when he wakes up; Tachycardia; His CRP was up a little at 1.1; Nausea; Shortness of breath; Fatigue; Pain at injection site left shoulder; This is a spontaneous report from a contactable physician reporting for himself. A 44-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 28Dec2020, at a single dose on the left shoulder (arm left) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 28Dec2020. Since receiving the vaccine, he has experienced multiple side effects at varying time points: pain at injection site left shoulder (experienced pain first day of receiving vaccine on 28Dec2020 and couple of days after fever (unspecified date) resolved (on an unspecified date); he was currently experiencing intermittent minimal pain especially when he wakes up; feels something is different; fever (experienced 08Jan2021); fatigue (developed 07Jan2021). He went to the ER on 08Jan2021 when he developed fever, nausea and shortness of breath which also resolved that day. When he went to ER, his CRP was up a little at 1.1. His PCR and antigen test was negative at that time (08Jan2021); a retest of PCR done 5 days after sxs started (unclear of time window) was negative. He was concerned that he had the fever many days after the vaccine. HCP was asking if any cases of fever and fatigue reported after 7 days (around the 10 day mark) of receiving the first dose. He stated that he is planning on taking the second dose. The patient is a physician calling about the Pfizer covid vaccine. He received his first dose on 28Dec2020. He had a little bit of pain in his left arm on same day, but it went away. About 10 days later, 07Jan2021, he had fever and fatigue. On 08Jan2021, he went to the ER with a temp of 101. He had tachycardia, nausea and shortness of breath. He was not admitted, stated his fever was controlled and his breathing was better. His oxygen was 100% and everything was ok and he was sent home. In the ER he had xrays and labs and everything was ok, except his CRP was a bit up. In the ER he had an antigen and pcr covid test (08Jan2021) and they both came back negative. About 4 or 5 days after the symptoms started, he had an outpatient repeat pcr test and nucleic acid rapid test (unspecified dates) and they both came back negative. He is on his way to get his second dose and he is asking if the symptoms could be side effects from the vaccine. Outcome the event fever was recovered on an unspecified date. Outcome of nausea and shortness of breath was recovered on 08Jan2021, while outcome of pain at injection site left shoulder was recovered on 28Dec2020. Outcome of the remaining events was unknown. Information about lot/batch number has been requested.
44 2021-01-29 headache Pain in arm below injection site persists over 24 hours later. Strong headache few hours after that ... Read more
Pain in arm below injection site persists over 24 hours later. Strong headache few hours after that lasted hours, which is very uncommon for me
44 2021-01-31 fatigue Body aches, fatigue, upset stomach, dizziness, and light headiness.
44 2021-01-31 fever Jan 28. 2nd dose vaccine, sore arm at injection site. Slight fever at night. Jan 29. Still sore arm,... Read more
Jan 28. 2nd dose vaccine, sore arm at injection site. Slight fever at night. Jan 29. Still sore arm, temp 99.7F Jan 30. 8pm rashes all over the body and scalp. Fever 100.7F. Tylenol and Benadryl taken. Jan 31 went to urgent care. Possible rashes due to covid vaccine. Methylprednisolone prescribed. HEart rate 115-130s Feb 1 still with rashes temp 99.1 heart rate 100-120s
44 2021-02-01 chills, lethargy, fever Fever, chills, body aches, lethargy; strong onset approximately 11 hours after injection. Minor pa... Read more
Fever, chills, body aches, lethargy; strong onset approximately 11 hours after injection. Minor pain/redness at injection. Symptoms lasted 3 days, gradually improving after first day. Highest recorded fever ~101F via forehead scanner, but suspect higher the first night (did not record it) based on very strong chills and shivering. Multiple Fever Blisters/Cold sores after 2 days, treated with Abreva. Note there were no symptoms/side effects after first dose (Lot# EL3302, administered 01/08/2021).
44 2021-02-01 headache lightheaded, headache
44 2021-02-01 fever Myalgias Fever- 100.3
44 2021-02-02 headache bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) repor... Read more
bell palsy; Headache; rash; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 44-years-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 15Jan2021 15:30 at single dose in deltoid left for COVID-19 immunisation. Medical history included ongoing hypertension, Lactose intolerance, and lipids were a bit elevated on 14Jan2021. Family history included mother has diabetes and hypertension. The patient was allergic to Olives. There was no other vaccine in four weeks. Concomitant medication included ongoing lisinopril daily for blood pressure, ongoing colecalciferol (VITAMIN D) weekly, ongoing duloxetine to help with the blood pressure control, and ongoing Multivitamins daily. On Friday 15Jan2021 night around 11:00 PM he started experiencing headaches and rash. On Sunday night (17Jan2021) he experienced the bell palsy/Facial Paralysis and went to the ER. For bell palsy, the patient first had a shot of steroid, then was given oral Methylprednisonole and oral Famcyclovir. Treatment also received for headache and rash. He is still taking Still taking Methyl-prednisolone and the Famcyclovir and he will end these medications tomorrow. The patient had blood work on 14Jan2021 with normal result, lipids were a bit elevated. Events outcome was not recovered. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
44 2021-02-02 headache C/O lightheaded, headache, arm soreness, did not eat before taking vaccine
44 2021-02-03 headache, fatigue, sluggishness Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear any... Read more
Migraine; body aches; a headache; nausea; right ear became clogged, and today he can hardly hear anything out of his right ear.; sluggish; kind of tired/felt fatigued; The injection site was sore; This is a spontaneous report from a contactable consumer. This 44-year-old male consumer (Patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176) at single dose for COVID-19 immunisation on 19Jan2021. The vaccination was given at 08:15-08:30. He assumed the anatomical location of administration was the muscle in his left shoulder (left arm). Relevant history included back surgery with nerve impact. He was just a big guy. Family medical history was none. Relevant concomitant drugs included Gabapentin 600 mg due to back surgery with nerve impact for 2 years, and Generic cholesterol medication for High cholesterol for years. The patient received the vaccine on Tuesday morning (19Jan2021). He reported that he was kind of tired and the injection site was sore, but nothing significant. He experienced being tired and fatigued at 20:00 and progressively got worse, by Wednesday (20Jan2021), he was more sluggish. On 20Jan2021, he had a headache, nausea and body aches at 10:00. In the evening, his right ear became clogged/"clouded" or muffled, and on 21Jan2021 he could hardly hear anything out of his right ear at 17:00- 18:00. The tiredness got significantly worse on Wednesday, but it had improved on 21Jan2021. The headache lasted about 12 hours, but it was better. The nausea also started with the headache. It was persisting, but mild. The body aches progressively got worse and were gone at the reporting time. He took Treximet for Migraine around 14:00 on 20Jan2021. NO ER or physician's office required. Depending on what he finds out on 21Jan2021, he will go see someone. The outcome of events Tired and fatigued, Body aches, headache, injection site was sore was Resolving, the outcome of events Nausea, Right ear became clogged and can hardly hear anything out of it was not resolved. The muffled ear maybe even worse on 21Jan2021. The outcome of other events was unknown. There was no additional Vaccines Administered on the Same Date of the Pfizer Suspect. No history of previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations (within 4 weeks) was none. Relevant test was none.
44 2021-02-04 chills Lost taste Body and joint ache Shivering at first 2 nights Feel cold and hot.
44 2021-02-07 fatigue, fever, nasal congestion, headache I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost... Read more
I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost every day since the injection. I sleep at night, and wake up around 2am with sever chills, take 800mg Ibuprofen, and within an hour my chills break and I start feeling better. The process repeats itself in the afternoon and then again in the evening. I'm constantly tired and fatigued, and have been unable to exercise or work out since. I'm still experiencing the symptoms as of today.
44 2021-02-09 headache, chills, fatigue Injection site soreness; tiredness; headache; muscle soreness; chills; joint soreness; This is a spo... Read more
Injection site soreness; tiredness; headache; muscle soreness; chills; joint soreness; This is a spontaneous report from a non contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EL9261), via an unspecified route of administration on 22Jan2021 10:30 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Military Base. Patient age at time of vaccination was 44 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included chronic sinusitis. The patient has no known allergies. Concomitant medications included atorvastatin, ibuprofen (ADVIL), guaifenesin (MUCUS RELIEF), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A DAY). On 23Jan2021 20:00 the patient experienced injection site soreness, tiredness, headache, muscle soreness, chills, joint soreness. No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
44 2021-02-10 fever, fatigue, chills, headache Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache... Read more
Twelve hrs. after the second dose on 1/7/2021; I developed fever of 103 with severe chills, headache,bodyaches faligue,nausea,loss of appetite ,joint pain, unable to get out of bed due to weakness. Severe symptoms lasted around 24 hrs , better next day but persisted for another 24 hrs then fatigue lasted another 7-10 days
44 2021-02-11 fatigue Joint aches, fatigue
44 2021-02-11 fever Injection site muscle pain, arthalgia, & short course fever
44 2021-02-16 headache loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoheren... Read more
loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
44 2021-02-18 chills, headache Headache, chills, muscle ache
44 2021-02-20 headache, fatigue, chills Headache Chills Body aches Fatigue
44 2021-02-20 headache, fatigue The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I t... Read more
The night of the injection, I woke up with a 10/10 headache, tinnitus, and shortness of breath. I thought nothing of the shortness of breath as I am asthmatic. The next couple of days I felt completely drained, fatigued. Ten days later I have partial facial paralysis. I saw the emergency physician at the hospital who prescribed prednisone, acyclovir, over the counter eye drops, and an eye patch to wear at night.
44 2021-02-21 chills The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a ha... Read more
The morning after receiving vaccine I worked out lifting weights and jumping rope. After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.
44 2021-02-24 influenza like illness, fatigue, fever Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. S... Read more
Around 4 hrs after vaccine, he felt down and tired. that night he had worsening flu like symptoms. Since the vaccine he endorses having a fever, feeling tired and aches all across the body. He also complains of being dizzy and numbness of both his hand that developed since the vaccine. He has taken tylenol and it resolves all the symptoms, however he says that the symptoms return as soon as the tylenol wares of. Denies constipation, diarrhea, chest pain, SOB but endorses nausea. Suggested to contact PCP and to see a doctor, also advised that if symptoms worsen, he should visit an ED.
44 2021-02-26 headache My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensa... Read more
My blood pressure shot up to 155/105, I got flush, dizzy and had a headache. I had a tingling sensation around my nose and upper lip. Prior to this, my blood pressure had been in the 120's / 70's. I went to the emergency room and was sent home 4 hours later. I had headaches every day, multiple times a day, for the next 10 days and my blood pressure was fluctuating between 130/90 to 150/99 during that time. On February 25, my blood pressure dropped back down to 123/88 in the morning, but shot back up to 152/93 by the evening. My blood pressure continues to fluctuate from 124/89 to 146/106.
44 2021-02-28 sweating Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient had a near syncope event... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient had a near syncope event. They were diaphoretic. They were monitored by the EMS. No further intervention.
44 2021-03-01 runny nose, chills, headache small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My ... Read more
small heart attack; myocardial/paracardial issues.; My injection location had redness, hardness; My injection location had redness, hardness; pains in chest; headache; chill; running nose; shortness of breath.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 17:45 at single dose for COVID-19 immunisation at hospital. Medical history included coronary artery disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on unknown date for covid-19 immunisation. The patient did not have covid before vaccination. The patient experienced small heart attack and myocardial/paracardial issues on an unspecified date with outcome of unknown. These events were serious as life threatening, disability and requiring hospitalization from 21Feb2021 till 23Feb2021 at 14:00. On 20Feb2021 07:00 the patient experienced headache, chill, running nose, shortness of breath with outcome of recovering. The patient experienced also pains in chest on 21Feb2021 11:00 with outcome of recovering and injection location had redness, hardness on an unspecified date with outcome of recovering. Clinical course was as follows. 19Feb2021-5:45pm the patient went to receive vaccine shot. 20Feb2021 the patient had headache, chill, runny nose, and shortness of breath. 21Feb2021 11am still had shortness of breath and pains in chest. Went to clinic had a rapid Covid test come back negative, pain increased and he went to emergency room. The patient was admitted to the hospital with small heart attack and myocardial/paracardial issues. Inflammatory response seems to possibly triggered possible underlying issue of minor heart disease. Then induced heart attack and myocardial issue. The patient would gladly be admitted to a clinic for observation and testing to assist Pfizer in understanding this unfortunate situation. The injection location had redness, hardness. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment due to the event which included multiple lab tests, Angiogram, CR scan and pain medicine.
44 2021-03-03 fatigue, fever, headache, chills Sudden onset of fatigue followed by body aches, chills, fever 102.5F, night sweats, headache
44 2021-03-03 sweating, fever, fatigue 1. First COVID vaccine was received on Dec 30, 2020. 2. COVID symptoms begin on January 6, 2021. 3... Read more
1. First COVID vaccine was received on Dec 30, 2020. 2. COVID symptoms begin on January 6, 2021. 3. Positive COVID PCR test on January 7, 2021 4. Moderately sick from January 8 through January 19. 5. Cleared by employee health division to return to work on January 22. I inquired as to whether or not I should receive the second dose of the vaccine as scheduled, on January 22. I was told that it was safe. 6. Between 4-5pm on January 22, 201, I received my 2nd COVID vaccine. 7. At approximately 1am on January 23, 2021, I awoke dripping w/ sweat, fever of 102.2, and severe body aches. I took 800 mg Ibuprofen and 1g Tylenol at 4am. Neither helped w/ symptoms. At approximately 11am, I took 60 mg prednisone. Approximately 1 hour later, fever broke and body aches began to resolve. Mild soreness and fatigue persisted for approximately 24 hours.
44 2021-03-05 sleepiness I felt light headed, dizzy and I almost passed out approximately 20-25 minutes after the injection. ... Read more
I felt light headed, dizzy and I almost passed out approximately 20-25 minutes after the injection. I then took 1 tablet of Claritin in order to counter the reaction. I sat down outdoors, removed my mask and jacket so I could breathe better. I also ate a sandwich since I thought maybe I felt dizzy because I didn't eat a full breakfast. I stayed outdoors sitting down for 2 hours before getting up. I felt better after about 1 to 1.5 hours. However, as of March 6, 2021, sometimes I have a drowsy feeling like I'm on cold medication. However, I did not take any medication today. Also, for the 1st COVID vaccine I took on 11 Feb 2021, I took 1 tablet of Benadryl, which countered the allergic reaction which is why I did not have symptoms to report for the 1st dose.
44 2021-03-07 fatigue Arm and hand twitchy, extreme fatigue, double vision, mental confusion
44 2021-03-07 sweating Pale, diaphoretic (reacted this way in past with other vaccines) - placed in gurney. Juice provided.... Read more
Pale, diaphoretic (reacted this way in past with other vaccines) - placed in gurney. Juice provided. Vitals within normal limits.
44 2021-03-08 fatigue Soreness at injection site - started approximately 5 hours post vaccine - no treatments required G... Read more
Soreness at injection site - started approximately 5 hours post vaccine - no treatments required Generalized fatigue - started approximately 12 hours post vaccine - no treatments required
44 2021-03-09 chills, fatigue sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is... Read more
sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
44 2021-03-12 fatigue Pain and tightness in chest. Fatigue
44 2021-03-13 nasal congestion nasal congestion, throat tightness, hoarseness
44 2021-03-14 fatigue sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went n... Read more
sitting in car in 30 min line, got dizzy, thought was because of playing on phone, then mouth went numb, tongue swelling and lower jaw numbmess. Notified the MD's taken out of car had BP given claritin was being monitored and BP kept rising given epipen. The epipen helped felt swelling go down started to relax. Taken by ambulance to hospital. Treated with Steroid and benadryl and prevacid. No breathing treatments given epipens there and taken home prescribed. after he went home sore arm, dizzy, tired then symptoms started to come back took steroids and bendadryl which helped the reaction to go away. sx lasted 2-3 days. mild towards the end.
44 2021-03-14 headache, chills, fatigue a tender lump under my left arm in my armpit; Chills; headache; tiredness; This is a spontaneous rep... Read more
a tender lump under my left arm in my armpit; Chills; headache; tiredness; This is a spontaneous report from a contactable consumer for himself. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 10:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization at workplace clinic. The patient had no medical history and not had allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 14:30 (Lot number: EL3247) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has not taken any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient experienced chills, headache, tiredness the second morning after the second dose administered on 23Feb2021 the patient noticed a tender lump under his left arm in armpit on 25Feb2021 06:45. The reporter assessed the events as non-serious. The patient has not received treatment. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-14 headache Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient was feeling paralized. However, we can cleary see the patient moving all his extremities-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild
44 2021-03-15 headache, sweating Sweating Headache
44 2021-03-15 headache Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: dose 1-day 2-3-soreness inj si... Read more
Dizziness, Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: dose 1-day 2-3-soreness inj site; day 2-3 nausea; aches; dizziness; ha Other Relevant History:
44 2021-03-17 fatigue, fever About 12 hours after the vaccine shot I woke up feeling nauseated and had a fever. The fever lasted ... Read more
About 12 hours after the vaccine shot I woke up feeling nauseated and had a fever. The fever lasted about 8 hours but fatigue and body aches have continued now 15 hours after first sign of symptoms. I took exerting about 2 hours after the first symptoms and nothing else so far.
44 2021-03-18 headache, fatigue Headache, Arthralgia, Injection site pain, injection site erythema, Injections site swelling, Fatigu... Read more
Headache, Arthralgia, Injection site pain, injection site erythema, Injections site swelling, Fatigue Narrative:
44 2021-03-18 headache, fever Slight fever; soreness at the site of injection; headache; This is a spontaneous report from a conta... Read more
Slight fever; soreness at the site of injection; headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247, second dose) solution for injection intramuscular on 16Feb2021 at 10:00 (at the age of 44-years-old) at single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 26Jan2021 with no adverse effect reported. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID. On 16Feb2021, after the second vaccination, the patient experienced slight fever, soreness at the site of injection and headache. There was no treatment for the events slight fever, soreness at the site of injection and headache. The outcome of the events slight fever, soreness at the site of injection and headache was recovering. Since the vaccination, the patient has not been tested for COVID-19.
44 2021-03-20 fever, fatigue, chills I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night;... Read more
I have had off and on chills; sometimes fever; body aches; fatigue; tiredness; can't sleep at night; This is a spontaneous report from a contactable Other HCP. A 44-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302; dose number=2) via an intramuscular on 01Feb2021 at 14:00 at single dose for Covid-19 immunization. Medical history included colitis ulcerative and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. Also, the patient had covid-19 prior to vaccination. The patient had allergy to erythromycin. The patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EN9581; dose number=1) via an intramuscular on 11Jan2021 at 14:00 at single dose for Covid-19 immunization. Concomitant medications included famotidine, finasteride and omeprazole. As per the adverse event description, on 02Feb2021 01:00 AM, the patient had off and on chills, sometimes fever, body aches, fatigue, tiredness since the second dose. He can't sleep at night, because each night around 2am, he woke up with severe chills. He probably have a fever, but don't tested himself. He took 800mg of Ibuprofen and within an hour to his chills break. That usually lasts till midafternoon. Then he get the chills again, take more ibuprofen and wait for bed. He usually an active person, but have been unable to work out since the shot. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
44 2021-03-22 fatigue, headache Fatigue, weakness, red eye, headache, hot flashes, nausea, stomach pain
44 2021-03-22 sweating P found in car sweaty, pale. VSS. No breathing difficulty, weak. hx of anxiet and passing out with ... Read more
P found in car sweaty, pale. VSS. No breathing difficulty, weak. hx of anxiet and passing out with shots. 911 called. vss. pt tried to stand causing sx to return. pt transported to hospital via ambulance.
44 2021-03-23 fever Myalgia, low fever
44 2021-03-25 headache, chills Arthralgia, NauseaVomiting, NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN Narrative: NAUSEA, HA, C... Read more
Arthralgia, NauseaVomiting, NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN Narrative: NAUSEA, HA, CHILLS, KNEE, HIP AND HAND PAIN after 2nd Covid Pfizer vaccine
44 2021-03-27 fatigue Tiredness, body aches, discomfort in lungs, brain fog (15 days, acetaminophen)
44 2021-03-28 headache, chills Severe headache, chills, body aches, swollen lymph nodes
44 2021-03-29 headache After arriving at the observation area, patient complained of a headache, has no other symptoms. BP ... Read more
After arriving at the observation area, patient complained of a headache, has no other symptoms. BP on arrival 148/79, hear rate 82. Sufffers with headaches from time to time. Advised to remain for 30 more minutes. BP 15 mins later, 135/83 and at 10:08 125/76- felt better, headahce resolved.Advised to seek medical support if he becomes unwell later in the day. Patient verbalsed understanding.
44 2021-03-30 headache Injection site soreness; headache; body aches; This is a spontaneous report from a non-contactable c... Read more
Injection site soreness; headache; body aches; This is a spontaneous report from a non-contactable consumer, the patient. This 44 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) , single dose, dose 2 via unknown route of administration in the left arm on 16Feb2021 at 13:30 (at the age of 44 years-old) for COVID-19 vaccination. Medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 26Jan2021 at 2: 15 PM. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient was not on any medications in two weeks. On 16Feb2021 at 16:00, the patient experienced injection site soreness, headache and body aches. No treatment was received for injection site soreness, headache and body aches. The clinical outcome of injection site soreness, headache and body aches was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
44 2021-03-30 nasal congestion, throat pain sore throat; nasal congestion; very difficult to breath; This is a spontaneous report from a contact... Read more
sore throat; nasal congestion; very difficult to breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 16:00 as SINGLE DOSE for covid-19 immunisation. There was no other vaccine in four weeks. No known allergies. The patient medical history was not reported.Concomitant medications included atorvastatin and Irbesartan, both taken for an unspecified indication, start and stop date were not reported. The patient started with sore throat that got progressively worse and nasal congestion. The 2 combined made it very difficult to breath. The events onset date were reported as 14Mar2021 05:15 PM, they resulted in Emergency room/department or urgent care. Patient received Benadryl, Pepcid and IV for treatment, and recovered in Mar2021. Patient didn't have Covid prior vaccination nor teasted Covid post vaccination. Information about lot/batch number has been requested.
44 2021-03-30 paranasal sinus discomfort, fatigue 03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADE... Read more
03-31-2021 COVID-19 PCR POSITIVE, PT REPORTS SINUS PRESSURE, TIRED, DECREASED ENERGY AND LIGHT HEADED. PT STATES HE COMPLETED THE COVID-19 VACCINE SERIES. PRIME DOSE 12-30-2020 AND BOOSTER DOSE 01-20-2021.
44 2021-03-31 headache, chills Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. B... Read more
Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. Began 9 hours after injection. Rash on both forearms within 4 hours. Headache and body aches same time as chills.
44 2021-03-31 headache Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for... Read more
Unsteady feeling in my head and body, like a shaky feeling and headaches. Been experiencing this for almost 3 weeks now.
44 2021-03-31 sweating, malaise After dose administration, while waiting during the 15 min observation period, the patient stated th... Read more
After dose administration, while waiting during the 15 min observation period, the patient stated that he did not feel well. The pharmacist asked the patient to have a seat and applied a cold, wet towel to the back of his neck. While seated the patient became pale, began sweating and became unresponsive for about 10- 15 seconds. After the 10-15 seconds the patient began to rise up and response to his name being called. 911 was called and the patient was evaluated for vitals. The patient declined hospital transfer and waited for his with to pick him up.
44 2021-03-31 sweating Nnurse was called to assist a patient that had left the monitoring area. Upon arrival, patient was s... Read more
Nnurse was called to assist a patient that had left the monitoring area. Upon arrival, patient was sitting in mall with back leaning on wall. Patient was AAAx3. He was pale and diaphoretic. Patient stated he waited his 15 minutes and felt fine. Patient received dose 1 of Pfizer Covid Vaccine (Lot #EN6207, Exp 5/31/21). When he was walking back to his car he "blacked out" and fell to the floor. Patient stated he hit his head on the ground. No visible injury to back of head was observed. Patient reported he did not eat or drink anything prior to coming. He stated it was warm in the mall and he was having difficulty breathing with the mask on. Patient was instructed to take his mask off. VS were assessed: 98/68, HR 82, pulse ox 98% room air. Patient was given water and some chocolate. Patient stated he started to feel better. Patient was assisted into wheelchair and continued to be observed. Patient stated he initially started to feel better, but then felt lightheaded again. VS reassessed @ 0948 BP 92/64, HR 72, pulse ox 98% room air. This nurse advised patient EMS should be called for further evaluation. Patient refused and stated he did not want to go to the hospital. Nurse again advised that his blood pressure remained low and he should be further evaluated. Patient continued to refuse. Patient was advised to call someone for a ride home as it was advised he should not drive at this time. Patient called his father for transport home. Patient was given a sprite to drink while waiting for his ride. Patient was accompanied by monitor until ride arrived. Patient was picked up and left without further incident.
44 2021-04-01 headache Headache, body aches, mild nausea
44 2021-04-02 headache, fatigue Fatigue, Increased heart rate, Nausea, Vomiting, Headache
44 2021-04-02 fever, cough, fatigue, respiratory tract congestion, headache, fatigue, fever, nasal congestion, cough, headache Patient reported COVID-19 like symptoms including fever, cough, fatigue, headache, muscle aches, and... Read more
Patient reported COVID-19 like symptoms including fever, cough, fatigue, headache, muscle aches, and congestion
44 2021-04-03 fever, malaise, chills Low grade fever 100.2; chills; malaise; This is a spontaneous report from COVAES. A 44-year-old male... Read more
Low grade fever 100.2; chills; malaise; This is a spontaneous report from COVAES. A 44-year-old male contactable consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 13:30 as single dose in left arm for covid-19 immunization. The patient medical history included mild food allergy to soy and tree nuts. Historical vaccine included bnt162b2 on 03Mar2021 (at 13:00 PM, vaccine location=Left arm, dose number=1, lot number=EL3247). Concomitant medications included cetirizine hydrochloride (ZYRTEC) from Mar2021 and multi vitamin. On 24Mar2021 at 21:00, the patient experienced low grade fever 100.2, chills and malaise. The patient did not received treatment for the events. The outcome of the events was recovering Information on the suspect expiry date has been requested.
44 2021-04-04 fever, chills Starts at 12 hour mark then I get fevers, then cold chills and then vomiting
44 2021-04-05 fatigue, chills Fatigue, chills, swollen lymp nodes in neck,
44 2021-04-05 malaise Loss of appetite, malaise, nausea, falls, mental fog, death.
44 2021-04-05 sleepiness, headache, nasopharyngitis, throat pain I had Eye allergies issues with gritty feeling in the eyes, swelling, burning sensation, and watery... Read more
I had Eye allergies issues with gritty feeling in the eyes, swelling, burning sensation, and watery eyes. Also had sour throat and cold symptoms after the vaccine with headache and drowsiness
44 2021-04-06 chills, fever With in a few hours of the shot I had pain up and down my right arm, up and down my right side and i... Read more
With in a few hours of the shot I had pain up and down my right arm, up and down my right side and into my shoulder/ neck. I went to home and had a slight fever with chills and could not sleep that night. I called off from work and stayed home. Over the weekend the pain in my neck. shoulder and arm continued. I went to a chiropractor treatment that Tuesday 3/2/21. He made some adjustments and the shoulder / upper arm still did not feel better. My right arm became more numb and weak on Thursday 3/4/2021 . My wife was sitting next me on our couch when I suddenly had a spasm in the upper arm. The next morning I waking and had even more trouble lifting the arm or moving it. I attempted to suffer through it thinking it would get better. Over that weekend conditions with the arm became even worse and was unable to lift it. I returned to chiropractor. He evaluated me and i described what had happened after the second covid shot. He recommend an MRI and I attempted to contact my PCP. With no answer from the PCP i went to the ED who said My PCP would need to order a MRI. I was then sent to physical therapy and Orthopedics. They ordered an X ray and MRI. Both showed nothing. Still seeing physical therapy with some improvement and movement. Have a EMG scheduled for April 22,2021
44 2021-04-06 fatigue, throat pain, chills significant chills; slight dizziness; sore throat; had substantial body aches; fatigue; This is a sp... Read more
significant chills; slight dizziness; sore throat; had substantial body aches; fatigue; This is a spontaneous report from a contactable consumer (patient) A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown), via an unspecified route of administration, in arm left on 01-FEB-2021 at 09:15 single dose for Covid-19 immunization. The patient previously took vaccine which included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number el3248, Expiration date unknown) via an unspecified route of administration, in arm left first dose on 12Jan2021 at 06:30 AM for Covid-19 immunization. Prior and Since to vaccination, the patient not diagnosed with COVID. Concomitant medication was not reported. on 02-FEB-2021 03:00 AM patient experienced significant chills, slight dizziness and a sore throat, substantial body aches and fatigue. The patient woke up at 3 am with significant chills, some slight dizziness and a sore throat. The patient was able to go back to sleep, when the patient woke up again in the morning the patient had substantial body aches and fatigue. I took some motrin and tylenol in the morning. The symptoms subsided by the afternoon. The symptoms subsided by the afternoon. The outcome of event was recovered.
44 2021-04-06 headache seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a ... Read more
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
44 2021-04-06 fever, chills Fever, chills, muscle aches, joint pain, burning eyes
44 2021-04-07 sweating Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ANXIETY-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient drank water as we talked to him. He started to look and feel better after a few minutes. He was able to hold a steady conversation throughout event. Within 5 minutes of being notified of event, patient was scrolling through his phone with no difficulty. We made patient wait for 20 additional minutes while monitoring him and patient stated \"I feel back to normal\" before leaving.
44 2021-04-08 cough patient called covid clinic with complaints of coming down with "vicious cough" 1 week after 1st dos... Read more
patient called covid clinic with complaints of coming down with "vicious cough" 1 week after 1st dose of vaccine, called on-call physician for recommendations for cough, no admit
44 2021-04-08 fever Patient had fever after second dose for 1 week associated with right shoulder pain and limited range... Read more
Patient had fever after second dose for 1 week associated with right shoulder pain and limited range of motion. He was neutropenic and found to have MSSA Bacteremia. MRI of right shoulder with no drainable collection, no septic arthritis. No procedures, lines, dental work, nothing else that could explain it.
44 2021-04-09 sweating Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He... Read more
Patient received their vaccine at 5:12pm and at 5:15pm felt light headed, sweaty, and spaced out. He did not faint, he did get back to baseline after drinking a bottle of water, and resting .
44 2021-04-09 fever, fatigue, headache Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain func... Read more
Fever from 2pm until about 2am. Next day felt OK. Day after that was fatigued with slowed brain function and mild headache. This lasted about 5 more days.
44 2021-04-10 chills, sweating He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had dif... Read more
He had his first vaccine March 19th, 2021 at 12:15, same lot as above, and 24 hours later he had difficulty breathing, shortness of breath, fatigue, shakes, chills and feeling of weakness/dizziness. It lasted a few days. Then, April 9, 2021, he received his second Covid19 Pfizer shot, same lot at 12:15 pm and the next morning, Saturday, April 10th around 9 am Ira felt the same symptoms from shot 1, but more intense. He was feeling weak, had chills, shakes, profuse sweating, difficulty breathing, shortness of breath, dizziness and vomiting. He was unable to keep water down and stayed in bed. A little after 12pm, he complained of difficulty breathing and possibly not getting enough oxygen so I grabbed my equipment (since I'm a CNA) and checked his vitals. His B/P was very high ( 166/107), no fever (96.7), pulse was normal 72, and low respiration but oxygen was above 90. He said he needed to use the bathroom, I suggested using his urinal but he said he needed to have a bowel movement. Once he was in the bathroom, I went downstairs for a glass of water and then suddenly I heard a huge thump. I ran upstairs, knocked on the bathroom-no response but I could hear noises, so I opened the door and I saw he was face down on the floor, head under the bathroom sink counter, blood everywhere, and he was convulsing. I grabbed him immediately and moved him to his side (I had my fitbit on, it said it was 12:30pm), and he kept seizing. He looked discolored almost blueish color. I held him on his side, he vomited, making noises, but unable to speak, continuing to have a seizure. Seizure lasted three minutes. At 12:33pm, once he had calmed, I ran downstairs to find my phone. I was back at his side calling 911 at 12:35. Paramedics arrived 9 minutes later and took him to the hospital. My brother picked me up and took me to the hospital. Once outside his door, I noticed he was finishing taking X-Rays when he suddenly had another seizure.
44 2021-04-11 fatigue, headache, fever I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fa... Read more
I got the Phizer 2nd shot this past Wednesday. 24 hrs later I had the normal symptoms, headaches, fatigue. Through the weekend things were fairly normal till Sunday night. I had a hard time sleeping and a low grade temperature 99.4. Over night I hoped it would get better but in the morning it got a little worse 100.0. Didn't sleep till 2am. A little bit ago I took my temp again and it's 100.2. I don't have flu type symptoms, just tired and fever. I've been taking Tylenol every 8 hrs or so. Drinking water and resting.
44 2021-04-11 headache, chills, sweating 4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6.... Read more
4/9 - No issues 4/10 - Woke up with alternating sweats/chills throughout day. Temp never above 99.6. Slight headache and nausea. No energy at all. Took doses of ibuprofen throughout day. 4/11 - Continued with alternating sweats/chills. Continued taking ibuprofen and generally able to function. 4/12 - Morning of 4/12 similar to 4/11.
44 2021-04-11 headache Severe headache that started the day after the shot, developed change in taste, neck muscle pain. S... Read more
Severe headache that started the day after the shot, developed change in taste, neck muscle pain. Symptoms progressed until 4/8/2021 and woke up with left sided facial drooping. He was seen and in the ER and diagnosed with bell's palsy. Was hypertensive 180/110
44 2021-04-12 chills severe migraine severe body/joint aches chills
44 2021-04-12 headache Severe headache the day after the vaccine, followed by a regular headache until present, worsening i... Read more
Severe headache the day after the vaccine, followed by a regular headache until present, worsening intensity. Then on 4/10/2021, he developed changes on the right side of his face that were diagnosed in ED as Bell's Palsy.
44 2021-04-12 malaise Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/20... Read more
Patient's physician reported this adverse event by phone to Medical Center administration on 4/13/2021. Per the physician, the patient received his 2nd Pfizer COVID19 vaccination dose on Friday 4/9/2021 at the drive through vaccination clinic. On Saturday 4/10/2021 the patient told to his wife that he felt ill, continuing through Sunday. On Sunday, 4/11/2021, at his home, the patient told his wife that he felt ill and went to sleep. The patients wife found him not breathing, called 911 and started CPR. The patient was pronounced deceased at his home and was not transported to hospital.
44 2021-04-13 headache, fatigue, fever fever, fatigue, headache, nausea, cold sweat
44 2021-04-13 sweating Bad Migraine with sensory issues - sensitivity to sounds, Trouble sleeping, Acidity, Sweating
44 2021-04-13 throat irritation Voice loss - Occurred next day after injection No hx of smoking/chewing/drinking CPAP machine pres... Read more
Voice loss - Occurred next day after injection No hx of smoking/chewing/drinking CPAP machine prescribed 2 days before injection No rxn to injection day of. No redness/swelling Spoke with patient on 04/14/2021. Patient stated voice was 'altered' - voice loss by the end of the day each day. PCP visit, no allergy/irritation doctor could find. Prescribed Zyrtec. 2 weeks later, patient still claims voice loss/'altered'. Describes as 'tickle' in throat
44 2021-04-14 fatigue March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial... Read more
March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc. April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation
44 2021-04-14 fever verything tastes like metal. nothing is good to eat, everything tastes bitter or like it's gone bad... Read more
verything tastes like metal. nothing is good to eat, everything tastes bitter or like it's gone bad. a metal taste lingers in my mouth. doubt it's anything important, but wanted to mention it for data collecting sake as i'd not heard of it from anyone else. other side effects were fever and achiness, however it seems to be more severe in my case than in others I personally know with their 2nd shot, probably not statistically worse than the general population if I were to guess at it, however.
44 2021-04-15 chills, headache, fever Chills, Body Aches, Headache, Mild Fever & Diarrhea
44 2021-04-15 fatigue, chills Muscle pain mainly in the legs. Body cut (chills), no temperature. Tiredness in general. This lasted... Read more
Muscle pain mainly in the legs. Body cut (chills), no temperature. Tiredness in general. This lasted all day. The next day without problems.
44 2021-04-15 headache, sweating This is a 44 year old male, history of high cholesterol, not currently on medications. Patient prese... Read more
This is a 44 year old male, history of high cholesterol, not currently on medications. Patient presented for Pfizer covid-19 vaccine today, approx. 9 minutes post vaccination, patient reported he felt dizzy and light headed with left arm pain at injection site. Patient then began to report seeing flashes of lights, frontal headache, left arm and left leg heaviness and felt sweaty and if he was going to pass out. EMS was activated, patient was transferred to the ED.
44 2021-04-15 sweating Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapi... Read more
Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapid pulse at around 1410. Client was unresponsive and out of it like he passed out for a few seconds and came out of it and was coherent and responsive again. Client was safe, with three EMTs and lead nurse alongside him. Vital signs taken at 1414, BP 138/88, O2 99%, and P 80. Client started feeling better, no longer sweaty or dizzy at around 1415. Client informed healthcare staff that he had not eaten or had any water since 0800. Vital signs taken again 1425, BP 140/90, O2 100%, and P 72. Client was stabilized and ambulated out of the facility and driven home by his mother at 1430.
44 2021-04-15 malaise As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted ... Read more
As I was administering the vaccine I was discussing with the patient the adverse reactions I wanted to monitor after the injection. The patient winced as the vaccine was being injected and said it was more painful than the last time he go it. He immediately stated he didn't feel well. I applied a little pressure to the injection site which he said made it feel better but he was starting to feel flushed and faint. I kept the patient in the chair and got him some water. He reported that he had experienced this before with vaccines but it had been a long time. He asked to lay on the floor so we got him into a prone position on the floor on his right side. He laid there for a few minutes then drank some more water and laid back down. After a few more minutes he was ready to sit up. He moved to a chair in our waiting area left when he felt well enough. I called patient 2 hours later to check on himand he reports he is doing fine.
44 2021-04-16 fever, chills Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM... Read more
Soreness in left arm lasting about 24-28 hours (started around 8PM 4/15/2021) and fading around 10PM 4/16/2021 Fever peaking at 100.3 starting at 4PM 4/16/2021 and lasting until around 12AM 4/16/2021, mild chills Mild body aches during fever in both shoulders, back and neck, gone by 10PM as fever started to recede.
44 2021-04-17 headache, chills, fatigue, sweating Chills; sweats; headache; very tired, could not get out of bed; This is a spontaneous report from a ... Read more
Chills; sweats; headache; very tired, could not get out of bed; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported about a 44 year old male patient reported that the patient received the second dose of BNT162B2; Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6204; expiry date: unknown; Solution for injection);via an unspecified route of administration in the left arm on 28Mar2021 at 11:45 and received the first dose of Pfizer-BioNTech COVID-19 Vaccine; Lot number: EN6206; Solution for Injection) on 07Mar2021. The known allergies were Digestive allergies to Dairy and Gluten. The patient experienced chills, sweats, body aches, headache, very tired and could not get out on 28Mar2021 at 11:30 pm. The patient received Tetanus shot on 3/18, Prozac. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
44 2021-04-17 headache, fatigue Extreme fatigue for 48 hours post injection Low grade headache for 96 hours post injection
44 2021-04-17 fever, chills, fatigue Extreme fatigue, migraine, fever, chills & nausea.
44 2021-04-19 headache, chills Severe, nausea, diarrhea ( at least 6 episodes day one) onset two days after vaccine with severe HA... Read more
Severe, nausea, diarrhea ( at least 6 episodes day one) onset two days after vaccine with severe HA, bodyaches, , rigors. No one else sick in family
44 2021-04-19 headache Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it fi... Read more
Numbing in left arm, within 5 minutes, that traveled halfway up the left side of my face. Once it finished traveling, approximately 10 minutes after shot, the taste of metal appeared on the back of my tongue. The numbness passed within 15 minutes of the shot and then pain began radiating from the shot to my elbow every few minutes. I had a feeling that could be best described as inebriation after about 15 minutes and could smell pizza to be specific. There was no pizza around. This went away within about 10 minutes of onset. I slept for about 4 hours, woke up with a headache, and arm pain for 2 days.
44 2021-04-19 sweating Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/swea... Read more
Vaccine administered 13:54, adverse event started 13:55 same day. Patient had syncopy, flushing/sweating. BP 115/72 -- > 101/67 -- > 110/78, HR 64 -- > 58 -- > 60, O2=100% -> 97% -- > 98%, RR = 16, Temp 95.1F -- > 96.6F -- > 97.3F. At 15:01, Patient stated no longer lightheaded, patient stable, released from vaccination site.
44 2021-04-19 nasal congestion, cough, throat irritation, fatigue, fever, headache I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire,... Read more
I have fever, throats scratch, cough, breath with dificulties, body pain, back pain, very very tire, thirsty, Head pain, congestion, dificulties to function
44 2021-04-20 fatigue, sweating 4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening ... Read more
4/21/2021 was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, he experienced an adverse reaction with the following symptoms: nausea and tingling and numbness to cheeks and tongue/ c/o of tiredness. Assessment : Time of assessment *1634. Alert and oriented, Tachycardia, Pallor, Diaphoretic, Clammy and Nausea. Actions taken: Vitals sign taken VAERS form obtained and completed by RN. Water x 2 and 1 juice, VS taken at 1634- BP- 141/89, P- 110, O2- 98%, 1642, BP- 139/88, P- 102, O2- 100 %, 455pm, BP- 123/78, P- 97, O2- 100%, 514pm, BP- 123/81, P- 100, O2- 100% Medications administered: Loratadine (Claritin) 10 mg by mouth. Time: 1645. Administered by RN. Famotidine (Pepcid) 10 mg by mouth. Time: 1645. Administered by RN. Diphenhydramine (Benadryl) 12.5 ml (25 mg) by mouth. Time: x 2 doses at 1634 and 1645. Administered by RN. Disposition: Reports no further symptoms of adverse reaction after observation for 60 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system. Wife with patient. Immunizations Administered Name Date Dose VIS Date Route Pfizer COVID-19 Vaccine 4/21/2021 4:16 PM 0.3 mL 2/25/2020 Intramuscular Manufacturer: Pfizer, Inc Lot: ER8735 NDC: 59267-1000-2 Electronically signed at 4/21/2021 5:33 PM Immunization on 4/21/2021 Detailed Report Note shared with patient
44 2021-04-20 head discomfort, paranasal sinus discomfort Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face ti... Read more
Woke up with extreme severe migraine dizziness, vertigo nausea and loud tinnitus! Scalp and face tingling. Ear fullness, head pressure, sinus pressure, visual haze, brain fog. Never experienced this in my life! Persisting for weeks and weeks and continues. Still ongoing. Please help!
44 2021-04-20 headache, chills, fever Fever, chills, muscle aches, headaches
44 2021-04-20 headache 2ND Pfizer covid-19 vaccine administration 1/14/2021. Patient symptom onset 3/16/2021 - headache, 3/... Read more
2ND Pfizer covid-19 vaccine administration 1/14/2021. Patient symptom onset 3/16/2021 - headache, 3/21/2021 - rash diagnosed to be herpes zoster V1/V2 distribution, 4/12/2021 - herpes zoster ocular involvement with scratchiness, visual halos and decreased visual acuity of 3 days duration.
44 2021-04-21 fatigue, headache Headache, fatigue, lightheaded, pain at injection site. All resolved in 36 hours
44 2021-04-21 sweating Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water... Read more
Pt became diaphoretic and light-headed 5 minutes after vaccine was administered. He requested water and as I was giving it to him he started to pass out. He was conscious but slightly convulsing. He appeared to have a minor seizure for approximately 5-10 seconds. He was transferred to a wheelchair and sent into our recovery room. As we were transporting him, he had two episodes of vomiting and continued to feel diaphoretic and weak. He rested laying down but was not feeling better. He could not tolerate any water or juice.
44 2021-04-22 fatigue, sleepiness Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressu... Read more
Dizziness, light headedness, nausea, cold sweat, fatigue, sleepiness accompanied by low blood pressure of 90/59 and a low pulse rate of 50 bpm 10 minutes following injection. Symptoms alleviated within 30 minutes of onset except fatigue without further intervention.
44 2021-04-22 headache Bruise-type pain at injection site starting +5 hours lasting for about a day. Mild Diarrhea starting... Read more
Bruise-type pain at injection site starting +5 hours lasting for about a day. Mild Diarrhea starting +8 hours roughly every 1-2 hours for a day or so. Persistent headache starting +12 hours for a few days (somewhat hard to judge causation given being a long time regular migraine sufferer but seemed more than usual / different). Mild vertigo / balance issues starting +2 days lasting for 3-4 days. Can't confirm causation but definitely atypical / no other known cause. Difficulty maintaining balance (like walking while drunk only I don't drink anymore) NO nausea/spinning just balance.
44 2021-04-23 body temperature increased, malaise 103 temp with nausea and vomiting. 129/72, 123 hr/ 94%
44 2021-04-23 chills, headache, fatigue muscle ache; Chills; soreness at site of injection; headache; fatigue; This is a spontaneous report ... Read more
muscle ache; Chills; soreness at site of injection; headache; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: el3247) via an unspecified route of administration in the left arm on 18Feb2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247), via an unspecified route of administration in the left arm on 28Jan2021 at 10:15 as a single dose for COVID-19 immunization. On 18Feb2021 at 21:00 (reported as 12 hrs after injection), the patient experienced chills, soreness at site of injection, muscle ache, headache and fatigue. The patient did not receive any treatment for the events. The outcome for the events was recovered on an unspecified date in Feb2021(reported as symptoms lasted 18 hrs). Follow up attempts are completed. No further information is expected.
44 2021-04-23 fatigue, fever Fever of 102 F Fatigue Body aches started 9am 03/16/2021 lasted 36 hours until 9pm 03/17/2021
44 2021-04-23 headache, chills, fatigue Headache; Felt real tired; Chills; This is a spontaneous report from a contactable Other HCP (patien... Read more
Headache; Felt real tired; Chills; This is a spontaneous report from a contactable Other HCP (patient himself). A 44-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration in Arm Right on 04Feb2021 at 15:00 as single dose for covid-19 immunization. Historical vaccine included bnt162b2 (COMIRNATY, Formulation; solution for injection, Batch/Lot Number: EL3247), dose 1 via unspecified route of administration, administered in Arm Right on 04Jan2021 at 15:00 for covid 19 immunization. The patient had no medical history and no known allergies. The patient had no concomitant medication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine, no treatment was received for the adverse events, has not been diagnosed with covid-19 prior vaccination. The patient underwent lab tests and procedures, which included Nasal Swab post vaccination on 28Dec2020 which resulted negative. Patient experienced a headache, felt real tired and chills for about 6 hours all on 05Feb2021 at 04:30 PM. After 6 hours the symptoms went away. The outcome of the events was recovered.
44 2021-04-24 fatigue Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities... Read more
Extreme fatigue; Light dizziness; disorientation; Sore/stiff muscles, particularly lower extremities; Sore/stiff muscles, particularly lower extremities; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old male patient received first dose of BNT162B2 (Pfizer COVID Vaccine, solution for injection, Lot# EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 05:00 AM (at the age of 44-years) as single dose for COVID-19 immunisation. Medical history included sleep apnea, headache and CALM supplement. The patient had no known allergies. Concomitant medication(s) included naproxen sodium for headache. On 23Feb2021 at 06:15 (1-hour and 15-minutes after vaccination), patient experienced extreme fatigue, light dizziness, disorientation, sore/stiff muscles, particularly lower extremities. The patient had not taken any other vaccine four weeks prior vaccination. The patient not had COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
44 2021-04-24 fever, chills chill; half face was swelling; fever (99-100F); much stronger pain with the tooth; much stronger pai... Read more
chill; half face was swelling; fever (99-100F); much stronger pain with the tooth; much stronger pain with the tooth; This is a spontaneous report from a contactable consumer reported for himself. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 15:45 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included one tooth with some inflammation and pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. None allergies to medications, food, or other products. The patient's concomitant medications were none. The patient experienced much stronger pain with the tooth on 24Mar2021 18:15 with outcome of recovered, half face was swelling on 25Mar2021 (next morning)with outcome of recovered, fever (99-100f) on 25Mar2021 (next morning)with outcome of unknown, chill on unspecified date with outcome of recovered. The chill, swelling and pain last 3-4 days post injection. Therapeutic measures (Advil) were taken as a result of much stronger pain with the tooth. Follow-up attempts have been completed and no further information is expected.
44 2021-04-24 fever, headache 12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had... Read more
12 hours after first shot, had 48 hours of chills and nausea, recovered, 8 days after first shot had 5 days of chills, fever, nausea, headache. 12 hours after second shot, had 24 hours of chills, nausea, fever, headache, recovered. 13 days after second shot, all symptoms returned for the 4th time
44 2021-04-24 fever Fever spiking to 101, with 99-100 fever steady for 24 hours from onset. Fever onset was 15 hours fro... Read more
Fever spiking to 101, with 99-100 fever steady for 24 hours from onset. Fever onset was 15 hours from time of injection.
44 2021-04-25 headache, chills, fatigue This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not... Read more
This is sharing a concern / reporting a concern. This is not a complaint against anyone. This is not reporting side effect. The adverse effect date and time is a mandatory field. This is the reason I filled adverse date and time. I had my 2nd dose of vaccine on April 25, 2021 at campus at 1.20 PM. I just felt the syringe just touched the peripheral of my skin. I told the nurse that I do not feel I get the shot. Later, I do not feel any side effect any effect. I had no pain, or the site of injection was not swollen. I am worried I did not get the 0.3ml dose. During the first shot on April 4, 2021 at 1.43 PM, I felt pain on shoulders. I felt my tongue got thickened/ some tingling sensation on tongue and a little slur in speech. After 6 hours, I felt headache, a little chill, light head, nausea, more pain on shoulders and the next day, I felt light headedness and I felt tired for few days. I consider these as normal side effects and nothing unusual from what I read in internet and what I heard from others. So, I did not report it and it was a normal thing for me. Since I experienced this in first dose, I expected a more severe reaction than first dose. But I did not even feel pain at the site of injection nor any usual symptoms that usually appear. This made me to doubt I got required dose or the vaccine was correctly withdrawn from the vile. I do not know how to confirm that I got correct dosage. If I have not received the full dose, I am ready to take an additional shot and I would be flexible to take the shot at the available time near to my living place on any day. Again, I am not complaining anything. Probably the nurse is very proficient in taking shot with no pain. I do not know why my body does not react to the second dose.
44 2021-04-25 headache Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot a... Read more
Pt received Covid vaccine complained of pounding headache, dizziness, chest pressure, feeling hot all over. BP 131/87. HR 82, RR 18, O2 sat 98%, temp 98.3. Pt taken to Emergency Department to further care required.
44 2021-04-25 headache Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to e... Read more
Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to experience light pain in scrotum area (first two weeks strong pain), and unable to empty bladder completely (always an urge to urinate even right after urinating). This bladder issue is ongoing, joint pain at times.
44 2021-04-25 sweating, lethargy Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which w... Read more
Patient began to feel hot and sweaty after injection. Pharmacist took patient's temperature, which was 96 F. Patient still felt hot and was lethargic but remained responsive. 911 was called when patient stared to droop head to side as if he was falling asleep. We provided cooling measures and kept patient awake until paramedics arrived.
44 2021-04-25 nasopharyngitis Hearing loss and ringing in left ear. Hearing is only about 10%. Shortly after getting 1st shot, ... Read more
Hearing loss and ringing in left ear. Hearing is only about 10%. Shortly after getting 1st shot, my household also get colds. I went to doctor and was prescribed Amoxacilin. I thought hearing loss could have been from minor infection. Once antibiotics were complete and I still could not hear (& tinnitus) I went to primary doctor and he prescribed Methylprednisolone (a steroid). That treatment has now completed and hearing loss & tinnitus still persist.
44 2021-04-26 chills, sweating chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year... Read more
chills; sweats; nausea; This is a spontaneous report received from a contactable consumer. A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6198), via an unspecified route of administration in left arm on 22Feb2021 15:15 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills, sweats, and nausea. The outcome of the events was reported as recovered on an unspecified date.
44 2021-04-26 fatigue, headache, fever nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and ad... Read more
nausea, headache, fatigue on 4/19/21. He begin having difficulty concentrating today, 4/20/21 and admits to sleeping poorly last night. He has not taken anything for his symptoms. It was advised for him to obtain quality restful sleep tonight, take multivitamin with D and C, APAP/NSAID for pain/fever, drink plenty of fluids. 4/21-Woke up this morning feeling better after a restful nights sleep. He did not take anything for his symptoms and his symptoms resolved completely.
44 2021-04-26 sweating 44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat ... Read more
44 year old male, while in post-vacc recovery area, c/o diaphoresis, feeling anxious, wiping sweat from brow and forehead. Initial vitals: 144/80, 60, 20. Encouraged to do breathing exercises to assist with relaxation. Remained seated, upright. Second set of vitals at 0850: 11/60, 60. Reassessment of client- clam, no s/s of distress. Final set of vitals at 0905: 110/78, 60. Discharged from clinic at 0906, unassisted.
44 2021-04-27 fatigue, chills, headache, sweating Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling thr... Read more
Dizziness, body aches, headache, strong fatigue, sweating and chills at night, vibration feeling throughout body, sore arm
44 2021-04-28 chills, headache, fever Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous ... Read more
Delirium; Severe fever 102+; Aches; chills; Restlessness; Headache; Weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration administered in arm right on 14Apr2021 09:30 AM (Lot Number: EW0158) at vaccination age of 44 years old as single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol, Cephalosporin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included atorvastatin calcium (LIPITOR) taken for blood cholesterol increased; tadalafil (CIALIS). The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6206) via an unspecified route of administration administrated in Left arm on 24Mar2021 at time of 09:45 AM at vaccination age of 44 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe fever, 102+, aches, chills, delirium, restlessness, headache, weakness on 14Apr2021 at time of 11:00 PM. No treatment received for the adverse event. The patient underwent lab tests and procedures which included body temperature: greater than 102 fahrenheit on 14Apr2021. The outcome of events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
44 2021-04-28 sweating Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were wat... Read more
Patient started feeling sweaty and clammy about 20 minutes after his second vaccination. We were watching him for 30 minutes. He asked to have his blood pressure checked. He was cold and sweating and said he was having chest pain. We called 911. his blood pressure was high but his pulse was normal. The EMT took the patient to run tests.
44 2021-04-29 fatigue, fever, headache Started right after the vaccine having headache then fever and body pain the next day. Fatigue, bod... Read more
Started right after the vaccine having headache then fever and body pain the next day. Fatigue, body pain, head ache, temperature of over 100 degrees F, temperature not changing will only go away after taking Acetaminophen. It has been 2 days still monitoring, no actions taken yet just taking Acetaminophen for the fever.
44 2021-04-29 sweating Sweaty, pale and Dizzy reports has not eaten. Has a hx of anxiety b/p 110/78 PSO2 98% pulse 64 r... Read more
Sweaty, pale and Dizzy reports has not eaten. Has a hx of anxiety b/p 110/78 PSO2 98% pulse 64 respirations 14 monitored condition improved. informed to seek medical attention with any further problems.
44 2021-04-30 fatigue, headache fatigue, soreness, headache, nausea
44 2021-04-30 fever Stiff arm, low fever, body aches for about 30 hours
44 2021-05-01 fever, chills, fatigue It started earlier in the day, just tired, then around the time stated I got intense chills to the p... Read more
It started earlier in the day, just tired, then around the time stated I got intense chills to the point of shuddering. Ran a slight temperature but it cooks have been all the blankets I was under. With it being about two weeks after the first injection im not sure if it was a reaction or a bug but it was very intense and the same as other reported symptoms but 2nd dose symptoms not first dose.
44 2021-05-02 fatigue Vertigo, nausea and vomiting for 36 hours, then dizziness and heavy fatigue for five days
44 2021-05-03 fatigue, malaise, fever Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having bee... Read more
Adverse event occurred Friday February 5th around 1430hours, I began to feel "not right" Having been in mental health services and care for a number of years, I naturally am and have developed great self-awareness of my condition. I began to feel a developing despair and decline to overall mental function. As if a switch had been turned in my brain, and it became more difficult to focus. Myself and others close to me started to notice that I would space out and kind of shut down at random moments without regard to what was currently going on around me. I must note that I did not have anxiety related to receiving the vaccine, even after becoming ill after the first dose. I cannot get back to my baseline level of functioning (mentally), and I struggle every single day (some worse than others) to focus, be productive, stay connected to those around me, and sometimes just stay on track getting through the day. I understand "battle-fatigue" and this long, on-going pandemic and it's toll of myself and others around me. I am an infection preventionist, during the pandemic, in an acute care hospital, being only in my role for a year when it all hit. Absolutely something occurred after receiving the vaccine. I have waited this long to help rule-out other potential causes, and to see if things would get better. I feel broken, though things are not getting worse, I cannot get back to where I was.
44 2021-05-04 fatigue My left arm broke out in a rash with blisters. Mainly around site, but was present through wrist an... Read more
My left arm broke out in a rash with blisters. Mainly around site, but was present through wrist and on palm of the left hand. Shoulder pain and fatigue.
44 2021-05-04 runny nose, respiratory tract congestion, cough Cough Difficulty breathing Congestion or running nose
44 2021-05-05 fatigue Swollen lymph node in left armpit/same side as injection. Additional symptoms include fatigue, joint... Read more
Swollen lymph node in left armpit/same side as injection. Additional symptoms include fatigue, joint pain, overall aching.
44 2021-05-05 fever, influenza like illness Flu symptoms, fever, body aches
44 2021-05-05 sleepiness, fatigue May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one.... Read more
May 1 18:15 dose 2 of vaccine received. No immediate adverse effects. Shot hurt less than first one. May 2 09:00 woke up with severe muscle soreness, joint pain, mental fog, extreme fatigue and a slight temp. Took Advil and went back to sleep. Didn't get out of bed majority of the day due to continued fatigue and muscle soreness and joint pain. May 3 went to work with continued mental fog, extreme fatigue, muscle soreness (still everywhere), and joint pain. Continued taking Advil to keep working. Condition did not get better at all throughout this day. May 4 woke up with mental fog lifted, fatigue gone, however; the muscle soreness and joint pain continued... but ONLY from my lower back all the way down both legs. I have never felt anything quite like this before. Continued to take Advil to deal with the pain May 5 aching and pain still present in lower back and both legs May 6 aching and pain still present and annoying in lower back and both legs and is not getting better. At this point I'm concerned as I was completely healthy before receiving the second dose of the vaccine with ZERO health problems and ZERO pain. Please tell me what is going on and if this will pass with time. I was healthy before and want to be healthy again. I'm dealing with the pain and will not miss work if I can help it. My wife is a pharmacist and insisted I get the vaccine.
44 2021-05-05 upper respiratory tract infection, fever, productive cough, nasal congestion, fatigue, chills High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, na... Read more
High fever, bad chills, bad body aches, loss of appetite, coughing up mucus infection from chest, nasal congestion and infection, very weak and tired
44 2021-05-06 sweating, malaise A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling w... Read more
A couple minutes after patient got the first dose of Pfizer vaccine, patient complaint not feeling well, sweating, tongue feeling funny and not able to see. My technicians laid him down on the floor and contacted 911 to send medics. Patient was still alert but later complaint difficulty breathing. Pharmacist notice swelling around pt's neck area and weak pulses. Pharmacist administered an epipen and stayed with patient. A few minutes later, patient symptoms subsided , medics arrived and brought him to the hospital.
44 2021-05-08 fatigue Immediate reaction: fatigue only Approximately 1 week after vaccine, developed rash on back of hands... Read more
Immediate reaction: fatigue only Approximately 1 week after vaccine, developed rash on back of hands. I have had this twice before but this time it did NOT respond to any topical treatment. Urgent care gave me medrol pack and it cleared 90%. days later moved to my face--everywhere I touched (e.g., around eyes) or had pressure (e.g., forehead where I rest when sleeping). Again no response to topicals--another medrol pack and it cleared 90%. I've had lingering symptoms for the past 4 weeks, but it is getting worse again.
44 2021-05-08 fatigue ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigue... Read more
ITP - he received the Pfizer COVID vaccine the day prior to admission. He subsequently felt fatigued and awoke this morning with intermittent petechiae. While golfing, he subsequently noticed increased bruising over his left shoulder. He had two episodes of epistaxis for which urgent care and then ED evaluation revealed evidence of thrombocytopenia. Platelets found to be 3,000, normal Hb, normal WBC, no splenomegaly, no lymphadenopathy,. Oncology saw recommended decadron 40mg daily for 4 days
44 2021-05-09 chills, fever 102 fever, chills, muscle pain, back pain.
44 2021-05-10 cough, sneezing, malaise, fever subjective fever, malaise, right upper quadrant abdominal pain, pain, cough, sneezing, poor appetite... Read more
subjective fever, malaise, right upper quadrant abdominal pain, pain, cough, sneezing, poor appetite, decreased smell and taste
44 2021-05-10 headache Periodic minor headaches
44 2021-05-10 sweating, fever Loss of feeling in right foot and blurred vision on evening of second day after vaccination. Sympto... Read more
Loss of feeling in right foot and blurred vision on evening of second day after vaccination. Symptoms developed at same time as fever started. Fever lasted the evening with bed soaked in sweat then broke by the morning. Lose of feeling in foot improved by next day and feeling returned entirely after 5 days. Blurred vision improved by next day but has been lasting one and off for two weeks. After feeling returned in right foot there was one evening of right ankle cramping. Finally fasciculations and "pins and needles" feeling happened in the face, right wrist, and right leg happened during the 2nd week after the shot but improved by the third week.
44 2021-05-11 fever, dehydration, headache Headache, fever (100.7), body aches, & dehydration. The symptoms lasted from 10:30p (5/10) to 6:00p... Read more
Headache, fever (100.7), body aches, & dehydration. The symptoms lasted from 10:30p (5/10) to 6:00p (5/11)
44 2021-05-12 fatigue, lethargy, headache After the first shot, very tired all day. Slept 3 times, a little headache, minor arm pain at spot o... Read more
After the first shot, very tired all day. Slept 3 times, a little headache, minor arm pain at spot of injection. Felt lethargic the next day, by the third day I was fine. After the second shot, a little tired, less than after first shot. No other symptoms. By night time I was fine.
44 2021-05-12 sweating Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine.... Read more
Onset of warmth, dizziness, sweating after the vaccine. No Syncope. Felt better quickly when supine. VSS No orthostasis before dismissal. Self resolving vasovagal reaction.
44 2021-05-13 fatigue, headache, fever Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Feve... Read more
Severe headache/His headache is severe it feels like he is being hit on one onside of his head; Fever; Fatigue; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; He feels like its shocking his body because of the pain all over, his body shakes because of the pain.; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Apr2021 at 44 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, fever, fatigue, shaking, pain and diarrhea in Apr2021 with outcome of not recovered. The patient reported severe headache, a fever and fatigue, not sure when he will get relief. The patient wanted to know when he will get some kind of relief. His headache was severe it feels like he was being hit on one onside of his head. He felt like it was shocking his body because of the pain all over, his body shaked because of the pain. He was surviving on Tylenol and Ibuprofen right now. The patient clarified having a maybe a little diarrhea along with the pain all over, fever, fatigue and severe headache. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-05-14 chills, fever, fatigue, headache I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection ... Read more
I had a 102.5 degree fever off and on for two days; severe body aches; chills; headaches; injection site soreness; redness; skin sensitivity; brain fog; hot flashes; fatigue; swollen lymph nodes (left armpit); This is a spontaneous report from a contactable other hcp. A 44-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9268), via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:00 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included migraines. Patient had no known allergies. Patient had not covid prior and post vaccination. Concomitant medication(s) included ibuprofen (ADVIL LIQUI GELS); acetaminophen (ACETAMINOPHEN). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 02:45 (at the age of 44-year-old) as 1st dose, single for COVID-19 immunization. The patient stated that on 13Feb2021 02:00, he had a 102.5 degree fever off and on for two days, severe body aches, chills, headaches, injection site soreness, redness, skin sensitivity, brain fog, hot flashes, fatigue, and swollen lymph nodes (left armpit). Patient did not received any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts have been completed and no further information is expected.
44 2021-05-14 headache Patient complaints of headache which improved over time. Patient was evaluated by EMS. Patient given... Read more
Patient complaints of headache which improved over time. Patient was evaluated by EMS. Patient given water to hydrate .
44 2021-05-15 influenza like illness, headache Flu like symptoms, headache, swelling of injection site.
44 2021-05-16 sweating, fatigue Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the ent... Read more
Severe body ache, chills, sweating, nausea, and vomiting. Vomited 9 times in a row and spent the entire night with a bucket. For the next week every morning, diarrhea and unsettled stomach, lack of energy, excessive sleep, no ability to exercise without severe fatigue or a return of digestive problems. This lasted a week. Sexual activity also impossible, erection quality greatly reduced. Many of these symptoms got better but have now returned with my second dose. Second dose has given me significant fatigue, digestive problems again, diarrhea, and reduced erection quality once more. I hope these problems resolve themselves. The vaccine has made going to work very difficult and I will seriously reconsider taking any vaccine in the future.
44 2021-05-17 headache Prior to receiving both Pfizer COVID19 shots I had been diagnosed with New Daily Persistent Headache... Read more
Prior to receiving both Pfizer COVID19 shots I had been diagnosed with New Daily Persistent Headache since 07/20/17. This primary headache condition has left me with a constant tension headache, heavy fatigue and related cognitive issues. I had no side effects after receiving my first Pfizer COVID19 shot on 4/1/21. I had my 2nd Pfizer COVID19 shot on 5/3/21 and the only side effect has been a substantial increase in head pain within 5 hours of receiving the shot. The baseline pain was a 4 out of 10 prior to the 2nd shot and has been a 7 out of 10 since 5 hours after my 2nd shot. I've had no other side effects and the pain has been unrelenting and indefinite.
44 2021-05-18 chills possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under m... Read more
possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
44 2021-05-20 fatigue Fatigue, back pain, joint pain, lack of mental acuity
44 2021-05-20 headache, fever Fevers, headache, body ache/myalgias
44 2021-05-20 fever This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches fo... Read more
This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.
44 2021-05-21 headache, fatigue Fatigue, headache, muscle aches
44 2021-05-21 influenza like illness Swollen, sore lymp node in armpit of injected arm. Sore joints throughout body. Flu like symptoms.
44 2021-05-23 fatigue Slight fatigue after first shot. A lot more fatigue after the second shot. Developed Tinnitus 5 days... Read more
Slight fatigue after first shot. A lot more fatigue after the second shot. Developed Tinnitus 5 days after the second dose.
44 2021-05-23 headache, sinusitis 5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuan... Read more
5/24/21 - 44-year-old male with a past medical history significant for nicotine dependence, marijuana use, who presents for slurred speech. Accompanied by wife. Patient was in his normal state of health until Friday when he got his Pfizer Covid vaccine. About 5 hours later he was noted to have a headache and some slurred speech but patient and wife did not think anything of it. They went to some graduation parties this weekend and his speech continued to get worse which is what prompted them to present to the ED today. He denies that this is happened before. Feels like it is difficult for him to find words but not to actually say words. He does surf but denies being in murky water or swimming in fresh water. He denies IVDU. No underlying coagulopathy or cardiac history.
44 2021-05-25 sweating Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vi... Read more
Fainting; Remained unconscious for a few seconds; Sweating; Minor tightness in the chest; Blurred vision; This is a spontaneous report was received from a contactable consumer (patient). A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), via an unspecified route on 08Apr2021 at 13:15 as 1st dose, single in the left arm for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included Betamethasone Dipropionate Cream USP 0.05%. The patient had known allergies with Keflex (cephalexin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 (5 minutes after vaccination), the patient experienced sweating, minor tightness in the chest and blurred vision followed by fainting and remained unconscious for a few seconds. After regaining consciousness, continued sweating for maybe 10 minutes. The patient visited emergency room. The patient did not receive any treatment for the events. On an unspecified date in APR-2021, the patient had recovered from the events.
44 2021-05-25 influenza like illness the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to g... Read more
the first 36 hours was normal pain with flu type symptoms, now there's vision changes and I had to go to the ER because it was really bothering me. They only helped with the anxiety and did an eye exam. It seemed to have gone away some but now it's coming back and it's like having dirty contacts in and having hypersensitivity to light and dark textures.
44 2021-05-27 headache Neuropathy in the right arm (not the arm I got the shots), irradiating to head and left foot.
44 2021-05-27 throat pain, sleepiness Received 1st dose covid vaccine 4/8/2021. Few days after c/o fatigue, muscle aches, headache, drowsi... Read more
Received 1st dose covid vaccine 4/8/2021. Few days after c/o fatigue, muscle aches, headache, drowsiness and dizziness which overall resolved after 1 wk but still mild headache, muscle aches and still some drowsiness and dizziness did not resolve. After 2nd dose, 2d after started experiencing drowsiness and dizziness, still ongoing, improved while sitting or resting. 1 wk after 2nd dose, muscle aches resolved. Also 2 weeks after 2nd dose, dry mouth, 8/10 throat pain which is now 2-3/10. He feels it is improving every day.
44 2021-05-27 fever, sleepiness Developed a large lump under skin at left arm pit. Fever. Dizziness and drowsiness.
44 2021-05-31 cough immediate onset cough, not resolved. New onset tinnitus
44 2021-05-31 fatigue, headache 1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, f... Read more
1st shot 4/13, no issue with injection site. About a week later had trouble breathing, chest pain, felt like lungs were hurting in my back, weak, tired, couldn't catch my breath when i went upstairs and almost passed out. 2nd shot 5/04, felt pain at injection site (that was expected), that night started to get a bad headache and got worse and worse. Next morning, whole body aching, upper body, lower back, bad headache, Left underarm (lymph) swollen. 2nd day slight headache, neck ache, left underarm swollen. That night had rash on arms, chest, and stomach. 3rd day, nighttime rash arms, chest, stomach. Still red where band aid was over injection site. Over a week later still have redness shape of band aid, Seems I have sensitive skin since the 2nd covid shot. 10 days after 2nd shot I still have redness the shape of the Band Aid on my left arm. Got a red spot on my nose (looks like Rosacea). 4 weeks later, still have a red spot on my nose. I have itchiness between fingers left hand, on my face left side, neck, arms (left wrist, right arm in places) redness on chest, and rashes on back, left buttocks, and itchiness on legs. i noticed that it gets worse at night. As far as i know i did not get the Covid Virus, i did the rapid test and regular test and both were negative. But i was very sick with my stomach and had issues breathing in late 2019 and again early 2020, took medication (antibiotics) both times. I had to write on this form over and over again kept getting frozen with error from the PDF. Even if I hit OK, it keeps popping up and does not let me finish, so I can imagine that lots of people gave up, like I may. Pfizer 4/13/2021 EW0162. After 5pm Pfizer 5/04/2021 EW0170. After 2pm
44 2021-05-31 headache Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was a... Read more
Patient presented to the ED on 5/8/21 with hypertensive emergency. Per ER provider's notes: He was at the VA today getting his 2nd Covid vaccine (Pfizer) and during the post vaccine waiting period, he developed frontal headache and transient L arm tingling. He was sent to ED in Superior and BP was as high as 219/114. He was given amlodipine and toradol and dilaudid and BP did not come down. He also had a slight elevation in troponin and had second episode of L arm tingling. Decision was made to not give ntg since he already had a headache. No chest pain or other neuro sx. Head CT neg for bleed. No chest pain. Patient presented to the ED again on 5/11/21 with similar symptoms as previous visit.
44 2021-06-02 headache, chills, fever, sweating, fatigue Fever, chills, body aches, headache, fatigue, sweating.
44 2021-06-02 lethargy Pain in both shoulders, neck and chest. Shortness of breath and lethargy
44 2021-06-03 chills, fever, headache Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After... Read more
Patient who had been infected with COVID19 in December 2020 and received bamlanivimab therapy. After recovery he received his COVID-19 vaccine series 4/1/2021 & 4/22/2021 with Pfizer-BioNTech. Patient then developed headache, chills, fever, body aches, thrombocytopenia, and elevated troponin levels on 5/10 and was admitted to the hospital 5/14. Concern for COVID-19 vaccine induced MIS-A or myocarditis. Patient received IVIG after ruling out other diagnosis and had a good recovery resulting in discharge home.
44 2021-06-03 headache Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs a... Read more
Headache, stomachache, tightness in chest, shortness of breath, onset at ~2:30am, approx. 14.5 hrs after first shot. Headache lasted approx. 3 hours. At time of this report, the stomachache, chest tightness, and shortness of breath are continuing.
44 2021-06-07 chills, fever This is a spontaneous report from a contactable consumer (Patient wife) or other non hcp. A 44-years... Read more
This is a spontaneous report from a contactable consumer (Patient wife) or other non hcp. A 44-years-old male patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiration date was not reported), dose 1 via an unspecified route of administration on 26May2021 (at the age of 44-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 2020 to an unknown date. concomitant medications were not reported. on 27 May 2021 the patient experienced severe chills, muscle weakness, fever/he is having a temperature, nothing crazy. it was 99.9. the patient underwent lab tests and procedures which included body temperature: 99.9 on 27May2021. The outcome of event severe chills was not recovered, while outcome of other events was unknown. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient new information included event detail was updated. Follow-up (27May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (wife) reported for a 44-year-old male patient Limited information available over the call. Information on the lot/batch number has been requested.
44 2021-06-07 cough I was driving home from my town to another town. About 15 mins I thought I had to take leak and my g... Read more
I was driving home from my town to another town. About 15 mins I thought I had to take leak and my groin area was warming up on the inside and then it started to burn up on the inside and it was painful I was thinking what could have caused and it then I realized I had the pfizer vaccine and then I have implant all of sudden I loss use of arms and it took about 20 mins for me to get use in them and then they started to burn up on the inside. Later on that night I started to cough really bad and my lungs had a hard time keeping me breathing and then I knew I had got the covid from the shot and it was much worst than the actual covid. This was the first dose of the pfizer that I got these reactions and plus I heard about how the vaccine has been sterlizing people from having kids. I knew that the pfizer vaccine is 100% unsafe for anybody to take and that it was a bad batch or wrong vaccine. But I am letting you know that you need to keep money set aside for damages from the vaccine. But please do not be like the other states giving people money, guns, trucks for getting the vaccine. I am warning people not to get it because I almost die in the first dose of the pfizer vaccine.
44 2021-06-07 headache Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back ... Read more
Woke up day after with headache 2nd day after severe muscle spasms in arms , legs, chest and back 3rd days after muscle spasms over entire body
44 2021-06-09 sleepiness Drowsiness; This is a spontaneous report from a contactable consumer or other non hcp (patient himse... Read more
Drowsiness; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date not reported), via an unspecified route of administration, administered on the left arm on 11Mar2021 12:00 (at the age of 44-years-old), as first dose, single dose for COVID-19 immunisation. There were no pertinent medical history and concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced drowsiness on 11Mar2021 14:00. No treatment was received as a result of the event. Event did not result to physician office visit or urgent care. The outcome of event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
44 2021-06-10 fatigue Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon eve... Read more
Tingling hands and feet started same day. Continues off and on for 6 weeks now. Chest pain upon even mild exertion like walking around the block. Lasted for a few weeks. Right arm bone pain severe lasted for about 3 weeks Spine felt swollen near coccyx/sacrum and C7-C6 pain. Feeling of Lower spine swelling and pain started less than 24 hrs. after. Lasted approx 2 weeks. Extreme tiredness lasted 2 weeks Baseball shaped raised area on chest near right arm(vaccinated arm) started perhaps a week in and lasted about a week.
44 2021-06-12 headache 1. Sharp headache in middle of my head. 2. Ringing in my right ear
44 2021-06-12 headache WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT ... Read more
WITHIN MINUTES OF TAKING THE FIRST DOSE, MY BLOOD PRESSURE AND PULSE DRAMATICALLY INCREASED. I FELT DIZZY, AND MY FACE WAS NUMB. WITHIN MINUTES OF TAKING THE SECOND SHOT, MY BLOOD PRESSURE AND PULSE SPIKED. SINCE THE SHOTS, I HAVE EXPERIENCED DIZZINESS, FEELING OF FAINTING AND ELEVATED BLOOD PRESSURE. I HAVE EXPERIENCES PIERCING PAIN IN MY HEART, PRESSURE IN MY CHEST AND INCREASED PULSE EVEN WHEN RESTING. I HAVE EXPERIENCED HEADACHES, BLURRED VISION.
44 2021-06-16 fatigue Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-cont... Read more
Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unknown route, on 02Feb2021 11:30 (at the age of 44-year-old) as single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient did not have a relevant medical history and concomitant medications. On 03Feb2021 at 10:00, the patient developed sore at injection site, bloody nose, diarrhea, and fatigue. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021. No follow-up attempts are possible. No further information is expected.
44 2021-06-16 fever, chills Nausea; Vomiting; Cold shakes; Entire body aches; 101.6 temp; This is a spontaneous report received ... Read more
Nausea; Vomiting; Cold shakes; Entire body aches; 101.6 temp; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 09:00 am (age at vaccination 44-year-old), as single dose for COVID-19 vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: En 6202) via an unspecified route of administration in left arm on 20210225 at 11:30 am as single dose for COVID-19 vaccination. Medical history included high cholesterol and penicillin allergy. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19. The patient experienced Nausea, vomiting, cold shakes, entire body aches and temperature of 101.6 (units unspecified) on 17Mar2017 at 22:00. The patient did not receive any treatment for the reporting events. The clinical outcome of nausea, vomiting, chills, general body pain and high temperature was not resolved. No follow-up attempts are possible. No further information is expected
44 2021-06-18 headache Since the day after my first injection (4/3) I have had a constant headache. Every single day since ... Read more
Since the day after my first injection (4/3) I have had a constant headache. Every single day since that headache has not left. It varies in intensity, it is generally the worst in the morning and evening or at least I block it out enough to do my job. Pain is in the back of my head/upper neck, in front of my ears on the sides of my head, sometimes I also get it on the crown of my head. I have also been nauseous pretty much every day since then. I have vomited once. Nausea is worst in the mornings. Occasionally I feel like I have a concussion, hard to describe that feeling.
44 2021-06-20 fever Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, a... Read more
Waxing/waning constellation of symptoms that include shortness of breath, chest pain, tachycardia, and fever along with recurrent eosinophilic pleural effusions.
44 2021-06-22 head discomfort, cough, chills 1st shot Reactions- shot was at 3:30 in the afternoon of 5/7/21. No immediate reactions to note. Aro... Read more
1st shot Reactions- shot was at 3:30 in the afternoon of 5/7/21. No immediate reactions to note. Around midnight of that night though, sweating, hot & cold, chills, Next day- nausea, diarrhea, and headaches. Could also feel soreness in my jaw. Intermittent lightheaded. Gradually started to notice swollen joints, achy bones. Popping/crackling of joints when moving/especially doing stairs. At a couple points, felt like I had frostbite while in the shower. Worst Joint pain of round 1 was May 27-31st. 6/1/21 Went to Dr. at hospital Reported symptoms. Was told that it could be from the vaccine but could be something else. Ran bloodwork. Liver levels came back elevated. 6/9/21 Still having joint p See Continuation Page- 6/9/21 Still having joint pain. Also noticing frequent urination/urgency to pee. Bones feel fragile, like living with the skeleton of a 95 year old man. Dr. ran blood work and I asked him how he felt about me getting the second shot- Worried that if my issues were vaccine caused, that I might be pouring gas on a fire by getting the second shot? He said that it's possible but the chances were small. Told me to see how the blood work came back and proceed if all clear. Blood work came back and was normal. Second shot (6/11/21) Friday afternoon- shot at hospital at 3:30. No immediate reaction. Spoke with nurse at location and she had not heard of anyone having my symptoms. Only numbness. Friday night around midnight, couldn't get comfortable. Skeletal pain grew unbearable in bed so I took a salt bath around 5am. Literally couldn't move my body/unable to get out of bathtub. Stayed in there for about an hour and a half. Drank 3 bottles of coconut water. Couldn't make a fist. Pains shifted all throughout my body. Quick sharp pains. Had a slight cough and when i did cough, it blasted pressure from the inside of my skull, out. I've never felt that before. Slowly made progress and went to see a Reflexologist. She helped but the issues continued throughout the day. No energy, couldn't move much without groaning. Couldn't get out of a chair on my own without pulling/pushing on something else. Had the chills but never a fever. Cold sweats. Hydrated with electrolytes. Got some sleep Saturday night and felt much better Sunday.
44 2021-06-22 lethargy Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also sm... Read more
Altered sense of taste and smell. Things tasted different. I had a very dry mouth as well. I also smelled things that were not there. I lost my sense of smell 10 years ago due to sinusitis. I experienced lethargy about 5 days after the shot up to 4 weeks after. I had some tightness in my chest, my albuterol inhaler helped with that. The tingling in my hand and feet happened on a few occasions. I had numbness that lasted about an hour. I had frequent night sweats that woke me. I had muscle tightness in my leg and abdomen. I also had soreness in my arm, which made it hard to grasp a pen. I did test my reflexes which were normal.
44 2021-06-24 sweating, fever weakness; sweat; feverish; dizziness; hot flashes; This is a spontaneous report from a contactable c... Read more
weakness; sweat; feverish; dizziness; hot flashes; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 (age at vaccination: 44 years) at 12:24 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine and Adverse events following prior vaccinations was reported as none. The Pertinent Details (include surgical procedures and dates) was reported as not applicable. There was no Family Medical History Relevant to Adverse events. On 21Jan2021, The patient experienced dizziness after a couple minutes of receiving the injection, hot flashes, broke out into a sweat which lasted about 15 minutes after receiving the first dose of the Pfizer COVID-19 vaccine and experienced weakness and felt that he had to roll down window, turn on AC, drink water and felt whole car spinning and experienced feverish. It did clear up before he left, however he felt dizzy on the drive home. He noticed that dizziness was on the list of potential severe allergic reactions. He states he has never had an allergic reaction to any other vaccines. He states that he has only been allergic to one antibiotic in the past (he did not name the medication) and he checked the list of ingredients prior to receiving the Pfizer COVID-19 vaccine and it was not a listed ingredient. The patient was concerned about the potential for a more severe reaction after receiving the second dose of the Pfizer COVID-19 vaccine because he has heard that the second dose is "more potent" than the first dose and if he should receive the second dose of the vaccine considering the side effects he experienced immediately after receiving the first dose. The nurse walked by his vehicle to check to see how he was feeling and he was fine and didn't feel anything. After she walked away, he felt as though the whole car was spinning and he had hot flashes. He called the nurse back over and told her what was going on and that he felt dizzy and a little weak, really hot and he broke out in a sweat. He rolled down window, turned on AC and he was given water. Was monitored for some time at least 5-10 minutes before he felt a little better. Still had a little dizziness up until the end, but they continued to monitor him. He was felt better after that and was able to drive home. Because dizziness and weakness is listed as severe side effects, does this mean that they will last more than 10-15 minutes because he is concerned about getting the second dose. Knows and heard the second dose is a little more potent and if he had these reactions 2 minutes post injection should he be concerned about getting the second dose. No other vaccines given the same day or 4 weeks prior. Had a flu shot 2 months prior, but unable to provide NDC, Lot, or expiry for flu shot. No problems with vaccines in past. Again, mentions the only thing that concerned him was the dizziness and hot flashes he had 2 minutes post injection. No further details provided. The events has not resulted in emergency room or physician visit. The relevant lab test was reported as none. Therapeutic measures were taken as a result of fever and treatment included over the counter Ibuprofen to help him feel better. Outcome of the event feverish was recovered and while all other events was recovering. Follow-up attempts are completed. No further information is expected.
44 2021-06-28 fever, fatigue Fever, between 100 and 101 degrees approximately 12 hours after inoculation. Injection site soreness... Read more
Fever, between 100 and 101 degrees approximately 12 hours after inoculation. Injection site soreness, muscle aches, fatigue, and a lip blister.
44 2021-06-30 fatigue, runny nose, pneumonia, cough Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his thro... Read more
Interrupted his sleep; Stuff in his throat/weird stuff on his throat; Cough; weird stuff on his throat; Rapid heart rate; really bad chest pains; vomit; nausea; gasping for air; Neck spasms; Blood pressure, clarified as low blood pressure; It was like he was catching pneumonia but then his nose was running,; severe congestion, like bad stuff in his chest and lungs; severe allergies; tired; he got really sick; It was like he was catching pneumonia but then his nose was running,; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and from a Pfizer sponsored program. A 44-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0167, Expiry date: UNKNOWN, NDC number: Unknown), via an unspecified route of administration at the right arm on 29May2021 11:15 as a SINGLE DOSE for covid-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing, illness from Feb2020 to an unknown date, whole family was sick in February, palpitations from an unknown date and unknown if ongoing. History and investigation included "he said he had nothing to add during that time. But about a year ago he had gone to the emergency room for a heart attack scare. he thought, because this was when COVID first started happening, his whole family was sick in February and they would not test them at that time because they had not been to China and they never found out if they had it but he ended up getting tested for COVID when he was sick like 6 months later and then that went away and he started having heart palpitations and then after that he thought he would get a COVID antibody test and that came back negative, they told him by the time he got the antibody test, they told him he could have had it but it is not showing up on their antibody rapid test thing. He confirms this all occurred last year in 2020, he thinks it was almost a year ago. He would be sitting on the couch and his heart started racing like crazy. He did not know what that was all about". He said he had no discomfort at all. Concomitant medications were not reported. On an unspecified date in 2021 patient experienced it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running, on an unspecified date in 2021 severe allergies, on 29May2021 rapid heart rate, really bad chest pains, stuff in his throat/weird stuff on his throat , cough, on an unspecified date in May2021 vomit, nausea, on an unspecified date in May2021, gasping for air, on an unspecified date interrupted his sleep. Caller received his first dose and was experiencing symptoms such as rapid heart rate and neck spasms and blood pressure. He was too tired to go to the emergency room. He had the weird cough and also stated he had weird stuff on his throat and severe allergies. Regarding his second dose, he wanted to receive but he wanted to know if he could receive a half dose. He also had really bad chest pains and he was going to go to the emergency room but he was too tired to even go. The other reason for calling, he was trying to find out because he was afraid to take the second dose, he wanted to know if he could take a half dose or something, he was trying to find out what he should do. Severe allergies, caller clarified it was like severe allergies or like hay fever kind of, but it was different. Rapid heart rate: He said this began happening the same day as the dose was given, 29May2021, 4 hours after he got the shot. It was not ongoing, it lasted about a day. The rapid heart rate went away the next morning, it stopped doing the crazy things it was doing the next morning, 30May2021. He confirmed that has recovered completely. The chest pain coincided with the rapid heart rate. It went way the same time as the rapid heart rate. It seemed like they both would come and go until the next morning, He confirmed that had recovered completely. He said then the low blood pressure was going on too. It was like it interrupted his sleep, he did not know how to explain it, like he had low blood pressure or like his heart would stop beating and he would wake up gasping for air. It was kind of like a nauseous feeling, he wanted to vomit. It happened with the low blood pressure and was mostly when he was sleeping and a little through the day, the nausea he means, it lasted about a day and a half. The nausea went away on the 30May or the 31May he cannot remember for sure. The cough and stuff in his throat began at the same time the heartbeat stuff started and the cough went away after 2 days. He felt pretty good for about 3 days and then he got really sick, with severe congestion, like bad stuff in his chest and lungs. It was like he was catching pneumonia but then his nose was running, it felt weird like a sickly poison kind of feeling like after he got the shot, he could not tell but it seemed like severe allergies or like hay fever kind of but it was different, it was a weird feeling. He had taken a bunch of herbal remedies Benadryl took herbal allergy stuff and it worked really fast and after like 3 days it was gone. He does not know what that was but it was pretty intense. No further information provided. It was reported that, caller got his first dose of the Pfizer Covid-19 vaccine on 29MAY2021 and had side effects. He wanted to know if he could get only a half dose of the COVID-19 vaccine. He also wanted to know if there was any correlation to having COVID-19 and having more of a reaction. Caller wanted to know if there was a correlation between having COVID-19 and having more side effects to the vaccine. He stated that his Pharmacist said there might be a correlation to people having COVID before getting the vaccine and having more problematic side effects from the first vaccine instead of the second. Response was given as "he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. He was referred to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Healthcare provider would have known the health situation and could access to information that better help inform the decision. From the CONS document on efficacy. Two shots were generally needed to provide the best protection against COVID-19 and the shots were given several weeks apart. The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens the immune response. Side effects after the second shot might be more intense than the ones experienced after the first shot. The side effects are normal signs that body is building protection and should go away within a few days". The patient underwent lab tests and procedures which included sars-cov-2 antibody tested negative. Therapeutic measures were taken as a result of severe allergies (drug hypersensitivity). He visited emergency room due to the event chest pain. On an unspecified date in 2021 the outcome of the events it was like he was catching pneumonia but then his nose was running, neck spasms, blood pressure, clarified as low blood pressure, tired, he got really sick, severe congestion, like bad stuff in his chest and lungs, it was like he was catching pneumonia but then his nose was running was unknown, on an unspecified date in 2021, severe allergies was recovered, rapid heart rate, really bad chest pains, cough was recovered on 30May2021, on an unspecified date in May2021 vomit, nausea was recovered, gasping for air, interrupted his sleep and stuff in his throat/weird stuff on his throat was unknown. Information on the lot/batch was available, Additional information has been requested.
44 2021-06-30 headache Mild body aches; Mild body aches and head ache; Soreness at injection site; This is a spontaneous re... Read more
Mild body aches; Mild body aches and head ache; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 22Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), via an unspecified route of administration in the right arm on 01Mar2021 at 12:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The Patient previously took Penicillin for unknown indication and experienced an allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 12:00, the patient experienced mild body aches, headache and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the mild body aches, headache and vaccination site pain was recovering. No follow-up attempts are needed. No further information is expected.
44 2021-06-30 respiratory tract congestion He has a chest congestion; his is a spontaneous report from contactable male consumer via Pfizer spo... Read more
He has a chest congestion; his is a spontaneous report from contactable male consumer via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and guaifenesin (MUCINEX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. he took the vaccine on unspecified date hour and half an hour ago and he has a chest congestion on an unspecified date that's why he was asking if he can take the medication Mucinex. The outcome of the event was unknown. Information on the lot/batch number has been requested.
44 2021-07-01 head discomfort Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was pr... Read more
Right side of the head has pressure, ringing in the right ear, right arm sore, and no energy. Was provided medication by healthcare professional. (Prednisone 10mg)
44 2021-07-01 respiratory tract congestion, headache Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, ... Read more
Headache, congestion, aches and pains, joints, loss of energy, Concentration, loss of testosterone, chest pain, heart
44 2021-07-02 fatigue, malaise Pain at the injection site; Tiredness; feeling unwell; This is a spontaneous report from contactable... Read more
Pain at the injection site; Tiredness; feeling unwell; This is a spontaneous report from contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration to his left arm on 22Mar2021 at 3:30 PM for COVID-19 immunisation. Medical history and concomitant medications of the patient was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 21:00 PM the patient experienced pain at the injection site which began several hours after injection, leading to intense stabbing pain whenever the upper arm was moved, tiredness and generally feeling unwell. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse event. The clinical outcome of the event pain at the vaccination site pain, tiredness and feeling unwell was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
44 2021-07-02 headache Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizzines... Read more
Throbbing in my head as if to start a headache, shortness of breath, pressure in the chest, dizziness, fluttering of the heart, feeling agitated.
44 2021-07-08 fatigue, fever, chills, cough Cough; Chills; Fatigue; Body aches; Joint pain / joints below waist ache; Low grade fever; This is a... Read more
Cough; Chills; Fatigue; Body aches; Joint pain / joints below waist ache; Low grade fever; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 25Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient had no past medical history as the patient was very healthy middle-aged man. The patient did not take any concomitant medication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) as solution for injection on the left arm, on 04Mar2021 at 14:00 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 (within 12 hours of vaccination), the patient experienced chills, fatigue, body aches, joints below waist ache and low-grade fever. On 27Mar2021 (36 hours of vaccination), the patient experienced slight cough. The patient did not receive any treatment for the reported adverse events. The clinical outcome for events chills, fatigue, general body pain, joint pain, low grade fever and cough were resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
44 2021-07-15 headache Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treat... Read more
Severe stiffness and pain in upper neck/base of skull. Severe headaches. Blurred vision. No treatment.
44 2021-07-15 sweating, chills, fever Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, ... Read more
Large rash on chest, pain through the body, wakes up drenched in sweat, low grade fever and chills, sensations throughout body, feels as though electricity is going throughout body, stabbing pains in veins, heart pains, organ pains, reflux in veins and legs stabbing pains in eyes, double vision, blurred vision, light headed and dizzy, allergic reactions to foods. Doctor's were unable to diagnose him with anything. He stated that he has a history of mental illness,
44 2021-07-15 fever, fatigue Hard lump in left arm near injection site. Swollen lymph node. Slight fever. Irritability. Tiredness
44 2021-07-17 fatigue Tiredness; swollen lymph node by jaw; This is a spontaneous report from a contactable consumer, the ... Read more
Tiredness; swollen lymph node by jaw; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration 24Mar2021 at 02:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as no. There were no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 19:00, the patient experienced tiredness and swollen lymph node by jaw. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events tiredness and swollen lymph node by jaw was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
44 2021-07-17 headache headache, everyday for 90 days since his first Pfizer vaccine; He is in lot of pain.; This is a spon... Read more
headache, everyday for 90 days since his first Pfizer vaccine; He is in lot of pain.; This is a spontaneous report from a contactable consumer or other Non HCP. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: ER8737), via an unspecified route of administration, administered on 02Apr2021 as single dose for COVID-19 immunisation. Medical history included nausea from an unknown date and unknown if ongoing, weight decreased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache, everyday for 90 days since his first vaccine, ever since with no relief. He is in lot of pain on an unspecified date. He is been seeking medical treatment, he is been seeing a neurologist. Neurologist agrees, probably an adverse reaction which is don't know, what to do and we don't know he get him seen what the next step or there is no plan in place on. Reporter stated, he need to talk to someone to get him Medical treatment. What do I do? He need to know how to get in touch with them. What date and time and what option to choose because he have already done that. Therapeutic measures were taken with Tylenol as a result of headache, everyday for 90 days since his first vaccine, he is in lot of pain. The patient underwent lab tests and procedures which included helicobacter test: negative on 10Jun2021. The outcome of events was unknown.
44 2021-07-17 fever, influenza like illness, headache Flu like symptoms; headache; fever; This is a spontaneous report from a contactable consumer, the pa... Read more
Flu like symptoms; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 25Mar2021 at 09:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: unknown), via unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced flu like symptoms, massive headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events flu like symptoms, massive headache and fever was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
44 2021-07-17 runny nose Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny... Read more
Pain in between shoulder blades, pain in right shoulder; Warmness in corner of the right eye.; Runny nose; Warmness in the right tricep; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BN6201) via an unspecified route in the left arm on 24Mar2021 at 08:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included difluprednate (DUREZOL) for unknown indication received within two weeks of vaccination. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9265) via an unspecified route of administration in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. On 24Mar2021 at 19:00, the patient had pain in between shoulder blades, pain in the right shoulder, warmness in corner of the right eye, warmness in the right tricep, and runny nose. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the pain in between shoulder blades, warmness in corner of the right eye, warmness in the right tricep and runny nose was not resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
44 2021-07-18 sweating The patient stated he was getting tunnel vision. At this point I came to the site of the patient and... Read more
The patient stated he was getting tunnel vision. At this point I came to the site of the patient and his pupils dilated. He became unresponsive. The patient started responding after about 1 minute. When the patient finally became responsive he began sweating quite a bit. We immediately began the emergency response and called 911 and called for store help. I stayed with the patient and when the paramedics got there they took over in the patient's care. The patient remained hypotensive, so the paramedics advised him going to the hospital. The patient agreed and was taken to the hospital.
44 2021-07-19 fatigue, fever, headache Nausea; Full body muscle ache; Fever; Excessive tiredness; Dizziness; headache; This is a spontaneou... Read more
Nausea; Full body muscle ache; Fever; Excessive tiredness; Dizziness; headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 44-year-old) at 17:30 as a single dose for COVID-19 immunisation. Medical history included HIV and obesity. The patient did not have any allergies to medications, food, or other products. Concomitant medications included ergocalciferol 50,000 (MANUFACTURER UNKNOWN), dolutegravir sodium (TIVICAY), emtricitabine, tenofovir alafenamide fumarate (DESCOVY) and fenofibrate (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. On 30Mar2021 at 02:00, the patient experienced nausea, full body muscle aches, fever, excessive tiredness, dizziness and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, full body muscle aches, fever, excessive tiredness, dizziness and headache was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
44 2021-07-19 headache, fatigue I experienced nothing but arm soreness and some fatigue after the second dose. Four months after the... Read more
I experienced nothing but arm soreness and some fatigue after the second dose. Four months after the second dose I got a Prodromal Headache which progressed to Herpes Zoster which was isolated to my face. I had to get eye drops for my eye. It has healed with treatment but I have some scarring.
44 2021-07-19 throat pain, fever, cough daily fever of 103.3, cough, diarrhea, chest pain, SOB, sore throat
44 2021-07-22 malaise Profound malaise, nausea, vomiting within 24 hours afterward. Then ongoing cardiac palpitations and... Read more
Profound malaise, nausea, vomiting within 24 hours afterward. Then ongoing cardiac palpitations and a sense of skipped heart beats and vague dyspnea, still ongoing as of 7/23/2021 here in urgent care.
44 2021-07-23 headache Beginning the second day following vaccination to current day, I have the following symptoms: a st... Read more
Beginning the second day following vaccination to current day, I have the following symptoms: a stiff neck, severe headache, brain fog, and highly disturbed sleep.,
44 2021-07-27 fatigue Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration... Read more
Hypertension; Tiredness; Weakness; losing some muscles; He is also experiencing muscle deterioration (no muscle pain); he's been feeling a light body (not hard to move); elevated liver enzymes; he told him he doesn't get enough sleep; nervous; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration on 22Apr2021 (at the age of 44-year-old) as dose 2, single for covid-19 immunisation. Medical history included, hypertension from 29Apr2021 to an unknown date, glucose tolerance impaired from 2010 to an unknown date Verbatim: Prediabetes, haemorrhoids from 09Mar2021 to an unknown date Verbatim: Hemorrhoids, hypovitaminosis from an unknown date and unknown if ongoing, asthenia from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for haemorrhoids, pain, start and stop date were not reported; ascorbic acid, biotin, folic acid, iron, nicotinic acid, pantothenic acid, pyridoxine, riboflavin, vitamin b1 nos, vitamin b12 nos, vitamin e nos (CENTRUM ADULT B+ IRON) taken for hypovitaminosis from an unspecified start date and ongoing; ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) taken for covid-19 immunisation from an unspecified start date and ongoing; vitamin b complex (VITAMIN B) taken for asthenia from an unspecified start date and ongoing. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as dose 1, single for covid-19 immunisation. On 25Apr2021, patient experienced losing some muscles, 0n 26Apr2021, patient experienced weakness, on 27Apr2021, patient experienced tiredness, on 29Apr2021, patient experienced hypertension. on an unspecified date in 2021, patient experienced muscle deterioration, he's been feeling a light body, elevated liver enzymes, he told him he doesn't get enough sleep, nervous. The patient underwent lab tests and procedures which included aspartate aminotransferase: 28 on 22Sep2020 Normal, aspartate aminotransferase: 46 on 30Apr2021 slightly elevated, blood test: elevated liver enzymes on 30Apr2021. Therapeutic measures were taken as a result of hypertension included losartan 25mg. The outcome of the events losing some muscles, tiredness, weakness were not recovered and the outcome of the remaining events were unknown.
44 2021-07-27 fatigue Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician. A 4... Read more
Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly, administered in Arm Right on 05Apr2021 (Lot Number: EW0150, expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation. Medical history included neoplasm left kidney from 2007 to an unknown date. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on 15Mar2021 (Lot Number and expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation and experienced Nausea. The patient experienced nausea, fatigue, decreased appetite, all in 2021. Nausea, fatigue and decreased appetite which has persisted after his second Pfizer COVID-19 vaccine 05Apr2021. The outcome of the events was not recovered. The report was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events.
44 2021-07-27 headache, fatigue, fever Headache; fatigue; Mild fever; This is a spontaneous report from a contactable consumer, the patient... Read more
Headache; fatigue; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 09:45(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:00, the patient experienced headache, fatigue and mild fever. The patient received tylenol at home as treatment of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event headache, fatigue and mild fever was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
44 2021-07-27 headache, paranasal sinus discomfort, fever, chills 21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadr... Read more
21 hours after; hives all over left side chest, waist, ankles, inner thighs. Although after a Benadryl it subsided, it did come back several days again. Otherwise 24 hours after the shot exprienced, slight fever, chills, muscle aches, headache, head sinus pressure, joint pain, diarrhea and nausea. Also several days later arm still hurts. 3 days after had shooting pain in injection arm, leaving me to not use my left arm. 4th day much better.
44 2021-07-28 fatigue, fever, cough, chills Loss of appetite; Coughing; High fever (104); chills for over a day; Fatigue; This is a spontaneous ... Read more
Loss of appetite; Coughing; High fever (104); chills for over a day; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0175) via an unspecified route of administration in the left arm on 02May2021 at 11:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 02May2021 at 16:00, the patient experienced high fever (104 degrees), chills, loss of appetite, fatigue and coughing. The patient underwent lab tests and procedures which included body temperature on 02May2021 and resulted as 104 degrees (units unspecified). The clinical outcome of the events fever, chills, loss of appetite, fatigue and coughing was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
44 2021-07-29 headache, fatigue, malaise Dizziness; Tiredness; Stomach pain; Headache; Feeling sick; This is a spontaneous report received fr... Read more
Dizziness; Tiredness; Stomach pain; Headache; Feeling sick; This is a spontaneous report received from a contactable consumer(patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 15:00 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included gastritis from an unknown date and unknown if ongoing. Patient said he had bad gastritis for a while and cyclic vomiting syndrome from an unknown date and unknown if ongoing. It was reported that patient has cyclic vomiting syndrome adult, which was diagnosed two months ago. Patient concomitant medications were not reported. He got no other vaccinations in the four weeks prior to getting his Pfizer coronavirus vaccine shot. On 26May2021 the patient experienced dizziness, tiredness, stomach pain, headache and feeling sick. The patient got his first dose of the shot, he is not sure what it was, yesterday, and he is having some side effects that are common, he would like to know how long they will last. He later clarified that the shot was the Pfizer coronavirus vaccine. Patient said he doesn't have his vaccine card with him to provide NDC/LOT/EXP from it, his vaccination was at 3PM. He said his side effects were basic dizziness, tiredness, stomach pain, headache, and feeling sick. His side effects started next morning when he woke up. Patient just took pills for stomach pain and let it pass. Therapeutic measures were taken as a result of stomach pain. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. Information on the batch number not available.
45 2021-01-03 sweating Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reob... Read more
Patient became unresponsive for 10-15 seconds. Medical emergency called, along with 911. Upon reobtaining consciousness, patient was diaphoretic and clammy. Vital signs obtained - SBP in the 70s and HR in the 40s. Patient transport to the ED.
45 2021-01-03 sinus congestion Patient tested positive for COVID-19. Symptoms include sinus congestion, partial anosmia, partial a... Read more
Patient tested positive for COVID-19. Symptoms include sinus congestion, partial anosmia, partial ageusia
45 2021-01-04 head discomfort, throat clearing, throat irritation palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, b... Read more
palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure. Evaluated in ED received solumedrol, benadryl. Discharged home and returned to hospital as direct admit due to continued symptoms. Pertinent labs reveled AKI, elevated LFTs. AKI and LFTs improved with IVFs.
45 2021-01-04 headache, nasal congestion headache, nausea,nasal congestion, dizziness, Symptoms resolved in 48 hrs , took Tylenol
45 2021-01-04 headache, fever, chills Fever; body ache; Chills; Headache; This is a spontaneous report from a contactable Nurse (patient).... Read more
Fever; body ache; Chills; Headache; This is a spontaneous report from a contactable Nurse (patient). A 45-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose to prevent COVID. Medical history included ongoing cholesterol abnormal. Concomitant medication included metformin and Cholesterol Medicine. The patient experienced Fever, body ache, Chills, Headache on 22Dec2020. Nurse stated, he have some question regarding the side effects of COVID Vaccine. He received the COVID Vaccine on 21Dec2020 (Monday), he was a nurse and knew it was normal to get fever in some cases but he has had a fever, body ache, the chills, the headaches. He did take Ibuprofen, Tylenol to cut the fever around the clock for the last three days. Nurse further stated, "he wanted to know how long he was going to expect the fever, the chills, the body ache. It was a bit too long and started to worry him. When probed for the causality, Nurse stated, "These are related to vaccine because he tested negative to COVID-19 on 21Dec2020 (Monday) and these symptoms started the next day after the vaccine on 22Dec2020." Therapeutic measures were taken as a result of fever. The outcome of the events was unknown. The causality assessment for events Fever, body ache, Chills, Headache was provided as related by Reporter via Method of assessment Global Introspection.
45 2021-01-04 fever mild fever; body and joint aches; body and joint aches; This is a spontaneous report from a non-cont... Read more
mild fever; body and joint aches; body and joint aches; This is a spontaneous report from a non-contactable physician. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, an unspecified route of administration, from 26Dec2020 at a single dose, for COVID-19 immunization. Medical history included penicillin allergies. The patient's concomitant medications were not reported. On 26Dec2020 20:00, the patient experienced mild fever and "body and joint aches", lasted for 24 hours. Therapeutic measures were taken as a result of the events included tylenol and advil. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
45 2021-01-05 fever Fever 102 and taken Tylenol 650 mg q8h for 3 dose Fever spike again twice in 24 h Symptoms resolved... Read more
Fever 102 and taken Tylenol 650 mg q8h for 3 dose Fever spike again twice in 24 h Symptoms resolved on 01/06/2021
45 2021-01-06 chills, fever, fatigue Got fever on 2nd January morning, fever was there continuously till 3rd January. Fever varies 101.3 ... Read more
Got fever on 2nd January morning, fever was there continuously till 3rd January. Fever varies 101.3 to 101.5 degree F Took Tylenol twice a day 12 hrs interval (1000 mg/ dose) 4th January morning onwards there is no fever Still I feel Chills, Fatigue and muscle pain moderately exist. My PCP (Dr.) and her nurse denied to schedule appointment in person on 01-06-2021
45 2021-01-06 chills, fever, headache, sweating, malaise, fatigue joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will ... Read more
joint pain; it doesn't seem to be feeling well; sweating; Fever; chills; night sweats, that he will randomly start sweating; headache; muscle pain/mild muscle aches; gastric upset; Fatigue; he had mild arm soreness right after he got the vaccine; This is a spontaneous report from a contactable Other-HCP (patient). This 45-year-old male Other-HCP received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, NDC number: 59267-1000-1) on 22Dec2020 at single dose in his right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. It was reported that patient experienced Fever on 27Dec2020 with outcome was recovered on 29Dec2020, chills and night sweats on 27Dec2020 with outcome was not recovered, Headache on 27Dec2020 with outcome was not recovered, muscle pain 27Dec2020 with outcome was not recovered, gastric upset on 27Dec2020 with outcome was Recovering, Fatigue on 27Dec2020 with outcome was unknown, arm soreness on 22Dec2020 with outcome was not recovered, joint pain with outcome was unknown, it doesn't seem to be feeling well with outcome was unknown, sweating with outcome was unknown. All events were serious (medical significant). Caller stated that he thought having a reaction to the vaccination, spoken with Occupational Health at his job and with a doctor, stated everyone is a bit stumped. Caller stated he has had for over a week now, fever, chills, night sweats, that he will randomly start sweating, headache, joint pain, gastric upset, and it doesn't seem to be feeling well. Stated the joint pain is actually more muscle pain. Stated he got the vaccination on Tuesday 22Dec2020, stated he has been having these symptoms for over 5 days now. Stated he does not think this is something infectious, that no one in his family is getting sick, his wife or child are not catching it from him. Stated he tried to do research online for data about delayed side effects, would like to know if we have any information on delayed side effects. Stated he considers these events medically significant because he cannot be cleared to go back to work. Stated he had mild arm soreness right after he got the vaccine, states he had mild muscle aches Wednesday and Thursday, then they went away and came back all on Saturday night and Sunday. Stated he is worried about getting a second vaccine. Stated he tested negative for the COVID on 29Dec2020. Stated he has a CBC and other blood work scheduled for today, results unknown at this time. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-06 headache, malaise, fever, fatigue, chills I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade... Read more
I am an anesthesiologist reporting my own event: injection received 0900. At 1400 I began low grade fever and not feeling well. By 1600 I had extreme fatigue and severe mental fogginess. This fogginess lasted approximately 24 hours. Other reactions included chills, fever, myalgia, arthralgia, headache as expected. I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty. I did not experience this with the first dose.
45 2021-01-07 chills chills, no appetite, symptom free today
45 2021-01-07 throat pain, headache, cough sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache... Read more
sore throat, cough, and headache; sore throat, cough, and headache; sore throat, cough, and headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient experienced sore throat, cough, and headache on an unspecified date. No treatment was given for the events. The outcome of sore throat, cough, and headache was not recovered.
45 2021-01-07 fever, chills, fatigue chills, fever fatigue
45 2021-01-07 fever, chills Chills; body aches; high fever; This is a spontaneous report from a contactable other HCP (patient).... Read more
Chills; body aches; high fever; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old male patient received first dose of BNT162b2 (Lot number: EL0140), via an unspecified route of administration at left arm on 03Jan2021 20:00 at single dose for covid-19 immunization. Medical history included Sleep apnoea. Concomitant medication included ramipril. The patient experienced Chills, body aches, high fever within 23 hours of vaccine administration on 04Jan2021 19:00. No treatment received. The outcome of the events was recovering.
45 2021-01-07 fever Patient reports fever and general body aches that has resolved with Ibuprofen
45 2021-01-08 chills, fever, fatigue Fever, treated with Tylenol Chills Body Aches Fatigue Symptoms lasted about 24 hours
45 2021-01-08 fever, chills, fatigue Severe Chills, Fever to 103 F, myalgias, fatigue, axillary lymphadenopathy
45 2021-01-09 chills Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every ... Read more
Patient developed chills/shivering/tingling day 4 post-injection. The episodes are occurring every 10 minutes and last 30-45 seconds. Symptoms continue at day 11 post injection. Symptoms are similar to the patients pre-ictal aura. However, no generalized seizures have occurred.
45 2021-01-09 fatigue, chills, fever After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some join... Read more
After first dose: arm pain a few hours after and chills 24 hours later that lasted 24hrs. Some joint pains persisted. After second dose: arm pain a few hours after. Twelve hours later I had chills, low grade fever 100.5, body aches, arthralgias, fatigue. These symptoms lasted for 24 hours continuously. 48 hrs later I still had fatigue and early morning chills. The body aches have continued to present time.
45 2021-01-09 sweating Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swoll... Read more
Increased bp, diaphoretic, skin turned red, pins and needle sensation, increased heart rate , swollen lower lip, nauseated, weird sensation of not feeling right almost like out of body
45 2021-01-09 sweating Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of ... Read more
Diaphoresis, petechiae, and tachycardia. onsent post vaccine, Benadryl 25 mg by mouth, 2nd round of sweating onsent: Benadryl 25 mg by mouth. Lower lip swelling, administered Epi-pen, called rapid response. Transferred to ED at 09:11am
45 2021-01-11 chills Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hour... Read more
Chills/rigors starting about 16 hours post-vaccine (second dose), lasting intermittently for 24 hours, improved with a Tylenol. Sore arm starting about 2 hours post-vaccine, lasting about 24 hours, improved with Tylenol.
45 2021-01-11 cough, headache, fever, influenza like illness loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs... Read more
loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
45 2021-01-11 fatigue, headache Severe dizziness with onset at 12 to 14 hours after injection Moderate to severe headache Moderate ... Read more
Severe dizziness with onset at 12 to 14 hours after injection Moderate to severe headache Moderate overall body ache, and fatigue
45 2021-01-11 fever, chills Fever, chills, body aches approximately 12 hours after vaccination.
45 2021-01-11 fever, headache HA, Nausea, fever, chills, stayed home
45 2021-01-12 chills, headache Headache, Body aches, Chills
45 2021-01-12 fever, headache Dizziness, Headache, Myalgia & Fever Narrative: Had fever of 100.8F , took Tylenol.
45 2021-01-13 chills, fever Chills, aches, fever max 100.3 post second dose Pfizer COVID vaccine. Patient was followed up with o... Read more
Chills, aches, fever max 100.3 post second dose Pfizer COVID vaccine. Patient was followed up with on 1/8/2021 and the patient stated that his symptoms had resolved. No further escalation of care.
45 2021-01-13 fatigue Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - I woke up in the middle of the night sweating, and felt tired the next morning with slight brain fog. Otherwise, I felt fine.
45 2021-01-13 headache headaches - starting Jan 6th and persisting but less intense joint pain - starting Jan 6th and persi... Read more
headaches - starting Jan 6th and persisting but less intense joint pain - starting Jan 6th and persisting but less intense Rash on arms, legs, thorax - erythematous, raised, vesicular in places and mildly pruritic - Jan 10 and persisting
45 2021-01-14 fatigue, cough 12/28/20 EE received 1st COVID vaccine; 1/4/21 EE began feeling increased fatigue with dry cough; CO... Read more
12/28/20 EE received 1st COVID vaccine; 1/4/21 EE began feeling increased fatigue with dry cough; COIVD(-)
45 2021-01-14 headache, fever, fatigue Fatigue; fever; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male... Read more
Fatigue; fever; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number:Ek9231, via an unspecified route of administration on the left arm on 08Jan2021 22:30 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paroxetine (PAROXETINE), finasteride (FINASTERIDE), testosterone (TESTOSTERONE) and rosuvastatin calcium (ROSUVASTATIN VIAL). The patient experienced fatigue, fever and headache on 09Jan2021 11:00 with outcome of recovered.
45 2021-01-16 fatigue, chills, fever, headache High Fever got at 2nd and 3rd Day, Body Pain for 4 days, Chills for 3 days, Tiredness still , Heada... Read more
High Fever got at 2nd and 3rd Day, Body Pain for 4 days, Chills for 3 days, Tiredness still , Headache is continuously in mild way.
45 2021-01-16 headache Dizziness, headache, loss of equilibrium. checked into the ER, received tests to rule out a heart a... Read more
Dizziness, headache, loss of equilibrium. checked into the ER, received tests to rule out a heart attack and stoke, received IV fluids and released. remained home in bed for the remainder of the day, symptoms lasted through the night
45 2021-01-17 chills, malaise TOOK IBUPROFEN BEFORE GETTING VACCINE AND AROUND 0230 AM WOKE UP WITH CHILLS THAT LASTED UNTIL MORNI... Read more
TOOK IBUPROFEN BEFORE GETTING VACCINE AND AROUND 0230 AM WOKE UP WITH CHILLS THAT LASTED UNTIL MORNING AND AS THE DAY WENT ON HAD GENERAL MALAISE/BODY ACHES.
45 2021-01-17 fatigue Starting from the first night after the vaccination and each and every night after that to date of t... Read more
Starting from the first night after the vaccination and each and every night after that to date of this form completion, I have had extremely interrupted sleep. I have woken up several times in the middle of the night (i.e., 2 am, 4 am, etc..). Each time I have woken up and felt wide awake and difficulty going back to sleep. As a consequence each of the following days after this poor sleep I have been in extreme fatigue and not able to function properly. I do not have any other notable side effects. No fever or major headaches. This disturbed sleep which coincidentally started right after the vaccination is highly concerning for me, especially since it has happened on 4 consecutive nights. This has not happened to me before. In the past even if I woke up in the middle of the night, I would fall back asleep relatively quickly. Furthermore, it has not been the case of this type of lack of sleep for this many consecutive nights. Another observation is that my feeling of hunger seems to have increased for some reason. Even in the middle of the night when I wake up I have felt great hunger and then starting in the morning that hunger continues. This is more hunger than normal for me. My diet and eating patterns have not changed compared to what it was before getting the first dose of the vaccination. Given that today is Martin Luther King Day and a Holiday my PCP is closed, so could not make an appointment or report this to her. I will call my PCP again tomorrow, 01/19/21. If this disturbed sleep continues, then I am sure how I can properly function during a normal work day on the job. Given all the above I am also concerned about the second dose of the vaccination and what side effects that may result in.
45 2021-01-17 fatigue Very weak and tired immediately after vaccine.
45 2021-01-17 headache PRONOUNCED PAIN @ INJECTIONS SITE TRAVELING DOWN ARM. HEADACH AND BODY ACHES. NAUSEAS. TOOK ADVIL FO... Read more
PRONOUNCED PAIN @ INJECTIONS SITE TRAVELING DOWN ARM. HEADACH AND BODY ACHES. NAUSEAS. TOOK ADVIL FOR PAIN, PEPTO AT NIGHT (1/12) AND MORNING (1/13)
45 2021-01-18 fever, headache, chills feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a con... Read more
feeling bad; 100 degree fever; chills; body aches; headache; This is a spontaneous report from a contactable nurse. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CH9899), via an unspecified route of administration from 11Jan2021 08:30 to 11Jan2021 08:30 at a single dose for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) On 21Dec2020 at first dose. Concomitant medication included melatonin. It was reported that the patient feeling bad after injection, got 100 degree fever, chills, body aches and headache; all on 11Jan2021 16:00. Took aspirin to reduce side effects but headache remains. The outcome of the event headache was not recovered while recovering for the other events.
45 2021-01-19 fever, chills, sweating Appendicitis, presenting as periumbilical tenderness at onset (26 hrs after vaccine admin) migratin... Read more
Appendicitis, presenting as periumbilical tenderness at onset (26 hrs after vaccine admin) migrating to RLQ approx 20hrs later (46hrs after vaccine admin) accompanied by fever, chills, sweats, and nausea. Presented to ER that evening and CT confirmed appendicitis (52hrs after vaccine admin). Surgery following day laparoscopic appendectomy (69hrs after vaccine admin). Recovery and clinical improvement over next 8hrs (77hrs after vaccine admin). Discharged following day (96hrs after vaccine admin)
45 2021-01-21 fatigue Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccinatio... Read more
Received second dose of Pfizer COVID vaccination on January 9, 2021. At the time of the vaccination he experienced discomfort of left deltoid (site of injection) as well as paresthesia at the injection site. He also experienced systemic symptoms of fatigue, myalgias, and arthralgias for 24 to 36 hours. Over the course of the next several days he experienced continued significant numbness and weakness in left upper extremity, specifically in left deltoid muscle. By Sunday 1/17/2021 the significant left deltoid weakness and numbness persisted, specifically not being able to lift his arm greater than 45 degrees using his deltoid. He contacted health on 1/17/2021. On 1/19/2021 he had a consultation with a physician. Based upon his clinical examination, and symptom complex, physician does not believe that this is a cervical spine issue but rather a local nerve injury related to the injection site. He was prescribed a steroid taper. Unclear whether this is temporary or permanent issue.
45 2021-01-21 fever, chills Fever, chills with temperature range between 101.8 - 102.5 F while on acetaminophen to max 24 hour d... Read more
Fever, chills with temperature range between 101.8 - 102.5 F while on acetaminophen to max 24 hour dose; unilateral left axillary and subpectoral adenopathy - easily palpable nodal conglomerate; fever resolved the next day; adenopathy resolved in 5-6 days
45 2021-01-22 fatigue, chills The arm muscle that received the shot became quite sore overnight, and lasted throughout the next da... Read more
The arm muscle that received the shot became quite sore overnight, and lasted throughout the next day. The rest of me felt like I had a mild case of the flu. Aches and fatigue all over, with some chills. I have been training for a half marathon, and this through off my training due to knee pain. I also had diarrhea that has lasted through Saturday. The first day after was the worst, and things have improved each day since.
45 2021-01-23 fever, fatigue Body aches, fatigue, and fever of 100.5
45 2021-01-24 chills Pain at the site of the vaccination, chills and generalized pain.
45 2021-01-24 fatigue, headache Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / s... Read more
Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / slept for 3 hours woke to just severe fatigue; Headache started about 6 hours after, progressively worsening about 12hrs; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899), via an unspecified route of administration at single dose in the left arm on 11Jan2021 14:00 to for Covid-19 immunisation. Medical history included was none. Concomitant medication included fluticasone propionate and multi vitamin. The patient experienced headache started about 6 hours after, progressively worsening about 12hrs on 11Jan2021 20:00, motion sickness, and fatigue started about 11am on 12Jan2021. Completely wiped out by noon and had to lay down could not work slept for 3 hours woke to just severe fatigue, slight headache no nausea. Therapeutic measures were taken as a result of headache included Advil but no help. No treatment received for the other events. The vaccine was administered at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
45 2021-01-24 headache Left axillary adenopathy and mild headache
45 2021-01-24 fever, headache, fatigue Low grade temp (100 deg f) beginning about 3 hours after receiving shot. Became very tired and loss... Read more
Low grade temp (100 deg f) beginning about 3 hours after receiving shot. Became very tired and loss of appetite followed by diarrhea about 8 hours after shot followed by mild headache through the next 24 hours. I am reporting this mainly because my reaction was unexpected and happened on the first dose. I have not yet received my second dose.
45 2021-01-25 fatigue BEGAN FEELING FATIGUED AROUND 4PM YESTERDAY. WOKE UP THIS MORNING WITH BODY ACHES AND FATIGUED.
45 2021-01-25 fever, chills He has a fever of 102.2 and having chills and body aches complaint about lack of energy .
45 2021-01-26 fever coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 10... Read more
coronary spasm; STEMI COVID vaccine induced; slight 1-2/10 substernal chest pain on/off; fever of 101 to 101.7; diffuse severe muscle aches; tachycardia of 110 to 130; painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN); This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included benign prostatic hyperplasia (BPH). Concomitant medication included alfuzosin. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) in the left arm on 23Dec2020 16:00 at the age of 44 years old for COVID-19 immunization. On 14Jan2021, the patient started having fever of 101 to 101.7, diffuse severe muscle aches, and tachycardia of 110 to 130. Thursday evening (14Jan2021) through Sunday (17Jan2021), the patient also had painful lymphadenopathy of the ipsilateral axilla and clavicular lymph node (LN). Thursday evening (14Jan2021), the patient had slight 1-2/10 substernal chest pain on/off. Friday evening around 23:30 (15Jan2021), the patient had chest pain substernal 7-8/10 that lasted for one hour. The burning sensation was worse with cold air. It resolved with paracetamol (TYLENOL) and ibuprofen. Monday early morning at 04:00 (18Jan2021), the patient experienced STEMI COVID vaccine induced wherein the patient woke up with 10/10 chest pain and shoulder pain which lasted for 30 to 40 minutes and resolved with paracetamol and ibuprofen. The patient also decided to check blood work Monday morning (18Jan2021) while in the hospital. Trop came back 16.28 ng/ml. This is the old trop not high sensitivity. Normal high is 0.30 ng/ml. The patient went to the hospital. ECG showed ST elevation inferior lead. Left heart catheterization was done. The patient have clean coronaries. No evidence of any atherosclerosis. Echocardiogram showed normal EF. No wall motion abnormality. It was concluded that the patient also had coronary spasm. The patient underwent other lab test and procedure which included nasal swab COVID test showed negative on 18Jan2021. Outcome of the lymphadenopathy was recovered on 17Jan2021, of the chest pain was recovered on Jan2021, of the coronary spasm and STEMI was recovering, while of the remaining events was unknown. The events coronary spasm and STEMI resulted in hospitalization and life threatening illness.; Sender's Comments: The reported coronary spasm with chest pain and suspected STEMI were likely related to the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship, and no evidence of any atherosclerosis during left heart catheterization. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-01-27 headache Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headach... Read more
Days after receiving first shot, would wake up within 2 hours of falling asleep with a sharp headache on left side of head. Would sit up and move around and headache would dissipate with 30 minutes. Am not able to lay on back or on side. Received booster on 1/26/2021 and have had same events. OTC pain killers are not working. Once I initially wake up I move to recliner and fall asleep. We have a sleep number bed and have not had this issue in the past, although don't know if it is the vaccine or a unknown subtle change in day to day activities.
45 2021-01-27 fever, chills fever; chills; severe body aches; This is a spontaneous report from a contactable physician (patient... Read more
fever; chills; severe body aches; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 13Jan2021 14:30 at single dose for Covid-19 immunization in a hospital. Medical history and concomitant medications were none. Historical vaccines included first dose of BNT162B2 on 23Dec2020 for Covid-19 immunization and with a week (30Dec2020 16:15) he developed COVID positive test, had a mild to moderate illness. The patient received second dose and developed fever, chills and severe body aches on unspecified date in Jan2021. The outcome of the events fever, chills and severe body aches was unknown. Follow-up activities are possible, information on the batch number has been requested.
45 2021-01-29 chills, headache 15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin ... Read more
15-36 hours after: headache, chills, injection site pain 9 days after: Hair follicle and or skin tenderness concentrated to the back left lower quadrant of head.
45 2021-01-31 fatigue, chills achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection sit... Read more
achiness in his legs and hands; Chills; Fatigue; injection site swelling and achiness; injection site swelling and achiness; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 45-years-old male patient received bnt162b2 (BNT162B2; Batch/lot number: EK4176), via an unspecified route of administration at left arm on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient experienced fatigue on 17Jan2021 with outcome of not recovered, achiness in his legs and hands on 18Jan2021 with outcome of not recovered, chills on 18Jan2021 with outcome of not recovered, injection site swelling and achiness on 13Jan2021 with outcome of recovered on 14Jan2021. The patient reported after he got the first COVID vaccine on 13Jan2021 he experienced fatigue, achiness, and injection site swelling. Patient wanted to know if this is normal after the first dose and this was discussed. Patient explained that the fatigue - this didn't start until 17Jan2021 and was ongoing. On 18Jan2021 he starting having achiness in his legs and hands and he also had a few chills today. The injection site swelling and achiness there, was gone after the 14Jan2021. Patient was really looking for an answer to his question on if it was normal or should he get a COVID test. He was on day 5 after getting the vaccine and from what he read most people have side effects within a 24 hours and gone within 48 hours. Some of his side effect didn't start until 4 days later. The Vaccination Facility Type was hospital. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not go to Emergency Room or Physician Office. There was no Prior Vaccinations (within 4 weeks).
45 2021-01-31 headache, chills 01/19/21 1:30 pm Body ache, temp. 99°F, chills, headache for tow days. Verbalize feeling well and... Read more
01/19/21 1:30 pm Body ache, temp. 99°F, chills, headache for tow days. Verbalize feeling well and recovered.
45 2021-01-31 fever, chills Low grade fever, chills, Red, hot, swollen rash at injection site that is spreading to half of upper... Read more
Low grade fever, chills, Red, hot, swollen rash at injection site that is spreading to half of upper arm
45 2021-02-01 nasal congestion, fever, chills Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with blo... Read more
Fever of 103-104 degrees for 10-12 hours; chills; congestion with bloody mucous; congestion with bloody mucous; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 15Jan2021 at 08:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included GERD and sleep apnea, both from unspecified dates and unspecified if ongoing. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported; however, it was reported that there were no other medications taken in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 27Dec2020 at 08:15 (at the age of 45-years-old) in the left arm for COVID-19 vaccination. On 16Jan2021 at 03:00 the patient experienced fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous. It was reported that the patient did not receive treatment for the events. The clinical outcomes of the events fever of 103-104 degrees for 10-12 hours, chills and congestion with bloody mucous were all recovered/resolved on unspecified dates in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
45 2021-02-02 headache, head discomfort Continuously headache (something like poking inside head, heaviness in head)
45 2021-02-03 fatigue arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administratio... Read more
arm soreness, fatigue Narrative: Developed arm soreness and fatigue following vaccine administration. Resolved by 1/1/21.
45 2021-02-04 fever, headache HA, BODY ACHES, FEVER
45 2021-02-06 fatigue, body temperature increased, headache, chills Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/ine... Read more
Symptoms began 12 hrs after injection and lasted for 24 hrs from onset of symptoms. Sore deltoid/inection site, chills, body aches, fatigue, mild headache, max recorded oral temp = 99.6 degrees (personal norm 96-97 degrees oral). Out of work x1 day due to COVID-19 screening/symptom algorithm.
45 2021-02-07 fatigue Local nerve injury/significant numbness and weakness in his upper extremities specifically in his le... Read more
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist. A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown. He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
45 2021-02-07 headache, malaise well that night i lost all taste and smell that was Friday today is Monday and still no better - Sat... Read more
well that night i lost all taste and smell that was Friday today is Monday and still no better - Saturday was the hardest i just tried to sleep the pain away- by Sunday i had full on covid19 symptoms and was very sick - now 4 days in i still have a headache , cant brethe these symptoms arent just mild and i worry about someone older then me taking this
45 2021-02-08 fatigue, malaise Soreness at injection site initially which progressed to mediate pain, like a knot in the arm that w... Read more
Soreness at injection site initially which progressed to mediate pain, like a knot in the arm that was painful. Also, around 4 hours after the injection, extreme fatigue set in and it felt like I was getting sick, like I normally do with a cold or flu. After 12 hours of sleep from the tiredness, I felt normal the next day, but site where shot was in the left arm was very sore and painful.
45 2021-02-08 headache 45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his fi... Read more
45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.
45 2021-02-08 sweating felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swell... Read more
felt dizzy and weak. Was diaphoretic. BP at time was 98/32 w P 64. chest clear, no SOB no oral swelling. Rested supine for 30 minutes. Felt much better. BP 118/72, P 68
45 2021-02-09 chills 1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful... Read more
1. Moderate Pain Site of the Injection (started 12 hours after injection) lasted (4 days) 2. Painful Lymph-nodes : Location Right cervical , Right side supra clavicular and infra clavicular , lasted for 1 week 3. Light headed lasted 2 days 4.nauseas lasted 3 days 5 diarrhea mild lasted 2 days 6. Chills , lasted for 3 days 7 weakness , lasted 10+ days
45 2021-02-09 fever, headache Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (pati... Read more
Headache; Mild fever; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248; Expiration date was not reported) on 19Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included Celiac disease and gluten allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA). On 20Jan2021, the patient had headache, mild fever and lack of energy. The patient did not receive any treatment for the reported events. The outcome of the events, headache, mild fever and lack of energy, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination. No follow-up attempts are possible. No further information is expected.
45 2021-02-10 sweating, headache Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began ... Read more
Profuse sweating followed by headache and numbness to my head. After a few minutes my tongue began to swell followed by my lips and face. Was given 50mg PO Benadryl five minutes later a shot from an EpiPen. Trip to ED via ambulance IV Benadryl and Solu-Medrol was administered. After 3 hrs all swelling was gone and was discharged.
45 2021-02-11 pneumonia, fever Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform r... Read more
Pt received vaccine on 1/22/21. On 1/31/21 he presented to urgent care with fever and morbiliform rash. He tested negative for the flu and was given empiric oseltamivir. He had persistent fever and was given doxycycline and ceftriaxone by urgent care on 2/2. On 2/4 at urgent care he was noted to be hypotensive and referred to ER. He had findings of cardiogenic shock and intra-aortic balloon pump was placed. He was treated for acute heart failure with improvement in symptoms. He was also treated for pneumonia with piperacillin/tazobactam as well as amoxicillin / clavulanic acid. He was discharged with resolved fever, resolved rash, and improvement in EF based on cardiac MRI. Workup for other viral causes of myocarditis was negative.
45 2021-02-17 chills fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost contro... Read more
fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.
45 2021-02-18 head discomfort 2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and ... Read more
2 days after 2nd dose of vaccine, there were vision changes (blurred vision), pressure in head, and palpitations. Vision (only have one eye) has been hazy when looking at computer. This is still on going. Work up done by optometrist at this point eye checks ok but problem persist. Referral to ophthalmologist is place. Feeling of fogginess in head - "drunk like feeling" persisted for several weeks. This still seems to be on going. Palpitations and some check pain. - This was never a finding prior to 2nd dose of vaccine. This has resolved.
45 2021-02-18 headache, fever Headache fever body aches
45 2021-02-19 throat pain 1st Vaccine 1/9/21; 2nd Vaccine 1/28/21; symptomatic 2/18/21 with sore throat, mild SOA, and diarrhe... Read more
1st Vaccine 1/9/21; 2nd Vaccine 1/28/21; symptomatic 2/18/21 with sore throat, mild SOA, and diarrhea ; seen at Facility 2/19/21 for symptoms and tested COVID + ; >14 days post 2nd vaccine
45 2021-02-21 fatigue large mass under the armpit. possible swollen lymph nodes. muscle pain, fatigue, tingling feeling o... Read more
large mass under the armpit. possible swollen lymph nodes. muscle pain, fatigue, tingling feeling on the lower lip left hand side,
45 2021-02-23 fatigue moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a conta... Read more
moderate fatigue/tiredness; some difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL 3247, expiry date unknown) in the workplace clinic, via an unspecified route of administration on 26Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that on 27Jan2021 at 06:45, the morning after the patient was vaccinated, he had moderate fatigue/tiredness with some difficulty concentrating. The patient stated that it felt similar to getting 2-3 hour sleep, but he had no issue sleeping last night. The patient did not receive treatment for the event. The patient was recovering from the events. The events were reported as non-serious.
45 2021-02-23 headache Headache; pain in left arm; This is a spontaneous report from a contactable consumer (patient himsel... Read more
Headache; pain in left arm; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 3247), via an unspecified route of administration in left arm on 27Jan2021 11:15 AM at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications included PROBIOTIC and colecalciferol (VITAMIN D). The patient have not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 12:00 PM, the patient experienced headache and pain in left arm. The patient did not receive treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was recovered on an unspecified date in 2021.
45 2021-02-28 sweating 1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left... Read more
1. Diaphoretic 10 minutes after vaccine administration 2. Tongue swelling 3. Right arm cold and left arm hot 4. Throat tightening Was treated with Bendryl and EpiPen then sent to the ER
45 2021-03-02 body temperature increased Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over... Read more
Mental fogginess, to the point a coworker had to drive him home. In the evening became achy all over severe arm pain at injection site, and temperature. Phoned PCP who told to go to the ER and he did not. went to PCP office 2/1/21.
45 2021-03-02 headache, fatigue Extreme fatigue, Joint Pain full body, muscle pain, rapid heart rate, chest discomfort onset within ... Read more
Extreme fatigue, Joint Pain full body, muscle pain, rapid heart rate, chest discomfort onset within 2-3 hours. Progressive joint pain and headache within 24 hours, chest discomfort in and around the heart. Sought medical treatment after pain discomfort dis not alleviate within 3 days, on 3/1/21. Dr. prescribed steroid injection for inflammation, ordered cbc (negative) with follow up. Possible indications of possible Pericarditis. Follow up within 24-48 hours. Joint pain has lessened from total body to being located in wrists, knees, ankles, toes. Pressure/discomfort around heart/chest has lessened but not been eliminated. Awaiting possible ECG/EKG
45 2021-03-03 throat irritation Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left... Read more
Went into anaphylactic shock with 5 minutes. Throat started to itch, ears were popping and the left side of my face began to feel pressure. My wife injected me with my EpiPen. Within 10-15 minutes, the symptoms began to recede.
45 2021-03-05 chills Sore left arm - 15 hours after dose administration Body Aches and Chills - 24 hours after administr... Read more
Sore left arm - 15 hours after dose administration Body Aches and Chills - 24 hours after administration
45 2021-03-09 fatigue, fever I sat for 15 min and not symptoms. About 3 or 4 hours later I was tired and had achy joints. The nex... Read more
I sat for 15 min and not symptoms. About 3 or 4 hours later I was tired and had achy joints. The next morning I had a fever that maxed at 100.7. I experienced pain in my shoulders, hips and knees. I was fine the next day. I didn't have to actually get treatment, but I did have to get tested for COVID again before I could return to work.
45 2021-03-09 fever I had Covid in Dec 2020. About 24 after shot I experienced symptoms that were far worse than my expe... Read more
I had Covid in Dec 2020. About 24 after shot I experienced symptoms that were far worse than my experience with Covid. I did not have a fever with Covid, a day after the shot I had a fever of 103.1, I have not ran a fever in 15-20 years.
45 2021-03-10 malaise Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left v... Read more
Recipient stated began feel bad almost immediately after his injection, stayed 15 minutes and left vaccination area but waited in the parking lot and reported back into the vaccination clinic approx 45 minutes. Reported feeling very bad all over, trembling, glucose per his report of 148. skin was somewhat clammy to touch, bp 150/105 and 5 minutes later 170/110, hr 120s, rr 20, referred to PCP
45 2021-03-12 cough, bronchitis, malaise, respiratory tract congestion NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALL... Read more
NEXT DAY STARTED GETTING COUGH, CONGESTION, DYSPNEA, MALAISE, LOSS OF TASTE, LEFT ARM PAIN. GRADUALLY WORSENED, PERSISTING.
45 2021-03-14 headache headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male ... Read more
headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 20Jan2021 at 12:30 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. After the first dose (Jan2021), the patient just had a slight headache. No treatment was provided for the event headache. The outcome of the event headache was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.;
45 2021-03-14 fever, throat pain slight fever; sore joints; sore injection site; a slight sore throat; This is a spontaneous report f... Read more
slight fever; sore joints; sore injection site; a slight sore throat; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular in the left arm on 10Feb2021 at 11:45 (at the age of 45-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 20Jan2021 and experienced headache. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 05:00 (after second dose), the patient experienced slight fever, sore joints, sore injection site and a slight sore throat. No treatment was provided for the events fever, sore joints, sore injection site and sore throat. The outcome of the events fever, sore joints, sore injection site and sore throat was recovering. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148082 same patient, different vaccine dose/AE
45 2021-03-15 fatigue, headache Headache Injection site pain, fatigue Narrative: Other Relevant History:
45 2021-03-15 fever Fever over 100.8, server body ache, swollen on arm, lump size of fist under my arm, vexation pain , ... Read more
Fever over 100.8, server body ache, swollen on arm, lump size of fist under my arm, vexation pain , shortness of breath
45 2021-03-16 headache Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have som... Read more
Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have some tingling in his face. He received 25 mg of oral diphenhydramine with good results within 30 minutes. Pt has a h/o anaphylaxis to allergy shots as a child one time, but then never had a reaction again.
45 2021-03-18 body temperature fluctuation, sweating, cough, fatigue, runny nose, throat pain, chills I have had fatigue, temperature fluctuations (chills and sweats), runny nose, more frequent cough. O... Read more
I have had fatigue, temperature fluctuations (chills and sweats), runny nose, more frequent cough. On third day sore throat started.
45 2021-03-18 malaise, chills, fatigue, fever Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chill... Read more
Injection site pain (severe for 24 hours and mild for next three days), 24 hours of tiredness, chills, feeling unwell, slight fever, dizziness.
45 2021-03-18 fever Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of ... Read more
Beginning 6 days after 2nd vaccine dose, had one day of low grade fever (first day only), 2 days of arthralgia of MCP and IP joints of hands, knees, ankles, MTP joints of feet; 4 days of peripheral worse than central neuralgia (mild on anterior torso and thighs, increased over both forearms and legs, and extreme/severe of hands & feet, with even light touch, clothes, bedsheets causing burning pain. Neuralgia responsive to Gabapentin, but not acetaminophen or ibuprofen. After 4 days of neuralgia resolved, then still had altered heat and cold sensation/perception for hands and feet (palms & soles more than dorsa) for 3-4 more days, but no pain.
45 2021-03-18 fever 3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pai... Read more
3 days after vaccination severe nerve pain and neuropathy; 3 days after vaccination severe nerve pain and neuropathy; Low grade fever, under 100; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 27Feb2021 at 12:00 PM (at age of 45 years old) at a single dose for COVID-19 immunization. Medical history included hereditary spastic paraplegia. No known allergies. The patient did not have COVID prior vaccination, also not tested COVID post vaccination. No other vaccine in four weeks. Concomitant medications included dextromethorphan hydrobromide, quinidine sulfate (NUEDEXTA), pregabalin (LYRICA), cetirizine hydrochloride (ZYRTEC), venlafaxine. On 02Mar2021 at 09:15 AM (3 days after vaccination), severe nerve pain and neuropathy occurred. Sensation common with my disorder, but never this severe. Affected arms and legs. Lasted about 18 after onset. Typical incident will last no more than an hour. Low grade fever, under 100. No treatment received. The outcome of the events was recovering.
45 2021-03-19 body temperature increased, chills, headache At 7am after a good night's sleep I started feeling a mild headache, naseua, muscle aches and chills... Read more
At 7am after a good night's sleep I started feeling a mild headache, naseua, muscle aches and chills. Took Tylenol and slept 3.5 hrs. Woke up w a mild elevated temperature, but all other symptoms had nearly completely subsided. Rested the remainder of the day and felt fine the following day.
45 2021-03-19 chills, fever Severe fever with rapid onset accompanied with chills. At least 103.4 F measured with a very precise... Read more
Severe fever with rapid onset accompanied with chills. At least 103.4 F measured with a very precise thermometer. Resolved in 3-4 hours with bedrest, Tylenol and ibuprofen.
45 2021-03-21 fatigue After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 da... Read more
After 2nd dose, I did not have a high fever but been fatigue and lightheaded/energy drained for 3 days with heart palpitations like If I had OD on energy drinks. The symptoms disappeared on 4th and 5th but returned the 6th day morning ... feeling like I woke up after 2 tablets of Bynadril
45 2021-03-21 headache, fatigue, chills, sweating Severe fatigue, headache, chills, sweats and diarrhea lasting until the morning of March 22, 2021.
45 2021-03-22 headache, chills Body aches, chills, headache
45 2021-03-22 fever, headache, fatigue fever, headache, fatigue
45 2021-03-23 chills, headache, fever, sweating Fever, chills, sweats, nausea, muscle aches and headache. Happened about 12:30am. Took some nausea ... Read more
Fever, chills, sweats, nausea, muscle aches and headache. Happened about 12:30am. Took some nausea medication and Tylenol. Was able to get back to sleep after an hour of fighting off vomiting . Nausea is mostly gone this morning. Headache and muscle soreness still persist.
45 2021-03-24 fatigue, chills Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog f... Read more
Burning Skin (face, feet) alternating with deep chills (but no fever); Extreme fatigue; Brain fog fatigue and brain fog still persistent 6 days after symptom onset (13 days post-vaccination). Burning skin significantly lessened after 5 days (still happens occasionally)
45 2021-03-25 runny nose, fatigue Headache, runny nose, red, bloodshot and sore eyes
45 2021-03-27 head discomfort, headache Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ... Read more
Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ,jaw and tongue. Left eye does not blink so constantly tears, slurred speach and no taste. Symptoms started on 3/21/21 and got worse. Meds prescribed acyclovir 800mgs , prednisone 10mg and Diclofenac sod dr 75 mg for pain.
45 2021-03-27 sweating 0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instru... Read more
0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instructed to lay down on floor as also reported "feeling like I am going to pass out". Pt placed on gurney via backboard and placed in Trendelenburg position. transported to medical observation area. vs taken upon arrival to medical observation BP 116/79 P 93 pox 95%, strong pulse, pallor noted. Pt stated "feeling better" and color improved to pink , strong pulse noted. Pt placed in supine position on gurney. 0958 Pt continued to improve with HOB elevated to 45 degrees and pt given graham crackers and 4 0z apple juice . BP 133/89 P 90 pox 95%. 1010 Pt reports feeling much better, drank 4 oz water and ate more graham crackers. Pt reported that he had not eaten breakfast and only drank a cup of caffeinated coffee prior to receiving vaccine. Reports "feeling much better" with the water , juice and crackers. BP 124/84 P 89 pox 97%. 1025pt sitting in chair and reportins feeling "back to normal" BP 125/84 P 83 pox 96%. Pt discharged with instructions to f/u with pcp if any other symptoms today. instructed to remain hydrated today and to eat healthy lunch and dinner.
45 2021-03-28 fatigue Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
45 2021-03-29 throat pain Swollen gland in the neck, sore throat (left side), ear pain (left side), and swollen lymph node in ... Read more
Swollen gland in the neck, sore throat (left side), ear pain (left side), and swollen lymph node in armpit (left armpit)
45 2021-03-30 headache, chills headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consume... Read more
headache; left arm pain; chills; body aches; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:30 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome and GERD (gastrooesophageal reflux disease) from an unknown date and unknown if ongoing. Concomitant medication(s) included probiotics taken for an unspecified indication, start and stop date were not reported; clotrimazole taken for an unspecified indication, start and stop date were not reported; diphenhydramine taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. The patient previously administered first of BNT162B2 (lot number :EL3247) on 27Jan2021 11:30 AM administered in Left arm for covid-19 immunisation. The patient experienced headache, left arm pain, chills and body aches on 17Feb2021 11:45. The patient did not received prior vaccination and covid tested post vaccination and also reported known allergies as no. Therapeutic measures were taken as a result of headache, left arm pain, chills and body aches and included treatment with acetaminophen 500 mg x 2 tablets. The outcome of the events was reported as not recovered.
45 2021-03-30 headache, fatigue, sweating, nasal congestion, fever 27 MAR: Received dose #2. Gradual onset of headache and unusually fatigued. 28 MAR: Slight headache,... Read more
27 MAR: Received dose #2. Gradual onset of headache and unusually fatigued. 28 MAR: Slight headache, achy joints, sore lower back (kidneys), diarrhea, congestion and runny nose, slight fever (100), unusually fatigued. 29 MAR: Significantly improved, but severe congestion on left side while extremely runny nose on right side. 30 MAR: Regression - complete congestion (only able to mouth-breathe all day). By mid-day, achy joints returned. 31 MAR: Still heavy congestion, but able to breathe through nose. Very sore lower back. Minor achy joints. Mild sweating (with no fever - 98.5) shortly after waking up.
45 2021-03-30 fever, fatigue Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical ... Read more
Within the first few day - typical AEs (low grade fever, sore arm, fatigue). However, the atypical AEs included daily and persistent dizziness, "brain fog", fatigue, difficulty going up the stairs without getting winded (difficulty with physical exertion). These symptoms are still present on March 31st (11 days post injection). GI / diarrhea symptoms are also present. Of note, I did have COVID in the past (January 2021) - and had similar symptoms that had resolved at the time of the vaccine. These symptoms are severe enough that it may prevent the second shot (due to concerns of worsening AEs or prolonged events). Of note, the fatigue was worse with the actual disease vs. the vaccine.
45 2021-03-30 fever Nausea, diarrhea, fever, light headedness.
45 2021-03-31 chills, fatigue, fever Within 4 hours of the 2nd shot, I notice that I experienced fatigue. Within 12 hours of taking the 2... Read more
Within 4 hours of the 2nd shot, I notice that I experienced fatigue. Within 12 hours of taking the 2nd shot I had minor body aches and chills with a low grade fever. This lasted approximately 12 hours. I took Ibuprofen and it helped with the minor symptoms.
45 2021-03-31 chills, influenza like illness, fever There were chills (like I was having a fever) at mid-night of the shot (shot was given in the mornin... Read more
There were chills (like I was having a fever) at mid-night of the shot (shot was given in the morning), to the extent that I was shivering. I had a low grade fever for most of the day. I measured it once and it came to 99F. I felt like I had a bad cold or mild flu. Symptoms prompted me to take the day easy (took off work and stayed in bed). Symptoms completely resolved by the next morning. I did not take any medication. I had no reaction to the first shot at all (besides a sore arm which was common for both shots)
45 2021-03-31 fatigue All started the morning of the day after the vaccine shot and got progressively got worse the entir... Read more
All started the morning of the day after the vaccine shot and got progressively got worse the entire day. They were all gone by the next day. Fatigue Nausea Muscle Aches Confusion/dizziness
45 2021-03-31 malaise, sweating A few minutes after shot administered pt slumped in seat was unconscious for a short time. he came t... Read more
A few minutes after shot administered pt slumped in seat was unconscious for a short time. he came too was embarrassed said he felt fine but a few minutes after he stated he was not feeling well at all. pt became pale, extreme sweating, and low blood pressure/pulse with BP machine. at that time paramedics was called and arrived when patient was beginning to feel better. Paramedics offer to take to hospital but pt declined and could walk with not feelin dizzy. followed up with patient this evening and he is feeling much better. Patient contact his MD and discussed with him. His MD advised him to receive shot lying down for second shot.
45 2021-03-31 fever, chills Chills, Fever starting 12-13 hours after injection, lasting 8 hours. Sore arm.
45 2021-04-01 fatigue On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy... Read more
On the first dose I was very tired. On the second dose I had right arm pain for a day. Very heavy.
45 2021-04-01 lethargy sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhe... Read more
sore arm, brain fog, headache, swollen lymph nodes, pain in brain stem, sore neck, lethargy, diarrhea, bowel discomfort, arthritis flare-up
45 2021-04-01 fever, chills 10-12 hours after getting the shot I started to experience body aches, chills, and fever. These sym... Read more
10-12 hours after getting the shot I started to experience body aches, chills, and fever. These symptoms lasted through the night. The following day I felt better but had no energy. It was a one day thing. I've felt fine since then.
45 2021-04-01 fever At night began a fever, body aches, similar to a cold, he took advil,
45 2021-04-02 body temperature increased, headache, throat pain I had a high temperature all day, pain throughout my body, a headache that I still have and for a mo... Read more
I had a high temperature all day, pain throughout my body, a headache that I still have and for a moment I felt pain in my throat but I did not go to the hospital, I am recovering at home.
45 2021-04-02 headache sore and achy all over; headache; sore arm at injection site; soreness and achiness progressed; This... Read more
sore and achy all over; headache; sore arm at injection site; soreness and achiness progressed; This is a spontaneous report from a contactable consumer. A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 at single dose for covid-19 immunization. The patient medical history was not reported. Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 21Jan2021 09:45 at single dose for covid-19 immunization. Concomitant medications included loratadine (ALAVERT) taken for an unspecified indication and melaleuca multivitamins/minerals. As per adverse event description, on 11Feb2021 18:00, sore and achy all over, headache, sore arm at injection site, but not right away, it took until the evening the same day as the 2nd injection. The soreness and achiness progressed a bit more from the evening into the morning, today. I felt nothing at all after the first injection. The patient did not received treatment. Upon follow up, it was confirmed that he mentioned that he noticed the onset on 11Feb2021 at around 6 pm, the start of it, but then felt the symptoms increase into the night and then more so the next morning on 12Feb2021. The outcome of events not recovered. No follow-up attempts are possible. No further information was provided.
45 2021-04-02 headache I am having consistent and chronic headaches well over a week later. Have never suffered from heada... Read more
I am having consistent and chronic headaches well over a week later. Have never suffered from headaches like this after the 2nd injection. Had the headaches stopped within 48-72 hours after the injection this wouldn't be a big deal, but I am still having bad headaches 8 days later. Tylenol sometimes helps a little, but sometimes it doesn't. I am concerned about my long term health.
45 2021-04-03 chills, fever Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, diz... Read more
Within 3 minutes of receiving vaccine I had Instant fever, nausea, arm pain, face and lips numb, dizziness, blood pressure low, chills. The pharmacy had to call 911 for a paramedic. I'm still feeling symptoms almost 24hrs later. I chose not to go to hospital in ambulance.
45 2021-04-03 malaise patient developed malaise, abdominal pain and nausea 2 days after the vaccination. It did not impr... Read more
patient developed malaise, abdominal pain and nausea 2 days after the vaccination. It did not improve for a week and he presented to the hospital and was diagnosed with acute superior mesenteric vein and portal vein thrombosis along with pancreatic edema
45 2021-04-03 fever, headache Three weeks after the second vaccination, the patient developed fever to 102, headache and myalgia. ... Read more
Three weeks after the second vaccination, the patient developed fever to 102, headache and myalgia. Two COVID tests and a respiratory viral panel were negative. EBV IgM and IgG were positive. Several small (only a few mm) lesions of biopsy-proven cutaneous vasculitis appeared on the face, upper and lower extremities. PCR from the skin biopsy was positive for HSV2. All skin lesions self-resolved and patient and patient is now well.
45 2021-04-05 fatigue, fever Persistent mild fever (99.5+) Ache (bone-ache, almost like arthritis) Fatigue Sleep trouble
45 2021-04-05 throat irritation, fatigue Caller stated very minimal soreness approx 2 days after rcvding the vaccine, more of a discomfort ar... Read more
Caller stated very minimal soreness approx 2 days after rcvding the vaccine, more of a discomfort around the injection site but otherwise felt okay. Caller stated on Friday morning on 3/26/2021 he felt fatigue, tired, and muscle ache in his arms and legs. He took Ibuprofen on Sunday evening 3/28/2021, felt better the next morning but still felt very fatigue. Caller also stated he tests positive for COVID-19 on 3/31/2021, and as of today his throat feels scratchy and itchy, and still feeling fatigue. 4/5-Patient symptoms have resolved, awaiting to take second vaccine in the upcoming week.
45 2021-04-07 body temperature increased Severe diarrhea about 72 hours after first dose, persisting for about 5-6 days. Also experienced som... Read more
Severe diarrhea about 72 hours after first dose, persisting for about 5-6 days. Also experienced some aches and temperature of about 102 degrees F about 72 hours after first dose, but this only lasted about 1 day.
45 2021-04-07 chills, fever, fatigue Chills, fever, body ache, tired
45 2021-04-07 headache Pt was sitting at the observation area when he informed the Observer that he felt dizzy with no othe... Read more
Pt was sitting at the observation area when he informed the Observer that he felt dizzy with no other symptoms. At the moment when the observer came to me, I was helping with the reconstitution of the vaccine. I literally had the vial in hand with syringe. I kindly asked her to get one of the RN's that were awaiting the arrival of pt's. She went to grab RN who then went to speak to the pt. Pt was taken to the bed we have set up here at the vaccination clinic. Pt laid down on bed as I walked in to assist RN. I then elevated pt's legs and RN proceeded to take pt's vital signs. The ONLY symptom pt had was dizziness and a slight headache. No hives, breathing problems or swelling of the the throat. We applied a cold pack to the back of pt's neck. stayed and observed him for 15 minutes. He then stated he felt better besides the headache. No new symptoms at this point. vitals were re-taken and pt was allowed to sit up to see how he felt. Pt felt fine we then proceeded to have pt stand in which he also stated he felt fine .Pt was provided the post-vaccine handouts and verbally explained the signs and symptoms to him as well. Explained if anything severe were to happen, to call 911. Pt verbalized understanding and stated that he would. pt's wife and 2 sons were also here for a vaccine. Pts wife was instructed to drive home. No further action was required. 312pm- pt informed observer of dizziness 313pm-pt was sent to cot 315pm-BP: 158/92 HR: 69 RR: 16 O2: 98% 321pm-BP: 120/78 HR: 78 RR:20 O2: 98% T: 97F Temporal 325pm-No dizziness on cot but did complain of headache 2/10 328pm- BP: 122/78 HR:77 O2:99% T: 98F Temporal 330pm-Sat on side of bed with no dizziness 332pm-No dizziness, left facility with wife.
45 2021-04-08 influenza like illness, headache, malaise flu like symptoms; Body aches; headache; feeling unwell; This is a spontaneous report from a contact... Read more
flu like symptoms; Body aches; headache; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EM9810, Expiration Date: Jun2021) via unspecified route on 11Feb2021 at 11:30 AM in the left arm as single dose for covid-19 immunisation at hospital. Patient's medical history included GERD, take 20 mg Nexium and allergic for clyndamycin antibiotics. Concomitant medications not included. The patient did not receive any other vaccines in 4 weeks. The patient was not diagnosed with COVID-19 prior or since the vaccination. On 12Feb2021, at 02:00 AM the patient experienced body aches, flu like symptoms, feeling unwell and headache for about 2 days. After a day 2 days of headache still lingers. Events were treated with Tylenol twice a day and once on next day. Outcome of events was recovered with lasting effects.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021363289 Same reporter/ drug, different patients/ events;US-PFIZER INC-2021363288 Same reporter/ drug, different patients/ events.
45 2021-04-09 fatigue, headache Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely naus... Read more
Went to get up to get ready for work and instantly collapsed-scraping up knee. Became extremely nauseous, weak, excruciating headache and dizzy. Unable to stand, had to crawl to nearby chair and call for wife. Thought might be dehydrated, extremely pale, tried to drink water, but began vomiting. BP was elevated, but no temperature. Tried to eat crackers and drink more water, but continued to violently vomit. Never felt so badly in entire life. No strength to stand or get up the stairs to be taken to ER, so had to call paramedics. When they arrived, BP had come down, but they felt needed to be transported to ER, so they took to healthcare facility at about 1:30 pm.
45 2021-04-09 headache, fatigue Within 4hrs of receiving the 2nd dose of Pfizer COVID-19 vaccine I began to experience ringing in th... Read more
Within 4hrs of receiving the 2nd dose of Pfizer COVID-19 vaccine I began to experience ringing in the ears followed by onset of extreme headaches and body aches somewhat dissimilar from the flu. These aches felt like painful internal construction of the head neck back and thigh muscles. Severe pain in the left arm where I received the jab. I was extremely fatigued and could barely make it from bed to the bathroom. I treated the condition with Tylenol 1g every 4hrs followed by 200mg of Motrin. I also ensured adequate fluid hydration and electrolytes 120+ oz per day. The symptoms continued for about 36hrs. I began to feel better but 48hrs later I relapsed with the onset of ringing ears then headache followed by extreme fatigue. I treated the 2nd round with continued bed rest over 3 days with Tylenol (1g) and Motrin (400mg). I eliminated Tylenol day 2. I reduced Motrin to half on Day 3. I felt better for 48hrs and again relapsed but only needed smaller 200mg doses of Motrin for a day along with bed rest. The ringing in the ears have been consistent since the onset of the symptoms 4hrs after receiving the 2nd shot. The ringing is greater when I?m active and late in the day. The ringing in the ears is less after min of 6hrs full sleep during the night. I have yet to be able to exercise since racing that 2nd dose. I?m slowly progressing in reducing the fatigue by consuming 30mL shots of ginger juice daily along with 500mcg of Vitamin B12 as directed by my Dr.
45 2021-04-09 lethargy, fatigue Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain ... Read more
Patient had generalized weakness, dizziness, fatigue, confusion, blurry vision, lethargy, neck pain 5 minutes after the first dose of Pfizer coronavirus disease vaccine. MRI C spine negative for COVID related transverse myelitis. CT head negative. His glucose was also low that was treated. He felt better the next day and was discharged.
45 2021-04-10 chills, fever, sleepiness Chilled and feverish, drowsy, all over body aches, dizziness, nausea in the morning, injection site... Read more
Chilled and feverish, drowsy, all over body aches, dizziness, nausea in the morning, injection site pain. Symptoms did not require a dr appointment. Symptoms appeared morning after Vaccination and lasted only one day.
45 2021-04-10 sweating On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool ... Read more
On initial assessment, client found sliding downwards from the chair, skin pale, diaphoretic, cool to touch, speech slurred. Client aroused to verbal stimuli. Client transferred to cot after ~ 15 seconds. Able to ambulate to observation with assistance.
45 2021-04-10 fever, chills Fever, chills & body aches No treatment 12-18 hours with symptoms
45 2021-04-12 chills, headache, cough first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pa... Read more
first, 2 days arm soreness, the 4th 5th 6th continued, nausea throwing up, chills, chest and body pain when coughing, headache, light shortness of breath.
45 2021-04-13 chills, fatigue, sweating Severe fatigue 01Apr2021 to 04Apr2021 Chills 01Apr2021 to 02Apr2021. Sweating 01Apr2021 to 02Apr202... Read more
Severe fatigue 01Apr2021 to 04Apr2021 Chills 01Apr2021 to 02Apr2021. Sweating 01Apr2021 to 02Apr2021 Entire body aches 01Apr2021 to 02Apr2021 Took Tylenol for body aches (650 mg) twice
45 2021-04-13 cough, chills, fever, sweating, headache chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sw... Read more
chills, fever, shortness of breath, headache, vomiting, nausea, chest and rib pain when coughing, sweating
45 2021-04-13 cough severe cough with CXR and CT abnormalities suggestive of diffuse bronchiolitis
45 2021-04-14 cough Had a dry cough for over 8 weeks
45 2021-04-14 fatigue Body aches, tiredness 04/14-04/15
45 2021-04-15 chills, fever Fever (100.4F), chills, and muscle ache started within 24 hours and lasted for one day. Took Tylenol... Read more
Fever (100.4F), chills, and muscle ache started within 24 hours and lasted for one day. Took Tylenol which eliminate the fever and all the aforementioned issues were resolved. The second day noticed swollen painful lymph nodes on the right side of my collarbone (same side of the injection). The issue is still ongoing. Currently, I am taking Ibuprofen and using warm compression to alleviate pain.
45 2021-04-15 chills - In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restle... Read more
- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.
45 2021-04-15 fever, cough, fatigue, headache 2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. heada... Read more
2 hours after 2nd shot I became tired and slept for 24 hours. Had mild fever and itching skin. headache. confusion. 48 hours after 2nd shot random blurred vision and Hives all over but more on the arm I received the shot. Random cough followed by extreme heartburn with a lot of saliva being produced and nasua.
45 2021-04-15 fever, headache PATIENT REPORTS HAVING HEADACHE AND FEVER ONSET 4/9/21; APPROXIMATELY 48 HOURS AFTER VACCINE. HE TOO... Read more
PATIENT REPORTS HAVING HEADACHE AND FEVER ONSET 4/9/21; APPROXIMATELY 48 HOURS AFTER VACCINE. HE TOOK APAP FOR SYMPTOMATIC RELIEF. HE BEGIN FEELING BILATERAL KNEE PAIN AND PROGRESSED TO DIFFICULTY WALKING 4/10/21 - WENT TO URGENT CARE DUE TO DIFFICULTY WALKING/BILATERAL KNEE PAIN. 4/11/21 - WENT TO MEDICAL CENTER AND IS CURRENTLY BEING TREATED FOR "TWO SWOLLEN KNEES" -- LEFT KNEE WAS DRAINED OF FLUID. 4/10/21 - WENT TO URGENT CARE DUE TO DIFFICULTY WALKING/BILATERAL KNEE PAIN. 4/11/21 - WENT TO MEDICAL CENTER AND IS CURRENTLY BEING TREATED FOR "TWO SWOLLEN KNEES" -- LEFT KNEE WAS DRAINED OF FLUID.
45 2021-04-15 sleepiness, lethargy, headache, fatigue Headache, lethargic, tiredness and sleepy soreness at injection site
45 2021-04-16 fatigue, chills Chills. Fatigue
45 2021-04-16 fever, fatigue Low grade fever and fatigue the next morning
45 2021-04-17 fatigue sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable cons... Read more
sore arm; muscle soreness; general fatigue; This is a spontaneous report from a non-contactable consumer. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 22Mar2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced sore arm and muscle soreness and general fatigue on 22Mar2021. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
45 2021-04-17 sweating passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very ... Read more
passed out; fingers were tingling on both hands; very hot and sweating; breathing was labored; very hot and sweating; This is a spontaneous report received from a contactable consumer (patient) . A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Batch/Lot Number: EP7533) as single dose (at the age of 45 years old) for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included magnesium citrate taken for an unspecified indication, start and stop date were not reported. It was reported that about five minutes after the shot, the patient passed out in the observation area. When he awoke, his fingers were tingling on both hands, a was very hot and sweating, and his breathing was labored. Events onset date was 27Mar2021. The patient received lactated ringers as treatment. The outcome of the reported events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
45 2021-04-17 fever, cough Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we co... Read more
Patient received his second Pfizer vaccine on Friday. Saturday he came down with symptoms that we considered were like the stereotypical second dose. Fever, cough, shortness of breath, coming and going. It lingered until Tuesday, at which time he got a Covid test- negative. Went to dr, and he said there was a possibility of blood clots. Tests showed that he had severe pulmonary embolisms in both lungs- the main and 3 secondary arteries.
45 2021-04-18 headache Headache
45 2021-04-18 fever, headache, sweating, chills Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I ... Read more
Around 09.50 at night, I started to feel chills and a feeling of cold for no apparent reason, and I had to go to bed because I could barely stand. Once in bed, I began to feel severe back pain, headache, and a progressive increase in fever to 103.5. I was taking Tylenol during the night and trying to hydrate myself, since I perceived that due to the fever, I was sweating frequently. The next day I also had a fever and a severe headache, but I was able to rest well, and today, Monday, I am already without apparent symptoms, beyond a feeling of moderate weakness.
45 2021-04-19 chills, sweating, influenza like illness Since the first shot I?ve experienced mild chills with low grade flu-like symptoms with no fever (te... Read more
Since the first shot I?ve experienced mild chills with low grade flu-like symptoms with no fever (temperature taken) every night. Once a sleep I awake in the middle of the night every night with mild sweats. Every day in the morning and throughout the day I am perfectly fine, only develops each evening and nights.
45 2021-04-19 chills Chills no matter how much clothing I had on. Also a strong stomach ache. Also a soar arm.
45 2021-04-19 cough, fever 3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR sh... Read more
3/28/21 Patient presented to ED w/SOB x 5 days, fever and cough for one day. RA pulse ox 42%. CXR showed bilateral infiltrates. Pt refused intubation and was started on BiPAP w/FiO2 of 100%. Given Remdesivir and Decadron. Was placed in ICU. Also covered with zithromax and rocephin which was stopped after procalcitonin found to be normal. 4/1 Pt was weaned off BiPAP to HFNC 4/3 Pt was weaned off HFNC to 4L per NC. From 4/3-4/5 he had significant improvement. On 4/5 did not require O2 at rest but still had desaturation to 88% with ambulation. The team wanted to keep him an additional night but he demanded D/C. He finished 5 day course of Remdesivir prior to D/C and was to finish 10 course of Decadron after discharge
45 2021-04-19 headache, head discomfort I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I... Read more
I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing. A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly This has affected my work. My doctor told me to report this to you. I got the 1st vaccine shot on 04/05/21. I suffer from Meniere's disease and have had 2 episodes over the past 6 months. Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. . A big episode will knock me out for hours even up to a day. See symptoms below. Small episodes: Dizziness Nausea Headaches Vomiting Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking. Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly My second does is scheduled for 04/26/21, should I take it?
45 2021-04-19 sweating Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lighthe... Read more
Pt reports he felt weak and diaphoretic shortly after receiving vaccine. Denies dizziness or lightheadedness. Given water and crackers and transported to med obs #1 via wheelchair. Pt prefers to sit on side of bed, rather than lying down in stretcher. No s/s of distress noted. Pt reports resolution of symptoms. Registration called to bedside to schedule pt for second dose per his request, prior to d/c to home. VS are as follows: 1300: BP 145/95, HR 85, RR 17, O2 sat 96% on RA. 1305: BP 127/87, HR 79, RR 16, O2 sat 97% on RA; 1310: BP 137/94, HR 77, RR 17, O2 sat 97% on RA.
45 2021-04-20 body temperature increased Metal taste in mouth about 12-20 hours after second injection. Lasted approximately 2-3 days. Ran sl... Read more
Metal taste in mouth about 12-20 hours after second injection. Lasted approximately 2-3 days. Ran slightly elevated temp (~100F) for a day, but fever responded well to Tylenol and subsided within 48 hours.
45 2021-04-20 cough Coughing, shortness of breath, aches/pains, chest tightness
45 2021-04-20 fatigue, chills, headache CHILLS, SEVERE FATIGUE, NAUSEA, SWOLLEN ARIAL LYMPH NODE LEFT SIDE (INJECTION SITE), AND HEADACHE. T... Read more
CHILLS, SEVERE FATIGUE, NAUSEA, SWOLLEN ARIAL LYMPH NODE LEFT SIDE (INJECTION SITE), AND HEADACHE. TOOK TYLENOL AND MOTRIN. REST. SYMPTONS LASTED 24-48 HRS
45 2021-04-20 fatigue, cough, malaise, fever Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm... Read more
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
45 2021-04-20 fatigue Intense nausea, fatigue, right arm pain and rash on both forearms
45 2021-04-20 headache, malaise Injection site pain, headache, malaise, joint swelling/pain, testicular pain, general body pain
45 2021-04-20 headache, fever, fatigue Fever of 100.1° at peak Extreme fatigue for 36 hours Severe headache unresponsive to Tylenol
45 2021-04-20 fever, sweating 8 hours after 2nd pfizer covid vaccination. Fever 101.3 , chest pain with diaphoresis, trended tropo... Read more
8 hours after 2nd pfizer covid vaccination. Fever 101.3 , chest pain with diaphoresis, trended troponins to a nadir of 19.0. EKG changes with ST changes in 3 non-contiguous leads. Initially treated for an NSTEMI with heparin. Transitioned to colchicine and ibuprofen for myocarditis.
45 2021-04-21 headache Developed shingles under left arm, next to pit, and above left nipple. Approx 20 vesicles at each ar... Read more
Developed shingles under left arm, next to pit, and above left nipple. Approx 20 vesicles at each area, 40 in total. Developed intense, debilitating headache several days later (Apr 18th) which lessened the following day, but continues to the present day (Apr22)
45 2021-04-21 headache Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 h... Read more
Patient experienced a headache within 4 hours of vaccination. Took recommended dose of Tylenol. 4 hours after that (8 hours after vaccination) he was still experiencing extreme headache and also vomiting and took another dose of Tylenol. Was still feeling poor at 1am but coherent and talking, not thinking that it was serious enough to warrant going to hospital, as he believed it was just a bad headache and the vomiting was from the headache. At 6am, he was found blue/dead in his bed.
45 2021-04-23 headache, influenza like illness, sweating, nasopharyngitis Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizz... Read more
Headache. Body aches. Hot/cold/freezing. Boiling eyeballs. Not able to sleep. Perfuse sweating. Dizzy. Nausea. Like bad flu symptoms, like the worst flu I have ever felt.
45 2021-04-24 sleepiness, malaise, headache, fatigue, runny nose #1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 ... Read more
#1 ...extreme fatigue, sleepiness, drowsiness. (several days) #2 mild low grain headache (3 hrs) #3 mild nausea (short period) #4 sniffles... runny nose. #5 soreness on right arm I have a general negative disposition to the Pfizer vaccine, overall I felt much better before taking the vaccine then after. There are well defined 'side effects' that are notable. Overall feeling after the vaccine is unwell. (Nothing like the side effects for say the flu virus) The side effects are much more pronounced. The side effect that is/was most notable is fatigue and drowsiness. I've felt unusually fatigued and sleepy over the past few days with the severest fatigue occurring the day after taking the vaccine. (I've felt fatigue like symptoms over the past few days since taking the vaccine on 4/22.)
45 2021-04-25 fatigue No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, ... Read more
No symptoms on day of vaccination. Day 1 following vaccination, tired. Day 2 following vaccination, diffuse rash on face, neck and chest. Day 3 following vaccination, rash worsening and spreading to arms; also cold feet, especially toes. Day 3, met with telehealth physician who prescribed prednisone 40 mg once daily for 5 days and diphenhydramine 50 mg TID.
45 2021-04-25 headache, chills, fever Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had... Read more
Starting around 9am Tuesday 4/6/21 I began getting chills and my entire body hurt. By 12 noon I had a splitting headache. I left work and went home to sleep. I was unable to sleep due to the headache. I took my temperature with a digital thermometer around 4PM. I was running a 102 fever. I took three 200 mg Advil around 6pm. My headache got better over the next hour. My fever broke around 9pm that night. I soaked through a shirt. That afternoon and evening I experience joint pain. It felt like needles being jabbed into my joints. Or like lightening strikes in my joints. I got a full nights sleep and the next day I felt 95% better. This was my second shot. I got it at the pharmacy.
45 2021-04-25 lethargy Both elbow and knee joints in severe pain. Lower back on the right side in severe pain. Severe full... Read more
Both elbow and knee joints in severe pain. Lower back on the right side in severe pain. Severe full body muscle pain, every muscle in extreme pain. Complete Lethargy, couldn't get out of bed.
45 2021-04-25 fever, fatigue, headache Fever; muscular pain; joint pain; fatigue; headache; pain in the eyes, shaking; sweetness;
45 2021-04-26 fatigue, chills Fatigue, shortness of breath, thirsty, joint pain, lower left back pain, nausea and chills. All symp... Read more
Fatigue, shortness of breath, thirsty, joint pain, lower left back pain, nausea and chills. All symptoms have been going on for 5 days now
45 2021-04-26 fatigue He received the show on 4/23. That night he thought he was a little more achy. The next morning he w... Read more
He received the show on 4/23. That night he thought he was a little more achy. The next morning he was driving his family to a track meet around 9:30. He and his wife were having a conversation. According to his wife, he seemed to become dazed. Their conversation just stopped. The car started to veer off the road and they were onto the rumble strips. He wasn't making a correction, so his wife had to tell him to drive back into their lane, but he overcorrected and ended up into the lane of oncoming traffic. He was able to correct that and pull the car off of the road. He and his wife switched so that she was driving. He seemed to have a glazed look on his face, but he didn't have any difficulty walking or getting in/out of the vehicle. He does not remember the incident of the car veering and overcorrecting. When they got to the track meet he felt tired and just laid down for 10-15 minutes. Afterwards, he felt like he was fine. They entire incident lasted about 30 minutes. He has been fine since.
45 2021-04-26 fever Abdominal pain, diarrhea and fever starting 48 hours after injection. Lasted 4 days. Required treatm... Read more
Abdominal pain, diarrhea and fever starting 48 hours after injection. Lasted 4 days. Required treatment with antibiotics.
45 2021-04-27 chills, fever, headache Splitting headaches, chills, fever, nausea, vomiting, soreness in left arm
45 2021-04-27 headache, fatigue 12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness o... Read more
12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness of breath, activity intolerance, heat intolerance , headaches, fatigue that have not subsided since.
45 2021-04-28 chills 3 days after second dose: Itchy hives on legs and torso, and arms to a lesser extent. Persisted for ... Read more
3 days after second dose: Itchy hives on legs and torso, and arms to a lesser extent. Persisted for 2.5 days. After hives subsided, achy and mild chills. Some post-Guillain-Barre residual sensations in legs recurred as well and still continuing, 9 days after the second dose.
45 2021-04-28 fatigue, fever, sweating, headache, body temperature increased, cough After the 2nd vaccine (4/11/21), during early hours of 4/12/21 around 3-4 am, woke up in sweat fever... Read more
After the 2nd vaccine (4/11/21), during early hours of 4/12/21 around 3-4 am, woke up in sweat fever body hurting, felt like throwing up but only saliva was coming out, headache. After 2 days on Wednesday 4/15, was felling better went to work temperature was less than 100.4. Was felling ok very tired, sweating but not a lot. On Thursday 4/16 felt a little cough and tired. By Friday morning the cough was more, while working I started to get cold sweat. Called doctors same Friday, they told me to wait until Monday unless it worst and call them. Through out that weekend I had cold sweats, headache, felling like throwing up, chills temperature up to 104.6. This lasted about 2 weeks until 4/27. During this time was taking Tylenol and Mucinex. Also got two rapid test and a cpr test for COVID and all 3 came back negative
45 2021-04-28 lethargy, fatigue, chills When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had... Read more
When I woke up the day after (Day #2) being given the vaccine I was extremely tired exhausted, I had intense chills and hot flashes. Never a fever. I felt nauseated. Completely lethargic. Muscle aches all over my body, was hard to move. I couldn't stay awake. My eyes hurt. I had intense migraines. And no appetite. My right arm hurt, but not as bad as many others' reported. I took ibuprofen to help, it didn't. I drank lots of water and gatorade zero for the electrolytes. It didn't help either. On day #3, this was when it got scary. The previous symptoms carried over, minus the nausea and I was able to be mobile (less lethargic). But something new started to happen. I took my dog out for a short walk, a slow pace, I am very athletic, and I had shortness of breath. I was winded from just walking slowly. Then the brain fog started to set in. This I hated the most. I wasn't able to comprehend things. I tried to assemble an item I bought from Amazon and it was extremely hard to follow simple instructions. I wasn't able to see clearly for some reason. And even comprehending emails that I was receiving was troublesome. I kept drinking water, and was able to eat a little. Had two more bottles of Gatorade Zero. On day 3, most of all the symptoms subsided except that I still got winded from movement. On day 4, I was fine.
45 2021-04-29 fatigue, throat pain, upper-airway cough syndrome Body aches, post nasal drip, sore throat, fatigue, tactile sensitivity, joint aches -- last 4 weeks ... Read more
Body aches, post nasal drip, sore throat, fatigue, tactile sensitivity, joint aches -- last 4 weeks so far.
45 2021-04-29 fever, runny nose, fatigue, nasal congestion, cough Fever Cough Fatigue Muscle or body aches Elevated BP Shortness of breath Congestion or running n... Read more
Fever Cough Fatigue Muscle or body aches Elevated BP Shortness of breath Congestion or running nose
45 2021-04-30 chills, fatigue so nauseated; hot flashes and chills; hot flashes and chills; Caller reports one minute feels hot, n... Read more
so nauseated; hot flashes and chills; hot flashes and chills; Caller reports one minute feels hot, next minute feels cold; started having abdominal pains in stomach; has absolutely no energy and no strength; Arm was sore; so fatigued and so tired/extremely exhausted; This is a spontaneous report from a contactable consumer (patient). A 45 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150) in left shoulder (arm) on 08Apr2021 14:45 at age of 45 years old at single dose for COVID-19 immunization. No medical history (including any illness at time of vaccination) reported. There were no prior vaccinations within 4 weeks. There was no adverse event (AEs) following prior vaccinations, this is the first he can ever recall. There was no family Medical History patient can think of. Patient knew his Dad got the Covid-19 second dose about the same time patient got his first shot Pfizer Covid-19 vaccine and his Dad was not doing so well. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Patient was a consumer reporting he received the first dose Pfizer BioNTech Covid-19 vaccine last Thursday in his left shoulder was calling about his side effects. Patient stated his arm was sore for a couple of days. Patient confirmed it was his left arm that was sore. Reports this arm soreness was still ongoing. Stated his arm is still sore if patient touches his arm. The pain in the arm has faded but it is still there, if patient bumps his arm, he noticed. By starting Saturday, patient was so fatigued and so tired, reported he could not stay awake. Then yesterday the patient was so tired and went for a walk for a few hours. Patient was still extremely exhausted. Reports tiredness is ongoing today. Patient still felt exhausted and did not get out of bed until 14:00, just seems ongoing. Last night (11Apr2021) after patient went to bed, started having abdominal pains in stomach, not able to sleep all night because of the pain. Reported the abdominal pain in stomach was touch and go. By morning (12Apr2021), patient was so nauseated, had to call out of work, patient did not get out of bed until 45 minutes ago. Had absolutely no energy and no strength, ongoing. Patient reported the only other side effect had today (12Apr2021) was hot flashes and chills, took hot bath to get rid of chills. Began about 0900 or 1000 this morning. After patient started getting really nauseated this morning, tried throwing up to empty out stomach and nothing there. A little while later patient noticed hot flashes real bad, later on had to take hot bath to get rid of chills. It was still going on but it was minor, not as strong as what it was, seems to be improved but still having hot flashes and chills. Patient reported one minute feels hot, next minute feels cold. Patient wondering if they should try to go to work tomorrow or if patient should let his body rest more. He was not sure what to do. The adverse events were not required a visit to Emergency room or Physician office, but a friend of the patient's says he should go. Outcome of event arm was sore and hot flashes and chills, one minute feels hot, next minute feels cold was recovering, for event so fatigued and so tired/extremely exhausted, no energy and no strength was not recovered, for abdominal pains in stomach was recovered, for so nauseated was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-04-30 fatigue, headache Headache, fatigue, soreness where I got the shot
45 2021-04-30 headache, dehydration, fatigue, head discomfort stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor functi... Read more
stroke/mini stroke; he couldn't move/loss of motor function/movements were off; Loss of motor function including movement and speech/couldn't speak; head was very tingly; speech was not slurred but more like there was an impediment; he couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to; Caller states he thought he was going to die, his body was shutting down; behavior change; his legs are shaky; eyes feel a little dry; thumbs weren't working right; rule out MS or Parkinson's; rule out MS or Parkinson's; I have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head; he was a little dry thought he may be dehydrated; very tired; pounding headache in the back of his head constantly; he was twitching; really off-feeling; digestive issues/digestive problems; eyes were real mucusy/First week mucous in my eyes/could be allergy; eyes were real mucusy/First week mucous in my eyes/could be allergy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 25Mar2021 as single dose for COVID-19 immunization on an unspecified facility. There were no medical history. No known allergy. The patient had no health issues with any severity, he is pretty athletic, pretty healthy. The patient's concomitant medications were not reported. No COVID-19 prior to vaccination. On 26Mar2021, the patient had digestive issues/digestive problems, eyes were real mucus, first week mucous in my eyes which could be allergy which resolved on 01Apr2021. On 06Apr2021 08:00 the patient reported that he couldn't move/loss of motor function and movements were off but his cognitive functions were fine, loss of motor function including movement and speech/couldn't speak, had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, suffered a stroke or mini stroke and was sent to the emergency room. On 06Apr2021 at unspecified time the patent couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, head was very tingly, speech was not slurred but more like there was an impediment, very tired, pounding headache in the back of his head constantly, he was a little dry thought he may be dehydrated, he was twitching, really off-feeling, and states he thought he was going to die, his body was shutting down. On an unspecified date, the patient had eyes feel a little dry, thumbs weren't working right, his legs are shaky, and noticed behavior change. The patient was hospitalized for 3 days from 06Apr2021 to 09Apr2021 due to thought he was going to die, his body was shutting down, stroke/mini stroke, couldn't move his mouth properly, his tongue and the bottom of his jaw wasn't moving like he wanted it to, couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak. The patient underwent lab tests and procedures which included IGG antibody test: positive and IGM antibody test: negative both on 19Apr2021, computerised tomogram: showed nothing on 06Apr2021, echocardiogram: unknown result on unspecified date, magnetic resonance imaging brain: showed nothing both on an unspecified date in Apr2021 (not sure if 15Apr2021 or 16Apr2021) and on 07Apr2021, COVID-19 test: negative on 06Apr2021, repeat COVID-19 test: negative on 07Apr2021. Therapeutic measures were taken as a result of stroke/mini stroke, loss of motor function including movement and speech/couldn't speak have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head which includes TPA and digestive issues/digestive problems were treated with high fiber diet. The outcome of the event he was going to die, his body was shutting down, stroke/mini stroke, he couldn't move/loss of motor function/movements were off, head was very tingly, speech was not slurred but more like there was an impediment, loss of motor function including movement and speech/couldn't speak, have had some sort of off feeling in my head, occasionally worse than other days/feels like he has a really tight cap on his head, very tired, pounding headache in the back of his head constantly was not recovered, for the events digestive issues/digestive problems, eyes were real mucusy/first week mucous in my eyes/could be allergy was recovered on 01Apr2021, while for the rest of the events was unknown. Caller states he has an appointment with a neurologist and he's trying to get it moved up. Caller states his doctor wants to do a lumbar puncture to rule out MS or Parkinson's that sort of thing. Caller states but at this point they are trying to rule things out. Caller states he doesn't have a family history of really either them. Caller states there was no diagnosis. Caller states the doctor said he was pretty sure its a stroke, mini stroke, but his general practitioner doesn't think its a mini stroke. Caller states the effects are so long going and they will improve and fall back and then the doctor also said at the fact that has been cognitively aware the whole time, so there's been no official diagnosis yet.
45 2021-04-30 headache It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by ... Read more
It's difficult to pinpoint the exact time the symptoms started, but they were definitely present by the time I awoke the following morning. No arm pain -- but nine days of brain pain, waking up feeling like my head was split, at least five days of altered vision, and most disturbed were my breathing and my heart. I felt for many days like I had a Brillo Pad in my lungs and heart, as well as lots of pressure in the chest and shortness of breath/labored breathing. Two days ago I thought I might be having a heart attack. The symptoms lightened yesterday morning (day nine) though I still have strange sensations in the head and taking a full, deep breath is not totally easy yet. .
45 2021-05-01 sweating, fatigue Sweating fatigue body aches
45 2021-05-03 fatigue, fever, productive cough Patient states that he has a lump of productive cough after getting the first Covid vaccine on April... Read more
Patient states that he has a lump of productive cough after getting the first Covid vaccine on April 13 and developed fevers in 12 hours and has been having fever, fatigue and generalized body aches since that time.
45 2021-05-04 fatigue, headache, malaise cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that ... Read more
cold sweat; headache; cramping/spasm; bumps on the side of neck; body aches; Bumps on his head that were also painful; stomach cramps; diarrhea; he threw up several times; nauseous; disorientated; just not feeling good at all; tired; neck pain; felt weird; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; /Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 04Apr2021 (at the age of 45-years-old) at 14:00 as single dose for covid-19 immunisation. Medical history included COVID: he had gotten diagnosed with COVID back in December or January and twice tested positive for covid and his body had fought it off (as reported). Medical history included also back pain Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken to sleep, start and stop date were not reported. The patient reported that around the night of vaccination he experienced cold sweat, headache, and cramping for several hours then subside and come back later. Patient had some bumps appear on the side of his neck. He stated that he could not say that's from the shot, something may have bit him. The patient did bump his head a chandelier and went to the ER. He received Ibuprofen for the symptoms. Patient stated that the reported events occurred the same day as his COVID Vaccine and began a couple of hours later and wakes up every night in a cold sweat; stated he was in and out of the emergency room in about an hour and they gave him Ibuprofen 400mg and a of nights had to take two Ibuprofen because his head and body was hurting so bad and he had to take some kind of relief and he does not like taking stuff like that and pain pills make his stomach hurt. Patient stated he did a whole Ibuprofen and did not feel good after that and can't take the Ibuprofen anymore and then took 1-2 Aleve after that and does not like taking pain medication. He stated he was healing with the bumps but had this every day since the Pfizer Vaccine and he was starting to heal but the bumps were still there on the side of his neck and were improving and healing and he had the bumps on his head that were also painful; states the bumps occurred the same day as his Pfizer COVID Vaccine; states he was up in his attic and could have gotten into a spider nest and might have poison in him from the spiders and then went to the hospital emergency room with these issues. States he told the emergency room about the bites and bumps and that he had the Pfizer COVID Vaccine and they gave him the Ibuprofen and sent him home. The patient stated that this was a real concern for him due to the blood clots stuff coming out about how people have different reactions after a vaccine. States he felt like the hospital did not even do anything; he could have hit his head a couple of times on a chandelier; states the emergency took an image of his head and they did not address the bumps or anything else and said his head was not bleeding and gave him Ibuprofen and he did not think you should take Ibuprofen like when you have COVID and they sent him home and nothing was done. Caller states he does not know but when he received the Pfizer COVID vaccine he noticed a patch of bumps in his neck, and his neck got really tight and his neck still hurts on the left side; states he could have gotten bitten by something. The patient reported that after he had the Pfizer COVID vaccine, he was waking up every night with cold sweats, and recently last night had extreme cramps in his stomach area like was crawling around the floor getting away from the pain and is still having abdominal cramps. He ate a burger and had extreme cramps and diarrhea for days and this was after his Pfizer COVID vaccine and he is doing this again with stomach cramps and diarrhea; he can't distinguish what the cramps and diarrhea were from and maybe he ate something bad and is confused about his body; states the cramps are way worse and the diarrhea began after the burger. States the diarrhea is a lot and this time is less diarrhea but more abdominal cramps and he threw up several times last night and did not throw up a lot but was so nauseous and threw up twice a little bit. Patient stated that the reported events were just like when he had covid and after waking up at 12:00 he had body pains and was not able to go back to sleep until 4:00; states he had pretty bad headaches which are ongoing and had had headaches ever since he was diagnosed with COVID, stated it is the same thing also as when he had covid; states with covid he got sick and was up from 12:00 4:00 and had fatigue, had body pain, had headaches and nausea and then it got better and he started sleeping through the night. States the Pfizer COVID shot and it was like the same all over again where he was up from 12:00 4:00, had pain and was disorientated, just not feeling good at all which has gone on since the shot; states there were two nights where he slept through the night and was up in a cold sweat which wakes him up and drenches him head to toe and he has to get out of bed to change clothes and sit there til he is tired again and sometimes goes to sleep in the chair and then sleeps ok. Patient stated he took Benadryl just to sleep through the night and did not and got up once and then went back to sleep. He stated on the left side where the headaches were and he had neck pain and it was kind of the left side and felt weird. The patient stated also that in the emergency room he was given Valium in his arm and also has a knot on the back of his neck and tried to address it with the emergency room and they said it was a spasm and did not seem concerned and it felt hard and not a bump under his skin in his neck and it just felt like maybe a pea sized hard knot and noticed this after his Pfizer COVID Vaccine. Caller stated he actually felt pretty good and was sleeping through the night after he had COVID and felt back to normal and then after his Pfizer COVID vaccine everything went downhill. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
45 2021-05-04 fatigue, headache 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, ... Read more
14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache,14 days after the vaccine I am feeling a bit better but still unusually tired; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), dose 1 via an unspecified route of administration, in left arm (shoulder) on 16Jan2021 09:15 (at 45-years age) as single dose for covid-19 immunisation. Medical history was and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 06:00 7 days after first Pfizer Covid vaccine patient developed severe fatigue and moderate headache. 14 days after the vaccine he was feeling a bit better but still unusually tired. At first, he was weak, wobbly and tired, every day got a bit better, but he was still feeling it as of today. On 24Jan2021 patient underwent laboratory test that include post vaccination COVID-19 nasal swab test which results negative. The patient did not receive any treatment for the events. The event outcome was reported as resolving. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
45 2021-05-04 headache, fatigue Joint pain, headache, extreme fatigue, cotton mouth, upset stomach
45 2021-05-04 malaise, fever, headache fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbillifo... Read more
fever and malaise began 4/12/21 followed by migratory headaches and myalgia, several days morbilliform rash, brief diarrhea and abdominal pain
45 2021-05-04 fever, chills Chills, fever, vomiting, migraine
45 2021-05-06 cough, headache, fatigue Nausea diaherra coughing headaches fatigue muscle arm soreness
45 2021-05-06 fatigue Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID ... Read more
Myopericarditis with fatigue, myalgias, joint pains, and dispnea on exertion since his second COVID 19 shot. Pt also found to have a DVT.
45 2021-05-08 headache Systemic: Headache-Medium
45 2021-05-10 chills, fever dizziness a few hours after the shot on May 10th; then fever and muscle aches/chills the following d... Read more
dizziness a few hours after the shot on May 10th; then fever and muscle aches/chills the following day
45 2021-05-10 cough, headache, fever Fever, cough, body ache, headache weakness
45 2021-05-10 runny nose, cough, sneezing, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA - late afternoon of the first dose I began having major allergy... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - late afternoon of the first dose I began having major allergy symptoms - coughing, sneezing, runny nose, fatigue, and began wheezing. These continued for 48 hours despite OTC medications, and I wound up in the ER with difficulty breathing. I received a negative quad swab, negative chest xray, and was given a nebulizer treatment and sent home with an inhaler. Despite f/u with my PCP and aggressive allergy symptom treatment, one week later I returned to the ER with an 88% oxygen level.
45 2021-05-11 fatigue Fatigue; body aches.
45 2021-05-11 headache Dull headache and nausea for over a week.
45 2021-05-13 cough, fever By next morning arm sore injection site arm. The 21st of January, I had exposure to a patient who te... Read more
By next morning arm sore injection site arm. The 21st of January, I had exposure to a patient who tested positive to COVID. Wednesday, 13th, is when I developed high fever, shortness of breath, cough, body aches. My SATS were 93/94. I had those symptoms for about a week. Treatment: Z Pak and support supplements Tylenol/ Advil/ OTC Nyquil; Tessalon Pearls for cough suppressant. In between I was due for my second vaccine I still had a fever when I had my second vaccine 1/18/2021. After that second vaccine, my fever spiked and my fever was worse. Since I've been sick I've been having weird abdominal pains that come and go and I have more irritable and down since I've been sick.
45 2021-05-13 sweating, headache Sweats, cold sweats, nausea, headache, dizziness
45 2021-05-17 fever, throat pain I have a severe sore throat and believe due to me my daughter also got this infection, she has been ... Read more
I have a severe sore throat and believe due to me my daughter also got this infection, she has been not tested Covid but has same issue as me. She first got the sore throat, fever, and stomach pain, then I got and we both are at the recovery stage.
45 2021-05-18 throat irritation Pt received covid vaccine and reported he felt his "throat closing" and itching. Reports he has had ... Read more
Pt received covid vaccine and reported he felt his "throat closing" and itching. Reports he has had similar reaction in past to the flu vaccine. Benadryl 50mg IM given. Patient reports his symptoms resolved immediately after IM Benadryl.
45 2021-05-21 headache, fatigue, chills, fever At approximately 7:30p.m.; pain at injection site 10 minutes later at 7:40p.m. ; severe headache an... Read more
At approximately 7:30p.m.; pain at injection site 10 minutes later at 7:40p.m. ; severe headache and fatigue At approximately 8:00p.m.; severe fever and chills At 8:30p.m.; dizziness
45 2021-05-22 fever, headache, chills Chills, fever of 101 degrees, body aches, headache, unable to sleep. 18 hours.
45 2021-05-24 fatigue, headache headache; naseau; tiredness; bones aching; This is a spontaneous report from a contactable consumer ... Read more
headache; naseau; tiredness; bones aching; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:45 as 1ST DOSE, SINGLE (at the age of 45-year-old) for covid-19 immunisation. Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan potassium (LOSARTIN) once daily, colecalciferol (VITAMIN D [COLECALCIFEROL]) and Men's one a day multivitamin. The patient previously took codeine, neomycin and experienced drug hypersensitivity. The patient experienced headache, naseau, tiredness, bones aching 5 days after vaccine. The outcome of the events was recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
45 2021-05-25 fatigue Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea... Read more
Significant increase in neuropathic pain lasting over 45 days. Breathing difficulties, daily nausea episodes, upper right abdominal pain, muscle weakness, increased pain to all areas below T6, inability to breath without pain. Fatigue. Lasted acutely for over 30 days. Symptoms including breathing difficulty, nausea, and increased peripheral nerve pain continue to linger.
45 2021-05-25 headache, fever From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of i... Read more
From hospital discharge summary: "45 y.o. right-hand-dominant male who presents with few hours of improving left arm heaviness/left hand cramping in the setting of getting his second Pfizer COVID-19 vaccination in his right arm 3 days ago and 3 weeks of mildly increased exercise/intermittent fasting. The patient reports getting his first Pfizer COVID-19 vaccination on April 7, 2021. Reports some mild symptoms afterwards. Around that same time, the patient reports having a checkup with his primary care doctor that was notable for a cholesterol elevation to 200. This prompted him to try and lose weight including intermittent fasting and increase in exercise, especially for exercises and cardio. The patient reports approximately 20 pound weight loss over the past 3 weeks. 3 days ago, the patient reports getting his second Pfizer COVID-19 vaccination in his right arm. Reports fever (maximum 103 Fahrenheit) and mild headache the subsequent 2 days after the vaccine. Last night, the patient went to sleep on his left side at around 8 PM. He woke up at 4 AM with significant left arm heaviness and left hand cramping. He tried to massage his hand with some slight improvement of the symptoms but otherwise the symptoms persisted. Hence, this morning, he called his PCP, who told him to come into the ER for further evaluation. Here, the patient reports improving left arm heaviness/left hand cramping. He also does report family history of heart attack and an uncle at a similar age and massive heart attack of his grandfather in their 60s. He denies fever, anorexia, unexpected weight change, headache, blurry vision, sinus pressure, cough, hemoptysis, orthopnea, PND, SOB, DOE, chest pain, pleurisy, changes in taste/smell, N/V/D, abdominal pain, flank pain, urinary sxs, genital sxs, black stools, incontinence, absence of flatus, calf pain, leg swelling, numbness/tingling, streaking redness/rash/skin changes, easy bruising. Also, deny history of HTN, DM, smoking, prior MI, prior PCI, prior CABG, prior TIA/CVA, or history of PAD. Further, denies recent trauma/fall, history of cancer, blood thinner use, recent drug use, recent travel, sick contacts, family history of connective tissue disease/congenital aortic anomaly, or family history of similar sxs. --- Hospital Course by Problem # Troponinemia (Likely myopericarditis) The patient has a family history notable for MI and CABG in relatives aged 50-70 on his mother's side. The patient notes that most of these family members were heavy smokers and drinkers, which he is not (never-smoker, rare EtOH, never illicit drugs). His symptoms are notable for L arm heaviness/cramping that began around 8pm on 4/30/21 at 9/10 severity and subsequently was 3-4/10 severity on presentation to ED and is 0-1/10 severity at time of admission to the floor; he has no associated numbness, weakness, coolness, or pallor. His symptoms are non-exertional. He denies CP, SOB, lightheadedness, nausea, jaw pain, abdominal pain, fatigue. He noes that he recently got the second COVID shot in the R arm, and had a post-vaccine course notable for Tmax 103 ~3d ago and 101 as recently as yesterday. His EKG was notable for ST-elevation in II/III/aVF and his troponins were elevated 305 -- > 298 -- > 328. Of note, his CRP was elevated at 69. The patients symptoms and findings could certainly be compatible with atypical ACS and, given the low risk of bleeding associated with heparin, he was treated conservatively upon admission with heparin infusion, metoprolol tartrate 6.25mg q6h, atorvastatin 80mg (he received ASA 325mg in the ED). However, given his recent covid vaccination and elevated CRP and reported fevers, this could also be compatible with myocarditis or other inflammatory etiology. TTE on 5/3 demonstrated preserved EF 55% with no WMA. Given reassuring TTE, a cMRI was ordered to assess for myocarditis vs scar tissue from recent ischemic event. Cardiac MRI on 5/5 was notable for finding consistent with myopericarditis (see below). Aspirin and atorvastatin was stopped on discharge. Patient was discharged with metoprolol 25 mg daily."
45 2021-05-25 sweating A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel rig... Read more
A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.
45 2021-05-25 fever, headache, fatigue Sore arm, Fever, fatigue, headache, treated with Advil/Tylenol, ok by next morning.
45 2021-05-26 fatigue, influenza like illness, lethargy, fever Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and ... Read more
Started with flu like symptoms, after 3 days my left arm would swell slightly, become red/warm, and itchy at injection site. At 1 week I began feeling extremely worn down, exhausted, short of breath after moving at all, coupled with a slight fever and continuous nausea.
45 2021-05-26 malaise, fatigue My brother had his second vaccine shot on 4/30. When I talked to him on 5/5 he told me he'd had a l... Read more
My brother had his second vaccine shot on 4/30. When I talked to him on 5/5 he told me he'd had a lot of joint pain and fatigue but thought he would go into work the next day. Thursday he left work feeling sick with a lot of 'rib pain'. At some point that night he passed away. We still do not have an autopsy report, but the timing seems odd.
45 2021-05-27 sweating Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He... Read more
Approximately 5 minutes after administering the vaccine, he was waiting in his car with a friend, He became unresponsive and appeared to have lost consciousness. Upon arrival to the vehicle he looked to be having a seizure. Did not respond to verbal commands but did respond to sternal rub. EMS called. BP 118/58 and pulse 60. He was diaphoretic and pale. EMS arrived and during their interview he had another more intense and longer seizure. Transported to the Emergency Room.
45 2021-05-27 malaise Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous r... Read more
Patient went to sleep and died within 12 hours of vaccination; feeling sick; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 45-year-old on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 45-year-old healthy male patient received Pfizer Covid vaccine in the morning, reported feeling sick by the evening on 20May2021. Patient went to sleep and died within 12 hours of vaccination on 20May2021. Event took place after use of product. The patient died on 20May2021. It was not reported if an autopsy was performed. The outcome of event feeling sick was unknown. The outcome of event 'Patient went to sleep and died within 12 hours of vaccination' was fatal. Information on lot number/batch number has been requested.; Reported Cause(s) of Death: Patient went to sleep and died within 12 hours of vaccination
45 2021-05-28 headache Continuously headaches - something like poking inside my head; This is a spontaneous report from a c... Read more
Continuously headaches - something like poking inside my head; This is a spontaneous report from a contactable 45-year-old male Other health professional reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 45-year-old) as single dose for COVID-19 immunization. The patient medical history included raw shrimp allergy. No other medical history was reported. The concomitant medications for patient were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685, and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 23Dec2020 at 03:30 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. On 12Jan2021 at 14:00, the patient had an event described as "continuously headaches - something like poking inside my head". The patient had emergency room visit and physician office visit. The patient received unspecified pain medications as treatment. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was reported as not recovered. Follow-up attempts are completed. No further information is expected.
45 2021-05-29 headache, chills Symptoms: chills, low body temperature (especially at night, last night's measure: 96.2 F), muscle p... Read more
Symptoms: chills, low body temperature (especially at night, last night's measure: 96.2 F), muscle pain (particularly around kidneys' area), joint pain, and headaches. Treatment: after 3 days of persistent symptoms, I talked to a doctor who recommended taking ibuprofen. I took ibuprofen for 3-4 days which mitigated the symptoms. Symptoms returned after a few days and persisted until now (17 days after vaccination)
45 2021-05-31 fever, headache On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 1... Read more
On April 7, I received the first Pfizer vaccine, on April 9 my left knee started to hurt, on April 10 I had to go to an urgent care because my left knee hurt and I was limping, on April 11 In April I went to the emergency room because I had a very strong pain in both legs, I could not walk and a severe headache, I also had a fever. On Monday the 11th they operated on my left knee because there was a lot of inflammation, that same day the second knee became inflamed, I was hospitalized from April 11 to 17 with a lot of pain in both legs. On April 21 I continued with a lot of pain and swelling in both legs and even in the ankles there was swelling. A rheumatologist doctor, because of the laboratory tests she conducted, did come to the conclusion that it was reactive arthritis caused by the Pfizer vaccine. Today June 1, 2021, I still have pain in both knees and ankles, especially the right one, both knees and the right ankle are a little swollen, until May 24 I walked with a walker and I did it with too much pain.
45 2021-06-01 headache, cough, fatigue dizziness, nausea, weakness, fatigue, cough, headache
45 2021-06-01 sweating Following 2nd dose COVID vaccine, the patient complained of itching in torso and arms, diaphoresis a... Read more
Following 2nd dose COVID vaccine, the patient complained of itching in torso and arms, diaphoresis also noted. The nurse monitored the patient and administered 50 mg of Benedryl by mouth at 10:34 am. Symptoms resolved around 10:45 am.
45 2021-06-01 sweating Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pre... Read more
Shortness of breath when physically active. Chest pains, pain / numbness in arms. Elevated Blood Pressure, sweating, light headedness, dizziness, nasuea.
45 2021-06-02 fever On first night, broke out in hives. Now on day 11 of fevers. Fevers have gotten as high as 103.7, ... Read more
On first night, broke out in hives. Now on day 11 of fevers. Fevers have gotten as high as 103.7, but usually around 102
45 2021-06-03 chills, fever Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non... Read more
Sore arm; Fever; body aches; chills; This is a spontaneous report from a contactable consumer or non-health care professional (patient). A 45-year-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration and administered in Left arm on 05Mar2021 at 09:00 am as single dose for COVID-19 immunization. The patient experienced COVID-19 prior to vaccination and not tested post vaccination. The patient didn't receive any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. On 06Mar2021, at 03:00 am the patient experienced Sore Arm, Fever, body aches and chills. The patient did not receive any treatment for events. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.
45 2021-06-03 headache, fever muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm p... Read more
muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation. Medical history included covid-19, No known allergies. The patient's concomitant medications received within 2 weeks of vaccination were none. The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts possible. No further information expected.
45 2021-06-03 malaise Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual);... Read more
Unwell feeling; Nausea; diarrhea; heart beats a bit higher than normal at rest (+10 mre than usual); This is a spontaneous report from a contactable Other Healthcare Professional. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on Left arm on 11Feb2021 at 02:30 PM, (at the age of 45-years-old) as a 1st dose single for COVID-19 immunization at Public Health Clinic The patient's other medical history was not reported. Patient had Advil PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) the day before, and a Pre-workout supplement in two weeks both on unspecified dates. Patient did not have any known allergies. The patient did not receive any vaccine within 4 weeks prior to the dose of vaccine. He did not have covid prior vaccination. On 12Feb2021 patient experienced Unwell feeling. Nausea, diarrhea and heart beats a bit higher than normal at rest (+10 mre than usual). Patient did not have any treatment for the events. He had tasted for covid post vaccination for Nasal Swab, on 02Jul2020 which was Negative. The Outcome of the events was not recovered. Information about lot/batch number has been requested. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
45 2021-06-03 fever, chills, headache, fatigue Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a sponta... Read more
Arm soreness; Low grade fever; Headache; Body fatigue; Weakness; Dizziness; Chills; This is a spontaneous report from a non-contactable physician, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient did not receive any concomitant medications within two weeks prior to the second dose of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 14:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021 at 05:00, the patient experienced weakness, dizziness, arm soreness, low grade fever, headache, body fatigue and chills. The patient did not receive any treatment for the events. The clinical outcome of the events weakness, dizziness, pain in arm, low grade fever, headache, fatigue and chills were recovering. Information about lot/batch number cannot be obtained. No further information is expected.
45 2021-06-04 headache, fever headache; fever; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A 4... Read more
headache; fever; This is a spontaneous report from a contactable consumer (patient) from Pfizer. A 45-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown), via an unspecified route in the Arm right on 18May2021 as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) at unknown dose daily for having some troubles with his heart (Has been taking this medication for about one month) and clonazepam (KLONOPIN), 7.5mg daily dose for mental care (Has been taking this medication for about one month). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736, Expiration date: Unknown) via an unspecified route in the Arm right on 21Apr2021 as, single for COVID-19 immunisation. On 01Jun2021, the patient experienced headache and fever. The patient confirmed he was calling in regard to Pfizer covid-19 vaccine. The patient received his second dose of the vaccine on 18May2021. However, last night he experienced a lot of headaches and fever. The patient asked that if it was normal that he received second dose of Pfizer Covid Vaccine 2 weeks ago and he started having a headache and a fever. The patient reported his headache has completely went away, but stated it was kind of hard yesterday. He clarified the headache hit him hard. The patient confirmed the fever also started last night, and it also went away. The patient clarified the headache and fever began last night around 18:00 or 19:00, stated he checked temperature at 22:00 last night and it was 38 degrees Celsius and he took the temperature with the one they point at the head with the light. Stated he was unsure of the time the symptoms went way, just when he woke up. He did not do anything for the headache or fever. He just wanted to know if this was normal. Outcome of the events was reported as resolved on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
45 2021-06-06 fatigue Extreme Fatigue that started 5 days after receiving the first shot and has persisted for 12 days as ... Read more
Extreme Fatigue that started 5 days after receiving the first shot and has persisted for 12 days as of the date of this report.
45 2021-06-06 fever, headache Fever, headache, confusion, encephalopathy, hospitalized 5/28/21-6/1/21.
45 2021-06-07 headache severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactabl... Read more
severe headache by night time; got a light nosebleed; This is a spontaneous report from a contactable consumer (patient himself). A 45-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8737; Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 07May2021 as single dose for COVID-19 immunization. Patient medical history included food allergy, allergic to aspirin and shellfish, everybody got COVID-19 in the house from, local anaesthesia from 07May2021 to 07May2021, Caller stated he had a dental cleaning that same morning as the vaccine with anesthesia that was local, from 07May2021 to 07May2021. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was not provided. The patient had not any other products. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient's concomitant medications were not reported. The caller reported that he was about to get his second dose of the vaccine and the nurse asked about his first dose. On 07May2021 after first dose he had a severe headache by nighttime about an hour later which lasted for 4 days. Caller stated the nosebleed started on the same day 07May2021 as receiving the vaccine around 10:00-10:30 which lasted until Sunday. The pharmacist asked him to call us to see if he could get the second dose. They did not know what could happen to him with his second dose because of this. He stated he was really allergic to aspirin and shellfish too and didn't know if that was the problem. The caller wanted to know if shellfish was a part of the vaccine. It was enquired that, Pfizer-BioNTech COVID-19 Vaccine contain aspirin or not. Patient was not visited to Emergency Room/ Physician Office. Reporter seriousness for headache and nosebleed was Unspecified. AE(s) following prior vaccinations was not provided. Caller stated he just took Tylenol for side effects and went to bed. Patient had not any relevant tests. The outcome of event headache was recovered on 09May2021 and nosebleed on 10May2021. Information about lot/batch number available, no further information is expected.
45 2021-06-07 sweating client complained of dizziness 3 mins after receiving vaccine. Client signaled EMTs for assistance. ... Read more
client complained of dizziness 3 mins after receiving vaccine. Client signaled EMTs for assistance. EMT began assessment and vitals and EMT informed PHN and PHN. Upon arrival client sitting upright in chair, alert and oriented x4. PHN continued assessment. Per client felt dizzy, blurred vision and sweaty. Vitals at 1854: blood pressure 148/96, pulse 71, oxygen 99%. Client denied chest pain, shortness of breath, headache, no swelling or flushing noted. Medical history of hypertension, per client takes medication at night. Medication Micardis for blood pressure. No known allergies. EMT gave client water. Vitals at 1900: blood pressure 149/98, pulse 72, oxygen 99%. Client stated dizziness improving and blurry vision resolved. Vitals at 1905: blood pressure 139/86, pulse 70, oxygen 98%. Vitals at 1910: blood pressure: 147/92, pulse 68, oxygen 98%. Per client normal blood pressure 130s/80s. Per client dizziness resolved. 1915 vitals: blood pressure 128/91, pulse 68, oxygen 98%. PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1920: blood pressure 140/95, pulse 64, oxygen 99%. Per client all symptoms resolved, able to stand with no dizziness. Wife present with client and would drive client home. Client left facility at 1922 with steady gait.
45 2021-06-07 fever Lymph node swelling. It started on his left side then it spread all over; Nausea; Fever; Lymphedema ... Read more
Lymph node swelling. It started on his left side then it spread all over; Nausea; Fever; Lymphedema in some areas; believes the vaccine went into his lymph node/lymph system instead of the muscle tissue in his arm; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; ER doctor believed the caller had a hernia due to the swelling in the lower abdomen; This is a spontaneous report from a contactable consumer, the patient. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: Aug2021, NDC number: unknown) via an unspecified route of administration, administered in left arm on 19May2021 at 13:00 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included sinus infection in 2011 (for which he visited a doctor 10 years ago to get an antibiotic). Other than that, he was healthy. Patient had no family history. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 28Apr2021 13:00 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient had no problems after first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 6 hours after vaccine, the left side blew up. About 12 hours after the second shot in the middle of the night, patient had the initial reaction and pretty normal side effects (little nausea and fever). Patient had a lymph node inflammation/swelling, which was severe on his left side including his arm pit, down his side, even down into his groin. The reaction died down after about 2 days but spread to rest of the body. On 28May2021, Friday of last week (about 10 days later), everything just blew up. Every one of his lymph nodes went crazy. So many were down in his groin area, the lymph nodes blew up so badly. It was putting enough pressure in that region, it was cutting off circulation to his manhood. Patient had to go to the hospital around 1:00AM. Patient was diagnosed finally at 04:56 and clarified it to be an emergency room visit. Patient was seen in the ER for about 3-4 hours. He was never actually admitted into the hospital. ER doctor believed that patient had a hernia due to the swelling in the lower abdomen. Patient did not know all the tests that were done in the ER. When patient mentioned the swelling that cut off the circulation to manhood, the ER doctor had them ultrasound his manhood, but the doctor never actually listened to the patient. The doctor basically did not want to hear that there were any problems with the vaccine. Patient felt that administration led to lymph node reaction. Instead of sitting in arm for a couple of days or going into a fatty or muscle tissue, vaccine went into the lymph system and now his lymph system was going crazy. He believed this one time when the person jabbed the COVID vaccine in and squeezed the plunger, it put the product right into a lymph node and all of it right into the lymph system. Patient never had a lymph node problem. Patient still had severe lymph node problems. Patient was getting lymphedema in some areas. The only reaction that was abnormal was the extreme lymph node swelling. Outcome of the events was unknown. Investigation Assessment: Yes
45 2021-06-08 headache, fatigue mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a sponta... Read more
mild headache; Sore arm 11 hours post-vaccine; more tired than normal that evening; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN 6199) via an unspecified route of administration administered in right arm on 09Mar2021 09:45 (at 45 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included high blood pressure, acid reflux, fatty liver, and overweight; all from unspecified date and unknown if ongoing. Concomitant medications included unspecified blood pressure and acid reflux medicines. The patient did not have COVID prior vaccination and no COVID tests done post vaccination. The patient experienced sore arm 11 hours post-vaccine and more tired than normal that evening on 09Mar2021. The patient also experienced mild headache the next morning on 10Mar2021. All were non-serious. No treatment was given due to the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
45 2021-06-10 sweating I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively... Read more
I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021. even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
45 2021-06-11 chills, fatigue, productive cough significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitali... Read more
significant fatigue; peculiarly sticky but productive afebrile cough; shortness of breath; hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%; Afebrile chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 11:00 (at the age of 45-year-old) (Batch/Lot Number: EW0162) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient has not been diagnosed with covid-19 prior to vaccination and has been tested for covid-19 via nasal swab on 21May2021 which showed negative. Medical history included hypertension, depression, anxiety, attention deficit hyperactivity disorder (ADHD), and known allergies to Bactrim and Modanifil. Concomitant medications included methylphenidate hydrochloride (CONCERTA); vortioxetine hydrobromide (TRINTELLIX); bupropion; losartan; and zolpidem. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER2613) in the left arm on 23Mar2021 (at the age of 45-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. On 18Apr2021, the patient experienced afebrile chills which was resolved after about 18 hours bedrest. Furthermore, four days post-vaccination (20Apr2021), it was reported that suddenly back in bed, this time with significant fatigue and a peculiarly sticky but productive afebrile cough that responded to neither dextromethorphan nor guaifenesin, nor to liberal and frequent coadministration of these two drugs. Partial resolution by Friday, 22Apr2021. No chills that he remembers. Much more debilitating than the initial reaction (afebrile chills) described earlier. Cough has come and gone for weeks, never resolving for more than about three days at a stretch. About three weeks ago, patient began to suffer shortness of breath for the first time in his life - while making a very easy (and routine) walk from his car into CVS and back. The patient has been hospitalized with apparent cardiomyopathy for just over a week now (including a brief stay in CVICU) with an ejection fraction of 20%-25%. The onset date of shortness of breath and cardiomyopathy was 18Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events which includes Lasix, milrinone, metoprolol, and carvedilol. On an unspecified date in Apr2021, the patient recovered from afebrile chills while outcome of the rest of the events was not yet recovered.
45 2021-06-14 headache Strong constant headache that doesn't seem to go away
45 2021-06-16 sweating felt cold; sweaty repeatedly; felt weak; This is a spontaneous report received from a contactable co... Read more
felt cold; sweaty repeatedly; felt weak; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration on left arm on 16Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The past drug history includes the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration on left arm on 23Feb2021 at 11:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 23:45 evening the patient experienced cold. On an unknown date in Mar2021 the patient experienced sweaty repeatedly through the night. On an unknown date in Mar2021 morning following second dose the patient experienced felt weak all day. No treatments for the adverse event taken. The clinical outcome of the events feeling cold, sweaty repeatedly and felt week was recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected
45 2021-06-16 nasal congestion, sneezing, runny nose, influenza like illness pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symp... Read more
pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.
45 2021-06-16 nasal congestion extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vacc... Read more
extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vaccine/histamine reaction; left side of his face swollen and puffy in lips, chin and cheek; left side of his face swollen and puffy in lips, chin and cheek; left hand swollen and itchy/forearm swollen; left hand swollen and itchy; allergic reaction to the vaccine/histamine reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23May2021 12:50 (at age of 45 year old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient not had medical history and family medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02May2021 12:50 (at age 45 years old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient had the second dose of the Pfizer COVID-19 vaccine last Sunday (23May2021). Since then, he thinks he had an allergic reaction to the vaccine. On 26May2021 (Wednesday late morning, early afternoon), he woke up and the left side of his face was all swollen and puffy in the lips, chin and cheek. It started out in the lower cheek and then kind of spread through out the day. It eventually went down to the lower lip on the left side and moved up to the upper lip on the left side. His face was still swollen but to a much less degree. He took Benadryl and it kind of went away and was getting better. His left hand was all swollen and itchy now. It started after but was simultaneous with the face swelling. On 27May2021, he woke up this morning and his right wrist and forearm was swollen. Not really a rash but was red and swollen, and looks like a histamine reaction. Right wrist and forearm swollen was reported as worsened. He had been extremely congested the past 2 days. Was extremely congested with 99 percent blockage. He took Afrin which knocked it out. It was better but he was still very congested. No physician office visited. He was at Urgent Care right now. The outcome of the events "left side of his face swollen and puffy in lips, chin and cheek; extremely congested" was recovering. The outcome of other events was unknown. Information on lot/batch number has been requested.
45 2021-06-18 pneumonia My stepfather on 31May2021 was diagnosed with Covid and right now has pneumonia; My stepfather on Ma... Read more
My stepfather on 31May2021 was diagnosed with Covid and right now has pneumonia; My stepfather on May 31 was diagnosed with Covid and right now has pneumonia; He had some trouble breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (Patients Stepchild) via medical information team. A 45-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23May2021 (at the age of 45-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (it was a light condition. Arthritis was not getting worse he takes some medication). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient did not have any adverse events. On 31May2021, the reporter stated that patient was diagnosed with Covid and right now had pneumonia. Patient went to the hospital 2 days after that. Patient had to go back to the hospital a second time because he had some trouble breathing (unknown date in 2021). After the second time going to the hospital was when he was diagnosed with pneumonia. Patient was diagnosed with pneumonia a week ago (unknown date in May2021). Patient still had pneumonia, but it was much better with the medication. The reporter clarified that the patient had COVID-19 PCR testing and it took 2 days for the results to come back and patient went to the hospital he was referring to the Emergency Room for trouble breathing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31May2021. Therapeutic measures were taken for the results of the event pneumonia. The events covid-19 and pneumonia assessed as serious. The clinical outcome of the event pneumonia was recovering and outcome of the other events was unknown. The patient scheduled to received second dose of Pfizer COVID Vaccine on 13Jun2021. Follow-up attempts are needed; information about lot/batch number can be obtained.
45 2021-06-24 headache Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year... Read more
Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198) via an unspecified route of administration in the right arm, on 09Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of diabetes, blood pressure high (high blood pressure) and high cholesterol. Concomitant medications include simvastatin (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and metfor (MANUFACTURER UNKNOWN). The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. On 14Mar2021,the patient experienced headache and nausea. The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of headache and nausea was not resolved. No follow-up attempts are needed. No further information is expected.
45 2021-06-25 headache, fatigue, fever, chills No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vacci... Read more
No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot. At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine. As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup. As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held. As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
45 2021-06-29 chills, headache night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A... Read more
night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A 45-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, gout and fatty liver. The concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced headache, night sweats and chills for 3 days which was reported as ongoing. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events headache, night sweats and chills were not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
45 2021-06-29 chills Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Kne... Read more
Bilateral lower extremity pain; pain 9/10 ankle swelling w pain; pain 9/10 ankle swelling w pain/Knee pain; Unable to difficulty to ambulate; Night sweats; Chills w/o fever; Nausea; This is a spontaneous report from a contactable other hcp. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 19Jan2021 14:30 (at the age of 45-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included none. The patient concomitant medications were not reported. AE treatment was given at physicians office visit. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 the patient experienced bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate. Night sweats, chills w/o fever and nausea. On 24Jan2021 the patient underwent lab tests and procedures which included pain assessment: 9/10. Therapeutic measures were taken as a result of bilateral lower extremity pain, pain 9/10 ankle swelling w pain, knee pain, unable to difficulty to ambulate, night sweats, chills w/o fever and nausea. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected
45 2021-06-29 headache, paranasal sinus discomfort, throat redness, fever, throat pain, sweating under his eyes felt swollen and painful; under his eyes felt swollen and painful; intense all around... Read more
under his eyes felt swollen and painful; under his eyes felt swollen and painful; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; dark red streaks down the back of his throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured; sore throat; his arm was hot to the touch around the area where the COVID vaccine was; soreness in his arm/but then on the second day he had soreness but for the second COVID vaccine it was the worst on the first day; little bit of dizziness right after the vaccine; flash fevers where he would get hot almost to the point of him sweating; flash fevers where he would get hot almost to the point of him sweating; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162, age at vaccination 45 years), dose 2 via an unspecified route of administration, administered in arm left on 20Apr2021 as single for COVID-19 immunisation. Medical history included thyroid condition (he thinks it is hypothyroid, it is a new condition to him he was only diagnosed a couple months ago), kidney stones and asthma. Concomitant medications included spironolactone, potassium citrate, both taken for kidney stones and thyroid medication taken for thyroid condition (he thinks it is hypothyroid). The patient previously took the first dose of BNT162B2 (Lot number: ER8733) as single for COVID-19 immunization and experienced his arm didn't feel too bad when he got it but then on the second day he had soreness. On 20Apr2021, the patient has had soreness in his arm and on-and-off fevers for the last two days. For the second COVID vaccine they happened that day which was the worst day for the arm soreness. He also had a little bit of dizziness right after the vaccine when he was sitting there. And a couple times throughout the day he had like flash fevers where he would get hot almost to the point of him sweating with some and then it would go away and that happened throughout the night. On 21Apr2021, the soreness had let up on his arm a little and he had more movement, but his arm was hot to the touch around the area where the COVID vaccine was and it was a little hard. Also, he had some headaches on and off but they would last only a few minutes and then they would go away. On 22Apr2021, his arm was still sore and hot but he had some more movement but that was about all that he had noticed so he thought that he was getting better. On 23Apr2021 night, he woke up at around 04:30 in the morning with an intense all around headache that was pretty much circling his whole head and his sinuses were feeling pressured too/ face pressure. As he started going through the day, he realized that his throat was sore. He looked in the mirror noticed that he has dark red streaks down the back of his throat and he knew that he can get a sore throat and headaches after the COVID vaccine but was it normal for him to get the redness in the back of his throat or was that something that he should talk to someone about. The patient further reported that his arm was still tender to the touch and if he rolls or bumps into it or his arm was just hanging for a while, it would get achy. He was feeling it but he can move it without much pain, but it was still painful. It got better with each day a little bit. With his first COVID vaccine it was kind of opposite, his arm didn't feel too bad when he got it but then on the second day, he had soreness but for the second COVID vaccine it was the worst on the first day. Caller confirmed that his dizziness was only after the COVID vaccine on 20Apr2021 and he says that the flash fevers were from 20Apr2021 to 21Apr2021. He confirmed that the intense all around headache, his sinuses feeling pressured and the sore throat began today, 23Apr2021 at around 04:30 when he had woken up. He confirmed that he was still experiencing this to now and when probed for outcome he reported that the headache has gotten a little better. He has been trying to not drink any caffeine to try and open things up a little and he knew that part of this was in his sinus area, so he has tried using steam to get it to open a little bit. He can still feel it on his temples and it was still there. It was not as intense but it was a discomfort. Later in the call, he confirmed that the arm soreness that began the day after his first COVID vaccine began on 31Mar2021. The patient thought it was the 3rd day that it had gotten pretty decent. Still, again, there was a little bit of pain but it wasn't very noticeable and it didn't limit anything he was doing. The patient assessed the events as non-serious. The outcome of events pain in eyes, eyes swollen, rash and vaccination site warmth was unknown, dizziness was resolved on 20Apr2021, fever and sweating was resolved on 21Apr2021, and was resolving for the rest of the events. No follow-up attempts are possible. No further information is expected
45 2021-06-29 throat pain, malaise, fever, headache, cough, runny nose, chills, sinus congestion, upper respiratory tract infection Head ache; Muscle ache; Malaise; Fever; Chills; Swollen lymph nodes; Runny nose; Sore throat; Coughi... Read more
Head ache; Muscle ache; Malaise; Fever; Chills; Swollen lymph nodes; Runny nose; Sore throat; Coughing up greenish/brown phlegm; Sinus congestion; URI; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration, on 17Mar2021, at 11:00, (at the age of 45 years), on left arm, as a single dose for COVID-19 immunisation. Medical history included Crohns, colitis and allergy to gabapentin, Lyrica and pecans. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration, on 24Feb2021, at 11:00, on left arm, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, at 03:00, the patient experienced head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, and cough. These have turned into an upper respiratory tract infection. The patient had sinus phlegm that was green/brown. It had now started to set up in the patients chest and the patient was coughing up greenish/brown phlegm. The treatment received as a result of events included unspecified antibiotics and the events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of head ache, muscle ache, malaise, fever, chills, swollen lymph nodes, runny nose, sinus congestion, sore throat, upper respiratory track infection, and cough were recovering. No follow-up attempts are needed. No further information is expected.
45 2021-06-30 cough, throat pain, fever FEVER, COUGH, SORE THROAT
45 2021-06-30 malaise, fever fever uncontrollable chills; Malaise; This is a spontaneous report from a contactable consumer, the ... Read more
fever uncontrollable chills; Malaise; This is a spontaneous report from a contactable consumer, the Patient. A 45-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) via an unspecified route of administration in the left arm on 12Mar2021 at 17:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had shellfish and environmental allergies. Concomitant medications included tetracycline hydrochloride (TRICOR), rosuvastatin calcium (CRESTOR), amlodipine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), and cetirizine hydrochloride (ZYRTEC) all for unknown indication from unknown date. The patient was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since the vaccination. On 20Mar2021 at 18:00 (8 days after vaccination), the patient experienced bedtime, fever, uncontrollable chills and malaise. In the morning the patient felt fine. But the same events reoccurred again 10 days after injection. The patient had COVID-19 virus test on 12Mar2021 and resulted negative. The patient did not receive treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever chills and malaise was not resolved (reoccurred after 10 days of vaccination) at the time of this report. No follow-up attempts are needed. No further information is expected.
45 2021-07-01 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
45 2021-07-01 fever, chills Chills; low-grade fever experienced approximately 16 hours after injection.; This is a spontaneous r... Read more
Chills; low-grade fever experienced approximately 16 hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 16Mar2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included seizures which was controlled with medicine and the patient also reported that there were no seizures in over 8 years. Concomitant medications included carbamazepine (TEGRETOL) 20mg once daily for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The Patient was not diagnosed with COVID-19 prior to the vaccination. The Patient had not been tested for COVID-19 since the vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 01:00, the patient experienced chills and low-grade fever, approximately 16 hours after injection. The patient did not receive treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills and low-grade fever was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
45 2021-07-02 sleepiness, headache sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little... Read more
sleepy; Back and knee are a little sore; feeling weak; a little headache; Back and knee are a little sore; Arm a little sore from the shot; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medication, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced little soreness in the arm from the shot, felt weak and sleepy. The patient also had little headache, little sore in back and knee. The clinical outcome of the events pain in arm, weakness, sleepy, headache, sore back and pain knee were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-07-03 sweating Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild
45 2021-07-07 fever, malaise First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and ... Read more
First dose, I only had a sore arm, second dose, I had fever beginning ~12 hours after injection and lasting until ~36 hours after. The subsequent illness I reported in V-safe seems unrelated to my vaccination. I experienced fever (up to 102 degrees) and general malaise for three successive nights starting on June 4th, 2021 (2+ months after second dose). The fever only came at night and broke in the early morning each night. I had two COVID screenings on June 7th, both came back negative. The final fever occurred the night of June 6th. I continued experiencing malaise and general weakness and had some bloodwork done. My bloodwork came back indicating Fe deficiency anemia, and I have been experiencing this condition since. The cause is suspected to be due to overuse of NSAIDs in dealing with a bulging disc in my cervical spine from early March onward. I am scheduled for endoscopy to further investigate whether I am having bleeding issues causing the anemia. as previously mentioned, seems unrelated to vaccination.
45 2021-07-08 fatigue pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling ti... Read more
pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling tired; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of COVID-19 vaccine. On 22Mar2021 at 14:00, the patient had experienced pain and swelling in arm where the patient had injection and was feeling tired. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain and swelling in arm where had injection and feeling tired was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-08 headache, cough, fatigue, fever Cough; Fever; Muscle pain all over thebody; Headache; Fatigue; Muscle pain at the injection site; Th... Read more
Cough; Fever; Muscle pain all over thebody; Headache; Fatigue; Muscle pain at the injection site; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6951), via an unspecified route of administration in the left arm on 22Mar2021 at 16:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was receiving unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 18:00 (reported as first day), the patient experienced muscle pain at the injection site. On 23Mar2021 (reported as second day), the patient experienced fatigue and muscle pain at the injection site. On 24Mar2021 (reported as third day), the patient experienced fever, muscle pain at the injection site, muscle pain all over the body, headache, cough and fatigue. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue. The clinical outcomes of the events muscle pain at the injection site, fever, muscle pain all over the body, headache, cough and fatigue were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
45 2021-07-08 headache Minor soreness in left shoulder (where vaccine was delivered); Very minor headache; This is a sponta... Read more
Minor soreness in left shoulder (where vaccine was delivered); Very minor headache; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have a history of allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced minor soreness in the left shoulder where vaccine was administered and a very minor headache. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shoulder soreness and the headache was resolving at the time of this report. No follow-up attempts are possible. No further information expected.
45 2021-07-15 fatigue Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of ... Read more
Chest pain (heart area), waves of extreme fatigue, occassional tingling in legs, three instances of pre-syncope.
45 2021-07-15 headache Major debilitating headache that lasted for 18 hours
45 2021-07-18 influenza like illness, fever, chills The day after second COVID vaccine, patient developed flu-like symptoms of fever, cold chills, nause... Read more
The day after second COVID vaccine, patient developed flu-like symptoms of fever, cold chills, nausea, and no appetite. Symptoms lasted 1.5 days.
45 2021-07-19 throat pain, fatigue, runny nose, respiratory tract congestion Pt is 46 yo male, employee at this institution. He is s/p Pfizer COVID-19 full vaccination: first do... Read more
Pt is 46 yo male, employee at this institution. He is s/p Pfizer COVID-19 full vaccination: first dose on 1/21/2021, second dose on 2/11/2021. Underwent voluntary COVID-19 rapid testing on 7/14 after experiencing symptoms including fatigue, muscle or body aches, sore throat, diarrhea and congestion/runny nose. Pt reported possible exposure to COVID-19. PCR test resulted positive.
45 2021-07-20 fever, chills, nasal congestion Fever; Diarrhea; Chills; Aches; Nasal congestion; This is a spontaneous report from a non-contactabl... Read more
Fever; Diarrhea; Chills; Aches; Nasal congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old, adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced fever, diarrhea, chills, aches and nasal congestion. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, diarrhea, chills, aches and nasal congestion was not resolved. No follow-up attempts are needed. No further information is expected.
45 2021-07-21 fever, headache Severe headache, muscleache, high fever (38.7 'C under arm), dizziness, overall weakness.
45 2021-07-21 runny nose, throat pain, lethargy, sleepiness Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mil... Read more
Terrible pain in left arm; Sore throat; Runny nose; Grogginess; Lethargy; Fogginess; Wobbliness; Mild general achiness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 17:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as no chronic health conditions. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events terrible pain in left arm, sore throat, runny nose, grogginess, lethargy, fogginess, wobbliness and mild general achiness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
45 2021-07-27 chills, fatigue, headache, fever Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent... Read more
Vomiting; Body Chills; abdominal pains; body aches,; sharp pains in knees,; back spasms; and violent headaches,; warmth throughout the body,; severe exhaustion.; 100F; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 14:45 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included asthmatic and mushroom allergy (Food allergy). The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 06:00 the patient experienced vomiting, body chills, 100 degrees Fahrenheit, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion. The clinical outcome of the events vomiting, body chills, abdominal pains, body aches, sharp pains in knees, back spasms, violent headaches, warmth throughout the body, severe exhaustion and 100 degrees Fahrenheit were recovering at the time of the report. No follow-up attempts are needed; information about the lot number cannot be obtained.
45 2021-07-27 chills, fever, headache Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant ful... Read more
Temperature 100.4; Muscle aches; Insomnia; Chills; Headache; Inflammation/feeling of significant fullness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171), via an unspecified route of administration in the arm left on 28Apr2021 at 14:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not provided. The patient previously took bupropion for hives. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate 60 mg QD (ADDERALL) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 for COVID-19 immunisation (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150), via an unspecified route of administration in the arm left on 07Apr2021 at 11:30 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021 at 20:30 (after 6 hours of vaccination), the patient experienced inflammation/ feeling of significant fullness at site. On 29Apr2021 at 01:30 (after 11 hours of vaccination), the patient experienced insomnia, chills, headache and muscle aches. On 29Apr2021 at 08:30 (after 18 hours of vaccination), the patient experienced high temperature. On 29Apr2021 at 08:30, the patient underwent body temperature and the result was 100.4. The clinical outcome of the events headache and muscle aches was recovering; while the clinical outcome of the events inflammation at site, insomnia, chills and high temperature was not recovered. No follow-up attempts are needed. No further information is expected.
45 2021-07-27 fatigue, fever, cough Total body soreness and fatigue; Total body soreness and fatigue; 2. Fever like symptoms without fev... Read more
Total body soreness and fatigue; Total body soreness and fatigue; 2. Fever like symptoms without fever; Cough sporadically; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the left arm on 01May2021 at 09:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and diphenhydramine hydrochloride (BENADRYL); both started on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 19:00, the patient experienced total body soreness and fatigue, fever like symptoms without fever and cough sporadically. The clinical outcome of the events total body soreness and fatigue, fever like symptoms without fever and cough sporadically were recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
45 2021-07-28 sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Was walking around and started to get dizzy, and blacked out fell. He woke up and thought he hit his head and yelled for help. Called an ambulance and they took to the ER. No trouble breathing.
46 2021-01-02 headache Onset of headache and nausea feeling a migraine coming on
46 2021-01-03 fatigue patient developed fatigue approximately 24 hours after immunization that lasted for about 24 hours. ... Read more
patient developed fatigue approximately 24 hours after immunization that lasted for about 24 hours. Patient also had soreness at injection site 24 hours after that lasted 24 hours.
46 2021-01-03 headache, chills, sinus congestion, runny nose, cough No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected... Read more
No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected with Covid-19. Started with symptoms Tuesday Dec. 29 2020 at 6am (Chills, severe body aches) I currently work in a jail setting with active covid-19 cases. Exposure to covid-19 at work high. Covid symptoms as of Jan. 3 2021 have been: mild headache, body aches, muscle stiffness, chills, sinus congestion/runny nose, mild cough, loss of taste/smell.
46 2021-01-03 sweating, fatigue Sweating profusely and mild fatigue since injection.
46 2021-01-03 fever, malaise I was coincidentally exposed to covid prior to the Covid vaccine so I don't think the symptoms were ... Read more
I was coincidentally exposed to covid prior to the Covid vaccine so I don't think the symptoms were a result from the vaccine. 12/21/2020 I received the vaccine in the AM I started to have a low grade fever, body ache, malayse, next morning I woke up and had a higher degree fever body ache and increasing feeling of sickness. I got worse and contacted my own Dr and he let me know that I may have been exposed and I got tested and I was positive for Covid. I
46 2021-01-04 fatigue, headache Patient describes being very fatigued and a low grade headache, patient also said he was advised tha... Read more
Patient describes being very fatigued and a low grade headache, patient also said he was advised that his body temperature is lower than normal
46 2021-01-04 fatigue Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR e... Read more
Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA). He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired". Patient was taken by ambulance to the emergency room. Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-01-04 fatigue tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spon... Read more
tachycardia(HR-90's to 130) for 3 days; injection site discomfort; myalgias; fatigue; This is a spontaneous report from a non-contactable physician (patient). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular at right arm on 21Dec2020 09:30 at single dose for COVID-19 immunization at a hospital. The patient's relevant medical history was reported as none, other medical history was none. No allergies to medications, food, or other products. Concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. It was reported that the patient got the vaccine on Monday (21Dec2020). On 21Dec2020 13:00, the main symptom that he was having was tachycardia (HR-90's to 130) for 3 days. Only other symptoms were injection site discomfort, myalgias and fatigue. The above events resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken for the above events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
46 2021-01-04 headache Severe headache, profuse vomiting
46 2021-01-04 malaise Shoulder soreness, malaise; Shoulder soreness, malaise; This is a spontaneous report from a non-cont... Read more
Shoulder soreness, malaise; Shoulder soreness, malaise; This is a spontaneous report from a non-contactable physician reported for himself. A 46-year-old male patient received bnt162b2, lot: EH9899, via an unspecified route of administration at 11:00am on 24Dec2020 at a single dose for covid-19 immunization. The patient's medical history included gout from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced shoulder soreness and malaise. The outcome of the event was recovered on an unknown date. It was reported that the vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was given to the patient for the events. Patient was not diagnosed with COVID-19 prior to vaccination and patient have not been tested for COVID-19. Patient has no allergies to medications, food and other products. No follow-up attempts are possible. No further information is expected.
46 2021-01-04 fever, headache, fatigue, chills No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the ... Read more
No immediate reaction within 15 minutes of injection. Increasing injection site pain throughout the day with mild chills and nausea starting around 7:00 pm (Approx 11 hrs after injection). Chills steadily intensified, with fever beginning, became severe over the next 2-3 hours, and persisted throughout the night. Along with the fever/chills & nausea, there was also moderate muscle/joint pain (mainly neck and back), moderate to severe fatigue and weakness, weird freaky dreams, restlessness, and moderate headache. Symptoms started to relent around 6:00 am the morning after injection, however fatigue/weakness, nausea, and mild fever/chills have persisted throughout the day with minimal improvement.
46 2021-01-05 fatigue, headache Fatigue & Headache
46 2021-01-06 chills, fever Fever, chills, soreness at injection site and muscle aches lasted about 24 hours.
46 2021-01-06 headache, fatigue, fever 5 days after vaccine dose, began with COVID-like symptoms. Fever (101°), fatigue, body aches, head... Read more
5 days after vaccine dose, began with COVID-like symptoms. Fever (101°), fatigue, body aches, headache, and skin burning sensation. Had a rapid COVID test today, which was negative, but symptoms still persist after 2 days.
46 2021-01-06 headache Headache
46 2021-01-07 fatigue Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slig... Read more
Pfizer-BioNTech COVID-19 Vaccine Approx 8 hours after receiving the vaccine, I suddenly became slightly dizzy and moderately nauseous. I also became very tired even though I was well rested. The nausea and dizziness lasted approx 2-3 hours. At that time I developed moderate injection site pain. I was very fatigued for the remainder of the night and through the next day (6 Jan). I was no longer fatigued as of 7 Jan but starting that morning I had a very difficult time focusing mentally. That condition lasted until late on the evening of 7 Jan. As of 8 Jan, all symptoms have resolved and I feel fine.
46 2021-01-07 fatigue Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also bec... Read more
Approx 8 hours after injection I suddenly became slightly dizzy and had moderate nausea. I also became very tired and fell asleep for about 1.5 hrs even though I was well rested. For the remainder of the night of 5 Jan and all day on 6 Jan I was fatigued and had moderate injection site pain. On 7 Jan, I felt much better (no fatigue or injection site pain) but had a very hard time mentally focusing. All symptoms resolved by the night of 7 Jan and as of 8 Jan feel normal.
46 2021-01-07 headache, fever Chills, body aches, head aches,fever and felt dizzy
46 2021-01-08 chills, fever, headache Headache, Myalgia, Arthralgia, Fever, Chills Narrative: 2nd vaccine on 5th at 14:45 2245 Nausea, lo... Read more
Headache, Myalgia, Arthralgia, Fever, Chills Narrative: 2nd vaccine on 5th at 14:45 2245 Nausea, low-grade fever 99, bad headache like a migraine. Used ibuprofen, "living on it" Had headache all night extending down to shoulders. Chills x 2 hours.
46 2021-01-08 fatigue Arthralgia fatigue
46 2021-01-08 headache, fatigue Headache Fatigue Narrative:
46 2021-01-08 headache Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body an... Read more
Headache, SkinRash & Rash Narrative: Had to go to the ER, started with a rash all over his body and itchiness, was given Prednisone and Benadryl, and today feels like he has a headache. Also feels clammy. Meds given in ER helped the rash some, less reddened today.
46 2021-01-08 sweating c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat... Read more
c/o tingling in both hands, light headed, profuse sweating and color pale. 120/68, 83, 28, 98%O2 sat. T 97.7 Narrative: c/o tingling to both hands, light headedness, profuse sweating, and color pale. 120/68, 83, 28, 98%O2 sat.; 122/62, 84, 24, 98% O2sat.; 119/60, 82, 20, 97% O2sat. ; at discharge 125/88, 78, 18, 98% O2 sat.. 09500: Recovered and "feeling better."
46 2021-01-09 chills, headache Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treate... Read more
Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treated with rest, acetaminophen for pain, fluid replenishment.
46 2021-01-10 fatigue, chills Myalgia, Arthralgia, Diarrhea, Injection site pain; chills; fatigue Narrative:
46 2021-01-10 fatigue, headache The next day 1/10 headache, tiredness and injection site pain
46 2021-01-10 malaise Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarr... Read more
Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4. Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over. Stomach hurts and lots of gas and diarrhea consistently.
46 2021-01-10 fever, chills, headache Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hou... Read more
Vaccine recipient experienced shivering, fever, severe headache, nausea, and generalized ache 12 hours after receiving the vaccine. On a follow-up call on 1/8/2021, he reported that the symptoms have resolved. Pfizer-BioNTech COVID- 19 Vaccine EUA.
46 2021-01-11 fever, fatigue Myalgia, Fever, Fatigue Narrative:
46 2021-01-12 headache Roughly a hour after vaccine was administered I started getting a headache. I went to get coffee/bre... Read more
Roughly a hour after vaccine was administered I started getting a headache. I went to get coffee/breakfast thinking that would help however that was not the case. While eating I began to fill nauseous so I stopped but still vomited(only once). I started to feel pains i started to feel pains in my back as well as increasing headache so I left work. Roughly 2/3 hours after taking vaccine my entire upper back was stiff and it hurt to turn my head left. I took muscle relaxers and rested throughout the day. About 10 hrs after vaccine my headache was gone but still had moderate muscle aches. When I woke up (20 hrs after) the muscle pains were moderate so I came into work. 26 hrs later I I'm still having mild body aches.
46 2021-01-12 headache About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee think... Read more
About an hour after taking vaccine I begin to get a headache. I went to get breakfast & coffee thinking that would help but it didn't. While eating I become nauseous. I stopped eating but still vomited (only once). At this time I started having shoulder pains and headache was worsting so I left work. About 2/3 hours after taking vaccine my entire upper body(shoulders up) was stiff! I took muscle relaxers and rested remainder of day. About 10/12 hrs after vaccine my headache was gone but still had moderate muscle pains. Upon waking up up my body aches were only moderate so I went to work. 26 hrs after vaccine, I'm still having mild/moderate body aches.
46 2021-01-12 fever, chills EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken... Read more
EH9899 - Lot number wasn't indicated as different on the second dose. Few hives returned - had taken Benadryl 50mg - prophylactically . Subsided. Next evening (7th) - Hives returned and I took Zyrtec - 10 mg and they went away. (24 hours also - on the 7th) Did feel feverish, chills and achy after 24 hours after and I took an ibuprofen for that. Bumpy night; fitful sleeping but when I woke I was symptom free. Feverish went away sometime in the night and hives by the morning.
46 2021-01-13 fever, throat pain, chills, headache Arthralgia; Rigors; Severe headache; Severe myalgia; Nausea; Sore throat; Fever; first dose on 18Dec... Read more
Arthralgia; Rigors; Severe headache; Severe myalgia; Nausea; Sore throat; Fever; first dose on 18Dec2020, second dose on 07Jan2021; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable Physician reported for himself. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 in left arm at single dose for COVID-19 immunization. Medical history included carotid dissection. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included atorvastatin, acetylsalicylic acid (ASPIRIN). The patient experienced arthralgia, rigors, severe headache, severe myalgia, nausea, sore throat, fever all on 07Jan2021 20:00 with outcome of recovering. No treatment was received. Information about lot/batch number has been requested.
46 2021-01-14 chills, malaise, fever woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and ... Read more
woke up in the middle of the night; shivering; shaking; feverish, general malaise; muscle aches and pains; headache. Lasted about 36 hours. Patient took ibuprofen; acetaminophen.
46 2021-01-14 headache, chills, fever, fatigue Muscle aches, joint pain, chills, fever (100.8) in order of onset; starting ~6:30 pm progressing to ... Read more
Muscle aches, joint pain, chills, fever (100.8) in order of onset; starting ~6:30 pm progressing to severe chills at 9:00 pm followed by fever (100.8) at 9:30 pm. Fever resolved by 1 am. Fatigue, mild headaches throughout the course of symptoms. (All events resolved 12 hours after onset of events.)
46 2021-01-14 headache feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm;... Read more
feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
46 2021-01-15 headache, fever Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely... Read more
Low grade headache/dizziness/cobwebs still 10 days after vaccine - always there but sometimes barely feel, sometimes stonger
46 2021-01-17 fatigue Allergic conjunctivitis in both eyes and extreme fatigue
46 2021-01-17 fatigue Body aches, fatigue, poor balance All resolved within 40 hours. Injection site pain - resolved withi... Read more
Body aches, fatigue, poor balance All resolved within 40 hours. Injection site pain - resolved within 72 hours
46 2021-01-17 headache, fever, fatigue, chills Fever and chills were first symptoms. Passed within 5 hours Body aches, fatigue, headache began two... Read more
Fever and chills were first symptoms. Passed within 5 hours Body aches, fatigue, headache began two hours after first symptoms. They passed within 36 hours.
46 2021-01-20 chills, fever, headache, fatigue fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; T... Read more
fever; chills; fatigue; weakness; pain in the arm (injection site)/sore arm; joint pain; Headache; This is a spontaneous report from a contactable other HCP. This 46-Year-old male Other HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at 1 DF single dose at right upper arm for covid-19 immunisation on 11Jan2021 around 10 AM. Relevant history included ongoing asthma, environmental and food allergies (ongoing). The patient was also allergic to a few medications, both had his entire life. Relevant concomitant drugs were unknown. The subject previously received the first dose BNT162B2 (Batch/lot number: EK4176, Lot number: EJ1685) at the right upper arm on 21Dec2020 for covid-19 immunisation. The patient was tested for COVID Virus before his vaccination either on 07Jan2021 or 08Jan2021. The patient experienced fever last night (11Jan2021), this symptom was gone but he described it as if fever went and came back but it seemed to be gone, he had also experiencing waking up with chills, fatigue, weakness, pain in the arm (injection site) and joint pain since the evening/night of 11Jan2021. He went and saw his primary care doctor. He had been using Tylenol and Antihistamines. He took Tylenol for joint pain. The patient stated it was not bad to start. Experienced fever, headache, fatigue, weakness, joint pain, waking up with chills, and a sore arm, which was to be expected. In general he was just really fatigued. Fever: Had come and gone. It was hopefully gone for good. He had a low grade fever last night, but he checked his temperature an hour ago and it was 98.6 Fahrenheit on 14Jan2021. The outcome of fever was recovered on 13Jan2021, the outcome of headache was recovering, the outcome of event pain in the arm (injection site)/sore arm was unknown. The outcome of other events was not recovered. on the 3rd day. He did a test for the virus and it came back negative. Information about lot/batch number has been requested.
46 2021-01-20 fever, fatigue, chills Chills mild fever mild fatigue joint pains
46 2021-01-20 fever Fever 102.3
46 2021-01-21 headache Non-pulsatile, constant headache in bilateral temporal areas of head that radiate into neck and trap... Read more
Non-pulsatile, constant headache in bilateral temporal areas of head that radiate into neck and trapezius muscles bilaterally - also feel pressure being the eyes when the headache is bad. Bending over to pick things up definitely makes all this worse.
46 2021-01-22 chills, fever low grade fever chills diarrhea dizziness body ache
46 2021-01-23 chills, fatigue, headache Headache, fatigue, muscle ache, chills
46 2021-01-23 fever, fatigue, cough, chills The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours s... Read more
The next morning after the vaccine I began feeling light-headed and weak. Over the next few hours symptoms worsened to include fever of 102.3, chills, body-aches and extreme fatigue. I was coughing more as well. Heart rate elevated to 110 bpm. These symptoms lasted about 12 hours. By the next morning, approx 24hrs after symptoms started, I was back to normal.
46 2021-01-24 chills, headache, body temperature increased Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes bef... Read more
Sunday, Jan 24th 2:22 am - woke to violent, uncontrollable chills/shivers - lasted for 8 minutes before stopping. Severe migraine-level headache. 6:30 am - thoracic muscle pain/soreness, occasional chills continued, axillary temp 100.4 F. 17:35 pm - repeat episode of violent chills/shivering - lasted for 5 minutes, severe headache continued, axillary temp 101.8 F. Monday, Jan 25th 3:30 - woke with continued severe headache and mild chills. Axillary temp 100 F.
46 2021-01-25 chills, lethargy That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and b... Read more
That evening extreme funny feeling in left arm. Next day chills. After slight pain above chest and below neck. Lathirgec and joints creeking. These feelings off and on even to today. Unable to go to work and stayed in bed with very little movement for over 12 hours. Able to function once I got up.
46 2021-01-25 chills chills but no fever
46 2021-01-26 headache, fever Mild fever 99.5F; headache; This is a spontaneous report from a non-contactable Other Health Profess... Read more
Mild fever 99.5F; headache; This is a spontaneous report from a non-contactable Other Health Professional. A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 12Jan2021 at single dose on arm left for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild fever 99.5 F and headache, both on 13Jan2021 with outcome of unknown. Patient did not have COVID prior vaccination. Patient did not have COVID tested post vaccination. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
46 2021-01-27 runny nose, fatigue, headache, sweating, fever fever (up to 101.8); mild nausea; slight fatigue; aching joints; runny nose; slight headache; breaki... Read more
fever (up to 101.8); mild nausea; slight fatigue; aching joints; runny nose; slight headache; breaking into sweats; injection site pain; This is a spontaneous report received from a non-contactable other healthcare professional. A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in the right arm, on 13Jan2021 15:15, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730), via an unspecified route of administration in the right arm, on 23Dec2020 at 16:00, for COVID-19 immunization. On 13Jan2021 at 18:00, the patient experienced fever (up to 101.8), mild nausea, slight fatigue, aching joints, runny nose, slight headache, breaking into sweats and injection site pain. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
46 2021-01-28 headache, fatigue 30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart... Read more
30 minutes after injection started feeling extreme anxiety, panic, and feelings of doom. Fast heart rate, headache, and fatuige.
46 2021-01-28 sweating, fever, chills Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent inte... Read more
Difficult to determine if this event was related to vaccination. 46 y.o. male with a pertinent interval and past history of HTN, sponge kidney, ckd, gerd and HLD. Presents to ED with worsening redness and tenderness of his right upper mid thigh. Patient states that he got the Pfizer vaccination yesterday second shot evening and then developed some subjective fevers sweats and chills. Also had myalgias this all lasted approximately 2 hours but he was able to get to bed and fall asleep. Woke up this morning feeling better but still with some chills but noticed some tenderness and redness in his right upper mid thigh. This got progressively worse. Continues to have chills but improving.   ED work-up including CBC unremarkable, CMP with mild hyponatremia and hypokalemia of 134 and 3.4 respectively. ED drew blood cultures and then started vancomycin. Vitals normal and stable in ED. Admitted to hospital. Provider notes on 2nd day of admission as follows. Cellulitis and abscess of the right medial thigh likely secondary to a skin tag tear which introduced infection. Patient currently is on broad-spectrum antibiotics in the form of doxycycline and vancomycin. Unfortunately, the patient has been eating just ate lunch and also has been getting Lovenox. He is not going to tolerate a bedside incision and drainage. We will plan on proceeding to the operating room tomorrow for quick I&D and cultures. Procedures been explained. The wound will need to be packed afterwards and ultimately healed in. Patient seems understand plan and we will proceed accordingly
46 2021-01-28 malaise, chills, fever, headache Not feeling good; Chills; Fever/it was a low grade fever of about 99.5; Headache; This is a spontane... Read more
Not feeling good; Chills; Fever/it was a low grade fever of about 99.5; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 13Jan2021 19:40 at single dose for COVID-19 immunization. Medical history included blood pressure occasionally and it was high when the patient did not get much sleep. The patient's concomitant medications were not reported. The patient was a healthcare worker and the patient just got his second COVID Vaccine last night. The patient just started not feeling good about an hour and a half and then chills and then the patient checked a low grade fever. He had not had a fever in years. It looked like that it was one of the side effects, the patient was not (incomplete sentence), just trying to follow the process. The patient guessed within last couple hours he started not feeling good, headache, chills and then he just checked it half hour before and it was a low grade fever of about 99.5 (on 13Jan2021). The patient's body height just about 6 feet, just like 5'11", weight about 272 lbs. The outcome of the events was unknown.
46 2021-01-31 chills, fatigue "Wednesday January 20th I received my second COVID vaccine, returning to work the next day. I felt s... Read more
"Wednesday January 20th I received my second COVID vaccine, returning to work the next day. I felt some fatigue and chills through Friday, but woke up Saturday the 23rd feeling normal, except for a rash developing on my neck and the left side of my head. By Sunday, it spread, so I made a virtual appointment. Yesterday, it got worse, so I made an appointment with my primary care and saw him in the afternoon. Apparently, I was his second patient yesterday with the same diagnosis: shingles trigglered by the COVID - 19 vaccine."
46 2021-02-01 fatigue rash, soreness, tired, dizziness, muscle aches
46 2021-02-01 sweating, fever, fatigue, chills, headache Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I... Read more
Approximately 10 hours after receiving my second COVID shot and right before I went to bed at 10pm I started getting chills. My symptoms worsened as the night went on, I was shaking and could not get warm. I also had a very bad headache and I had trouble lifting myself up. At about 3am I started sweating and feeling feverish. I got out of bed to take Tylenol and drink water, and had trouble walking and I was breathing heavy. At 6am I decided to take a hot bath with Epsom salts to help with my aches and headache. When I got out of the bath I felt very dizzy and fatigued and need assistance from my wife to get back in bed. At about 9am I started feeling better. I sat myself up and ate apples and salty tortilla chips and drank lots of water. By 1pm I was able to walk without difficulty and I felt better with only a mild headache.
46 2021-02-02 headache, fatigue headaches for 20+ days, fatigue; brain fog and vertigo that still continue 38 days now.
46 2021-02-02 malaise, fatigue Injection site pain, joint pain, feeling unwell, muscle stiffness, fatigue
46 2021-02-02 fever Fever of 101.7 until 2/1/21 Blood pressure 169/110(with meds taken) Swollen lymph nodes under arm of... Read more
Fever of 101.7 until 2/1/21 Blood pressure 169/110(with meds taken) Swollen lymph nodes under arm of shot site(to date) Stiffness in said arm Joint pain on left side of shot site
46 2021-02-03 chills started chills after few hours of vaccination; bodyache; This is a spontaneous report from a contact... Read more
started chills after few hours of vaccination; bodyache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 29Dec2020 at 11:15 at a single dose for COVID-19 Immunization. Medical history included COVID-19 prior vaccination. The patient had no known allergies. Concomitant medications included atorvastatin (ATORVASTATIN) and multivitamins. The patient had no other vaccine in four weeks. The patient had not tested for COVID post-vaccination. The patient started having chills after a few hours of vaccination and body ache on 29Dec2020. No treatment administered for the events. The events resolved on an unspecified date. Information on the lot/batch number has been requested.
46 2021-02-03 fatigue, fever, chills Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of eve... Read more
Fever, Chills, Fatigue, Body aches, cold hands / feet even with the heater blasting. Duration of events: ~2 days.
46 2021-02-03 malaise Elevated BP 176/108 , shakiness, didn?t ?feel right?, several episodes of vomiting.
46 2021-02-03 fever, headache, chills I have never had a seizure in my life before or since, but that morning I had five partial focal sei... Read more
I have never had a seizure in my life before or since, but that morning I had five partial focal seizures in y right arm, over the course of six minutes. As I was on the phone (to report the first one to my caregiver) when the second hit, I inadvertently punched myself rapidly and repeatedly in the right side of my head, with the phone handset functioning as an impromptu bludgeon, leaving bruises reminiscent of the victim of a fist fight. Also at the time I had a strong headache, cold chills, a 102 degree Fahrenheit fever and body aches. None of which persisted beyond noon.
46 2021-02-04 fatigue, chills, headache, fever Fever, chills, myalgias, fatigue, headache. Began 8 hours after the vaccine and lasted for 48 hours.
46 2021-02-04 headache, fatigue injection site soreness headache fatigue
46 2021-02-04 fever, chills Fever, chills, myalgias. Began 1/7/21 at 0130 and persisted until 1/7/21 at 2200.
46 2021-02-04 runny nose, throat pain, upper-airway cough syndrome Sore throat; post-nasal drainage/rhinorrhea; post-nasal drainage/rhinorrhea; This is a spontaneous r... Read more
Sore throat; post-nasal drainage/rhinorrhea; post-nasal drainage/rhinorrhea; This is a spontaneous report from a contactable healthcare professional. This 46- year-old male patient received the first dose of BNT162B2 on 29Dec2020 6:30 PM (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EL1284), via intramuscular route of administration, (at the age of 46-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Hospital and anatomically located on the left arm. Allergies to medications, food, or other products: Lactose intolerance. The medical history included: Heart/Double Lung Tx, Bronchiolitis obliterans. Concomitant medications included: Tacrolimus, Sirolimus, Enalapril, Prednisone, Bactrim, Zithromax, Prenatal vit, Citrical +D. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021, he experienced Sore throat, post-nasal drainage, and rhinorrhea. The patient did not receive treatment for the events. The clinical outcome of the events Sore throat, post-nasal drainage, and rhinorrhea was not recovered without treatment. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient received second dose BNT162B2 on 19Jan2021 at 06:30 pm (lot number: EL8982),Intramuscular, anatomically located on the left arm. No follow-up attempts are possible. No further information is expected.
46 2021-02-07 fatigue, malaise tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a co... Read more
tired; not feeling well; nausea; dizziness/almost passed out; This is a spontaneous report from a contactable nurse and a consumer. A 46-year-old male patient received the first dose of BNT162B2 (lot number: EL3247, expiry date: 31May2021), via an unspecified route of administration in left deltoid on 15Jan2021 12:56 at single dose for COVID-19 immunization. Medical history included had allergies as a child and carried as an epi pen. Concomitant medications were not reported. Reported to the waiting area for 15 minutes observation and left then came back to facility at 14:05 was not feeling well, reported dizziness and nausea. RN assessed patient, vital signs 122/84, pulse was 78 and O2 97 on room air, respiratory rate was 20, alert and oriented, was monitored for 30 minutes, reassessed at 14:25 188/76, heart rate 76, respiratory rate 18, O2 sats 98% on room air, encouraged patient to follow up with PCP or ER. Patient walked out with companion and stated he was feeling better. On 18Jan2021, patient was called for follow p, only complained he was as still tired, all other side effects had resolved. Stated he almost passed out upon coming back to the observation unit on 15Jan2021. Reporter stated it was noted that when patient returned for 2nd dose, would monitor for 45 minutes. Outcome of the event tired was not resolved, of event not feeling well was unknown, and of other events was resolved.
46 2021-02-07 headache, chills diarrhea, body ache, headache, chills
46 2021-02-07 fever, fatigue, headache, nasal congestion tightness on the chest; chest was hurting and felt like it has been compressed; congested; body ache... Read more
tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
46 2021-02-07 fever AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIIS... Read more
AFTER INJECTION GOT FEVER, NORMAL, NEXT DAY I STARTED TO GET RINGING IN MY EARS, SAW PRIMARY PHISIISON AND HE SAID IT WAS FROM THE VACCINE, RINGING IN EARS FOR 11 DAYS NOW, CAN'T SLEEP, THINK, WORK, SCHOOL, ALL EFFECTED.
46 2021-02-07 fever At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at t... Read more
At 1700 01/10/2021, he began to feel numbness in his left lip, like he was given a numbing shot at the dentist. Over the next hour, it traveled superiorly up to his left cheek and to the inferior ear. He had a steroid and antihistamine sent in to the pharmacy and took this once he got home about 1930. Shortly thereafter, he started developing tongue numbness. He woke up in the middle of the night to use the restroom and reports he nearly fell into the bathroom wall due to the intensity of vertigo he was experiencing. The vertigo worsened throughout the day and he is very unsteady on his feet, requiring assistance and support from his wife to ambulate. He is unable to drive and reports exacerbation of dizziness when moving his head side to side. His wife reports he had a fever throughout the night 01/10/2021-01/11/2021. He feels the left eye is dryer and a bit weaker than usual and he has had to administer drops to help keep it moist.
46 2021-02-08 headache Nausea and light headed on Feb 7, day of shot. Light headache and more severe muscle and join pain o... Read more
Nausea and light headed on Feb 7, day of shot. Light headache and more severe muscle and join pain on Feb 8.
46 2021-02-08 headache Severe headaches on day 5 after receiving vaccine; took Tylenol every four hours and was relieved
46 2021-02-08 fever, influenza like illness, fatigue, headache The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over... Read more
The first dose of Pfizer vaccine was on 1/17/2021. I did not feel anything except a severe pain over my left arm only. But the second dose of this vaccine (on 2/7/2021) was different. In addition to the severe pain on my left arm, I had (and still) a severe headache, pains all over my body and bones, high fever (102), dizziness, shaking, fatigue, cold at all times, and a little bit taste loss (as of right now, 24 hours after the vaccine). It looks like a hard flu symptoms exactly.
46 2021-02-09 sneezing, cough nausea coughing sneezing sore and numb arm
46 2021-02-10 cough experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021... Read more
experienced significant shortness of breath, heavy wheezing, and coughing on the weekend of 2/6/2021. Slight wheezing had been ongoing for months (difficulty breathing in January of 2020 when diagnosed with influenza A and intermittent slight wheezing continued throughout the year). Symptoms became worse throughout the weekend. I did continue my normal routine (taking trash to the dump, helped move a heavy tank out of a walkout basement, and moving twelve 40 pound bags of wood pellets from store into truck then from truck into my home on day of hospitalization) Hospitalized on 2/7/2021
46 2021-02-12 chills At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bone... Read more
At 10:30pm (received vaccine shot #2 at 8:18am), i stood up and immediately felt chilled to the bones and started shaking/shivering uncontrollably for 5min. Took temp, no fever. No other issues
46 2021-02-12 headache, fatigue, chills, fever 102 fever, chills, body aches, fatigue, head ache.
46 2021-02-13 fatigue, chills On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thur... Read more
On December 17, 2020, my husband, received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7, 2021, he received this second COVID-19 vaccination. The following three days after his second vaccination, he felt fine. The fourth day, on Sunday January 10, my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th, he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night, he started vomiting. On Wednesday January 13, he woke up and had swollen eyes. Once again, he felt extremely fatigued, even after a full nights rest. He had the day off but had an early meeting. After his meeting, he was still tired so he went back to sleep. I left to get lunch, and drop off our kids, and upon my return, I found him on the walk in closet floor, face up, having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.
46 2021-02-15 chills, headache Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No... Read more
Lingering headache for 6 days. Hot flashes/night sweats and on-going chills. Tiny mouth sores. No appetite. No libido. All symptoms have lasted for 6 days.
46 2021-02-16 fatigue LEFT ARM PAIN, OVER ALL MUSCLE WEAKNESS AND PAIN, & FATIGUE.
46 2021-02-17 fatigue, chills, headache Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spon... Read more
Extreme fatigue; headache; diarrhea; stomach pain; joint pain; chills; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiry date not reported), via an unspecified route of administration in the left arm on 29Jan2021 18:15 at single dose for COVID-19 immunization. Medical history included COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown, expiry date not reported) in the left arm on 08Jan2021 07:15 PM at single dose for COVID-19 immunization. On 30Jan2021 13:00, the patient experienced extreme fatigue, headache, diarrhea, stomach pain, joint pain, chills, and upset stomach. No therapeutic measure was taken as result of the events. Clinical outcome of the events was recovering. Information on the lot/batch number has been requested.
46 2021-02-18 fever, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA Approx 7.5 hours after the injection, I began to experience si... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approx 7.5 hours after the injection, I began to experience significant fatigue and moderate injection site pain. That night, the arm pain became more severe such that anytime I moved the pain would wake me. I could not lift my arm without severe pain until around 1800 the following day. On 11 Feb, I began to have a low fever around 1000. The fever stayed between 99.0F - 99.8F and persisted until around 1800 that evening. After 1800 on 11 Feb, all symptoms rapidly resolved and I was only left with very minor injection site pain by the morning of 12 Feb.
46 2021-02-22 cough, fatigue, fever Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardi... Read more
Atrial fibrillation; ventricular arrythmias; mild fever; Cough; Short of breath; Fatigue; Tachycardia; This is a spontaneous report from a contactable consumer and a contactable nurse. This 46-year-old male patient received the second dose of BNT162B2 (PFIZER BIOTHCH MRNA VACCINE, LOT: EL3302), via an unspecified route of administration on 25Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included lone atrial fibrillation, IgA nephropathy. No Covid prior vaccination. No known allergy. Concomitant medication included metoprolol, lisinopril and acetylsalicylic acid (BABY ASPIRIN). The patient did not received other vaccine in four weeks. The patient previously received the first dose of Pfizer BNT162B2 (Lot number=ZK9231) on 04Jan2021 on right arm for COVID-19 immunization. On 26Jan2021, after 2nd vaccine, the patient had mild fever, cough and short of breath. He went to urgent care, chest X-ray clear, Covid test negative. Mild fever subsided after one day, but short of breath and cough continued. Covid test again negative. PCP prescribed azithromycin (Zpack) and methylprednisolone sodium succinate (SOLUMEDROL). Short of breath and cough continue and amoxicillin / clavulanic acid (AUGMENTIN) and prednisone prescribed. Short of breath, cough, and fatigue. Reported to ER on 15Feb2021. The patient had atrial fibrillation, tachycardia, ventricular arrythmias and were treated and admitted for further evaluation. Covid test collected again-negative. Currently in the hospital at time of this report. All of the events were on 26Jan2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment included diltiazem hydrochloride (CARDIAZEM), enoxaparin sodium (LOVENOX), furosemide (LASIX). Covid test type post vaccination included nasal swab on 26Jan2021 with result negative, nasal swab on15Feb2021 with result negative, blood test on in Feb2021 with result negative. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pyrexia, cough, fatigue and short of breath. The events atrial fibrillation, ventricular arrhythmia and tachycardia are considered not related to BNT162B2, but rather due to underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
46 2021-02-22 fatigue, headache, lethargy Headache, fatigue, joint pain, lethargy
46 2021-02-23 headache 1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. ... Read more
1. Minor headache 2. Moderate pain in left underarm. Minor swelling of lymph node in the same area. I feel discomfort when trying to place my arm against my body. I have to keep arm extended to avoid discomfort.
46 2021-02-23 fever "I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4... Read more
"I had an uncomfortable night and bad dreams, left arm soreness more painful than flu soreness. 1/4/21 5am fever 100.5, and took Tylenol at 5am." Reported feeling better now at 10:30 am
46 2021-02-25 malaise, fatigue, sluggishness, headache, fever Received shot at 08:20 on Thursday. By 12:00 I was feeling sluggish and rundown. At 06:00 (Friday), ... Read more
Received shot at 08:20 on Thursday. By 12:00 I was feeling sluggish and rundown. At 06:00 (Friday), I woke with a massive pressure headache, malaise, very sore left arm (where the injection was), and a fever of 100.2. Tylenol at 06:20 seems to have broken fever, still feel very rundown and the headache is debilitating. It is 10:00 hrs. as I fill this out. The Tylenol made no difference to the headache.
46 2021-02-25 fever fever, vomiting, body aches
46 2021-02-26 fatigue, chills Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills,... Read more
Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills, and swollen glands around his neck,
46 2021-02-27 chills Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Ref... Read more
Pale, SOB, cold/chills, nausea, emesis, feels like I am drunk the patient stated. EMS evaluated. Refused transport.
46 2021-02-28 headache, fatigue 1.) Moderate GI issues, diarrhea. (8 episodes) Pepto Bismol. 12 hours duration. Resolved. 2.) Moder... Read more
1.) Moderate GI issues, diarrhea. (8 episodes) Pepto Bismol. 12 hours duration. Resolved. 2.) Moderate fatigue. 24 hours. "Not normally fatigued. Very fit". Resolved. 3.) Mild headache, OTC ibuprofen. Resolved.
46 2021-03-02 chills, fever, sweating, headache Fever; chill; headache; body aches; sweats; This is a spontaneous report from a contactable consumer... Read more
Fever; chill; headache; body aches; sweats; This is a spontaneous report from a contactable consumer reported for himself. A 46-year-old male patient received his 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) at single dose via an unknown route in left arm on 15Feb2021 08:15 AM for Covid-19 immunization. Medical history included vitiligo. No allergies to medications, food, or other products. Concomitant drug that patient received within 2 weeks of vaccination included Vitamin D 50,000 IU once a week. Historical vaccine included 1st dose of PFIZER-BIONTECH COVID-19 VACCINE (lot number: EL3247 on 27Jan2021 10:00AM in left arm for Covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 12 hours after injection (on 15Feb202108:30 PM), patient experienced adverse events of Fever, chill, headache, body aches, sweats. No treatment received for the adverse event. Outcome of the events was resolving. Since the vaccination, the patient had not been tested for COVID-19. The report was considered non-serious.
46 2021-03-04 sweating 11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patie... Read more
11:42am Patient complaint of feeling "tingling and warm" throughout body. RN present and took patient to treatment area. Vital signs BP 142/91, HR 68, RR 18, O2 sat 98% on room air. Patient reports NKA, no past medical history, and takes vitamins at home. Patient observed and noted to be diaphoretic. Post vital signs patient states feeling better. Vital signs recheck BP 138/84, HR 66, RR 18, O2 sat 97% on room air. Education on sign/symptoms to monitor and adverse reactions provided by RN. Patient escorted to car accompanied by patients wife and RN at 12:10pm.
46 2021-03-05 throat irritation, sweating Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat an... Read more
Immediate metallic taste, flushing, sweating, itchiness. Patient progressed to itching in throat and mouth, mild SOB, tachycardia, nausea, and rash over chest, abdomen, upper arms, and back over the next 30-60 minutes. Treatment: Benadryl 50 mg PO, Zofran 4 mg PO, Loratidine 10 mg PO, ranitidine 150 mg PO. Repeat doses of Benadryl, Zofran, and Loratidine given later that day. Patient stated improved symptoms within a few hours. The facial redness and rash on chest persisted until the next morning.
46 2021-03-08 throat pain vomiting last night but has resolved, still presents with sore throat referred to primary provider i... Read more
vomiting last night but has resolved, still presents with sore throat referred to primary provider if symptoms worsen
46 2021-03-10 runny nose, fever, throat pain, chills, headache, fatigue, cough Fatigue started around 2pm on March 9th and progressed throughout the afternoon/evening to sore thro... Read more
Fatigue started around 2pm on March 9th and progressed throughout the afternoon/evening to sore throat, runny nose, headache chills, nausea, cough, feeling feverish but no fever.
46 2021-03-11 sweating Immediately after receiving first dose of vaccine, pt felt lightheaded and started sweating profusel... Read more
Immediately after receiving first dose of vaccine, pt felt lightheaded and started sweating profusely. Pt also became pale. Immediately had patient lay down on the bed and elevated bilateral legs. Pt reports feeling better shortly after.
46 2021-03-12 fatigue, fever Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, litera... Read more
Starting about 5-6 hours after the shot I developed severe bloating, cramping and gassy-ness, literally constant burping. My stomach has been in constant pain. I?ve also had a slight fever and a very sore arm. Tylenol and rest has worked for the fever and arm, and I've had some addition body aches. Not sure how much is due to being in bed for an extended period. Also on Friday (about 24 hrs after getting the shot I was pretty fatigued. I just woke up from 13 hours of sleeping. But the stomach cramps/pains was severe and prompted me to try to find a way to report it, especially since it doesn't seem to be too common. It's been really bad.
46 2021-03-12 fever, chills, headache, fatigue Initial 24 hrs: Injection site pain, slight headache and slight nausea; After 24 hrs through 72 hrs... Read more
Initial 24 hrs: Injection site pain, slight headache and slight nausea; After 24 hrs through 72 hrs: fatigue/tiredness, headache, nausea, muscle pain, chills, fever (100.5 deg), significant joint pain
46 2021-03-15 fatigue, cough Developed a cough and fatigue day after shot. Thought it was symptoms and would go away. They persis... Read more
Developed a cough and fatigue day after shot. Thought it was symptoms and would go away. They persisted. Went and got tested for COVID on 1/15/21 and tested positive. Took oral steroids and azythromycin antibiotics but did not help. Was hospitalized with Covid Pneumonia on 1/19/21 and received steroids and Remdesivir. Was released from the hospital on 1/27/21. I CANNOT EMPHASIZE ENOUGHT THAT THERE SHOULD BE AN EMPHASIS MADE FOR PEOPLE TO GET TESTED FOR COVID BEFORE GETTING THE VACCINE. I WAS THE 9TH PERSON AT THE HOSPITAL WITH THE SAME ISSUE.
46 2021-03-16 headache Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hou... Read more
Headache within an hour of the shot, left work. Muscle spasms in my upper back and neck within 4 hours. Major spasm that prevented me from turning my head or laying down at around 6-8 hours. Upper back, neck, and muscle pain in my head and jaw continue today (3/17/21) but symptoms are slowly decreasing in severity.
46 2021-03-18 sweating Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhe... Read more
Woke up next morning at 7am with itching hands, slight swelling in lips and ears, nausea and diarrhea. Itching and swelling subsided with a dose of Loratadine. Nausea worsened that night and vomiting ensued with diarrhea worsening. At bedtime, itching returned, sleeplessness, vomiting and sweating profusely from the scalp and face, slight difficulty filling lungs with air. Another dose of Loratadine calmed symptoms. Wednesday (10th) through the next Thursday (18th ), nausea persisted, but eased with Benadryl and Emerton. Diarrhea persisted through Monday (15th). No fever, no soreness, no headache.
46 2021-03-18 fever, fatigue Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf ... Read more
Had fatigue and myalgias and low-grade fever, so stayed in bed most of the next day. Developed calf pain 2 daysafter that. Was diagnosed with DVT via Doppler ultrasound on Monday, March 8, 2021.
46 2021-03-19 malaise After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EM... Read more
After receiving first dose of pfizer covid vaccine, patient alerted EMS he didn't fell well. When EMS responded to the patient the patient went unresponsive slumped over in his chair with seizure like activity. Patient was being moved when he regained consciousness. Patient was moved to EMS area. Patient was pale, lightheaded and nauseous. Blood pressure was taken as well as oxygen and heart rate. Blood sugar was checked and an IV was started. Patient was stable and transported.
46 2021-03-20 chills, sweating Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minut... Read more
Chills and Shakes started at time indicated, 2 hours later vomiting. Vomiting only lasted 20 minutes. Second night, extreme sweating. Sunday still have some sweating and nausea but feel 90% better than Friday night.
46 2021-03-21 headache Diplopia and headache, found to have ring enhancing lesions on MRI brain. Ddx broad right now, but g... Read more
Diplopia and headache, found to have ring enhancing lesions on MRI brain. Ddx broad right now, but given proximity to vaccination reporting in case this is an adverse event. May be CNS lymphoma vs infection vs autoimmune.
46 2021-03-21 sweating Patient developed severe dizziness, sweating, and became very pale as soon as the pharmacist gave hi... Read more
Patient developed severe dizziness, sweating, and became very pale as soon as the pharmacist gave him the injection. We put the patient on the floor and elevated his legs and feet. His color came back to normal. Paramedics were dispatched because of his underlying medical condition. Paramedics checked his blood sugar and it was 145. Patient became very dizzy again when paramedics helped him to sit in a chair so patient decided to go to hospital with them to be checked out.
46 2021-03-21 sweating Patient complained of feeling nausea and lightheaded around 3:54 pm. The patient was assisted to pat... Read more
Patient complained of feeling nausea and lightheaded around 3:54 pm. The patient was assisted to patient room and sat in chair. Patient began to sweat and skin was pale. The patient verbalized he felt like he was "going down". EMS called. Vital signs at 3:56 pm were blood pressure 82/50, pulse 58, oxygen saturation 95%. 0.3 mg of epi administered intramuscularly to right arm at 3:58 pm. Patient verbalized improvement in symptoms around 4:03 pm. Oxygen dropped to about 88% and back up to 96% and heart rate 88. EMS arrived around 4:10 pm and took blood pressure of 133/86. Patient transported to ER for further evaluation. Patient alert and oriented x4 at time of transfer.
46 2021-03-22 chills Chills, BP drop, and flush after Covid-19 vaccine
46 2021-03-22 chills Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous re... Read more
Lost consciousness; fell face first onto floor; Arm pain; Chills shivering; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in right arm on 05Mar2021 08:45 as single dose for COVID-19 immunization at a hospital. The patient has no medical history. Concomitant medications were not reported. Patient has no known allergies. The patient previously received the first dose of bnt162b2 (lot number: EL9264) on 12Feb2021 14:30 (2:30 pm) for COVID-19 immunization. The patient did not received other vaccines in four weeks. No COVID-19 test post vaccination was done. On 06Mar2021 at 13:45 (1:45 pm), the patient lost consciousness and fell face first onto floor. The patient also experienced arm pain and chills shivering. No treatment was received. The event required doctor's office visit. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
46 2021-03-23 chills facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety;... Read more
facial paralysis; dizziness; weakness; palpitations; tingling; extremities numbness; panic; anxiety; chills; This is a spontaneous report from a contactable consumer(patient) reported for himself. A 46-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 at single dose for covid-19 immunisation. Medical history included left kidney missing. Patient had allergies to Ambroxol, levofloxacino, cefalosporina, hidrocortizona. The patient's concomitant medications were not reported. First symptom took place 5 minutes after receiving the vaccine, it started with a severe dizziness followed by body weakness, quite accelerated and uncontrolled palpitations, tingling and extremities numbness, mild right-sided facial paralysis, panic feeling and anxiety. Finally, severe chills. Full recovery after 40 minutes with a mild lightheadedness for a few hours. Vital signs kept stable at all times according to paramedics' diagnosis. Patient received treatment for these events. Outcome of events was recovered. Information on the lot/batch number has been requested.
46 2021-03-24 fatigue lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; con... Read more
lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown. Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product "BNT162B2" role cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-03-25 fatigue, headache Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hot... Read more
Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline. Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
46 2021-03-25 sweating "Happens every time I see a needle". Diaphoretic and dizzy, but never passes out.
46 2021-03-26 headache, fever, chills, malaise, fatigue Tiredness, headache, muscle pain, chills, fever, feeling unwell, and swollen lymph nodes. Ongoing fo... Read more
Tiredness, headache, muscle pain, chills, fever, feeling unwell, and swollen lymph nodes. Ongoing for the last 6 days
46 2021-03-28 chills, fatigue I immediately began feeling some mild/moderate symptoms (aches, chills, fatigue, etc.) after my shot... Read more
I immediately began feeling some mild/moderate symptoms (aches, chills, fatigue, etc.) after my shot on Tuesday, March 16th. Whether this is related or not these symptoms moved to what I later learned to be appendicitis on or about Saturday, March 20th. On March 22nd, my appendix ruptured and an appendectomy was performed the next morning. I am not suggesting that there is a definitive causal relationship, but merely that it is very strange coincidence in case there are others.
46 2021-03-28 fatigue Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body... Read more
Left arm lymph nodes are swollen and painful. My entire arm hurts down to my fingers. Diarrhea, body pain and fatigue.
46 2021-03-28 headache, chills, fever fever,chills,headache
46 2021-03-28 fever I feel very light-headed, as with fever but no fever. My whole body has kind of a dull ache...aspiri... Read more
I feel very light-headed, as with fever but no fever. My whole body has kind of a dull ache...aspirin doesn't seem to help. I feel a little nauseous. Nothing debilitating, but all in all an unpleasant morning at work.
46 2021-03-29 malaise Patient stated he didnt feel well, had no t eaten since 10AM
46 2021-03-30 fatigue fatigue; loss of appetite; constipation; nausea; This is a spontaneous report from a contactable phy... Read more
fatigue; loss of appetite; constipation; nausea; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, primary sclerosing cholangitis, prior NAFLD (nonalcoholic fatty liver disease); and had allergies to medications, food, or other products, all from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced allergy and DILI (Drug induced liver injury) in Dec2019. Concomitant medication included mesalazine (LIALDA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior vaccination and was not tested since vaccination. It was reported that the patient got first COVID vaccine (Pfizer) on 16Jan2021 with second dose on 06Feb2021. He mentioned that he works in healthcare and as testing weekly for COVID as part of his job and has been negative. On 26Jan2021, 10 days after first dose, he developed fatigue, loss of appetite, constipation and nausea, all with outcome of recovering. The events are reported non-serious. No treatment received for the events. Information on the lot/batch number has been requested.
46 2021-03-30 headache, runny nose, fever, fatigue Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body A... Read more
Here are my side effects: 1. Low grade Fever 2. Arm so sore that you dont want to move it 3. Body Aches 4. Fatigue 5. Headache 6. Metallic Taste in my mouth. Nothing tasted good yesterday. 7. Nasal Drip with Nausea
46 2021-03-30 headache, runny nose Received 2nd dose of Pfizer COVID vaccine. on 3/24/2021. On 3/28/201 developed body aches, headache... Read more
Received 2nd dose of Pfizer COVID vaccine. on 3/24/2021. On 3/28/201 developed body aches, headache and rhinorrhea. Tested positive for COVID-19.
46 2021-03-30 sweating Client received 1st Pfizer dose and approx. 7 minutes later c/o being "light-headed", having "tunnel... Read more
Client received 1st Pfizer dose and approx. 7 minutes later c/o being "light-headed", having "tunnel vision" and was observed to be diaphoretic and pallor. He was led to a zero gravity chair by EMT and experienced syncope for several seconds. When he regained consciousness, V/S were taken every 5 mins, all WNL. At 9:50am, he reported feeling a little better but a light headed. At 10am, he was observed to have normal skin tone, no diaphoresis, and walked away unassisted with a friend who came to pick him up. He reported "feeling better." Client reported to RN that he has a history of "passing out when giving blood." No medication was given.
46 2021-03-30 throat irritation 1106-Vaccinated 11:19-C/O Tickle in Throat, Throat 11:23-Epi 0.3mg/0.3 ml given and was transferred... Read more
1106-Vaccinated 11:19-C/O Tickle in Throat, Throat 11:23-Epi 0.3mg/0.3 ml given and was transferred to ER
46 2021-03-31 sweating syncope sp vaccine diaphoretic pale, VSS with EMT, monitored for 30 min, refused hospital, wife drov... Read more
syncope sp vaccine diaphoretic pale, VSS with EMT, monitored for 30 min, refused hospital, wife drove home. hx of syncope sp vaccines blood drawl
46 2021-03-31 influenza like illness, fatigue I already suffer from mild tinnitus. About 14 hours after the 2nd vaccine dose my tinnitus became n... Read more
I already suffer from mild tinnitus. About 14 hours after the 2nd vaccine dose my tinnitus became noticeably worse for a period of about 24 hours. I also experienced the typical flu-cold like symptoms after the 2nd vaccine dose including muscle ache, stiff and achey joints, and general I'll feel for a period of 8 after that began 14 hours after the 2nd dose was administered. I experienced fatigue for roughly 4 days after the 2nd dose. I had no symptoms nor adverse reaction after the 1st dose. My biggest concern was the tinnitus. The cold and flu like symptoms I understand should be expected.
46 2021-03-31 fever, fatigue, headache Headache, fatigue, joint pain, low fever, severe lymph node swelling in left armpit.
46 2021-04-01 chills, fever 03/25/2021 at 7 pm i developed body aches, chills and fever which resolved in 12 hrs ams then just h... Read more
03/25/2021 at 7 pm i developed body aches, chills and fever which resolved in 12 hrs ams then just had muscle aches for a few days after. then on day 5 - 03/29/2021 i developed a severe rash on my hands and feet urticaria. saw pcp and then dermatologist at clinic. unsure if from the vaccination at day 5 but was the only thing different. still have some today 04/02/2021 but resolving with big dose antihistamines and cream.
46 2021-04-01 fatigue tiredness, very loud tinnitus
46 2021-04-01 fatigue injection site pain - 24 hours, fatigue - 24 hours , muscle stiffness in legs - 12 hours
46 2021-04-01 influenza like illness, fatigue, fever, headache About two hours after the shot, I began experiencing joint and mussel aches. Between about 18-30 ho... Read more
About two hours after the shot, I began experiencing joint and mussel aches. Between about 18-30 hours after the shot was the worst with flulike symptoms: very achy (mostly joint, but muscular too), mild headache, fever at its highest was 99.3 F, and generally mild fatigue. On the second morning and about 40 hours after the shot I still had these symptoms, except for the fever which was gone, and they were much less and decreasing. About 48 hours after the shot, I felt better and back to normal. I took Tylenol after the shot for the two days which helped some and I had not adverse reactions to the Tylenol.
46 2021-04-01 throat irritation Received first Pfizer Covid-19 vaccination today and shortly thereafter with tightness in throa... Read more
Received first Pfizer Covid-19 vaccination today and shortly thereafter with tightness in throat, itching. No generalized rash, itching, dyspnea, wheezing, swelling of lips, tongue and no dizziness. Has not seen a provider for a while. Medication name: benadryl inj Dose: 50mg/1ml Route: IM DIAGNOSIS Adverse reaction to Pfizer Covid-19 vaccine Hypertension Obesity DM type 2 PLAN: Feels better after RX. Has HTN and DM type 2. Begin Lisinopril, Metformin, follow-up with PCMC, would defer 2nd Covid vaccine unless premedicated and in monitored setting. Per Dr. Note Site: right deltoid Time of administration: 0908 Medication name: solu-medrol inj Dose: 125mg/2ml Route: IM Site: right glute maximus Time of administration: 0910
46 2021-04-02 headache, fatigue Myalgias, Headache, Fatigue
46 2021-04-03 fever Appointment with family doctor next week
46 2021-04-04 fatigue, headache Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast are... Read more
Headache, nausea, cloudy thinking, overall body aches, swelling in neck and under arm pit-breast area on arm where shot was given, fatigue not able to sleep, day 5 and symptoms have continued and are getting worse.
46 2021-04-04 headache DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM T... Read more
DIFFICULTY BREATHING, SEVERE CHEST PAIN, STOMACH ACHE, HEADACHE, JOINT PAIN WENT TO EMERGENCY ROOM THAT EVENING ON 3/15/2021 WENT TO BED WITH CHEST PAIN AND DID NOT WAKE UP THE NEXT MORNING PARAMEDICS WERE UNABLE TO REVIVE HIM, PRONOUNCED HIM DEAD AT THE SCENE.
46 2021-04-06 dehydration Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous re... Read more
Sore arm; Muscle cramps all over the body; Sugar was very high; Dehydrated; This is a spontaneous report from a contactable consumer (patient's mother). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 27Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history included heart attack (at the age of 39) and had couple of stents (and the things done) later after that, and Lyme disease (past this Summer). The patient was taking several concomitant medications (unspecified). The patient's mother was calling for her son (patient) as he works out on the road, but he has had a heart attack at 39 years old and has had some other problems. The patient got his first Pfizer shot and about 2 to 3 days later while he was working, he first just had the sore arm on 03Mar2021. The patient worked in fiber glass repair on pools and it was very warm, and he started having muscle cramps all over the body on 03Mar2021. The patient ended up in the hospital on 03Mar2021 and his sugar was very high, and he was dehydrated. As treatment taken for the events, they gave him fluids through an IV and they gave him metformin medication 500 mg. The patient underwent laboratory tests and procedures (his doctor did the laboratory work), and they did laboratory work at the hospital where he went. It was clarified that they just did blood work on 03Mar2021, but the patient's mother didn't know what it was. The patient was just held for observation and was out the next day (04Mar2021). That was only the first shot, so the patient was really afraid to get the second shot one. The patient's mother told him she will try to find out something about it. patient's mother looked up the side effects and she did not see that as a side effect. At the time of reporting, the patient still had cramps once in a while. The patient had not recovered from "Muscle cramps all over the body". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
46 2021-04-06 malaise patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physicia... Read more
patients appointment is the same day as Covid vaccine, 28Feb2021; States he was told by the physician that it is possible the Covid vaccine is note safe; them on Saturday and his kinase was 1015; he wasn't feeling well; nausea; unable to articulate how he feels due to depressed ability to speak; panic; anxiety; This is a spontaneous report from a contactable pharmacist. A 46-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Feb2021 15:45 as single dose for COVID-19 immunization. Medical history included learning disability (found out last March he has a genetic disability, MECP2, which is a gene that carries Rhett's, autism, and Asperger's), rectal hemorrhage, fecaloma. The patient previously took Lipitor and experienced blood creatine phosphokinase increased, Aricept (2 doses, 1 in am and 1 in pm) and experienced gait inability and rhabdomyolysis, simvastatin (20mg for years and that was discontinued back in Jan or Feb of 2020), atorvastatin and experienced rhabdomyolysis and coumadin and experienced atrial fibrillation. Concomitant medications was not reported. Around Apr or Mar of 2020, the patient was hospitalized, and his creatinine kinase level was about 6000 and got better and was diagnosed with rhabdomyolysis. The creatinine kinase level on 16Jun2020 was 131 and on 17Dec2020 his creatinine kinase total level was 56 and that the range is 44-196. After receiving the first dose of vaccine, the patient wasn't feeling well, he reportedly has at baseline of being unable to articulate how he feels due to depressed ability to speak, but "he began talking to himself, had nausea and wasn't feeling well". So they took him to the doctor and had labs drawn on 12Feb2021 which showed elevated creatinine kinase levels measuring 1,019. They were instructed to speak to a rheumatologist and got another level on 22Feb which came back as 66. The pharmacist reported that back in Dec2020, the patient's kinase level was 55. Kinase was 1015 (blood creatine phosphokinase increased) on 12Feb2021, feeling unwell, nausea, unable to articulate how he feels due to depressed ability to speak, panic, anxiety in 2021. The pharmacist reported that he was told by the physician that it is possible the COVID vaccine is not safe. They were instructed to speak to a Rheumatologist and got another level on 22Feb which came back as 66. The patient's appointment is the same day as COVID vaccine, 28Feb2021. The patient is scheduled to receive his second dose of the vaccine this Thursday and he asked if it is safe to receive the second dose of the vaccine after reacting to the first. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 6000 on 2020, 131 on 16Jun2020, 55 on Dec2020, 56 on 17Dec2020, 1015 on 12Feb2021, 1019 on 13Feb2021, 66 on 22Feb2021, magnetic resonance imaging: diagnosed with MECP2 on 12Feb2021, weight: 180-190 lbs, weight: 141-142 lbs, weight: 140.2 or 140.8 lbs on 12Feb2021. The reporter assessed the events to be non-serious. The outcome of the events was unknown. Information about lot/Batch requested.
46 2021-04-07 headache, body temperature increased, chills Chills, headache, and tempature got as high as 101.7, which i usually run 98.7.
46 2021-04-07 headache, chills Began to notice chills around bed time, along with severe headache and muscle weakness. Continued t... Read more
Began to notice chills around bed time, along with severe headache and muscle weakness. Continued through the night and as of this writing is continuing. FYI, I had COVID 19 in January 2021.
46 2021-04-07 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
46 2021-04-07 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventil... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium
46 2021-04-07 malaise arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male pati... Read more
arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation, at Workplace clinic. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. On 12Feb2021, the patient experienced arm pain and malaise. No treatment was received for the events. Patient was not diagnosed with COVID prior vaccination. Patient has not been tested for COVID post vaccination. Outcome of the events was reported as not recovered. Information on Lot/Batch number has been requested.
46 2021-04-08 headache, sweating Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: ... Read more
Site: Pain at Injection Site-Medium, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium, Additional Details: PT HAD FLUSHING AT 9 PM HEADACHE AND PASSED OUT FRACTURING HIS MANDIBLE IN PROCESS. PT HAD ATRIAL FIBRILLATION PT IS IN STABLE CONDITION ON DILTIAZEM HAD NO HX OF HEART DISORDERS PRIOR TO VACCINE
46 2021-04-08 sweating patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic ... Read more
patient admits to vagal response and passing out in past. few mins after vaccine became diaphoretic and near syncopal. arrived to obs and placed in tredelenberg, bp 119/80 hr 58 rr 18 sats 98% on ra. offered snack and water, refused snack. few mins later, diaphoresis resolved. stretcher sat up, bp 123/78 hr 50 rr 18 sats 98% on ra; states baseline is bradycardic around 50's. sat up to side of bed with feet dangling, bp 116/81 hr 52, then 112/80 hr 58, then standing bp 104/70 hr 63, patient started to feel dizzy and needed to lie back down, once laying down bp returned to 123/81 hr 50. 5 mins later, sitting bp 118/81 hr 53, standing 111/75 hr 58, few mins of standing had bp 90/63 hr 57, tingling in fingers and dizziness, causing patient to need to lay back down. few mins later lying bp 109/69 hr 59 sitting bp 113/70, 114/79, 121/86. standing bp checks 121/87, 114/82, and stabilized with final bp at 117/83. no further s/s of issues or orthostatic hotn. escorted with spouse, who was driving, to exit with no issues.
46 2021-04-09 headache, fatigue headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme ... Read more
headache; Shortness of breath; Chest pain; Difficulty breathing; Heart palpitations; Aches; Extreme fatigue/fatigue; This is a spontaneous report received from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch ER2613), via an unspecified route of administration in left arm on 19Mar2021 09:45 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Medical history: hodgkins lymphoma survivor (1996), splenectomy. Concomitant medication was not reported. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. The patient experienced extreme fatigue on 19Mar2021 at 07:00 PM, aches on 20Mar2021, chest pain, difficulty breathing and heart palpitations on 22Mar2021, first episode of shortness of breath and headache on 24Mar2021. The patient assessed events as non-serious. Treatment received for the adverse event was unknown. Test Name: RT-PCR. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. The patient was recovered from the event headache where not recovered from the events extreme fatigue, aches, chest pain, difficulty breathing, heart palpitations and first episode of shortness of breath.
46 2021-04-09 sweating syncopal episode x3. Loss of consciousness each time less than 1 minute. pale, diaphoretic. Brady... Read more
syncopal episode x3. Loss of consciousness each time less than 1 minute. pale, diaphoretic. Bradycardic, HR low 50's. Blood pressure stable. Neurologically intact. EMS notified and transported to Hospital for further evaluation. 7:36 to 800:
46 2021-04-10 chills Nausea, cold chills
46 2021-04-10 fatigue Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the sh... Read more
Tinnitus. Continuous ringing in ears that will not go away. I was perfectly healthy before the shot.. then several days after developed an ache in my right abdomen, fatigue and constant ringing in ears that will not go away. I'm also having a very hard time sleeping.. sometimes only being able to get 2 or 3 hours a night regardless of how tired I am. I'm very disappointed and not sure if I should get the second shot or not given how I'm feeling now. Before the shot I was perfectly healthy. I eat well, exercise and have never in my life experienced tinnitus or any type of hearing problem. This shot was the ONLY thing that could have caused this. I'm not sure what to do next or if I should get the second shot which could make it worse. I'm very worried because the ringing and aches have been constant for 10 days.. some days worse than others.
46 2021-04-10 fever Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the sh... Read more
Pfizer-BioNTech COVID-19 vaccine EUA Patient passed out after waking up at 3 AM the day after the shot was administered. Symptoms included nausea and dizziness. Fever around 100°F begin the following day April 11, 2021 and persisted throughout the day.
46 2021-04-10 sleepiness, fatigue 4/9/21 - second covid vaccine recorded at 9:30 AM. 730 PM started to get sleepy 830 was exhausted w... Read more
4/9/21 - second covid vaccine recorded at 9:30 AM. 730 PM started to get sleepy 830 was exhausted went to bed and slept 14 hrs. Also started having tinnitus when woke 4/10/21. Has decreased over 24 hrs.
46 2021-04-11 fatigue, chills, headache 11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left ar... Read more
11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches
46 2021-04-11 fever, fatigue, chills The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by ... Read more
The day of the vaccine patient started feeling tired, and weak with arm pain . As the days went by the patient started deteriorating and was feeling more tired and and weak and abdominal pain 4 days later patient decided to go to urgent care (March 4,2021) Patient was declined because he had Covid symptoms such as chills and fever. Patient instead got Covid tested, results came back negative. Abdominal pain that patient had was getting worse and fever and chills had not improved. On Monday March 8,2021 patient was admitted into hospital and underwent 2 surgeries. He also had 6-8 inches of his colon cut and was left with and Ostomy bag and will be needing a 3rd surgery in June. patient was released from the hospital Wednesday 24th, 2021
46 2021-04-12 headache I woke up with very bad headache and feeling nauseous 18 hours after receiving second dose
46 2021-04-13 chills, headache, fever, body temperature increased 9 hours after taking the vaccine, I had chills, fever with high temperatures (101.4), severe headach... Read more
9 hours after taking the vaccine, I had chills, fever with high temperatures (101.4), severe headache, body pains and difficulty moving my left arm where I received the shot. I'm still experiencing all these symptoms until the following day.
46 2021-04-13 fatigue Patient reports received COVID19 Pfizer dose #1 on 4/4/2021 with persistent side effects presenting ... Read more
Patient reports received COVID19 Pfizer dose #1 on 4/4/2021 with persistent side effects presenting 2 hours post dose to include severe myalgia, dyspnea with activity, excessive fatigue, vomiting x 1, and loose stools.
46 2021-04-13 lethargy, fatigue Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of b... Read more
Symptoms: lethargic, exhausted, tired, sleepy, low energy, short of breath while talking, short of breath even with minimal physical activity , it's been 7 days since vaccine, unable to finish 8 hr shift at work
46 2021-04-14 fatigue, lethargy Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhau... Read more
Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: difficulty walking had to call 911-Severe, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: per Nurse, pt developed severe vertigo and pt had developed weakness and lead to difficulty walking
46 2021-04-14 fever, malaise Fever, aches, general malaise
46 2021-04-15 fatigue Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving t... Read more
Patient presented to Hospital 5 days after second Pfizer dose with myocardial infarction involving the Left Anterior Descending artery. He had no significant risk factors for coronary artery disease. He reports feeling very fatigue and dyspneic after first dose, and started to have chest pain after second dose.
46 2021-04-15 headache a 46-year-old male with no known past medical history who initially presented complaining of headach... Read more
a 46-year-old male with no known past medical history who initially presented complaining of headache and neck stiffness with onset the morning of 04/03/2021. The patient states that his headache was initially gradual in onset and eventually decreased in severity on 4/5 however, on 04/06 after a day at the beach the patient developed a severe headache with rapid onset that he described as the worst headache in his life. He did try to medicate himself at home with 600-800 mg of ibuprofen every 6 hr with minimal decrease in his headache pain. As result he presented to urgent care for initial evaluation who sent him to the emergency department for possible brain bleed. On arrival to the emergency department the patient had a head CT which showed trace subarachnoid hemorrhage in the basilar cisterns likely due to ruptured cerebral aneurysm. He was transferred to for continued workup of the subarachnoid hemorrhage with CTA and possible IR intervention. At time my evaluation patient was resting comfortably in the bed. He continued to complain of severe headache and neck stiffness. He additionally notes that light and loud sounds make his headache worse. He denied any focal weakness, paresthesia's, numbness, speech difficulty, visual changes, or any other concerning neuro symptoms. Patient was hypertensive during my evaluation despite being on a Cardene drip. Patient's mother was at bedside and was able to assist with history.
46 2021-04-15 sweating hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, r... Read more
hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, room swirling; stated felt like would pass out. Leaning back in chair. Rapid response called; BP 98/60. 1615 Treatment/intervention : given epi 0.3 mg in R thigh. BP 100/70; feeling better; pulse up to 64, p ox 96%. Still grey, sweating. Able to drink water. 1630 Pulse 68; p ox 93-94%, with mask off 96%. Patient reports past history of reaction to flu vaccine; no allergies noted. Agreeable to be monitored in ED; got in wheelchair without dizziness; still grey.
46 2021-04-15 lethargy, chills, fever, headache Fever, headache, muscle pain, shivering, lethargic
46 2021-04-15 pneumonia Multifocal Pneumonia
46 2021-04-15 fever, fatigue I HAVE FEVER FOR 15 DAYS
46 2021-04-16 fatigue, body temperature increased Joint pain, injection site pain, extreme fatigue, and a 101.4 fever for roughly 12 hours.
46 2021-04-16 nasal congestion, headache Extremely sore shoulder, headache, stuffy head, body aches and nausea.
46 2021-04-16 throat pain, headache Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. D... Read more
Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. Day 2 on 04/13 weeks after 1st shot headaches, joint and muscle pain. Sore throat and Covid Rapid Antigen Abbot Testing ministered on 04/16 . Results negative. Constantly joint tingling and some leg muscles felling sores.
46 2021-04-16 fever, chills Extreme body shivers and temperature fluctuations for a 14 hour period, starting at 5pm the day afte... Read more
Extreme body shivers and temperature fluctuations for a 14 hour period, starting at 5pm the day after the vaccination r
46 2021-04-16 fever, chills Fever, chills, generalized body aches
46 2021-04-16 sleepiness, fatigue, fever, headache, cough A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetful... Read more
A 46 y.o. male who presents today with numbness in both legs, difficulty concentrating and forgetfulness, and cough with chest tightness. Covid symptomatic in November. Received Covid Pfizer vaccine on 4.13.21 at 1pm. Felt fine headed into the vaccine. He completed the observation period and felt chest tightness after about 5 minutes similar to Covid in November. He felt slightly better and went to work. At work his cough and chest tightness worsened. Very tired, unable to eat with no appetite. Extreme fatigue Wednesday sleeping most of the day. Cough and chest tightness and feeling he cannot catch breath like being submerged in a pool. On 4.15.21 his feet became numb and tingling bilaterally. He felt more confusion, forgetting what he was doing, left frozen food in the sink and unable to recall why. He is also having headache posteriorly 7-8/10 which began on 4.14.21. He reports headache is not common, now 3-4/10 and feels very similar to Covid in November. Does have some mild neck stiffness associated. Chest tightness almost identical to Covid in November. Reports numbness and tingling in the feet has been ascending in nature. He felt unsteady on his feet yesterday morning. He is having tingling and cramping in the bilateral calf muscles today. His cough continues with no phlegm. Comes in coughing spells with chest tightness. He also noted cough is worse with exertion. Fever 99.8 yesterday. No diarrhea. No loss of smell or taste. In ED noted to have right LE weakness. Wife reports that he seemed unsteady while walking Kept for observation. difficulty concentrating - back to baseline 4/17/21 at 3:26 pm assessment SOB: CTA thorax 4/16/21 unremarkable CT angiogram thorax Symptoms began approximately 5 minutes after his Pfizer. Reports that his cough and shortness of breath now seems to be improving. Continues to have some mild chest tightness, intermittent cough. Robitussin significantly helped. Extensive workup including CT angiogram of the thorax reveals no evidence for pulmonary embolism or infiltrate. COVID-19 PCR testing is negative x2, severe respiratory isolation has been discontinued. Patient has a negative D-dimer, LDH, ferritin, CRP. Cardiac troponin has been negative x2. Patient does have some wheeze, after cough, suggesting some bronchospasm. Will trial albuterol inhaler q.i.d.. Patient does report a history of what sounds like an environmental triggers asthma like event in the past, though reports that he has undergone evaluation for asthma and was told that he does not carry a diagnosis of asthma. Patient is currently on room air. I have reviewed the reported adverse reactions from the Pfizer vaccine and coughing shortness of breath are not listed. Continue supportive care, with Tessalon and Robitussin, IS
46 2021-04-18 headache On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the ... Read more
On March 25, 8 days after the vaccine shot in my left arm, I began experiencing intense pain on the left side of my neck and head. By March 28 the pain had become so excruciating I went to an Urgent Care facility and they sent me to the Emergency Room. While in the ER I had blood tests and a CT scan which all came back negative. I was given Oxycodone-Acetaminophen for the pain and prescribed Cephalexin in case there was some type of infection. They also ruled out Shingles. I continued to have pain and contacted my Primary Care Physicians Office and spoke with one of the Physician Assistants two times the next week. She prescribed Baclofen 10 mg and took me off the Cephalexin and put me on Amoxycillin because we thought the problem might have been an ear infection. The next week I spoke with my Primary Care Physician, and he believed I was suffering from Trigeminal Neuralgia, so he put me on Carbamazepine 200 mg twice a day. That same week, on April 9, I was finally able to meet with the Physician Assistant at the Neurologists office and she also believed I was suffering from Trigeminal Neuralgia. I continued to take the Carbamazepine daily and the Baclofen and Oxycodone-Acetaminophen as needed. On Monday April 12 I informed the nurses at the Neurologist office that I was experiencing several symptoms/side effects that included dizziness, weakness, difficulty swallowing and a pounding heartbeat. The nurses talked with the PA and the PA took me off the Carbamazepine and put me on Oxcarbazepine 150 mg twice a day and she prescribed Methylprednisolone 4 mg. On Thursday April 15 I began to have intense prolonged pain behind my left ear down to the neck and in the Trigeminal nerves in the forehead and top of the head on the left side. I was in so much pain I slept for less than 2 hours. The next morning, I vomited and went to the Emergency Room again. At the ER they treated my pain with a headache IV cocktail that included Ibuprofen, Benadryl, an anti-nausea medication, Fentanyl, and a steroid. Within an hour my pain level dropped from a 9 to a 3 and I was released. The ER prescribed Gabapentin 300 mg (3 times a day) which I started the evening of April 16. I have had less constant pain since leaving the ER and starting the Gabapentin, but I continue to have pain in the Trigeminal nerve areas and neck with some flare ups that reach a 7 out of 10 in pain. I am scheduled for an MRI on April 23 and a visit with the Neurologist on May 10.
46 2021-04-19 headache Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and s... Read more
Diarrhea came two days after for four days. Sore arm. Head felt numb-ish, tingly on right side and sore shoulder/arm. Then, small bumps on head and headache. Then, five days or later large bumps formed on head. Top of head, then moved to right side of head, lymph nodes and right side of neck swelling. Very severe head ache 7 days later. Emergency call to doctor and doctor visit. Bumps moving and forming in different areas side of vaccine. Face swelling. Throat swelling...all on right side.
46 2021-04-19 sweating "Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. ... Read more
"Administered - 12:02 Adverse event started - 12:05 Patient had flushing/sweating, lightheadedness. Worked night shift per patient. BP 90/48 (57) -- > 101/65 (73), HR 71 -- >73, RR 16 -- > 16, O2 99% -- > 100%. Provided VSS, water, crackers. Patient stable, released from vaccination site."
46 2021-04-19 fever fever, body aches, lack of energy
46 2021-04-20 headache Ringing in both ears, started a few hours after vaccination and continues. Left ear is more audible.... Read more
Ringing in both ears, started a few hours after vaccination and continues. Left ear is more audible. Headache in the evening left temple
46 2021-04-20 headache Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness... Read more
Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness on 3/23. Diagnosed per Dr. on 3/23 with shingles and prescribed VALACYCLOVIR HCL (1GM) and PREDNISONE (30MG) for symptoms.
46 2021-04-20 sweating, fever Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing ... Read more
Pt recieved 2nd dose of pfizer vaccine on 4/14. on 4/15 pt had fever up to 103. Pt has had ongoing fevers since. On 4/20 pt became confused and displayed s/s of stroke. Brought to hospital by EMS and evaluated for stroke like sx. Pt was treated for stroke- given TPA and placed in ICU. CT showed show evolving subacute infarct. Pt has word difficulty, confusion, diaphoresis. Currently still in ICU.
46 2021-04-21 chills, headache Headache, chills, body aches
46 2021-04-21 sweating Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand ... Read more
Pt was nervous before getting shot. After receiving shot he was in a monitor area. He raised hand and stated he felt weak. He was pale and diaphoretic. Helped him to ground and allowed to rest. Felt better. Pt evaluated by paramedics. VS @ 1107 HR 68, OxSat 99%, BP 96/47. @1115 Sit in chair. BP 104/56, HR 70, OxSat 100%. @ 11:45 Pt ambulated w/o difficulty. Taking bus home. Told to call nurse when he arrives home.
46 2021-04-22 chills, fatigue, cough Body aches, joint pain, shaking, chills, cough, fatigue, shortness of breath on exertion
46 2021-04-22 headache, fever After two hours of putting the first dose, I experienced headache, pain in the joints of the feet an... Read more
After two hours of putting the first dose, I experienced headache, pain in the joints of the feet and hands, abdominal pain in the lower part of the back. A little fever at night and nausea. I took acetaminophen for the fever and the pain subsided quite a bit in my symptoms.
46 2021-04-22 fever, chills, fatigue, headache In less than 24 hrs. after injection, experienced pain in the injection site, fever with chills, fat... Read more
In less than 24 hrs. after injection, experienced pain in the injection site, fever with chills, fatigue, muscle/joint pain and headache.
46 2021-04-23 headache, fever, fatigue Headache, fever, tiredness
46 2021-04-23 headache constant tinnitus in left ear, headaches, ear pressure.
46 2021-04-23 sweating Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 lef... Read more
Pt became nauseated, c/o burning hot/cold, diaphoretic, head spinning, feeling weak. PB 170/100 left arm. Pt still symptomatic and was taken to Emergency Department.
46 2021-04-24 headache, fever, fatigue, chills Fever up to 102.3 degrees, severe chills, body aches, headache, loss of taste & smell, fatigue, dizz... Read more
Fever up to 102.3 degrees, severe chills, body aches, headache, loss of taste & smell, fatigue, dizziness. Most symptoms including fever lasting at least 36 hours. Still experiencing fever, fatigue, dizziness.
46 2021-04-25 headache Shortly after, lightheadedness. Muscle soreness and headache the following 2 days.
46 2021-04-26 chills, sweating, cough Client reports that on 4/23/2021 received Pfizer vaccine in left arm. Client reported that around 1:... Read more
Client reports that on 4/23/2021 received Pfizer vaccine in left arm. Client reported that around 1:00 pm started with symptom of diarrhea, next day chills, fevers, mild sweats and coughing. Client stated the coughing may be from his smoking. Client expressed that he is still experiencing diarrhea now for four days. Per Client does have underlying medical condition. No follow up MD and no medication taken for symptoms. Client has been drinking Pedialyte to try and stay hydrated. PHN suggested that Client follow up with PCP, urgent care, ER and call 911 for medial emergency. Client verbalized understanding information provided by PHN during TC and plan to follow up with ER, due to, no longer having a PCP.
46 2021-04-26 headache Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting h... Read more
Client reported receiving Pfizer COVID 19 vaccine on 4/22/2021 in right arm. On 4/23/2021 starting having body aches, dizziness, headache and filling flushed. On 4/24/2021 lip swelling started and now both lips, sides of mouth with clear blisters. Per Client, allergic to shellfish and no other known past medical history. Per Client has taken Benadryl and Ibuprofen, but symptoms are still presenting. PHN recommended that Client follow up with PCP, be seen at urgent care, ER and to call 911 with any respiratory concern or medical emergency. Client verbalized understanding information provided by PHN and plans to follow up and seek medical attention.
46 2021-04-26 headache After second vaccination, an intermittent "squeezing" full head headache (each lasting around 2-3 se... Read more
After second vaccination, an intermittent "squeezing" full head headache (each lasting around 2-3 seconds) starting; This is a spontaneous report from a contactable pharmacist. The 46-year-old male patient received bnt162b2 (COMIRNATY) solution for injection, dose 2 (Batch/Lot Number: EL3249) on 22Jan2021, at 09:30 AM, and dose 1 (Batch/Lot Number: EK9231) on 02Jan2021 at 10:00 AM via an Intramuscular route of administration in right arm as a single dose for covid-19 immunisation. The medical history and concomitant medication were not reported. Patient reported on 22Jan2021 at 01:15 PM after 1st vaccination, mild intermittent headache that subsided after 24 hours. And after second vaccination, a intermittent squeezing full head headache (each lasting around 2-3 seconds) starting 2 hours post vaccination. It seemed to subside after 2 weeks and now has returned. Patient took other medications in two weeks once time. Patient received treatment drug as Ibuprofen. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Patient did not have any known allergies. The outcome of event was Not recovered.
46 2021-04-27 cough Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and coll... Read more
Cough and diarrhea the day after receiving vaccine. The next day, had difficulty breathing and collapsed.
46 2021-04-27 fatigue Vomiting and nausea for 8 days post shot number 1, fatigue for several days
46 2021-04-27 fatigue Fatigue/extreme tiredness
46 2021-04-27 headache 10:05am Headache, 10:21am Patient stated he is feeling much better. 128/78, HR 80, O2Sat 99%. EMS in... Read more
10:05am Headache, 10:21am Patient stated he is feeling much better. 128/78, HR 80, O2Sat 99%. EMS informed patient that if still feeling symptoms to call 911 or primary care doctor. Understanding verbalized. (Patient is alert x3.)
46 2021-04-27 headache Headache 4/10 left side. Pt. stated that he still had a headache. pt. informed that if symptoms pe... Read more
Headache 4/10 left side. Pt. stated that he still had a headache. pt. informed that if symptoms persist or worsen to call 911. Pt. told to follow up with primary care provider. Pt. verbalized understanding. Pt. A+Ox3.
46 2021-04-27 malaise, sweating, nasopharyngitis, chills I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was... Read more
I received my second Pfizer COVID vaccine shot at 11:00 am. The first 12 hours after everything was normal and fine. I ate dinner and got ready for bed. But then, starting 12 hours after my shot, starting at 11:00 pm, I began to have severe chills and total body shakes. I was curled up into a ball under blanket, both freezing cold and profusely sweating. My breathing was very fast and I couldn't slow it down. My stomach was very upset and I was unable to eat anything. At 3:30 am, I got a severe Migraine which lasted until 6:00 am. I continued to feel very ill the whole rest of the day. Finally, around 9:00 am some 34 hours after syptoms began, they left me.
46 2021-04-27 fever, lethargy, chills Extreme chills and fever in the night. Woke up with 100-degree fever at 5:30am. Took Tylenol. Fel... Read more
Extreme chills and fever in the night. Woke up with 100-degree fever at 5:30am. Took Tylenol. Felt lethargic all day, but was better after about 24-hours later. I did have Covid-19 testing positive on 10/31/20.
46 2021-04-28 chills, fever Fever, chills, aches for 24 hours
46 2021-04-28 chills Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have sl... Read more
Patient received first dose of Pfizer vaccine and started to feel dizzy, weak, nauseous, and have slight chills about 5 minutes after receiving vaccine. Patient's symptoms were on and off. Blood pressure was taken and fluctuating. Paramedics were called per patient's request. Patient did not leave with paramedics and signed waiver. BP 1: 90/60 Pulse 1:104 BP 2: 124/86 Pulse 2:74 BP 3: 114/74 Pulse 3: 61 BP 4: 109/75 Pulse 4: 84
46 2021-04-28 headache, fever, fatigue 46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, a... Read more
46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.
46 2021-04-28 headache, fever 101 fever, headache
46 2021-04-28 headache Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Cal... Read more
Regular pain feeling; Headache; Muscle pain; Calf feels tight, stiff, it feels like dead weight; Calf feels tight, stiff, it feels like dead weight; Pain running up the right arm up to the shoulder/Calf pain; He asked if someone can tell him if it is a blood clot in the back of his calf; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm (shoulder) on 12Mar2021 10:07 (Lot Number: EN6202) as single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient has no prior vaccinations within 4 weeks. The patient was not sick at time of vaccination. The patient reported that on 12Mar2021, he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes. However, he said that the last few days (2021), there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping. His calf feels tight, stiff, it feels like dead weight. It wakes him up at times. He also reported pain running up the right arm up to the shoulder on unknown date in 2021. He was just curious in terms of what that might be. He asked if someone can tell him if it is a blood clot in the back of his calf. The headache went away after 2-3 days. He also reported that his eyes also hurt a little bit and was the same time frame as the headache (onset date reported as 12Apr2021: after the second dose, pending clarification). He stated that those things were just mild, nothing major. He did not take anything for these. He confirmed he no longer had muscle pain. He just has pain behind the calf and right arm up to his shoulder. His calf pain, started to feel tight, started within the last 2- 3 weeks (2021). The arm pain in right arm up to shoulder started maybe within 2 days. The patient received the second dose on 02Apr2021. Outcome of the events muscle pain and headache was recovered in Mar2021, events pain running up the right arm up to the shoulder/Calf pain was not recovered, and outcome of other events was unknown.
46 2021-04-29 fatigue, chills, headache, fever, nasal congestion Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate... Read more
Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days. Stuffy nose - 1 day. muscle pain, chest, both shoulders, arms - 4 days. Joints pain - 2 days. Pain in the lymph nodes - 2 days. Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.
46 2021-04-29 fatigue, chills I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I wok... Read more
I experienced mild fatigue and chills about 12 hours after the shot. No treatment necessary. I woke up at approx. 1:30 am feeling very warm. I got out of bed. While in the bathroom, I began to feel very lightheaded and passed out while I was washing my hands. My wife heard me crash to the floor. I returned to consciousness but passed out again while trying to stand, unresponsive to my wife. I returned to consciousness after about 1 minute. I stayed sitting for several minutes while my wife brought me some water. I felt thirsty and it's possible I was dehydrated, but I had been drinking fluids (water) the day before as normal. Due to the two fainting spells and a possible head injury, I went to the Emergency Room for treatment at approx. 2 am.
46 2021-04-29 fever, chills Fever, chills, migraine
46 2021-04-30 cough, fatigue, fever, malaise, sweating moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sw... Read more
moderate muscle aches; mild fatigue; mild fever; mild cough; felt faint; ears were ringing; began sweating pretty; felt a little too ill to get up and walk away; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 13Apr2021 15:00 (Lot number was not reported) (at age 46 years old) as single dose for covid-19 immunisation in a pharmacy. Medical history included covid-19 from an unknown date and unknown if ongoing. Patient was not covid tested post vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 13Apr2021 15:00, within one minute of receiving the vaccine, his ears were ringing, he felt faint, and began sweating pretty significantly. He took a seat immediately, and these symptoms seemed to pass after about 8-10 minutes. He stayed seated for 40 minutes after in the pharmacy as he felt a little too ill to get up and walk away. Next day, on 14Apr2021, symptoms are mild fatigue, mild fever, mild cough, and moderate muscle aches. Treatment not given for the events. The patient was recovering from the events. Information on the batch number has been requested.
46 2021-04-30 cough Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins... Read more
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-04-30 fatigue, headache, fever, runny nose Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic ... Read more
Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination. No follow-up attempts are needed. No further information is expected.
46 2021-04-30 fatigue fatigue; muscle aches; testicular pain; This is a spontaneous report received from a contactable con... Read more
fatigue; muscle aches; testicular pain; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 30Mar2021 at 13:00 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient took unspecified concomitant medications. The patient did not have any allergies to medications, food, or other products. On 31Mar2021 at 07:00 the patient experienced fatigue, muscle aches, and testicular pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of fatigue, muscle aches, and testicular pain was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19 immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-01 headache, sleepiness, fatigue I had my second Pfizer vaccine on 1pm April 23rd. I had headache, nausea and tired feeling from Frid... Read more
I had my second Pfizer vaccine on 1pm April 23rd. I had headache, nausea and tired feeling from Friday afternoon and it improved Saturday afternoon. Sunday I had a slower but normal day. Monday morning I felt normal but by 2pm I started to feel drowsy and by 4pm the headache and nausea returned to the point I had to go to sleep. This morning I have a light headache and nausea. I have taken Tylenol. Thursday I went to the gym and had higher than normal heartbeat and would get lightheaded. Went to gym today and all is was back to normal.
46 2021-05-01 lethargy, malaise Extreme lethargy and feelings of general malaise.
46 2021-05-01 malaise Patient was observed not feeling well. He stated he was dizzy, given some water and then he was put ... Read more
Patient was observed not feeling well. He stated he was dizzy, given some water and then he was put on the floor by a nurse with his feet up. We brought him to the med observation 1 on a stretcher. He was able to get off the floor by himself. We offered him a snack but he refused. He said that he was feeling better. We did 5 viatls and he was fine to leave. Patient looked better to us and we wheeled him to the exit. We took vitals at 10:40 am heart rate 71, o2 98, BP 135/87, at 10:43 am heart rate 71, 02 98, BP 131/83, at 10:44 am heart rate 78, o2 98 BP 126/87, 10:47 am heart rate 75, o2 99, BP 127/80 and at 10:48 am o2 98, BP 131/81. Patient was released at 10:49 am
46 2021-05-01 fever, chills Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Too... Read more
Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills. Took Benadryl tablets about an hour after receiving the vaccine. Took Tylenol for the fever. Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.
46 2021-05-01 fever, sweating Fever, body aches, shakes, body sweats, sore arm at the injection site
46 2021-05-02 chills, fatigue, fever, headache Chills, fever, body pain, headache, fatigue, swollen ganglion
46 2021-05-03 chills, headache, fever, fatigue Within 5 minutes after receiving the shot, patient started having headache & heartache on and off fo... Read more
Within 5 minutes after receiving the shot, patient started having headache & heartache on and off for about 10 minutes. Patient also complaint about his throat/mouth was dry. 15 minutes after he started to have numbness around his mouth and on tip/ middle part of his tongue. Numbness lasted for about half an hour. That night he vomited and has chills. Next day he had very mild fever, pain in the right lung when he sneezed / coughed. He didn't have much symptoms on the 3rd day except for an sore arm and tireness.
46 2021-05-03 headache, fatigue Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 devel... Read more
Initially developed fatigue, myalgias, and headache after vaccine administration. On 5.3.2021 developed "brain fog" where patient had difficulty focusing, completing tasks, and subsequently developed anxiety symptoms.
46 2021-05-04 headache full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contac... Read more
full body aches; headache/headachy; fogginess/cloudiness; This is a spontaneous report from a contactable consumer reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 02Apr2021 (Lot Number: EP7533; Expiration Date: 30Jul2021) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine on 12MAR2021 (Lot number: EN6208, Expiry date: 30Jun2021), also at age of 46 years old for covid-19 immunization. He didn't have any kind of soreness after the first COVID vaccine. He had no tenderness, no side effects, nothing. For the first time it was about 13:30 in the afternoon and then the second time was he wanted to say about 10:00 am. He had both dose in his shoulders, one was in the left and one was in the right. Vaccine Administered at Military Facility was No. Vaccination Facility was Hospital. Prior vaccination (within 4 weeks prior) was none. The patient medical history and concomitant medications were not reported. Patient had the headaches and also had bad fogginess about 6 hours after the COVID vaccine was administered and the full body aches kicked in the next morning which was about 20 hours after the COVID vaccine was administered and then like he said the body aches went away and the only thing that has really lingered from time to time was the headaches. The body aches started on 03Apr2021 and were over by the following Monday, so 05Apr2021. The cloudiness and the headaches began on 02Apr2021 but he did not have the cloudiness anymore. He got headachy very easily now and he has never experienced that before. He got headaches really easy, they were lingering, but they were not migraines it was just an achy head in the background, in the distance, and he can tell it was something different. The outcome of event headache was not recovered, the outcome of event full body ache was recovered on 05Apr2021,the other event was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-05-04 fever, dehydration, sweating This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's fiance). A 46-year-old male patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:20 (Lot Number: EW0162) (received at the age of 46-years-old) as SINGLE DOSE for COVID-19 immunisation. Medical history included right knee pain. Concomitant medications were not reported. The patient received the Pfizer 1st shot 18Apr2021 11:20 am. On 19Apr2021, at midnight, he had low grade fever then swelling right leg. On the day of the report, 20Apr2021, he had swelling to both legs. The patient had taken ibuprofen as treatment beside propping legs up. The reporter wanted more information on the swelling and if it's related to taking ibuprofen. It was further reported that the patient experienced severe swelling from the knees down to the calves on both legs on 19Apr2021. He also experienced night sweats, fever, lightheadedness and dizziness on 19Apr2021. They want to know if there are any reports regarding the swelling side effects and if it is from the vaccine. The first dose of the vaccine was given 2 days ago (18Apr2021) and the second dose is due on 09May2021. The patient got his first shot on 18Apr2021 about 11:20am. After about 15 hours he developed swelling in one leg, she later clarified this to be his right leg, and now reports that both of his legs are swollen at the time of report (20Apr2021). She noted that patient told her his legs are not painful. She doesn't know if it's a blood clot or if they needed to go to the hospital. She also wanted to know if there is information about this as a side effects or if other people are having this too. She then reported that the patient started experiencing a fever, profuse sweating, and was spacey about 12 hours after the vaccine, a little after midnight 19Apr2021. She doesn't know if the dehydration made it worse. His fever was low-grade 99.8 degrees and lasted 4 and a half to 5 hours and has now resolved. When asked if patient received any treatment for fever, caller said it was so recent, and that was listed as a common side effect that goes away. Reported the patient drank fluids and she kept an eye on him. Leg swelling was about 15 hours after the vaccine, early morning 19Apr2021. She noted that the swelling in the right leg got bigger and didn't go down, but the left leg did. But today the left was more swollen and more prominent today. She further clarified that the patient takes ibuprofen for pre-existing right knee pain. Caller also reported that the patient propped his legs to alleviate the swelling, it has improved some but the swelling did not go away. The adverse events did not require a visit to the physician office or emergency room. Outcome of the event fever was resolved on 19Apr2021 (lasted 4 and a half to 5 hours); outcome of the event "severe swelling from the knees down to the calves on both legs" was not resolved; outcome of the remaining events was unknown.
46 2021-05-04 respiratory tract congestion, fatigue, cough, runny nose Cough Fatigue Muscle or body aches Congestion or running nose
46 2021-05-05 malaise Prior to vaccination patient experienced dizziness and feeling "sick". Denies symptoms of active ill... Read more
Prior to vaccination patient experienced dizziness and feeling "sick". Denies symptoms of active illness. Blood glucose level 280. Patient stated he would be more cautious and take his prescribed medications.
46 2021-05-06 chills SO I took the second dose on Tue around noon. Wed around noon I started feeling slight chills and sl... Read more
SO I took the second dose on Tue around noon. Wed around noon I started feeling slight chills and slight body ache. Slept it off until 7 pm . Thu around noon - more body ache about similar chills. Rest for a couple hours, slept it off for a couple of hours. Fri again around noon - similar body ache but significant uncontrollable chills. Body felt warm on and off through these periods noon to 7 pm. Treated with Tylenol (300) + advil (600). Some comfort, but that comfort seems to be lessening over the period. For example the uncontrollable chills today started concerning me. Tylenol took more than an hour to slightly lessen the chills. Had advil to see if that helps. As I write this chills seems to have subsided. But that feeling of warmth especially in the face has returned. Feel like placing a cold towel on the face. Weirdly enough its this noon to 7 pm time frame when the symptoms are at their worst and in any combination really any given day. Outside of that I function pretty well, almost normal! Its past 48 hours so thought I'd report.
46 2021-05-06 headache, fatigue Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour ... Read more
Within seconds of my first vaccine I had a massive headache. 20 mins later I had brain fog. An hour later I had exhaustion and then injection site arm began hurting. This lasted for 48 hours and then I was fine. It came on fast and stayed. I had difficult time thinking or retaining a memory. Second shot had no instant reaction, injection site just slowly began hurting. An hour later, and very suddenly, brain fog hit me and i lost all short term memory, mid sentence. Similar to what I would consider a form of Alzheimer?s. At the same time I developed a headache, not as severe as the first shot, but I was more exhausted than the first shot. Forming sentences, being able to think was very difficult for 72 hours. I was exhausted, arm hurt. After the 72 hours, I lost my sense to smell. I am in my 96 hour since my second injection and still have no sense of smell. I can taste. Never had a fever but for both shots it felt like it was absorbed by my muscles and was then converted to something else which was then released back into my system. It was like I had sore muscles it was like my muscles became the poison. This effect was grossly more profound after the second vaccine. The ability to think was the scariest side effect.
46 2021-05-09 fatigue, cough, productive cough, chills, headache 4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had... Read more
4/6/21 called PCP office stating ?Patient called stating since his first COVID 19 vaccine he has had wheezing in his lungs, short of breath on exertion and productive cough. Voice also sounds "harsh" per patient. He has used his inhaler and it is not helping.? Nurse recommended Urgent care tonight. Patient agreed. 4/6/21 went to urgent care. CXR no acute airspace process. COVID-19 PCR: neg. Given Prednisone. Sent home 4/13 allergy appointment cancelled. 2nd vaccine 4/20/21 received. Reports difficulty breathing, dizziness and weakness and headache on survey. Calls Nurse triage 4/20/21 and reports extreme fatigue, headache, nausea, vomiting, and chills. Calls Nurse triage phone on 5/6/21 reporting shortness of breath, phlegm and cough. Recommended to go to ED. Went to ED.
46 2021-05-10 cough, chills, headache, paranasal sinus discomfort contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestio... Read more
contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestion and tightness; chest congestion and tightness; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program. This 46-year-old male patient, weight: 90.72 kg & height: 180 cm, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 02Apr2021 11:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included sinus infection with his seasonal allergies. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken to manage his sinus flare ups and drainage during the allergy season. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no predisposing factors. The patient was not enrolled in the clinical trial. The patient received his first COVID 19 vaccine on 02Apr2021 and subsequently contracted the COVID 19 virus and tested positive for the COVID 19 virus on 12Apr2021 with a rapid test at a physician's office. During the first full week of Apr2021, he started having symptoms: body aches, chills, sinus pressure, headaches, cough, chest congestion and tightness but he did not have a fever. It went on for about 2 weeks, with some varying between his symptoms during that time. He reported that he normally has seasonal allergies and all of his symptoms were coinciding with his typical allergy symptoms. The chills dissipated during the first 3 days following the COVID 19 vaccine and the chills subsided. Then the sinus drainage and all the other symptoms kicked in. He thought maybe his symptoms were from the COVID 19 vaccine but he also thought it could be the sinus symptoms he has in the spring time. Obviously, his symptoms continued, and he knew it was not related to his seasonal allergies. He usually would get a sinus infection with his seasonal allergies, bacteria would jump in his sinus issues, and he didn't have that. His sinus infections can be. That's when he knew what he had was not related to his seasonal allergies. The patient stated that he is due to receive his second COVID 19 Vaccine on 23Apr2021 or if he needs to reschedule the vaccine considering his second vaccine is such close proximity to his COVID 19 diagnosis. The event, chills, was resolved in Apr2021 while the clinical outcome of the events, contracted the COVID 19 virus, body aches, sinus pressure, headaches, cough, chest congestion and tightness were unknown.
46 2021-05-10 sweating Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium
46 2021-05-10 fever, headache, chills chills; possibly fever; headache; This is a spontaneous report from a contactable Other HCP (patient... Read more
chills; possibly fever; headache; This is a spontaneous report from a contactable Other HCP (patient). This 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm at the same age on 20Apr2021 08:30 AM (lot number: ER8731) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Mar2021 08:00 AM (lot number: ER8733) as single dose for Covid-19 immunisation. About 12 hours after the 2nd dose, the patient got the chills, and possibly fever on 20Apr2021 at 08:00 PM. The patient woke up next morning with fever and headache. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
46 2021-05-10 throat irritation, fever, sweating, headache, sinus congestion, cough diaphoresis, fevers, sinus congestion, body aches, headache, scratchy throat, cough, lack of energy
46 2021-05-11 cough, nasal congestion NASAL CONGESTION LOSS OF TASTE/SMELL COUGH
46 2021-05-11 fever Fever of 37.3 C. Dizziness
46 2021-05-11 throat irritation itching in my throat and then I started scratching after that; started having the bruises like very ... Read more
itching in my throat and then I started scratching after that; started having the bruises like very dark red bruises after I scratch up my throat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: ER8729) as 1st dose, single in left arm for COVID-19 immunisation. There were no medical history and no concomitant medications. The patient had a vaccine on 12Apr2021 after one week on 18Apr2021 he started having side effect of like itching in his throat and then he started scratching after that. Then the itching was better but however he started having the bruises like very dark red bruises on an unspecified date in Apr2021 after he scratch up his throat. So he didn't know what's that if the concern because the patient had read in heard lot about bruises and hemorrhage maybe bleeding. So he didn't know if something is the concern. The patient needed to do a testing because he had another appointment for the second shot on 03May2021. There was no treatment for the events. The outcome of event itching in my throat and then I started scratching after that was recovering, and of the other event was unknown.
46 2021-05-12 fatigue aches and tiredness about 1 day after shot. lasted about 1.5 days
46 2021-05-12 influenza like illness NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HI... Read more
NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.
46 2021-05-13 throat pain Patient received this Pfizer vaccination outside of this clinic, tolerated first dose with no issues... Read more
Patient received this Pfizer vaccination outside of this clinic, tolerated first dose with no issues, however 3 days after receiving second dose he had the onset of diffuse erythematous rash covering his legs and arms, he also noted a mild sore throat, but no respiratory distress. he did not immediately seek medical attention but reported symptoms to a doctor friend, who advised benadry, and to seek medical attention. He began taking benadryl 50mg q8 hours and symptoms gradually improved, he later sought care through our clinic and was seen 3 weeks after onset of symptoms. He has been taking Benadryl regularly 50mg every 8 hours which has been effective in controlling symptoms but when he misses dose he experiences recurrence of rash.
46 2021-05-14 fatigue mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received... Read more
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021. Batch/Lot number has been obtained. further information has been requested.
46 2021-05-16 fever, fatigue, headache Headache Muscle ache Fatigue Fever Left sided hemiparesis
46 2021-05-19 chills, fatigue, fever Called health system call ceneter to report feeling tired, chills and slight fever but did not check... Read more
Called health system call ceneter to report feeling tired, chills and slight fever but did not check temp since 5/4/2021 after got 2nd dose covid vaccine Pfizer on 5/3/2021.Pt denies any emergency sx at this time. Pt took tylenol on 5/4 and 5/5 with relief. Home management pt education given, pt assure understanding. Pt requested MD consult appt for today, Scheduled telephone visit with urgent care MD 5/7/21
46 2021-05-20 sweating I didn't get sick or tired, only sweating. Today I went to the bathroom and have a rash on my hip, i... Read more
I didn't get sick or tired, only sweating. Today I went to the bathroom and have a rash on my hip, its hard like with a bunch of spots on it and it hurts to touch. It feels like I got a shot in my hip and it's about the size of a 50cent piece and my leg feels a little bit numb under the skin. Its weird and hard to explain.
46 2021-05-20 malaise Feel very very very sick not improved over time
46 2021-05-21 sleepiness, headache, influenza like illness, fever, chills, sweating, cough Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty ta... Read more
Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty taking deep breath. Sleepiness. Dizziness. Could not stand for long periods. Fever finally broke around 9pm. Chills turned to sweats. By 10:30pm, felling better, but still weak and joint aches. Went to bed, sweat most of the night.
46 2021-05-22 headache Patient arrived to the Emergency Department today with facial droop and left sided facial/mouth numb... Read more
Patient arrived to the Emergency Department today with facial droop and left sided facial/mouth numbness and headache.
46 2021-05-23 headache, fever, fatigue A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weaknes... Read more
A week after second shot: Intermittent 2 degree fever, lower back pain, tiredness, headache, weakness, brain fog.
46 2021-05-25 fatigue fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male p... Read more
fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 at 09:30AM (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension .The patient also reported allergy to shellfish. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient's concomitant medications included Cozaar (MANUFACRURER UNKNOWN), vitamin B12 (MANUFACRURER UNKNOWN), vitamin D (MANUFACRURER UNKNOWN) all for unknown indication from unknown dates and unknown if its ongoing. On 14Mar2021 (Day 5), the patient started to feel fatigue but on 16Mar2021 (day 7), it was so intense that prevented him to do habitual physical activity. The patient who was an athlete, preparing for a triathlon, was not able to finish a 4-mile run, which was very simple to his fitness level. The patient was treated for the event fatigue with Advil (MANUFACRURER UNKNOWN). The clinical outcome of the event fatigue was not recovered. No follow up attempts are possible. No further information is expected.
46 2021-05-25 headache mild intermittent headache; This is a spontaneous report from a contactable Pharmacist reporting for... Read more
mild intermittent headache; This is a spontaneous report from a contactable Pharmacist reporting for a patient. A 46-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Right on 02Jan2021 10:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced mild intermittent headache on an unspecified date with outcome of recovered. The event was treated with ibuprofen and subsided after 24 hours. No follow-up attempts are possible. No further information is expected.
46 2021-05-25 fever Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2... Read more
Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2. He presented to the ED 2 days later on May 21, 2021. An ECG showed acute pericarditis. His TnI was mildly elevated. An echocardiogram showed mild LV dysfunction with LVEF 40-45%. He was diagnosed with myopericarditis. Treatment included NSAIDS and colchicine and metoprolol. He was not admitted to the hospital.
46 2021-05-27 headache My blood pressure rose 30 points on both systolic and diastolic pressures to 160/130 with tightening... Read more
My blood pressure rose 30 points on both systolic and diastolic pressures to 160/130 with tightening of my chest. EKG showed no sign of heart attack and I was released from the emergency room after 3 hours of monitoring at which time the blood pressure normalized to 130/90. 12 hours after the injection I had pain at the injection, extreme full body aches, mild headache and slight nausea. All side effects were gone within 36 hours.
46 2021-05-28 fatigue Pt presents to clinic with c/o S/E to Pfizer Covid 1st Vac. to L delt 3 days ago, states since yeste... Read more
Pt presents to clinic with c/o S/E to Pfizer Covid 1st Vac. to L delt 3 days ago, states since yesterday has felt drained/tired then today while at work was nauseated.
46 2021-05-28 headache, cough I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back... Read more
I only slept 1 hour; My arm, head and back hurt.; My arm, head and back hurt.; My arm, head and back hurt.; Dry mouth; coughing; random thoughts; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 15May2021 12:00 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 15May2021 12:15, the patient only slept 1 hour, his arm, head and back hurt. Dry mouth, coughing, random thoughts. He felt like he was dying over here. Events were considered serious, disability. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-05-28 headache, malaise Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All ... Read more
Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.
46 2021-05-28 headache After 10 days I have experienced incrementally stronger daily headaches
46 2021-05-30 fever, fatigue Dizziness....tired....soar arm......chills.......low grade fever
46 2021-05-31 headache, chills Headaches, Migraines, Chills
46 2021-05-31 headache everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his sk... Read more
everything hurts; Ache; her husband said this morning he had a bad headache; her husband said his skin was feeling tight this morning; injection site pain after receiving the COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened; he has a charley horse-type pain in his left arm; he has a charley horse-type pain in his left arm; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps; her husband had red, raised hives on both sides of his abdomen, and both his shins; She said her husband said his skin burned really bad; her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened; This is a spontaneous report from a contactable consumer. This consumer reported for a 46-years-old male patient (husband) received Second dose (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN5318) on 12Jan2021 at 1:00PM (at the age of 46 years) on unspecified route in the left arm as a 2nd dose, single for COVID-19 Immunization. Medical history included ongoing Psoriasis, her husband doesn't have any allergies, except for Penicillin. Concomitant medications were not reported. The patient previously took her first dose on 12Jan2021 between 1:00-2:00PM (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3302) on unspecified route in the left arm as a 1st dose, single for COVID-19 Immunization and also experienced Injection site pain, got itchy immediately, a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, her husband said he felt run down a week after he received his first COVID-19 Vaccine dose, Rash. On 02Feb2021 patient experienced her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps, her husband had red, raised hives on both sides of his abdomen, and both his shins, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, on 03Feb2021 her husband said this morning he had a bad headache, everything hurts, Ache, her husband said his skin was feeling tight this morning. On Feb2021 she said her husband said his skin burned really bad. Reported her husband had the same experience after he received his first COVID-19 Vaccine dose on 12Jan2021, clarifying her husband said he got itchy immediately after receiving the COVID-19 Vaccine. She said her husband has had psoriasis for a long time. She said her husband has had psoriasis outbreaks before, but not in that area of his body. She said her husband usually has a psoriasis outbreak at his waist where his belt buckle is located, as well as, his elbows, and knees. And her husband didn't think anything of his itchiness and rash after he received his first dose of the COVID-19 Vaccine because he has a history of psoriasis. She said the rash he developed after his first COVID-19 Vaccine dose went away. Reported her husband used (Name) soap and Calamine lotion for the hives and rash on his abdomen and both his shins. She said the rash went away after 2-1/2 weeks. She clarified her husband bathed with Ivory soap, Clean Body Wash (Lot Number: 90845395GC, Expiration Date: Unknown) and applied Calamine lotion to his rash. She said he used the Calamine Plus Itch Relief pink-colored Calamine lotion (Lot Number: A49014, Expiration Date: 2023) only one day and then switched to the clear Calamine lotion with Pramoxine HCL 1% and Zinc Acetate 0.1% (Lot Number: A60023, Expiration Date: Sep2024), so he wouldn't stain his work clothes. Reported her husband told her when the itchiness and rash came back after he received his second COVID-19 Vaccine yesterday that he thinks he is allergic to the COVID-19 Vaccine and also her husband's rash is on both sides of his left and right upper abdomen, between his ribs and hips, and on both his left and right shins. Reported a week after her husband received his first COVID-19 Vaccine dose, he said he felt so bad, and felt run down. She said he was told at that time what to expect after receiving the COVID-19 Vaccine, and after a couple days he was OK. Reported today her husband said he can't move, and that everything hurts, and that he is achy. She said her husband's breathing is OK, so he is not having an anaphylactic reaction. She said her husband said his left arm was so painful with the first COVID-19 Vaccine dose, that he said couldn't put on his shirt. Reported her husband told her he doesn't want to go to the doctor. She said she told him he needs to see the doctor so he can have an allergy panel done. her husband has the bad rash at his waist, so his pant's are touching his waist, and it is uncomfortable. She said her husband said his skin is itching and burning at the same time. She said it wasn't until after receiving his second COVID-19 Vaccine dose that he made the connection with the itchiness and rash he had after receiving his first COVID-19 Vaccine dose. Reported they changed the filter for their showerhead in the bathroom to make sure it wasn't their public water causing the itchiness and rash and looked online for the Pfizer COVID-19 Vaccine ingredients and were confident in taking the COVID-19 Vaccine. She said the CDC had listed that a person can have hives and reactions like the itching and rash. The clinical outcome of the events her husband said this morning he had a bad headache, injection site pain after receiving the COVID-19 Vaccine yesterday, he has a charley horse-type pain in his left arm, her husband said his skin was feeling tight this morning, her husband said he got itchy immediately after receiving his COVID-19 Vaccine yesterday was reported as worsened, Her husband developed an itchy, red, rash on his abdomen & shins about 2 hours after receiving his 2nd COVID-19 Vaccine. She said the rash is red, raised bumps. was reported as worsened, She said her husband said his skin burned really bad were unknown. However, the outcome of the rest all events were not recovered.
46 2021-06-02 fatigue, fever Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydra... Read more
Initial discomfort subsided within 24hr (Sx pain, fever and fatigue). Tx was ibuprofen 800 and hydration. Lingering side effects, 1. I am an avid jogger/runner (5k and 10k and 13.1 miles). Since the vaccine was taken, I have not been able to run at the previous rate. Cannot complete a single mile without having to stop and massage legs muscles and stretch the joints. The week prior to the second dose I was running 4 miles every other day and a long distance run weekly. Also have not been able to complete my normal weight training routine. Arm, chest and back muscles shot in pain doing a previous dominate routine. example, from doing a 100 repetitions with 25pounds dumber, I cannot do 20 repetitions with 15 pounds dumber without having to stop in pain. To be able to run, take pain killers and rub muscles with pain relieving creams before a run. 2. Fatigue, without changing diet or sleep habits, raising from the bed is hard. Feel weak and struggle to get out of bed. Not mental health issues, just physical weakness.
46 2021-06-03 chills, fatigue Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 4... Read more
Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration, administered in Left Arm on 03Mar2021 12:45 PM (Batch/Lot Number: EN6205, Lot unknown: False) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, High heart beat rate. Facility type vaccine: Other, Facility type vaccine other: Vaccination Center. Known allergies: No, Other medical history: High blood pressure, high heart beat rate. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced night sweats (non-serious) on 05Mar2021 02:00 am, chills (non-serious) on 05Mar2021 02:00 am, tired (non-serious) on 05Mar2021 02:00 am. Adverse event: Night sweats and chills 36 hours after taking the vaccine. Tired up to 48 hours after taking the vaccine. Adverse event country: US. If patient recovered: Recovered. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Explicit consent: Yes. For all events, outcome was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
46 2021-06-03 pneumonia, cough It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed... Read more
It went into my lungs/lung infection/shortness of breath; pain; cough; My lungs hurt when i breathed; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 08May2021 10:30 (Batch/Lot Number: E100171) as 1ST DOSE, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included gout from an unknown date and unknown if ongoing, known allergies to latex. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The day after the vaccine on 09May2021 at 06:00 AM, patient developed a cough. It went into his lungs within a couple of days and was eventually put on strong antibiotics with a lung infection. His lungs hurt when he breathed, patient had shortness of breath. It's currently 20May2021 and patient still had pain when he cough but it seems to be improving. The events resulted in Doctor or other healthcare professional office/clinic visit. Events treatments included an inhaler, antibiotics, cough pearls. Covid test post vaccination included Nasal Swab COVID 19 test on 18May2021 and the result was pending. Patient was not recovered from events.
46 2021-06-03 sleepiness, chills, fatigue, headache had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt rea... Read more
had to go to sleep; Could not function correctly; They had headache; body aches; chills; He felt really exhausted and drained.; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; Pfizer Covid Vaccine first dose Date: 19 Apr 2021/Pfizer Covid Vaccine second dose Date: 03 May 2021; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 46-year-old male patient reported that who received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number and expiry date unknown) via an unspecified route of administration at left arm as a single dose for COVID-19 Immunisation. Past drugs included Lisinopril taken for quite some time, 3 or 4 years, Nifidipine for blood pressure. Historical vaccine BNT162B2 via an unspecified route of administration (Lot Number / Expiry Date was not reported) on 19-APR-2021 as a single dose at left arm for COVID-19 immunisation. On an unknown date patient could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. He felt exhausted and drained. Patient did not visit physician office or emergency room visit due to the event. Outcome of the events were recovered on an unknown date. Information on the lot/batch number has been requested.
46 2021-06-07 cough Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contacta... Read more
Compromised breathing; Tight chest; Dry cough; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via unspecified route of administration in left arm on 01Mar2021 03:15 PM (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. Vaccination facility type was reported as hospital. The patient's medical history was not reported. No COVID prior vaccination was reported. No concomitant medications were taken by the patient within 2 weeks. No other vaccine was administered within 4 weeks. On 03Mar2021 08:00 AM the patient experienced tight chest, dry cough, and compromised breathing. No treatment was received due to the events. Patient was not tested for COVID post vaccination. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.
46 2021-06-07 fatigue treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue inte... Read more
treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue intense that prevent me to do habitual physical activity; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at the time of vaccination: 46-year-old) as unknown, single dose for covid-19 immunization. The patient also received ibuprofen (ADVIL [IBUPROFEN]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypertension and allergy with shellfish. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Concomitant medications included losartan potassium (COZAAR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin d (VITAMIN D [VITAMIN D NOS]). On 14Mar2021 at 13:00 after vaccination, the patient experienced fatigue and received Advil for the treatment of adverse event. It was reported that the patient started to feel fatigue on 14Mar2021 (D5) but on Mar162021 (D7) fatigue intense that prevent him to do habitual physical activity. (Patient was an athlete preparing for a triathlon but 16Mar2021 and he was not able to finish a 4mile run, which was very simple to his fitness level. The outcome of the events was resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
46 2021-06-07 fatigue Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting hea... Read more
Initially, fatigue, joint pain, injection location soreness, then 3 days later I started getting heart palpitations that lasted for 2+ days (Thurs, Fri and part of Sat.), continued fatigue and shortness of breath.
46 2021-06-08 fatigue, sleepiness, headache, chills Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really ... Read more
Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
46 2021-06-08 fatigue Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Br... Read more
Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Brain fog/gotten worse; Fatigue /gotten worse; This is a spontaneous report from a contactable other health professional (registered nurse reporting for her son).A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.On an unspecified date, A week or two later after first dose he started getting a lot of fatigue and brain fog and became depressed and anxious over the last few months. The patient had second dose 09Mar2021. States it has just gotten worse. Caller wants to know if this has been reported or if this could be related to the vaccine. The outcome of the events was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of anxiety aggravated, depression worsened, brain fog, brain fog condition worsened and fatigue aggravated with the suspect product of BNT 162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
46 2021-06-08 fatigue blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's re... Read more
blood clot in his leg; swelling in his leg; sore arm; his muscle aches; didn't dilute it and he's received 6 times over the amount; didn't dilute it and he's received 6 times over the amount; Diarrhea; real tired; his blood pressure was real high; breathing problems; This is a spontaneous report received via a Pfizer-sponsored program. A contactable consumer reported that a 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on 20Apr2021 (at the age of 46-year-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, patient experienced diarrhea, was real tired and his blood pressure was real high. It was also reported that the vaccine wasn't diluted and the patient received 6 times over the amount on 20Apr2021. On an unspecified date, patient had sore arm and his muscles ached. On Apr2021, patient had breathing problems and was treated with breathing treatments three times a day and was put on steriods and inhalers. On May2021, patient had a lab work that confirmed that he had a blood clot in his leg, which has worsened because he has some swelling in his leg, the same leg that they found the blood clot in. The patient was hospitalized for the event blood clot in his leg and was given blood thinners. The patient underwent lab tests and procedures which included CAT scan of head and lungs both with unknown results on May2021. Outcome of the events blood clot in his leg, swelling in his leg and breathing problems was not recovered while outcome of all other events was unknown. Information on the lot/batch number has been requested.
46 2021-06-08 sweating Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the ... Read more
Passed out; Warm sensation; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 01Apr2021 (at the age of 46-year-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On 01Apr2021 (10 mins after receiving the vaccine), the patient passed out, had warm sensation and sweating. Patient was later transported to medical centre. Outcome of the events was unknown. Information on the lot/batch number has been requested.
46 2021-06-09 chills, headache, cough, fever fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire... Read more
fever; chills; vomiting; weakness; headache; cough; trace- pleural effusion; who received the entire vial of the undiluted Pfizer COVID vaccine; received the entire vial of the undiluted Pfizer COVID vaccine/The entire vial was administered all 6 doses in the right deltoid; This is a spontaneous report from a contactable nurse and a physician. The nurse reported similar events for two patients. This is one of the two reports. Only this case is serious. A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 46 years old, administered in right deltoid on 12May2021 (Lot Number: EW0168; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included ongoing CRD on hemodialysis since 25Sep2017, ongoing Polycystic kidney, ongoing HTN, ongoing Brain aneurysm, ongoing GERD, ongoing Seizure disorder; Fever, nausea, vomiting, sepsis, Secondary hyperparathyroidism. Family history included Polycystic kidney disease- brother/father/uncles. Concomitant medications included ongoing allopurinol, ongoing paracetamol (TYLENOL), ongoing amlodipine, ongoing cholecalciferol, hydralazine, metoprolol, vitamins nos (MVI), phenytoin. Historical Vaccine included first dose of BNT162B2 on 21Apr2021 (Lot number ER8736, Expiration date Jul2021) at the age of 46 years old, administered in right deltoid for COVID-19 immunization. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The entire vial was administered all 6 doses in the right deltoid. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and was sent home. They were instructed for any signs and symptoms to report to ER immediately. The patient also experienced fever/chills, vomiting, weakness, headache and cough, all on 12May2021 which were caused emergency room visit and hospitalization from 13May2021 to 15May2021 with treatment unknown. Lab data included CXR on 13May2021 with result: trace- pleural effusion. The outcome of the events were unknown. Follow-up (25May2021): new information received from a contactable physician included: new reporter-physician added, medical history and concomitant medications added, lab data added, vaccination on 12May2021 is updated as second dose and Historical Vaccine with first dose of BNT162B2 added, new events "fever/chills, vomiting, weakness, headache and cough, trace- pleural effusion" added and case upgrade to serious. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021540031 Same reporter/product, similar events, different patient
46 2021-06-10 fatigue, nasopharyngitis bad cold; feeling tired and significant fatigue; This is a spontaneous report from a contactable con... Read more
bad cold; feeling tired and significant fatigue; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2, via an unspecified route of administration, administered in right arm on 12Mar2021 11:30 (Batch/Lot Number: EL3247) at 46 years old as 2nd dose, single dose for COVID-19 immunisation. Medical history was none. No known allergies. No COVID prior vaccination. Not COVID tested post vaccination. There were no concomitant medications; no other medications in two weeks and no other vaccine in four weeks. The patient previously took BNT162B2 on 19Feb2021 (Batch/Lot Number: EL3247) as 1st dose (right arm) for COVID-19 immunisation. On 13Mar2021 07:30 (the next day), the patient was feeling tired and significant fatigue. He felt like he had a bad cold. No treatment provided. Outcome of events were recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
46 2021-06-10 headache pain in left knee was completely gone/completely pain free when going up and down the stairs/not tak... Read more
pain in left knee was completely gone/completely pain free when going up and down the stairs/not taking any pain medication, the only difference was getting the second dose of the vaccine; Soreness of left arm in the area of the injection; Headache; Body aches; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3247) via an unspecified route of administration administered in left arm on 12Mar2021 at 12:30 (at 46 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included cardiomyopathy and pain in left knee both from unspecified date. The patient had no known allergies. Concomitant medications included metoprolol 150mg and candesartan 16mg both from unspecified date for unspecified indication. The patient previously took the first dose of BNT162B2 (Lot Number: EL3247) via an unspecified route of administration administered in left arm on 19Feb2021 at 12:30 (at 45 years old) as single dose for COVID-19 immunization. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced soreness of left arm in the area of the injection, headache, and body aches; all non-serious on 13Mar2021. No treatment received for the events. The patient also added that for many years he had pain in left knee that would typically be felt when going up or down the stairs. However, over the past couple of days from the time of reporting on 14Mar2021, the patient noticed that the pain in left knee is completely gone. The patient was completely pain free when going up and down the stairs. The patient was not taking any pain medication, the only difference was getting my second dose of the vaccine on 12Mar2021. Outcome of the events was recovered on unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
46 2021-06-10 headache Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed... Read more
Bad headache on Left side of head where ear is toward the back. Confusion, Dizziness, , Light headed, Tingling and numbness from left eye to jaw. Drooping of left eye and lips. Memory and processing information issues. One month later still some head pain off and on and numbness around left eye. Still have memory and processing issues. I've never had any other prior issues with the head or face. No falls or activities such as boxing
46 2021-06-10 headache Sensation of throat closing and unable to swallow; slight headache. Patient is treated with diphenh... Read more
Sensation of throat closing and unable to swallow; slight headache. Patient is treated with diphenhydramine 50mg orally and prednisone 60mg orally. Doctor's notes state patient had soft palate edema that started 10-15 minutes after 2nd covid vaccine. Patient is prescribed a short course of steroids to take at home.
46 2021-06-11 chills, fever 47 yr old client presented to site for second dose and reported Pfizer 1st dose reaction of chills, ... Read more
47 yr old client presented to site for second dose and reported Pfizer 1st dose reaction of chills, fever, itching, and break out of rash in the LLE. Client presented with open circular lesion on the left lower leg with no c/o pain or discomfort at this time. Vital signs WNL. Left vaccine site in stable condition.
46 2021-06-13 headache, fever Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with lef... Read more
Patient is a 46 year old male who admitted to hospital for Facial nerve palsy. Patient felt with left sided facial droop and tingling sensation for 2 days. He reported symptoms onset at 1330 on 6/10/2021 while driving a truck. He also had left sided occipital headache and rested for 1 hour. His symptoms improved after the nap but never resolved completely. He got into a location and rested there for 1 night. In the morning after waking up he was having difficulty chewing food on his left side. He called EMS and was brought to hospital. While in the ED, he received workup including CT Head W/O, CTA Head/Neck with perfusion scan that were all negative. Other labs obtained included BMP, CBC, Troponin x1, Coag studies & CXR which were largely unremarkable. Neurology were called for stroke alert and given ASA 325mg and ordered MRI. Patient's MRI was unremarkable for stroke or masses. He was started on Prednisone 40mg once daily for Facial Nerve Palsy. He was seen by physical therapy and occupational therapy, they recommended him go home to family. His symptoms improved after therapies were initiated but are not completely resolved. Patient will continue taking his home medications per his primary care doctor. He will complete a 7 day steroid course, has 3 days remaining. He will take Acyclovir 5 times per day for 10 days. We also gave him lubricating eye drops since he continues to have difficulty closing his left eye. He spends a lot of time outdoors and works with horses. He reports getting tick bites before in his body but never noticed a rashes. He has never received treatment for Lyme Disease. He is a long-haul truck driver and has driven all around. He reports walking in wooded areas when he stops in the rest area. We obtained Lyme Titers, which were eqivocal for IgM and negative for IgG. Western blot was ordered to rule out Lyme disease. He should followup with PCP for treatment if he is positive. We will call him with results when available. Of note he received Pfizer 2nd COVID vaccine on 6/9/21 (LOT #EW0178). He reported fever and diarrhea that night and next morning. He then reports having presenting symptoms after 7 hours of driving. We also believe the cause of his facial nerve paralysis could have been a side effect of his vaccination.
46 2021-06-14 sweating Pt. became light headed, pale, and diaphoretic minutes after vaccine. Pt. reports it is not unusual... Read more
Pt. became light headed, pale, and diaphoretic minutes after vaccine. Pt. reports it is not unusual for him to pass out while getting an injection. Pt back to normal in 5 to 10 minutes. Pt was observed post vaccination and released home.
46 2021-06-15 fatigue Sore shoulder- localized to left arm; Body aches; Tired; This is a spontaneous report from a contact... Read more
Sore shoulder- localized to left arm; Body aches; Tired; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received second dose bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Feb2021 at 16:30 as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient was 46-years-old at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot Number: unknown) dose 1 via an unspecified route of administration, administered in Arm Left 12Jan2021 at 09:30 AM for COVID-19 immunization. Patient relevant medical history included high blood pressure. The patient concomitant medication(s) included valsartan (DIOVAN) taken for an unspecified indication. It was reported that on 02Feb2021 at 18:00, the patient experienced sore shoulder- localized to left arm, body aches, tired. On unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement was high. The outcome of event was recovered. Information about batch/lot number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
46 2021-06-16 chills Shoulder discomfort; chills; This is a spontaneous report from a non-contactable consumer, the patie... Read more
Shoulder discomfort; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on 14Mar2021 (at the age 46-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 15Mar2021, the patient experienced shoulder discomfort and chills but not fever. The patient did not receive any treatment for the adverse events. The clinical outcome of shoulder discomfort and chills was recovering. No follow-up attempts are needed. No further information is expected.
46 2021-06-16 fatigue Swollen underarm/lymph node area; Eighteen hours after shot slightly swollen injection site; Extreme... Read more
Swollen underarm/lymph node area; Eighteen hours after shot slightly swollen injection site; Extreme tiredness.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 9.30AM (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not provided. Concomitant medications included Ativan (MANUFACTURER UNKNOWN) on unspecified date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in left arm on 23Feb2021 at 03.45PM for COVID-19 immunisation. The patient had not tested positive for COVID-19. The patient experienced extreme tiredness on 16Mar2021 at 03:30 PM, slightly swollen injection site and slightly swollen underarm on 17Mar2021 at 03:30 AM and extremely swollen underarm/lymph node area on 17Mar2021 at 07:30 PM. The patient had not received any treatment for the events. Clinical outcomes of the event extreme tiredness, swollen injection site and swollen underarm were recovering. No follow-up attempts are needed. No further information is expected.
46 2021-06-16 headache Some chests pain. I had a headache. I went doctor, thought it was a chest inflammation. He did an ... Read more
Some chests pain. I had a headache. I went doctor, thought it was a chest inflammation. He did an EKG that came back negative. He did some muscle movements in chest. He also stated if I had any tingling in my arm to get to the ER. He also did some blood work. He did give me a presentation to take.
46 2021-06-22 fatigue, fever, headache Extreme tired and fstigue. Headache and fever persisting for weeks now. Heart feels stressed
46 2021-06-24 sweating PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER... Read more
PATIENT CLAIMED HE WAS ITCHY, HAD METALLIC TASTE, SKIN CRAWLING, NAUSEA AND SWEATING INSTANTLY AFTER RECEIVING VACCINE. AMBULANCE WAS CALLED BUT HE REFUSED TO BE TREATED AND LEFT UNDER HIS OWN POWER.
46 2021-06-24 sinus disorder having allergies like sinus in his eye areas; Caller is a patient who received the 1st dose of the P... Read more
having allergies like sinus in his eye areas; Caller is a patient who received the 1st dose of the Pfizer Covid vaccine in May and tested positive for Covid-19 on 9 Jun 2021; This is a spontaneous report from a contactable consumer via medical information team. This consumer (patient) reported for himself. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176 and Expiration date: unknown), via an unspecified route of administration, administered in Deltoid Left (left shoulder, like the side of the arm) on 28May2021 (at 11 AM or 12 PM) (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not ill at the time of vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not received Prior Vaccinations (within 4 weeks). No relevant tests before vaccination. On 28May2021, patient received first dose of vaccine and then he had a cold and tested positive for covid-19 on 09Jun2021 at about 12 in the afternoon. He confirms he was having a cold, he clarified that it was like he was having allergies like sinus in his eye areas and he reported that he had a viral infection and then he tested positive for COVID. He was supposed to get his second dose on 16Jun2021. He wanted to know should he continue and take the second dose or not. The reporter wanted to know if it is okay to get the 2nd dose of the Pfizer Covid vaccine on 16Jun2021. He confirmed he called about the COVID 19 vaccine by Pfizer. The patient was not used any antipyretics. The patient was not visited to emergency or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jun2021. Response included The CDC has provided interim considerations for the use of mRNA COVID-19 Vaccines during the Emergency Use Authorization. These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation. The outcome of events were unknown.
46 2021-06-26 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient reported extreme dizziness and light headedness; found on floor in waiting error. Remained conscious the entire time. Improved with water and cold compress. Called 911 but by the end of conversation patient was up and moving, no need for them to respond.
46 2021-06-28 productive cough, fatigue, runny nose Lightheadedness Difficulty breathing Excessive coughing Phlegm Tired Runny nose
46 2021-06-28 fever, chills chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures an... Read more
chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures and labs showed urinary tract infection; sensitivities showed resistant to rocephin and ceftin; bactrim didn't prove strong enough; improvement finally began with levaquin; fever persisted 8 days; ibuprofen was required around the clock
46 2021-06-29 sweating, chills Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-conta... Read more
Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration, on 18Mar2021, (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced diaphoresis, dizzy/lightheaded and increased anxiety. The patient also complained of chills and dizziness. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received treatment as a result of adverse events experienced which included water, snacks and laying down. The patient had excellent response to treatment. The patient was stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of diaphoresis, dizzy/lightheaded, increased anxiety and chills were recovered on 18Mar2021. No follow-up attempts are possible. No further information is expected.
46 2021-06-29 fever Pain, nausea, fever - diagnosed with acute Appendicitis - surgery to remove appendix (17 days after... Read more
Pain, nausea, fever - diagnosed with acute Appendicitis - surgery to remove appendix (17 days after 2nd dose)
46 2021-07-02 fatigue, headache light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minu... Read more
light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minutes after vaccine followed by dizziness and nausea. the back and chest pain come and go.
46 2021-07-03 respiratory tract congestion, head discomfort, cough, headache Pressure in upper chest left and right side, sometimes moves toward back left. Sensations in heart,... Read more
Pressure in upper chest left and right side, sometimes moves toward back left. Sensations in heart, tightness. Coughing related to fluid in chest. While sleeping on side, can feel heart beating inside against chest. Elevated heart rate resting. Dizziness upon standing. Appears to be a correlation with headache pressure: forehead, brain stem region. Professional cyclist in excellent health, overall fitness.
46 2021-07-04 headache vertigo; large, painful swollen lymph node under right arm; nausea; headache, severe pain at injecti... Read more
vertigo; large, painful swollen lymph node under right arm; nausea; headache, severe pain at injection site. No treatment, symptoms occurred over Fourth of July weekend and everyone is closed...
46 2021-07-07 chills, headache, fever Vertigo, Dizziness, Nausea, Headaches, Weakness, Shortness of Breath, Chills, Fever, Muscle Cramps, ... Read more
Vertigo, Dizziness, Nausea, Headaches, Weakness, Shortness of Breath, Chills, Fever, Muscle Cramps, Joint Pain, Slurring Speech, cannot drive or work. Has been occuring since injection.
46 2021-07-08 fatigue pt reports body aches fatigue nausea vomiting and diarrhea
46 2021-07-09 malaise, headache, fatigue Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling b... Read more
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse headache, difficulty concentrating, slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
46 2021-07-10 fatigue, headache Severe headache, extremely tired, left upper and lower arm had a raised rash, very itchy (looked lik... Read more
Severe headache, extremely tired, left upper and lower arm had a raised rash, very itchy (looked like goose bumps).
46 2021-07-11 fever At 36hrs the swollen of that same area(left armpit - lymph node area)increased a little bit and the ... Read more
At 36hrs the swollen of that same area(left armpit - lymph node area)increased a little bit and the pain ismild-moderate.; at 24hrs felt pain (pressure like) in thearmpit (same as shoot - left shoulder)- lymph node area; start to feel flu likesyndrome; at 24hrs felt little bit of fever; muscle ache; Mild pain right after shot and increased to moderate within 12hrs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ascorbic acid vitamin C (MANUFACTURER UNKNOWN), glocosamine (MANUFACTURER UNKNOWN) and condoitrin supplements (MANUFACTURER UNKNOWN) from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via an unspecified route of administration in the right arm on 06Mar2021 at 16:00 as a single dose for COVID-19 immunisation. Prior to vaccination patient not diagnosed with covid-19. The patient had not tested for COVID-19 since having the vaccine. On 28Mar2021 at 08:00 the patient experienced mild pain right after shot and increased to moderate within 12hrs. At 24hrs, on 28Mar2021 at 14:00, the patient felt pain (pressure like) in the armpit (same as shoot - left shoulder) - lymph node area also felt a little bit of fever and muscle aches similar to when somebody start to feel flu like syndrome. That fever and muscle discomfort resolved within two hours. At 36hrs, on 29Mar2021, the swollen of that same area (left armpit - lymph node area) increased a little bit and the pain was mild-moderate. The patient received paracetamol (PANADOL) as a therapeutic measure for the event Pyrexia. The clinical outcome of the events pain, lymph node pain, influenza and lymphadenopathy were resolving and pyrexia and myalgia was resolved after 2hrs, at 16:00 on 28Mar2021 at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No follow-up attempts are needed. No further information is expected.
46 2021-07-12 headache Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. ... Read more
Dizziness; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 26Mar2021 at 14:00 as single dose (at the age of 46 years) for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient had no known allergies. Concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 01:00, the patient experienced nausea, dizziness and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nausea, dizziness and headache was unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
46 2021-07-17 chills, fatigue, fever Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week a... Read more
Next day left arm soreness lasted 2 days. Also 2nd day started feeling tired, exhausted for 1 week and nauseous for about 4-5 days. I fely hung over, achey, had slight fever and chills for 5 days. I am feeling 95% better now going on 9 days. I'm scared 2nd shot will be worse?
46 2021-07-17 malaise, throat pain, fever, fatigue, sweating High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making... Read more
High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Sore throat; Teeth hurt; Teeth ache; Teeth all hurting; Pain on my teeth; Body ache; High fever; He was having a fever and he ended up sweating it out on the bed, he was not even making the signs; Actually woke up in a furrow of water that came out of his body with a 102 degree fever; Fatigue all over body; Sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; Really sweaty; Woke up super-hot like the whole bed was wet; Got sick; Feeling tired all over, Very tired; We were really hot at night, it is like burning inside; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; Extremely very hot, very thirsty, and dizzy, kind of tired, fatigue; This is a spontaneous report from a contactable consumer. There were 2 reporters on the call reporting for themselves. This is the second case out of the two cases where reporter handed over the phone to her Fiancée (Consumer) and he is reporting for himself. This consumer (patient) reported for himself that a 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 19Jun2021 at 16:15 (at the age of 46-year-old), as dose 1, single in deltoid left, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no family medical history. On an unspecified date, the patient experienced high fever; he was having a fever and he ended up sweating it out on the bed, he was not even making the signs; actually woke up in a furrow of water that came out of his body with a 102 degree fever; sore throat; teeth hurt; teeth ache; teeth all hurting; pain on my teeth; body ache; fatigue all over body; sweaty sweat all over body, dripping sweat; I broke out with sweat and sweaty palms and forehead; really sweaty; woke up super-hot like the whole bed was wet; got sick; feeling tired all over, very tired. Patient was really hot at night, it was like burning inside; and extremely very hot, very thirsty, and dizzy, kind of tired, fatigue. Patient received treatment for the events. Treatment medications included Tylenol 500mg and Advil 200mg and Naproxen 500mg, once every 12 hours, twice a day. Patient had to take Nyquil and half a Benadryl to help fall asleep because of the pain on his teeth, and sore throat. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of all events was reported as unknown. Follow-up attempts are completed. No further information is expected.
46 2021-07-19 dehydration, headache Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/1... Read more
Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below
46 2021-07-19 influenza like illness, fatigue Fatigue; Flu-like symptoms; This is a spontaneous report from a contactable physician, the patient. ... Read more
Fatigue; Flu-like symptoms; This is a spontaneous report from a contactable physician, the patient. A 46-year-old-male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID -19 immunisation. Medical history included hypocholesteremia. The patient was unknown about the allergies to medications, food, or other products. Concomitant medication included atorvastatin calcium (LIPITOR) of 10mg and clomiphene (MANUFACTURER UNKNOWN) of 50mg; both for unknown indications from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 00:00, the patient experienced fatigue and flu-like symptoms. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of fatigue and flu-like symptoms and included treatment with ADVIL of 400mg. The clinical outcomes of the events fatigue and flu-like symptoms were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
46 2021-07-21 cough 46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymph... Read more
46 Y male with a PMHx of HTN, HLD, DM, hypoT, stage II NLPHL with concomitant low grade B-cell lymphoma (dx 5/19/21) (5/2021, chemo scheduled later this month) presents with cough and SOB x6 days. 1) COVID Pneumonia, Acute hypoxemic Respiratory failure - Symptom onset on 7/15. COVID positive on 7/16. Pt was fully vaccinated on 4/1/21. Pt presented satting 88%. In the ED, he was put on 2L O2, solumedrol, remdesivir, and offer tocilizumab, which he refused at first. Pt took Tocilizumab at night. Pt now on 12L oxymizer. Offered tocilizumab again and increased methylprednisolone to Q6h. - 12L Oxymizer. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Methylprednisolone 125mg IV Q6h for 5 days (7/21 - 7/25) and taper down - Remdesivir 200mg IV x1, followed by 100mg IV daily until clinical improvement or 5 days (7/21 - 7/25 ) - f/u daily LFTs. Hold Remdesivir if ALT >10xULN or CrCl<30 - CRP, D-dimer, LDH, ferritin elevated. Trend QOD - Lovenox 40mg SQ BID and hold for Plt <25k, Fibrinogen <100, active bleeding - Tocilizumab 600mg IV x2 - Tessalon for cough - Encourage IS - Isolyte 500cc x1
46 2021-07-25 fatigue, influenza like illness, headache Client reports he had flu-like symptoms starting on 07/21/21. Client is still experiencing increased... Read more
Client reports he had flu-like symptoms starting on 07/21/21. Client is still experiencing increased fatigue, headache at night, and dizziness in the morning
46 2021-07-25 sweating PATIENT RECEIVED FIRST DOSE OF FIZER VACCINE. PATIENT FELT HIS PALM SWEAT AFTER 30 SECONDS. HE CAME... Read more
PATIENT RECEIVED FIRST DOSE OF FIZER VACCINE. PATIENT FELT HIS PALM SWEAT AFTER 30 SECONDS. HE CAME IN TO THE WAITING ROOM. THE PATIENT'S WIFE NOTICED THAT HE BECAME YELLOW, AND HIS HEAD WENT TO THE SIDE. HE STARTED TO SHAKE HIS HEADS FOR 10 SECONDS, AND THEN STOPPED SHAKING. PATIENT ALERTED THE PHARMACY TEAM. PHARMACY TEAM GAVE PATIENT SOME WATER AND GATORADE AS WIFE TOLD US THAT PATIENT HAS LOW BLOOD SUGAR. I CALLED 911 IN CASE IT BECAME WORSE. THE PATIENT THEN WENT INTO THE RESTROOM. PARAMEDIC ARRIVED AND MONITORED PATIENT BLOOD PRESSURE AND HEART RATE. HE WAS FINE, BUT PARAMEDICS RECOMMENDED HE GO IN THE AMBULANCE RIDE. THE PARAMEDICS SAID IT COULD JUST BE A SYNCOPE EPISODE AS PATIENT IS AFRAID OF NEEDLES. HOWEVER, THE PATIENT DECLINED THE RIDE. WIFE TOLD US SHE MIGHT TAKE HIM TO ER.
46 2021-07-25 fever, chills, pneumonia This is a 46-year-old gentleman who states that he has had 2 doses of the Pfizer vaccine in April. ... Read more
This is a 46-year-old gentleman who states that he has had 2 doses of the Pfizer vaccine in April. States he did go to an amusement park a couple weeks ago and on 07/05, he started having symptoms of fever, chills, diarrhea, shortness of breath, so went to a local pharmacy and a couple days later was told that he was positive. EMS was called to the house and his oxygen saturation was 60% on room air. Patient was admitted on 7/12 to PCU and started on COVId treatment for pneumonia and respiratory failure. He was discharged 7/19.
46 2021-07-27 fever fever; big lump under left armpit; swollen neck left armpit; This is a spontaneous report from a con... Read more
fever; big lump under left armpit; swollen neck left armpit; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 18:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to food, medications, or other products. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 18:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 13:00 the patient experienced fever, big lump under left armpit and swollen neck. The patient did not receive any treatment for the event. Events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, big lump under left armpit and swollen neck left armpit was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-01-04 chills, fever, headache, fatigue, cough, malaise, nasal congestion Patient tested positive for COVID-19 via rapid Antigen test on 1/5/21. Patient has a child who teste... Read more
Patient tested positive for COVID-19 via rapid Antigen test on 1/5/21. Patient has a child who tested positive on 1/3/21. Patient woke up on Sunday 1/3/21 feeling sick -- fatigue. Progressively, patient developed more symptoms: fever, cough, congestion, headache, chills, rigors. Patient is not sick enough at this time to go to doctor or hospital. Patient will quarantine for 10 days at home.
47 2021-01-04 headache At 1347 the recipient complained of a headache and dizziness. At around 1400 the recipient stated h... Read more
At 1347 the recipient complained of a headache and dizziness. At around 1400 the recipient stated he felt better and left the site.
47 2021-01-06 fever, chills Sore arm at injection site; Fever; Chills; body aches; This is a spontaneous report from a contactab... Read more
Sore arm at injection site; Fever; Chills; body aches; This is a spontaneous report from a contactable physician (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date and dust allergy. Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient experienced sore arm at injection site, fever, chills, body ache (mini COVID as compared to when he had COVID in early April) on 22Dec2020 03:00 (reported as 12-13 hours later). Symptoms controlled with Tylenol for about 15-20 hours. The patient underwent lab tests and procedures which included nasal swab on 09Dec2020, 14Dec2020, and 16Dec2020, results are all negative. The outcome of the events was recovered. Information about Lot/Batch number is requested.
47 2021-01-07 fatigue Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative: 12/21 employee received v... Read more
Myalgia, Tachycardia, fatigue, soreness at the injection site. Narrative: 12/21 employee received vaccine at 0930 - later in the afternoon he noted tachycardia to about 100. He was watching the rate on his Apple watch. The highest rate was 130. His only other symptom was fatigue which was bad enough on 12/22 that he had to go home. He saw his PCP on 12/22 for the tachycardia who ordered labs which were all normal. He is a resident so he asked anesthesia to do an EKG which showed sinus tachycardia. On 12/23 his heart rate average went down to 100. Today (12-28) his resting heart rate is 70-80 which is his baseline. He has not had recurrence of the tachycardia since 12/23. He also reports he had soreness at the injection site and myalgias both of which have since resolved.
47 2021-01-07 headache nausea, stomach cramps,dizzyness, HA
47 2021-01-07 fever, chills a. Injection site tenderness which has improved in less than 24 hrs. b. chills, unquantified fever o... Read more
a. Injection site tenderness which has improved in less than 24 hrs. b. chills, unquantified fever onset approximately 12 hrs after vaccine administration which improved with acetaminophen 1000mg once. Following morning, chills reappeared and improved with acetaminophen 1000mg once.
47 2021-01-08 cough CoughWheeze wheezing the next morning after getting vaccine Narrative: no wheezing noted on exam; p... Read more
CoughWheeze wheezing the next morning after getting vaccine Narrative: no wheezing noted on exam; pulse ox wnl. no resp distress noted
47 2021-01-08 headache, chills Headache, Arthralgia, NauseaVomiting, chills Narrative:
47 2021-01-08 nasopharyngitis Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Emp... Read more
Dizziness, Seizures, Syncope, Bradycardia, cold, clammy Narrative: 10 mins after administration, Employee began expressing lightheadedness, Employee assessed, employee was cold and clammy. Employee then began to have a seizure which last approx 30 sec. Vital signs assessed BP 110/80 HR 87 then dropped to 50 which is unusual for employee. o2 sat 94% on room. Employee regained consciousness and was able to state name, time and place. Reported no previous history of seizures. Employee handed off to ER staff for further eval.
47 2021-01-09 body temperature increased, chills Body aches, chills, temperature of 99.2F, diarrhea, injection site swelling, redness and pain. Sympt... Read more
Body aches, chills, temperature of 99.2F, diarrhea, injection site swelling, redness and pain. Symptoms resolved within 48hrs of vaccination
47 2021-01-09 headache, chills, fatigue Headache, Diarrhea, chills, fatigue, neck soreness, shoulder stiffness Narrative:
47 2021-01-10 chills, body temperature increased 99.9 temp, chills, achy, dizziness
47 2021-01-10 chills, headache, fever, fatigue fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical ... Read more
fever >100 , body aches/whole body muscle spasms, chills, nausea (no vomiting), headaches, physical exhaustion, all symptoms resolved approx 1.5 days of vaccine administered, symptoms began approx 12 after vaccine received.
47 2021-01-10 chills, fever 1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: feve... Read more
1. Onset roughly 12 hours after injection lasting until approximately 32 hours after injection: fever, chills, body aches, nausea, sore left arm. Treated with 600 mg Ibuprofen every four hours. Fever would break and then come back. 2. Onset roughly 51 hours after injection lasting until approximately 55 hours after injection: fever, chills. Treated with 600 mg Ibuprofen. No symptoms since.
47 2021-01-12 chills, headache, fever Fever,102, chills, body ache and headache
47 2021-01-12 chills, fever, headache, fatigue aprox 12 hours after injection, started with fever. chills. fatigue, body aches, fever went up to 1... Read more
aprox 12 hours after injection, started with fever. chills. fatigue, body aches, fever went up to 100.4 at 3am, 2 200 mg ibuprofen were taken. was in bed until 12 pm next day, fever gone, but still fatigue headache for aprox. 24 more hours. Symptoms then went away by Sat. am.
47 2021-01-12 fatigue Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready ... Read more
Approximately 13 hours after receiving the vaccine I became overwhelmingly tired. Went to get ready for bed by first going into the bathroom. While getting ready I passed out (micturation syncope). Hit my head on the floor and sustained a concussion. I am still experiencing post concussive symptoms but this is to be expected as it has been less than a week.
47 2021-01-12 headache, fatigue Systemic musculoskeletal pain in muscles and joints with mild headache and moderate fatigue.
47 2021-01-12 headache, fatigue Extreme fatigue, mild headache, swelling and extreme soreness at injection site
47 2021-01-12 malaise Myalgia Malaise missed one day of work following second dose due to symptoms
47 2021-01-13 chills, fever patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and wa... Read more
patient was up all night after vaccine with high fever and chills, went to ER due to symptoms and was admitted to hospital overnight for observation. He said his temperature hit 107. Was released from hospital and resting . Was COVID + previously where he had to be hospitalized .
47 2021-01-13 dehydration Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real deh... Read more
Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real dehydrated; Kidneys started hurting and felt like kidneys were overworking; Mouth dry; Kept having to go to the restroom; Kept using restroom and had to pee a lot; He is a little sore, but the pain is not as bad; Pain in kidneys woke him up from sleep.; Arm is still swollen but swelling went down; red spot under his arm that looks irritated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 via an unspecified route of administration in upper right arm on 02Jan2021 between 07:00-07:30 at single dose for covid-19 immunization. Medical history: None. There were no concomitant medications. The patient experienced swollen under arm and a knot/upper part of shoulder and chest area was swollen on 03Jan2021 18:00, nauseated, real dehydrated, kidneys started hurting and felt like kidneys were overworking, mouth dry, kept having to go to the restroom; kept using restroom and had to pee a lot, he is a little sore, but the pain is not as bad, pain in kidneys woke him up from sleep all on 03Jan2021. Got COVID Vaccine on Saturday. Was swollen up under arm. Over kidneys, started hurting. Swelling went down. Took Naproxen and Ibuprofen. Mouth was really dry. Felt like kidneys are overworking. Keeps drinking water and going to the restroom. Kidneys started hurting. Received through work. Employed at a mental health and mental retardation school. Arm swollen with a knot. Got off Sunday morning, 03Jan2021. By 18:00, under arm was swollen. Thought he slept wrong or he had an issue with an artery. Under arm and into upper part of shoulder and chest area was swollen. He was nauseated. Felt really dehydrated. Kidneys started hurting. Felt like kidneys were overworking. Felt similar to when he previously had a kidney infection. Knew something wasn't right. Kept using restroom and had to pee a lot. Kept drinking. Kidneys were hurting from 03Jan2021 to yesterday. He is a little sore, but the pain is not as bad. Was drinking water, cranberry juice, and orange juice to flush the COVID vaccine through. Pain in kidneys woke him up from sleep. Is a little swollen. Pain is better than what it was. Between 02:00-03:00 it was done. Swelling was really bad. Start taking Naproxen and Ibuprofen. He was hurting too. Arm is still swollen but swelling went down. There is a red spot under his arm that looks irritated. Supposed to receive second COVID Vaccine on 30Jan2021 but was not going to take it. Clarified he took Naproxen with Ibuprofen in it for the anti-inflammatory. Confirmed he was only referring to one product. Naproxen was just bought from the store. Unable to provide NDC/Lot/Exp because he does not have product at time of call. Formulation: 200mg per pill, took two pills then six hours later took another two for Voluntary; high number of COVID Cases at his work. Scared to take second COVID Vaccine. The patient underwent lab tests and procedures which included Covid Test: unknown results on an unspecified date (He has to take COVID tests twice a week). The outcome of events was unknown. Vaccination Facility Type: which is a mental health and mental retardation school. He has to take COVID tests twice a week. No additional vaccines administered on same date of Pfizer suspect. The event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Prior vaccinations within 4 weeks was none. Adverse event follow prior vaccinations was none. Relevant tests: none. Information about Lot/Batch number has been requested.
47 2021-01-14 fatigue, body temperature increased, chills, sleepiness In the evening 01/12/2021 started having bodyache, fatigue, chill 99.8. Took sick day yesterday and... Read more
In the evening 01/12/2021 started having bodyache, fatigue, chill 99.8. Took sick day yesterday and slept most of the time. Feeling fine today.
47 2021-01-14 malaise, lethargy, headache, head discomfort, fever, chills, cough, paranasal sinus discomfort 1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not... Read more
1/13/21 0740 Received second dose of COVID-19 vaccine, which was scheduled for that morning. Did not experience anaphylaxis or other symptoms of vaccine injury. I took 1gram of Tylenol PO when I got back to my motel by 0830. By 0924 I noted that my left deltoid (injection site) and arm were very sore/achy. I fell asleep until 1740. I noted that I was experiencing more body aches at this time (joint and muscle, especially in my bilateral shoulders, lower back, knees and pelvis). Calf muscles were quite sore. I made pasta with red sauce and made a pot of blueberry tea, ate and went back to bed. 2327 I woke again with weird fever dreams and my right bicep was intermittently twitching. I think I was starting to run a low grade fever at this time (my ears felt hot, and my stomach was queasy but was not nauseous), no diaphoresis, shortness of breath or airway constriction. I remained awake until 0200, 1/14/21. By 0400 I was experiencing mild chills, face was flushed, headache on the right, with pressure behind my right eye, parietal and occipital areas of my skull. The pain extended into the right muscles of my neck (trapezius, levator scapulae and sternocleidomastoid muscles). Bilateral upper arm muscles and joints were 5:10 pain. I was also experiencing mild photophobia, but not migraine related, and a mild non-productive cough and pressure behind my facial and ethmoid sinuses with scant viscous secretions at the back of my throat. 0433 I forced myself to get out of bed and head to the bathroom. My temp was 101. I took a very hot shower and am back in bed. Experiencing a lot of malaise and lethargy. 1/15/21 0830 temp is currently 99.1, headache is present, 3:10. Joint aches have mostly subsided. Injection site is warm and tender, but no erythema is present.
47 2021-01-15 fatigue Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration. Pu... Read more
Patient complained of feeling light-headed and a little dizzy at 10 minutes post-administration. Pulse-oximetry applied revealed normal spO2, but tachycardia to 140bpm (this patient's resting HR is approximately 55-65). Apple Watch data confirmed rapid increase in HR at that moment. BP increased from normal baseline to about 150-160 SBP. No chest pain reported. No signs/symptoms of anaphylaxis (rash, wheezing, etc.). HR gradually recovered to normal levels within 30 minutes and patient was released after 60 min observation. Patient reported generalized fatigue in weeks following injection. Nineteen (19) days after injection, patient developed unprovoked resting tachycardia to approximately 180bpm (following some moderate weigh-lifting exercise). Symptoms did no resolve sufficiently and patient was transported by EMS to ER for evaluation
47 2021-01-17 chills, fever, headache, fatigue Developed fever and chills 12 hours after receiving dose. Had extreme fatigue x 24hrs and significan... Read more
Developed fever and chills 12 hours after receiving dose. Had extreme fatigue x 24hrs and significant Headache.
47 2021-01-17 headache Mild/moderate headache (resolved within ~48hrs). Soreness at injection site (resolved within ~24hrs)
47 2021-01-17 fever Low grade fever not exceeding 100 degrees, body aches, lump on arm at vaccine site.
47 2021-01-18 fatigue About six hours after shot I started to notice weak, rubbery arms. Today, I was a little nauseous, v... Read more
About six hours after shot I started to notice weak, rubbery arms. Today, I was a little nauseous, very sore all over, and very tired.
47 2021-01-18 fever, fatigue Reports low grade fever which began about 4 hrs after receiving the injection on 1/14/2021. Fever r... Read more
Reports low grade fever which began about 4 hrs after receiving the injection on 1/14/2021. Fever reached a tmax of 103.6. Tylenol taken with good effect. Temperature resolved at time of reporting (1/19/2021). Also experiencing extreme fatigue which started at the same time as the fever.
47 2021-01-19 runny nose, productive cough, fever, fatigue On monday night Jan 11 after the covid vaccine shot i had a runny nose and flem. i also felt muscle... Read more
On monday night Jan 11 after the covid vaccine shot i had a runny nose and flem. i also felt muscle aches and very tired and disoriented. the symptoms continued through the week. on Wed i got covid tested and the results were positive. i began to have light chills through the week but no fever. on Jan 15-16 my symptoms peaked and i had a low grade fever and diarrhea for 2 days. i also developed a rash on my tighs and torso. on Jan 19 my fever went away along with my other symptoms except for an occasional flem cough.
47 2021-01-20 headache, chills, fever CHILLS, FEVER 103.0, CHEST RED, HEADACHES, BONE PAIN, MUSCLE ACHES
47 2021-01-20 headache nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report fro... Read more
nausea; vomiting; Mild headache; arm was hurting/Left arm soreness; This is a spontaneous report from a contactable physician reporting for himself. A 47-years-old male patient received the second dose of bnt162b2 (BNT162B2; Lot # EJ1686) vaccine , intramuscular in the left deltoid on 07Jan2021 11:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Previously on 17Dec2020 the patient received the first dose of BNT162B2 vaccine. The patient experienced nausea and vomiting on 10Jan2021 23:59 with outcome of recovered , mild headache on 07Jan2021 20:30 with outcome of recovered , arm was hurting/left arm soreness on 07Jan2021 20:30 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 20Nov2020. Nausea and vomiting were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events nausea and vomiting cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-01-20 fever, chills, fatigue Chills; fever; body and muscle aches; body and muscle aches; fatigue; This is a spontaneous report f... Read more
Chills; fever; body and muscle aches; body and muscle aches; fatigue; This is a spontaneous report from a contactable nurse (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 16:45 (04:45 PM) at a single dose for COVID vaccine. There was no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient previously had his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID vaccine. He had no other vaccine in four weeks. The patient experienced chills, fever, body and muscle aches, fatigue, all on 09Jan2021 08: 00 AM. Treatment was not received for the events. The patient had no COVID prior to vaccination and did not have COVID tested post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.
47 2021-01-20 fever, chills One hour after shot, was able to raise arm. Monday night (01/19/2021) started to get chills, body ac... Read more
One hour after shot, was able to raise arm. Monday night (01/19/2021) started to get chills, body aches, fever (103), vomiting and severe headache. All symptoms gone except headache Thursday morning (01/21/2021). Headache pain has lessened.
47 2021-01-21 fever, headache About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed ... Read more
About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -
47 2021-01-24 chills, lethargy, fever Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, le... Read more
Approximately 48 hrs after my second Pfizer vaccination for covid I experienced chills, migraine, lethargy, loss of appetite, and general digestive discomfort. Treated with plenty of fluids, naproxen, and rest. Experienced mild fever but never > 100 degrees that I know of.
47 2021-01-25 headache, chills, fatigue Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close th... Read more
Uncontrollable shivering shaking almost like a seizure type. Severe headache, pain muscles, close throat dry throat. Tiredness fatigue.
47 2021-01-25 headache, fatigue Extreme fatigue; mild headache; lump and extreme tenderness at injection site; lump and extreme tend... Read more
Extreme fatigue; mild headache; lump and extreme tenderness at injection site; lump and extreme tenderness at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 08Jan2021 (09:30 AM) at single dose for Covid-19 immunization. The patient received the first dose of Covid-19 vaccine (BNT162B2, lot number: unknown), via an unspecified route of administration left arm on 18Dec2020 (09:30 AM) at single dose for Covid-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme fatigue, mild headache, lump and extreme tenderness at injection site on 09Jan2021 (08:00 AM). There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.
47 2021-01-26 headache Systemic: Headache-Medium, Systemic: Warm, flush feeling at forehead; symptoms lasted 1 day
47 2021-01-27 fatigue, headache I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were ... Read more
I experienced headaches, severe abdominal pain, change in bowel movements, ribs felt like they were being ripped apart, tired/fatigue, blurry vision, dizziness, my body felt hot from the inside out, tingling sensation in feet and hands.
47 2021-01-29 sweating Dizzy & diaphoretic after vaccine, bp checked 190/110, taken to ED. Ed workup with ECG - normal, p... Read more
Dizzy & diaphoretic after vaccine, bp checked 190/110, taken to ED. Ed workup with ECG - normal, patient was monitored, symptoms resolved.
47 2021-01-31 fatigue, respiratory tract congestion soreness, fatigue, congestion, night sweats, itchy, rash, difficulty breathing
47 2021-01-31 headache tingling to face, redness to face, headache, throat swelling
47 2021-01-31 fever, headache, chills 01/20/21 @ 4:00 PM: Headache, fever, chills, and body aches for 2 day. Symptoms are resolved. Feelin... Read more
01/20/21 @ 4:00 PM: Headache, fever, chills, and body aches for 2 day. Symptoms are resolved. Feeling well.
47 2021-02-01 malaise Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was de... Read more
Staff experienced left shoulder tenderness and general malaise after vaccination. The malaise was determined to be enough for the staff to miss work to stay home and rest.
47 2021-02-01 throat irritation 0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg... Read more
0825 flushed, nausea , slightly SOB, O2 sat 96%, RR24 HR 77 BP 137/97. Pepcid 40mg, Benadryl 50mg 0830 Dizzy, flushed, SOB 0835 Dizzy, not flushed feeling, slightly SOB. O2 sat 95% 0840 Throat scratchy - slight difficulty to swallow O2 sat 93-94% HR 90 RR 28 0850 Epi pen injection, Throat tight and scratchy, hard to catch breath after coughing 911 called 0900 Ambulance transported to ER 0909 Ambulance arrived to ER still somewhat SOB and scratchy throat and nauseated, Dizziness improved. No stridor or wheezing, no hives or itching, no swelling of tongue or lips or facial swelling Received IV Benadryl, IV Decadron, IV Pepcid and albuterol nebulizer treatment and observed for an extended amount of time. SOB cleared, throat issue resolved and was discharged with just a slight residual tiny scratchy throat. He was discharged on Benadryl every 6hours until symptoms are completely resolved and Prednisone for 3 days starting on 1/26 if any residual symptoms are felt. Also given Albuterol inhaler if develop any recurrent SOB. Released home at 1413 on 1/25. Follow up on 1/27 and he stated he had fully recovered
47 2021-02-02 headache, fatigue After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme f... Read more
After the vaccine, within about an hour after, I started feeling a headache, diarrhea, and extreme fatigue. The next day I still had a headache, fatigue and arm soreness. On the 31st, the symptoms kinda went away. I did notice some SOB when walking. I did see my Pulmonologists and was prescribed a medicine.
47 2021-02-03 headache, chills, fatigue body aches; muscle soreness; headaches; being tired; chills; throwing up; This is a spontaneous repo... Read more
body aches; muscle soreness; headaches; being tired; chills; throwing up; This is a spontaneous report from a contactable other healthcare professional (patient himself). A 47-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer -Biontech Covid-19, lot/batch number and expiry date were not reported), intramuscularly in the left arm on 19Jan2021 20:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included CHF (congestive heart failure). He was not diagnosed with COVID-19 prior to vaccination and did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 22Jan2021 17:00 he started to have body aches, muscles soarness, headaches, felt being tired with chills and throwing up about a week. No treatment was given. The events were reported as non-serious. The outcome of events was unknown. Information on the lot/batch number has been requested.
47 2021-02-03 sleepiness, fever, lethargy Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, n... Read more
Muscle aches, fever of 102, got/cold feeling, loss of appetite, dry heaving, lethargic and sleepy, numnous in hands
47 2021-02-05 fatigue, headache Starting ~14hrs after injection: moderate headache, full body ache, fatigue, mild swollen neck lymph... Read more
Starting ~14hrs after injection: moderate headache, full body ache, fatigue, mild swollen neck lymph nodes
47 2021-02-05 headache, malaise, chills Injection site pain, headache, chills, nausea, feeling unwell. Injection site pain and chills went a... Read more
Injection site pain, headache, chills, nausea, feeling unwell. Injection site pain and chills went away after two days. Headache, nausea, and feeling unwell is still going on but intermittent as of 8 days after the first injection.
47 2021-02-06 headache, fatigue, fever, sweating I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both fro... Read more
I 'had Covid' beginning Saturday before Thanksgiving. During that period, I had two tests, both from facility, and both tests came back negative. Symptoms included fever 102-103 for 12 days. No appetite (didn't eat for that duration). Headache. Excessive sweating. Extreme shallow breath. Hyperventilation. Body ache. No loss of smell or taste. No nausea. No mucus response. Since that time, I have experienced extreme fatigue, weakness, shortness of breath, headache. After the first shot, those three symptoms increased. With the second shot, I had fever 99.5-101 from Tuesday though Saturday. Nausea, headache, body ache, weakness, shortness of breath. It felt 85% similar in symptom and intensity as when I 'had Covid'. The greatest difference is the nausea. When I 'had Covid' there was no nausea and I did not throw up. This time, I had persistent nausea and threw up multiple times in the first three days.
47 2021-02-07 body temperature increased, chills, fatigue, headache At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left han... Read more
At time of the vaccine: I experienced a tingling/numbing sensation down my left arm into my left hand and fingers. Approximately 18 hours after the vaccine: I experienced chills, elevated temperature (99 to 100 degrees F), headaches, fatigue. Approximately 42 hours after the vaccine: the chills, elevated temp, headaches, and fatigue were gone, but I had a armpit aching on the left side. The armpit ache faded over the next 24 hours. Today is 7 days post vaccine and I still have periodic tingling/numbing/cool sensation on the pinky and ring fingers on my left hand.
47 2021-02-09 fatigue Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate... Read more
Shortness of breath; palpitations/increased heart rate; palpitations/increased heart rate; Immediate left arm/chest pain; Immediate left arm/chest pain; fatigue; body aches; This is a spontaneous report from a contactable physician. A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via intramuscular, on 18Jan2021 at single dose on the left arm for COVID-19 immunisation, administered at Hospital. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided. No other vaccine was received in four weeks. The patient developed immediate left arm/chest pain, and fatigue/body aches. On 23Jan2021 (5 days later), he developed shortness of breath and palpitations/increased heart rate. Post-vaccination COVID test was not performed. The patient was not treated for the events. The patient was recovering from the events.
47 2021-02-09 nasopharyngitis, malaise, headache Headache; Feeling like have a cold; feeling sick; This is a spontaneous report from a contactable co... Read more
Headache; Feeling like have a cold; feeling sick; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EL3249) at single dose at left shoulder on 14Jan2021 13:00 for covid-19 immunisation. Medical history included ongoing muscular dystrophy since the age of seven. There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced headache and feeling like have a cold on 21Jan2021 in first part of the day when he woke up, and has been feeling sick all weekend in Jan2021. He did not know if he had a fever. The events did not require a visit to Emergency Room or physician's office. No relevant test done. The outcome of headache and feeling like have a cold was recovering (also reported as ongoing), of feeling sick was unknown. He was thinking about getting a test done, clarified as the quick COVID test, but he did not know if it will read a false positive. That is one reason why calling to determine if it would give a false positive.
47 2021-02-09 fever, chills Fever; Chills; body aches/muscle soreness; body aches/muscle soreness; This is a spontaneous report ... Read more
Fever; Chills; body aches/muscle soreness; body aches/muscle soreness; This is a spontaneous report received from non-contactable consumer (patient) via Pfizer Sales Representative. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in the left arm on 14Jan2021 15:00 at single dose for COVID-19 immunization in a hospital. Patient medical history and concomitant medications were reported as none. The patient had no other vaccines in four weeks and no other medications in two weeks. Patient previously received the first dose of BNT162B2 at the age of 47-years on 24Dec2020 at 03:00PM in the left arm, for Covid-19 immunization in a hospital. On 14Jan2021 23:00 patient experienced fever, chills, body aches/muscle soreness. No treatment was received. Patient was not tested for Covid post vaccination. Outcome of events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
47 2021-02-11 fever, headache, chills Presents to ICC with fever, chills, and headache six days after receiving 2nd dose of covid vaccine... Read more
Presents to ICC with fever, chills, and headache six days after receiving 2nd dose of covid vaccine. Tested negative for covid on 2/12. Diagnosed with Acute Viral Syndrome.
47 2021-02-14 chills Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a conta... Read more
Migraine Headaches; chills; body aches; sore arm; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), intramuscular in the left arm, on 26Jan2021 14:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included migraine and diabetes mellitus (diabetic). The patient has no allergies to medications, food or other products. Concomitant medication included metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-10 post vaccination. The patient experienced migraine headaches, chills, body aches and sore arm on 26Jan2021 at 14:00. No treatment was given for the events. The outcome of the events was unknown. The events were assessed as non-serious.
47 2021-02-15 chills, headache I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the lef... Read more
I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the left ear. I also experienced headache, vertigo, chest heaviness, vertigo, and chills for 3 days following the vaccine. Still have the ringing. I cancelled the 2nd vaccine.
47 2021-02-15 headache Mild headache
47 2021-02-15 headache Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose becaus... Read more
Had daily headaches after first dose of vaccine. For 3 weeks. Decided to skip the second dose because of that. Then had leg pain after nearly a month of the vaccine. Thought it was muscle pain but landed up in ER with shortness of breath and was diagnosed with DVT and large PE.
47 2021-02-16 malaise, chills, fever Pt reported that he received the 1st Pfizer dose on Feb. 10, on the 13th he reported fever, chills a... Read more
Pt reported that he received the 1st Pfizer dose on Feb. 10, on the 13th he reported fever, chills and feeling unwell. On Feb 14th, the pt went to his local doctor and was tested for COVID-19, on the 16th he was notified the COVID-19 test was positive. Pt was instructed to quarantine for the next 14 days, he understands the instructions he was given and will continue to monitor his health.
47 2021-02-17 pneumonia, fever, fatigue, cough onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/20... Read more
onset of dizziness and fatigue 24 hours after vaccine (1/30/2021). 48 hours after vaccine (1/31/2021), developed cough and low grade fever. Symptoms continued to progress with continued cough, fatigue, and generalized weakness with shortness of breath. Had O2 sat of 88% with activity on 2/9/2021 and went to emergency department and was diagnosed with pneumonia. Treatment started for community acquired pneumonia with Amoxicillin and Azithromycin. Patient discharge home from emergency department
47 2021-02-18 sleepiness, fatigue, sweating, headache, lethargy Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had ... Read more
Within a half hour, I felt dizzy and light headed. in 45 minutes - I could barely stay awake. I had to stop driving. Within two hours, I had a bad headache. I became slightly agitated that day. The headache lasted throughout the day - I took Ibuprofen but that didn't help much. Sunday, the headache was still there. It wasn't a migraine; but intense. I was agitated. My agitation level grew and my irritability grew and the headache I had the whole day. Sunday evening about 7 pm the agitation and irritability got very intense - I was having impulse control issues with it. I don't have anger issues but I wanted to yell at TV or throw my phone. From 8- midnight, I was lethargic and fatigued - I didn't have the energy to roll over;: had extreme anxiety I was sweating and having weird thoughts like harming my animals and harming myself; my mind was racing and then I would get really depressed. Until about midnight, I have had past struggles with anxiety and depression - there had been a past feeling like this - but it was really extreme - it was worse night of my life. Lasted four hours, and finally I slept for about one hour. I remember thinking, I finally can take a breath. My racing thoughts were gone and sweating was gone. The irritability had subsided enough that I could try to gain control of my thoughts again. I had really bad nightmares the rest of that night; I was confused _ I didn't know where I was - confused about that - occurred about three different times until I got up at 5:30 am for work. To summarize, for the next week, I had moments of anxiety and depression. I had mental fog. I played pro football - and I had post concussion syndrome. It was very identifiable to what I had had. So this was occurring in moments - forgetful; depressed; and random moments of anxiety - like I was going to go play football again. 7-10 days - it got a little better each day. Ten days it took to subside. I still exercised and taking extra fluids to get back to my normal. Exercised help. No fever occurred. With COVID - I had had a sense of anxiety and depression and some mental fog when I had COVID I didn't have it to this extreme. Did not get the second dose.
47 2021-02-22 sweating 0720: pt c/o feeling "faint, lightheaded, dizzy" 10 minutes post second dose of Pfizer COVID-19 vacc... Read more
0720: pt c/o feeling "faint, lightheaded, dizzy" 10 minutes post second dose of Pfizer COVID-19 vaccine. pt appears pale and diaphoretic. laid to the ground with bilateral lower extremities elevated above level of heart. pt states he feels better a few minutes after intervention. VS BP 121/76, HR 68, RR 16, SPO2 96 on RA, T 97.9.
47 2021-02-23 body temperature increased, chills Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccin... Read more
Vaccine given 2/17/2021. Client developed soreness in arm and shoulder area and chills post vaccine, joint achiness on day 2 post vaccine. On 2/21, client developed lower back and flank pain bilaterally which progressively got worse and continues yet on 2/24. Client rates pain a 6 or 7. Pain is constant. Pain will decrease to a 2 or 3 following Aleve. Denies blood in urine, urgency, burning with urination or difficulty starting urine stream. States bowel movements have been normal. States discomfort is not like a pulled muscle sensation. Has had temperature in the 99 degree range. Client started Potassium supplement on 2/22 thinking it may help but has had no relief. Pain continues as of time of report.
47 2021-02-24 headache Moderate headache for 5 hours the following day. I very rarely get headaches (one every few years, ... Read more
Moderate headache for 5 hours the following day. I very rarely get headaches (one every few years, often when ill)
47 2021-02-25 fever, chills, sweating, headache Headache, Fever, Chills, intermittent Sweating. Persisted throughout the night and started to fade a... Read more
Headache, Fever, Chills, intermittent Sweating. Persisted throughout the night and started to fade around 6:30 am.
47 2021-02-26 chills, headache Severe headache, severe chills, could not move(full body stiffness). Extreme thirst. Subsided aft... Read more
Severe headache, severe chills, could not move(full body stiffness). Extreme thirst. Subsided after 5.5 hours.
47 2021-02-26 fatigue Injection site muscle soreness, fatigue, palpable tender lymph nodes left axillary region.
47 2021-03-02 chills, headache Chills, Headache, and body aches.
47 2021-03-02 sweating Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was not... Read more
Patient received 1st dose of his Covid vaccine; after~10 min, during observation period, he was noticed to become pale ,diaphoretic and with decreased level of responsiveness; was put on the stretcher. Physician who was monitoring the vaccination area reported: "BP 110/64 HR 76 Sat 95% Patient was feeling better upon being placed supine and was verbalizing as well. Denied chest pain and shortness of breath. Just felt dizzy and weak." Patient was taken to ER; CBC,CMP,ECG- all normal and he was discharged after 2 hrs of observation with diagnosis of Vasovagal Syncope. Today, patient is well and went to work as per his spouse. Patient has history of similar syncope or near syncope events in the past during stressful situations, like seen blood .
47 2021-03-05 sweating Complaint of dizziness. Pale and diaphoretic. BP 108/60, P 53, R 16, T 96.8, O2 98%. Monitored in po... Read more
Complaint of dizziness. Pale and diaphoretic. BP 108/60, P 53, R 16, T 96.8, O2 98%. Monitored in post vaccination area and discharged without any complaints.
47 2021-03-07 fatigue, headache Sore at sight annoying headaches , body aches and fatigue still going on Taking Tylenol and Ibupr... Read more
Sore at sight annoying headaches , body aches and fatigue still going on Taking Tylenol and Ibuprofen
47 2021-03-07 malaise, headache, chills Feeling unwell; Injection site pain; Headache; Chills; Nausea; This is a spontaneous report from a c... Read more
Feeling unwell; Injection site pain; Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 29Jan2021 (13:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included diabetes. Concomitant medications included amlodipine, atorvastatin, lisinopril and metformin HCl. On 29Jan2021 (19:00), the patient was feeling unwell; had injection site pain; headache; chills; and nausea. The patient did not receive any treatment for the reported adverse events. The outcome of the events was not recovered for 'feeling unwell' and 'headache'; was recovered on 01Feb2021 for 'injection site pain' and 'chills'; and was unknown for 'nausea'. The patient was not diagnosed with COVID-19 prior to vaccination; and had not tested positive post-vaccination. Information about lot/batch number has been requested.
47 2021-03-07 fever I had adverse event to both vaccines, The second was and second dose EL 8982 Both times I had a sli... Read more
I had adverse event to both vaccines, The second was and second dose EL 8982 Both times I had a slight fever. Painful enlarged lymph node in left armpit. Body aches that kept me up at night. And feeling mentally cloudy. Symptoms lasted for 203 days. I called my oncologist on the phone.
47 2021-03-09 chills, headache, fatigue Body aches; Fatigue; headache; Chills; This is a Spontaneous report from a Contactable Consumer (pat... Read more
Body aches; Fatigue; headache; Chills; This is a Spontaneous report from a Contactable Consumer (patient). A 47-years-old male patient received bnt162b2 (BNT162B2; lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion) second dose, via an unspecified route of administration on 04Feb2021 15:00 at SINGLE DOSE for covid-19 immunization, vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. Patient had no Known allergies. Historical vaccine included first dose of BNT162B2 for covid-19 immunization on 14Jan2021. The patient experienced body aches, fatigue, headache and chills, all on 04Feb2021 20:00 with outcome of recovered. No treatment was received. Information on the lot/batch number has been requested.
47 2021-03-10 fatigue, headache Soreness at point of injection, beginning a few hours after shot. Greater swelling/discomfort at ap... Read more
Soreness at point of injection, beginning a few hours after shot. Greater swelling/discomfort at approximately 4AM the next morning. Mild fatigue, slight headache, mild swelling at lymph nodes approximately 20 hours after dose.
47 2021-03-12 chills, fatigue, fever I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fev... Read more
I have had multiple issues, back pain, chills, uncontrollably fall asleep, feel feverish with no fever, exhaustion, joint pain, weakness.
47 2021-03-13 chills, fever, malaise I have felt bad for over a week with body aches, fever and nausea chills non stop. for 8 days now
47 2021-03-13 headache Severe headache
47 2021-03-14 fever, fatigue, chills Myalgia, Fever, Injection site pain, fatigue, chills Narrative:
47 2021-03-15 cough, headache, influenza like illness, fatigue As bad as flu after first dose, aches, pain all over especially knees and groin area. Hard to breath... Read more
As bad as flu after first dose, aches, pain all over especially knees and groin area. Hard to breath at times as I have bad cough/fluid in lungs though not bad enough to require medical attention. Headache, fatigue I am currently on day2 of feeling like this. Note: this is not life threatening I justed wanted to provide honest feedback to you on my side effects. Advil/Tylenal does help a bit
47 2021-03-15 headache I had those symptoms in a discontinued manner: slight dizziness during the day, slight headache when... Read more
I had those symptoms in a discontinued manner: slight dizziness during the day, slight headache when I woke up, treated easily with paracetamol.
47 2021-03-16 headache Patient received vaccine. He preceded to wait area. Within minutes he slid out of his chair and hit ... Read more
Patient received vaccine. He preceded to wait area. Within minutes he slid out of his chair and hit his head on the floor. He appeared to be unconscious and possibly seizing. He came to. We asked him his name, date, and where he was. He was able to answer all questions. Said his head hurt. Medics arrived and took over
47 2021-03-16 headache Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't... Read more
Swollen face, tongue feels fat, headache behind R ear, facial dropping, slurring words, eye doesn't close all the way. Started Sunday night to the morning went to ER. Did blood test for Lymes. Diagnosed with Right sided BELLS PALSY Gave prednisone and Valtrex in ER and discharged on those meds too.
47 2021-03-16 sweating sweating Narrative:
47 2021-03-16 fever tinnitus Received a second shot of the Pfizer vaccine shipped to Hospital. Next day had fever , noi... Read more
tinnitus Received a second shot of the Pfizer vaccine shipped to Hospital. Next day had fever , noise and ringing (both). Fever disappeared after 3 days but noise and high pitched ringing remained and is still an issue as of today. Saw PCP, they were not sure if it is related and could not identify a cause. It seems moderate but affect ability to concentrate at work and read.
47 2021-03-17 body temperature increased Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he... Read more
Patient received COVID vaccine (Pfizer, lot# ER2613, exp 7/2021) at 3:00pm. EMT asked patient how he felt at 3:27 during his 30min observation, patient report he felt "spacey" because he had not eaten since breakfast. EMT alerted PHN'S. 3:30 blood pressure 200/130, pulse 86, respirations 18, O2 93%. Patient was A&Ox4, denied headache, dizziness, swelling, tingling, altered vision. Medications: simvastatin, amlodipine, gabapentin, methocarbinol, vitamins. Medical conditions include kidney problems, hypertension, polycythemia, spinal fusing, chronic pain. Patient receives therapeutic phlebotomy and is 1 week overdue. 3:35 blood pressure 182/120, pulse 88, O2 99%, respiratory rate 20. 3:40 blood pressure 192/119, repiratory rate 24, paitent reported anxiety and lightheadedness, continued to deny headache, blurry vision. PHN called 911 at 3:42, offered Bendaryl to patient who declined. 3:50 911 assumed care, reported blood pressure 210/palpated and temp 101.1. Patient's partner arrived. Patient declined 911 transport at 3:53. Patient reported he would have his partner drive him to urgent care. Patient left with steady gait at 4:09.
47 2021-03-17 sweating Pt. was monitored for 15 minutes after receiving the first dose of the COVID-19 vaccine, Pfizer. Com... Read more
Pt. was monitored for 15 minutes after receiving the first dose of the COVID-19 vaccine, Pfizer. Complained of chest discomfort, tightness, diaphoresis, and syncope when attempting to stand. HR was 166 at initial presentation, BP was 117/75, SPO2 98% on room air, R 18 equal and unlabored.
47 2021-03-17 sweating Patient received vaccine and while waiting his 15 minutes he reported feeling dizzy and was sweating... Read more
Patient received vaccine and while waiting his 15 minutes he reported feeling dizzy and was sweating. The nurse called for the EMTs and they took him in hall to take his vitals. His HR was in the 40s to 50s so they did an EKG. He has a history of heart disease and had an ablation about a year ago. The paramedics took him to a nearby hospital.
47 2021-03-17 fever, headache Headache, Myalgia, Fever, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
47 2021-03-17 fever Fever body aches and weakness Narrative:
47 2021-03-18 chills, headache Mild to moderate headaches, chills and flush feeling Ibuprofen 600 mg @ 2 times/day
47 2021-03-18 headache, malaise, nasal congestion, fever, fatigue I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint... Read more
I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint pain, severe fatigue, severe dry mouth, muscle and body aches, nausea, pounding headache, also just feel "out of it"
47 2021-03-19 lethargy, headache 1. Slight soreness around injection site starting around 6 hours after injection. Lasted about one d... Read more
1. Slight soreness around injection site starting around 6 hours after injection. Lasted about one day. No treatment needed. 2. Light headed starting around 8 hours after injection and lasted only a few hours. No treatment needed. 3. Headache starting around 8 hours after injection and lasted about 1.5 days. No treatment. 3. Strong lethargy starting about 12 hours after injection and lasting about 2 days. Lethargic enough that I had to take a day out of work. No treatment. 4. Flare up of what looks like plaque psoriasis on scalp and on face starting about 5 days after FIRST injection on 02/20/2021. Ongoing. No treatment yet.
47 2021-03-19 lethargy Slight soreness around injection site starting a few hours after injection. Some lethargy that night... Read more
Slight soreness around injection site starting a few hours after injection. Some lethargy that night and into the next day.
47 2021-03-21 sweating Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/20... Read more
Notes: APRN (Nurse Practitioner), Cosigned by: MD at 3/19/2021 9:22 AM, COVID VACCINE CLINIC 3/18/2021 Patient/Date: 3/18/2021 Subjective: a 47 y.o. male who was seen at SVH COVID Vaccine Clinic today for his first dose of the COVID Pt is a 47 y.o. male who was seen at COVID Vaccine Clinic for his first does of COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given and once pt was feeling better he was transferred to the ER bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for awhile we cooled down and he was allowed to leave. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness, and hot and sweaty: CONT negative, HENT negative, Eyes negative, Respiratory negative, Skin negative, GI negative, Musculo negative, Previous Reactions: None, Objective: Vitals - There were no vitals filed for this visit. Physical Exam - Constitutional: Appearance - He is well-developed. HENT: Head -Normocephalic and atraumatic. Right Ear- External ear normal. Left Ear: External ear normal. Nose - Nose normal. Eyes - Conjunctiva/sclera: Conjunctivae normal. Pupils - Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm - Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort - Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: General -Normal range of motion. Cervical backN -normal range of motion and neck supple. Skin: Coloration: Skin is pale. Neurological: Mental Status - He is alert and oriented to person, place, and time. Assessment/Plan: Treatment include - water and snacks. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash). Pt was released at 3:26, he was accompanied by his wife. APRN Electronically Signed 3/18/2021 3:19 PM
47 2021-03-21 nasopharyngitis Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypo... Read more
Pt appeared dizzy, cold and clammy, pale, and flushed. Paramedics accessed pt, found out he was hypotensive. MD on site examined pt and called management. Pt was transported to Hospital via ambulance, accompanied by wife. Pt was alert and oriented x3, EKG done on sinus rhythm .
47 2021-03-23 chills, headache, fatigue Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resul... Read more
Headache, Myalgia, NauseaVomiting, fatigue, chills occurred within days of 3/15 and 3/17 which resulted in unable to work 3/16/2021 and 3/17/2021.
47 2021-03-23 fatigue, malaise, fever, headache, chills Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their ... Read more
Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their policy is to wait until after second dose). The day after vaccination, patient was complaining of fatigue with subjective fevers and rigors with associated headache and neck stiffness and on the day of presentation he complained of increased fatigue and general malaise for which he left work early and was ultimately found poorly responsive in his private vehicle with concern for possible seizure activity. He was brought to ER by ambulance. He reported numbness in hands and legs, rigidity, and an episode of urinary incontinence. He was started on empiric antibiotics for possible CNS infection, lumbar puncture completed. Found to have acellular CSF and antibiotics were discontinued. Patient remains in hospital at this time with course complicated by post-LP headache.
47 2021-03-24 fever, chills, fatigue Fever with chills. Very sore and achey. Extremely tired. Much better today(2nd day).
47 2021-03-24 fever Fever within 24 hours
47 2021-03-25 fatigue I was feeling hot and agitated the night of the injection, the 22nd of March. It felt as if I have t... Read more
I was feeling hot and agitated the night of the injection, the 22nd of March. It felt as if I have too much coffee, I was unable to sleep. I was tired the next morning the 23rd of March, but by the afternoon I felt normal again. My left shoulder where I got the shot had a little muscle soreness for about a day.
47 2021-03-25 headache Patient reports 2/10 headache following vaccination. Took patient vitals to find him hypertensive. p... Read more
Patient reports 2/10 headache following vaccination. Took patient vitals to find him hypertensive. patient refused transport to ED
47 2021-03-25 fever, malaise 47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after ... Read more
47 year old Gynecologist with PMH of severe MDD, GERD, asthma, referred to the ED by his PCP, after 5 days of gait instability, and about 4 weeks of altered mental status, confusion, short term memory deficits and malaise. ADEM suspected and extensive infectious, inflammatory and neoplastic workup was initiated. CT brain - reported NAD MRI brain consistent with Acute Diffused Encephalomyelitis and suspected ADEM. MRI cervical spine with evidence of demyelination involving posterior cord. ICU course complicated by new onset of aphasia, partial left frontotemporal seizures, LGIB due to proximal rectal laceration and central diabetes insipidus. Admitted 3/15/21. On 3/17 he developed aphasia with right sided facial droop and stroke alert was called. Later on 3/17 he developed GI bleeding and was taken for emergent colonoscopy, from which no significant conclusions could be made due to lack of preparation and subsequent poor visualization. No foreign body was reported. After he continued to have ongoing bleeding, the patient had a sigmoidoscopy, during which the migrated clip could be removed and two new hemostatic clips were placed. He subsequently developed large volume urine output and nephrology was consulted; the patient was diagnosed with likely diabetes insipidus. On 3/20 acyclovir was discontinued after HSV PCR was negative. High dose solumedrol for ADEM completed 5 day course 3/21. VDRL was non reactive. There were no oligoclonal bands. Solumedrol 1g daily was started 3/24/21: MRI showed L>R patchy enhancement and diffusion abnormalities consistent with ADEM. Repeat MRI showed new restricted diffusion of the left superior cortex, bilateral medial temporal lobes and hippocampi, genu of the corpus collosum, and pericallosal white matter, with ddx including status epilepticus, autoimmune encephalitis and infectious encephalitis including herpes simplex. Completed 5 day course of high dose steroids, 6 days of IVIG and on ongoing PLEX. Neurological improvement noted 3/25
47 2021-03-27 chills, fatigue Chills and fatigue
47 2021-03-27 chills, fever, headache Nausea, fever, chills, headache, body ache, swollen lymph node under right arm.
47 2021-03-27 chills Cold chills
47 2021-03-27 malaise S/P 1st dose of shot. Pt reports feeling "off" and "not well". Ten days after injection, pt experien... Read more
S/P 1st dose of shot. Pt reports feeling "off" and "not well". Ten days after injection, pt experience Vfib. Pt has an ICD and LVAD. Pt was shocked 8 times was in sustained vfib until. EMT called. admitted to hospital. amiodarone bolus x2 and cardioverted. LVAD contributed to pt remaining conscious
47 2021-03-28 headache Patient called into clinic to report about two hours after receiving vaccine he passed out and the p... Read more
Patient called into clinic to report about two hours after receiving vaccine he passed out and the person that was with him said he had a seizure. Patient reported feeling fine after about an hour, but was very tired and had a headache.
47 2021-03-29 sweating swelling and pain under left armpit the next day after receiving the vaccine
47 2021-03-30 cough, fever, chills Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weaknes... Read more
Chills, fever, muscle aches, joints pain for the first 4 days. On 5th day cough, generalized weakness. I took Ibuprofen, vitamins, Airborne pills, Tylenol, antihistamines with some improvement. On 5th day due to caught and low grade temperature I started Augmentin 500mg po TID.
47 2021-03-30 fatigue Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on so... Read more
Got my first Pfizer shot on March 24 at 2 pm. The first day I felt way off like I was drunk or on some kind of drug that gets you high with bouts of dizziness and some major hypertension. My back and chest were very tight the whole time. The tension finally subsided around 11 pm that night but I was still uneasy. The 2nd day I felt ok in the morning and throughout the day until about 3 or 4 pm I started getting really nauseated and tired. I went to lay down to sleep and felt a little better when I woke an hour later. Day 3 I started feeling extremely tired and fatigued with some major chills. Basically slept most of that evening and throughout the night. Woke that next day and couldn't get that dizzy foggy feeling out of my head the whole day. Day 4-5 still bouts of dizziness, chills and fatigue with some nausea also I noticed I developed a wheezing dry cough which points towards respiratory distress. Day 6 still feeling yucky, tired, fatigued, some nausea and that dam cough. Today 03-31-21, still feeling weak and tired with some episodes of dizzy spells, nausea and respiratory distress cough. Also forgot to mention on day 2 and 3 I had some major tingling on the right side of my head for most of the day. Felt like spiders crawling on my head and face. The last time I felt tingling like that I got shingles which also got me very sick and put me in the ER and ICU years ago. So there is also some post traumatic stress from that as well. Made an appointment to see a Doctor on 03-30-21 to have my blood pressure checked and get an overall check up. My blood pressure is elevated and stress levels are high with anxiety. Dr prescribed me some anxiety medication. No other recommendations from the Doctor.
47 2021-03-31 chills, fever, sweating within 1 hour I was slightly disoriented (foggy), my balance was compromised. at 24 hours I was swea... Read more
within 1 hour I was slightly disoriented (foggy), my balance was compromised. at 24 hours I was sweating and shivering, at 32 hours the fever broke, at 48 hours I was +80% of usual, at 7 days out I still have minor pain at the injection sight that feels like a deep bruise
47 2021-03-31 fever, fatigue, nasal congestion Fatigue, soreness, slight fever. congestion
47 2021-04-01 fatigue Fatigue Body Aches Nausea Vomiting
47 2021-04-01 fever, chills, fatigue Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9... Read more
Soreness on the left arm, Fatigué, Fever with chills remained for 2 days; readings ranged from 99.9F - 101F
47 2021-04-01 fever, headache, chills Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours aft... Read more
Severe Chills, Fever 102.2 on Tylenol, Body Aches, Headache, Arm soreness. Began about 10 hours after shot. Next day, fever down to 99 on Tylenol, still body aches. During severe chills was having hallucinations (I'm sure related to the fever).
47 2021-04-03 malaise, influenza like illness, fatigue, chills Experienced mild flu-like symptoms; including chills, fatigue, exhaustion, some nausea and general u... Read more
Experienced mild flu-like symptoms; including chills, fatigue, exhaustion, some nausea and general unwell feeling. Onset was approx 30hrs after receiving 2nd dose.
47 2021-04-03 fever, lethargy roughly 24 hours after receiving dose#2, i developed extreme body aches, lethargy, and fever - all s... Read more
roughly 24 hours after receiving dose#2, i developed extreme body aches, lethargy, and fever - all subsided abruptly after 12 hours after onset
47 2021-04-04 fatigue really tired, body aches, skin hurt lasted around 12 hours
47 2021-04-04 sweating Pt arrived to post vaccination having not eaten yet this morning. Per the Pt wife, Pt has white coat... Read more
Pt arrived to post vaccination having not eaten yet this morning. Per the Pt wife, Pt has white coat syndrome and get very anxious when in clinical settings. Pt almost fell while walking up the stairs to the bleacher as he was dizzy and diaphoretic. Aid was called and took over care of PT at 1025. EMT released Pt with wife at 1029 as he was back to baseline. Pt finished observation time and wife drove Pt home. Vitals at 1025 VItals: Bp 120/70 HR 64 RR 16 O2 99% on RA Pt is not a diabetic no BG was taken.
47 2021-04-06 influenza like illness, chills, fever, headache Severe flu like symptoms. Body aches, headache, chills, and fever of just over 102 for about 12 hour... Read more
Severe flu like symptoms. Body aches, headache, chills, and fever of just over 102 for about 12 hours. Over 100 degrees for approximately 36 hours.
47 2021-04-06 sleepiness Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt ... Read more
Pfizer vaccine given IM and approximately 13 minutes after injection pt states that his throat felt tight and "funny". States he can swallow but it felt "funny". Denied shortness of breath or any other symptoms. Oxygen sat was 96%. BP 172/80 pulse 74. He was on hemodialysis treatment at the time. No other medications had been given. After initial assessment, S Standish, NP notified and Diphenhydramine 50mg was given IV and oxygen was given. Pt states he felt sleepy and after about 30 minutes his symptoms subsided altogether other than feeling anxious. Nursing staff stayed right with pt and helped to let him know that we were with him and pt verbalized that he was "fine." Vital signs remained the same and treatment continued. Pt left after his 3:30 treatment with all symptoms completely resolved.
47 2021-04-07 chills, fever, fatigue Soreness in arm (worse than the first shot). Fatigue Fever chills
47 2021-04-07 fatigue Fatigue, sore neck, dizziness and vertigo, and now rashes.
47 2021-04-07 sleepiness heartburn, medicine taste in throat. "acid reflux" drowsy.
47 2021-04-08 sweating Client was in the observation area with his spouse post vaccination. Wife reported client dropped hi... Read more
Client was in the observation area with his spouse post vaccination. Wife reported client dropped his paperwork and became pale, diaphoretic and unresponsive. EMS responded immediately at which time the client was responsive, awake, alert and oriented. Client assessed and found to have vital signs within normal limits. 12 lead EKG performed and normal. Residual leg weakness improved quickly and patient was counseled regarding transfer to Emergency Department which was declined.
47 2021-04-08 sweating Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. ... Read more
Patient was sitting in a chair drinking a soda being observed for 15 minutes after his first shot. Ten minutes into his observation time, he started feeling sweaty, dropped his soda, started shaking and fell out of is chair face down. He gained cosciousness, turned onto his back and put his knees up. His blood pressure was 132/108. The ambulance was called. The patients vitals were normal whe the emt evaluated the patient. The patient refused treatment and called his wife to come pick him up and agreed to follow up with his primary care physician Monday.
47 2021-04-09 sweating Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Vision changes-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient presented with sweating, and pale face. Chest pressure/pain and left arm pain. Face was pale. Pt reported nausea and vision bluring in and out. Reported unable to stand and verbalized the desire to call an ambulance to evaluate. 911 was called and all advice followed until EMS arrived. Rph remained with patient until EMS arrival. Pt had NO swelling of lips/eyes or difficulty breathing. No hives. Unable to reach patient to assess curent status
47 2021-04-09 fever, fatigue, chills, sweating, headache Extreme fatigue (4/8; 10:30 PM - 4/9: 10:30 PM) Headache (4/9; 1:30 AM - 7:30 AM) Fever/sweating (4/... Read more
Extreme fatigue (4/8; 10:30 PM - 4/9: 10:30 PM) Headache (4/9; 1:30 AM - 7:30 AM) Fever/sweating (4/9; 2:30 AM - 3:00 AM) Chills (4/9; 3:00 AM - 7:30 AM) Body ache/myalgia (4/9; 3:30 AM - 4/10; present time); Note: symptoms are improving One (1) naproxen sodium taken (220 mg) on 4/9 at 1:30 AM One (1) naproxen sodium taken (220 mg) on 4/9 at 5:30 AM One (1) naproxen sodium taken (220 mg) on 4/9 at 11:00 AM Two (2) Tylenol taken (650 mg each) on 4/9 at 3:00 PM Two (2) Tylenol taken (650 mg each) on 4/9 at 11:30 PM
47 2021-04-09 fever, fatigue, chills Severe chills; pain at injection site began at night and lasted until morning. All of the next day, ... Read more
Severe chills; pain at injection site began at night and lasted until morning. All of the next day, fatigue and weakness. Following evening, fever of 100.9
47 2021-04-09 fever, headache Severe headache, fever initially, body aches, followed by joint/knee pain in both knees. Headache/f... Read more
Severe headache, fever initially, body aches, followed by joint/knee pain in both knees. Headache/fever subsided after 2 days but joint/knee pain severity has increased in both knees and the pain is unbearable. I am barely able to walk as of today (4/10/2021). Never in my life had i ever experienced any joint/knee pain.
47 2021-04-09 runny nose, headache, fatigue Extreme fatigue, lack of stamina, runny nose and headache
47 2021-04-10 headache Pain at injection site and mild headache.
47 2021-04-11 fatigue, fever, headache, chills Head/body aches Low grade fever Chills Tiredness Took acetaminophen for pain & fever
47 2021-04-11 headache, sweating, chills, fatigue first 3 days tired, headache, cold chills followed by sweating in bed. Now through day 10, I still ... Read more
first 3 days tired, headache, cold chills followed by sweating in bed. Now through day 10, I still have headaches and upset stomach pain/nausea.
47 2021-04-11 fever, cough Symptoms developed on 3/29/21 after exposure to COVID positive person and was tested. Was found to b... Read more
Symptoms developed on 3/29/21 after exposure to COVID positive person and was tested. Was found to be positive for COVID-19 on 3/29/21. Presented to emergency department on 4/1/21 for worsening symptoms including fever, hypoxia, and cough and was not admitted. Patient presented to ED on 4/5/21 for worsening symptoms and was admitted to the ICU.
47 2021-04-12 fatigue Arm pain, fatigue, trouble sleeping
47 2021-04-12 fatigue Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours a... Read more
Pain from injection. Lasted 2 days. Bad dreams 12 hours after injection. Very low energy 30 hours after injection with a metallic taste in my mouth, Aches and pains, diarrhea, nausea, racing heart, confusion, exhaustion, 5 days after injection energy is better. All other symptoms are slowly subsiding.
47 2021-04-12 headache, runny nose, fatigue, respiratory tract congestion Discomfort at shot site, fatigue, aches, sour stomach, headache, congestion, runny nose. Symptoms w... Read more
Discomfort at shot site, fatigue, aches, sour stomach, headache, congestion, runny nose. Symptoms were strong day of shot and day 2. Day 3 symptoms 50% milder. No symptoms day 4.
47 2021-04-12 malaise, headache Headache, fogginess, malaise. These have mostly resolved as of 07:31 on 4/13/2021. Ringing in both... Read more
Headache, fogginess, malaise. These have mostly resolved as of 07:31 on 4/13/2021. Ringing in both ears and slight pressure in ears(pressure was mildly painful 4/11-4/12. Ringing and pressure still present as of 07:31 on 4:/13/2021.
47 2021-04-12 malaise 1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITT... Read more
1430 PT SITTING IN POST VACCINE WAITING AREA AND HAD SYNCOPAL EPISODE. FALL TO FLOOR FROM CHAIR SITTING POSITION. PT TURNED TO BACK WITH ASSISTANCE FROM STAFF. PT QUICKLY REGAINED CONSCIOUSNESS AND NOTED TO BE WITH DILATED PUPILS AND TRYING TO FOCUS. NOTED CLAMMY SKIN. VS WITH HEART RATE IN 40'S WEAK RADIAL. BP 122/76. NOTED APPROX 1/2 INCH ABRASION TO RT TEMPORAL AREA FOREHEAD. PT ORIENTED TO SURROUNDINGS AND SITUATION. STATES "I TRIED TO RAISE MY HAND TO TELL NURSE I FELT FUNNY, THEN I FELT LIKE I WAS IN A DREAM AND WOKE UP WITH YOU ALL AROUND ME" EMS NOTIFIED IMMEDIATELY. PT DENIES ANY MEDICAL HX. VS MONITORED WITH BP 90/36 ON 2ND CHECK. EMS HERE AND TOOK POSSESSION OF PT
47 2021-04-12 nasal congestion, runny nose RUNNY NOSE / CONGESTION
47 2021-04-13 headache, fatigue Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. S... Read more
Mild tingling in the right foot, tachycardia during the first 15 minutes after getting vaccinated. Severe pain and swelling of the left shoulder, tachycardia or change in heart rate, mild swelling of the hands, mild headache, weakness and tiredness for 48 hours after the first 5 hours of getting the vaccine.
47 2021-04-13 headache, sweating severe headaches, tachycardia at rest
47 2021-04-14 headache, sweating Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: complained of heart burn and blood pressure rose
47 2021-04-14 sweating, fever Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/202... Read more
Patient received his first dose of Pfizer vaccine on 4/14/21 around 4pm and the next day on 4/15/2021 woke up with left deltoid soreness at the site of injection which pt. expected but otherwise felt well until around 11am when he developed lightheadedness, became clammy and diaphoretic and felt feverish. His temp was 98.0 (oral) during evaluation and Blood pressure slightly elevated 140/80s (did not take his BP meds yet) but otherwise unremarkable vitals with no orthostatic hypotension. Random finger stick glucose was 142. Pt. given Tylenol 2 tabs PO in clinic and a hydration pack with water and allowed to lay down in clinic. Pt. monitored for 1.5 hours and Vitals remained stable, lightheadedness resolved. Pt. still felt warm but no longer diaphoretic and remained afebrile and d/c home in stable condition. Symptoms reported via V-safe app by patient.
47 2021-04-14 malaise Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progre... Read more
Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.
47 2021-04-15 headache, chills Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all... Read more
Headache, chills, soreness in legs, tired. Starting the morning after the injection and lasting all day.
47 2021-04-15 headache, fatigue body aches, extreme fatigue, headaches and nausea
47 2021-04-15 fever, headache Fever. Headache. Muscle pain. Chills. Shakes.
47 2021-04-16 fatigue, sneezing, fever, chills, cough Cough, fever, chills, fatigue, sneezing for the past 62 hours.
47 2021-04-16 fatigue First day after the COVID 19 second shot was good. Felt tired in the afternoon and slept early at 9 ... Read more
First day after the COVID 19 second shot was good. Felt tired in the afternoon and slept early at 9 PM. Woke up at 1 AM and since then couldnt sleep. Later in the night got a sinking feeling like when you are coming down on an elevator at high speed. In the morning when I tried to get out of the bed I couldnt sit as I had sever Vertego. Finally had to ask my wife to help me sit. After few mins was ok then my wife walked to the restroom. I was feeling dizzy the whole time. I came back and was lying on the bed. Next time when I tried to wake up same problem. I was trying to sit and falling down. The dizziness was there for about couple of hours after that I didnt face that issue again. I never had Vertego problem in my life and this was a severe one on the second after taking the 2nd dose of the vaccine. Since that afternoon I am feeling normal but thought of reporting this adverse event.
47 2021-04-17 chills, fever, fatigue 04/16/21 - General fatigue and lack of focus for several hours, beginning approx 4 hrs after injecti... Read more
04/16/21 - General fatigue and lack of focus for several hours, beginning approx 4 hrs after injection. Unknown duration (was gone after sleeping) 04/16/21 through 04/17/21 - Injection site soreness for approx 24 hours. 04/17/21 - Body chills and feeling of low-grade fever (did not take temperature) for approx 10 hours, ending around 2am on 04/18/21.
47 2021-04-17 headache 20 minutes after the patient received the second vaccine the patient experienced a mild headache, ti... Read more
20 minutes after the patient received the second vaccine the patient experienced a mild headache, tightness in chest and tingling in the throat. The issue resolved without concern.
47 2021-04-17 nasopharyngitis Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as... Read more
Purple or blue toes, cold to the touch, tender and sore. Three smallest toes on foot on same side as receiving shot. Started about 4 days after receiving first shot of Pfizer. Worsened over about a day. Felt almost like bruising. Would no longer blanch when pressed or rubbed. Elevation helped. Seemed to stop progressing in severity by day 7.
47 2021-04-18 chills, fever Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days... Read more
Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days and eye almost closed completely. Wanted to report the blood shot eyes and puffy ness around left eye
47 2021-04-18 chills Extreme nausea, followed by immediate passing out on bathroom floor. I hit my face on the floor and... Read more
Extreme nausea, followed by immediate passing out on bathroom floor. I hit my face on the floor and woke moments later after my wife found me. I got in bed and had the chills for 30-60 minutes and neck pain.
47 2021-04-18 headache, malaise, fever Patient began to exhibit mild symptoms (malaise, low grade fever, headache, myalgia) that persisted ... Read more
Patient began to exhibit mild symptoms (malaise, low grade fever, headache, myalgia) that persisted and became worse by day 4 post vaccine. Then with worsening headache, fever >101 and oral ulcerations that persisted/became worse through 4/19 when he was seen again. Seen in ED on date of first visit at clinic 4/16/21. Extensive testing with elevated protein CSF. Otherwise unremarkable. Seen again 4/19/21 in clinic setting, fever improved but headache present and ulcerations worse. CHF w/u showed no viral or bacterial meningitis or encephalitis.
47 2021-04-18 sweating Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient ... Read more
Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
47 2021-04-18 fever, headache, chills Severe shivering. Fever. Aching. Headache. No energy. Lasted all weekend.
47 2021-04-19 lethargy Light headed dizzy. Lethargic
47 2021-04-20 dehydration, influenza like illness Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report ... Read more
Flu-like symptoms; Rhabdomyolysis; loss of consciousness; dehydration; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 26Mar2021 at 12:00 (at the age of 47-years old) as single dose for COVID-19 immunisation. The patient received the first dose on 05Mar2021 in arm left (lot number EN6198). Medical history included hypertension and gastrooesophageal reflux disease (GERD). The patient had n known allergy. He did not have COVID prior vaccination and he was not COVID tested post vaccination. Concomitant medications included omeprazole and hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). The patient experienced flu-like symptoms starting 6-8 hours after shot and continuing into the following day, rhabdomyolysis, loss of consciousness and dehydration. Adverse event start time was reported as 06:30 PM. The patient was hospitalized 3 days in ICU, plus 3 additional days. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and life-threatening illness (immediate risk of death from the event). The events were treated with IV Fluids and treatment to raise sodium. The outcome of event was recovering.
47 2021-04-20 fatigue, chills Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated... Read more
Chills. Aching muscles and joints. Tired and weak. Lasted 36 hours. Slept 13 hours and treated with ibuprofen.
47 2021-04-21 headache Low level headache (~20 hours), body aches (~20 Hours) and mild diarrhea (1 time) Took Advil for bod... Read more
Low level headache (~20 hours), body aches (~20 Hours) and mild diarrhea (1 time) Took Advil for body aches, worked OK
47 2021-04-22 fatigue Afyer first dose, extreme nausea and dizziness for about an hour. Almost called 911. Slowly subside... Read more
Afyer first dose, extreme nausea and dizziness for about an hour. Almost called 911. Slowly subsided over the course of day one. After that, ten days of extreme fatigue. Ringing in my ears that resurfaced after second dose.
47 2021-04-22 headache, fever High fever, headache and nausea
47 2021-04-22 headache 5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitor... Read more
5:41 patient mentioned feeling dizzy, weak and lightheaded. He sat down in a chair and began monitoring symptoms. He said he has a history of seizures. At 5:45 after making sure he could take deep breaths and his airway was cleared, he took a sip of water. At 5:47 he mentioned having an increased heart rate. At 5:49, he willingly laid on the floor. At 5:51 he said his chest hurt and had a headache. At 5:53 he then sat up and took a few more sips of water. He felt comfortable enough to stand back and go home. He and his fiancé left the building. He vocalized that his fiancé will be driving him home.
47 2021-04-22 sweating Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Additional Details: Patient reported that he had difficulty hearing. Patient sat in the chair and then lost conciousness. He was laid down on the ground, vitals were checked, and water was given. Noted high blood pressure. Patient regained conciousness within 3-5 minutes. Vitals were rechecked and returned to normal.
47 2021-04-22 influenza like illness, chills Flu-like symptoms; muscle aches; chills; more soreness at administration site than a normal injectio... Read more
Flu-like symptoms; muscle aches; chills; more soreness at administration site than a normal injection
47 2021-04-23 fatigue, headache, chills Swelling under left arm with some tenderness, chills headache, fatigue. Patient had COVID 6 weeks p... Read more
Swelling under left arm with some tenderness, chills headache, fatigue. Patient had COVID 6 weeks prior to this presentation. Patient given normal saline IV fluids. Clinical impression is cellulitis. Patient is discharged home from ER and given a prescription for cephalexin
47 2021-04-24 malaise Pain at the site of Injection; Feeling unwell; This is a spontaneous report from a contactable other... Read more
Pain at the site of Injection; Feeling unwell; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 09:15 and the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via an unspecified route of administration in left arm on 27Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patient medical history included mild seasonal allergies. The patient not had COVID prior vaccination. The patient had no known allergies. Concomitant medication received in two weeks was included loratadine (CLARITINE). The patient did not receive any other vaccine in four weeks. On 18Feb2021 at 20:30, patient experienced Pain at the site of Injection and feeling unwell. The patient was not tested COVID post vaccination. Therapeutic measures were taken as a result of events and included treatment with Tylenol. The outcome of the events is recovering.
47 2021-04-25 chills On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogg... Read more
On Saturday, April 24, around noon, I heard a ringing in my right ear, then it clogged up. The clogged sensation changes depending on how much I move around, but it has not gone away. I can clear my eustachian tubes, so whatever it is seems to be further in the ear. I can still hear, it's just muffled in the right ear. The only other adverse reaction I've had was on Monday, April 19, where I had very sore hips/back around 8pm and around 11pm when I went to bed, I had chills as if I had a fever. Those symptoms were gone by the morning of Tuesday, April 20.
47 2021-04-25 headache, fatigue SORE ARM, NUMB ARM, HEADACHE, NAUSER, TIRED, VOMIT.
47 2021-04-26 headache Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on th... Read more
Patient complained of getting hot. While sitting in the chair, he fell to ground, hitting head on the back of the chair. This patient was evaluated by EMT and Nurse. Patient denies double or blurred vision, nor nausea or vomiting, nor headache, nor dizziness, but some soreness at back of head. No noted swelling at this site. At 3:44 pm, vitals were: O2 sat 97%, B/P 110/60, HR 86, R 20. Offered water and tolerated well. Patient's family accompanied him to this event. At 4:07pm, vitals , O2 sat 99%, B/P 112/68, HR 86, R 20. At 4:26 pm, paramedics were called, and arrived, and evaluated patient. Vitals now, O2 sat 100%, B/P 125/73, HR 76, R 20. Paramedics deemed patient stable to go home. At 4:35 pm, patient released to go home with family.
47 2021-04-27 chills, headache Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremul... Read more
Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.
47 2021-04-27 chills, fever, fatigue Involuntary sleep; muscle pain; chills; feels feverish; Joint pain; Back pain; Exhaustion; This is a... Read more
Involuntary sleep; muscle pain; chills; feels feverish; Joint pain; Back pain; Exhaustion; This is a spontaneous report from a contactable consumer or other non-health care professional.A 47-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Feb2021 17:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunization. Medical history was reported as none. Concomitant medications included testosterone and HGH. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab, rapid covid test which was negative and PCR test which result was pending. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products were reported as none. On 28Feb2021 at 15:00, the patient experienced involuntary sleep, joint and muscle pain, back pain, exhaustion, and chills which are constant & for a couple of weeks now. Patient had No fever but feels feverish. Patient had not received any treatment for the events. The patient had not yet recovered from the events. No follow-up attempts are possible; no further information expected.
47 2021-04-27 headache, fatigue Nausea, Vomiting, head ache, injection site raised, fatigue, body aches
47 2021-04-28 throat redness, throat pain, chills 11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat fe... Read more
11:30 Shot administered at drive thru site 11:40-50 Feeling mild tingling on lips, back of throat feels dry, getting the urge to pass stool. In the mirror I see the arches around the uvula swollen and red 11:50 Inform the nurse. Body starts shivering, talking and breathing is labored- according to my wife my voice sounded very different. Nurse checks lungs through stethoscope and SPO2+ heart rate- All normal, does not detect any constriction of lung air passages. But I am panting while talking. 11:55 I decide to wait and monitor. Shivering slowly stops, breathing slowly starts to return to normal (in about 20 mins). The urge to pass stool stopped. 12:22 No change either way- Breathing is ok, but mild tingling around lips, and feeling of tightness at back of throat. I take 5mg Cetrizine HCl. [Note: My mouth and throat felt like I have felt in the past with a reaction to shellfish.] 1:15 Redness at back of throat is less, and I feel normal. I drive off the parking lot of the vaccination site Next day Throat feels sore, but otherwise ok
47 2021-04-30 headache, fatigue, chills, fever Tested positive for COVID; Chills; Headache; Tiredness; Fever; This is a spontaneous report from a c... Read more
Tested positive for COVID; Chills; Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unspecified (EN6205 or EW6205) intramuscular, administered in left arm on 24Mar2021 at 16:30-17:00, as single dose (also reported as 0.3) for COVID-19 immunisation. Medical history included high blood pressure. The patient was taking an unspecified concomitant medication for high blood pressure and was taking that prior to getting the vaccine. On 25Mar2021, the patient experienced chills, headache, tiredness and fever the day after getting the vaccine. On 05Apr2021, 13:30-14:00, the patient tested positive for covid. He tested positive and his wife also tested positive for COVID. He went and got tested not this past Monday, but last Monday. He later stated his wife received the Moderna vaccine and he did not have any other information to provide. The patient went to the physician's office to get COVID test on 05Apr2021. The patient had no additional vaccines administered on the same date as Pfizer vaccine. The patient had no prior vaccinations (within 4 weeks) and no events following prior vaccinations. He was supposed to take second shot after 14Apr2021. He would like to know if he can still get it or if he needs to wait. Outcome of event tested positive for COVID was recovered on an unspecified date; and outcome of the rest of events was recovering. Information on the lot/batch number has been requested.
47 2021-04-30 fever Missed second dose of Covid-19 vaccine on 17Apr2021; one week later I was positive for Coronavirus; ... Read more
Missed second dose of Covid-19 vaccine on 17Apr2021; one week later I was positive for Coronavirus; Fever; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, administered in left arm on 27Mar2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy (allergies 5 years ago). He reported that he was supposed to be getting the allergy injections for 3 years to be immune because allergy season was really bad for him, especially with pollen. He reported that he gets allergy injections every week in his arms. Concomitant products allergy injections: he began getting weekly allergy injections about 18 months ago. No Additional Administered Vaccines. No adverse event following prior vaccinations. On 07Apr2021, the patient experienced fever. On 08Apr2021, one week later he tested SARS-CoV-2 test: positive. He had a phone consultation with his physician after testing positive for Covid-19. He was supposed to be going for his second dose on 17Apr2021. Patient missed second dose of Covid-19 vaccine. He asked my doctor and she said she didn't know when he could get his second dose. They told me him had to call Pfizer. He missed second dose of Covid-19 vaccine. The events assessed as non-serious. On 10Apr2021, the event fever was resolved. On Monday, 19Apr2021, he went to get checked again for Covid-19 and he tested negative. He reported that he just recovered from the coronavirus last week. The outcome of the event tested positive for coronavirus is recovered on an unspecified date in Apr2021 and fever was recovered on 10Apr2021, missed dose was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-05-01 chills, influenza like illness, fatigue i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; ach... Read more
i was sick with flu like symptoms; i was sick with flu like symptoms; chills; hot; cold flashes; achy; i am extremely tired; This is a spontaneous report from a contactable consumer (reported for himself). This 47-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 17Apr2021 09:00, as a single dose for covid-19 immunization. The patient did not have any medical history or allergy to medications, food or other products. Concomitant medications were not reported. He received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Batch/Lot number: EP6955) via an unspecified route of administration at left Arm on 27Mar2021 09:00, as a single dose for covid-19 immunization. On 18Apr2021 07:00, he was sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He did not receive any treatment events. He did not visit doctor or other healthcare professional office/clinic or emergency room/department or urgent care. He did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was recovering from the events of sick with flu like symptoms, chills, hot, cold flashes, achy and felt extremely tired. He was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.
47 2021-05-01 fatigue, chills, headache, fever Fever, chills, muscle and joint pain, headache and fatigue.
47 2021-05-01 headache Shingles on head ,bad headaches.... prednisone 20mg...gabapentin 300 mg....valacyclovir hcl 1 gram t... Read more
Shingles on head ,bad headaches.... prednisone 20mg...gabapentin 300 mg....valacyclovir hcl 1 gram tablet
47 2021-05-02 headache, sweating, chills I received my 2nd dose of the Pfizer vaccine on April 1 2021 around 8:00 a.m. At approximately 8:00 ... Read more
I received my 2nd dose of the Pfizer vaccine on April 1 2021 around 8:00 a.m. At approximately 8:00 pm. I went to bed, within 1 hour I started having chills, within 2 hours I started sweating. Within 3 hours of going to bed I started vomiting every hour on the hour, until 8:00 a.m. on April 2nd 2021. During that time, my temperature got to 102.5...The sweating and chills, lasted until April 4th 2021, with my temperature getting down to 96.5...During this time and the next 2 weeks, I've had headaches on & off for about a month now. Today, I actually have pain in the injection site, after 1 month of getting the shot, not sure if this is normal?
47 2021-05-02 sweating Pt Pt became pale & diaphoretic, losing conciousness for 2-3 seconds. Transported to Observation Ar... Read more
Pt Pt became pale & diaphoretic, losing conciousness for 2-3 seconds. Transported to Observation Area. BP 118/72 P60 R16. Says has a history of fainting with IV's. Pt stabilized & released & he notified wife that he was coming home.
47 2021-05-03 chills passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a sponta... Read more
passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.
47 2021-05-03 malaise Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermi... Read more
Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology
47 2021-05-04 fatigue, chills, headache, sweating chills and sweats, headache, fatigue, and diarrhea
47 2021-05-04 fatigue, chills, influenza like illness Felt fatigue and chills all day. It felt like the onset of the flu. Reporting this only for data c... Read more
Felt fatigue and chills all day. It felt like the onset of the flu. Reporting this only for data collection. Felt fine the next day.
47 2021-05-04 headache, fatigue Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose;... Read more
Slight headache; Right arm was sore where shot was; Little tiredness; Arm swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:15 (Batch/Lot Number: EN6198) at the age of 47-years-old as single dose for covid-19 immunization (reported as 'protection for self and others'). Medical history included ongoing Fibroneuropathy, he had it in his feet, started after low back surgery 30 years before in 1991, L5 fractured, had 2 rods and 4 screws into low back, ongoing tremors both arms and hands, mainly left started in high school when first he first noticed, ongoing high blood pressure started in early 2000s, ongoing high cholesterol started in early 2000s, and patient had been on social security disability since 2014 and ongoing. The patient's concomitant medications were not reported. The patient experienced slight headache, right arm was sore where shot was, little tiredness, arm swelling after first dose on 17Mar2021. The outcome of the event headache was recovered on 17Mar2021 with duration of 15 minutes, the outcome of the other events was recovered on 19Mar2021. No follow-up attempts are needed. No further information is expected.
47 2021-05-04 headache Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. ... Read more
Within 72 hours, constant ringing in ears, headaches, slight vertigo and nausea, trouble focusing. Ringing and headaches persist to this day. -Antibiotic as well as Claritin and Flonase prescribed with no change in symptoms.
47 2021-05-04 fever Around 6 PM Same day felt dizzy and checked my blood pressure and read sys 208/ dia 104/ pulse 105 ... Read more
Around 6 PM Same day felt dizzy and checked my blood pressure and read sys 208/ dia 104/ pulse 105 . Rested called doctor and he prescribed Amlodipine besylate 5 mg tab.blood pressure stood high until 8 pm. So from 6 pm to 8 pm uncomfortable and high average 181/101/108 . At 8 pm blood pressure read 153/98/92 and that?s when I took 1 pill from doctor prescribed. Over evening and night had body temperature around 37.2-37.5 C. Feeling low fever. Morning at 7 am things improved blood pressure is 138/91/92 still had low fever 37.2C. Reporting currently my status to my doctor. Consultation with doctor was over the phone.
47 2021-05-05 headache, nasal congestion, cough Patient received 2 doses of COVID-19 vaccine. On 4/21/21 developed body aches, headache, cough, and... Read more
Patient received 2 doses of COVID-19 vaccine. On 4/21/21 developed body aches, headache, cough, and nasal congestion. Tested positive for COVID.
47 2021-05-06 fatigue, dehydration Severe diarrea and vomiting that begin late on Day 2 after receiving the second Pfizer covid-19 vacc... Read more
Severe diarrea and vomiting that begin late on Day 2 after receiving the second Pfizer covid-19 vaccine dose. Conditions lasted for over 36 hours. Drinking any liquids including water to stay hydrated during this time was not possible. Plain water created a severe gastro reaction too. Slowly recoved by going on a liquid diet on Day 4 and small bites of solid food Day 5. Week long body fatigue and dehydration as well.
47 2021-05-06 headache, fatigue Lingering, ongoing, and severe: Headaches, Brain Fog, Nausea, Fatigue
47 2021-05-07 chills, fever, headache, fatigue No immediate effects other than soreness at the injection site on Wed 4/28. Upon waking on Thurs 4/... Read more
No immediate effects other than soreness at the injection site on Wed 4/28. Upon waking on Thurs 4/29, I had a fever of approximately 99.5F. Took acetaminophen afterwards for the next 24/48 hours as the fever steadily rose throughout the day peaking at approx 102F around 5 pm. Also developed chills, fatigue, all over muscle soreness, a headache, and nausea. Overnight 4/29 into 4/30 was pure misery but by 4/30 a.m. the fever starting to break. Took pain relievers and antacids(for the nausea) through Sat 5/1.
47 2021-05-08 chills, headache, fever Fever chills body ache no energy head ache
47 2021-05-08 chills, fever Fever chills body ache 1 week after first shot
47 2021-05-09 cough, chills, fever, headache, fatigue Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive hea... Read more
Light headed, dizzy night of shot. Went to bed. 400 am fever and shivers for 5 hours. Massive headache. Lymph nodes and testicles swelled. All pounded to my heart beat. Kept taking Tylenol and didn?t seem to matter. Last for 5-6 hours. Massive headache continued...tired but hard to sleep sleep and in zombie like state. Woke up Friday feeling a little better. Went downhill about 5pm Friday. Headache returned. Tired and couldn?t sleep much. Brain in fog. Went to bed. Woke up with headache on Saturday. A wave of fatigue came over Saturday around 3pm. Tried to nap but couldn?t sleep. Persistent dry cough developed Saturday night. Lasted through Sunday. This is all to the best of my recollection.
47 2021-05-09 fatigue tired, aching, nausea
47 2021-05-09 throat pain, fever Hives around many areas of body including torso, legs, hands, feet, face. Low grade fever. Body ache... Read more
Hives around many areas of body including torso, legs, hands, feet, face. Low grade fever. Body aches. Sore throat.
47 2021-05-10 headache generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Gl... Read more
generalized convulsion/second seizure witnessed by medical staff; elevated CSF protein to 79, CSF Glucose 73; elevated CSF protein to 79, CSF Glucose 73; severe headache; confused; This is a spontaneous report from a contactable physician. A 47-years-old male patient received the first dose of BNT162B2 (PFIZER COVID 19 VACCINE), intramuscular on 22Apr2021 09:30 (Batch/Lot number was not reported) at age of 47 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had been tested for COVID-19. On Friday 23Apr2021, patient woke up with severe headache, per wife was confused. Then had a generalized convulsion. Presented to the ED, had a second seizure witnessed by medical staff. Workup with MRI, CTA and LP were notable for an elevated CSF protein to 79, CSF Glucose 73, otherwise no structural abnormality was identifed. Patient was clinically improving after being treated with seizure medications as of 26Apr2021. The adverse event result in Emergency room/department or urgent care, hospitalization. Covid 19 pcr nasal swab on 24Apr2021 was negative. Outcome of events was unknown. Follow-up needed. Information about batch/lot number has been requested.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect product BNT162B2 to the reported event seizures, CSF glucose increased, CSF protein increased, headache, confusional state cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
47 2021-05-10 fever, cough, headache cough, headache, fever and generalized body aches.
47 2021-05-10 fever, sweating, headache, fatigue, chills Fever; Nausea; Vomiting; No appetite; Chills; body ache; Headache; Excessive sweat; Difficulty breat... Read more
Fever; Nausea; Vomiting; No appetite; Chills; body ache; Headache; Excessive sweat; Difficulty breathing; Hyperventilation; Exhaustion; This is a spontaneous report from a contactable consumer (patient, reported on himself). A 47-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318 and expiration date not provided), via an unspecified route of administration in left arm on 01Feb2021 04:30 PM, as a single dose for covid-19 immunization. Medical history included depression, COVID in late Nov2020, she had two tests for COVID which were found to be negative. She was allergic to Fructans. Concomitant medications in two weeks included vortioxetine (Trintellix), esketamine hydrochloride (Spravato), rosuvastatin calcium (Crestor), Saw palmetto (SERENOA REPENS) Saw Palme and Fish Oil. 02Feb2021 Tuesday 09:00 AM, the patient experienced symptoms 85 percent similar in type and intensity to when she had Covid in late Nov2020. Beginning with fever 99-101 until Saturday. She also had nausea and vomiting. She had no appetite (no food Tuesday till Saturday). She experienced chills, body ache, headache, excessive sweat, difficulty breathing, hyperventilation and exhaustion. The patient did not receive treatment for the events. He did not have any other vaccine in four weeks. The patient was not tested for covid tested post vaccination. Vaccine facility type: Public Health Clinic/Administration facility. The outcome of the events was recovering. Information on batch/lot number has been requested.
47 2021-05-12 cough, fatigue, throat pain Onset of dry cough, moderate chest congestion, afternoon fatigue, and mild sore throat 1 day after r... Read more
Onset of dry cough, moderate chest congestion, afternoon fatigue, and mild sore throat 1 day after receiving 2nd dose of Pfizer COVID-19 vaccination on 01-May (8 days now).
47 2021-05-12 headache neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from... Read more
neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old) as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.
47 2021-05-12 fever Fever, 102 degrees. Muscle aches through body.
47 2021-05-16 headache Headache and body aches beginning the day after the second dose of the vaccine. The body aches were... Read more
Headache and body aches beginning the day after the second dose of the vaccine. The body aches were mild and subsided within 24 hours, but the headache persisted for more than a month.
47 2021-05-18 cough, fever Fever cough
47 2021-05-19 fever Patient positive for COVID-19 on 04/08/21 after completing vaccination. On 4/8 Patient directly admi... Read more
Patient positive for COVID-19 on 04/08/21 after completing vaccination. On 4/8 Patient directly admitted with fever of unknown origin, found to be COVID +, started on Remdisivir, on 4/9 ID consulted and recommends - Patient should have his remdesivir stopped, and should be started on casirivimab/imdevimab.
47 2021-05-20 fever Illness >> May 3, 2021 11:52 AM reporter wrote: Does the patient have current symptoms of illness?... Read more
Illness >> May 3, 2021 11:52 AM reporter wrote: Does the patient have current symptoms of illness? Yes Date symptoms started: 04/29/21 1. Does the patient have a fever (subjective or confirmed)? Yes (not currently) 2. Does the patient have a new onset of cough? No 3. Does the patient have a new onset of shortness of breath? No Patient is also experiencing runny nose and sneezing He did have first Covid-19 vaccine on 04/23/21 Please advise on scheduling Thank you
47 2021-05-21 headache Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next w... Read more
Woke up 12 hours after second shot at 3:30 in the morning. Was not able to sleep well for the next week. Had a prolonged headache. All of that eventually cleared but the lasting change is I now have tinnitus. It is constant and it does not go away.
47 2021-05-23 sweating Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, wea... Read more
Patient had become extremely paleness, sweating, coldness of the hands, light headed, dizziness, weakness, shaky like trembling sign of minor seizures.
47 2021-05-23 sleepiness, lethargy 1) Extremely sleepy - began the same evening as vaccination (5/7/21) and continues through current d... Read more
1) Extremely sleepy - began the same evening as vaccination (5/7/21) and continues through current date and time - fell asleep on the job while operating forklift the following night (5/8/2021); 2) Eyesight has worsened (depth perception, double vision) - began within a couple days of vaccine and continues through current date and time - had eye exam (5/18/21) needed new prescription - previously always near-sighted, now needs bi-focals; 3) Confusion/lack of concentration - began 5/9/21 and continues through current date and time; 4) Abnormally "lazy"/unmotivated - began 5/9/21 and continues through current date and time; 5) Little interest in sexual relations - began 5/9/21 and continues through current date and time; 6) Seems distant/ somewhat despondent - began 5/9/21 and continues through current date and time; 7) Generally speaking he is not himself
47 2021-05-25 dehydration, fatigue nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely ... Read more
nausea; vomiting; diarrhea; rapid heart rate; severe dehydration; unable to eat or drink; Extremely fatigued all day; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 28Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included spinach allergy, UC (Ulcerative colitis). Concomitant medication included mesalamine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 47 years old, administered in arm right on 07Apr2021 12:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 29Apr2021 01:00, less than 24 hours of second vaccine there was nausea, vomiting, diarrhea and a rapid heart rate and severe dehydration. This progressed and led to hospitalization from Saturday 01May2021 to 04May2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient also experienced unable to eat or drink and extremely fatigued in 2021. As of this message (10May2021), still unable to eat or drink without vomiting and hear rate up to 170+. This was up from a normal resting heart rate of near 60. Extremely fatigued all day, vomit several times per day and loose stool to diarrhea multiple times per day. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19, covid-test (blood test) on 02May2021: negative. Treatment was received for all events. The outcome of the events was not recovered. Information about batch/ Lot number has been requested.
47 2021-05-25 fatigue The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to deve... Read more
The Covid vaccine was given April 20 of 21 within eight days of having the vaccine I started to develop shortness of breath fatigue chest pain, I ended up at our local emergency room and was admitted with pulmonary embolism, blood clots in both lungs I stayed a total of three days hospitalized.
47 2021-05-25 fever, headache, malaise fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; ... Read more
fever keeps going up; 1st it was 99, then 100 and then 101; headache; body aches; Not feeling well; weak; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on 13May2021 at 15:00, (at the age of 47-years-old) at 1ST DOSE single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever and it kept going up, 99 at first, then 100 and then 101, had headache, body aches, not feeling well and weak in May2021 after the first dose. He stated he just took two pills of Tylenol Extra Strength. Treatment was given for the events. Patient wanted to know if it was normal to have a fever and other symptoms and how long it would lasts. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-05-26 sleepiness, fatigue swollen glands in right armpit, exausted,slept for 16 hrs two days after shot
47 2021-05-27 fatigue, headache Got dose 2 on 04/16/2021 and had soreness at the injection site for several days, Not much else init... Read more
Got dose 2 on 04/16/2021 and had soreness at the injection site for several days, Not much else initially - Headache and fatigue on day 1&2 and a few sparse and self resolving episodes of ringing in ears in the weeks that followed and the occasional light headache or itching sensation at the site of the injection. Woke up on 05/16/2021 with persistent high pitched tinnitus have seen an urgent care doc and ENT and Audiologist since all to no avail or relief. The condition persists and may be permanent at this point they don't know.
47 2021-05-28 fatigue, malaise Tired, body aches, malaise for 6 hours
47 2021-05-28 headache He has a major headache; dizziness; nausea; This is a spontaneous report from a contactable consumer... Read more
He has a major headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in right arm, on 01Mar2021 at 14:15, as single dose, for COVID-19 immunization. The patient medical history and concomitant medication were not reported. No vaccine was taken in four weeks. Prior the vaccination, was not diagnosis with COVID-19. post vaccination, no COVID test was performed. On 01Mar2021 at 14:30, patient experienced major headache, dizziness and nausea. No treatment was received for the events. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-05-28 fever, fatigue, headache I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over acc... Read more
I have diarrhea; intense body aches all over accompanied with fever; intense body aches all over accompanied with fever; didn't have an appetite; I had a splitting headache; arm felt heavy like it was falling asleep; pain at the injection site that I expected and radiated down to my wrist.; pain at the injection site that I expected and radiated down to my wrist.; he had pain in his shoulder, arm and forearm down to his wrist; he had pain in his shoulder, arm and forearm down to his wrist; His hand on the left side (on the injection site arm) felt very cold; He is tired and exhausted too; This is a spontaneous report from a contactable consumer reporting for himself. This is one of the two report from same reporter. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (Batch/Lot Number: EW0179; Expiration Date: Aug2021) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021, within a half hour after vaccination the patient arm felt heavy like it was falling asleep and recovered on the same day (reported as His arm felt heavy for 3 hours). Eventually that turned into pain at the injection site that he expected, and the pain radiated down to his wrist. On 30Apr2021, he had a splitting headache for a couple days. On 02May2021, reported as the next couple days he experienced intense body aches all over accompanied with fever. Also, he didn't have an appetite. The outcome of the event splitting headache was recovered on 02May2021. Reported as "today he still doesn't feel 100%". On 03May2021, he had diarrhea (reported as Yesterday and today). He did not have a prescribing doctor. He went to the clinic from the local health department. The body aches were starting to go away. He kept himself informed and up with the science, but he was just mostly concerned the effects have lasted this long. On an unknown date in 2021, he had pain in his shoulder, arm and forearm down to his wrist. His hand on the left side (on the injection site arm) felt very cold. It felt as though it was not having the circulation it should. As that went away, he could feel the pain in the injection site. He had a splitting headache that lasted Friday, Saturday, and Sunday. He recovered completely. He didn't normally get headaches. He was tired and exhausted too on unknown date in 2021. It was reported that, he didn't typically take naps, but he took a nap yesterday. His stomach feels a little better, but yesterday and today he did have diarrhea. He was a very healthy person. The injection site pain has gone away on unknown date in 2021. The body aches are starting to go away (recovering). On an unknown date in 2021, the events wrist pain recovered. On an unknown date in May2021, the patient recovered from the event fever. The outcome of the event diarrhea was recovering. The outcome of the events decreased appetite, pain in his shoulder, arm, and forearm down, felt very cold, and tired and exhausted was unknown. No follow-up attempts are needed. No further information is expected.
47 2021-05-30 headache, chills, fatigue, fever 12 hours after shot and a period at least 36 hours had fever between 99.5 and 100.3, chills, headach... Read more
12 hours after shot and a period at least 36 hours had fever between 99.5 and 100.3, chills, headache, muscle and joint pain, fatigue, and diarrhea.
47 2021-05-31 cough, chills, fatigue, nasopharyngitis, sneezing Two days after my second dose, I became sick for 7 days. The symptoms came on immediate, chronic cou... Read more
Two days after my second dose, I became sick for 7 days. The symptoms came on immediate, chronic coughing and sneezing, head cold symptoms, fatigue, chills with no fever. The symptoms ended immediate after seven days. I though it could be seasonal allergies; however, I have never had seasonal allergies with this strength and duration.
47 2021-05-31 fatigue, nasal congestion, runny nose This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient r... Read more
This is a spontaneous report from a contactable consumer (patient). This 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the right arm, on 23Feb2021 12:45 (at the age of 47-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Dec2020. The patient did not have concomitant medications. On 01Mar2021, the patient developed runny nose, congestion, a little bit of weakness and tired. He said he felt like he did when he had the COVID-19 virus in Dec2020. He said when he had the COVID-19 Virus in Dec2020, he had the virus for a few days, and the virus was not bad. He clarified he had the COVID-19 Virus for like 10 days total. He clarified he had a runny nose, congestion, a little bit of weakness, and was tired. He said today (on 02Mar2021) his symptoms were not as strong as yesterday, clarifying his symptoms were down by maybe 20% from yesterday. He took some liquid dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) for his symptoms. The events did not require emergency room visit/physician office visit. The patient was recovering from the events. No follow-up attempts are possible; information about Lot/Batch number cannot be requested.
47 2021-06-01 chills, fatigue, headache Next day: debilitating fatigue, headache. Nausea and chills. Slowly going away, but its been 6 weeks... Read more
Next day: debilitating fatigue, headache. Nausea and chills. Slowly going away, but its been 6 weeks and still have the symptoms, just not as severe. It is preventing me from exercising and doing activities and eating like I normally would.
47 2021-06-01 fatigue Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spont... Read more
Extreme body and joint aches; joint aches; extreme fatigue/ very tired; cold sweats; This is a spontaneous report from a contactable consumer (patient). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 09:00 (Batch/Lot number was not reported), age at vaccination of 43-years-old, as single dose, for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient previously took nitric oxide and experienced hypersensitivity, received BNT162B2 dose 1 administered in Arm Left on 03Feb2021 01:00 PM (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme body and joint aches, extreme fatigue, cold sweats and was very tired, all on 24Feb2021. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
47 2021-06-01 sweating Post COVID vaccination, the patient started to seem sweaty; increased HR (117), elevated BP (174/93)... Read more
Post COVID vaccination, the patient started to seem sweaty; increased HR (117), elevated BP (174/93). The patient declined Benadryl and continued to have her feet up on the recliner. Around 02:45 pm, the patient walked out of the clinic without dizziness.
47 2021-06-03 sweating Patient became diaphoretic, pale, hypotensive, BP dropped to 86/ 43, HR: 41 SaO2: 98%. patient was p... Read more
Patient became diaphoretic, pale, hypotensive, BP dropped to 86/ 43, HR: 41 SaO2: 98%. patient was placed in a Trendelenburg position, O2 via nasal canal at 2 liters per min. administered IV line with normal salin given. BP recovered ( 137/94) he was transferred to ED in stable condition
47 2021-06-06 fatigue Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn of... Read more
Severe exhaustion. After 3 weeks I got a B12 shot at recommendation of doctor. Benefit has worn off and I need to get another B12 shot. I went from running for an hour after work every day to having to take an hour nap after work if I want to make it through dinner.
47 2021-06-09 headache, fatigue Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-years... Read more
Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 16Mar2021 at 09:30 (at an age of 47-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration on 23Feb2021 at 09:30 (at an age of 47-years-old) as single dose for COVID-19 immunisation. On 17Mar2021, the patient experienced fatigue and headache. The patient didn't receive treatment for the events. The clinical outcome of fatigue and headache were recovered on an unknown date in Mar2021. Information about lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
47 2021-06-09 fever, headache, fatigue Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feveri... Read more
Blood pressure and it was 179/91/still 150 over 70 over 69 which is quite high for me; I felt feverish; Rash with bumps on my forehead/Broken out rash, turned red; Face was red; Heart rate has also been high; Head hurt; My arm was a little sore; I was a little tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8736), via an unspecified route of administration on 30Apr2021 (at the age of 47 years) as a 2nd dose, single dose for COVID-19 immunisation. The patient medical history included over active autoimmune disease, Rheumatoid arthritis. The patient concomitant medication included adalimumab (HUMIRA, Lot number and expiration date was unknown) 0.4 ml, once a week, a shot in his belly or leg all around for rheumatoid arthritis and Methotrexate (Lot number and expiration date was unknown) 2.5mg, took 6 of them once a week for rheumatoid arthritis and autoimmune. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8731), via an unspecified route of administration on 09Apr2021 as a 1st dose, single dose for COVID-19 immunisation. On 30Apr2021, the patient at first experienced arm was a little sore and little tired. On 04May2021, patient felt bad, felt feverish. On Wednesday, he got a rash with bumps on his forehead. The BP was 179/91. Heart rate has also been high and this morning BP was 150/71. Patient was send home from work and he was feeling that from two days after he got the shot but it's been couple of days ago. The patient went in upstairs and then was sent to medical to that they said his face was red, "I didn't look like, look good" and took blood pressure and it was 179/91 and patient was sent home and told to stay home today (06May2021). Patient called his doctor and he said 'it would be risky' for a couple of days. This morning my blood pressure has come down some but it was still high, it wasn't near high as it was, run like 129, 130 over 58 or some like that and this morning it was still 150 over 70 over 69 which is quite high. But it has still come down a lot that's the reason patient called the doctor and he said take it easy, stay out of sun don't work stay at home and her said if you want to call Pfizer call them. The events have improved since yesterday, patient kept thinking he was running fever because his head hurt. But it started on Tuesday and it was Wednesday when someone sent me when the second time patient had broken out rash again and it has turned red. But yesterday (05May2021) it was 170 and 150 is way better today (06May2021. Patient informed that as directed he did not to take his medications, the Methotrexate and Humira. He did not take it within 7 days of taking the shot because he was told not to take it within 7 days of taking the shot, so he got off the medicine for the shot. The patient went for one actually two weeks ago or three weeks ago for his heart checkup and all that stuff, everything was fine, cholesterol was fine, everything was good. The outcome of the events was recovering. Follow up (06May2021 and 06May2021): This is a follow up spontaneous report from a contactable consumer (patient): Added product details (Expiry date, lot details), Concomitant drug details, events (face was red, broken out rash, turned red, blood pressure was 179/91/ run like 129, 130 over 58 or some like that and this morning I was still 150 over 70 over 69 which is quite high for him, fever, head hurt), reporter's comments and clinical course and narrative was amended accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
47 2021-06-10 chills, fever, headache, fatigue Fever; chills; body aches; headache; fatigue; loss of appetite; This is a spontaneous report from a ... Read more
Fever; chills; body aches; headache; fatigue; loss of appetite; This is a spontaneous report from a non-contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 10Mar2021 at 14:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 19Fewb2021 at 12:30 pm (lot number EL3248) on left arm. Relevant medical history included Asthma, seasonal allergies, hypertension and Shellfish allergy. Concomitant medications included lisinopril and lansoprazole. On 11Mar2021 at 09:00 am the patient experienced fever, chills, body aches, headache, fatigue and loss of appetite. No treatment was received for the events. The patient recovered from the events on 12Mar2021. No follow-up attempts are possible. No further information is expected.
47 2021-06-10 malaise, sluggishness Wasn't feeling great after first vaccine; sluggish; This is a spontaneous report from a contactable ... Read more
Wasn't feeling great after first vaccine; sluggish; This is a spontaneous report from a contactable consumer (patient's wife). A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7533; Expiration Date: Jul2021), via intramuscular route of administration in Arm Left on 11Apr2021, as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient doesn't take any medication, doesn't drink or do drugs, he was a very healthy person. Patient has nothing and that's what was so strange, Patient was a tall, healthy person. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that he wasn't feeling great after first vaccine and sluggish. The patient underwent lab tests and procedures which included covid-19: and influenza: negative on 25May2021. The outcome of the events was unknown. Information on Lot/Batch number is available; Further information has been requested.
47 2021-06-11 headache, fatigue Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins... Read more
Headache 3 weeks, severe fatigue 3 weeks. Immediate reaction numbness in extremities, bulging veins in hands, increased heart rate.
47 2021-06-13 fever, cough, fatigue i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 day... Read more
i) Pain in left arm and shoulder started same evening. Lasted 3-4 days ii) High fever for next 2 days. Temperature was as high as 102 iii) Dry coughing and breathlessness iv) Ongoing asthma attacks and breathlessness. Started the day after second shot. v) General feeling of tiredness and lack of focus. (Ongoing)
47 2021-06-16 chills About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and mus... Read more
About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; About 02:30 am on 17 Mar 2021, I began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17 Mar, they resolved with the use; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199), via an unspecified route of administration, on 16Mar2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization, administered at clinic. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN5318), administered on 24Feb2021 at 10:45 AM (at the age of 47-year-old) at single dose for COVID-19 immunization. No relevant medical history was provided. Relevant concomitant medications included escitalopram, allopurinol, vitamin D NOS, and folic acid. About 02:30 am on 17Mar2021, he began to experience chills as well as upper extremity joint and muscle pain. The events continued during the day. As of 19:51 hrs on 17Mar2021, they resolved with the use of ibuprofen. No follow-up attempts are needed. No further information is expected
47 2021-06-16 fatigue, chills, fever, headache, nasal congestion, malaise difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weaknes... Read more
difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
47 2021-06-17 fever, chills Pt reported reaction to first dose of fever chills and skin break out on LLE. Client presented with ... Read more
Pt reported reaction to first dose of fever chills and skin break out on LLE. Client presented with open circular lesions from rash on the Left lower leg with no complaint of pain nor discomfort at this time. 2nd dose administered on left arm. Vitals WNL and client remains stable at this time.
47 2021-06-23 fatigue Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when ... Read more
Heart Attack. A feeling of burning in my arms and mouth of the stomach, in addition to fatigue when walking, started on June 12, 2021. I never had such pain before and thought it's just a stomach virus or so. As the pain continues, I called my primary-care Dr. early morning of June 17 and scheduled appointment for a week later. But around 9:30 pm that day, June 17, the pain became so severe, in addition to nausea and shortness of breath. I went to emergency room and have been told that there is acute heart attack in progress and was moved to the Critical Care Unit in the Heart and Vascular Center. A blockage has been removed and a stent was installed in morning of June 18, through heart catheterization procedure. As there was damage to the heart muscle due to the heart attack, I am supposed to go back later, in 4-6 weeks, to remove couple more blockages and install stents.
47 2021-06-24 fatigue Fatigue and Dizziness 24 hours after dose. Resolving without care
47 2021-06-24 malaise, sweating Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated li... Read more
Patient came in to receive his first Pfizer vaccination. The patient was signed up and vaccinated like normal. About 5 minutes after administering the vaccine to the patient, he stood up and came to the window to tell the technician on duty that he was not feeling well. He appeared sweaty and pale. The technician immediately advised the patient to sit down and called for the pharmacist on duty. The pharmacist went into the vaccine area and when she reached him, he went into a seizure-like state. He was foaming at the mouth, his hands were spasming, and he went stiff. The technician immediately called 911 and advised them of the situation. The employees stayed with the patient until the emergency services arrived approximately 7 minutes later.
47 2021-06-24 fever, nasopharyngitis Fever; Cold; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 47 ... Read more
Fever; Cold; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 47 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00, (at the age of 47 years old) as a single dose of COVID-19 immunisation. The patient had no medical history. Concomitant medications include TYNALOL from unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) (at the age of 47 years old), via an unspecified route of administration in the left arm on 07Apr2021 at 17:00, as a single dose of COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 19:00 the patient experienced fever, cold and dizziness. The clinical outcome of fever, cold and dizziness was not recovered. No follow-up attempts are possible needed ; information about lot number cannot be obtained.
47 2021-06-25 sweating After receiving the vaccination, patient experienced nausea , dizziness and sweating. He was in... Read more
After receiving the vaccination, patient experienced nausea , dizziness and sweating. He was instructed to lay down. Ambulance was called. Upon evaluation by the paramedics, patient's vital signs were stable, but the patient asked to go to the hospital for further evaluation.
47 2021-06-27 headache Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose Pfizer... Read more
Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose Pfizer 03/24/2021 Lot# ER8727. 2nd dose: Pfizer 04/14/2021 Lot# EW0150. Diagnosed COVID positive: 06/24/2021. Exposure: Home. Symptoms: Headache.
47 2021-06-29 chills, fatigue, headache Chills all day; Headache; injection site pain over 24 hours plus; pain under arm when lifting; Muscl... Read more
Chills all day; Headache; injection site pain over 24 hours plus; pain under arm when lifting; Muscle pain; Joint pain; tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 47years-old-male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ER 8727) via an unspecified route of administration in right arm on 20Mar2021 at 10:00 (at the age of 47 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had unspecified allergies to medication, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient did not have symptoms associated with COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 11:00, the patient experienced chills all day, headache which was gone with 3 hours, vaccination site pain over 24 hours plus, pain under arm when lifting, muscle pain, joint pain, tiredness. The patient was not treated with any medication for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of chills, Vaccination site pain, pain in arm, muscle pain, joint pain and tiredness was recovering and for headache it was recovered on the same day. No follow-up attempts are needed. No further information is expected.
47 2021-06-29 fever Fever (102.7); Rash Left Front forearm; This is a spontaneous report received from a contactable con... Read more
Fever (102.7); Rash Left Front forearm; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on 19Mar2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to PEN (penicillin). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 26Feb2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 15:00, the patient had fever (102.7) and experienced rash on left front forearm. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever (102.7) and rash on left front forearm. The clinical outcomes of the events fever (102.7) and rash on left front forearm were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
47 2021-07-01 headache, throat irritation, sinus disorder, fatigue, chills chills; Headache; body fatigue and aches; body fatigue and aches; Moved on next day to same symptoms... Read more
chills; Headache; body fatigue and aches; body fatigue and aches; Moved on next day to same symptoms I had with covid; Started off as allergy reaction; Scratchy throat; sinuses closed off; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), via an intramuscular route of administration (at the age of 47-years), administered in arm left on 22Mar2021 14:15 as dose 1, single for COVID-19 immunization. Medical history included allergy from only pollens, pet dander, covid-19, allergies from an unknown date and unknown if ongoing. Concomitant medications included cetirizine taken for allergies route: pill from an unspecified start date and ongoing. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient took other vaccine within four weeks which included allergy shot on 17Mar2021. On 23Mar2021 07:00, the day after both shots I had serious body fatigue and aches, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. On 22Mar2021 17:00, the patient stated that he started off as allergy reaction, scratchy throat, sinuses closed off and moved on next day to same symptoms I had with covid. No fever though. The treatment was received for the adverse events included flonase spray for allergies and tylenol. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Dec2020, sars-cov-2 test: negative on Jan2021. The vaccination facility type was reported as public health clinic/veterans administration facility. The clinical outcome for the events body fatigue and aches, chills and a headache was reported as recovered on 24Mar2021 while for other events reported as recovering. Follow-up attempts are completed. No further information is expected.
47 2021-07-05 fever, influenza like illness Tested positive for COVID-19 on 02/05/2021 Became sick with influenza like symptoms accompanied by h... Read more
Tested positive for COVID-19 on 02/05/2021 Became sick with influenza like symptoms accompanied by high fever April, May and June.
47 2021-07-08 respiratory tract congestion "Member got COVID vaccine and noted ringing in both ears. Got 2nd dose 4/20. Ringing started after t... Read more
"Member got COVID vaccine and noted ringing in both ears. Got 2nd dose 4/20. Ringing started after the first, got worse after the second. Is constant. Not sure about hearing loss. Seems worse in left ear by a little bit. No dizziness or vertigo. Was told it could be wax buildup or congestion but does not feel like this No other unusual symptoms. No medication changes noted. No trauma to head Diagnoses and all orders for this visit:
47 2021-07-10 cough, headache Patient c/o dry cough, left sided headache, since returing in may. was seen in ER on 5/17. COVID te... Read more
Patient c/o dry cough, left sided headache, since returing in may. was seen in ER on 5/17. COVID test neg. symptoms improved and patient received I dose of COVID vaccine on 6/4 21. since then c/o constant left sided headache, left eye pain, on/off blurring of vision, severe dry cough. c/o loss of vision in left eye, headaches and feeling "a lot of pressure" for about 3 weeks since receiving the vaccine, sees 2 spots in the left eye that got larger than before. Had 4 episodes of vision in left eye only going black for several seconds, then when vision comes back it is "no good" for 20-30 minutes, last occurrence was 10 days ago. Pt also felt dizzy. patient has a history of stroke. After multiple provider and specialist visits patient was diagnosed with iritis and transient vision loss. Patient received second dose of vaccine on 06/27/21 (both at pharmacy) and reported return of symptoms which resolved as reported on their 06/30/21 follow up with PCP and vision specialist.
47 2021-07-12 headache, chills, nasopharyngitis, fever Cold symptoms; Chills; Fever of 101.5; Body ache; Slight headache; This is a spontaneous report from... Read more
Cold symptoms; Chills; Fever of 101.5; Body ache; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: er8727), via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 47-years-old) at 09:45 as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no allergies to medications, food and other products. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), and digestive enzymes (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 28Mar2021 at 08:00, the patient experienced cold symptoms, chills, fever of 101.5 (unspecified units), body ache, and slight headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcome of the events cold symptoms, chills, fever of 101.5, body ache and slight headache were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-12 headache Slight headache; Brain fog; This is a spontaneous report received from a contactable consumer, the p... Read more
Slight headache; Brain fog; This is a spontaneous report received from a contactable consumer, the patient. A 47-Years old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) as a single dose via an unspecified route of administration in his right arm on 25Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patients medical history was reported as none. Concomitant medications included regular vitamins and tamsulosin hydrochloride (FLOWMAX) received within 2 weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6202) as a single dose via an unspecified route of administration in his right arm on 25Feb2021 at 17:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021, the patient experienced slight headache and brain fog. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes for the events slight headache and brain fog were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-12 fever, fatigue fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness stil... Read more
fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness still; it was much more painful than first shot /excruciating pain in his arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via left arm on 19May2020 as single dose for COVID-19 immunization. The patient medical history included arm pain, fever, achiness, and exhaustion. The patient concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0191, and expiration date was Sep2021), via left arm on 28Apr2021as single dose for COVID-19 immunization. After his 1st dose of the Pfizer COVID 19 vaccination, he called and reported his side effects and now he had received his second dose and he had some questions regarding his side effects. On 19May2021 patient experienced Severe arm pain. It felt as if someone was stabbing him with a large dagger that night and on 20May2021 he had an ugly bruise on his arm, and it was not going away. It been a week and it was still there and on same day had Fever as Persisting. On an unspecified date 2021 patient experienced pain, fatigue, little stiffness, body aches, and He was feeling the excruciating pain in his arm, so he did not want to look, and did not look until the next day, and took a look, removed the band-aid and was surprised, he had some arm pain with the first, but there was no sign of it on his arm with anything. The outcome of event (fever and body aches) was recovered, event of stiffness was not resolved and event of arm pain was recovering rest of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-07-16 fatigue, headache Extreme headache for 3 days. Started the morning of the next day after the shot. Mild headache for a... Read more
Extreme headache for 3 days. Started the morning of the next day after the shot. Mild headache for another 2 days. High fever for 3 days. Followed by fever only at night for 4 more days. Soreness in all major joints for 3 days. Extreme fatigue for 4 days.
47 2021-07-16 headache, fatigue Fatigue, muscle aches, bone pain, headache for 2 consecutive days (7/10 and 7/11) after COVID shot.... Read more
Fatigue, muscle aches, bone pain, headache for 2 consecutive days (7/10 and 7/11) after COVID shot. Symptoms resolved on 7/12 w/o intervention On 7/14/21, new symptoms of chest pain and shortness of breath started. Still experiencing chest pain and shortness of breath as of 7/17/2021. I have not sought out any medical attention
47 2021-07-17 fatigue, chills chills; body aches; fatigue; nausea; arm soreness at the injection site; This is a spontaneous repor... Read more
chills; body aches; fatigue; nausea; arm soreness at the injection site; This is a spontaneous report received from a non-contactable consumer, the patient. A 47 year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on 26Mar2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included tuberculosis as a toddler. The patient had no known allergies to food, medications, or other products. The patient did not receive any other medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if prior the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021, the patient experienced nausea the day of and the following day of the vaccine, arm soreness at the injection site and on 27Mar2021, the patient had chills, body aches and fatigue the date following the vaccine. Therapeutic measures were not taken as a result of nausea, chills, body ache, arm soreness and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, chills and body aches, arm soreness at the injection site and fatigue was recovered. No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
47 2021-07-17 headache head splitting throbbing/headache.; This is a spontaneous report received from a contactable consume... Read more
head splitting throbbing/headache.; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) as a single dose via an unspecified route of administration in the right arm on 27Mar2021 at 16:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the right arm on 06Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021, the patient experienced a head splitting throbbing headache after 35 hours of shot. The events had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received TYLENOL (3 x 325mg) as a treatment for the reported events. The clinical outcome of the event throbbing headache was recovered on 29Mar2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-17 sweating lightheadedness and dizziness; Hot; Sweaty; This is a spontaneous report from a non-contactable othe... Read more
lightheadedness and dizziness; Hot; Sweaty; This is a spontaneous report from a non-contactable other hcp. A 47-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6205) (at the age of 47yearsold) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported Patient previously received bnt162b2 (BNT162B2), via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as DOSE 1, SINGLE for covid-19 immunisation. on 18Mar2021 the patient experienced light headedness and dizziness, hot, sweaty. The patient didn't had symptoms of rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness/dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of light headedness and dizziness, hot, sweaty patient was laid on the floor and water and snacks were given patient was transferred to Emergency room for observation patient was stable to go home and was asked to follow up with PCP. The outcome of the event was recovered and the outcome of the events dizziness, hyperhidrosis was recovering. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country captured as, For event light headedness and dizziness Coding updated from Light headedness to PT Dizziness, For event Hot Outcome updated from Unknown to Recovered/Resolved with Stop Date Mar2021 per verbatim After sitting for a while we cooled down, For other two events light headedness and dizziness and Sweaty Please review if need update the Outcome from Unknown to Recovering per verbatim Stable to go home and follow up with PCP.Leading sentence was This is a spontaneous report from a contactable Health care professional. updated as This is a spontaneous report from a non-contactable Other Health Professional. Final sentence No follow-up attempts are needed. No further information is expected. updated as No follow-up attempts are possible. No further information is expected. since reporter was non-contactable. Initial information need review Reported Event. During his 15 minutes waiting period after the injection, the patient began to experience light headedness and dizziness. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. Pt received shot and complained of being hot and sweaty. He was laid on the floor in injection room 5, with his feet elevated, some water was given, and once patient was feeling better, he was transferred to the Emergency room bay for observation. He refused a wheelchair and walked to the bay with help. After sitting for a while, we cooled down and he was allowed to leave. Assessment Plan Treatment included water and snacks. Follow up response to treatment was excellent. Patient discharge reported as Stable to go home and follow up with PCP.
47 2021-07-17 sleepiness, fatigue This is a spontaneous report received from a non-contactable consumer, the patient. A 47-year-old ma... Read more
This is a spontaneous report received from a non-contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 10:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 12Mar2021 at 09:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 17:00, the patient experienced extreme fatigue and ache for at least 24 hours and counting. Being sleeping all day. The patient received first dose on 12Mar2021 and second dose on 29Mar2021 (inappropriate schedule of vaccine administration). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extreme fatigue, ache and sleepy were resolving at the time of reporting and the clinical outcome of inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
47 2021-07-20 headache, fatigue Whole body aches; fatigue; headache; Pain at injection site; This is a spontaneous report from a non... Read more
Whole body aches; fatigue; headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 30Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not received any other medications within 2 weeks of vaccination The patient had penicillin allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 13:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced pain at injection site which was started about 4 hours after dose and lasting at least 40 hours improving at the time of this report.. On 31Mar2021, the patient experienced body aches, fatigue and headache starting approximately 20 hours of vaccination and lasting approximately 24 hours. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events pain at injection site, whole body aches, fatigue and headache were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-20 sweating At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked... Read more
At Midnight I was going to sleep, I was sweating profusely and could not feel my pulse. When I asked my wife to call 911, I went into the bathroom to change into clothes to get ready to go. I do not remember going to get dressed, I passed out and 911 had arrived and they believed I was in cardiac arrest. I went to the ER, there was a right artery blockage and put in a stint. They also found out I had 8 facial facial fractures due to the fall I had. I was all swelled up in my face so in May I went back for surgery on my face to fix the multiple facial fractures. And now I am back to normal, except I am on blood thinners. The DR could not find anything wrong after follow up, so no one knows why the cardiac happens.
47 2021-07-21 runny nose, fatigue, headache, malaise, sneezing feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad hea... Read more
feeling incredibly sick; achy muscles; nausea; diarrhea; foggy memory; extreme fatigue; very bad headache; sore neck muscles; sneezing; runny nose; brief periods of rapid heart rate; no appetite; Sometimes it felt like a specific part of body was under attack, i.e. GI tract, various muscle groups, sinuses; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical fusion C3-C7. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (ADVIL) both for an unknown indication. The patient's history of allergies to medications, food or other products was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 10:00, approximately 20 hours after injection, the patient experienced feeling incredibly sick with no fever, but achy muscles, nausea, diarrhoea which still continued, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite and sometimes it felt like a specific part of the body was under attack, i.e., GI tract, various muscle groups, sinuses. The patient reported that likely forgot some symptoms, but these ranks among the worst that patient ever felt in life without running a high fever. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events feeling incredibly sick, achy muscles, nausea, diarrhoea, foggy memory, extreme fatigue, very bad headache, sore neck muscles, sneezing, runny nose, brief periods of rapid heart rate, no appetite, felt like a specific part of my body was under attack, i.e., GI tract, various muscle groups, sinuses was resolving at the time of report. No follow-up attempts are needed. No further information is expected.
47 2021-07-22 sweating, headache, fatigue I was fatigue, hard to swallow, headaches, sweaty palms, chest pressure pain.
47 2021-07-22 fever It started with three days of mild fever and then on day four 02/08/2021. I lost function of my musc... Read more
It started with three days of mild fever and then on day four 02/08/2021. I lost function of my muscles, I couldn't walk, I couldn't lift my arms, I couldn't chew and my kidneys shut down and quit working. My blood pressure was 80/50 at the hospital. There is a heart enzyme troponin its supposed to be 4 if it reaches 40 you're having an active heart attack and mine was 37. I was in the hospital for four days. In a weird series of events during this time they found some heart conditions that I had. Had I not been hospitalized they would have never found these heart conditions. The condition I had was similar to the reaction I have had to steroids before hence why I don't take steroids.
47 2021-07-22 sinus pain, fatigue, fever his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak;... Read more
his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.
47 2021-07-23 headache Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered... Read more
Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered tongue and blistered inside and outside of right ear (very painful).; Blistered tongue and blistered inside and outside of right ear (very painful).; This is a spontaneous report received from contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 AM (Batch/Lot Number: ER8735) at the age of 47 years as single dose for covid-19 immunisation. Patient had no medical history and no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Major headaches started 05Jul2021. Noticed crooked mouth and paralyzed on right side of face in the morning. Blistered tongue and blistered inside and outside of right ear (very painful). Admitted to Emergency room on 08Jul2021. Date of start of reaction/event was 05Jul2021 9:00. Treatment received included valacyclovir hcl and prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome of events were not recovered.
47 2021-07-26 fatigue, chills, runny nose, nasal congestion, cough, cough, nasal congestion, fatigue, chills, runny nose Sx onset 7/24/21 with cough, runny nose, nasal congestion, chills, muscle aches, fatigue, & nausea.
47 2021-07-27 headache, fatigue, fever, chills Fever, chills, extreme fatigue, headache, muscle pain all over entire body, nausea. Pain and swelli... Read more
Fever, chills, extreme fatigue, headache, muscle pain all over entire body, nausea. Pain and swelling at the injection site. Ongoing muscle weakness on left arm and shoulder. (Hasn?t recovered since second shot in May.) I test this every week at the gym. -note: I?m marking Disability or permanent damage in Item 21 below. That is the best answer at this time. I still am hoping that this isn?t the case though. I still hope to recover with weekly physical therapy at the gym.
47 2021-07-27 headache Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure... Read more
Half of head became very numb; Drooping eye lid; Earache; Sharp pain in head on right side; Pressure behind eye; Tongue weakness in back of tongue on right side; bell's palsy; This is a spontaneous report from two contactable other health care professionals one of the (patient). A 47-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0183), via intramuscular, administered in Deltoid Left on 20May2021 10:20 (age at the vaccination 47-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included been dealing with tinnitus for over a year and hypertension from 12Jul2017 and ongoing. There were no concomitant medications. The patient previously took flush from alcohol and experienced known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient experienced bell's palsy on 20May2021 13:00, half of head became very numb, drooping eye lid, earache, sharp pain in head on right side, pressure behind eye, tongue weakness in back of tongue on right side on 20May2021 03:30 PM. Patient received treatment of Prednisone for the event Bell's palsy. Patient visit physician office for this event. Patient did not receive treatment for other events. The outcome of the event bell's palsy was recovering and not recovered for another events. Follow up attempts are needed; further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the suspect product, BNT162B2 vaccine, cannot be excluded for the reported event Bell's palsy due to close temporal relationship. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
47 2021-07-27 sweating, fatigue large taste buds in the back of the throat became swollen and sores bumps were seen in the throat; l... Read more
large taste buds in the back of the throat became swollen and sores bumps were seen in the throat; large taste buds in the back of the throat became swollen and sores bumps were seen in the throat; tired; randomly break out in a sweat; the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it; the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it; developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in the left arm on 28Mar2021 15:45 (at the age of 47 years old) as dose 1, single for COVID-19 immunization. Vaccination was done in a pharmacy or drug store. Medical history included allergy: penicillin, high blood pressure and borderline diabetic, all from an unknown date and unknown if ongoing. There was no other vaccine in four weeks. Concomitant medications included lisinopril, metformin, atorvastatin and omeprazole (PRILOSEC), all taken for unspecified indications, start and stop dates were not reported. The patient experienced the "spot" became irritated and inflamed turning into a rash/painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it, large taste buds in the back of the throat became swollen and sores bumps were seen in the throat, tired and randomly break out in a sweat on an unspecified date in Apr2021; and developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm on 31Mar2021 19:00. It was reported that three days after the injection, the patient developed a slick spot (oily) on the left hip buttocks directly inline with the injection site on the left arm. Three days after that, the "spot" became irritated and inflamed turning into a rash. The location was painful to touch and had the appearance of a reddened area the size of a grapefruit with white folded blistered skin over it. He applied hydrocortisone cream to the area and took Benadryl thinking it was a reaction. Four hours later, the large taste buds in the back of the throat became swollen and sores bumps were seen in the throat. He admitted himself to the ER to be treated. He was tested for strep throat which came back negative. He was examined and the attending doctor who didn't know what to make of it. He was given lidocaine to ease the sensation of the swollen taste buds and bumps in the throat and released. The day after, he experienced being tired and randomly break out in a sweat. The adverse events resulted in emergency room department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included Streptococcal throat test: negative (tested for strep throat which came back negative) on an unspecified date in 2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
47 2021-07-27 lethargy, chills Body aches (across entire body); Chills; Sore arm where injected; Lethargy/ need to sleep; This is a... Read more
Body aches (across entire body); Chills; Sore arm where injected; Lethargy/ need to sleep; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on 29Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. It is unknown, if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient got tested for COVID-19. On 30Mar2021 at 06:00, the patient experienced body aches (across entire body), chills, sore arm where injected and lethargy/ need to sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of body aches, chills, sore arm and lethargy. The clinical outcome of the events body aches, chills, sore arm where injected and lethargy was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/ batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: reporter reported for brother, patient name removed from reporter tab, and reporter address detail removed from patient tab.
47 2021-07-27 fever, chills Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills a... Read more
Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 03:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis (reported as sinus) and reflux. The patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), pantoprazole sodium sesquihydrate (PROTONIX) and loratadine (CLARITIN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 10:00 the patient experienced low grade fever 100.2 (units unspecified) and chills also sore arm at injection site. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever 100.2 and chills also sore arm at injection site was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
47 2021-07-29 throat pain Morning of 4/6 (4 days after shot), woke to sore throat; Swollen lymph nodes; Joint/muscle aches; Jo... Read more
Morning of 4/6 (4 days after shot), woke to sore throat; Swollen lymph nodes; Joint/muscle aches; Joint/muscle aches; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. Allergies to medications, food or other products were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Apr2021, at 05:00 in the morning 4 days after the shot the patient woke up with sore throat, swollen lymph nodes, joint/muscle aches, and slight dizziness. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events sore throat, swollen lymph nodes, joint aches, muscle aches and dizziness was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-01-03 headache I had right sided headache for the first two days, then resolved. The right sided headaches recurre... Read more
I had right sided headache for the first two days, then resolved. The right sided headaches recurred along with right tongue numbness initially on 12/29/2020. The symptoms worsen on 12/31/2020 and severe on 1/1/2021. I was initially started on Valtrex thinking it maybe due to shingles but soon with the right sided facial paralysis, it was obvious it was Bell's Palsy and was started on steriods on 1/1/21 and also received acupuncture treatment on 1/2/21 which significant help improve the symptoms. I still have some residual weakness of the right eye with some tearing and mouth weakness.
48 2021-01-04 chills, fatigue, headache weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath;... Read more
weak from lack of nutrition; weak from lack of nutrition; Tired; stomach cramps; felt out of breath; nausea; vomiting when exercised; headache; Sore arm; chills; no appetite; clammy hands/clammy hands and feet; very sore at injection site; This is a spontaneous report from a contactable other HCP (patient) reported for himself. A 48-years-old male patient received first dose of BNT162B2, via intramuscular in left arm on 21Dec2020 10:15 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included known allergies: Shellfish, Corn, Whitefish. The patient's concomitant medications were none. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. The patient experienced no appetite, clammy hands, very sore at injection site on 21Dec2020 (reported as day 1), sore arm, no appetite, clammy hands and feet, chills on 22Dec2020 (reported as day 2), no appetite, nausea, vomiting when exercised, headache, clammy, chills on 23Dec2020 (reported as day 3), no appetite, nausea, stomach cramps, headache, felt out of breath, clammy, chills on 24Dec2020 (reported as day 4), tired, clammy, headache on 25Dec2020 (reported as day 5) and symptoms resolved but weak from lack of nutrition on 26Dec2020 (reported as day 6). No treatment was received for all the events. The outcome of the events was recovered in Dec2020. The information on the Lot/batch number has been requested.
48 2021-01-04 headache, fatigue I have had whole body myalgias since the first day of the vaccine. I am now 19 days since the vaccin... Read more
I have had whole body myalgias since the first day of the vaccine. I am now 19 days since the vaccine and continue to feel them most of the day. They were the most intense the first weeks but have improved slightly since then. I also have had fatigue during this time period with occasional headaches. I have had lightheadedness for the past week.
48 2021-01-05 headache Arm soreness, headache for a day
48 2021-01-06 fatigue, fever Fever, exhaustion back pain
48 2021-01-06 fatigue Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal... Read more
Fatigue that requires daily naps and 12-14 hours of sleep daily. Shortness of breath, despite normal saturation 97% on room air. Dyspnea with exertion with normal sinus rhythm rate in 80s. Cheat tightness.
48 2021-01-06 headache, fever, chills 15 hours after the vaccine I came down with fever, headache, chills, and body aches
48 2021-01-07 chills, fever Chills, Muscle Aches, Fever 101
48 2021-01-07 fatigue Persistent fatigue
48 2021-01-07 headache, fever, chills Chills, fever, night sweats, nausea, bad headaches
48 2021-01-07 headache Headaches so severe went to ED, neg MRI brain. Last day of work was 17 days ago, so possible vaccin... Read more
Headaches so severe went to ED, neg MRI brain. Last day of work was 17 days ago, so possible vaccine reaction has lasted 17 days and not improving, better when taking steroids.
48 2021-01-08 headache Headache Lightheadedness Narrative:
48 2021-01-08 throat pain, chills, body temperature increased temperature to 100.5, chills, sore throat Narrative:
48 2021-01-09 headache, chills, fatigue Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost... Read more
Arm soreness, chills, fatigue, headache lasted 24 hours. Had same reaction to the first dose, almost identical.
48 2021-01-10 fatigue SkinRash Chest tightness Narrative: Due to history of LATEX ALLERGY carrying EpiPen, immunization... Read more
SkinRash Chest tightness Narrative: Due to history of LATEX ALLERGY carrying EpiPen, immunization done in ER. Almost immediately developed chest tightness extreme fatigue and erythema off chest & face; pt says she was told by staff she was "Red as a Lobster" O2 Sat fluctuated 87-93% Treated with Benadyl 50-mg IM. Discharged with Prednisone 20-mg po daily x 3 and Benadryl 50-mg PO TID prn. Today feels normal.
48 2021-01-10 fatigue three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke ... Read more
three hours after administration felt fatigued (drunk) and uncoordinated. slept for four hours woke up with no affects
48 2021-01-10 productive cough, headache, throat pain, sneezing, nasal congestion JAN. 6 THIS WRITER RECEIVED FIRST DOSE OF PFIZER-BIONTECH COVID VACCINE, AT MY HOSPITAL. AFTER VACC... Read more
JAN. 6 THIS WRITER RECEIVED FIRST DOSE OF PFIZER-BIONTECH COVID VACCINE, AT MY HOSPITAL. AFTER VACCINATION ONLY FELT SORENESS ON THE INJECTION SITE, JAN.7 TO JAN 9 FEEL FINE, BY JAN 10TH PAST MIDNIGHT TO 1AM STARTED TO SNEEZE, LOSS OF VOICE, SORE THROAT AND NASAL CONGESTION. TODAY JANUARY MORE SYMPTOMS ADDED LIKE NON PRODUCTIVE COUGH AND HEADACHE.
48 2021-01-10 fever, influenza like illness, chills Fever CHILLS, MYALGIA, FLU-LIKE SYNDROME Narrative:
48 2021-01-11 chills, headache, fever Headache, Myalgia, Fever, CHILLS Narrative:
48 2021-01-11 chills, fever, headache Fever, chills, nausea, dizziness, headache. Improving.
48 2021-01-11 fatigue Sedation injection site discomfort, fatigue, and tiredness Narrative:
48 2021-01-11 headache, fatigue Headache fatigue muscle aches
48 2021-01-12 chills, body temperature increased, malaise Employee received the second dose of the vaccine and was fine. He awakened the next morning with sev... Read more
Employee received the second dose of the vaccine and was fine. He awakened the next morning with severe chills and a temperature of 101.1 that would not come down. He had aches all over and general malaise.
48 2021-01-12 chills, headache, fever Patient describes fever and chills, headache, body aches, pain in your back especially where the kid... Read more
Patient describes fever and chills, headache, body aches, pain in your back especially where the kidneys are located. Site injection soreness. Patient report nausea, but also says he hadn't eaten all day
48 2021-01-12 chills, fever Vaccine was given 09:30 and early next morning, 01:00, had low grade fever, aches, and chills. These... Read more
Vaccine was given 09:30 and early next morning, 01:00, had low grade fever, aches, and chills. Theses symptoms lasted for about 16 hours and then improved quickly. By 6 pm day after vaccine, felt close to normal.
48 2021-01-12 fatigue, chills Chills at night; Tiredness; This is a spontaneous report from a contactable physician (patient). A 4... Read more
Chills at night; Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 (Lot number and expiration date were not reported), and the second dose on 05Jan2021 (Lot number: EL3246; Expiration date was not reported), both at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included ongoing hypertension and ongoing hypercholesterolaemia; both diagnosed more than 10 years ago. There were no concomitant medications. On 06Jan2021, the patient had chills at night and tiredness. The outcome of the events, chills at night and tiredness, was recovered on 06Jan2021.
48 2021-01-12 fatigue, fever, sneezing, cough Fevers, fatigue, sneezing, coughing
48 2021-01-12 fatigue Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male p... Read more
Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of bnt162b2 (also reported as COVID 19 vaccine, lot number and expiry date were unknown), via an unspecified route of administration on 16Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension and hypercholesterolaemia; both were diagnosed more than 10 years ago and ongoing. There were no concomitant medications. The patient received his first dose of bnt162b2 on 16Dec2020. He doesn't have the lot number for that one. With his first dose he experienced tiredness on unspecified date, but the second dose was worse. The hospital staff get the vaccine. He is always in contact with patients with COVID. The outcome of the event was unknown. Information on the lot/batch number has been requested.
48 2021-01-12 fever, chills Fever and chills for approximately 24 hours post vaccination
48 2021-01-13 fatigue swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report f... Read more
swollen lymph nodes under left clavicle; tiredness; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EK9231) via an unspecified route of administration on his left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient had no medical history and no relevant family medical history. There were no concomitant medications. The patient worked at 12-13 different hospitals and around first responders and COVID positive patients. The patient got the first dose of the Pfizer BioNTech COVID vaccine on 28Dec and he has developed adverse events as of 'yesterday'. Reported he was tired and having swollen lymph nodes under the left clavicle, no fever or other symptoms. The patient noticed the swollen lymph nodes on 06Jan2021 when coming out of the shower. Since he worked in the hospital he asked a few Physicians about it. Mentioned he did do something with the (Public health agency name) and signed up and they sent him text messages every day to see how he was feeling the first 7-8 days. He never had symptoms that day except for pain at the site and a little tiredness post day (29Dec2020) of getting vaccine and then nothing after that. The Physicians he spoke to were only to palpate the one lymph node, it was pretty visible. He had none visible or palpated in the neck and they couldn't feel anymore there or anywhere else. He has had some tiredness today also, but no fever or anything else. He did not receive any other vaccines the same day or 4 weeks prior. Has not had any problems with previous vaccines. He was to go back for the second vaccine scheduled on 15Jan, but not sure if he should hold off. He worked with medical Devices, pacemakers, defibrillators, pacemaker devices. He does not take any medications and has not had any bloodwork. Patient was asking what should he do if he still has the swollen lymph nodes when he is due to get the second vaccine. The patient had no relevant tests done. Outcome of the events swollen lymph nodes and tiredness was not recovered, while unknown for the other event.
48 2021-01-13 malaise, fever, chills Chill; temp of 99.6; body malaise; pain at injection site; This is a spontaneous report from a conta... Read more
Chill; temp of 99.6; body malaise; pain at injection site; This is a spontaneous report from a contactable Nurse. A 49-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number Ek5370 via an unspecified route of administration on 17Dec2020 15:00 at single dose (first dose) vaccine location=Left arm and lot number EL3246 on 05Jan2021 at single dose (second dose) vaccine location=Left arm for covid-19 immunisation. Patient age of vaccination is 48 years. Facility type vaccine: Hospital The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension, gastrooesophageal reflux disease, erectile dysfunction, milk allergy and arthritis. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), ibuprofen (MOTRIN [IBUPROFEN]), lisinopril (LISINOPRIL), paracetamol (TYLENOL), sildenafil (SILDENAFIL). On 06Jan2021 07:00 the patient developed chill, temperature of 99.6, body malaise, and pain at injection site. The patient recovered from events. in Jan2021 and no treatment was received. the action taken is not applicable.
48 2021-01-14 chills, fatigue Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/... Read more
Fatigue starting at 22:00 Impaired night vision starting at 0500 1/9/22 Rigors starting at 0500 1/9/21 Neuropathy in the hands starting at 0500 1/9/21
48 2021-01-14 chills, malaise chills; tonsillitis/tonsils were inflamed; uvulitis/uvula were inflamed; body malaise; This is a spo... Read more
chills; tonsillitis/tonsils were inflamed; uvulitis/uvula were inflamed; body malaise; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, then intramuscular on left arm from 06Jan2021 08:15 to 06Jan2021 08:15 as SINGLE DOSE for COVID-19 immunisation. Medical history included eczema. Historical Vaccine includes: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 16Dec2020 09:15. Concomitant medication included halobetasol propionate 0.05% ointment. On 07Jan2021, experienced body malaise (after 24 hours of receiving vaccine). On 08Jan2021, the patient experienced uvulitis, tonsillitis (after 48 hours of receiving the vaccine). The patient suddenly woke up from sleep feeling something was in his throat. Looked in the mirror and my uvula & tonsils were inflamed. On 08Jan2021, 08:00am, the patient experienced chills. No other symptoms accompanying the swelling of tonsils, uvula. The patient underwent nasal swab, L UMIRADX SARS-COV-2 AG test on 21Dec2020 with negative result. The outcome of the events was recovering at the time of the report. No treatment was given for the events.
48 2021-01-14 headache, chills Headache, Cold Feet and Hands, Chills, body aches.
48 2021-01-14 headache Headache - migraine
48 2021-01-14 fever 1/8/21, 1600: Received second dose of COVID-19 vaccine 1/9/21, 1800: Began to feel feverish and achy... Read more
1/8/21, 1600: Received second dose of COVID-19 vaccine 1/9/21, 1800: Began to feel feverish and achy, and later identified some pruritic lesions beginning to emerge 1/10/21: Developed a crop of raised red pruritic lesions on distal extremities; later noticed visible swelling of the face. Patient did not experience swelling of tongue or respiratory compromise. Patient self-administered Benadryl and a Medrol Dosepak. The lesions expanded to involve torso. 1/11/21: Symptoms subsided, though there was a sensation of recrudescent pruritis at unspecified time. 1/11/21, 1631: Labs ordered; patient CBC and CMP were WNL. Noted that platelets were normal, no eosinophilia, and LFTs were WNL. Positive COVID-19 antibody test. The patient stated he had COVID-19 in November, but no positive test is noted in the patient chart.
48 2021-01-17 chills, headache, fatigue After the injection my arm got really sore. I began to feel really tired and begin to have chills a... Read more
After the injection my arm got really sore. I began to feel really tired and begin to have chills and shakes. I started having diarreah and began throwing up. I had a sever headache and body aches which all symptoms lasted for about 3 days and I felt so bad so on Wed 12/30 I went to Urgent Care and was given fluids which did make me begin to feel a little better. On Monday I was sent for a COVID test which was negative. On Friday 1/1 i was finally able to return back to work.
48 2021-01-17 sweating During 15 minute observation period post vaccine individual became slightly diaphoretic and felt wea... Read more
During 15 minute observation period post vaccine individual became slightly diaphoretic and felt weak. He does comment that he has not had much to eat or drink. Was offered juice and a snack which he tolerated and improve his symptoms. Vital signs were taken stable with slight tachycardia that improved at second set of vitals. Seen by provider on site and physical exam was benign. No medication intervention was needed. Left observation on own recognizance
48 2021-01-17 fever, headache Headache, Fever 101.0, sore at injection site. Treated with Tylenol. Headache lasted all day. Fever ... Read more
Headache, Fever 101.0, sore at injection site. Treated with Tylenol. Headache lasted all day. Fever lasted 2 hours.
48 2021-01-17 fever 12/22/2020 - Fever - jumped up from 98.9 which is warm for me to 102.5 and that took me in to get te... Read more
12/22/2020 - Fever - jumped up from 98.9 which is warm for me to 102.5 and that took me in to get tested. Four days of fever. Tylenol and Ibuprofen. Went in and got tested for COVID positive.
48 2021-01-18 chills, headache, malaise, fever Fever to 102, rigors, myalgia, headache, malaise x 36 hours post vaccination. Same symptoms for 1st ... Read more
Fever to 102, rigors, myalgia, headache, malaise x 36 hours post vaccination. Same symptoms for 1st and 2nd immunizations.
48 2021-01-18 chills, malaise tested positive for COVID; tested positive for COVID; achiness; Chills; not feeling well; This is a ... Read more
tested positive for COVID; tested positive for COVID; achiness; Chills; not feeling well; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient's wife) reported similar events for four patients. This is the first of four reports. A 48-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer-Biontech Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 17Dec2020 at single dose, for Covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient received the vaccine last 17Dec2020. The following day, 18Dec2020, he was not feeling well. Clarified those side effects as achiness and chills. He had been working so hard and thought initially were getting side effects from the COVID Vaccine. He was tested positive for COVID on 22Dec2020. He was in bed basically until 31Dec2020. His wife wants to know if he should get the second dose. The outcome of events was recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021019513 same drug, similar events, different patient;US-PFIZER INC-2021019535 same drug, similar events, different patient;US-PFIZER INC-2021019534 same drug, similar events, different patient
48 2021-01-18 fatigue, headache Fatigue, Headache, Sore arm, Achy muscles
48 2021-01-18 fatigue, lethargy Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pa... Read more
Patient reports fatigue, soreness and swelling to the injection site, hot and cold flashes, joint pain and muscle soreness and lethargy
48 2021-01-18 fatigue After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start ... Read more
After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start driving, and suddenly felt that my right arm was heavy, numb, with a tingling sensation. I stopped the car and called the nurse and I was told that it will go away, and I can take a tylenol/motrin. It improved over the next hour and I felt it resolved a few days later but then it returned on 1/18 but not to the same extent, and I also felt intermittent tingling and numbing in my right foot. I also experienced intermittent episodes of fast heartbeats and missing heartbeats since the vaccine almost daily. I was fatigued and extremely thirsty for 3 days but that resolved completely.
48 2021-01-18 fever, chills Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received t... Read more
Fevers; Chills; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; he is suspecting that he got infected with the Covid-19 though he already received the 1st dose; Body aches; Patient suspected that he has gotten infected also from his spouse; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 (Tuesday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported body aches developing the evening of receiving the vaccine, and it has persisted for three days. Patient started to get the chills on Wednesday (06Jan2021). Patient said his wife has been tested positive after he took the 1st dose and he is suspecting that he got infected with the Covid-19 though he already received the 1st dose. Patient thought that he may have been infected by his spouse. He got the vaccine on Tuesday and on Wednesday had fever and chills and still has them. Stated that his spouse lost her sense of smell and taste and tested positive for Covid on Wednesday. Patient stated that this was the day after he received his vaccine. Patient suspected that he has gotten infected also from his spouse and was not aware when he got the vaccine. Stated that now that he is having expected side effects of fever and chills. The outcome events was not recovered. This case was reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and suspected got COVID-19 infection via exposure to COVID-19 living with his wife, who lost her sense of smell and taste and tested positive for COVID on 06Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Further information is needed for full medical assessment.
48 2021-01-19 chills, fever fever chills body ache
48 2021-01-19 headache, fever, chills Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, ... Read more
Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, 14JAN21 - 17JAN14; used diphenhydramine (50 mg ) at night to control swelling - weakness - fast heartbeat Side effects (each of the side effects lasted around the same time period, 13JAN21-17JAN21; alternated acetaminophen and ibuprofen to try and relieve symptoms -injection site pain (began about 1 hour after injection) -headache (severe) -muscle pain -chills - joint pain (severe), began during sleep and I first felt it in my hands - fever (even while taking acetaminophen and ibuprofen, I still had a fever of 100.6 degrees) -injection site swelling (13JAN21-19JAN21) -injection site redness
48 2021-01-20 chills, headache, malaise, fever, fatigue Fever Chills Malaise Headache Tiredness Muscle aches
48 2021-01-20 cough, fatigue, runny nose Body aches Migraine Cough High fever Massive Dizziness Runny nose Fatigue
48 2021-01-20 lethargy, fatigue, fever Extreme lethargy/fatigue, fever 100.1, joint aches
48 2021-01-21 fatigue, headache I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a b... Read more
I received the first dose of Pfizer EK5730 at 18:07 on 12-30-2020. For the first day my arm was a bit sore but nothing to bad. The next few days 48-72 hours later I started to have many more symptoms, some minor to sever including joint pain, headache, fatigue, and dizziness. lesser included some nauseas. The joint pain was so bad at one point i had to pull over while driving. on 1-2-21. as of writing this now 14 days out I still have some joint pain especially in my arms. No other symptoms of note. I would add that I tested positive for COVID -19 on 10-18-2020 and was not released from quarantine until 11-5-20 I did seek treatment during this time through by calling my Dr. did not require any hospitalization.
48 2021-01-21 headache, sweating, fever The shot was administered at a vertical position rather than a horizontal position. The physician a... Read more
The shot was administered at a vertical position rather than a horizontal position. The physician asked me to wait 30minutes after the vaccine. I did experience sweats, fever and headaches. I pre medicated myself with Benadryl 25mg an hour in a half before the injection. My BP readings were 130/90. I discussed with my physician i was doing a daily log on my BP. My systolic BP reading were between the 90-100. I was prescribed Losartan 25mg. After post 24 hours after the injection it dissipated the next day.
48 2021-01-21 headache 36 hours later fog, headache, floaty. no fever. no gi issues. No cough
48 2021-01-21 fever, cough, fatigue, chills, productive cough, sleepiness Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker a... Read more
Some background: I normally react badly to flu/respiratory vaccines in that I generally get sicker after the vaccine than I do when I get the virus. So this isn't entirely unexpected. However, the timing is really strange and Now I wonder if I should get COVID tested. Here is the chronology of events. Day of shot (Friday) - pain in arm lasted about 2 days but wasn't too intense. As the pain in the arm began to fade, I started getting really sleepy. I slept probably 48 hours over the next three days but did not experience any pain except maybe slight muscle aches and a little of the accompanying eye burn that is associated muscle aches and sleepiness. By Tuesday, the sleepiness had passed. Thursday night (last night), I started to experience ALL general symptoms of a respiratory flu/COVID. I developed an intense cough and associated phlem (though it is very sporadic rather than persistent) and the precursors to intense muscle pain. I woke up at around 3am Friday with a fever, the muscle pain, burning eyes (associated with flu-muscle pain and fever), and extreme chills (though my windows was open... a normal practice as my computer makes it hot in my room). I felt oddly rested however, as though the getting sick, while making me tired, was also helping me sleep better. My body is definitely reacting to something. If it wasn't 6 days afterward, I would say it was my normal reaction to virus shots. However, the timing is alarming. I have not knowingly been exposed to anyone with COVID. This morning the chills are gone, the fever is down (though not entirely gone), but I still feel "down for the count." Like I said... it is my normal reaction to virus vaccine except that it is about 6 days late (usually sets in within 24 hours). This morning is the week "anniversary" of the shot.
48 2021-01-22 fever low grade fever, body aches and vertigo.
48 2021-01-24 fatigue, chills, headache Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to... Read more
Arm is very painful. The day after achy, muscle pain, head ache fatigue and chills. Just lasted 4 to 5 hours.
48 2021-01-24 headache On 1/23/21 at approximately 3:30pm I began to develop headaches. Approximately 2-3 hours later I be... Read more
On 1/23/21 at approximately 3:30pm I began to develop headaches. Approximately 2-3 hours later I began to feel nauseous and began to vomit. I then was taken to the Emergency Room where I had begun to suffer from an Addisonian Crisis where I was given Stress Dose steroids. The stress does steroids where given through 1/24/21 and medicine for the headaches are still be used to relieve the pain from the headaches. I was released from the hospital the late morning in the late morning of 1/25/21
48 2021-01-25 fever body aches; a fever of 101; This is a spontaneous report from a contactable nurse (patient). A 48-ye... Read more
body aches; a fever of 101; This is a spontaneous report from a contactable nurse (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), intramuscularly on 06Jan2021 10:00 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose in Dec2020 10:00 intramuscular at left arm for covid-19 immunization. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), emtricitabine, tenofovir disoproxil fumarate (TRUVADA). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches and a fever of 101 on 07Jan2021 14:00. He fully expected this immune response from his body and it only lasted 12-24 hours. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 08Jan2021. The events were reported as non-serious. Information about Batch/Lot number has been requested.
48 2021-01-26 chills, body temperature increased, headache, fatigue Exhaustion, chills, body aches, headache temperature oral 101-102.8
48 2021-01-26 headache c/o headache, juice given and symptoms improved
48 2021-01-27 fatigue 1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent w... Read more
1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent with herpes II/Zoster, nerve down right leg tingling, testing for all venereal diseases June 18, 2015, July 2015-Present married to wife no sexual activity outside of marriage, hyper sensitive to venereal disease. Wife is negative, PT is negative for IGA and IGE, PT received vacc and is now showing symptoms positive for herpes 2, PT is waiting for results as to if he is POSTIVE, blister on right side of penis-clear fluid filled, right sores/blisters crusty on buttocks, right inner thigh leg blister on scrotum with red dots in the middle, nothing on glands penis/urethra or anus. Thursday night, pt had intimacy and it was dryer than normal, uncomfortable on the right side with penetration-skin is compromised. Saturday, PT was not feeling great, shaft not showing, in a rush to urinate, scrapped scrotum and now has lesions. Sunday, fatigue, outbreak/whelp on legs, PT wore gauze/bandages to prevent chafing. Monday, shaft not showing, patient went to urgent care. PT was told it presented as Zoster. Nothing on penis at this point in time. Penis issues did not show until 1/26/2021. EX wife had herpes II. PT again was tested after in 2015 and was negative for IGE and IGA. Tuesday, patient started meds from urgent care. Wednesday morning, chest pain/pleurisy like-pain across chest. Arm vaccination site sore, bruised to this day. Herpes Zoster not typically going to end up on shaft, its unusual, PT is probable he has cross contaminated by itching his buttocks and then going to the restroom and touching right side of penis.
48 2021-01-27 fever, headache Headache, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative:
48 2021-01-30 sinus congestion, fatigue, headache Pt states that she has been experiencing a headache, sinus congestion, and fatigue since yesterday m... Read more
Pt states that she has been experiencing a headache, sinus congestion, and fatigue since yesterday morning.
48 2021-01-31 headache 01/20/21 @ 12:00 PM: Headache and body aches for less than 24 day. Went to bed. Symptoms are resolve... Read more
01/20/21 @ 12:00 PM: Headache and body aches for less than 24 day. Went to bed. Symptoms are resolved. Feeling well.
48 2021-01-31 lethargy, fatigue fatigue, decreased mobility, minimal swelling of feet, O2 dips, lethargy
48 2021-02-06 chills, headache Injection site pain on 2-5-2021 and headache The following was present on 2-6-201 Shoulder and upp... Read more
Injection site pain on 2-5-2021 and headache The following was present on 2-6-201 Shoulder and upper arm and warm to touch. Fear / chills, severe headache, body ache, loss of appetite, nausea. On 2-7-2021 site injection pain mildly present, mild to moderate headache body ache,
48 2021-02-07 chills Lost all sense of smell and taste; Lost all sense of smell and taste; Pain in the injection site; Ch... Read more
Lost all sense of smell and taste; Lost all sense of smell and taste; Pain in the injection site; Chills that he could not shake; Upper arm discomfort; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 15Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 16Jan2021, the patient had upper arm discomfort. On 17Jan2021, the patient had pain in the injection site and chills that he could not shake. On 20Jan2021, the patient had lost all sense of smell and taste. The outcome of the events was recovered on 19Jan2021 for 'upper arm discomfort'; was recovering for 'chills that he could not shake'; was not recovered for 'lost all sense of smell and taste'; and was unknown for 'pain in the injection site'. The patient had COVID-19 test on 08Jan2021 (results were not provided). Information about lot/batch number has been requested.
48 2021-02-07 headache, chills, fever, sweating Extreme shivering and feeling of freezing temp even in hot shower. legs and knees ached very painful... Read more
Extreme shivering and feeling of freezing temp even in hot shower. legs and knees ached very painfully, headache, nausea, vomiting, diarrhea, sweating, fever at 100 degrees, full body aches and felt very restless. Not able to sleep well. Symptoms lasted until 2/7/2021 @ 1200pm. Worse than reaction to 1st dose.
48 2021-02-07 headache, chills, fever Chills, fever, cold sweats, nausea, diarrhea, headache. All lasting @ 48 hours.
48 2021-02-08 fatigue Shortness of breath, tight lungs, tingling of face, tight lips, very dizzy, and extremely fatigued.
48 2021-02-08 fatigue tight lungs, shortness of breath, tingling face, tight lips, extreme fatigue, dizziness
48 2021-02-11 fatigue, cough, sleepiness, fever Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time... Read more
Within 30 seconds pain on my arm and it increased slightly. I was able to do my work. But every time I was stable and tried to use it again I felt pain again. Pain was always there - it was tolerable. I was told to take Ibuprofen about three hours later. Second day, I could feel it but I didn't take medication. It slowly went away. No swelling, nothing. On January 4th started having symptoms nose bleeding; diarrhea; cold sweats; had a fever - but I didn't take it to know what it was. I very tired/ extremely sleepy; my eyes started feeling warm- these symptoms creeped up on me. It started around 10:00 am and within an hour an a half I had to tell my boss and they told me to leave work - but I couldn't drive. I stayed in my car and just slept and I was extremely tired. I had a coworker keep an eye on my because I looked really bad. I slept two or three hours in my car. I was still tired and I couldn't drive yet. So I stayed in my car a little longer until I felt stronger and drove home. I had started coughing and knocked out - but I was beginning to coughing a lot on drive home- the first hour I couldn't sleep because I was coughing so much - lasted an hour. Chest coldness for a couple of days - cold chest. It wasn't tight. Next day, January 5, 2021 - went to doctor and they ordered COVID test. Dr thought I had a stomach virus. Diarrhea continued for two days. Weak and fatigue for 5 days. My Fever - temperature was on the first day was one day only. Second day, I did have a lot of fatigue and I was coughing a lot. The fatigue lasted 10 days.
48 2021-02-11 headache, fever, lethargy low grade fever headache eyes were warm breath is warm lethargic
48 2021-02-13 chills, fever Chills, shakes and fever (103.7) 72 hours after vaccination.
48 2021-02-16 fatigue I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I wa... Read more
I awoke from sleep freezing cold. Colder than I have ever felt. violent shakes. So much that I was worried my muscles would begin to sieze up and cramp. I had warm clothes and 5 blankets and could not get warm for over 2 hours. Elevated heart rate and breathing. Nothing warmed me. Eventually (and with ibuprofen) the incident subsided. I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
48 2021-02-16 headache left Lower jaw and neck Numb, Pain in shoulder (not at inection site), headache
48 2021-02-16 fever, headache, chills passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendou... Read more
passed out; terrible headache; still some body aches; general bad feeling all over; nausea/tremendous chills and nausea; tremendous chills and nausea; low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 48-year-old) on 02Feb2021 at 10:30 AM as a single dose for COVID-19 immunisation, lot number: EL9262. Medical history included high cholesterol and allergies to some seaweeds. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 via an unspecified route of administration in Left arm (at age of 48-year-old) for COVID-19 immunisation, lot number: EL3246. Concomitant medications in two weeks prior to the vaccination included atorvastatin and multi- vitamin. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient started about 12 hours after getting vaccinated (reported as 02Feb2021 at 10:00 PM) with a general bad feeling all over, 15 hours after (03Feb2021 at 01:00 AM) patient got out of bed because of nausea and passed out, his wife found he on the floor. Patient had tremendous chills and nausea with a low grade fever 99.5 for several more hours, maybe 6 hours, (onset date 02Feb2021) the next morning patient had a terrible headache and still some body aches. Patient was treated with extra strength paracetamol (TYLENOL) and ondansetron (ZOFRAN). Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the events, at the time of the report.
48 2021-02-17 fever, headache Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following ... Read more
Headache, vertigo, body aches, fever, axillary swelling and pain for 3-4 days immediately following the administration. Headaches and vertigo continued and became sustained leading to an MRI to be done on 2/1/21 resulting in a neurology consult and high doses of prednisone for short term treatment of symptoms. Further lab work revealed elevated ANA levels. Now awaiting a rheumatology consult. Although moderately improved, vertigo and disorientation remains, unable to work.
48 2021-02-18 fever, headache, chills Headache, fever, body aches, chills
48 2021-02-19 chills, cough Difficulty breathing, swelling of throat, cough, warmth in chest, dry mouth, chills, violent shaking
48 2021-02-20 headache Headache started later that day that never went away. It has been 2 weeks. It is a dull throbbing he... Read more
Headache started later that day that never went away. It has been 2 weeks. It is a dull throbbing headache. My vision also got blurry. I was told my cataract in my left eye (left arm was shot) had gotten just a little worse after seeing my ophthalmologist. I also noticed the cataract originally appeared after using the scopolamine patch (on my left side) a few years ago. I don't know if there is a connection. Also, I was told the left eye has become very dry. I also went to a retinologist, but said the retina seemed okay.
48 2021-02-24 sweating Facial flushing, diaphoresis, nausea, patient refused to be seen by EMS
48 2021-02-26 headache, fatigue Day after 2nd shot of vaccine: generalized muscle and joint aches and soreness, fatigue, mild headac... Read more
Day after 2nd shot of vaccine: generalized muscle and joint aches and soreness, fatigue, mild headache This lasted all day. Second day after vaccine, just fatigue and mild headache. Third day after vaccine, no further side effects.
48 2021-02-27 fatigue, fever Day after injection I had aches pains fatigue and low grade fever (99.2. ). That evening I had stoma... Read more
Day after injection I had aches pains fatigue and low grade fever (99.2. ). That evening I had stomach cramps and bloody diarrhea. This continued the next morning. Given the obvious bright red color I decided to seek medical assistance.
48 2021-02-27 fatigue Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegr... Read more
Aural symptoms and seizure like symptoms. Patient has been seizure free for eight years with Zonegran controlling tonic/clonic seizures. The patient experienced persistent seizure like aural symptoms, ringing in ears for four to five hours post onset and post dictal tiredness.
48 2021-03-04 sinus headache, headache, fever, fatigue, chills ON 2/28/2021- HEADACHE, NAUSEA , FEVER, FATIGUE AND CHILLS- LASTING UNTIL 3/2/2021. ON 3/2/2021AND 3... Read more
ON 2/28/2021- HEADACHE, NAUSEA , FEVER, FATIGUE AND CHILLS- LASTING UNTIL 3/2/2021. ON 3/2/2021AND 3/3/2021- SINUS HEADACHE , EYE AND EAR PRESSURE BEGAN. ON 3/4/2021 WOKE WITH SYMETRICAL RASH TO ARMS, HIPS, UPPER LEGS AND BUTTOCKS. NOT ITCHY UNTIL EVENING OF 3/4/2021. RASH BECAME BLOTCHY, RAISED "HIVE-LIKE" PROMPTING TO SEEK MEDICAL ATTENTION AT URGENT CARE. THEY PRESCRIBED- BENADRYL AND CALAMINE LOTION. STATES NO RELEIF AS OF TODAY.
48 2021-03-05 headache, fatigue ~36 hours: fatigue, muscle aches, joint pain, headache, dizziness
48 2021-03-06 chills, headache, fever 2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate ... Read more
2/05/2021 @ 5pm: Received first dose (no adverse reaction) 2/26 @ 6:20pm: Second dose (no immediate adverse reaction) 2/27 @ 6am: woke up and felt fine 2/27 @ 7am: feeling of being hungover (dizziness, slight nausea, slight headache, mild chills) 2/27 @ 10am: low-grade fever of 99.5F, general ashiness, moderate headache 2/27 @ 1pm: fever of 100.4F, severe headache, general weakness/achiness 2/27 @ 4pm: fever of 101.4F, severe headache, general weakness/achiness 2/27 @ 7pm: fever of 102.0F, extreme headache, general weakness/achiness 2/27 @ 10pm: fever down to 99.0F (without any medications), extreme headache, loud ringing in the ears -- took 1 dose of ibuprofen 2/28 @ 7am: normal body temp, mild headache, slight dizziness 2/28 @ 11am: mild headache, fever returned to 99.6F -- took 1 dose of acetaminophen 3/01 @ 8am: normal body temp, slight headache (especially when standing up or bending over), slight weakness 3/02 @ 8am: slight headache when standing or bending suddenly, mild episodes of dizziness 3/03: No noticed symptoms
48 2021-03-07 sweating Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 s... Read more
Flushing/sweating, racing heart, and warmth over entire body. Initial BP 158/89 (pulse 80), 99% O2 sat. Final BP 135/80 (pulse 76), O2 sat 100%.
48 2021-03-07 runny nose Soreness in upper left arm at injection site; Runny nose; dry throat; This is a spontaneous report f... Read more
Soreness in upper left arm at injection site; Runny nose; dry throat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of bnt162b2 (Solution for injection, Lot number: Not reported) via unspecified route of administration on left arm at 10:30, on 28Jan2021 at single dose for COVID-19 immunization at workplace clinic. The patient relevant medical history was none. The patient concomitant medication included finasteride from an unknown date in 2021 (received within 2 weeks of vaccination). On 28Jan2021, the patient experienced soreness in upper left arm at injection site, runny nose, and dry throat. The patient did not receive treatment for the events. The patient hand did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
48 2021-03-09 fatigue, fever Pt presents to ED 2 days after covid vaccine with body aches, low grade fever, fatigue. Also with mi... Read more
Pt presents to ED 2 days after covid vaccine with body aches, low grade fever, fatigue. Also with mild swelling on anterior lower neck. CT scan showed non-specific mild swelling, no sign of infection. Sent home with steroids.
48 2021-03-12 headache Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observ... Read more
Pt reported left periorbital headache and left arm numbness. Vitals signs were stable. Pt was observed in car for 30 mins. Pt endorsed similar reaction to initial vaccine
48 2021-03-14 fever Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow tur... Read more
Was given shot in top of right shoulder straight into joint. Had infectious cellulitis in elbow turn into gangrene. Was hospitalised for 4days and had to have surgery to remove dead tissue and clean out infection!
48 2021-03-14 throat irritation hoarse voice, throat tightness Narrative: Patient received his 1st COVID shot 3/11/21. Ten minutes ... Read more
hoarse voice, throat tightness Narrative: Patient received his 1st COVID shot 3/11/21. Ten minutes later he developed intense itching, a horse voice, and felt itching in his throat stating " I feel like my throat was getting tight". Spoke in full sentences without difficulty, O2 sat 98% on RA, denied chest pain or shortness of breath. Denied throat or facial swelling or n/v. Denied any prior similar reaction except for pruritus from opiates. Admitted to ER. IV Diphenhydramine and dexamethasone were administered with 1L of normal saline. Observed for 2 hours and discharged as symptoms resolved, no longer flushed, and voice returned to normal. Advised not to have second COVID vaccine administered due to concerns of increased reaction with second dose.
48 2021-03-15 fatigue, headache Muscle soreness and aching in left shoulder / neck / head slightly more than usual. If other intram... Read more
Muscle soreness and aching in left shoulder / neck / head slightly more than usual. If other intramuscular shots have been a pain level of 2, this was a 4. Symptoms lessened to a 1 after 400 mg of ibruprofen. The headache has remained a 3. Minimal fatigue for 24 hours.
48 2021-03-15 malaise I had COVID in December. Felt like I had it again. All symptoms returned except shortness of breath... Read more
I had COVID in December. Felt like I had it again. All symptoms returned except shortness of breath. Lasted 4 days.
48 2021-03-16 chills, fever 2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunda... Read more
2nd Dose of Pfizer vaccine administered at 9:30 am on Saturday 3/6. Saturday afternoon through Sunday evening felt feverish, chills, body aches. Felt fine Monday morning. Monday about 11 am began to feel tightness in chest, thought it was bad heartburn. Pain kept me awake Monday night, and continued into Tuesday morning. Called the doctor, was sent to urgent care. Urgent care detected elevated tritonin and had me transported to the emergency room. Elevated heart rate and rising tritonin levels had me admitted to the hospital. Given heperin and a beta-blocker, given a CT scan, and monitored over night. On Wednesday had a echocardiogram and then a heart catherter and imaging, which showed a healthy heart, no plaque, no blockages. Tritonin levels and heart rate returned to normal. Released from hospital on evening of 3/10.
48 2021-03-16 sweating 48-year-old male who received his Covid vaccine states that he waited the mandatory 15 minutes and a... Read more
48-year-old male who received his Covid vaccine states that he waited the mandatory 15 minutes and actually stayed over a few extra minutes after the vaccine and felt fine got in his car and decided to attempt to drive home when he was driving he became somewhat sweaty diaphoretic and felt lightheaded states that he thought himself he should probably pull over but proceeded to continue driving for short distance until he states the last thing he remembers was thinking he needed to merge into this traffic and then the next thing he knows he woke up to the onstar representative asking if he is okay he noted that he had struck a tree when EMS arrived the patient was approximately quarter of a mile into a field and then struck a tree. The patient states he was ambulatory at the scene he was having right-sided chest wall pain especially with movement or breathing he is noted to have seatbelt sign to that side. The patient denies being on blood thinners denies any other complaints at this time. Restraints: air bag deployed, lap and shoulder. Do to the severity of his syncope, he was admitted for observation overnight.
48 2021-03-17 chills, fatigue As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaust... Read more
As per patient reporting : Sx: Sorearm; 10pm : Shivers ; Next day (1/12/21). 12pm : Nausea ; exhaustion, feelings i was going to die ; unable to sleep at night for 2 nights. As per my evaluation : Patient presented with worsening of psychosis and manic sx.
48 2021-03-17 fever, chills, fatigue Fever chills muscle aches confused foggy mind, aches, weird taste vivid dreams mild ear ache total e... Read more
Fever chills muscle aches confused foggy mind, aches, weird taste vivid dreams mild ear ache total exhaustion debilitating exhausted since 8 hrs after 2nd shot. 1st dose only mild soreness at injection site but 2nd dose is awful. On 3rd day getting worse as is my partner. Both literally bedridden.
48 2021-03-18 chills Chills and body shaking for 3-4 hours
48 2021-03-18 fever, chills Sore arm on day one then day 3 fever chills and aches muscle aches and just for the night day 4 okay
48 2021-03-19 fatigue, head discomfort, headache, fever, sleepiness * All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, no... Read more
* All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, not numb, not shooting pain, not pricking of pins and needles. * Upper body muscles tingling. * Muscles relaxed to weakness or numbness. * Feeling tired, sleepy, fatigue. * Forehead pressure; not congestion, headache, or fever. * Eyes tired and burning.
48 2021-03-20 sinus congestion, headache, cough, chills, fatigue, sweating BECAME ILL AT 15:15 ON 3/16/2021. SYMPTOMS ARE SINUS CONGESTION, COUGH, FATIGUE, CHILLS, SWEATS, HEA... Read more
BECAME ILL AT 15:15 ON 3/16/2021. SYMPTOMS ARE SINUS CONGESTION, COUGH, FATIGUE, CHILLS, SWEATS, HEADACHE, BODY ACHES
48 2021-03-21 dehydration, fever 104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care... Read more
104 fever, dangerous tachycardia, incessant vomiting, dehydration, difficulty breathing. Urgent care immediately called ambulance and taken to ER. Admitted to step down unit to reduce fever and monitor dangerous. tachycardia. Ruled out bacterial, fungal or viral infection.
48 2021-03-22 chills, headache I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, b... Read more
I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021. I was fine all day, but near bedtime felt like something was beginning to happen. My upper left arm was also sore from the injection. I fell asleep at 11:30 PM and awoke at 1:00 AM with body aches and chills. I was never able to get back asleep the entire night. The following morning, March 22, I had body aches, chills, shaking and a terrible headache all day. All of these symptoms continued throughout the day and evening. I stayed hydrated with Gatorade and Sprite and ate very light foods. By the next morning, March 23, the headache was gone, but still have a little remaining of the body aches. No more chills or shaking. Moving slow still, but getting better.
48 2021-03-22 fatigue Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tire... Read more
Weakness in muscles, joint pain, muscle pain and aches affecting movement, injection site pain, tiredness/fatigue
48 2021-03-22 fever, chills Fever for 3 days and chills. TINNITUS has not stopped very loud ringing never had it before.
48 2021-03-23 chills, headache Chills, joint pain (especially in hands), muscle pains, headache. Symptoms resolved by 48 hours po... Read more
Chills, joint pain (especially in hands), muscle pains, headache. Symptoms resolved by 48 hours post vaccination.
48 2021-03-23 sweating Patient sweated and almost passed out after received the shot. He recovered after 10 minutes and BP ... Read more
Patient sweated and almost passed out after received the shot. He recovered after 10 minutes and BP resumed normal.
48 2021-03-24 chills, fever, fatigue injection site pain, Chills, body aches, fever (101-deg F), tiredness, diarrhea
48 2021-03-25 headache, fever Fever. Headache. Body aches. Lower back aches. Possible kidney ache. Lasting 16 hours and counting
48 2021-03-26 headache, fever On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they go... Read more
On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they got more server as the night progressed. I could not sleep with the pain. Then on 3/25/2021 at about 2 am in the morning I started getting a headache while still having stomach cramps. At about 7:00 am I had a fever of about 99.5 degrees then at about 11:00 am I had a fever of about 100.2 degrees and the stomach cramps were still there. I drank lots of water and Pedialyte to stay hydrated but had a very difficult time urinating. it was very little. At about 10 pm the cramps started to subsided but were still lightly present. my appetite went to almost nothing but soup for 2 days, I have had leg and arm cramps off and on during this process as well. I did not want to eat. today 3/27/2021 is the first day I have started to feel normal.
48 2021-03-26 sweating COMPLETED OBSERVATION TIME OF 15 MINUTES POST VACCINATION, WENT TO CAR AND FELT DIZZY AND SWEATY. ME... Read more
COMPLETED OBSERVATION TIME OF 15 MINUTES POST VACCINATION, WENT TO CAR AND FELT DIZZY AND SWEATY. MEDICAL PERSONNEL RESPONDED WITH GURNEY AND TRANSPORTED PATIENT TO TRIAGE 1. ECG COMPLETED BY EMT WITH PHYSICIAN AT BEDSIDE AND 2 RNS. RESPONDED TO WATER, ICE PACK TO BACK OF NECK. NORMAL PALLOR RETURNED. REMAINED TRIAGE 1 UNTIL 17:05. PATIENT CALLED FRIEND TO PICK HIM UP AND DRIVE HIM HOME. SAT, THEN STOOD THEN WALKED TO INSURE SYMPTOMS RESOLVED PRIOR TO DISCHARGE.
48 2021-03-28 headache, fever Headache, sore arm, body aches, fever of 100.5 day after 1st shot. Second day still had a very mild... Read more
Headache, sore arm, body aches, fever of 100.5 day after 1st shot. Second day still had a very mild headache. Advil helped symptoms
48 2021-03-28 malaise After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. ... Read more
After receiving the 1st dose of Pfizer COVID-19 vaccine, the patient moved to the observation area. After 5 min, patient reported feeling light-headed and tried to stand up. The patient sat down on the floor and leaned against the wall. Patient was able to stand and walk to the provider room for closer observation. Patient felt hot and looked pale. The provider placed a blood pressure cuff on the patient, at which point the patient slumped forward and stopped breathing. A carotid pulse was not able to be appreciated. The patient was pulled to the floor, positioned airway open and was given oxygen. BP was 96/40. Blood sugar was checked (104) and the AED pads were placed. EMS was called. AED advised no shock, patient had a pulse and was breathing. Patient gradually became alert, though reported not feeling well. Patient was disoriented and was not aware of passing out nor the current event. Repeat BP 115/50. Patient began vomiting (~300-400 mL). Patient left with EMS to be evaluated at local Emergency Department. Of note, patient reports history of vasovagal syncope events 2/2 to various situations.
48 2021-03-28 throat pain, headache Patient had his second Covid vaccine 3/25 at covid vaccination site. Initially had redness at injec... Read more
Patient had his second Covid vaccine 3/25 at covid vaccination site. Initially had redness at injection site (patient thinks as hives) immediately after administration, but subsided within 15 minutes on its own. Patient reports he really started having symptoms 72 hours after vaccination, including: Dizzy spells, sore throat comes and goes, headache comes and goes, occasional chest tightness. Patient states he did also have these symptoms with the 1st dose as well. Patient is still able to eat and drink fine. Taking Tylenol during the day, and Benadryl before bed for some relief. Patient is monitoring at home, drinking lots of water and will seek care if symptoms to not dissipate or worsen in any way. No shortness of breath, difficulty swallowing or breathing, rashes, etc at this time.
48 2021-03-29 headache, chills Vomiting. 24hrs Diarrhea 30 hrs Headache Muscle Ache Chills Hives (severe) Nausea Stomach pain... Read more
Vomiting. 24hrs Diarrhea 30 hrs Headache Muscle Ache Chills Hives (severe) Nausea Stomach pain Anaphylaxis
48 2021-03-29 sweating PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just f... Read more
PT was administered vaccine at 1025 and shortly there after started to shake, felt sweaty and just felt weird. Then passed out. PT was quickly assisted by vaccination staff at car side and then medical staff was notified. Upon arrival PT was very pail and lacked color, but was awake and stated that he has never had that happen before. Denies any history of having adverse effects to medications. NKDA. Ambulance was called. 1045 Vitals BP: 80/60 Pul: 68 Sp02: 97 1045 Ambulance arrived 1050 BP: 92/58 PT was taken to local ER for further observation.
48 2021-03-30 chills, headache, influenza like illness, malaise, fever, sinus pain low fever; chills; headache; week muscles; joint pain; sinus pain; feeling unwell; He has flu-like s... Read more
low fever; chills; headache; week muscles; joint pain; sinus pain; feeling unwell; He has flu-like symptoms; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. The patient took Advil, Flonase and pseudoephedrine, this morning he woke up feeling much better and many of his symptoms resolved, however under his armpit he has a very pronounced and tender swollen area that was not there before, he assumes it is a lymph node. On Tuesday, he had a good number of the possible side effects. He was feverish, and had chills, pounding headache, sinus pain, painful joints and generally felt pretty bad. He took Sudafed last night, Flonase and Advil and woke up this morning feeling much better. He also noticed a really swollen area near armpit, which he assumes is a lymph node, and is very tender and swollen. He doesn't want to say it is a baseball size. It is not small either. It is unusual and was not there before. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of low fever, chills, headache, week muscles, joint pain, sinus pain, feeling unwell and he has flu-like symptoms. the outcome of events was unknown. Information about lot/batch number has been requested.
48 2021-03-30 headache Slight headache within an hour of dose.; This is a spontaneous report from a contactable consumer. A... Read more
Slight headache within an hour of dose.; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 09Feb2021 08:15 as single dose at Workplace clinic for COVID-19 immunisation. Medical history included none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 09Feb2021 09:30, The patient experienced slight headache within an hour of dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered.
48 2021-03-30 sweating Client became hypertensive and diaphoretic after vaccine administration. BP was 69/49, HR 42, Gluco... Read more
Client became hypertensive and diaphoretic after vaccine administration. BP was 69/49, HR 42, Glucose 136. Client was evaluated by Fire Rescue. Fire Rescue called and patient declined transport to Medical Center ER at 1:58 pm.
48 2021-03-31 chills, headache No medical treatment needed. Headache chills and upset stomach.
48 2021-03-31 fatigue, chills, throat pain - chills, fatigue, sore throat, myalgias
48 2021-03-31 sweating felt dizzy and became sweaty,brought to cot to lay down,VSS, felt better after 30 minutes and let o... Read more
felt dizzy and became sweaty,brought to cot to lay down,VSS, felt better after 30 minutes and let on own
48 2021-03-31 fever, fatigue Body aches, unable to raise arm where vaccine was administered, fever between 102 to 104, extreme fa... Read more
Body aches, unable to raise arm where vaccine was administered, fever between 102 to 104, extreme fatigue, lose of appetite, and anxiety.
48 2021-04-01 chills Joint pain Chills Both was significantly noticeable around 6pm on the day of the second dose
48 2021-04-01 headache Headache, hot feeling body
48 2021-04-01 sweating pt is deaf. as soon as shot was administered pt was holding his heart and made a motion that he ha... Read more
pt is deaf. as soon as shot was administered pt was holding his heart and made a motion that he had chest pain. pt became diaphoretic. he wrote on a piece of paper that he had chest pain. plain twp ems assessed him. he did have elevated blood pressure of 130/90 as well. squad took him to the hospital.
48 2021-04-02 fatigue, headache Aches and pain throughout body (similar to flu aches), fatigue, headache. Silo mar to when I had COV... Read more
Aches and pain throughout body (similar to flu aches), fatigue, headache. Silo mar to when I had COVID
48 2021-04-02 fever, fatigue Extreme fatigue Fever ranging from 99.3 - 100.7 Muscle aches
48 2021-04-02 fever Woke up with a 102.1 fever. Was extremely achy and feverish for 24 hours. 102.3 was the highest I re... Read more
Woke up with a 102.1 fever. Was extremely achy and feverish for 24 hours. 102.3 was the highest I recorded. There is also some swelling and warmth and redness around the injection site.
48 2021-04-03 headache, chills This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT16... Read more
This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced headaches, chills, "loose stomach" i.e. diarrhea, all on Mar2021. The event outcome for events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained
48 2021-04-03 headache, chills injection site soreness; fairly severe chills; body aches; headache; This is a spontaneous report fr... Read more
injection site soreness; fairly severe chills; body aches; headache; This is a spontaneous report from a contactable consumer. A 48-Year-old male consumer (patient) reported that for herself that: he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration on 17-FEB-2021 10:00 AM at single dose in left arm for covid-19 immunization. The patient's medical history included Factor V Leiden blood clotting disorder or mutation. Historical vaccine included BNT162B2 for covid-19 immunization (lot number: EL3247, administration date: 27Jan2021, administration time: 11:00 AM, vaccine location: Right arm and dose number: 1). Concomitant medications included eliquis (APIXABAN). On 18-FEB-2021 at 12:00, the patient experienced approximately 14hours post 2nd vaccination, injection site soreness, fairly severe chills, body aches and headache. Chills lasted 4- 5hours then subsided. Body aches and headache continue 26hours post vaccination. The patient took OTC pain reliever help to alleviate symptoms. The outcome of the events was recovering.
48 2021-04-04 fatigue, chills, fever Chills, fever, severe body aches, exhaustion and severe axillary lymph node swelling in left armpit.... Read more
Chills, fever, severe body aches, exhaustion and severe axillary lymph node swelling in left armpit. 5 days
48 2021-04-05 head discomfort Head pressure without nausea or tingling.
48 2021-04-05 fever, chills Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, ran... Read more
Swollen/painful left arm, tingling in left finger tips, fever, chills, pain in left collar bone, random abdominal pains, muscle aches
48 2021-04-05 fever, headache Headache, Fever, soreness in joints and muscles, dizziness, heavy chest, slowed reaction time
48 2021-04-06 fatigue, chills Muscular pain, especially lower back. Pain first noticed upon waking at 5:45am. Took 3 ibuprofen i... Read more
Muscular pain, especially lower back. Pain first noticed upon waking at 5:45am. Took 3 ibuprofen in morning and 3 again mid afternoon. Fatigue - around 3pm. Slept for 3 hours. Chills at night. Covered up. Pain much improved the following day.
48 2021-04-06 sweating 48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt pres... Read more
48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt presented diaphoretic with drool dribbling from his mouth with eyes rolling back, staring straight up with beats of horizontal nystagmus slumping in his chair. Pt did not respond to verbal or tactile stimuli. This episode lasted ~20 seconds. After this episode pt was AOx3 with eyes open. Pulse remained regular throughout the entire encounter. Denies: SOB, CP / dyspnea, HA, N/V, trauma, numbness, tingling, erythema. EMS was called to monitor vitals. Pt was transported via EMS to hospital (as per patients request), pt agreed to be transported. EKG was unable to be obtained due to chest hair. PMH: HTN, hyperlipidemia PMH: HTN, hyperlipidemia, Anxiety Meds: amlodipine, metoprolol, simvastatin, remapril, pepcid, lexapro Allergies: Penicillin (rash) Patient was advised for second dose of Pfizer to request to be laying down while getting the vaccine in case of a repeat episode or vasovagal risk.
48 2021-04-06 sleepiness Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with gene... Read more
Anxiety, Panic, Weakness, unable to stand, generalized weakness. 98/60 68. Pt. observed with generalized weakness. unable to keep eye open. Emergency personnel notified and pt. was transported to Hospital for further evaluation.
48 2021-04-07 fatigue Extreme fatigue. Inability to stay awake past 5:00 PM in the afternoon. Very high blood sugar.
48 2021-04-08 sweating 5 minutes after receiving the vaccine, the client fainted. Attending nurse performed a sternum rub ... Read more
5 minutes after receiving the vaccine, the client fainted. Attending nurse performed a sternum rub and administered an ammonia inhalant. The client woke up pale and diaphoretic. Fire Rescue responded. Client presented hypotension, Client's vitals recovered to normal limits. Client was released to home at 4:45pm. No further evaluation needed as per Fire Rescue.
48 2021-04-08 sweating Light headedness, sweating, Anxious. BP 84/64, 82/46, 100/60, HR 82, O2Sat 98% 1:15 BP 118/70, talki... Read more
Light headedness, sweating, Anxious. BP 84/64, 82/46, 100/60, HR 82, O2Sat 98% 1:15 BP 118/70, talking with friend on phone, stated feel better.
48 2021-04-09 chills, fever Chills, dizziness, slight fever. Started at 8:30 pm. Went to sleep at 12:30 am. Woke up fine.
48 2021-04-09 fatigue shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a ... Read more
shortness of breath; tight chest/lungs; tingling in face; tight lips; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in right arm on 06Feb2021 at 05:30 PM at single dose for COVID-19 immunisation. Medical history included allergies to macadamia and brazil nuts, and was on medication for a few health issues. Concomitant medications included unspecified medication (medications in two weeks). No other vaccine received in four weeks. Patient has not tested COVID prior vaccination. The patient experienced shortness of breath, tight chest/lungs, tingling in face, tight lips, dizziness, fatigue on 06Feb2021 at 06:15 P.M. Events resulted in visit to doctor or other healthcare professional office/clinic. No treatment was given for events. Patient has not tested COVID post vaccination. The outcome of events was recovered with sequel. No follow-up attempts are possible. No further information is expected.
48 2021-04-09 sweating patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his... Read more
patient stated he was sitting after receiving the vaccine he start feeling a tingling feeling on his forehead then he started feeling light headed then bust into a feverish sweat patient was assessed vitals are as follows 5:27p b/p 154/96 p 89 r 18 sat 100% 5:45p b/p 148/93 p 87 r 18 sat 99% 6:00p b/p 152/93 p 81 r 18 sat 99% patient stated he is feeling better patient will be wheeled out to the front entrance where patient will be released to go home.
48 2021-04-09 fever Low grade fever (chills & weakness); Injection site soreness; This is a spontaneous report received ... Read more
Low grade fever (chills & weakness); Injection site soreness; This is a spontaneous report received from a contactable male consumer (Patient herself) of 48-Year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247, Expiration date: unknown) via an unspecified route of administration on right arm on 12Feb2021 01:00PM and first dose (Lot no: EL3247) on 21Jan2021 02:00 PM via unspecified route of administration both as single dose for COVID-19 Immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included for first dose. Patient was not reported to known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not received other vaccines within 4 weeks and within 2 weeks of prior to the COVID vaccine. Post vaccination patient was not tested with covid. On 13Feb2021 12:00pm (24 hours after second dose) patient experienced low grade fever (chills & weakness) and Injection site soreness for 24 hours. Patient did not receive any treatment for the events. Outcome of the event Low grade fever was recovered after approx 8 hrs and Injection site soreness on an unspecified date. No follow-up attempts are possible. No further information is expected.
48 2021-04-09 sleepiness Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vacci... Read more
Patient was inadvertently given a COVID19 vaccine as the second dose after receiving a COVID19 vaccine. Patient was given one manufacturer on 3/28/21 at another pharmacy and incorrectly thought he had missed his second dose. He came to our pharmacy to get the second dose, and it was not realized he had already received different manufacturer just 12 days before. Patient is not experiencing any unusual adverse effects, just a sore arm and drowsiness as would be expected after theCOVID19 vaccine.
48 2021-04-10 chills, fever, fatigue extremely sore shoulder muscle for 36 h. low grade fever with whole body ache and chills (onset appr... Read more
extremely sore shoulder muscle for 36 h. low grade fever with whole body ache and chills (onset approx 12 h after injection; duration 12 h). substantial body fatigue lasting approximately 24 h. normal health status after approximately 2 days
48 2021-04-11 fatigue Fatigue and tiredness increased after about 2 hours post vaccination and continues on the day after ... Read more
Fatigue and tiredness increased after about 2 hours post vaccination and continues on the day after vaccination. I eat a healthy diet; oatmeal and fruit in the morning, yogurt, vegetables and drink water throughout the day.
48 2021-04-11 sweating sweaty, light headed. Monitored and resolved within 25 min.
48 2021-04-12 fever, malaise One day after receiving COVID-19 vaccine dose #1 at vaccine clinic patient presents to ED ill-appear... Read more
One day after receiving COVID-19 vaccine dose #1 at vaccine clinic patient presents to ED ill-appearing and reporting fever and feeling unwell for five to six days. Patient is a living-related liver transplant recipient and also reports mild abdominal discomfort and nausea. Patient transferring to Hopsital transplant hepatology, receiving antimicrobials, improved, and discharged to home two days later medically stable.
48 2021-04-13 cough, fatigue, fever As of 4/12/2021 started dry cough in the evening. Started getting feverish and achy 4/13. Ongoing c... Read more
As of 4/12/2021 started dry cough in the evening. Started getting feverish and achy 4/13. Ongoing cough, fever, fatigue and aches led to covid test on 4/14 which was positive.
48 2021-04-13 sweating Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. ... Read more
Five minutes after receiving dose, stated he started to feel warm and light headed, so he sat down. He then lost consciousness, falling out of his chair and hitting his head. Staff at his side immediately; pale and extremely diaphoretic; started to come to after 10-20 seconds. He sat up immediately on his own. He was oriented to self, place, date. After about 30 seconds, stated he thinks he should lay down again. Lowered his head to the floor, blanket placed under his head and feet elevated using a chair nearby. BP 120/52 Sats 100%, HR 72. Cool packs applied to his neck and forehead. After 2-3 minutes requested to move him to the medical area. Got up to wheelchair, but lost consciousness again; head fell forward, appeared as if upper extremities stiffened and contracted, like sz activity. When in medical evaluation area, client was conscious, but starring blankly and not responding verbally. At 3:02, with assist of 2, moved to the cot to elevate his feet, but again, not responding to requests, such as lay down or elevate your feet, so assisted client to this position. Continues to be diaphoretic, pale and ashen. 911 called at 3:07. Informed him of this and the plan. Friend is by his side. Client denies allergies, states he takes meds for hypertension. 3:15 BP 100/56, HR 52, Sats 92%, hands cool to the touch. EMS here at 3:23; report given and client transferred to Hospital via ambulance.
48 2021-04-13 sweating 0938 Patient became diaphoretic. Did not have breakfast. Offer water and cheese crackers. 0944 Pati... Read more
0938 Patient became diaphoretic. Did not have breakfast. Offer water and cheese crackers. 0944 Patient has eaten and hydrated. States he feels much better. 1000 Patient sitting on side of stretcher. Stated he feels much better. No longer diaphoretic. Color is good. Escorted patient to door.
48 2021-04-14 headache, lethargy After my first shot it took, I woke up during the night and had a headache and felt lethargic . The... Read more
After my first shot it took, I woke up during the night and had a headache and felt lethargic . These symptoms lasted about 4 to 5 days. However they went away. After my second shot, the same thing happened. I woke up and had a bad headache and felt lethargic. It has been 8 days and I still have a throbbing headache. My primary care prescribed steroids.
48 2021-04-14 headache, fever, chills High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches cont... Read more
High fever onset 04/03/2021, chill and shakes, night sweats nightly until 04/13/2021; headaches continue Ibuprofen and Acetamenophen to reduce fever.
48 2021-04-14 sweating Post vaccine pt developed dizziness, nausea and became sweaty. Pt transferred via wc and arrived to ... Read more
Post vaccine pt developed dizziness, nausea and became sweaty. Pt transferred via wc and arrived to obs at 0905. Vitals obtained and monitored. Symptoms resolved. Per physician, pt experienced classic non syncopal vasovagal reaction - resolved. Pt released to home by self at 0920. Vitals as follows: 0909 Lying BP 123/83 HR 67 RR 20 SPo2 96 0915 Sitting BP 134/84 HR 67 RR 18 SpO2 99 0916 Standing BP 119/83 HR 70 RR 18 SpO2 98
48 2021-04-14 lethargy, headache Muscle aches, headache, lethargic, severe pain in injection site, redness, swelling. Tylenol, rest, ... Read more
Muscle aches, headache, lethargic, severe pain in injection site, redness, swelling. Tylenol, rest, increased fluids, cold compresses on injection site. Vicks Vapor Rub with Lavender 4 days.
48 2021-04-15 chills, headache, fatigue Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually i... Read more
Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually improving
48 2021-04-15 fever, chills, headache Fever & chills, whole body muscle aches, headache. Treated with tylenol. Symptoms abated after 36 ho... Read more
Fever & chills, whole body muscle aches, headache. Treated with tylenol. Symptoms abated after 36 hours.
48 2021-04-15 fever, chills Chills, fever, slight nausea
48 2021-04-16 fever, chills, fatigue, headache Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, nig... Read more
Extreme fatigue, constant headache that Tylenol and Ibuprofen would not help. Chills, fever, night sweats.... from 6:00 p.m. to noon the following day.
48 2021-04-16 sneezing, fatigue, influenza like illness, runny nose Somewhat flu like symptoms, mild fatigue, general nausea, basically feel like I just got over the fl... Read more
Somewhat flu like symptoms, mild fatigue, general nausea, basically feel like I just got over the flu or something, two days after it felt more like a cold, some sneezing and a runny nose for one day.... then turned into what felt like my normal response to pollen based allergies for like a day and now is more like day after as if i had the flu (or day before) thought I felt better yesterday, worked - now I feel bad again.
48 2021-04-17 chills, body temperature increased I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly a... Read more
I started shivering around 1am. It got so bad that my teeth were chattering, too. I slept poorly and at 6am took my temperature. It was 101.4. I used a digital thermometer under the tongue. I took 2 acetaminophen at 8am. At around 10am my fever broke. My temperature stayed around 99 throughout the day. I felt "whoozy" and weak for the rest of the day. Today, April 18th at 10am I don't have any symptoms.
48 2021-04-17 chills, fever Chills; fever; muscle soreness; This is a spontaneous report from a contactable consumer (patient). ... Read more
Chills; fever; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration, in left arm on 29Mar2021 at 08:45 (at the age of 48-year-old) at single dose for COVID-19 immunization. Medical history included Epstein-Barr and diagnosis of COVID-19 prior to vaccination. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced chills, fever and muscle soreness the night after the vaccine on 29Mar2021 at 22:00. He woke up with the same. The patient didn't receive any treatment for the events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-04-17 fatigue, chills, sweating Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea al... Read more
Extreme dizziness and nausea resulting in fainting twice and hitting chin on furniture. Diarrhea all night at least once per hour. Chills and shaking. Sweats, very fatigued, no appetite, no sleep. Rested all Sunday, no more chills but still nauseous, diarrhea all day. No energy or appetite.
48 2021-04-17 fatigue, chills Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; ... Read more
Upset stomach starting about 36 hours after injection. Stomach issues continued for 5 days; nausea; body shakes; weakness; fatigue; chills; This is a spontaneous report received from a non-contactable consumer reported for self. This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Mar2021 11:30 AM Left arm as single dose (lot: EP7533) for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Eosinophilic Esophagitis. Prior to vaccination, the patient did not diagnose with COVID-19. No allergies to medications, food, or other products. Concomitant medication included Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He experienced Upset stomach on 26Mar2021 02:00 AM. Stomach issues continued for 5 days culminating in an episode of nausea, chills, body shakes, weakness, and fatigue. This episode passed fairly quickly in about an hour. Since the day after this episode have felt fine (approximately 48 hours). Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event Upset stomach was recovered on 31Mar2021 02:00. Outcome of the events nausea, chills, body shakes, weakness, and fatigue were recovered on 28Mar2021 02:00. No follow-up attempts are needed. No further information is expected.
48 2021-04-17 fatigue, chills It's like brittles on my back through my shoulder blade; Chills; My muscles aching; It hurts my lowe... Read more
It's like brittles on my back through my shoulder blade; Chills; My muscles aching; It hurts my lower back; I am tired; This is a spontaneous report from contactable consumer (patient). This 48-years-old male patient received the first dose of bnt162b2 (PFIZER BIOTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 26Mar2021 as single dose for covid-19 immunisation. There has no medical history or concomitant medications. On 26Mar2021, the patient reported it's like brittles on his back through his shoulder blade. The patient had chills and his muscles aching. It hurts his lower back and he was tired. The outcome of the events was not recovered/not resolved..
48 2021-04-17 fatigue, headache, fever Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatig... Read more
Pfizer 1st Shot gave me loud Tinnitus and hasn't stopped.; headache; Had fever for a few days; fatigued; arm soreness; he was scared; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation, age of vaccination 48 years old at workplace clinic. Medical history included Heart Disease and Covid-19 from an unknown date. No other vaccines in four weeks. Concomitant medication included losartan taken for an unspecified indication, start and stop date were not reported. The patient experienced loud tinnitus and hasn't stopped. Described as screaming High Pitch Ringing. Patient stated he was praying it will go away. Patient had headache, had fever for a few days, fatigued, and arm soreness on 19Mar2021 20:30 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): negative on 20Mar2021. Treatment was not received for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. Physician office visit was made for tinnitus, headache, had fever for a few days, fatigued, and arm soreness. The patient stated "This is really scary stuff. Please stop blaming it on Covid". Patient further stated, "Since day 2 of shot which I got on St Patty's Day 17Mar2021. I am on Day 13 of this new hell with no end in sight". He filed a VAERS report and notified his Primary care Dr and ENT. Patient won't get the 2nd shot, as he was scared (Mar2021)." Outcome of the event scared was unknown while not recovered for the other events. The patient considered the tinnitus as serious (very serious and others have experienced this). No follow-up attempts are possible. No further information is expected. Lot number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366081 Same reporter/drug/AE, different patient;US-PFIZER INC-2021366082 Same reporter/drug/AE, different patient
48 2021-04-17 fatigue 4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremit... Read more
4/11/21 generalized fatigue 4/14/21 shortness of breath and chest pain 4/15/21 right lower extremity Deep vein thrombosis and bilateral Pulmonary emboli 4/16/21 mechanical thrombectomy of pulmonary emboli 4/15/21 - 4/18/21 treatment with heparin infusion which was transitioned to eliquis
48 2021-04-17 fatigue I am having fatigue; muscle soreness; This is a spontaneous report from a contactable consumer (pati... Read more
I am having fatigue; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was ER2613),via an unspecified route of administration, administered in Left arm on 27Mar2021 at 13:30 (at the age of 48-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced fatigue and muscle soreness on 30Mar2021. The events were reported as non-serious. No treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
48 2021-04-17 malaise, chills, fever Heart stopped 6 times; unresponsive; soreness; felt like unwell; vomiting; Body aches; achiness; pas... Read more
Heart stopped 6 times; unresponsive; soreness; felt like unwell; vomiting; Body aches; achiness; passed out 7 times; fever; chills; Left arm soreness at injection site and up back of shoulders; Left arm soreness at injection site and up back of shoulders; This is a spontaneous report from a contactable consumer.A 48-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EN5318), intramuscular, administered in left arm on 27Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included asthma, myocarditis and allergies to Fruit or nut that grows on trees. Concomitant medication included esomeprazole magnesium (NEXIUM). The patient's heart stopped 6 times on 29Jan2021, he had a low grade fever, achiness and chills at 01:30, but they were gone the next day. Basically, at first, he took the shot and got the reactions that everyone else does, right arm soreness 01:30. On 07Jan2021 17:00, patient took the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number: EL1042), intramuscular, administered in left arm. No prior vaccination was given within 4 weeks. He fell in the shower and passed out and hit his head at 18:00. He was not hooked up to a machine. About 18:30, his wife got him to the couch. He drank carrot juice and ate a granola bar. At 18:30 his eyes were wide open, but he was unresponsive. About every 30 minutes, he was going down. The third one came about 18:45-19:00. The pass outs lasted 15-20 seconds. and all he remembers was waking up to her screaming at him. The next one came at 19:15 and was in the ambulance on the way to the hospital and that is when he vomited in the ambulance and on the couch. Pass out number 3 was at home and 4 was in the ambulance. There was vomiting with both of them. Pass out number 5 was in the hospital when she was getting in the bed and was not hooked up in the room yet. Finally, they got him hooked up to a machine at 20:30 and into a room. They said if you feel dizzy, press the button. He found out his heart rate went from 80's down to 30's. That was the 6th pass out. This was the first time he was on a machine. His heart did not actually stop, it just went down to 30's and would come back. Then, it happened one more time on the machine and at that point, they were hooking him up to an IV and giving him medication to keep him from vomiting. He does not have the name of that medication or the dose or lot or expiration. He got stabilized but they had him hooked up shockpads in case anything happened. They recorded his heart stopping 6 times during the night and of those 6 times, he does not have the times.2 seconds was the longest time of all of the stops. He does not know how many each were. This was when he woke up on 30Jan2021. He later stated he was hospitalized 28Jan2021 at 7pm and those 6 stops occurred 29Jan2021 through the night previously. The patient was hospitalized for heart stopped 6 times from 29Jan2021 and discharged on 01Feb2021. The patient underwent lab tests and procedures which included body temperature was low grade fever, echocardiogram, brain scan and electrocardiogram shows normal,heart rate: 80 beats, heart rate was down to 30 on his heart beat. They gave shot in the leg for blood clots, nausea medication and a bunch of pills given as treatment. The outcome of heart stopped 6 times was recovered with Sequel, patient passed out 7 times, body aches, fever and chills, left arm soreness at injection site and up back of shoulders was recovering, unresponsive and soreness next day felt like unwell and vomiting was unknown, achiness was recovered. No follow-up attempts are possible. No further information is expected
48 2021-04-18 chills, headache Had chills and could not get warm all night. Lasted for about 6-8 hours. Got headache in the morni... Read more
Had chills and could not get warm all night. Lasted for about 6-8 hours. Got headache in the morning at 7 a.m.. Went back to bed, woke up around 4 p.m. feeling much better.
48 2021-04-18 fever 1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling a... Read more
1). Fever (100.1) 2). Body ache 3). Lower left Leg moderate pain 4). Right under Arm pit swelling and moderate pain
48 2021-04-19 chills, fever, sweating, headache 5 days: Fever, chills, sweats, headache, muscle ache, dizziness, nausea, all-over body rash, all-ove... Read more
5 days: Fever, chills, sweats, headache, muscle ache, dizziness, nausea, all-over body rash, all-over body swelling, loss of appetite No injection site problems
48 2021-04-19 fatigue Diarrhea Started at 5:30pm and until I fell asleep at 11pm. Woke up next morning fine. Fatigue start... Read more
Diarrhea Started at 5:30pm and until I fell asleep at 11pm. Woke up next morning fine. Fatigue started on Tuesday and lasted until Friday (4 days)
48 2021-04-20 headache VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lighthead... Read more
VS: 106/67, SPO2 98%, HR 75, RR 18, Pt altered observational nurse, he was feeling hot and lightheaded. Pt fell to the ground, states he has a history of passing out with needles. Small laceration to forehead and small abrasion to nose. Within 10 minutes in observation hall pt states he felt much better. A&Ox3, with slight HA. Pt wife at bedside. Educated on s/s of when to seek medical attention. Ambulated with steady gait. Denies PMH, meds or allergies. Offered to call EMS to take to hospital, patients wife at bedside stating she feels comfortable taking the pt home. Educated on when to seek medical care if needed.
48 2021-04-21 headache, throat pain Dizziness, oncoming headache, sore throat. BP 157/93. O2 sat 98%.
48 2021-04-21 sweating Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Giv... Read more
Syncope, flushing/sweating, dizziness. Patient fainted. BPs 99/57 (pulse 64), 103/61 (pulse 67). Given water, juice, crackers.
48 2021-04-22 headache Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head fo... Read more
Red patch on arm for about 10 days, he in size to 4"x6". Tingling on tongue. Pain on back of head for several days, still continuing. Numbness in left jaw, Loss of muscle use on left side of face. Went to ER where they indicated Bell's palsy.
48 2021-04-23 chills, lethargy, fever 102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness a... Read more
102° fever, extreme muscle aches (sharp pain, pressures, cramps), chills, lethargic and soreness at injection area. Most symptoms began approximately 12 hours after the shot and lasted approximately 18 hours. Took Tylenol for fever and pain.
48 2021-04-24 fatigue, chills, malaise, fever, headache clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted;... Read more
clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted; had little sleep; pain in my neck and left shoulder; pain in my neck and left shoulder; sore muscles; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fish oil, Men's Multivitamin and "avmacol," all from unknown dates for unknown indications. The patent reported he started having pain in his neck and left shoulder; further described as like sore muscles, for which he was annoyed enough to take ibuprofen and use ice packs. On Sunday 07Mar (2021) the patient noticed there were clusters of small blisters all over his left shoulder and neck, overlaying a splotchy red rash; reporting they were mostly on the left shoulder, but started in the center of his chest and went all through to his back and stopped at his spine. The patient also reported the past very days he felt very unwell, enough to miss work. Aside from the rash/blisters, he had a headache, chills, and a fever that had come and gone, which measured 103.4 at it's worst. He reported taking dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) every six hours which he thought helped, and he reported using cold compresses for the rash, blisters. He stated he felt exhausted the whole time but had little sleep, which was helped by the dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol for a few hours. He reported today (as of 22Mar2021) was the first day in a few that he'd felt alive enough to report. The blisters/rash were about the same, "but the blisters." The events required a doctor or other healthcare professional office/clinic visit. The clinical outcomes of pain in my neck and left shoulder, sore muscles, cluster of small blisters, splotchy red rash, felt very unwell, headache, fever, chills, exhausted, and had little sleep were reported as recovering. It was also reported the patient was tested for COVID-19 post vaccination, and on 14Mar2021 had a negative nasal swab. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
48 2021-04-24 fatigue Soreness at and around vaccination site for several days; fatigue for two days.
48 2021-04-24 headache, chills, throat irritation, throat pain Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spon... Read more
Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spontaneous report received from a contactable consumer (Patient) reported for himself. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and expiration date was not provided) and (lot number: EK5730 and expiration date was not provided), via an unspecified route of administration, in Arm left, on 25Mar2021 at 01:30 PM (at the age of 48-years-old) at a single dose for COVID-19 immunisation, at workplace clinic. Medical history and concomitant medications were not reported. Allergies to medications, food, or other products included: gluten, penicillin, ciprofloxacin, differin, tessalon pearls. The patient previously took first dose of BNT162B2 (lot number: EJ1685) on 04Mar2021 at 03:30 PM (at the age of 48-years-old) in Left arm for COVID-19 immunisation and experienced headache /sore arm started after first dose, headache started within 1 hour of receiving vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that on 26Mar2021 at 01:00, the symptoms started after receiving second dose at around 1 am after 2nd dose, dose time was 1:30 pm day before sore arm sore throat/scratchy throat, headache, chills. The events were reported as non-serious. No treatment was received for the events. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-04-24 headache Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himse... Read more
Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: EJ1685) via an unspecified route of administration in left arm on 04Mar2021 at 15:30 (at the age of 48-year-old) for COVID-19 immunisation. Medical history included allergies to tartrazine, gluten and penicillin. Concomitant medications were not reported. Patient previously took ciprofloxacin, differin and tessalon perle and experienced with allergy for all. On 04Mar2021 (stated within 1 hour of receiving vaccine) patient had headache and on an unknown date in Mar2021 (after first dose), patient had sore arm. Treatment was not received for the adverse events. Outcome for the event headache was not recovered and was unknown for sore arm.
48 2021-04-24 fever, headache COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a ... Read more
COVID-19 test / PCR nasal swab test was positive; COVID-19; Headache; Fever of 99.0; Ill; This is a spontaneous report from a contactable consumer (patient) and nurse. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at age 48-years old, the first dose via intramuscular route of administration in the left arm on Jan2021 08:00 (Batch/Lot Number: EL3248) as a single dose, then at age 48-years old the second dose via intramuscular route of administration in the left arm on 02Feb2021 16:45 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunization at a workplace clinic. Medical history was not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. Concomitant medications were not reported. On 08Apr2021, the patient reported he was ill. On 09Apr2021, the patient began to experience headache and a fever of 99.0. On 12Apr2021, COVID-19 test (PCR nasal swab test) was positive. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The outcome of events vaccine failure, COVID-19 test positive, illness, headache and fever was recovering
48 2021-04-24 fever his is a spontaneous report from a contactable consumer (patient's wife) via Medical information tea... Read more
his is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 (Lot Number: EN6207) as SINGLE DOSE for COVID-19 immunization. Medical history included back pain from an unknown date and unknown if ongoing , COVID-19 from Nov2020 to an unknown date and family history of Amyotrophic lateral sclerosis (ALS) from an unknown date and unknown if ongoing. The patient previously had dose 1 of BNT162B2 (lot number: EN6198) on 17Mar2021 in left arm as single dose for COVID-19 immunization. Concomitant medications included ibuprofen taken for back pain, start and stop date were not reported and probiotics twice a day. The patient had fever that reached 101.5°F on 07Apr2021 and last night when he laid down in his stomach he got nosebleeds on 08Apr2021 until this morning. The patient was given Tylenol and the fever has receded and the nosebleeds have stopped and he can get upward. She is just concerned about the nosebleeds of the patient and she would like to know if this has been reported as a side effect since she was not able to find anything about this. The patient has been having a pretty rough fever of 102 today, which was higher than last time. States that the patient did get a little fever last time but was still able to work. If the patient lays on his stomach, it just drains out and if he lays on his back, he is basically swallowing it. The patient has been having other symptoms, like aches, pains and 102 fever but is most concerned about the nosebleeds. The patient was feeling feverish last night. States that temperature was 101 or something two hours ago and went checked 15 minutes ago, was 102. States that it has raised in the last couple of hours. The patient just took Tylenol when temperature was 102 as treatment. The nosebleeds started this morning and is still going on now. Drainage is not as much but still has drainage and is now sitting upright. States that when he lays on his stomach, it starts flowing. States that when he came to bed this morning, he suddenly felt like his nose was draining. Explains that he just took another nap on his stomach and found a little blood on the sheets. The patient had no emergency room visit or visit to physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fever was not recovered and outcome of the rest of events was unknown.
48 2021-04-25 headache Headache, pain in joints , lack of focus, lose of appetite, lose of smell.
48 2021-04-26 fatigue, fever Please note that I am the patient in question here, but also an physician, so I will write this in t... Read more
Please note that I am the patient in question here, but also an physician, so I will write this in technical terms as best as I understand what happened. For background, my cardiac history is important. I had a work-up for palpitations performed more than a year ago that revealed normal cardiac function (EF > 65% by NM myocardial perfusion study), normal coronary arteries, and significant exercise tolerance (I maxed out the treadmill test). Usuallly I have to engage in vigorous exercise to raise my heart rate > 160 bpm. My resting heart rate is typically in the 50s or less. On Jan 15, 2021 I had an elective cerebral angiography and embolization procedure performed. I was asymptomatic prior to this procedure. The procedure requires general anesthesia for several hours. I have had the procedure conducted a few months previously and it typically has an unremarkable recovery, one night required in the hospital. After the procedure and following extubation, I had hypoxia on room air, tachycardia, wheezing and fatigue. The working cause for this was suspected atelectasis due to general anesthesia and I was given bronchodilators. While my breathing improved overnight, I was very tachycardic even while sleeping ? pulse greater than 130. Overnight telemetry noted arrhythmias with sinus tachycardia. The tachycardia persisted long after prior albuterol use so I had CTA chest on 1/16. No PTE was noted, though some basilar atelectasis and mild upper lobe ground glass opacities. I was discharged but due to continued mild hypoxia overnight, low grade fever (< 101F), and persistent tachycardia with any movement, I went to the ED on 1/17 for additional evaluation. In the ED, I had tachycardia with arrhythmias noted (rate up to 160). Sinoatrial exit block noted on EKG and telemetry. COVID-19 testing was negative by nasopharyngeal PCR and antigen testing. Resting heart rate was > 90 even when sleeping. Follow-up echocardiogram on 1/21/21 revealed depressed ejection fraction (40-45%). Cardia MRI on 2/1 was performed to evaluate for cardiomyopathy. Symptoms at this point were fatigue, dyspnea with even mild activity (e.g. walking), and tachycardia > 140 bpm with even just walking. My resting heart rate improved to 40s-50s. It showed normal wall motion and ventricle size with slightly reduced ejection fraction. Cardiology recommended cardiac event monitoring which I wore for 28 days. It only revealed sinus tachycardia and bradycardia. I still don?t feel great but able to do more physically than a couple of months ago. I await further f/u cardiac imaging to see if there has been improvement in the heart function.
48 2021-04-26 throat pain, headache, fever, head discomfort Shingles. Started with sore throat and headache. Pain intensified on left side only of back of head... Read more
Shingles. Started with sore throat and headache. Pain intensified on left side only of back of head and throat/neck. Head swollen. Low fever developed. Went to urgent care twice over the weekend. Rules out strept and mono at first visit. Ruled out Covid at 2nd visit. Finally went to Emergency Rrom at hospital and they diagnosed with shingles. Treated with Acyclovir.
48 2021-04-26 sleepiness pt came to get the second dose appearing to not feel well. several of us asked him several times if ... Read more
pt came to get the second dose appearing to not feel well. several of us asked him several times if he was feeling ok and he responded several times that he was just sleepy. pt waiting his 15 min in the waiting area and when he was leaving out of the door he vomitted. Rescue was called and his father was called who came to the pharmacy and encouraged him to go to the hospital in the ambulance.
48 2021-04-27 dehydration, head discomfort, fever Felt fine except for dehydrated for several days after shot. On the 4th day started to feel feverish... Read more
Felt fine except for dehydrated for several days after shot. On the 4th day started to feel feverish and head stuffed up. 5th day still feeling much of the same.
48 2021-04-27 fatigue, fever, headache Fever, body aches, headache, fatigue
48 2021-04-27 headache Swollen lymph nodes. After about a week after the 2nd vaccine I developed pain in the joints in the ... Read more
Swollen lymph nodes. After about a week after the 2nd vaccine I developed pain in the joints in the back of my head. The pain is now persisting for over a week. No specific treatment except using Voltaren 2.32% gel.
48 2021-04-28 cough, fever, productive cough, throat pain Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck st... Read more
Choking; Coughing out foamy mucus from his mouth and throat; soreness at the injection side; Neck stiffness; slight fever; sore throat; slightly bloody, foamy mucus from his nose; slight cough; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 48-year-old via an unspecified route of administration, administered in Arm Right on 13Apr2021 14:00 (Lot Number: Ew0153) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder, and post-traumatic stress disorder (Adhd and ptsd). There was no covid prior vaccination, and no covid tested post vaccination. No other vaccine in four weeks. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); marijuana; calcium; acetylsalicylic acid (ASPRIN); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE); acetaminophen; MULTIVITAMINS [VITAMINS NOS] all in two weeks. The patient experienced choking, coughing out foamy mucus from his mouth and throat on 14Apr2021 02:00, he said it took him several hours to cough out the foamy mucus and also cleared out a significant about of slightly bloody, foamy mucus from his nose. He said all of the foamy mucus felt like it was in his throat and nose but not in his lungs. He fell back asleep, after clearing the mucus and slept another 6 hours and the foamy mucus did not return during the second sleep session. Other symptoms he experienced were soreness at the injection side, neck stiffness, slight fever, sore throat and slight cough on 14Apr2021 02:00. No treatment was received. The events outcome was recovered in Apr2021.
48 2021-04-28 fatigue, headache, fever 100 degree fever lasting 12 hours, headache, fatigue and dizziness
48 2021-04-28 sweating Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse a... Read more
Client fainted after receiving the COVID-19 vaccine as per the vaccinating nurse. Attending nurse administered an ammonia inhalant. The client woke up, Fire Rescue arrived to evaluate client. Showed symptoms of weakness, diaphoresis and paleness. Client presented hypotension and bradycardia. Client needed to be transported to a hospital as per Fire Rescue. Client was transferred to Clinic by Fire Rescue at 3:27pm.
48 2021-04-29 sweating, fatigue 7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, ... Read more
7 days after vaccine I had a pretty intense, unprovoked anxiety attack. I was not under any stress, have never had anything like this occur, was not doing anything strenuous and all of a sudden had what I thought might even be a stroke or heart attack. I walked back to the house and took BP and it was 172/75 and pulse rate was only 64...but I was sweating, faint feeling, blurred vision, completely exhausted and it felt like my heart was pounding...but it wasn?t.?? I took BP multiple times but it was fine. Just a really strange anxiety attack I guess that lasted a few hours. I wasn?t worried about it and was t going to report it but have had 3 other people who unsolicited told me about their anxiety attack between 5 -7 days after shots. Two were phizer and one was Modena. Figured I would report it in case it helped someone else to not panic if they had an event like this. It was quite scary and I don?t get worried about things like that!
48 2021-04-30 fatigue, cough, chills coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he... Read more
coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he has been in his bed and falling asleep in his chair for the past few days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8131), via an unspecified route of administration on 14Apr2021 at 09:20 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The first vaccine has been experiencing loss of vision, chills, body and back pain, and fatigue for the past 3 days, from 14Apr2021. He wanted to know if he should go to the ER. The patient was audibly coughing while on the call. He went to the appointment at 09:20 on 14Apr2021 and while driving back he noticed the loss of vision at about 10:15 on 14Apr2021. He said that the loss of vision comes and goes but is still persisting. On fatigue: Patient has been in his bed and falling asleep in his chair for the past few days. Chills, body and back pain and fatigue were reported as worsened. The outcome of the events loss of vision, chills, body and back pain, and fatigue was not recovered, while of coughing was unknown.
48 2021-04-30 fatigue, headache Fatigue. Moving slowly. Feeling like trying to ?walk through water?. Slight headache (front of head ... Read more
Fatigue. Moving slowly. Feeling like trying to ?walk through water?. Slight headache (front of head above eyes) that wasn?t resolved with ibuprofen.
48 2021-04-30 sweating, headache, fever syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; bo... Read more
syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.
48 2021-05-01 fatigue, fever, malaise, sweating, chills Woke up next morning around 3:15 am with dizziness, injection site pain, and then had fever and chil... Read more
Woke up next morning around 3:15 am with dizziness, injection site pain, and then had fever and chills (sweats), and felt unwell. By 4 am most symptoms gone, but I was tired and felt dizzy until 8 am. Tired rest of the day.
48 2021-05-02 fatigue, chills, fever 6 days after my second vaccination dose, I began to have itchy hives on my arms and legs in the earl... Read more
6 days after my second vaccination dose, I began to have itchy hives on my arms and legs in the early afternoon. By 5 p.m. I began to feel fatigued and by 6 p.m. I had a mild fever of 99. Soon after I had very strong chills and aches with my fever increasing to 102 by 8 or 9 p.m. The fever reduced after I took some ibuprofen but returned by 11p.m. when I went to bed. I slept soundly through the night with no recurrence of high fever or chills and felt very fatigued the next day or two.
48 2021-05-02 fatigue, headache, malaise It all started with body aches, tiredness, and headaches and in the morning the next day after the v... Read more
It all started with body aches, tiredness, and headaches and in the morning the next day after the vaccine started this rash on my buttock and then it was spreading all over my private part. I felt very bad and I went to the emergency room in my city on Saturday 5/1/21 at 8:00pm. And then the doctor detected it as Herpes Zoster (Shingles) and she prescribed me Valtrex 1 tablet (1000 mg total) by mouth 3 times a day for 7days. Unfortunately I'm still feeling really bad and this morning I started with back pain and fatigue and I called my primary doctor office to report what had happened and try to get an app.
48 2021-05-02 fatigue, sleepiness, sweating Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Ver... Read more
Insomnia, being "jolted" awake or just waking up at random times and unable to go back to sleep. Very tired and groggy most days. Hard to concentrate at work. Depression, excessive anxiety. Always worried about there not being a cute for this. Tingling, burning back, shoulder, and neck pain. Never too severe, but there a lot. Painful to sleep after a few hours. Nausea over half the time. Loss of appetite. Eating significantly less. Lost 15 lbs in two months. Fatigue, brain fog, dizziness, lightheadedness. Extremely tired. Originally neck pain in the front, now teeth/jaw hurt in the mornings. Random sensitivity to cold/hot foods. Unpredictable desire to have a bowel movement or to urinate. Usually unproductive. Sweaty hands/feet. Elevated heart rate randomly. Skin tingling/burning on the tops of arms and cheeks. Numbness in fingers. Originally ring/pinky, now thumb/index/middle finders. Mostly left side. Tinnitus, ear pain. Has gotten slightly louder and more noticeable. Symptoms appeared starting a few days after vaccine #1 and are still ongoing as of date of VAERS report.
48 2021-05-02 nasal congestion, fever, throat pain May treat fevers and body aches with Tylenol or Motrin Please keep well hydrated May use hot tea wit... Read more
May treat fevers and body aches with Tylenol or Motrin Please keep well hydrated May use hot tea with lemon and honey or gargle warm salt water for sore throat if desired for symptomatic relief May use saline nasal spray for congestion
48 2021-05-03 headache, fever, fatigue Beginning about 10 hours after the shot, I experienced, extreme fatigue with body and muscle aches a... Read more
Beginning about 10 hours after the shot, I experienced, extreme fatigue with body and muscle aches and a low-grade fever. As the day progressed I developed a terrible, splitting headache, much like a migraine, which I do not normally get. The fever subsided, but the body aches, fatigue and headache continued all day long. Just as the headache was subsiding, I developed a terrible, painful case of heart burn due most likely to not eating much during the day. I could not lay flat at all. The heartburn continued for five hours. I threw up twice after which I was able to fall asleep. By the next morning I felt better from the Pfizer shot, but extremely tired from little sleep. As the day progressed I continued to improve.
48 2021-05-03 fever On day following, suffered high fever and aches for the following 36 hours. On Sunday, experienced ... Read more
On day following, suffered high fever and aches for the following 36 hours. On Sunday, experienced NSTEMI due to myocarditis (not previously diagnosed) and remained hospitalized for two days following.
48 2021-05-04 fever, fatigue, chills, headache Fever or Chills Fatigue Headache
48 2021-05-05 fever, chills, headache Fever 101.5, chills, aches, headache
48 2021-05-06 fatigue, sweating pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside... Read more
pt states he developed symptoms of covid. His body is itchy feeling all over his body on the inside. His muscles felt heavy, he felt hot and was sweating with no fever. His heart beating about 125 bpm. On 4/30/21 he went to ER. EKG was normal. Blood test results showed TSH low and T3 is high. He repeated test 4 days later and had the same results. These test were normal before taking the vax. He was discharged to see a endocrinologist on 5/26/2021. Pt still has the itchy sensation, his eyes burn, still feeling extremely tired and feels like he dying.
48 2021-05-06 fatigue, fever, chills times are in hours after vaccination: muscles aches, fatigue at 12h, chills at 23h, 101.7F fever at ... Read more
times are in hours after vaccination: muscles aches, fatigue at 12h, chills at 23h, 101.7F fever at 33h
48 2021-05-06 fever Got slight pain in armpit and little swelling found next day of first shot. And that went of couple ... Read more
Got slight pain in armpit and little swelling found next day of first shot. And that went of couple of days. Next day after second shot, got a lemon sized swelling and pain in under arm - armpit where the shot taken (left hand). Got slight fever but not bad. Still having armpit pain and swelling. But pain is reduced slightly
48 2021-05-06 sleepiness, fatigue Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four... Read more
Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four full days afterwards before easing off on the fifth day, and gone by the sixth. During this time I also had some confusion and difficulty comprehending reading and verbal explanations. Unsure what day it was. I found myself misspeaking words with the wrong meanings. I also was confused if I had completed tasks such as going for a scheduled unrelated blood test, taking my car in for maintenance, etc, and could not recall if I had done these things or if they still needed done. I would stay awake no more than a few hours, 5 at most, then sleep for 8-10 hours. This went on until the fifth day.
48 2021-05-07 fatigue, fever Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exh... Read more
Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism . Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021. Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found pome-(pulmonary oil micro embolism)." The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
48 2021-05-07 influenza like illness No adverse events after 1st dose. I had very mild flu like symptoms 24 hours after 2nd dose. Then a... Read more
No adverse events after 1st dose. I had very mild flu like symptoms 24 hours after 2nd dose. Then a week later I began having ringing in my ears. This has been continuous since that day.
48 2021-05-07 pneumonia This 48 year old male received the Covid shot on 12/22/20 and went to the ED on 1/5/21 with th... Read more
This 48 year old male received the Covid shot on 12/22/20 and went to the ED on 1/5/21 with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism U07.1 - COVID-19
48 2021-05-09 headache, fever Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She stat... Read more
Per pt's wife 1 hour within receiving the vaccine, pt got a fever, headache, and dizziness. She states he took ibuprofen at home . She states that on April 26,2021 pt's primary care physician - was contacted. She states that on April 28,2021 she heard back from him . She states hat on April 29,2021 he went to get lab work (WBC) that md ordered. she states that pt was contacted on May 1,2021 by primary care physician to go to the ER . She states that he was admitted to hospital from May 1,2021- May 4,2021 and diagnosed with Leukemia (CML)
48 2021-05-10 fatigue, headache passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous re... Read more
passed out; felt dizzy; Felt fatigue; headache which lasted about 10 hours; This is a spontaneous report from a contactable consumer report for self. A 48-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 23Apr2021 08:30 as single dose for covid-19 immunisation. None Medical history reported. No covid prior vaccination. No other vaccine in four weeks, no Other medications in two weeks. Patient received first dose of bnt162b2 (Lot number=ER8733) on 26Mar2021 03:30 PM in left arm. About 20 hours (on 24Apr2021 04:00 AM) after injection felt dizzy, passed out. Felt fatigue and headache which lasted about 10 hours. No treatment received, Patient recovered from the events. Patient has not been tested for COVID-19 Since the vaccination.
48 2021-05-10 headache, fever, cough Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respirator... Read more
Hot and cold flash fever off and on Cough Muscle or body aches Headache Acute hypoxemic respiratory failure Pneumonia due to COVID-19 virus Received plasma therapy remdesivir dexamethasone?changed to oral Decadron upon discharge
48 2021-05-10 headache, fever Fever; Vaccination site pain; Headache; This is a solicited report from marketing program based on t... Read more
Fever; Vaccination site pain; Headache; This is a solicited report from marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3862391-00). A contactable 48 year old male consumer (patient) reported for himself that patient started to receive first dose of BNT162B2 (BNT162B2 Solution for injection) on an unknown date via Intramuscular route of administration at SINGLE DOSE for COVID-19 immunisation. On 09Apr2021 patient received 2nd dose Covid-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unknown date the patient received Adalimumab (HUMIRA) at Citrate Free via Subcutaneous route of administration for Crohn's disease). The patient's medical history and concomitant medications were not reported. On 09Apr2021 the patient experienced Fever Sore arm from Covid Vaccine, Headache resolved and Vaccination site pain. The events were assessed as non-serious. Fever, sore arm from Covid Vaccine and Headache with Humira(Adalimumab). Covid-19 vaccine was also considered suspect for all events. The outcome of the events was recovered. The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-05-10 headache A male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for in... Read more
A male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:30 or 12:35 (Batch/Lot Number: ER8731) as single dose for covid-19 immunisation. Medical history included migraine from 2000 to an unknown date, ongoing hepatitis c. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) taken for migraine. The patient previously took atropine and experienced hypersensitivity. Caller states that he got the vaccine at 12:30 in the morning and he got a headache at 5 or 6 o'clock in the evening. He read also, in his country, that with other vaccines, not Pfizer, that after each shot they had a mild headache. He states that he read on line that it is normal to get a headache after getting the vaccine and that it can last up to three days. He states that the headache can come on again and off again. He states that once you get a migraine it doesn't go away until you take medication. He states that he has been taking medication for years so he knows that this is a migraine headache and not related to the vaccine. He states the next day after getting the vaccine the headache was gone. From Friday until Sunday he was fine, for 3 days he had nothing. Now he states its a migraine. He woke up and felt like he has motion and wants throw up. He states that if you are hungry and you go to sleep and then you wake up that feeling will come back after sleep. So when he goes to sleep, and wakes up with a migraine, he takes medication and it goes away. He states that he read online that within 24 hours don't take any medication because it can lessen the effect the vaccine. He states he knew that getting a headache was normal, now he know it is not Pfizer's vaccine effect, he knows it's a migraine. He was just wondering if he can take his medication. He states that he read that you can have a headache for two or three days after the vaccine. He is calling because has been sick with a migraine for a long time. He has been taking Excedrin migraine medication for migraines because it saves him all the time. He wants to know if he can take medication now or should he avoid it. He states that he read somewhere that it is normal to have a headache for up to three days after getting the vaccine so he was ready for it. He also read some where that he should not to take and medication with in 24 hours of getting the vaccine and he wants to know if he can take the medication now. The outcome of the event headache was recovered The outcome for the events migraine and he has a motion and wants to throw up was unknown. No follow-up attempts are needed. No further information is expected.
48 2021-05-10 fever -Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has be... Read more
-Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has been having fever since yesterday morning running 102.7-103.9F. Called PCP and was advised to present to the ED yesterday but he did not. He fell after losing his balance today. Endorses nausea, confusion. Has extensive medical history. Patient has signs of sepsis with likely bacterial infection acute cystitis/pyelonephritis. His lactate and procalcitonin are unremarkable and vitals remained stable however he does have an elevated total bilirubin as a possible sign of a more serious systemic response. The patient does have chronic cirrhosis and persistent fever and tachycardia. Given these clinical findings he is referred for admission for IV antibiotics and further close monitoring. Unfortunately, urine cultures were not sent. His blood cultures however did grow 2 of 2 bottles positive for Klebsiella pneumonia. These are both sensitive to Levaquin. In the course of his hospitalization, he has improved. He is now requesting discharge. Will discharge home on p.o. Levaquin. Is discharged in improved condition.
48 2021-05-11 headache, fever About 14 hours after the COVID vaccination (shot #2), I had joint aches, headache, followed by fever... Read more
About 14 hours after the COVID vaccination (shot #2), I had joint aches, headache, followed by fever (peaked at 100 degrees Fahrenheit). Duration of symptoms about 18-24hrs.
48 2021-05-11 malaise I developed a black eye the day after the shot. I felt moderately sick as has been reported for othe... Read more
I developed a black eye the day after the shot. I felt moderately sick as has been reported for others after the second dose, otherwise no other symptoms.
48 2021-05-12 chills Second day after the second dose, I started feeling chill and muscale pain for two days, and it went... Read more
Second day after the second dose, I started feeling chill and muscale pain for two days, and it went away. The following week, I started feeling loss of taste on sweetness mostly. The loss is sudden and signficant. Few days after and now I am pretty much lost the taste to sweetness. Other tastes are not as bad, but less sensitive.
48 2021-05-12 fatigue Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired altho... Read more
Became sore, achey, flueish and tired that night. Sore arm. Next 10 days was extremely tired although other initial symptoms cleared up in 36 hours after shot.
48 2021-05-13 headache, chills, fatigue, fever lose smell and taste; lose smell and taste; Positive Rapid Covid Test; progressively fatigue; he had... Read more
lose smell and taste; lose smell and taste; Positive Rapid Covid Test; progressively fatigue; he had a headache; at night he had chills; fever with more fatigue; fever with more fatigue; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), (Lot number: EL3248, expiry date: 31Mar2021), via unspecified route of administration in left deltoid on 08Jan2021 as single dose for COVID-19 immunization. Patients medical history was not reported. Patient concomitant medications are Multivitamins, Zinc, colecalciferol (VITAMIN D), fexofenadine hydrochloride (ALLEGRA), Aspirin, and famotidine (PEPCID) from unspecified date and unknown still ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Jan2021, Patient underwent Rapid Covid Test (nasal swab test), tested positive for SARS-CoV-2 test positive. On 26Jan2021, Caller clarified that b he did not have any further symptoms at all, no fever, everything had resolved. Caller clarified that the reason he got tested was because he was having symptoms, on the 19Jan2021 Tuesday he became progressively fatigue at lunch he had a headache, and probably by 7-8pm at night he had chills and fever with more fatigue. He had No chest pain, No shortness of breath, and No wheezing. The symptoms improved, the headache improved Friday, he had mild lingering fatigue and low-grade temperature for next day or so, but it was Tuesday at which he had no symptoms at all. He did lose smell and taste for 24 hours, it was on Friday 22Jan2021, 100% percent couldn't even smell Vicks Menthol. His Second Dose is schedule for 29Jan2021. He enquired about contraindication to getting the second dose of the vaccine. The Outcome of events was recovering for pyrexia ,headache, fatigue The outcome of chills, loss of smell and taste was unknown. Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable other HCP (patient). New information includes clinical information. Follow-up attempts are completed. No further information is expected.
48 2021-05-14 headache, fatigue heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pa... Read more
heart beat is going to 144 and 120; his body is a heavy weight/he is very tired; his body is very pain; has a headache in his head; when he wants to walk he feels dizzy; forgot a lot of things after the vaccine and he forgot his wife.; feel his heart go bum bum bum, too fast; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included inflammatory bowel disease- IBA colon and blood pressure. Concomitant medication included enalapril 5mg for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. On 25Apr2021, at 04:00, the patient started experiencing symptoms, the body was heavy weight and his heart beat was going to 144 and 120, very tired. Patient did not know what was going on as he was heavy for too long, which he though will last for 2 days but it was 7 days now. The patient heart beat fast and when he slept he could feel his heart go bum bum bum, too fast. Patient had body pain and headache. He felt dizzy when he wants to walk. Patient informed that he cannot go to his work and he wanted to know what to do next as the symptoms continue day by day to today. Patient started to forget lot of things after vaccine and he forgot his wife. The patient stated that the symptoms are getting worst and he wants be normal as he finds it very hard to play with his children and that when he stands up to walk his heart goes bum bum bum. The patient underwent lab tests and procedures which included heart rate: 144 and 120 on 25Apr2021. The patient spoke to his primary doctor and was informed to take Tylenol. The patient took Tylenol 2 tablets 500 mg, 1000mg and it was no benefit. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-05-14 throat pain, headache I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a... Read more
I felt fine after the shot, but two hours later, my throat felt like it was closing and it hurt in a way I've never felt before. I had a bad migraine and my whole body was sore. My blood pressure was high for me at 143/94 with a heart rate of 94. I trend at 120/80 with a heart rate around 90. I take my blood pressure regularly to help manage Type II Diabetes. I was concerned with my throat, as the other symptoms seemed normal for the vaccine. It was very uncomfortable. I phoned the nurse line and was told to have someone bring me to the ER to check me out and take a Benadryl. I took the Benadryl and packed for the ER with meds and ID and my friend drove me. I was still uncomfortable enough to warrant wanting to go and had become very dizzy. When we got to the ER there was a wait and I went to my friend's car until called. After about 30 minutes (about 45 minutes after the Benadryl) my throat released and felt much better. My vitals were taken and seemed normal. The normal aches of the vaccine didn't concern me enough to stay, so I returned home. My symptoms remain what seem to be normal reactions to the vaccine: sore joints, slight headache, slightly sore throat, Charlie horse feeling at the injection site. Nothing of major concern. My largest worry was with the throat feeling closed, but it appears the Benadryl took care of it.
48 2021-05-16 malaise, fever This is a Healthcare employee working at a facility, divested this center and it is under new manage... Read more
This is a Healthcare employee working at a facility, divested this center and it is under new management. Previously on 12/1/2020 PT was diagnosed as COVID-19 positive, remained asymptomatic and returned to work on 12/11/2020. On 12/28 administered the vaccine at a workplace clinic . 4 days post-immunization on 12/31/2020 PT reported feeling "unwell' to his direct supervisor and was sent home. On 1/4/2021 PT reported to his supervisor that he had gone to the hospital due to having a fever and shortness of breath, he was tested for COVID at that time and was negative. PT returned home. On 1/13/2021 the center received a call from PT mother reporting that her son had returned to the hospital on the evening of 1/12/2021. Per his mother, PT was attempting to drink from a straw, but was unable to and had noted a facial droop. When he arrived at the hospital he was diagnosed with "suspected Bell's Palsy". Due to the immunization being administered on 12/28/2020 and suspected diagnosis of Bell's Palsy on 1/13/2021 it is unclear if the two events are related.
48 2021-05-16 throat clearing C/O throat closing "like an egg in my throat" clearing thraot -- no c/o SOB, HA, itching, swelling e... Read more
C/O throat closing "like an egg in my throat" clearing thraot -- no c/o SOB, HA, itching, swelling externally. 25mg Diphenhydramine PO w/ effect after 10 minutes
48 2021-05-17 fatigue, runny nose, cough Symptomatic and Positive COVID-19 - cough, runny nose, fatigue
48 2021-05-17 headache, fatigue 05/08/21 -(a tnight)Stomach pain - loose stools 1 time 05/09/21 - Stomach pain all day - loose sto... Read more
05/08/21 -(a tnight)Stomach pain - loose stools 1 time 05/09/21 - Stomach pain all day - loose stools 4 times - muscle pain all day - headache - tired 05/10/21 - Stomach pain all day - loose stools 3 times - muscle pain all day - headache - tired 05/11/21 - Stomach pain all day - loose stools 2 times - tired 05/12/21 - Stomach pain sometimes - loose stools 2 time 05/13/21 - until now - Stomach pain here and there
48 2021-05-17 headache, head discomfort Starting approximately a week after the vaccine was administered, cranial pressure / burning sensat... Read more
Starting approximately a week after the vaccine was administered, cranial pressure / burning sensation started particularly in the forehead area. This has been accompanied by headaches / pain experienced in the forehead areas and sometimes spreading to other areas of the head. This has been constant now for over 11 weeks with varying degrees of intensity. Nothing else changed (diet / lifestyle / etc.) that seems to be able to account for these symptoms, never experienced before that appeared all of a sudden, other than the administration of the vaccine.
48 2021-05-17 sweating, fatigue Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation are... Read more
Pt states he passed out & not feeling good. Diaphoretic. BP 102/67 Via w/c taken to Observation area to lie down. Feeling cold, tingly all over & "wiped out". 3:25PM Taking juice & crackers. Still dizzy when tried to stand up. BP 127/92 3:40PM Left w/o assistance. Feeling much better
48 2021-05-17 sweating Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nerv... Read more
Patient told pharmacist he has habit of passing out when giving blood or getting shots. He was nervous. He did well getting shot, set in room for 5 min., then moved him to waiting room where I asked him to stay 15-20 more min. Over a few min he looked very pale, we offered him water. (he barely sipped any). after 5 min he started sweating. He did not call for help, but technician on duty saw him put his head in his lap. We both went out to tend to him. While we were talking to him, he passed out. We called 911. While giving vitals and info to 911, he came to before they got on scene. While paramedics were assessing him, after about 5-10 more min...he passed out again. This time when he came to, seconds later...he projectile vomited on the paramedics. They tended to him until about 1:15-1:30. PT refused their suggestion and urging to go with them to hospital. Paramedics left him in pharmacy to leave facility on his own will. Pt refused our suggestion to call someone to come pick him up and not drive. After sitting outside to get some fresh air, PT came through our drive thru to tell us he was much better and leaving Store. We told him we would call and check on him 5/17/2021. We have called now 2 days (5/17/ and 5/18) and can not get him to return our call.
48 2021-05-17 fever, headache, chills Headache, body aches, fever, chills, Hand Cramps. Started about 10 to 12 hours after shot and last... Read more
Headache, body aches, fever, chills, Hand Cramps. Started about 10 to 12 hours after shot and lasted for around 16 hours after starting.
48 2021-05-18 chills, fatigue, fever, sweating Immediately tired Chills Shaking Sweating Fever 101 Lymph swelling Sight injection swelling
48 2021-05-18 headache, fatigue Itching throughout the body, fatigue the next day of vaccination, head aches. and right eye a blood ... Read more
Itching throughout the body, fatigue the next day of vaccination, head aches. and right eye a blood vessel rupture with both vaccinations recovered from the fist one and still have the redness in the eye from second doze.
48 2021-05-19 fatigue Skin hot to touch, tiredness
48 2021-05-20 headache Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period pa... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after post-vaccination 15 minute observation period patient experienced loss of conscioussness and a fall from standing. Patient transported by ambulance to emergency department alert and oriented with stable vital signs reporting headache. Patient found to have moderate right subarachnoid hemorrhage, extensive facial and mandibular fractures, bilateral nasal fractures, and right ribs six and seven fractures. Patient determined not to be a candidate for surgery and admitted for pain control, antibiotics, and monitoring. Discharged medically stable on antibiotics with neurology and oral maxillofacial surgery follow-up in place.
48 2021-05-24 chills Moderate chills, muscle aches, joint pain beginning about 12 hours following the second dose of Pfiz... Read more
Moderate chills, muscle aches, joint pain beginning about 12 hours following the second dose of Pfizer vaccine. Moderate pain at the injection site beginning about 6 hours following the second dose.
48 2021-05-25 chills, fever, headache Low Grade Fever; Headache; Chills; Body aches; Sore arm at injection area; This is a spontaneous rep... Read more
Low Grade Fever; Headache; Chills; Body aches; Sore arm at injection area; This is a spontaneous report from a contactable Consumer, Patient. A 48-Year(s)-old Male patient received COVID-19 mRNA VACCINE BIONTECH, Batch No: Lot EL3247 administered in Left arm through Intra muscular on 12-MAR-2021 11:45 AM for covid-19 Immunization. Medical history included High Blood Pressure & Cholesterol. Concomitant medication(s) included Lipitor, Amlodipine, Valsartan, Omeprazole. The patient has taken medications within 2 weeks of vaccination. The patient experienced Body aches, Chills, Headache, Low Grade Fever, Sore arm at injection area. The patient experienced Sore arm at injection area on 12-MAR-2021 and Body aches, Chills, Headache, Low Grade Fever on 16-MAR-2021, 03:00AM. The patient had not done Covid-19 test during vaccination. He was not diagnosed for covid-19 infection. The patient has no allergies to medications, food, or other products. No therapeutic measures were taken. The patient was recovered on 16-MAR-2021 by 11:00 AM. No follow-up attempts are needed. No further information is expected.
48 2021-05-26 headache Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my should... Read more
Starting 04Feb2021 I began having a headache; And then my left arm had pain radiating from my shoulder blade to my pinky; This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284) via an unspecified route of administration in Right arm on 12Jan2021 (at the age of 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included Herpes, eczema and concomitant medications included Truvada, escitalopram. Historical vaccine included first dose of COVID 19 (lot number= EH9899) via an unspecified route of administration in Right arm on 21Dec2020 at 07:00 AM. Patient had known allergies to Gluten/Wheat. The patient did not received any other vaccines within 4 weeks. The patient had no covid prior vaccination. Post vaccination, the patient was not tested covid. On 04Feb2021 at 08:00 AM, the patient reported that I began having a headache and then my left arm had pain radiating from my shoulder blade to my pinky. It has persisted for two days now and has made it difficult to hold heavy objects (10 lbs+). Though, it felt slightly better on day 2 than day 1. Treatment was not received. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
48 2021-05-26 fever, headache mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp.... Read more
mild fever; Headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (at the age of 48-years-old) (Lot Number: EL3247) as 2nd DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no COVID prior vaccination and not tested to covid post vaccination. On 01Feb2021, the patient administered first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration, administered in Arm Left (Lot Number: EL3247). On 24Feb2021, the patient experienced mild fever, headache. No treatment was received for the events caused. The patient underwent lab tests and procedures on 24Feb2021 which included body temperature as mild fever. Outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.
48 2021-05-26 fever voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hip... Read more
voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6204) on 09Mar2021 (at the age of 48-years-old) in the left arm for COVID-19 immunization and had no events following the first dose. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 30Mar2021, the patient experienced body aches, muscle pain and joint pain in his hips, shoulders, knees, and back of neck. On Apr2021, the patient experienced a mild fever and could hardly walk. On an unspecified date, the patient's voice had been messed up. The course of events was follows: On 30Mar2021 at around 20:00-21:00, the patient had full body aches (further described as muscle pain and joint pain in his hips, shoulders, knees, and back of neck ) and then it got a little better for a couple of days. The patient woke up on 31Mar2021 and it was really bad. He tried to work through it. However, he finally went to the doctor and then the Emergency Room (ER) for the first time. He was put on meloxicam 15mg for 4 days and it didn't do anything, although it was reported he didn't take them all. On Apr2021, the first week after the second vaccine (also reported as a few days later, even up to 5 days), the patient had a mild fever, for one or two days it got up to 100.3 degrees F. The patient had not had respiratory problems or breathing problems. When the meloxicam didn't work, the patient went back to the ER. He received a steroid shot while there. He received 5 days of 60mg daily of prednisone. The patient felt fine when he was taking it, but when it wore off, he crashed real hard and was right back to where he could hardly move. After the prednisone wore off, he went back to the ER for the third time, on approximately 23Apr2021, because he could hardly walk. He was told to take ibuprofen and paracetamol (TYLENOL) until he could get into see his primary care. That was probably for about a week. The patient saw his new primary care and was so bad he had to use a wheelchair. The patient had regular blood panels completed with unknown results. The provider put him on the second round of prednisone, but he was told he couldn't keep taking it because it could really screw him up. He was prescribed prednisone 10 mg tablets to take 6 tablets for 3 days (for a total of 60mg), then 4 tablets for 3days, then 2 tablets for 3 days, then 1 tablet for 3 days and stop. He felt good at the beginning, but as the dosage went down, the medication wore off, his pain came back real bad. He was hurting really bad because he was tapering off the steroid, prednisone. He went in "last Friday" and they put him on duloxetine (CYMBALTA) 30mg by mouth once a day. He was also taking over-the-counter naproxen sodium (ALEVE) 220 mg about every 8 hours for pain. The patient was checked for "rheumatoid stuff" with unknown results. The patient was put on duloxetine because he was normally a very active person, but this had been debilitating, some days he cannot even get off the couch because of the pain and not being able to walk. He just started a new job and now he's not been able to work. For example, "today", the patient can hardly lift his arms above his head because his shoulders hurt so bad. The patient reported that the muscle and joint pain persisted, but some days the pain got real bad. "Yesterday" he couldn't even get up hardly to go use the restroom, he had to use a cane. This morning, he has been able to get up better today. The pain is just always there since this all happened. He can't move very good, it hurt so bad. The patient also added that his voice had been messed up since all of this. The patient underwent the following lab tests on 27Mar2021 COVID-19 rapid test: negative, on 09Apr2021 COVID-19 test: negative, on 10Apr2021 COVID-19 rapid test: negative. The clinical outcome of mild fever, voice had been messed up and hardly walk was unknown, of body aches and muscle pain and joint pain in his hips, shoulders, knees, and back of neck was not resolved. No follow-up attempts are needed; no further information expected.
48 2021-05-28 fatigue, headache, chills Severe headache; Fatigue; Chills; Mild nausea; This is a spontaneous report from a contactable consu... Read more
Severe headache; Fatigue; Chills; Mild nausea; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration Date: unknown) via an unspecified route of administration in left arm on 04Mar2021 (age at vaccination was 48 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Mar2021, few hours after vaccination, the patient experienced severe headache, fatigue, chills and mild nausea. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
48 2021-05-31 fatigue, headache, chills chills; Headache; Injection site pain; Tiredness; Muscle pain; This is a spontaneous report from a c... Read more
chills; Headache; Injection site pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable Other Healthcare professional, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration, in left arm as 2nd dose, single, on 15Mar2021 at 10:15 (at the age of 48-years-old) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient past drug history include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration, in left arm as 1st dose, single, on 22FEB2021 at 13:15 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received Symbicort, Nasacort and Allegra within 2 weeks of vaccination. On 16Mar2021 after vaccination, the patient experienced injection site pain, tiredness, headache and chills. Patient was treated with Tylenol for events. Clinical outcome of the event injection site pain, tiredness, headache and chills was reported as recovering/resolving. No follow up attempts are needed. No further information is expected.
48 2021-06-01 chills Severe chills and some body aches
48 2021-06-01 fever, fatigue, malaise I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weak... Read more
I felt like 8-10 hours after the vaccine around 8:00PM, I experienced the general tiredness and weakness and malaise. I had a low grade fever and body aches. 1-2 days after that around 01/06/2021 I felt like my legs were sore like I had done a leg work out. The fatigue and weakness lasted about 24 hours and the muscle aches lasted a couple weeks.
48 2021-06-02 chills prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a ... Read more
prolific cold sweats; Muscle pain; restlessness; severe chills; This is a spontaneous report from a contactable Consumer. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP6955) via an unspecified route of administration, administered in left arm on 06Mar2021 at 12.45 PM (at the age of 48-year-old) as single dose for COVID-19 immunization. The did not have allergies to medications, food, or other products. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not diagnosed with COVID-19. On 07Mar2021 (next day of vaccination) It was in the middle of the night (probably after midnight), the patient experienced muscle pain, restlessness, severe chills, prolific cold sweats. Did not received treatment for the adverse event. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
48 2021-06-02 fatigue, headache One week after second shot (5/29/21) I developed fatigue and dull headache along with protruding gol... Read more
One week after second shot (5/29/21) I developed fatigue and dull headache along with protruding golf ball size swelling on the left side of my neck. Symptoms continue into today 6/3/21. Tomorrow will be 2 weeks since the second shot.
48 2021-06-02 headache, head discomfort, fever cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation ... Read more
cranial pressure; has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead; the pain can move from one place on his head to another; has a burning pressure sensation in his head; fever; elevated heart rate; headache after second dose; experienced arm pain; arm soreness; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 20Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included eczema, psoriasis, neuropathy peripheral feet. The patient's concomitant medications were not reported. The patient previously took amoxicillin, bnt162b2, 1st dose, Batch/lot number: EL9264 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received various vitamins within 2 weeks of vaccination. Caller reported adverse events following his second dose of the Pfizer COVID-19 vaccine. He had the second dose of the vaccine on 20Feb2021. He said that he has a burning pressure sensation in his head and it is still ongoing. He said the pain can move from one place on his head to another. He wanted to know if that has been reported as an adverse event for the Pfizer COVID-19 vaccine (immediate and long term). He added that he never experienced anything like it. He said that he did not have any lifestyle change, no diet change, and no change in supplements. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The patient experienced cranial pressure/ burning sensation in forehead accompanied by headache pain in forehead and other areas of head with varying degrees of intensity starting approximately a week after the second vaccination. For the past 11 weeks the symptoms have been constant with varying levels of intensity. The adverse event result in doctor or other healthcare professional office/clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cranial pressure on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head/ cranial pressure/ burning sensation in forehead on 27Feb2021 with outcome of not recovered, the pain can move from one place on his head to another on 27Feb2021 with outcome of not recovered, has a burning pressure sensation in his head on 27Feb2021 with outcome of not recovered, experienced arm pain on 20Feb2021 with outcome of recovered, fever on 21Feb2021 with outcome of recovered, elevated heart rate on 21Feb2021 with outcome of recovered, arm soreness on 30Jan2021 with outcome of recovered, bad headache after second dose on 20Feb2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. Information on Lot/Batch number was available. Additional information has been requested.
48 2021-06-03 headache, fatigue muscle aches; Joint pain; headache; dizziness; fatigue; This is a spontaneous report from a contacta... Read more
muscle aches; Joint pain; headache; dizziness; fatigue; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported) via an unspecified route of administration, administered in arm left on 03Mar2021 08:30 as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration date was not reported) via an unspecified route of administration, on 10Feb2021 10:00 as 1st dose, single dose for COVID-19 immunization. 36 hours after injection, on 03Mar2021 4 hours after vaccine application the patient experienced fatigue, muscle aches, joint pain, headache and dizziness. No treatment was given for adverse events. Patient not tested prior or after vaccination. The patient had no history of allergies. The outcome of the events was recovered on an unspecified date. No follow up attempts are possible. No further information is expected.
48 2021-06-03 headache, malaise, fever After vaccination I got vertigo; vomiting; fever; headache; feeling sick; This is a spontaneous repo... Read more
After vaccination I got vertigo; vomiting; fever; headache; feeling sick; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in an unspecified anatomical site on 16Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, after vaccination the patient experienced vertigo, vomiting, fever, headache and feeling sick. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, vomiting, fever, headache and feeling sick were not resolved at the time of report. No follow-up attempts are possible. No further information is expected.
48 2021-06-03 fever, chills, fatigue 1) Pain around the location of the first shot. The pain went away after a couple of days. 2) Chills... Read more
1) Pain around the location of the first shot. The pain went away after a couple of days. 2) Chills, fatigue, and body ache after the second shot. They all went away after 2 days. However, 2 days ago (June 2, 2021) - that is 2 months after the second shot (April 2, 2021), I started to have chills, fatigue, body ache, and some low fever (99.5), the same exact feelings that I had right after the second shot! I took one pill of ibuprofen and it helped with the body ache. However, fatigue did not go away until 2 days later (June 4, 2021). I was worried and thought I had caught covid, so I got tested, and the result was negative! Today, June 4, 2021, I got up and felt like myself again! What is the possibility that the side effect keeps coming back like this? I asked the nurse, who informed me about my negative result, this question, and she said that I might have caught a bug! I told her that it was unlikely I would have recovered quickly if that had happened!
48 2021-06-05 fever This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in... Read more
This is a follow up to a previously filed report.... Conditions continue to worsen. Swollen gland in neck continues, I've begun having fevers (days 16-17 after second vaccine shot), loss of appetite, difficulty opening mouth because something is now going on on my right jaw/ear area. Also, I'm not developing small skin infections on both hands and those are being treated by a dermatologist with topical antibiotic.
48 2021-06-06 headache april 3 hyperacusis april 8 hyperacusis amplified to inability to work and tinnitus started. disor... Read more
april 3 hyperacusis april 8 hyperacusis amplified to inability to work and tinnitus started. disorientation feelings. no sleep possible. no sound masking possible. tinnitus was louder than two sound machines on FULL volume. april 13. GP prescribes claritin, flonase (double dose), neomycin drops april 18 brain on fire with headache, pain april 19 ENT did blood work, visual and hearing tests. stopped flonase. started azelastine. april 26. started to hear crackling in right ear april 27 soreness below right ear may 2 SETBACK almost a panic attack (I assume) hyperacusis returned but not as severe as before. may 3 new ENT restarted flonase (double dose) may 6 brain on fire again. reduced flonase to normal dose. may 10 rock hard lymph node right side below ear. feeling better on lower flonase. may 11 lesser panic attack. lesser hyperacusis reaction. may 13 given doxycyclene 7 days june 3 slept without sound machine 8 weeks in
48 2021-06-07 fatigue, headache fatigue; Pain at the sight of injection; headache; This is a spontaneous report from a contactable c... Read more
fatigue; Pain at the sight of injection; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204, expiration date not reported), via an unspecified route of administration, administered in the right arm on 08Mar2021 09:00 (at the age of 48-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included chronic bronchitis, penicillin allergy, and COVID-19. Concomitant medications included losartan (manufacturer unknown); cod liver oil (manufacturer unknown); and unspecified multivitamin, all taken for an unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient was diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, pain at the sight of injection, and headache on 09Mar2021 07:00. Patient was scheduled for 2nd dose on 30Mar2021. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
48 2021-06-09 fatigue Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable con... Read more
Swollen inner checks; Extreme arm pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 11Mar2021 13:00 (at the age of 48-years-old) at 1st dose, single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient has no allergies to medications, foods, or other products. On 11Mar2021 23:00, the patient experienced swollen inner cheeks, extreme arm pain, and fatigue. The patient did not receive any treatment for the events. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not receive any other medications within 2 weeks of vaccination, has not been diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Outcome of all the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
48 2021-06-09 fatigue Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having ligh... Read more
Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.
48 2021-06-09 sweating Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for abou... Read more
Heart attack in right carotid artery. Severe chest pain, shortness of breath, clammy, sweat for about 45 minutes. Then irregular heart beat and significantly high blood pressure (over 190). Stent put in.
48 2021-06-13 chills, fatigue, headache, fever I had typical fatigue, fever, headache and chills for 24-48 hours after the shot but then a week lat... Read more
I had typical fatigue, fever, headache and chills for 24-48 hours after the shot but then a week later had diarrhea and vomiting for 24 hours. I then developed tinnitus about 3 days later that is terrible with constant high pitched ear ringing.
48 2021-06-13 chills, sweating, fatigue, headache, head discomfort - presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7t... Read more
- presents with a cc of chest and shoulder pain - he had the 2nd dose of covid vaccine pfizer May 7th and then soon after started having chest pain into his back, both shoulders, and down both arms; also into his neck and head and jaw; pain is constant and worsening - pain is achy; it is worse with sitting and walking around/standing makes it better - denies numbness but has has tingling in his arms - sometimes his heart is beating fast, has palpitations - feels overall weak - reports lower back pain for a while prior to the vaccine, sometimes this goes down his legs bilaterally, he is not worried about - HA is hard to describe, he has never had headaches before the vaccine; sometimes his head feels light, other times it feels heavy; hurts all over his head and into his neck; turning his head makes his head worse; pain is constant - sometimes he has blurry vision, not currently - sometimes he feels presyncopal but has not actually passed out; he sits down and feels better; its a fleeting sensation - symptoms are worse with sitting, moving around makes all his symptoms better - has intermittent room spinning sensation - has general overall fatigue and weakness, nonfocal - denies dyspnea on my exam - denies rash - feels intermittent diaphoresis and chills/rigor like shaking - reports he was evaluated by an ER since the symptoms started (5/28) and also has seen his pcp who is working him up for fibromyalgia - reports brain fog and feels slower and harder time with his memory
48 2021-06-13 malaise patient presented to emergency department 6/12/2021 after testing positive 6/7/2021 (approximately 6... Read more
patient presented to emergency department 6/12/2021 after testing positive 6/7/2021 (approximately 6 months after completing Pfizer mRNA vaccine series). He describes feeling generally unwell, difficulty sleeping and difficulty moving left upper extremity. Neurology and infectious disease consulted; ruled out stroke/TIA and treated with dexamethasone even though not requiring supplemental oxygen.
48 2021-06-15 sweating 48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt pr... Read more
48 y/o M presented to receive first dose of Pfizer vaccine. Pt received vaccine at 0915 to LD, pt presented with symptoms shortly after vaccine at 0918. Symptoms included pallor, weakness, nausea, and diaphoresis. RN attended to patient immediately- ice pack applied to back of neck, pt asked to take off mask to allow increased tissue perfusion, ice water offered and pt only able to take a few sips due to nausea. Vital signs were obtained (while patient was sitting up in chair) as the following 76/49 BP, HR 53, SpO2 at 97% at 0923. Vital signs were repeated at 0930 while patient was laying on gurney. Vital signs recorded as the following 101/54 BP, 53 HR, 94% SpO2. RN stat called at 0925, staff arrived to assist patient. Pt taken to treatment room for further observation. Upon arrival to treatment room, vital signs obtained and recorded as the following at 0935 BP 102/70, HR 61, SpO2 96%, RR 20. Pt stated symptoms has improved significantly.
48 2021-06-19 fatigue My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I... Read more
My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I had never had problems with nausea before, but have needed nausea meds ever since for every meal since that time. No change since then. Vaccine dose 1 given Mar 18. On Mar 24 began having body temperature regulation issues. For example my feet would be freezing and buzzing, similar to restless leg/body, but my upper body would be so hot I couldn't rest my hands on my chest. This happened every time I would lay down. Walking around or sitting up made it netter, but laying down the symptoms would begin quickly. This made it impossible to sleep without taking some type of strong medicine that would relax my body enough to even it out. Luckily I was taking morphine for back pain and that seemed to help. Normal OTC pain killers would not make any effect. This still occurs nightly, or even daily if I'm trying to nap during the day. Without morphine or something similar in my system at the time my body temperature and buzzing / restless body feeling continues. On Mar 27 I began experiencing a worse inability to stay asleep than I have ever experienced. This continues to this day. I awake every hour to an hour and a half regardless of how exhausted I am. Without a significant sleeping pill, which I am not currently prescribed, I cannot remain asleep through the night. Xanax has helped but does not always keep me asleep. I am still searching for a sleep doctor to assist to help address this sleep issue which was largely controlled by my CPAP once I finally was diagnosed and treated with sleep apnea. But now I am having nightly issues of awakeness, what appears to be called "coronasomnia" in some places, which makes me exhausted during the day. Finally, I ended up in the ER for kidney stones on Apr 8, the day I was scheduled for my second vaccination shot. I have never had kidneybstones before. Though I understand they would not develop so quickly, I understand there have been many reports of kidney stones making themselves known shortly following COVID vaccinations. I have not received my second vaccination and do not plan to do so given the effects I've had so far.
48 2021-06-20 sweating, headache Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizz... Read more
Facial numbness, hot flash, Sweating, increased heart rate, palpitations, shortness of breath, Dizziness, faintness, nausea, headache, fullness in the ears, lightheadedness, stomach pain.
48 2021-06-23 chills Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart ... Read more
Phase 1. Injury (6 APR) Pain during Injection (tip of needle) and immediate flinch/twitch in heart area. Racing heart, Intensity of beat, Severe tinnitus left ear only, adrenaline, Can?t sleep; Symptoms worst when I get into bed Phase 2. (10 APR) Urgent Care Visit: Chest very weak, each day gets worse; inflammation left side of body (chest, hand, face), felt like hole in heart, shortness of breath, numb hand, easy to excite, pain when lean forward; heart out of rhythm; Phase 3: (13 APR) Nighttime rushed by wife to ER due to symptoms of a heart attack couldn?t breathe, numb hands, shivering, heart going berserk, dizzy, aggressive, heart out of rhythm. Did EKG and diagnosed with Arrhythmia and Palpitations Phase 4: 14 APR Condition Stabilizes with bed rest; heart speed and intensity reduces slightly, heart still out of rhythm; ringing in left ear continues; noticed left hand, face, chest all swollen, out of breath walking to mailbox; can?t breathe deeply; Chest begins to bubble, gargle, fizzle when I lay down. Palpitations in throat, legs, need to drink a lot water; can?t sleep due to heart racing then sore and breast bone enlarged; chest tenses up often. Phase 5: Visit to Cardiologist (26 APR) He mentions potential Nerve damage with injection and prescribes Ultrasound. Days later I have second ?ER like? Scare and confirm in my mind this also nerve related. Phase 6: Mid May Start Recovery: Chest still tenses up doing emails, phone, late at work; easily excited; Each night total relaxation; start to feel nerves twitching like electric pulses in left chest; Feels like Electric Pulses/Pain from injection site to location of original twitch in heart area. Lean forward pain/discomfort; Still very weak chest muscles that get painful and sore easily Phase 7: Early June: Ultrasound at Heart Dr. (2 JUN) looks better /normal size. Heartbeat steadier and quiet but palpitations persist (extra heart beats felt in my throat); Overall body feeling stronger but chest muscles still weak and sore after ultrasound experience. Ringing in the left ear is better and milder twitches in chest at night. Teeth sensitive to cold liquids and Numb hands while walking esp 4 June; tense chest at work/home and need to step away and breath; Heart faster; long time to calm after warm/hot bath Currently late June still suffer from muscle weakness especially left chest, left arm where shot went in. Hands are still numb and Heart races when in bed.. Chest also still freezes up during work. Have to focus on breathing calmly. Overall though my condition continues to improve.
48 2021-06-23 cough, fever, productive cough, influenza like illness Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most... Read more
Within 15 minutes of 2nd shot had significant pins and needles (and some numbness) in right leg most significantly below knee in calf to foot area - this persisted for approximately 24 hours. Typical flu like symptoms (aches)/fever along with slight cough with phlegm occurred from 18-48 hours as these resolved patient was left with significant and persistent pain in chest on day 3 post vaccination. This pain persisted and spread to neck, back, jaw. Ultimately due to persistent pain patient went to a hospital emergency room for evaluation. Nuclear stress came back abnormal and patient was admitted for further evaluation but eventually released to follow up with cardiologist. Patient currently following up with medical professionals for continuing care for suspected myocarditis.
48 2021-06-25 fatigue Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer... Read more
Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 14Jan2021 12:00 (Batch/Lot Number: EL1283) at age of 48-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included atorvastatin calcium; venlafaxine hcl; capsaicin, menthol (ALLEVESS). No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced muscle pain and weakness, joint pain, fatigue on 15Jan2021 12:00. The outcome was not recovered. The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included Blood tests, neurological tests, x-rays. Follow up attempts needed. Further information is expected.
48 2021-06-28 fever Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain... Read more
Crohn's Flare Up; Brain Fog; fever; cramps and major abdominal pain; cramps and major abdominal pain; heart rate increased; neck area twitching and in face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 15:00 (Batch/Lot number was not reported) at the age of 48 years old as dose number unknown, single for COVID-19 immunization. Medical history included ongoing Crohn's. The patient's concomitant medications were not reported. The patient previously took fexofenadine (ALLEGRA) and fluoxetine (PROZAC), with known allergies to both. No other vaccine was received in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Jun2021 19:00, the patient experienced Crohn's flare up, brain fog, fever, cramps and major abdominal pain, heart rate increased, and neck area twitching and in face. Adverse events (AE) resulted in doctor or other healthcare professional office/clinic visit. No treatment received for AE. Outcome of events was recovering. Information about batch/lot number has been requested.
48 2021-06-29 fever, chills Chills and fever 12 hours after injection.; Chills and fever 12 hours after injection.; Lingering bo... Read more
Chills and fever 12 hours after injection.; Chills and fever 12 hours after injection.; Lingering body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er2613), via an unspecified route of administration in the left arm on an unspecified date in Mar2021 at 10:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6201) via an unspecified route of administration in the left arm on an unspecified date in Feb2021 at 10.30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Mar2021 at 23:30, the patient experienced chills and fever twelve hours after injection and later it subsided after twelve hours. The patient also had lingering body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, fever and lingering body aches was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
48 2021-06-30 chills, fatigue, headache, nasopharyngitis Had really bad chills; Really bad nausea; Bad headache; He felt colder and sicker; He felt colder an... Read more
Had really bad chills; Really bad nausea; Bad headache; He felt colder and sicker; He felt colder and sicker; Started feeling worse/ It started getting worse as he was driving to work.; He was tired or something like that; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 48-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left am on 09Jun2021 at around 12:25 or 12:35 (Batch/Lot Number: EW0186; Expiration Date: Aug2021) as single dose for covid-19 immunisation. Medical history included kidney transplant (He had kidney transplant, 2 years ago) and gave up a kidney (really protective of the one that is left). He had a check-up at the transplant centre the same day that he got the vaccine. He gets a check-up every 4 or 5 months. Relevant family history included high blood pressure and strokes (other than that nothing). There we no concomitant medications reported.The patient did not receive any vaccination within 4 weeks prior to covid-19 vaccine. The patient reported that he and his daughter got the Pfizer BioNTech covid vaccine last week as the first dose. His next shot was on 30Jun2021. The side effects were taking effect now. On 17Jun2021, the patient experienced he was tired or something like that. On 18Jun2021, the patient had really bad chills, really bad nausea, bad headache, he felt colder and sicker and started feeling worse/ it started getting worse as he was driving to work. The clinical course was reported as follows earlier this morning he had really bad chills, really bad nausea and a really bad headache. The chills were so bad that had on a short sleeve and a long sleeve shirt and a coat. He was at work and just started feeling worse, and colder and sicker. His headache started at 0000 this morning when he woke up. At 21:00 or 22:00 last night he thought he might have a headache, or he was tired or something like that. It started getting worse as he was driving to work. He got to be in so much pain he had to turn around and call out from work and come back home and took a nap and 5 hours later, the chills had resolved, and the nausea was pretty much gone. The headache was better, he does have a lingering headache, but it was not as bad as it was. It started with a headache, then nausea, then chills. He still has a little nausea. He is still having some headaches, but that was it. In the morning his headache was at a 10, now it is between 4 and 6. Nothing higher or lower. The nausea is pretty much depleted. The chills are okay. The patient was just worried because he heard of people getting sick and worried about my kidney shutting down. He further reported that he was hesitant to get the vaccine, but his doctor pushed him to get it and asked if this was normal to have side effects a week later and how long will they last. On 18Jun2021, pain assessment showed 10 in the morning and 4-6 later. The outcome of event chills was resolved on 18Jun2021, nausea, headache was resolving, whereas unknown for all other events. Follow-up attempts are completed. No further information is expected.
48 2021-06-30 fever, fatigue, chills Chills; Fever; Symptoms of tiredness; Muscle aches; watery/weapy eye; This is a spontaneous report f... Read more
Chills; Fever; Symptoms of tiredness; Muscle aches; watery/weapy eye; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 09:15 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EL9266), via an unspecified route of administration in the left arm on an unknown date in Feb2021 at 09:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 08Mar2021 at 03:00, the patient experienced chills, fever identified in morning and fever ranged from 102 to 103.8 F for several days. Symptoms of tiredness, muscle aches, chills, water/weepy eye were also reported. Therapeutic measures were taken as a result of fever and included treatment with acetaminophen 500mg (single dose) on 10Mar2021. The fever abated on 11Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, tiredness, muscle ache, watering eyes and fever was resolved on 12Mar2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-01 influenza like illness, fatigue, fever Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, bel... Read more
Stated that he had shot on May 15, 2021 and had flu like symptoms for 48 hours afterward (fever, belly aches, very tired-and slept for 14 hr.) Seven days later he noticed feeling dizzy, having chest pain described as very heavy feeling in chest, light-headed and exhausted. Had biometric screening done at work on 6/29/21 and began to "feel faint". BP 73/42. He layed supine on floor, took deep breaths and drank apple juice and felt better. He said he had gone to the ER on 6/28/21 with shortness of breath and chest pains. BP went up to 98/66 and he was sent home from work. He went to his family doctor who did x-rays and referred him to cardiologist. Has an appt. with Dr., cardiologist, on July 12, 2021.
48 2021-07-01 influenza like illness Swelling in Lymph Node by collarbone on Left side next day and still have 5 day later. 4 days after... Read more
Swelling in Lymph Node by collarbone on Left side next day and still have 5 day later. 4 days after vaccine having flu like symptoms
48 2021-07-01 malaise Felt really bad in my whole body. My muscles were achy.
48 2021-07-04 fatigue Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the n... Read more
Three weeks after the first Vaccine, I developed numbness in both feet between the big toe and the next one. This numbness/Cold feeling/Tingling slowly started spreading up my legs and seemed to settle the thigh area for a short time which even caused my clothes that touched it to generate a strange sensation (Almost like a hyper sensitivity) and it was a constant feeling. Then the feeling/numbness started affecting my calves and shin areas to a greater degree where they both feel like I have some fatigue and after walking or using them for a short time I feel like I have been running a marathon. At this point the skin around my ankle would come and go with becoming numb to the touch. As the numbness continued to spread further up to my waist area It eventually started to affect my abs, back and around the right and left outside edges of my chest. They have strange sensations and occasionally I can feel them as numb or some sort of sensory deprivation with the exception of my chest area which was sensitive to the touch (Pain). Continuing further I now have the same tingling/cold issues with both of my arms and there have been instances where both of my shoulders feel weak along with the numb behavior. This has all been going on over the past 6 months and is still continuing. I have been to multiple Urgent Care facilities, Doctor Visits, Whole barrage of tests: MRI's, Cat Scans, EMG's, Blood Work, Spinal Tap, etc. And so far all tests have come back normal. Jan 14 -- Trip to Urgent Care for numbness -- They said that I got too cold / did an X-Ray of my back.. Everything looked fine they said. Jan 25th -- Trip back to Urgent Care, numbness getting worse. Around Jan 28th -- MRI of lower Lumbar area. Nothing found Feb 17 -- Initial Consult Dr. Neurologist -- Orders Complete Bloodwork and does basic nerve tests Feb 12th -- Bloodwork done Health -- All normal Feb 22 -- Office Visit Dr. Neurologist -- Electromyogram of both legs. All normal Feb 24 -- MRI Lumbar Spine -- nothing that could cause the issues noted. March 10 -- Office Visit March 22 -- MRI Brain with and without contrast -- nothing that could cause the issues noted. April 16 -- Office Visit May 3 -- MRI - Neck area --nothing that could cause the issues noted. May 17 -- Office Visit -- Electromyogram (EMG) of arms and hands -- all Normal. May 21 -- ER visit -- Bowel issues, tiredness, fatigue ? Cat Scan performed.. All tests normal and released May 26 -- Gastro visit to make sure the numbness had not affected bowel control May 28 -- Dr. -- Changed Neurologists --- Scheduled Spinal Tap (Suspected MS even though nothing was showing up in all tests) June 3 -- Spinal Tap -- Everything normal not showing any signs of MS or any other disease. June 10 -- Spinal Headaches (received Blood Patch) June 18 -- Office Visit -- Doctor suggested could be Covid Vaccine related but sending to Medical Center and giving medicine in case it is Lyme disease
48 2021-07-05 headache Woke up next morning in pain from head to toe. Every joint in body hurts .both shoulderd and going u... Read more
Woke up next morning in pain from head to toe. Every joint in body hurts .both shoulderd and going up the neck painful . non-stop headache for 4 weeks . Nausea really bad . Went to urgent care. EKG was done SED rate was elevated 28.
48 2021-07-05 pneumonia J18.9 - Pneumonia
48 2021-07-06 sweating Patitent felt like he was going to faint. He started sweating and blood pressure was 175/95
48 2021-07-08 fever, fatigue, headache I took the first dose of the vaccine (EW0196) on 06/16/2021, And I took the second dose (FA6780) on ... Read more
I took the first dose of the vaccine (EW0196) on 06/16/2021, And I took the second dose (FA6780) on 07/07/2021. The injection site started to swell and be very painful , I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. I also had a fever. And my back and joints started hurting.
48 2021-07-09 chills - Blood blisters in mouth the day after each vaccine shoot - Chills from 2nd vaccine shoot (02/26/21... Read more
- Blood blisters in mouth the day after each vaccine shoot - Chills from 2nd vaccine shoot (02/26/21) and still ongoing (7/10/2021) - Vertigo started approximately on the 6/10/2021 and still ongoing (7/10/2021)
48 2021-07-12 chills, headache Cold sweats; chills; muscle fatigue; headache; This is a spontaneous report from a non-contactable c... Read more
Cold sweats; chills; muscle fatigue; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (at the age of 48-years-old) for COVID-19 immunisation. The patient had known allergy to guaifenesin. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 48-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included vitamin D (MANUFACTURER UNKNOWN) and famotidine 20mg acid reducer (MANUFACTURER UNKNOWN). The patient experienced cold sweats, chills, muscle fatigue and headache on 27Mar2021 at 03:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of cold sweats, chills, muscle fatigue and headache were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
48 2021-07-13 headache I started with being sensitive to bright lights and then anything could bring migraines on - 1, 2 to... Read more
I started with being sensitive to bright lights and then anything could bring migraines on - 1, 2 to 4 or 5 a week. They mimicked that of a TIA (the migraines).Doctor has prescribed A medicine injectable (Emgality)- I have to take it once a month. (My insurance doesn't want to pay for the meds that the doctor has prescribed but luckily there is a company where I can get coupon cards to help with the costs of the meds) I'm still getting them now - so My nose will still go numb and twinge and I still have vision at most times - before the injectable medication I couldn't feel my arms, blurred vision, numbness in face (that numbness came first before the left side of my body) and it was almost like I was getting a stroke. Sometimes it felt like bright light brought the migraine on and sometimes it would come on out of nowhere. I used to have an issue of these years and years ago but it wasn't the amount of having these like I was having every day - at most I'd get one or two a year - the ones after the vaccine may be slightly worse than what I got years ago but they were still very debilitating. I still get pain in the Right back side of my head - pain -and that is controlled by Tylenol - so it still happens one or two times a week but it's tolerable compared to what it was doing.
48 2021-07-13 sinusitis, cough 48 year-old man referred for admission from outpatient echo appointment after finding of large peric... Read more
48 year-old man referred for admission from outpatient echo appointment after finding of large pericardial effusion. Patient's history includes iron-deficiency anemia from hiatal hernia and season allergies. Was in usual state of health until received second Pfizer mRNA Covid-19 vaccine 5/18/21. A few days later developed cough, 'brain fog,' dyspnea. Had remote outpt visit and treated with abx for sinusitis. Covid test was negative 5/28/21. Symptoms worsened and developed swelling of legs and abdomen, worse exertional dyspnea and had to sleep sitting up due to orthopnea. Began on lasix 20 PO BID as outpt with significant improvement in swelling and other symptoms over past week - thinks he lost 20 lbs. Still feels more bloated than usual. Had outpt echo as part of eval and sent to ED. Denies chest pain, palpitations, dizziness. Brain fog is improving. Mildly constipated. No black or bloody stools. No abd pain. PERICARDIAL EFFUSION (6/15/2021) Assessment: echo Large pericardial effusion noted mostly post and no echo evidence of tamponade. Smaller in size. no need for pericardiocentesis Discharge home on lasix 20 mg daily Net neg 5.4 L chest xray looks improved unbale to get thoracentesis due to not enough fluid Vitals stable
48 2021-07-14 fever, cough, paranasal sinus discomfort, headache Fever (low-grade to 101°) started July 11 and has persisted through today, July 15. Persistent dry... Read more
Fever (low-grade to 101°) started July 11 and has persisted through today, July 15. Persistent dry cough. Sinus pressure and headache. Diarrhea started today, July 15.
48 2021-07-17 chills, headache Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous... Read more
Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:00, the patient experienced mild injection site pain, also experienced the same on 25Mar2021. On 26Mar2021, the patient experienced moderate chills, difficulty sleeping and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, chills, difficulty sleeping, headache and included treatment with TYLENOL. The clinical outcomes of the events vaccination site pain, chills, difficulty sleeping and headache were resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 chills High blood pressure, blood in urine , chill, body ache,pressure on the chest, nausea,
48 2021-07-17 headache, cough, fatigue heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or so... Read more
heaviness that feels like he needs to cough/Kind of heaviness on my chest like I have to cough or something; every joint hurts and aches; He also has headache, nausea which was on and off; He also has headache, nausea which was on and off; trouble sleeping because of the neck and joint pain; having trouble sleeping because when he lays his head on the pillow, because his neck is hurting, it's very uncomfortable to sleep at night; he was in so much pain that he can't work; feeling awful/miserable; its like every joint and muscle in his body, he literally feels everything and it aches; cough; that his muscles just kind of tense up from lack of sleep; he's so tired; unable to work; This is a spontaneous report from a contactable consumer (patient) and nurses via Medical Information Team. A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 11Jun2021 13:00 (Batch/Lot Number: EW0167) (at the age of 48-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no prior vaccinations in 4 weeks. Medical history included high blood pressure for years and high cholesterol about 2, maybe 3 years ago. Family history also includes high blood pressure and high cholesterol, both on his dad's side and also reported that diabetes was really high on his dad's side of the family. Ongoing concomitant medications included lisinopril taken for blood pressure and atorvastatin taken for cholesterol. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8736) administered in left arm on 21May2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunization where patient experienced arm just got a little swollen from 22May2021 to May2021; also received flu shots and pneumonia shots for immunisation and never had any problems. He received the second dose of the bnt162b2 on 11Jun2021 and the next day or 12Jun2021, he said that every joint hurts and aches. He also has headache, nausea which was on and off, heaviness that feels like he needs to cough, and trouble sleeping because of the neck and joint pain. He said that he was unable to work. He had COVID pay for the first 2 weeks but in the third week he's not getting paid. Starting on Sunday he stop getting paid. He wanted to know what he needs to do and how long the symptoms will last. He already contacted his doctor and was advised to call Pfizer because his doctor doesn't know what to do either. He was asking if his doctor can call Pfizer. Additionally, patient reported that he has been seeing his doctor for about 3 weeks now and his doctor does not know what to do, so he advised the caller to contact Pfizer. Patient reported that he got his first dose of the Covid-19 vaccine back in May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Patient got the number two Covid-19 shot on 11Jun2021. Patient reported that he came home, everything was fine, he woke up the next morning, and he's been feeling god awful for 3 weeks. Patient stated that basically what was happening was, its like every joint and muscle in his body, he literally feels everything and it aches. He stated that every joint and muscle in his body he literally feel everything and it aches: patient reported that the only way he can describe it was when you've been in a car ride for many hours and you get the leg jerks. That's what his entire body feels like. Patient reported that his shoulder are and then going up his neck, that's where the aggravation was so bad that it actually hurts. Patient reported that he was having trouble sleeping because when he lays his head on the pillow, because his neck was hurting, it's very uncomfortable to sleep at night. Also, patient has had a mild headache this entire time. Patient reported that every once in awhile, the headache will actually get worse. When the headache gets worse, he can literally feel the blood pumping in his temples. That's how bad it gets. The headache getting worse has only happened a couple of times. He has had a mild headache for 3 weeks now. The patient also reported that he has had nausea and a kind of heaviness on his chest like he has to cough or something. Patient reported that from talking to his doctor, the first thing that he had the patient do was take another Covid test. Patient reported the Covid test came back negative. Patient reported that his doctor then turned around and had him to see the practices urgent care. Patient reported that the doctor from urgent care said that, most likely from the way it was sounding, most side effects of the Covid-19 vaccine either happen immediately or within 12 hours. Patient reported that the urgent care physician informed him that the patient going to bed the night of 11Jun2021 and waking up the next morning and feeling awful, that coincides with possible side effects to the Covid-19 vaccine. The urgent care physician informed the patient that the side effects were going to last roughly 2 weeks. Patient reported that its been past 2 weeks and he's still feeling miserable so he went back to the doctor Monday, 28Jun2021, and his physician ran some blood tests. Patient reported that his physician did a complete blood count (CBC), sedimentation (sed) rate, and also did an electrocardiogram (EKG). Patient reported that his sed rate was elevated but all his other stuff looked pretty decent. Patient reported that he called his physician's nurse and asked what they do now because the caller was still in a lot of pain. Patient reported that his physician's nurse stated that he had not heard of anyone having these kinds of side effects and stuff, and recommended that the patient contact Pfizer. Patient reported that his physician's nurse gave him the number for Pfizer and instructed the caller to call and ask what Pfizer thinks he should do. Patient reported that he only got Covid pay for 2 weeks at work, and since this is his third week off, he was not getting paid. Patient stated that whatever he needs to do to get better because he needs to go back to work as he has a wife and child to support. Patient reported that right now he was in so much pain that he can't work. Caller stated so we've got to figure something out. Furthermore, patient reported that he has been experiencing nausea off and on. Patient reported that his physician gave him these pills that dissolve in your mouth. When he talked to the doctor about it, he said they're nasty but they give those to people that are recovering from cancer. His physician instructed him not to be alarmed, but it was just the best medicine they could give him to get rid of the nausea. The medication instructions state not to take the medication with water and let it dissolve in your mouth, but it just tastes nasty so he takes it with water. Patient reported that the nausea was getting slightly better. Patient reported that at first, he was so nauseous that he was afraid to eat anything. Patient reported that now he gets a little nauseous when its time to eat but as soon as he eats he feels better, so he's not having to take those dissolving pills as much anymore. Patient reported that he was prescribed Ondansetron 8 mg. Patient reported that the urgent care physician also prescribed him Fluticasone 50 mcg spray, 16 count. The patient also reported that he was having trouble sleeping because when he lays his head down on his pillow, it puts pressure on his neck and it hurts. Patient reported that he was only averaging 5-6 hours of sleep per night. Patient reported that his trouble sleeping was basically the same. Patient reported that since he's not working, he has been sleeping on and off all day long. Patient reported that he has been having some car trouble and needs to get new tires and brakes on his car, but he hasn't been able to do it because he's so tired. The patient also reported that the heaviness on his chest was why his doctor did an EKG. Patient reported that he tried telling his doctor that for years, every time his chest gets tight its normally because of lack of sleep. Patient reported that his muscles just kind of tense up from lack of sleep. Patient reported that his doctor informed him that they just wanted to check him out anyway. Furthermore, patient reported that his physician ran a CBC and there was one thing that was slightly above the green. Patient reported that the way his physician was acting with all the others, he was not concerned about it. Patient reported that his sed rate was 28 and the normal was 0-15. Patient reported that his physician instructed him not to be concerned about the result. Patient reported that he asked if his physician was sure the result was ok as his sed rate was almost double the normal range and his physician instructed him not to freak out and informed the patient that he was not concerned. CBC on 28Jun2021 showed the following results: white blood cell (WBC): 9.3, red blood cell (RBC): Within green range; Hemoglobin: Normal; Hematocrit: Normal; mean corpuscular volume (MCV): Normal, patient reported it was lower on the green scale; mean corpuscular hemoglobin (MCH): normal; mean cell hemoglobin concentration (MCHC): Normal; red distribution width (RDW): patient reported that between 11 and 15 was normal and his was 15.7, so it was slightly up; Platelets: 253; mean platelet volume (MPV): 8.1; Neutrophils: 68; Lymphocytes: 24; Monocytes: 6; Eosinophils: 2; Basophils: 0; Absolute (Abs.) Neutrophil count: 6.31; Abs. Lymphocyte count: 2.2; Abs. Monocyte count: 0.51; Abs. eosinophil count: 0.2; and Abs. basophil count: 0.03. The patient also reported that his Covid-19 test was collected on 15Jun2021 and he got the results on 17Jun2021. Patient reported that the results stated SARS Cov-2 not detected. Patient reported that he had a Zoom call with his physician and his physician instructed the patient to go get tested for Covid. Patient reported that the test results came back negative and his physician instructed him to come into the office, but it was Thursday night and there were no appointments for the next day. Patient reported that his physician instructed him to go to urgent care. Patient reported that when he went to urgent care, the physician informed the patient that him getting the Covid-19 vaccine and waking up the next day coincides with what they've seen with side effects. Patient reported that the physician informed him that he would be miserable for 2 weeks, some people feel better sooner and some people it takes longer, but the average length of time for side effects was 2 weeks. The events "every joint and muscle in my body I literally feel everything and it aches, headache, nausea, heaviness on chest" did not require emergency room visit, but did require physician office visit. Additionally, the nurse reported that the patient said that they have the ongoing symptoms and patient was frustrated and he wanted to know what was causing the patients symptoms. He has ongoing joint aches, Headache, nausea on and off, neck pain, and cough. The doctor has run tests and labs, showing nothing and was asking. The outcome of the event nausea was recovering; outcome of feeling awful/miserable and tiredness was unknown, while outcome of the rest of the events was not yet recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
48 2021-07-17 headache, fatigue trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness ... Read more
trouble sleeping; Fatigue,; general muscle soreness all over; injection site soreness; skin redness at injection site; headaches; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol, GERD and sleep apnea. The patient was allergic to casein and dust mites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), paracetamol (TYLENOL), pravastatin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and ESCILOP, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 01Mar2021 at 10:30 (at the age 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 23:00, the patient experienced fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and had trouble sleeping. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment with paracetamol (TYLENOL) for the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping. The clinical outcomes of the events fatigue, general muscle soreness all over, injection site soreness, skin redness at injection site, headaches and trouble sleeping were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 fever, headache slight fever; headache; body aches; diarrhea; This is a spontaneous report from a non-contactable co... Read more
slight fever; headache; body aches; diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 48-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm on 29Mar2021 at 11:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and central sleep apnea syndrome. The patient did not have a history of allergies to any food products, medications or others. Concomitant medications included losartan (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO), atorvastatin (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in left arm on 08Mar2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 06:00, the patient experienced flu-like symptoms such as slight fever, headache, body aches and diarrhea. The patient did not receive any treatment for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event slight fever, headache, body aches and diarrhea was resolving. No follow-up attempts are needed. No further information is expected.
48 2021-07-17 fever, headache severe nausea; severe vomiting; fever; headache; diarrhea; This is a spontaneous report from a conta... Read more
severe nausea; severe vomiting; fever; headache; diarrhea; This is a spontaneous report from a contactable other healthcare professional. A 48-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 27Mar2021 at 14:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient had no allergies to medications, food, or other products. Concomitant medications included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 06Mar2021 at 14:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 17:00, the patient experienced severe nausea, and vomiting 48 hours after vaccine, fever, headache and diarrhea. Therapeutic measures were taken as a result of events and included treatment with ZOFRAN, TYLENOL, rest, oral hydration. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events, severe nausea, vomiting, fever, headache and diarrhea were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-19 headache numbness of half left face; numbness of tongue; headache; pain on left arm; This is a spontaneous re... Read more
numbness of half left face; numbness of tongue; headache; pain on left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Mar2021 at 12:00(at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included gout and high cholesterol. Concomitant medications included pyridoxine hydrochloride, biotin, folic acid, cholecalciferol, cyanocobalamin, phytomenadione, nicotinamide, sodium ascorbate, calcium pantothenate, thiamine mononitrate, zinc oxide, potassium iodide, manganese sulfate, chromic chloride, dl-alpha tocopherol acetate, sodium selenate, sodium molybdate dihydrate (CENTRUM VITAMINTS). No known allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:30 the patient experienced numbness of tongue, headache, pain on left arm and numbness of half left face. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL 500 MG. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness of half left face, numbness of tongue, headache, pain on left arm were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
48 2021-07-20 nasopharyngitis, malaise Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient w... Read more
Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Patient not feeling good; Severe Cold and Flu; Severe Cold and Flu; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 1 via intramuscular route, administered in arm left on 26Mar2021 at 09:30 (at the age of 48-year-old) as dose 1, single and dose 2 (Batch/Lot Number: ER8729) via intramuscular route, administered in arm right on 16Apr2021 at 09:30 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Levocetirizine as allergy medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jul2021, the patient experienced got 2 doses of the vaccine tested positive with the covid-19 virus; breakthrough infection/ patient was just diagnosed last week Friday and on an unspecified date in 2021, the patient not feeling good, severe cold and flu. The clinical course of the events was reported as: he mentioned that he got 2 doses of the vaccine and he was really glad to have the vaccine but unfortunately after that (incomplete sentence), well actually he got the 1st dose last 26Mar and the 2nd dose last 16Apr but unfortunately after a month he was tested positive with the COVID-19 Virus. He stated, he got diagnosed just last week and his shot were between 26Mar and 16Apr of this year and he did not have COVID before this ever. He stated that right now (as reported) since he was not feeling good he had some over the counter medication but when he first came down with this (COVID-19 Virus), the only thing I was taking was allergy medication. I take Levocetirizine (Intent: treatment), 5 mg and I take I once a day in the evening. Laboratory test: included sars-cov-2 test: positive on an unspecified date in Jul2021 and he stated, not for at least, he wanted to say 4 or 5 months, it was the last time he had lab test. Treatment in response to events: he stated, yes, he started on Nyquil and Dayquill and they were severe cold and flu. He took some Aspirin also. He added, that was everything, he just wanted to call and let Pfizer know what happened to see if they ever wanted more information. The outcome of the events was unknown. Product quality complaints: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
48 2021-07-21 fatigue, headache, chills, throat pain The First vaccination was received on Saturday, July 3 at 1pm. Patient experienced common injection... Read more
The First vaccination was received on Saturday, July 3 at 1pm. Patient experienced common injection site soreness that lasted approximately 48 hours with no other symptoms. New symptoms appeared approximately 80 hours post-injection (approximately 8pm on July 6), including left ear ache, fatigue, sore throat and muscle aches. By the following morning additional symptoms appeared including nausea, chills, and headache. Symptoms persisted up to bed on July 18 and by the morning of July 19 all symptoms were gone. Temperature readings were normal throughout symptom period.
48 2021-07-21 fatigue Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perha... Read more
Interesting dreams while sleeping perhaps from extra sleep.; Interesting dreams while sleeping perhaps from extra sleep.; Blotchy face and blotchy around neck; Redness or flushed; Sore arm at injection site; Very tired; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6455 or EP6955), via an unspecified route of administration in the right arm on 20Mar2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and COVID-19. The patient did not receive any other medications in two weeks. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 at 09:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 09:00, the patient experienced sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events sore arm at injection site, redness or flushed, blotchy face, blotchy around neck, very tired and interesting dreams while sleeping perhaps from extra sleep were recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-21 headache Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-o... Read more
Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 26Mar2021 at 14:15 (at the age of 48-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient did not take any concomitant medications. The patient had no known allergies to medications, food or other products. Historical vaccine included tetanus (TETANUS VACCINE, Lot number: 5), via an unspecified route of administration on 17Feb2021 as a fifth dose for immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 15:00, the patient experienced headache and nausea. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events for headache and nausea was not recovered. No follow-up attempts are needed, information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine facility information was added. Concomitant therapy was left as blank since case contain concomitant medication. TETANUS VACCINE was removed from concomitant drug and updated as Historical vaccine as it was administration outside the 4 week interval.
48 2021-07-22 head discomfort, cough Dry cough, congested head, lasted ~2 weeks. Diagnosed as viral sinusitis after 1 week.
48 2021-07-22 headache All other symptoms, like headache, muscle pain, dizziness, were gone 1 week after the shot (this is ... Read more
All other symptoms, like headache, muscle pain, dizziness, were gone 1 week after the shot (this is the second shot). But starting from 2 weeks after the shot, I started to have tinnitus in my right ear, then my left ear. The ear ringing is high pitched. Its magnitude will increase along with the background noise. It's affecting my sleep and mood a lot.
48 2021-07-25 cough, runny nose After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The seco... Read more
After receiving the vaccine I had the occasional sore arm and pain at the vaccination site. The second day after I started to feel my chest started to burn, which was accompanied by trouble breathing. It was a pain that I have never experienced before in my chest it felt tight and was burning very bad. I started to feel light headed as if I was going to faint while doing my normal daily activities. I decided to stop doing anything that caused my heart to beat too fast. So later on that night i decided to go to the ER, where they did an ekg and some blood work. They also did a scan of my chest where the doctor said everything came back and looked normal. Over time the pain and everything I was experiencing started to get better. I still have a hard time breathing every now and then. Also after the vaccine I experienced a slight cough and runny nose.
48 2021-07-26 cough, throat pain develop cough, sore throat and body ache
48 2021-07-27 fatigue, headache Nausea; Muscle ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer, ... Read more
Nausea; Muscle ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included autosomal dominant polycystic kidney disease (ADPKD). Concomitant medications included valsartan (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), tolvaptan (MANUFACTURER UNKNOWN) and allopurinol (ALLOPRIM), all from unknown dates and for unknown indications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Apr2021 at 16:00, the patient experienced nausea, muscle ache, headache and tiredness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event nausea, muscle ache, headache and tiredness was recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
48 2021-07-27 head discomfort, nasal congestion, headache I felt like a hey fever attack, congestion in the head, over the next day nothing really changed. By... Read more
I felt like a hey fever attack, congestion in the head, over the next day nothing really changed. By Wednesday, I could not breathe through my nose at all, and I had a slight head ache. By Thursday, I had upper chest congestion with the head ache. On Friday, I lost my taste and smell and I went to urgent care and that is where they told me I had Covid after having a Covid test done.
48 2021-07-27 headache, fever, chills fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a... Read more
fever; Chills; headache; Body Aches; forgetting stuff worsening; This is a spontaneous report from a contactable consumer (male patient reported for himself). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included allergies, migraines, nerve pain, acid reflux, JC levels getting too high, ongoing pneumonia, ongoing COVID-19. The patient concomitant medications included teriflunomide (AUBAGIO), hydrocodone bitartrate, paracetamol (NORCO), gabapentin, omeprazole (PROTONIX), azelastine, fluticasone propionate (FLONASE ALLERGY RELIEF), montelukast sodium (SINGULAIR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), allergy shots. The patient experienced fever, chills, headache, body aches, forgetting stuff worsening on 18Mar2021. The patient underwent lab tests and procedures which included JC levels getting too high. Outcome of the events was recovered on an unspecified date in 2021. No further information was reported. Information on lot/batch number has been requested.
48 2021-07-27 headache This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, fusion surgery on c6/c7, known allergy to cantaloupe and known seasonal allergies. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), rosuvastatin 5mg (MANUFACTURER UNKNOWN), and cyclobenzaprine (MANUFACTURER UNKNOWN); all for unknown indication from unknown dates. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Mar2021 the patient experienced mild headache for the first 2 days. On 21Mar2021, on the third day, the patient experienced severe migraine. On an unknown date in 2021 the patient experienced vertigo periodically. The patient reported to have had hazy and mild headache lasting since the vaccine. The headache "comes and goes" as reported. The patient had no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, migraine, and vertigo were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
48 2021-07-27 fever, chills Body temperature at 101; Chills; This is a spontaneous report from a contactable consumer, the patie... Read more
Body temperature at 101; Chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient did not receive any concomitant medications. The patient previously received 'coconut' for an unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 around 22:30, the patient experienced chills. On 28Apr2021 at 23:30, the patient experienced body temperature at 101 (unspecified units). The patient reported that he drank water had a thick robe and blanket on. The clinical outcome of the events chills and body temperature at 101(unspecified units) was not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
48 2021-07-28 headache Pain in half of his head, like a headache, after first vaccine; Pain in left arm, after first vacci... Read more
Pain in half of his head, like a headache, after first vaccine; Pain in left arm, after first vaccine; This is a spontaneous report received from a contactable consumer(patients wife). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE FOR COVID 19) via an unspecified route of administration on the left arm on 21Jul2021 at 17:00 (Batch/lot number:FA6780; Expiration Date: Unknown) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Investigation Assessment was none. Family Medical History Relevant to AEs was not provided. Because it was requested at the patient workplace thus the patient taking Pfizer vaccine for COVID-19. The patient was not related to a study or programme. Prior vaccination (within 4 weeks), the patient didn't received any other vaccinations. Relevant Test was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. AEs following prior vaccinations was none. On 22Jul2021 morning, the patient experienced pain in half of head, like a headache and pain in left arm. The events were ongoing. The reporter stated she needs some information because her husband went to work, and he experienced side effect. The reporter stated her husband didn't saw any one doctor at the clinic. The reporter wanted to known whether it would be better to call his doctor and whether this was normal and whether they could prescribe medication. The reporter stated that her husband was calling her asking for some medication for the pain, and she confirmed, that her husband hadn't taken any medication. The events didn't resulted in emergency room and physician office. The outcome of events was not recovered.
48 2021-07-28 sweating, lethargy, fatigue Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainti... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: EMS arrived on scene, gave patient o2 and monitored vitals until stable
48 2021-07-28 fever, cough Patient was vaccinated on 1/2/21 and 1/25/21 with the Pfizer COVID-19 vaccine. He began to develop s... Read more
Patient was vaccinated on 1/2/21 and 1/25/21 with the Pfizer COVID-19 vaccine. He began to develop symptoms on 7/21/21 (fever, cough, GI sx). He test positive for COVID on 7/27/21
48 2021-07-29 influenza like illness, headache, nasal congestion Flu like symptoms; Headache; Was having pain, headaches, mostly in the eye areas.; having very low e... Read more
Flu like symptoms; Headache; Was having pain, headaches, mostly in the eye areas.; having very low energy/feeling weak; nasal congestion; dizziness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm right on 17May2021 (at a age of 48 years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. High blood pressure runs in his family. Takes high blood pressure medicine once a day. Ongoing Amlodipine taken for high blood pressure frequency: once a day. Medicines for a year and a half. Concomitant medications were not reported. Historical vaccine included bnt162b2 (First dose: three weeks before last Monday) administered in left shoulder at administration time: 5:00 or 6:00 PM on an unknown date 2021 (at a age of 48 years-old) for COVID-19 immunisation. On an unknown date May2021, experiencing nasal congestion, dizziness, feeling weak, and having very low energy and asked would it be something to do with the vaccine, or something else. On an unknown date May2021, experienced feeling weak, was having pain, headaches, mostly in the eye areas. On 18May2021, the second day he had flu like symptoms and was starting to feel better on the third day. He is now congested, feeling dizzy and back to being weak again and has low energy. Towards the end of the week, he had lack of energy again and head was so congested, and wondering was this anything he could be dealing with or if it something else and was mostly lack of energy. Height was between 5.9 and 5.10, weight was about 240 to 245. The symptoms started over the weekend and end of last week, he had no get up and go like he used to have before he took this last shot. Flu like symptoms started the first day after, he was having flu like symptoms big time and had to go home early from work. Wednesday, he had started improving a little. Towards the end of the week, Friday or Saturday, he had a lack of energy and was congested. Was having pain, headaches, mostly in the eye areas. It may not be the shot, he is just trying to see if he could still be having symptoms. He says the lack of energy, feeling congested, headache in his eye area all began Friday or Saturday, like into the weekend. Sometimes he tried to work on Sunday, but yesterday it was just not happening because of his lack of energy and today he was starting out the same way. It was a little worse Friday and Saturday now, was not quite as bad as it was. He did not take anything for the treatment. He took 2 water pills with the blood pressure medicine and does not remember the name of the 2 water pills. The dosage wasalso unknown. He took all of these once a day. Has had blood work 3 or 4 months ago but nothing recently. The patient underwent lab tests and procedures which included blood work resulted as unknown results on an unknown date 2021. The clinical outcome of the event dizziness was unknown, and rest of the events was resolving. Information related to batch/Lot no. was requested.
49 2021-01-03 chills, lethargy, malaise 8:00 AM received second vaccine shot at the Hospital 8:30 checked in with nurse - felt fine - went ... Read more
8:00 AM received second vaccine shot at the Hospital 8:30 checked in with nurse - felt fine - went home 4:00 PM began to notice some injection site pain 6:00 PM some slight lethargy, aches and malaise 10:00 PM above symptoms worsen 12:00 midnight full on aches, pains, chills, shivering, and nausea. Took advil + tylenol and felt better within 24 hours.
49 2021-01-03 cough, throat irritation On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift ... Read more
On December 23, 2020 she had the Pfizer COVID-19 vaccination at 7:30 p.m. She then worked her shift as a dialysis nurse and went home the following morning. She did not have any symptoms until 5:00 p.m. the following afternoon when she woke up. She developed itching of her back and a mild erythematous rash across her chest. That evening around 7:00 p.m. she noticed a rash on her arms that was itching. At 7:30 p.m. she had tightness in her chest and a nonproductive cough. She attributed the symptoms to her asthma. Her symptoms improved throughout the night. She went home on Christmas morning and went to bed. She woke up at around 5:00 p.m. She had swelling of her eyelids and an urticarial rash across her face and chest. She did have some mild throat itching. She reported to work at 7:00 p.m. but continued to have symptoms with increasing shortness of breath. She reported to the emergency department and was evaluated. She was given famotidine, Methylprednisolone, and hydroxyzine. She was also given ipratropium/albuterol nebulized. Her respiratory symptoms did improve, and she was discharged around midnight. She continued to have a slight erythematous rash that was present until she went to bed the following morning. When she woke up it had resolved.
49 2021-01-03 fatigue, chills, fever Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (wit... Read more
Background, I had Covid back at the end of May/beginning of June with 1 week of constant fevers (with 500mg tylenol q6), shortness of breath, fatigue, but no real cough. O2 sats somtimes in low 90's . I am one of the radiology faculty at the hospital I work at. Received my 1st dose of the Pfizer vaccine on Friday Dec 18 at about 21:30. After the injection, I had moderate pain at the site of injection about 6 hours later, not unexpected. However, the next evening, I was feeling fatigued and went to bed at about 7 p.m. For the next three hours, I felt chills and finally at about 10 p.m. I took my temp after I felt that my fever had "broke" and temp was 101.9. Used a finger pulse ox just to make sure sats were ok, they were at 97%, but unexpectedly, resting heart rate was 130 bpm. I took some tylenol and called the ER, and they suggested calling the covid hotline pager and coming in if I did not improve. I called the hotline pager, and we discussed things and eventually decided that I should go to the ER as temp remained at 101.6. By the time I reached the ER, my temp was down to 100.8, but pulse still 122 (EKG with no other abnormalities) and BP was 165/100. I had no other symptoms to account another infection. Over the next two hours, vitals became more normal with HR down to 95 to 100, and BP down to 145/85 or so without any other intervention. Sunday, still with some mild low grade temps of 99.8, but heart rate at 85 to 90 (I'm usually at about 80). In the ER, we came to the conclusion that my body mounted a significant immune response to the production of antigens after processing the mRNA given the lack of alternative diagnosis and the improvement of sx without any other intervention besides the 500 mg of tylenol I took before coming in.
49 2021-01-04 fatigue Vertigo starting at 7pm the night of the vaccine. The next morning woke with continued vertigo and ... Read more
Vertigo starting at 7pm the night of the vaccine. The next morning woke with continued vertigo and fatigue. Still in bed on 1/5/2021 at 12:30pm.
49 2021-01-04 fever, malaise, chills High grade fever with chills almost like rigors 103.8 F Happened after 9 pm Initially started with ... Read more
High grade fever with chills almost like rigors 103.8 F Happened after 9 pm Initially started with malaise Fever being monitored throughout the night
49 2021-01-05 chills, fever Chills, Body Aches, Fever of 101/102 for 3 days.
49 2021-01-05 headache, chills, fever, head discomfort Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse r... Read more
Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown
49 2021-01-05 malaise, chills, headache, fever The body aches started in his shoulder and now are all over his neck, back and whole body aches; The... Read more
The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. "Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-01-06 fatigue, headache, chills Headache chills, 99 degree F temp, tired for 24 hours, soreness at injection site, body aches, mild ... Read more
Headache chills, 99 degree F temp, tired for 24 hours, soreness at injection site, body aches, mild nausea Narrative: employee gave consent for information to be share with FDA and CDC, felt that event was not over yet, still experiencing some chills at time of interview, Jan 6, 2021, 10:30am.
49 2021-01-06 fatigue, malaise moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccinat... Read more
moderate injection site pain and swelling, fatigue after 1 day from vaccination, day 2 from vaccination developed unwell feeling and congestion, scratchy voice, and worsening fatigue
49 2021-01-06 fatigue, fever, headache, chills Fatigue, approximately 11am day of (may have been exacerbated by less sleep the night before), (last... Read more
Fatigue, approximately 11am day of (may have been exacerbated by less sleep the night before), (lasted 36 hours). Chills (lasted an hour or so), spiked fever (lasted maybe 8 hours mostly while sleeping), muscle soreness/tightness (shoulders/neck, Lasted 12-15 hours,) Headache ( lasted about 12-15 hours, and I never get headaches).
49 2021-01-06 headache, chills, fatigue Had a slight headache a few hours after the injection, three hours later felt tired and headache wor... Read more
Had a slight headache a few hours after the injection, three hours later felt tired and headache worsened but improved with 500mg Tylenol. That night fatigue got worse but headache improved. Went to bed at 9pm and had severe chills and shaking, heart was beating fast. Chills lasted for several hours. Increased heart rate all night and could not sleep at all. Fitful night sleep and started to sweat in the Early morning. Woke up for work at 5:30 am and had headache, dizziness, and flu-like symptoms with joint and muscle aches. Had sweats all day today. Went home early from work and slept from 9:30 am to 4:30 pm. Most symptoms improved now but feel like I still have a fever and sweats.
49 2021-01-07 headache body aches and HA started at noon
49 2021-01-07 headache approximately 5" after receiving injection, headache developed. Progressively got worse within 30",... Read more
approximately 5" after receiving injection, headache developed. Progressively got worse within 30", rated 6/10. described as "felt like the Hulk was squeezing the back of my neck". Returned back to CVCU and coworkers commented on how red he looked- "face and arms were red like he had just ran a marathon, but not blotchy or rash". HIs entire arm began hurting and has been hurting and waking him up every night and needing repositioned several times throughout the night. L arm shakes/tremors, constantly - described incident where he was holding a plate at home a few days after injection and his left arm involuntary shook, uncrontrollably.
49 2021-01-07 influenza like illness On the evening of 1/6 patient started to develop flu like symptoms that continued through the mornin... Read more
On the evening of 1/6 patient started to develop flu like symptoms that continued through the morning of 1/7. Patient then begin to develop swelling in the left armpit/axillary region. As of 1/8 swelling was the size of an orange or grapefruit and described as being "almost like subcutaneous swelling." As of 1/8 the swelling could be seen through his shirt and looked like hypertrophy. Patient has taken photos for documentation.
49 2021-01-08 headache Headache Narrative:
49 2021-01-08 headache Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better af... Read more
Headache tingling and numbness in R side down to toe's then whole body, HA on R side, felt better after standing up. stayed 30 minutes. Felt better and left. Narrative:
49 2021-01-08 malaise, chills employee received Pfizer Covid vaccine 12/28/20 afternoon 2:30 PM at 2:45 PM, he began feeling "odd"... Read more
employee received Pfizer Covid vaccine 12/28/20 afternoon 2:30 PM at 2:45 PM, he began feeling "odd". States he felt chilled, but no fever states he "could not warm up" Whole body felt bad had 2 to 3 hour episode of diarrhea symptoms lasted 2 days, then he felt better
49 2021-01-09 fever, fatigue, chills I received the vaccine at 1;17PM on 01/07/2021.. At 9pm I experienced muscle aches, fatigue, chills ... Read more
I received the vaccine at 1;17PM on 01/07/2021.. At 9pm I experienced muscle aches, fatigue, chills and a fever (100.4F). These symptoms waxed and waned over the next 32 hrs. At 5am, on 1/09/2021, my symptoms resolved. Since then, I am completely fine.
49 2021-01-09 fever, fatigue, chills RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shakin... Read more
RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shaking chills began. waxed and waned throughout 01/08/2021 and finally ended approximately 05:00 Saturday 01/09/2021. I have felt totally fine since then. I received the first dose 12/17/2020 in my left arm at 1230pm. I had no side effects except for paining some swelling in the deltoid muscle that lasted a day or so. I get the full vaccine every year and never have any sort of reaction, even a mild one. I am a physician and understand the purpose of the vaccine and how it works.
49 2021-01-10 fatigue, fever, headache, chills Headache, Fever, CHILLS, FATIGUE Narrative
49 2021-01-10 headache, chills Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection sit... Read more
Vaccine given at 07:50 (AM), with no immediate concerns. Within 4-6 hours, soreness at injection site was noted (soreness took 12-18 hours to start after first dose) By 8 hours after vaccination, had generalized "tingling" like a flu prodrome. By 12 hours after vaccination, experienced generalized aches, chills, mild headache and ipsilateral axillary lymphadenitis All symptoms persisted for 48 hours before resolution, except for axillary lymph node pain. Axillary lymphadenitis persisting , but resolving, by 72 hours after vaccination.
49 2021-01-10 headache, fever Fever headache nausea
49 2021-01-11 chills, fever, fatigue Was prior COVID POSITIVE patient in April, 2020. Inpatient at Facility. Experiencing mild symptoms s... Read more
Was prior COVID POSITIVE patient in April, 2020. Inpatient at Facility. Experiencing mild symptoms similar to COVID. General body aches, mild fever (99.7), chills, muscle soreness at injection site and fatigue. Symptoms first noticed about 0600 - approximately 18 hours after vaccination. Treating with CareOne Daytime Multi Symptom Cold/Flu relief, distributed by FOODHOLD.
49 2021-01-11 chills, fever Patient describes pain at injection site, chills and fever.
49 2021-01-11 chills, fever Body Aches; Chills; 101/102 fever; This is a spontaneous report from a contactable other healthcare ... Read more
Body Aches; Chills; 101/102 fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm on 29Dec2020 13:30 at a single dose for COVID-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 30Dec2020, the patient experienced body aches, chills, and 101/102 fever. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious.
49 2021-01-11 chills Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after ... Read more
Approximately 24 hours post shot I experienced severe joint pain in most all joints. Shortly after onset of joint pain experienced severe chills. Those symptoms persisted for approximately 12 hours after which I continued to experience injection site pain, but began to experience pain with some numbness that radiated from the injection site distally down my arm and into my pinky and ring fingers on my left hand. No other symptoms. As of today the injection site pain persists as does the pain and numbness in my pinky and ring fingers, but I get the feeling that it is getting slightly worse. The pain and slight numbness is present when I awake, but gets worse throughout the day. Some evenings there is considerable discomfort.
49 2021-01-11 fatigue, body temperature increased Nausea and vomiting. Started about 14 hours after vaccine. Lasted about 8 hours. Fatigue the followi... Read more
Nausea and vomiting. Started about 14 hours after vaccine. Lasted about 8 hours. Fatigue the following day but not sure if secondary to promethazine or being up all night. Maximum temp was 99.4 orally
49 2021-01-12 chills, fatigue Fatigue, chills, body ache. Improving.
49 2021-01-12 chills, fever, malaise Body malaise Chills Fever
49 2021-01-12 fatigue "Starting late last week, around the 7th, I?ve been feeling easily fatigued, sometimes absolutely sp... Read more
"Starting late last week, around the 7th, I?ve been feeling easily fatigued, sometimes absolutely spent by the end of the work day. Also kind of light headed, almost dizzy and slow. Easily recognizable if I stand too fast; I get a pressure drop and light headedness but not quite vertigo. "
49 2021-01-12 fatigue Starting Jan 7, he has been experiencing fatigue and light-headedness, which gets worse if he stands... Read more
Starting Jan 7, he has been experiencing fatigue and light-headedness, which gets worse if he stands up too fast.
49 2021-01-12 headache, malaise, cough Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomi... Read more
Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomiting Narrative: Employee reports he was so ill he thought he was going to die. He is very fearful of getting second vaccination. He currently is refusing to get it.
49 2021-01-12 headache Headache, body aches, and large swollen lymph node under left arm. Headache and body aches started a... Read more
Headache, body aches, and large swollen lymph node under left arm. Headache and body aches started about 24 hours post vaccination and resolved after 12 to 18 hours. Swollen lymph node came on about 12 hours post vaccination and continued a good 72 hours. Took 3 doses of acetaminophen 1000mg (one each night at bedtime).
49 2021-01-12 fever, chills 14 hours after the shot I started running a slight fever. 20 hours after the shot my fever was over ... Read more
14 hours after the shot I started running a slight fever. 20 hours after the shot my fever was over 100 and I had bad chills. My fever topped out at 102.7 and it came with severe chills and body aches. My fever keeps fluctuating and the chills come and go.
49 2021-01-13 chills Body aches and chills began on 12/26/2020. Continued body aches and loss of sense of smell on 12/27/... Read more
Body aches and chills began on 12/26/2020. Continued body aches and loss of sense of smell on 12/27/2020.
49 2021-01-13 fatigue, headache constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body sorene... Read more
constipation; neck stiffness; headaches; fatigue; soreness/Body soreness; soreness (both body soreness and injection site soreness); This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 12:00 pm at single dose at left arm for covid-19 immunization. There were no concomitant medications. Patient previously had the flu vaccine and had what was described as a less reaction, like a sensitivity. He had a slight fever and fatigue, like his body was fighting something. The patient has no product name, NDC, Lot, or Expiry for that product. Patient had no other medical history (including any illness at time of vaccination). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 07Jan2021 01:00, patient had the side effect of constipation after getting the vaccine, neck stiffness, and headaches, patient was experiencing these as well as fatigue and soreness (both body soreness and injection site soreness). The body soreness was like he worked out and his whole body was sore, the injection site soreness was more sore than his body but this was to be expected and it was about the same though didn't feel at first but felt it more on 07Jan2021. All the events started at about 1am on 07Jan2021. No history of all previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events. Outcome of events neck stiffness, and headaches was recovering, and outcome of other events was not recovered. This report is considered as non-serious. The adverse events didn't require a visit to emergency room nor physician office. Information on Lot/Batch has been requested.
49 2021-01-13 fatigue Body Ache and fatigue began the afternoon of 12/26. Body ache intensity increased on 12/27. Loss of ... Read more
Body Ache and fatigue began the afternoon of 12/26. Body ache intensity increased on 12/27. Loss of sense of smell became apparent on the afternoon of 12/27.
49 2021-01-13 headache Swollen left arm pit, achy feeling and headache
49 2021-01-13 headache Headache; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient r... Read more
Headache; This is a spontaneous report from a non-contactable consumer. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 08Jan2021 (lot number: EK9231) and first dose on 19Dec2020 (lot number: EN9899); both via unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced headache on 08Jan2021. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included COVID-19 test: negative on 17Dec2020. Outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
49 2021-01-13 malaise Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good... Read more
Was working on a shower door and i got dizzy, called my wife (She's a RN) because i didn't feel good. She came in and said it looked like i had a stroke. She called 911 and i was taken to ER
49 2021-01-13 fever, malaise, chills Chill; temp of 99.6; body malaise; pain at injection site; first dose on 17Dec2020 at 03:00 PM/ seco... Read more
Chill; temp of 99.6; body malaise; pain at injection site; first dose on 17Dec2020 at 03:00 PM/ second dose on 05Jan2021; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on left arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included Hypertension, GERD (Gastroesophageal reflux disease), ED (Erectile dysfunction), arthritis, allergies to milk, all from an unspecified date. The patient received first dose of BNT162B2 (lot number: Ek5370), via Intramuscular on left arm on 17Dec2020 at 03:00 PM at single dose for covid-19 immunisation. Concomitant medications included lisinopril, ergocalciferol (VIT D), paracetamol (TYLENOL) for arthritis, sildenafil, ibuprofen (MOTRIN). The patient experienced chill, temp of 99.6, body malaise, pain at injection site on 06Jan2021 at 07:00 AM. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Jan2021.
49 2021-01-14 headache, malaise, chills, fever Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is... Read more
Arm pain; Injection site pain; Fever; Chills; Nausea; Headache; Body aches; General malaise; This is a spontaneous report from a contactable nurse, the patient. This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9231 ), dose 2 , single dose via an unspecified route of administration in the left arm on 07Jan2021 at 07:30 AM (at the age of 49 years-old) for COVID-19 vaccination. Relevant medical history included high cholesterol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0140,), single dose, dose 1 in the left arm on 18Dec2020 at 09:30 AM. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin, rosuvastatin (CRESTOR), D3, zinc and multivitamin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Jan2021 at 10:00 PM, the patient experienced arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The report was reported as non-serious. The patient was not treated for arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise. The clinical outcome of arm pain, injection site pain, fever, chills, nausea, headache, body aches and general malaise was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-01-14 influenza like illness prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness ... Read more
prominent lower axillary swelling same side as shoulder injection site; Flu-like symptoms; soreness (other than injection areas including thighs); soreness (other than injection areas including thighs); more severe soreness/generalized soreness (other than injection areas including thighs); more severe soreness including back of shoulder; generalized weakness; This is a spontaneous report from a contactable physician (patient himself). A 49-year-old male patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration (right arm), on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received chlorhexidine and propylene glycol and experienced allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) in the left arm on 17Dec2020 at 17:30 for COVID-19 immunization. On 08Jan2021, the patient experienced more severe soreness including back of shoulder, generalized weakness, and generalized soreness (other than injection areas including thighs) beginning at 13:00 following day lasting the rest of the day. On an unspecified date, the patient also had prominent lower axillary swelling same side as shoulder injection site, flu-like symptoms, and focal soreness. The patient received over the counter (OTC) Motrin as treatment for the events. The patient recovered from flu-like symptoms, but has not yet recovered from the remaining events.
49 2021-01-14 fever Patient had a fever that reached a maximum of 101.0 and later resolved.
49 2021-01-14 throat irritation, sweating Sweating profusely, scratchy throat
49 2021-01-15 fever, fatigue, chills, malaise 12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hour... Read more
12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills. 18 hours after injections, body aches, joint (back and hips mostly) pain, and severe chills. Low grade 100.4 F fever and malaise / fatigue. Symptoms all resolved, except mild fatigue, after 24 hours
49 2021-01-15 fever, fatigue, throat pain Swollen gums, sore throat, low grade fever, fatigue- all started within 12-24 hours of vaccination; ... Read more
Swollen gums, sore throat, low grade fever, fatigue- all started within 12-24 hours of vaccination; treated with advil/tylenol and warm salt water gargling
49 2021-01-16 chills, fever Pfizer-BioNTech COVID-19 Vaccine EUA on 1/15/21 at 8:00 p.m. On 1/16/21 I had body aches in the morn... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA on 1/15/21 at 8:00 p.m. On 1/16/21 I had body aches in the morning. I had increasing chills and shivering in the afternoon. My temperature was 102.5 degrees by 6 p.m. with severe body aches. On 1/17/21 my temperature was 99.5 in the morning and 98.3 in the afternoon with continued body aches. I had an uncommonly large bowel movement in the morning and needed to make about 5 more trips to the bathroom due to a small amount of loose stool. I felt lightheaded and spacy in the afternoon and evening.
49 2021-01-17 chills Chest tightness, Chills, Dizziness, 'cold sweats'
49 2021-01-17 runny nose, fever Pain in my next, Lung when i breath hard, runny nose ,fever and body ache.
49 2021-01-18 body temperature increased Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse re... Read more
Vasculitis of hands and feet. Symptoms first noted in hands on 1/17/2021 - intermittent - adverse reaction on 1/18/2021 at 11:08 pm - hands became bright red as well as feet. Burning sensation (similar to taking Niacin) Color changed in feet from bright red to dark red with some purple in digits 2 and 3 of both feet. Appears swollen. I was informed on 1/12 (4 days after being vaccinated) that my daughter had been exposed to COVID. We family quarantined. The adverse reaction led me to go to an urgent care clinic to be tested for COVID. I had the POC test performed and came back positive. My temperature was recorded at 99.3 F.
49 2021-01-18 headache, chills, fever slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, heada... Read more
slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient). A 49-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took migraine pain medicine. The patient's concomitant medications were not reported. The patient previous received 1st dose of bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts. Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021. The even outcome of chills was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown. Information on the lot/batch number has been requested.
49 2021-01-18 fever Fever 38.5°C (101.3°F) 24 hours; This is a spontaneous report from a contactable other HCP. This 4... Read more
Fever 38.5°C (101.3°F) 24 hours; This is a spontaneous report from a contactable other HCP. This 49-year-old male other HCP reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek4176) at Left Arm at single dose for COVID-19 immunization on 07Jan2021. Relevant history and concomitant drugs were unknown. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) Intramuscularly at Left arm at single dose on 16Dec2020, 12:00 PM for COVID-19 immunization. The patient experienced Fever 38.5°C (101.3°F) for 24 hours since 07Jan2021, 04:00 AM. Treatment was received for the event (unspecified), outcome of event was resolved on unknown date in Jan2021. The patient was not COVID infected prior vaccination. The patient had not COVID tested post vaccination.
49 2021-01-19 chills, headache, fatigue Chills for about 2 hours duration starting at hour 10 after dose. Headache, fatigue, and moderate ar... Read more
Chills for about 2 hours duration starting at hour 10 after dose. Headache, fatigue, and moderate arm pain at injection that lasted from about hour 12-36 on and off, requiring some acetaminophen and ibuprofen and rest. By 48 hours after vaccine dose, asymptomatic other than arm pain that lingered for 5 days total. I had no symptoms after dose 1.
49 2021-01-19 fatigue Exhausted and cold then hot.
49 2021-01-19 headache, fatigue mild headache skin hypersensitivity generalized aches mild fatigue right deltoid muscle soreness
49 2021-01-19 lethargy NauseaVomiting LETHARGIC, INJ SITE PAIN Narrative:
49 2021-01-20 chills Muscle pain, Chills, injection site pain
49 2021-01-21 headache, influenza like illness Woke up yesterday morning (1/20/21) flu like symptoms. Body ache, headache, stiff joints. Today wok... Read more
Woke up yesterday morning (1/20/21) flu like symptoms. Body ache, headache, stiff joints. Today woke with mass in armpit, injection side, left arm. About golf ball size, soft and squishy to touch. Flu like symptoms are gone. Has followed up with Dr. Currently treating with warm compress and seems to be helping pain
49 2021-01-21 headache First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection a... Read more
First injection in left arm, Head ache lasting for 4 Days, arm sore for 5 Days. Second injection after an hour tingling in left side of lip and pain in the left jaw joint. Head ache still persistant. Tingling went away after 6 HR and pain in jaw joint stopped.
49 2021-01-22 fatigue, chills, headache Aching joints at 8p.m. followed by severe chills through the night. After restless sleep, woke with ... Read more
Aching joints at 8p.m. followed by severe chills through the night. After restless sleep, woke with headache, body aches, general fatigue through the next day.
49 2021-01-22 fatigue Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was... Read more
Monday, 1/18: Extremely tired., shaky, diarrhea 4 times, legs very week and heavy feeling like I was walking with cinder blocks on my feet. Tuesday 1/19 : Very tired, no bowel movement (took imodium AD 1/18) ,legs very painful after sitting and the pain was generally from knee to hip. Movement helped alleviate the pain. Tired/shaky feeling increased throughout the day. Wednesday 1/20: Same symptoms as 1/18 AND a sensation of pins and needles all over my body. It would randomly come and go from literally every area of my body and this was so pronounced it was hard to fall asleep that night. Thur 1/21. Leg pain gone but still week and tired. Pins and needles sensation better but not gone. Friday 1/22 same as 1/21 Saturday 1/21 same as 1/21. Tried to do a little work around the house and was exhausted. Pins and needle sensation remains the same.
49 2021-01-22 fever body ache,sligthly fever
49 2021-01-23 headache Pain at site, swollen lymph nodes. muscle aches, headache and joint pain
49 2021-01-24 headache, chills, fever, fatigue, runny nose runny nose, symptoms occurred 14 hours post vaccine, reaction site pain, nausea, fever 100.5, muscle... Read more
runny nose, symptoms occurred 14 hours post vaccine, reaction site pain, nausea, fever 100.5, muscle aches, chills, abdominal pain, fatigue, joint pain and headche
49 2021-01-24 headache, chills Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Sys... Read more
Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache, Systemic: Other- swelling and itchiness of the eyelids, dry mouth and nose, dizziness; symptoms lasted 9 days.
49 2021-01-25 fatigue, sneezing, cough Received the vaccine on 01/20/21.Patient reports on 01/21/21 started having myalgia throughout his ... Read more
Received the vaccine on 01/20/21.Patient reports on 01/21/21 started having myalgia throughout his body and fatigue. He had difficulty sleeping due to discomfort. Reports vomited x1 on 01/20/21. He reports that he noticed DOE on 01/21/21 and SOB with in one block of walking. Asthma wise: takes ventolin/combivent with no relief of symptoms. Reports he is specifically having pain in his lungs/pleuritic in nature worse with coughing/sneezing, went to the ER on 01/22/21.Chest xray,EKG and blood work were done. Xray and,EkG were normal with blood work showing anemia. Treated with IV pain medication with relief and D/C home with advise to take Nebulizer at home.
49 2021-01-25 fever, fatigue 2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a c... Read more
2nd dose had fatigue; mild fever; body ache; tension headache; This is a spontaneous report from a contactable nurse reported for himself. A 49-year-old male patient received second dose of bnt162b2 (BNT162B2, Lot#: EJ1686), via an unspecified route of administration on 11Jan2021 on Right Arm at single dose for covid-19 immunisation. Medical history included Ulcerative Colitis. No allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Mesalamine. The patient previously took first dose of bnt162b2 (Lot#: EH9899) via Intramuscular on 21Dec2020 09:30 AM on Left arm at single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2nd dose had fatigue, mild fever, body ache and tension headache from 12Jan2021 06:00 AM. The outcome of the events was recovered. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
49 2021-01-25 fever fever 101F, sore arm, large red swollen arm near injection site and warm to touch- possible cellulit... Read more
fever 101F, sore arm, large red swollen arm near injection site and warm to touch- possible cellulitis, referred to PCP for evaluation.
49 2021-01-27 fatigue Stiff neck and tiredness
49 2021-01-28 head discomfort, headache At 0905, Pt c/o heart palpitations, felt lightheaded, dizziness, and R knee felt tight. At the back ... Read more
At 0905, Pt c/o heart palpitations, felt lightheaded, dizziness, and R knee felt tight. At the back of the head, felt pulsating like his heartbeat. Transferred to private monitoring room, to gurnee. Lowered hob to 30 degrees. Heart rate: 71, BP 156/90, Resp 20, Puse ox 97% At 0915, BP 136/86/ heart rate 72, pulse ox 97%. Pt states his head is starting to feel better, but knee remains feeling tight. Denies heart palpitations now. At 0925 NBP 138/87, heart rate 64 pulse ox 96%. At 0927, sitting at edge of bed without complaints: BP 133/88, heart rate 78. Pulse ox 98%. Still c/o feeling lightheaded. R knee remains tight. At 0930, still light headed, but with R side of head felt heavy. Lighter on L side of head. Knee improving significantly. Patient states he feels well enough to return home. Pt returned home
49 2021-01-28 headache, fatigue HA, FATIGUE, BODY ACHES
49 2021-01-28 malaise, fatigue, fever, influenza like illness, chills nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; lo... Read more
nausea; malaise; flu-like symptoms; mild fever; chills; body aches; gastritis; diarrhea; Fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 06Jan2021 09:00 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 17Dec2020 via intramuscular at left arm with lot number: EK5730 for COVID-19 immunization and experienced mild arm tenderness. Second dose administered 21 days after 1st dose resulted in adverse effects (AE) approximately 40-43 Hours after 2nd dose was administered. On 08Jan2021 08:00, AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. acetaminophen was taken during first experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced. The patient received treatment for the events. The outcome of the events was recovered in Jan2021.
49 2021-01-28 fever, headache, fatigue, chills Severe Fever, Chills, Severe Fatigue, Headache, Joint pain
49 2021-01-28 fever, headache site soreness, low grade fever, body aches, headache; 24hr duration; OTC Aleve TID and Nyquil one ti... Read more
site soreness, low grade fever, body aches, headache; 24hr duration; OTC Aleve TID and Nyquil one time dose
49 2021-01-29 sweating, fatigue Pt was sitting in the 15 min waiting area after getting his vaccination. Pt stated that he began to ... Read more
Pt was sitting in the 15 min waiting area after getting his vaccination. Pt stated that he began to feel dizzy. Pt presented pale and diaphoretic. Pt's states that this happens when he donates blood. Pt was wheeled to the cot. Pt was seated on the cot. Pt states that he feels better when laying supine. Pt's vitals are normal. Pt states he is no longer dizzy and only feels fatigued. Pt's skin is now warm pink and dry. Pt is now able to stand. PT refused transport to hospital.
49 2021-01-29 fever fever, muscle aches
49 2021-02-01 fatigue Arm pain at injection site began a few hours after injection. Fatigue began 18 hours after injectio... Read more
Arm pain at injection site began a few hours after injection. Fatigue began 18 hours after injection.
49 2021-02-01 head discomfort, influenza like illness, fatigue dizziness; His head felt like it was too heavy; threw up; flu like symptoms; discomfort in his neck;... Read more
dizziness; His head felt like it was too heavy; threw up; flu like symptoms; discomfort in his neck; nausea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (lot number: EL3249, expiration date: May2021) first dose on 13Jan2021 15:10 to 15: 20 intramuscular injection in right arm at single dose for covid-19 immunization. Medical history included Type II diabetes mellitus, High cholesterol and Blood pressure, all diagnosed about 15 years ago and ongoing. Concomitant medications included insulin glargine (LANTUS) for diabetes, insulin aspart (NOVOLOG) for diabetes, metformin for diabetes, lisinopril for High cholesterol and pravastatin to control blood pressure, all ongoing. None History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was None. He is supposed to get second dose on 04Feb2021. He sat for 15 minutes after getting the shot and he had no reaction. About an hour or two into his shift for work he started having nausea, tiredness, and his neck was killing him, like something was on his neck, a discomfort in his neck. He worked through his shift. He was going through discomfort flu-like symptoms through Friday (15Jan2021). He thought he was ok as of Sunday. He went to work yesterday and his shift started at 6am, he was ok and then through breakfast, the room started to spin and he was experiencing dizzy spells (18Jan2021), nausea and his neck was extremely uncomfortable. His head felt like it was too heavy. He went to his supervisor to ask to go to the back and he threw up once and then he threw up again. He had to leave work around 12-12:30. He was told to go home. He is to go back to work tomorrow. He is hoping that he feels better tomorrow. Treatment: He took Tylenol. He took a lift home and he stayed in bed all day yesterday. His wife gave him some soup last night. He is not experiencing tiredness, nausea, discomfort in his neck as of now since he is laying down and not on his feet. He feels ok and he is not really experiencing anything of the events mentioned right now since he is laying down and trying to rest. Events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown.
49 2021-02-01 influenza like illness Flu like symptoms, full body aches, 98.8 temp Felt better 24 hours later having taken ibuprofen.
49 2021-02-02 fever On Dec 22, I had my Pfizer vaccine. I only had some injection site sore/pain until 5 days later when... Read more
On Dec 22, I had my Pfizer vaccine. I only had some injection site sore/pain until 5 days later when I started to have papular rash and vesicles in the areas around the injection site. The involved area got extensive from shoulder to thumb from day 6 to day 12. The rash is only limited to the arm receiving the vaccine injection. Then I have low fever and weakness for two days. I just started to feel better this morning (post injection day 14). I attached photos of my arm to show the rash. Confirmed by dermatologist as VZV positive on 1/5/2021. They did a biopsy and viral testing.
49 2021-02-03 chills, headache HA, CHILLS, NAUSEA, BODY ACHES
49 2021-02-03 fatigue arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-... Read more
arm pain; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration on 21Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included seasonal allergy and mild jackfruit allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included finasteride and testosterone. The patient experienced arm pain and fatigue on an unspecified date. Clinical outcome of the events was unknown.
49 2021-02-03 headache, chills, fever, fatigue headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous rep... Read more
headache; body aches; fatigue; fever; nausea; vomiting; brain fog; chills; This is a spontaneous report from a contactable health professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1685), via an unspecified route of administration on 18Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified multivitamin, as well as levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), fish oil/tocopheryl acetate (OMEGA 3). The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Dec2020 (at the age of 49-years-old) for COVID-19 immunization. On 19Jan2021, the patient experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of experienced headache, body aches, fatigue, fever, nausea, vomiting, brain fog, chills was resolved on an unspecified date in Jan2021. No follow-up attempts are possible. No further information is expected.
49 2021-02-04 fatigue, headache, lethargy Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic;... Read more
Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
49 2021-02-04 head discomfort, fatigue arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This... Read more
arm pain; fatigue; beginning 1/13 a constant high pitch whine in whole head; probably tinnitus; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown) via an unspecified route of administration in the left arm, on 11Jan2021 at 07:30, at a single dose, for COVID-19 immunization. Medical history included seasonal allergies and mild jackfruit allergy. Concomitant medications included testosterone, finasteride, and unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 21Dec2020, at 07:30 AM, in the left arm, for COVID-19 immunization and experienced arm pain and fatigue. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On an unspecified date, the patient had arm pain and fatigue from second dose but milder. On 13Jan2021, at 07:00 AM, the patient experienced a constant high pitch whine in whole head, probably tinnitus. The patient has not sought medical attention yet. The events were considered non-serious. Outcome of the events "beginning 1/13 a constant high pitch whine in whole head" and tinnitus was not recovered, while outcome of the other events was unknown. The patient has not been tested for COVID-19 since vaccination.
49 2021-02-04 headache, chills, fever, throat pain Headache; Chills; Fever; Sore Throat; Body aches; This is a spontaneous report from a contactable Nu... Read more
Headache; Chills; Fever; Sore Throat; Body aches; This is a spontaneous report from a contactable Nurse. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown) intramuscularly on 20Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE on 30Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Nursing Home/Senior Living Facility. The patient's concomitant medications were not reported. On 20Jan2021 at 11:00 the patient experienced headache, chills, fever, sore throat, and body aches. Treatment was not received for the events. The clinical outcome of headache, chills, fever, sore throat, and body aches was reported as not recovered. It was also reported that since the vaccination the patient has not been tested for COVID-19.
49 2021-02-04 headache, fatigue, chills, fever oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore... Read more
oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) . A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30 at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day. I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask. I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems. I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering. Information on lot/batch number has been requested.
49 2021-02-04 sweating Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 h... Read more
Minor soreness at injection site. Lasted about 48 hours; Minor sweats day of vaccination. Lasted 5 hours; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 09:00 at SINGLE DOSE on Arm Left for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination. No other vaccine in four weeks. Known allergies: No. Had other medications in two weeks. The patient experienced minor soreness at injection site. lasted about 48 hours since on 19Jan2021 with outcome of recovered on 21Jan2021, minor sweats day of vaccination. lasted 5 hours on 19Jan2021 with outcome of recovered in Jan2021. No treatment received. No covid tested post vaccination.
49 2021-02-10 chills, headache headaches, nausea/dizziness, and chills
49 2021-02-10 headache, chills This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old ... Read more
This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246), via an unspecified route of administration on 18Jan2021 at 09:00 (at the age of 49-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure and tachycardia. The patient does not have allergies to medications, food, or other products. The vaccination was administered to the patient in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. The patient's historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) on an unspecified date. Concomitant medications were not reported. On 18Jan2021 at 15:00 (reported as six hours after the shot), the patient experienced a headache. On 18Jan2021 at 21:00 (reported as twelve hours post shot) the patient experienced chills. The patient did not receive any treatment for the events. The clinical outcomes of headache and chills were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
49 2021-02-15 fever, fatigue, chills, headache, malaise 1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could functi... Read more
1/6/2021 vaccination; Later that afternoon, I started to go into a 'fog', tired, HA. I could function but nothing seemed 'clear' or 'sharp', 1/7/2021 fatigue, arm sore. The 'fog' was worse; 1/8 fog was really bad; forgetting conversations. 1/9 2:45 in morning. Went to bathroom. Walking, about 1/2 way there, felt like a 'spike' and instant HA. I went to bathroom, door closed, I got sick/vomiting. The shiver, shakes, and fever spiked. I bent down to throw up and I cant relieve. I fell into the wall, pushed self to stand up. Was back in bedroom, laying on floor and passed out. Wife woke me, I was bleeding. Don't know how long I was on the floor. BP144/78, 133 blood sugar, O2 was 98%, temp 98.1. 3:45 I decided to go to hospital, EKG, CT scan, Xray, etc. 'Just fainted' *PCP stated it was due to shot / vaccine. **busted lip, ER bill ***2nd vaccine; minor side affects (slight HA, )
49 2021-02-16 fever, chills, headache fever, chills, body aches, headache
49 2021-02-16 fever, headache FEVER, DIARRHEA, HEADACHE, WEAKENESS, MILS ABDOMINAL DISCONFORT
49 2021-02-17 fatigue Fatigue then sudden onset dyspnea with exercise in previously well and athletic physician/ health ca... Read more
Fatigue then sudden onset dyspnea with exercise in previously well and athletic physician/ health care worker
49 2021-02-20 fever Pfizer-BioNTech COVID-19 Vaccine EUA Injection site soreness x 48 hours. No treatment. Spontaneous ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site soreness x 48 hours. No treatment. Spontaneous resolution. Fever x 24 hours, started morning after injection. No treatment. Spontaneous resolution. Widespread muscle soreness x 24 hours, started morning after inj. No treatment. Spontaneous resolution.
49 2021-02-21 fatigue, fever Fatigue, nausea, slight fever, body aches. Lasted about 12 hours. Symptoms started almost exactly ... Read more
Fatigue, nausea, slight fever, body aches. Lasted about 12 hours. Symptoms started almost exactly 24 hours after 2nd dose. Woke up the next morning feeling fine.
49 2021-02-27 headache, fever Headache, body aches, fever, nausea,thirsty overnight, sore injection site and left deltoid.
49 2021-02-28 fatigue, headache Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mil... Read more
Injection site pain-minimal Tiredness- 3days, low energy Headache-severe for over 3 days Nausea- mild, 2 days Difficulty breathing- on two separate occasions after minimal activity
49 2021-02-28 headache Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I... Read more
Feb 15, 2021 Monday, I started feeling pain on the right portion of my neck; Feb 16, 2021 Tuesday, I felt the pain radiating inside my right ear and had a mild headache. Tuesday evening, my wife noticed that I am not fully blinking/closing my right eye; Feb 17, 2021 Wednesday, I didn't have the same pain but there's numbness on my right cheek extending to my right lips. Wednesday afternoon around 2pm, I went to my dentist thinking it was due to my Invisalign which I started on Jan 25, 2021. The dentist told me it is most likely Bell's palsy so I decided to go to Emergency.
49 2021-03-01 chills, nasal congestion, fatigue Nasal Congestion Diarrhea Chills Fatigue COVID positive
49 2021-03-01 fatigue At 8 hours post vaccination, developed gas pains. At 15 hours post vaccination, awakened from sleep ... Read more
At 8 hours post vaccination, developed gas pains. At 15 hours post vaccination, awakened from sleep with significant gas pains and nausea. At 16 hours post vaccination, vomited. At 17 hours, pain subsided enough to sleep. At 20 hours, awoke feeling mostly normal although with abdominal soreness and fatigue.
49 2021-03-03 chills, fever, headache 2/17/21 - Chills at 2:30am; increasing fever - peaked at 103.8 at 2:30pm while taking acetaminophen ... Read more
2/17/21 - Chills at 2:30am; increasing fever - peaked at 103.8 at 2:30pm while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Excruciating headache. 2/18/21 - Chills, Fever peaked at 102.5 while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Excruciating headache. 2/19/21 - Chills, Fever peaked at 101.3 while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Headache was gone. 2/20/21 - Fever peaked at 99.8 while taking acetaminophen and ibuprofen. 2/21/21 - No symptoms
49 2021-03-03 headache, chills, fatigue Had fatigue, chills, aches and a headache that started 24 hours after 2nd dose. No fever thought. ... Read more
Had fatigue, chills, aches and a headache that started 24 hours after 2nd dose. No fever thought. This generally subsided by 48 hours. But then 8 days after the 2nd dose, same side effects occurred again but worse. Was out of commission for two and a half days before feeling better. Had bad headache and body aches I couldn't relieve with Advil or Tylenol. Also my head broke out with a bunch of painful acne on the left side. This is still slowly resolving, the body aches/ chills resolved after 72 hours.
49 2021-03-03 fever, dehydration, chills IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; ... Read more
IBD; Fever of 100.1; Bad nausea; Chills; Dizziness; fell down from the dizziness, lost his footing; Dizziness; fell down from the dizziness, lost his footing/suffered from dizziness before, but that was maybe about a year ago; Dizziness; fell down from the dizziness, lost his footing; dehydrated; This is a spontaneous report from a contactable consumer. A 49-years-old male patient (husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK9231), via an unspecified route of administration on an unspecified date (49-years-old) at single dose (Left arm) for COVID-19 immunization. Medical history included dizziness. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. It was reported that the app is down, the safety app because they were trying it. Reporter was calling to report side effects. Reporter and husband, for which they were calling about, they took the Pfizer COVID-19 Vaccine at 7:30 am on an unspecified date. When probed for side effects, reporter stated that the patient experienced Fever of 100.1, really bad nausea, and chills. He also experienced some dizziness, so much that he fell, he fell down from the dizziness, and he lost his footing. Reporter was informed about role of Pfizer Drug Safety. When asked about other medical conditions, reporter stated that he had dizziness, he had suffered from dizziness before, but that was maybe about a year ago, he suffered from occasional dizziness but he may have been dehydrated because he didn't have that much water today. On lab work, reporter stated that actually he did, it said something about the (statement incomplete), he did have blood work, but it said something about he has disposition, well, it's such a small sign of IBD (further details unknown). Reporter stated that they gave him two Tylenols 500 mg each as treatment. The outcome of the events was unknown.
49 2021-03-03 fever, headache, fatigue Pt received 2nd dose on 2/27/2021. 3/1/2021 reports onset of fever, headaches, loss of taste, fatig... Read more
Pt received 2nd dose on 2/27/2021. 3/1/2021 reports onset of fever, headaches, loss of taste, fatigue, nausea and vomiting, body aches and shortness of breath.
49 2021-03-04 fatigue, headache Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontane... Read more
Bitter metallic taste in my mouth; fatigue; arm soreness; lip tingling; headache; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9262) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included kidney cancer from 2009 and unknown if ongoing; costochondritis from an unknown date and unknown if ongoing; non-alcoholic fatty liver disease (NAFLD) from an unknown date and unknown if ongoing; gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing; irritable bowel syndrome (GERD) from an unknown date and unknown if ongoing; migraines from an unknown date and unknown if ongoing, low immunoglobulin A (IgA) from an unknown date and unknown if ongoing; and steri strip allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included rosuvastatin calcium (CRESTOR) from an unknown date for an unknown indication; vitamin D from an unknown date for an unknown indication; and vitamin B12 from an unknown date for an unknown indication. The patient previously received a dose of BNT162B2 (lot number EK5730) in the left arm on 12Jan2021 for COVID-19 immunization. On an unspecified date in 2021 (reported as 02Jan2021 at 15:00) the patient experienced bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. Lab tests and procedures included polymerase chain reaction via nasal swab on 31Jan2021 with negative results. The clinical outcomes of bitter metallic taste in his mouth, fatigue, arm soreness, lip tingling and headache were not recovered. It was also reported that since vaccination the patient was tested for COVID-19.
49 2021-03-07 fatigue fatigue and body aches
49 2021-03-07 sleepiness Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER repor... Read more
Patient was administered COVID vaccine while in ER for monitoring of possible reaction. Per ER report: "Pt noted to be having reaction, pt with decreasing level of consciousness (groggy), did answer questions. Epi/Benadryl given from bedside. VSS at that time. Currently speech is slow but does answer appropriately." Patient was discharged home.
49 2021-03-10 throat irritation Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS ... Read more
Pt very anxious after receiving the pfizer covid vaccine c/o itchy throat and chest tightness. VSS on RA color pink throughout. Pt encouraged to take deep breaths and relax. Given water to drink. Tolerated well. Then given Benadryl 25 mg PO and observed for 15 mins more. Pt calmed down and denied further symptoms and went home without issue.
49 2021-03-16 nasopharyngitis Development of common cold symptoms 72 hours later.
49 2021-03-17 fatigue, fever, headache Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, Nausea Vomiting, EXHAUSTION, INJECTION SI... Read more
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea, Nausea Vomiting, EXHAUSTION, INJECTION SITE PAIN
49 2021-03-17 sweating 11:06 am Experience syncope episodes after receiving vaccine. Vital signs BP 102/55, HR 65. Sweaty... Read more
11:06 am Experience syncope episodes after receiving vaccine. Vital signs BP 102/55, HR 65. Sweaty and dizzy (afraid of needles). BP 127/75, HR 73, O2 sat 99 RA Accucheck 103. Client request to go home w/ spouse. Cleared by EMT.
49 2021-03-17 sweating Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen gi... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: loss of color, unresponsive, sweating. epipen given. ems evaluated and determined stress rxn and sent home. -Medium, Systemic: Flushed / Sweating-Medium
49 2021-03-18 headache, body temperature increased, fatigue Headache, muscle and joint pain, elevated temperature, extreme fatigue. The symptoms were mostly go... Read more
Headache, muscle and joint pain, elevated temperature, extreme fatigue. The symptoms were mostly gone after 3 days.
49 2021-03-18 sweating Post vaccination, patient sitting in waiting area for observation. Staff informed nurse that patient... Read more
Post vaccination, patient sitting in waiting area for observation. Staff informed nurse that patient appeared was not feeling well and appeared to have difficulty breathing. Attempt to move patient to assessment area, unable to ambulate and laid down flat. Appeared weak and pale, diaphoretic and labored breathing. Administered epinephrine per protocol and transported to nearest Emergency Department via EMS.
49 2021-03-18 fever, sleepiness, chills, fatigue Injection area became very sore, joint aches, skin aches, ran a fever, chills/shivering uncontrollab... Read more
Injection area became very sore, joint aches, skin aches, ran a fever, chills/shivering uncontrollably, very tired (slept the whole next day only waking to alternate Tylenol and Ibuprofen. Now that is it a day later, no fever, no chilling, but whole body is sore, not achy like when I had the fever.
49 2021-03-18 fever fever, altered mental status, aseptic meningitis.
49 2021-03-20 chills, fever Pfizer-BioNTech COVID-19 Vaccine EAU Vomiting, Diarrhea, High fever, Chills, Body aches. Symptoms be... Read more
Pfizer-BioNTech COVID-19 Vaccine EAU Vomiting, Diarrhea, High fever, Chills, Body aches. Symptoms began approximately 24 hours after the vaccine was administered and persisted for approximately 6-7 hours. No treatment was sought .
49 2021-03-21 fatigue, fever 3/16/2021 I had my first dose of Pfizer Covid-19 Vaccine. 3/19/2021 everything I ate or drank taste... Read more
3/16/2021 I had my first dose of Pfizer Covid-19 Vaccine. 3/19/2021 everything I ate or drank tasted horrible, I was running a slight fever and I was extremely tired. 3/20/2021, the tiredness and fever are gone, but still having issues with taste. 3/22/2021, still having issues with taste. Things I loved before the vaccine I can no longer tolerate because they taste so bad. I am eating ice so I don't dehydrate. This is the worst experience I have ever had and I doubt that I will get the second dose.
49 2021-03-23 fatigue, headache, fever, sweating, chills, cough joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeli... Read more
joint and muscle ache and fatigue, fever, chills, sweating, headache, shaking, cycling between feeling cold and shaking to hot and sweating. I was positive for COVID-19 in April of 2020, the reaction to the first shot of the vaccine was worse than the virus itself (with the exception of chest congestion and cough). it is nearly 48 hours from receiving the vaccine and I feel slight improvement, but still have body and muscle aches, slight fever, chills.
49 2021-03-23 headache, fatigue Slight headache and fatigue that lasted until the morning of 3/24/2021
49 2021-03-24 sweating Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, ... Read more
Approximately 5 minutes after vaccination was administered, patient was diaphoretic, pale in color, and unable to speak. Blood pressure was taken (48/28) with a pulse of 24. Patient stated that he had not eaten anything that day prior to coming to get his vaccination.
49 2021-03-25 headache Upset stomach...no nausea. Headache, difficulty concentrating with loss of focus
49 2021-03-25 malaise, head discomfort, chills, headache, lethargy Had a very strong erection through night most of the morning; Very horrible side effects; very unusu... Read more
Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.
49 2021-03-26 influenza like illness, malaise Extremely ill,weak and somewhat flu like but tested negative for both
49 2021-03-27 headache, fever, throat pain Headache, fever 100 degree?throat pain
49 2021-03-27 throat pain, sleepiness, fever, fatigue, headache Fever 99.7F,Headache, muscle soreness, tiredness/fatigue , sleepy, fast heartbeat (60 normal,to 85-9... Read more
Fever 99.7F,Headache, muscle soreness, tiredness/fatigue , sleepy, fast heartbeat (60 normal,to 85-90). Sore throat after 30 hours
49 2021-03-28 headache, chills, fatigue Chills - about 10 hours Headache - about 12 hours Joint/Muscle tightness - about 8 hours Fatigue - a... Read more
Chills - about 10 hours Headache - about 12 hours Joint/Muscle tightness - about 8 hours Fatigue - about 12 hours
49 2021-03-28 lethargy, chills 3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later... Read more
3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night. 3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe. 3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated. 3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It easily increases from simply walking around the house (much more than usual). 3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist
49 2021-03-29 headache Headache, muscle soreness, injection site soreness
49 2021-03-29 fever Fever, stiff neck, pain in low back, full body aches, flushed face.
49 2021-03-30 throat pain, upper-airway cough syndrome Sore throat, post-nasal drip. Non-severe.
49 2021-03-30 fever low grade fever; myalgia; joint pain; This is a spontaneous report from a contactable Nurse in respo... Read more
low grade fever; myalgia; joint pain; This is a spontaneous report from a contactable Nurse in response to HCP letter sent. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: E219899), intramuscular, administered in Deltoid Left on 21Dec2020 11:00 as Single dose for covid-19 immunisation at Workplace clinic. Medical history included colitis ulcerative from 15Jul1996 to an unknown date (mild symptoms). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced low grade fever, myalgia and joint pain. The action taken in response to the events for BNT162B2 was not applicable. The causality assessment from reporting person and reporting was unrelated. The outcome of events was recovered.
49 2021-03-31 body temperature fluctuation 1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a... Read more
1 hour after receiving the vaccine, my face and neck on the side of the shot started to burn like a nerve issue and then went numb. My arm where I received the shot went cold and burned. A friend came over and took the temperature of my hand because it was cold and it was 15 degrees colder than my other hand. I took 1 Benadryl of 25mg and laid down for a few hours. At around 4 hours after the vaccine my neck went stiff as well as my upper back. I am reporting this because I don't believe the neck and face going numb is a normal thing and it was concerning and had it continued I would have went to the ER. I am not sure if the Benadryl helped but maybe.
49 2021-03-31 chills uncontrollable shivering/shaking multiple times during the evening and night
49 2021-03-31 fatigue, malaise Fever, malaise, chills, body aches, nausea and fatigue for about 17 hours
49 2021-03-31 fatigue, fever Mild fever (peaked at 101f), mild nausea, severe fatigue. Started about 24 hours after the shot, la... Read more
Mild fever (peaked at 101f), mild nausea, severe fatigue. Started about 24 hours after the shot, lasted about 20 hours after that.
49 2021-03-31 headache Severe nausea and vomiting, headache, ear/neck pain, ear infection, eye infection, blisters in and a... Read more
Severe nausea and vomiting, headache, ear/neck pain, ear infection, eye infection, blisters in and around nose, eye, face, scalp, vision loss, inability to read/work 2+ days.
49 2021-04-01 chills, runny nose, fatigue Fatigue Chills Runny nose Sore arm
49 2021-04-01 fatigue Slight amount of soreness and swelling at the injection site. Approximately 4 hours after the inject... Read more
Slight amount of soreness and swelling at the injection site. Approximately 4 hours after the injection I became very tired and went to bed. The next day I was back to normal. No treatment necessary.
49 2021-04-01 fatigue Moderate swelling and soreness at the injection site. I started feeling fatigued a few hours after t... Read more
Moderate swelling and soreness at the injection site. I started feeling fatigued a few hours after the injection. And it continued through the next day. The swelling and soreness were one by the next day. No treatment was necessary.
49 2021-04-01 sweating, fatigue, headache, chills 1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. ... Read more
1800 hrs at work(same day as shot 1), started feeling nausea, vomited several times from 1815-1830. started with chills and sweating then and extreme fatigue. 1845 started vomiting again until about 1900 when it ended with violent vomiting and retching. Left work early, freezing the whole way home. fell asleep on the couch in clothes, sweatshirt and two blankets due to chills. Slept for 2 1/2 hours, woke up feeling much better. next day had slight headache and slight lethargy.
49 2021-04-01 fever, lethargy Loss of taste, smell Achy Fever and shakes Loss of appetite Irritability Lethargy
49 2021-04-03 fatigue, cough Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop a... Read more
Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop and catch breath, cough and rest. Has happened 7-10 times since vaccine. No fever. Some fatigue
49 2021-04-03 fever Fever, loss of equalibrium (fall), loss of coordination.
49 2021-04-05 chills, fever, malaise, fatigue Fever (Sat,-Tues), Chills(Sat-Tues), Nausea (Sat-Tues) Vomiting (Sat-all day) , Diarrhea(Sat-Sun), H... Read more
Fever (Sat,-Tues), Chills(Sat-Tues), Nausea (Sat-Tues) Vomiting (Sat-all day) , Diarrhea(Sat-Sun), Headache(sun-Tues), Fatigue(Sat-Tues), Muscle soreness(Fri-Sat). This is the fourth day since the vaccine and I am still not feeling well. I missed work yesterday and plan to stay home again today.
49 2021-04-05 fatigue, fever Fever, muscle aches, exhaustion
49 2021-04-05 sinusitis, chills, cough, headache, sweating Extreme sweats Chills Severe Headache Cough Sinus issues Restlessness Has taken over the counter ... Read more
Extreme sweats Chills Severe Headache Cough Sinus issues Restlessness Has taken over the counter meds - not helping
49 2021-04-06 chills, sweating Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (puls... Read more
Flushing/sweating, dizziness, chills. Initial BP 151/80 (pulse 80). Glucose 285. F/u BP 112/74 (pulse 72). O2 sats 93% and 95%.
49 2021-04-06 headache Body and Head Aches
49 2021-04-06 sweating Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in... Read more
Minutes after vaccination patient began feeling hot, was diaphoretic, hypotensive, and was placed in trendelburg position
49 2021-04-07 headache, fatigue He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could bar... Read more
He got the vaccine, 15 minutes later he got very fatigued, could not walk in his house and could barely make it to the bed and had to lie down. He had headache, nausea, disoriented. Then he went to bed, woke up at 9:00 AM and had a seizure, which he has had in the past but it had been over a year. He rested after the seizure and knew what to do and it took 2-3 days to recover from that due to the weakness in the legs, disoriented. He has gotten stronger and is pretty much back to his normal self. He has not had any additional seizures since then. He had his FU physical today and she is aware of the seizure and told them to report the incident.
49 2021-04-08 headache, fatigue Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch betw... Read more
Rash all over my body that looks like chicken pox, which started in my hair. I have a bad patch between my breasts. It itches horribly. Severely tired. My body, especially my ears and face, have this feeling of being on fire occasionally. Stomach upset with diarrhea that hits suddenly. Horrible headache. Skin is extremely itchy and dry. I cannot think. Memory loss.
49 2021-04-08 fever, chills Nausea, achy, fever, chills
49 2021-04-09 fatigue, chills, dehydration, headache, fever 3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigu... Read more
3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.
49 2021-04-09 fatigue, headache Persistent nausea Fatigue Headache
49 2021-04-09 sleepiness, fatigue, headache Mild headache about 2 hours after shot; increased urination about 2 hours after shot and continuing ... Read more
Mild headache about 2 hours after shot; increased urination about 2 hours after shot and continuing at least 2 days; soreness; tiredness; groggy
49 2021-04-10 fatigue Fatigue, dizziness, nausea
49 2021-04-10 headache, chills Had extreme soarness throughout entire body. Bad headache Chills Hot and cold episodes
49 2021-04-10 headache Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath. Ne... Read more
Lost consciousness, awoke with vomiting and nausea, low blood pressure, and shortness of breath. Never had previous issues with any vaccines or injections, and never previously had vasovagal response. Since injection, I was constipated for 3 days and suffering extreme muscular/skeletal pain and headaches.
49 2021-04-10 headache First was a continuing headache that started Saturday.. it worsened slowly. Then, a Rash appeared... Read more
First was a continuing headache that started Saturday.. it worsened slowly. Then, a Rash appeared in inner arm opposite the shot arm between the elbow and armpit in the evening. It was itchy. At 5 AM the next morning - I started vomiting... After 5 bouts of that about 3 hours apart, it stopped at 9 PM. The rash had faded but did not leave until Friday evening , finishing with an itchy spot around the elbow. - Had chicken pox as a child ..... - Did not experience congestion or diarrhea.
49 2021-04-10 fever, fatigue I felt general fatigue, found it difficult to concentrate, and had a low-grade fever. I spent most o... Read more
I felt general fatigue, found it difficult to concentrate, and had a low-grade fever. I spent most of the day resting and took some ibuprofen. The symptoms lasted less than 24 hours. I was fine the next day.
49 2021-04-11 chills, fever First feeling of throat closing up/narrowing, not the same feeling as a sore throat though. Then chi... Read more
First feeling of throat closing up/narrowing, not the same feeling as a sore throat though. Then chills and fever for the rest of the evening and into the night.
49 2021-04-11 chills Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Bac... Read more
Sore arm, lasted 2 days. Swollen lymph node in collar bone area on right side. Still ongoing. Back and joint pain lasted 36 hours. Mild chills lasted 48 hours.
49 2021-04-11 fatigue, chills, headache, cough Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day aft... Read more
Chills and body ache for 18 hours since symptoms started. Low energy and fatigue since the day after the second dose of vaccine. Dizziness, stomach ache 10 days after the vaccine. A mont later after the vaccine (3/30) I had headache, body ache and chills for 6 days. COVID test was negative Palpitations started on 4/4. Dizziness, chills, dry eyes, weakness and fatigue until today.
49 2021-04-11 headache, sleepiness General illness. Drowsiness. Headache. Full body muscle soreness, with greater soreness at the in... Read more
General illness. Drowsiness. Headache. Full body muscle soreness, with greater soreness at the injection site. Symptoms lasted until the next morning.
49 2021-04-11 sweating Patient received vaccine at 2:59pm. Within 3-5 minutes, he said he got dizzy. He laid himself on the... Read more
Patient received vaccine at 2:59pm. Within 3-5 minutes, he said he got dizzy. He laid himself on the floor because his vision got blurry . We went over to him right away. His BP was 110/80 and oxygen was 99. He was very sweaty. Patient reports he has a history of issues with needles. He reports he takes no meds and has no medical history. He reports only water today, and he hasn't eaten any food. Within 15 minutes, he sat up and felt okay.
49 2021-04-12 chills, fatigue Chill, fatigue, muscle ache, sore at injection site. Lasted for one day. No treatments, medications ... Read more
Chill, fatigue, muscle ache, sore at injection site. Lasted for one day. No treatments, medications were taken.
49 2021-04-12 headache 10:40 to cot room, reported a headache and that eyes ache after vaccine. 10:45 reports better Puls... Read more
10:40 to cot room, reported a headache and that eyes ache after vaccine. 10:45 reports better Pulse 68 PSo2 98% V- safe information given and was informed to seek medical attention with any other problems. 10:48 better and left clinic.
49 2021-04-12 headache I developed a headache within an hour of the shot. The following morning I developed a very swollen ... Read more
I developed a headache within an hour of the shot. The following morning I developed a very swollen lymph node under my right arm pit. This has since migrated down my rib cage. I also experienced nausea, dizziness, headache, and muscle aches the following two days. Those have since subsided. The swollen lymph node under my arm is still with me today.
49 2021-04-13 headache, fever - Ringing in ears began about 2 hours after the injection and has persisted constantly for last 24 h... Read more
- Ringing in ears began about 2 hours after the injection and has persisted constantly for last 24 hours and is ongoing (most annoying) - Significantly swollen lymph nodes near injection arm - Low grade fever started around 18 hour point post injection - Headache overnight and until around lunch time - subsided now with Tylenol - Body aches began at 24 hour post injection
49 2021-04-13 headache Headache
49 2021-04-13 sweating, malaise Five minutes after receiving the Covid shot , Patient start sweating and he mentioned that he is no... Read more
Five minutes after receiving the Covid shot , Patient start sweating and he mentioned that he is not feeling well. No other symptoms was reported. After drinking water and sitting at the waiting area for 30 minutes he was feeling better.
49 2021-04-14 chills, headache Metallic taste that lasted about an hour, Headache 6 days still going, chills in lower back, develo... Read more
Metallic taste that lasted about an hour, Headache 6 days still going, chills in lower back, developed a rash in that area of my back.
49 2021-04-14 chills Began experiencing chills and had difficulty breathing. Pulse oximeter was between 90 to 95%. Pul... Read more
Began experiencing chills and had difficulty breathing. Pulse oximeter was between 90 to 95%. Pulse as high as 106. Could not breath adequately laying down until after 4:00 am. So I had to sit up or dtand that time. Due to chills needed to have blanket wrapped around me.
49 2021-04-14 fatigue Muscle soreness and fatigue
49 2021-04-14 fever Severe lower back pain at site of herniated disk, fever, diarrhea, weakness.
49 2021-04-15 chills, headache Headache, Chills, Sore Injection Area, body aches, mild nausea.
49 2021-04-15 chills Chills, shiver; Pt was given a blanket, water, rest; s/s resolved; BP 153/93; HR 74; RR 18
49 2021-04-15 sweating, fever, fatigue Site pain, fevor, sweats, chills, serious fatigue, diarrhea: beginning 1a still ongoing (4:30p).
49 2021-04-15 malaise, headache stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 ... Read more
stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 hours after shot while sleeping (only an issue the first night) general malaise for 72 hours after shot massive headache that started 48 hours after shot and lasted ~24 hours before turning into a milder but continuous headache for about 4 days. Around the time the headache turned milder I developed a case of tinnitus which has still not gone away. Tinnitus is ever present in both ears
49 2021-04-16 chills, fatigue, fever Fatigue, body aches, low grade fever (peaked at 101.5). Peaked after about 24 hours with severe chil... Read more
Fatigue, body aches, low grade fever (peaked at 101.5). Peaked after about 24 hours with severe chills for 3 hours.
49 2021-04-16 chills Severe body aches Cold/chills
49 2021-04-16 fever, chills, fatigue muscle aches, tiredness, chills, slight fever
49 2021-04-17 chills Shaking, chills, and night sweats.
49 2021-04-17 headache trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous rep... Read more
trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous report from contactable consumer (patient). A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW6H02, expiry date not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 17:00 as single dose for covid-19 immunization. The patient medical history included allergies to IVP dye (reported as "die"). Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medication included insulin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin, codeine, and atorvastatin (LIPITOR) and experienced allergies to them. On 26Feb2021, the patient had chest pains, and on an unspecified date in 2021, had trouble breathing, terrible headache, and shortness of breath which lead to surgery. The events were reported as serious life-threatening and had caused hospitalization on unknown dates. It was reported that for the event chest pains the patient was hospitalized for 5 days, while for the other events it was not provided how many days the patient was hospitalized. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 on 20Mar2021 which was negative nasal swab. Therapeutic measures were taken as a result of the event shortness of breath which included surgery, and chest pains. The outcome of the event chest pains was recovering while the outcome of the other reported events was unknown.
49 2021-04-17 headache Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted... Read more
Metallic taste hour about an hour after shot that lasted about an hour. Severe headache that lasted about 4 days, mild headache another 3 days Most concerning was a super sensitive, tingly lower back. A ?rash? developed Monday (4/12). I went urgent care on 4/17 and was diagnosed with shingles.
49 2021-04-18 fatigue, sweating, headache, chills The evening of the shot my body basically turned on itself and began an all out mission to rid the v... Read more
The evening of the shot my body basically turned on itself and began an all out mission to rid the vaccine. Of course, that couldn't happen, but my body was going to proceed until I was dead or recovering. I began having severe chills, roasting heat flashes, headache, and body ache. Every sweat gland turned on full blast and did not turn off. I began to vomit in outrageous fashion. As violent as I've ever experienced. I had "sessions" of vomiting at least thirty times from Thurs night to Monday afternoon. When I could get out of the bathroom, I would collapse back into my sweat soaked bed. I would have an awful time trying to catch my breath. It would be up to ten minutes of hyperventilating and racing pulse, until it would suddenly normalize. And then I'd be utterly exhausted and slip into some kind of semi-sleep coma. This would not last even an hour before I'd be racing to the bathroom again. This was the first sixty hours. Vomit. Hyperventilate. Wish for death. Sleep coma. Repeat. About 24 hrs in I added severe diarrhea that was a part of every bathroom journey from then on. Ate nothing. Couldn't take normal meds. Sipped some pedialite. Late Sunday I turned a corner and felt like I wouldn't die. Took a full seven days for me to get any energy back and feel human again.- Every single symptom besides headache, was the worst I've ever experienced.
49 2021-04-18 sweating Lightheaded, change in skin color, Sweaty.
49 2021-04-19 fatigue, fever - Muscle pain around the inoculation area; - About 12 hours after the shot, my stomach started feeli... Read more
- Muscle pain around the inoculation area; - About 12 hours after the shot, my stomach started feeling upset then I threw up. The vomiting happened about half a dozen times over a period of roughly 2 hours. For the reset of the evening, I was feeling feverish and did not sleep well, if at all. Feeling exhausted in the morning. Had to skip work to get some rest.
49 2021-04-20 chills Developed chills and body ache approximately 13 hours after injection. Symptoms persisted for 36 ho... Read more
Developed chills and body ache approximately 13 hours after injection. Symptoms persisted for 36 hours after injection.
49 2021-04-20 lethargy, sleepiness Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. ... Read more
Extended period of lethargy after second injection, from day 7 (post injection) to at least day 18. Afternoon and evenings are mentally cloudy, low energy, and sleepy, requiring afternoon naps, and loss of work every day. Symptoms were worst at about day 10 to day 14, post second injection, and gradually reducing in severity through day 18 (though still existing at this time of reporting).
49 2021-04-20 fever, chills 6PM FEVER STARTED AND CHILLS INCREASING TO 105.4 BY 7:30PM. HIGH GRADE FEVER- LASTED UNTIL 10AM ON 1... Read more
6PM FEVER STARTED AND CHILLS INCREASING TO 105.4 BY 7:30PM. HIGH GRADE FEVER- LASTED UNTIL 10AM ON 1/14 FOLLOWED BY LOW GRADE FEVER 101 UNTIL 4PM 1/14. MOTRIN & TYLENOL ALTERNATING EVERY 4 HRS AND HYDRATION.
49 2021-04-20 fever, fatigue Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an a... Read more
Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an additional day. Started experiencing lupus flare symptoms 3 weeks after 2nd vaccine - rash, hair loss (alopecia), joint pain/swelling, low grade fever, worsening kidney function (elevated proteinuria). Continued to have symptoms for 2 months - led to change in medications with rheumatologist.
49 2021-04-22 sweating Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and w... Read more
Two 10 second convulsions followed by paleness and sweating. Patient was anxious prior to shot and was not responsive during convulsions. Wife stated that he "always has this reaction". Nurse Practioner that administered the vaccine stated that it was congruent with classic vasovagal symptoms after immunization. EMS arrived but patient did not want to go with them.
49 2021-04-22 runny nose, fatigue Strong smell of ammonia from my nose for 24 hours. Runny nose, extremely tired and thirsty.
49 2021-04-23 sweating After about 5 minutes of receiving his covid vaccine the patient became pale and was sweaty. I took ... Read more
After about 5 minutes of receiving his covid vaccine the patient became pale and was sweaty. I took his blood pressure and it was 105/64 with a pulse of 62. I brought him a cold pack from fridge to put on his wrist and neck. We watched him closely afterwards. I asked that he wait for 30 minutes so we could watch him. He felt better before he left and had a healthy appearance.
49 2021-04-23 fever Body aches, fever reaching 102.8. Symptoms lasted 24 hours.
49 2021-04-24 fatigue High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2... Read more
High blood pressure and heart rate elevated tired and very irritable this lasted 4 days with the 2nd and 3rd days being very bad.
49 2021-04-24 lethargy, fever, chills Severe lower back pain, oral blisters, Fever, Chills, Lethargy. All for 8 days post vax except the ... Read more
Severe lower back pain, oral blisters, Fever, Chills, Lethargy. All for 8 days post vax except the back pain which has yet to resolve but is improving.
49 2021-04-24 fever low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report rec... Read more
low grade fever; felt pressure on chest; slight difficulty breathing; This is spontaneous report received from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:45 (Lot Number: EP6955) (Age at vaccination: 49 Years) as single dose for covid-19 immunisation. Medical history included Psoriasis; psoriatic arthritis; No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included rosuvastatin; valacyclovir [valaciclovir]; finasteride; vitamin d [vitamin d nos]; cetirizine hydrochloride (ALLERTEC, OTC allergy medication)). The patient previously received the first dose of bnt162b2 (lot number: EP6955) in Left arm on 17Mar2021 10:00 for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 14: 00 (also reported as 13 minutes post injection), the patient felt pressure on chest/slight difficulty breathing for 15-20 minutes. On 08Apr2021 20:00 (one day post injection) had a low grade fever. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of events felt pressure on chest/slight difficulty breathing was recovered on 07Apr2021, of low grade fever was recovered on 08Apr2021. No follow-up attempts are needed. No further information is expected.
49 2021-04-25 cough Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 ... Read more
Chest congestion, weight in center of chest, little coughing, breathing ok Pfizer-BioNTech COVID-19 Vaccine EUA
49 2021-04-25 sweating, fever, headache, chills The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/... Read more
The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/shaking. The next day I began experiencing headaches, body aches, nausea and continued hot flashes and waves of fever. This has now persisted for over 48 hours.
49 2021-04-25 influenza like illness, fatigue, chills Flu like symptoms with chills, muscle pain and fatigue
49 2021-04-25 fever, fatigue Moderate to severe vomiting, diarrhea and fever that lasted several hours, followed by 2-3 days of n... Read more
Moderate to severe vomiting, diarrhea and fever that lasted several hours, followed by 2-3 days of no appetite and moderate to severe fatigue. Followed by 2-3 days of mild fatigue
49 2021-04-26 headache, fatigue moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy ches... Read more
moderate fatigue lasting 7 days, mild nauseous especially post eating lasting a few days, heavy chest pressure (still experiencing this after 30 days) with mild labored respiratory breathing and increased blood pressure to clinical high. Low grade headache (everyday for past 30-days).
49 2021-04-26 sweating Client observed vomiting and sweating. Client able to verbalize need and stated that he was/felt ext... Read more
Client observed vomiting and sweating. Client able to verbalize need and stated that he was/felt extremely nauseous after receiving second dose of vaccine. Client seen and assessed by EMT and V/S are: b/p 115/70, HR 65, O2 98. Client decline transfer to ER and voiced that he will go himself if symptoms worsen and cleared to go by EMT.
49 2021-04-27 headache, fever, fatigue Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Ach... Read more
Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report. Information on the lot/batch number has been requested.
49 2021-04-27 headache Pfizer-BioNTech COVID-19 Vaccine EUA. Tinnitus in both left and right ears. Onset was 18 hours afte... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Tinnitus in both left and right ears. Onset was 18 hours after vaccine dose. Continuing unresolved tinnitus at 4 days after dose administered. Separate Headache and hangover symptoms have resolved and started 18 hours after dose and subsided 42 hours after.
49 2021-04-27 sweating PATIENT REPORTED FEELING LIGHT HEADED. HE HAD SYNCOPAL EPISODE WITH OBSERVER PRESENT FOR 2-3 SECOND... Read more
PATIENT REPORTED FEELING LIGHT HEADED. HE HAD SYNCOPAL EPISODE WITH OBSERVER PRESENT FOR 2-3 SECONDS. HE ALSO REPORT FEELING NAUSEA WITH SWEAT. HE HAD A HEART RATE 63 WITH OK PULSE . HE HAS NOT TAKEN ANY MEDICATION , NO ALLERGIES. PATIENT WAS ADVICED TO LIE FLAT WITH FEET ELEVAT AND STAY HYDRATED. PATIENT ADVICED TO NOTIFY IF NO IMPROVENT IN SYMPTOMS. WHEN SYMPTOM NOT IMPROVING, HE WAS BROUGHT TO THE TENT. BP:127/87 HR :55 . PATIENT REPORTED IMPROVEMENT IN NAUSEA, DIZZINESS AND BY 13:20PM . AT 13:27 , PATIENT LEFT WITH WIFE AFTER SYMPTOM WAS RESOLVED
49 2021-04-28 chills, fever Chills, night sweats, fever, arm tingling, muscle aches
49 2021-04-28 fatigue Pain and swelling at injection site . Vertigo , nausea and vomiting. Fatigue and muscle aches . A f... Read more
Pain and swelling at injection site . Vertigo , nausea and vomiting. Fatigue and muscle aches . A few hours after receiving the second dose , The injection site was considerably more painful and swollen than the first dose . When I awoke the morning after I experienced severe vertigo . The vertigo was made worse by head movements. This was accompanied by nausea and vomiting, body aches and fatigue
49 2021-04-28 sweating Patient just got the vaccine and was standing near pharmacy and fell to the ground. On his way down... Read more
Patient just got the vaccine and was standing near pharmacy and fell to the ground. On his way down he hit his head on the shelf and cut his head in 2 places. When I got to him he was still out of it and within seconds he came to. I had him stay laying down and he was very pale and sweaty. We called 911 and they came within 5 minutes. In that time frame I took his BP and pulse and it was low. Ems took him to the hospital.
49 2021-04-28 throat pain, fever, runny nose, fatigue, headache, chills, nasal congestion VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/12/21pfizer,Lot#EL3248 2nd dose: 02/10/21Pfizer,Lot# EM9810 Diagnosed covid positive:04/24/21 Exposure:Home Exposure Symptoms:Fever, sore throat,fatigue,chills,runny nose,Headache,nasal congestion.
49 2021-04-28 paranasal sinus discomfort, throat pain, cough Sore throat,cough,sinus pressure
49 2021-04-28 fever FEVER
49 2021-04-29 cough, nasal congestion, fatigue cough, nasal congestion, fatigue and generalized body aches.
49 2021-04-29 fatigue, headache 1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm ... Read more
1st shot: No adverse reactions after the shot. 2nd shot: 3 minutes after the second shot, felt warm wave in my body and became dizzy. Did not have additional side effects and left in 20 minutes. During driving back and 1 hr after the vaccination became even more dizzier and fatigued, with walking balance issues. Second day dizziness disappeared, but I had a pain in the area of the shot, headache, body aches, and fatigue, balance issues. 3rd day started recovering. 3-8 day side effects gradually disappeared but started having panic attacks and generalized anxiety which I suffered years ago.
49 2021-04-29 headache 3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosi... Read more
3 days of intractable headache beginning 4/11. Right sided facial symptoms beginning 4/14 - diagnosis of Bell?s palsy. Later diagnosis of cluster headaches. Treatment: prescribed 7 days of Prednisone (60mg) and Valtrex. Currently acupuncture 2x weekly, oral B12 (2500mcg), TCM herbal supplements. Prescribed Sumatriptan for h/a but not used as they have subsided. Headaches currently subsided to jaw only. 15 days after diagnosis, Bell?s palsy symptoms show very minor improvement (R eyelid more functional now).
49 2021-04-29 headache Extreme headache. Behind my eyes hurt so bad. Even light coming through my eyes when they were clo... Read more
Extreme headache. Behind my eyes hurt so bad. Even light coming through my eyes when they were closed hurt really bad. Pain moved into my neck and my joints in my shoulders.
49 2021-04-30 chills, fever, headache bad chills, fever overnight, severe headache, body aches, shot site pain, and lymph node swelling an... Read more
bad chills, fever overnight, severe headache, body aches, shot site pain, and lymph node swelling and soreness
49 2021-04-30 fatigue hives on legs (close to plevic area) severe rash under right arm. Body aches and tired on 04/30 - mo... Read more
hives on legs (close to plevic area) severe rash under right arm. Body aches and tired on 04/30 - more concerned about the rash
49 2021-04-30 headache he has days when he can't hear, clarified as selective hearing; trouble finding veins/ he was stuck ... Read more
he has days when he can't hear, clarified as selective hearing; trouble finding veins/ he was stuck 20 times yesterday trying to get blood and find a vein; knot on face; his eyeball and bone around the eyeball hurts; jawbone hurts; inner ear and outer ear hurts all the way down to neck and shoulder; inner ear and outer ear hurts all the way down to neck and shoulder; inner ear and outer ear hurts all the way down to neck and shoulder; Headache; This is a spontaneous report from a contactable consumer (patient). A male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 31Mar2021 at 18:00 (Batch/Lot Number: ER8732; expiration date not reported) at the age of at a single dose for COVID-19 immunisation. The vaccination facility type was pharmacy. Medical history included diabetic from 2006 and ongoing; heart patient, had first heart attack in 2006; kidney stones, diagnosed during end of last year 2020 or beginning of this year 2021. Patient had his 1st car accident when he was . Family medical history relevant to adverse events was reported as none. There is no history of previous immunization with the Pfizer vaccine, no additional vaccines administered on same date, no other vaccinations within four weeks prior to the first administration date of the vaccine and no adverse events following prior vaccinations. There were no concomitant medications. The patient stated that he got the COVID vaccine at the end of the last month, the 30Mar2021 or 31 Mar2021. Patient then confirmed it was 31Mar2021. Patient stated that he is diabetic and a heart patient. He has been having kidney stones that has nothing to do with vaccine. He was supposed to have a procedure for the kidney stones done yesterday, 13Apr2021. He drank a lot of water 3 days before but when he went in yesterday, 13Apr2021, they couldn't find a vein and usually he does not have trouble with people finding a vein. They did try to go in his neck a couple of times to place an IV and he did end up with a knot in his face. They couldn't find a vein that would hold an IV, so he was not able to have the procedure done. Patient reported that the knot was just a little knot on the jaw below the ear lobe, and so he went home but it kept getting bigger and hurting a lot more. He reported that the knot is now all the way to the center of his nose, his eyeball and bone around the eyeball hurts. The patient's jawbone hurts, inner ear and outer ear hurts all the way down to neck and shoulder. He went back to the surgical center yesterday, 13Apr2021, they told him there was no bleeding and that he could go home or do whatever he wanted to do. Patient stated that he ended up in emergency room on 13Apr2021. He reported that the emergency room ran some bloodwork but doesn't know what kind and that they had to stick him 4 or 5 times and then had to use a sonogram machine to find a vein. He stated that he was stuck 20 times yesterday trying to get blood and find a vein. He stated that finding a vein on him has never been that hard and that he does have tricky veins sometimes, but if someone is good enough, they can get it. Patient reported that the emergency room basically did a CAT or CT scan, it wasn't an MRI, but he thinks it was a CAT scan with contrast. He stated that the emergency room didn't find anything and that they told him it was his imagination but that it is not his imagination to see a knot on the side of his face. Patient stated that he could be wrong, but he thinks it is because of the COVID vaccine. He stated that he has had needles, surgeries, IVs before and never had this where they can't get a vein and have never had knots just pop up on his body. Patient commented he has days when he can't hear, clarified as selective hearing since an unknown date. Patient stated that he will not be getting that second COVID vaccine. He stated that last month he had no problems with his veins, so the only thing new since last month is the COVID vaccine he received on 31Mar2021. He stated that he thinks he received the COVID vaccine on the left side but everything he is experiencing is on the right side. Patient reported that trouble finding veins started at 7:00 AM, the knot showed up around 8:00 AM or 8:30 AM and that he has a headache that started on 13Apr2021, around 8:00 AM or 8:30 AM that is ongoing and staying about the same as a constant headache. Patient stated that he was told that the hospital isn't for what he has. The outcome of the events knot on face and headache was not recovered while the outcome of the other events was unknown.
49 2021-05-02 bronchitis 2 days after receiving vaccine pt developed sudden onset of difficulty breathing. He could not take... Read more
2 days after receiving vaccine pt developed sudden onset of difficulty breathing. He could not take a breath in. Denies cough, wheezing, fever or URI sx. Went to ER and diagnosed with bronchitis and pleurisy. Given albuterol, medrol and toradol.
49 2021-05-02 throat pain, head discomfort high pressure, throat sore, ringing in the ear, pressure in the head whenever having intercourse, di... Read more
high pressure, throat sore, ringing in the ear, pressure in the head whenever having intercourse, dizziness
49 2021-05-03 chills, fever Fever or Chills Muscle or body aches
49 2021-05-03 cough, fatigue Cough, nausea, fatigue, dyspnea with exertion
49 2021-05-03 fever, headache Headache, low fever
49 2021-05-04 headache extreme constant throbbing headache to my right side and back of head. Never had a headache like thi... Read more
extreme constant throbbing headache to my right side and back of head. Never had a headache like this before. Position of head, neck movement does not make a difference. Tooke 600 mg of ibuprofen and only helps about 20%. Headache has not progress and stay the same on 05/01/21. 05/02/21, 05/03/21, 05/04/21. Felt better 05/04/21 around 10 pm. 05/05/21 headache has decrease in intensity. No other symptoms
49 2021-05-05 headache 30 minutes after the vaccine was administered I got a mild headache that lasted most of the day. Ar... Read more
30 minutes after the vaccine was administered I got a mild headache that lasted most of the day. Around 3:30 in the afternoon my wife noticed my left eye being red. It appeared to be burst blood vessels. I had not been straining or doing any activity that I believe would have facilitated this type of event.
49 2021-05-05 headache 4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 1... Read more
4:40pm: Patient complained of arms cramping, back of head pounding, coughing blood, tachycardia; 16:48pm EMS called. 17:08 EMS Arrived; Vitals: 16:50pm 148/90 101 18 O2 100%; 1700pm 144/100 100 20 O2 100%; 1730pm EMS departed to hospital. Pt. status when transported to hospital: Stable, no longer vomiting.
49 2021-05-06 fever, headache No adverse effects the first shot, second shot I had a light headache later that same day, and a low... Read more
No adverse effects the first shot, second shot I had a light headache later that same day, and a low fever the next day of 99.5, but generally felt good overall.
49 2021-05-07 fatigue Beginning the day of the 2nd dose I had elevated BPs (160s/110s) and tachycardia (100s) while at res... Read more
Beginning the day of the 2nd dose I had elevated BPs (160s/110s) and tachycardia (100s) while at rest, no matter from which arm or position taken). It has taken approximately 3 weeks for my HR to return close to baseline at rest but my diastolic BPs remain in the 90s (my resting baseline is 120-130/70-80 BP, 60-70 HR). I am now 4 1/2 weeks post-2nd dose and still 130-140/90s but HR 70s. Also, I had been diagnosed with CIDP earlier in the year and since the 2nd dose I have been increasingly fatigued and have pronounced hand and foot weakness each passing week--I have walking difficulty at this time and am unable to grasp and lift even 3# weights.
49 2021-05-07 sweating Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose ... Read more
Chest pain; Had irregular pulse; BP dropped; Patient felt faint minutes after receiving second dose of vaccine; Diaphoretic; This is a spontaneous report received from a contactable nurse. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 09Apr2021 for covid-19 immunisation. The patient experienced Patient felt faint minutes after receiving second dose of vaccine, BP dropped, had irregular pulse, became diaphoretic and complained of chest pain on 30Apr2021. The events assessed as non-serious. Unknown patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown list of any other medications the patient received within 2 weeks of vaccination. Unknown prior to vaccination, was the patient diagnosed with COVID-19. Unknown since the vaccination, has the patient been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered included Workplace clinic. The events were resulted in Emergency Room Visit. The outcome of the events was reported as unknown. Information about batch no/lot no has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events blood pressure decreased, irregular pulse, chest pain and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-05-09 fatigue, paranasal sinus discomfort, throat pain, headache Fatigue, body aches, headache, sore throat, sinus pressure, vomiting, shortness of breath
49 2021-05-09 fatigue He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even ... Read more
He felt very bad the night he received the 2nd shot of Pfizer covid-19 vaccine on April 27. He even joked he probably would die that night. He also complained that despite his protest, the person who administered the shot insisted to inject on his shoulder joint. He developed a bigger-than-quarter-size bruise on his right inner arm the next day. He was feeling tired the following days. On May 4 around 3:30, I heard he was making loud noises. I came to his side immediately. At the time I thought he was making louder than usual snores. I nudged him gently but he didn't respond. After about 15 seconds, the sound stopped, and he had no breath. I then called 911 within 10 seconds, tried to do CPR on him. It took EMS 6 minutes to arrive even though we live very close to a fire station in a well-accessed urban area. EMS worked on him for about 30 minutes before transported him to hospital. They continued to work on him for a while. He never regained breath.
49 2021-05-09 head discomfort Experience two large heart palpitations and what seemed stopped beating for a second, this was follo... Read more
Experience two large heart palpitations and what seemed stopped beating for a second, this was followed by tremendous pressure in my head, I thought I was experiencing a stroke. I felt like I was going to black out and was having tightness in my chest , my wife took me to the E.R. I had an EKG done and it not show any arrhythmia and CT scan of my head did not show any abnormality. They scheduled me to follow up with cardiologist. The whole week I experienced the following symptoms: Tightness and sharp pains in chest; Difficulty breathing, especially at night (had to sleep sitting up on couch one night and another night woke up with difficulty breathing , appeared to be the biggest problem when laying flat). Would get out of breath walking up stairs; Moments I would get really light headed with a feeling like I could pass out; Symptoms last until the 4/16 , when they finally went away. Follow up with Cardiologist, who scheduled an electrocardiogram and stress tests on 5/7. The tests results showed that I had a healthy heart and no underlying conditions. I'm 49 and never have experienced any cardiac events. before or have a family history of cardiac disease. I have no known allergies either.
49 2021-05-09 headache Tinnitus comes on goes. Sometimes is very low sometimes is unbearable with a headache.
49 2021-05-09 throat irritation Numb tongue in center. Itchy throat with cough. Ringing ears. Irritable skin sensation on face.
49 2021-05-10 fever Fever for 3 days. Extreme joint pain in shoulders, back, neck, left hand and left wrist for 6 days a... Read more
Fever for 3 days. Extreme joint pain in shoulders, back, neck, left hand and left wrist for 6 days after vaccine. I am still experiencing these symptoms and they are severe.
49 2021-05-11 fatigue have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6... Read more
have some clots; Neuropathy; autoimmune disorder; Fell and hit elbow and 3 ribs on left side; lost 6 (lbs) pounds/Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight; falling; felt super strong; dizziness; failed all the tests for motor skills for his arms and legs; Fell and hit elbow and 3 ribs on left side; Fell and hit head; Sensory nerves are all gone; Fatigue; scabs; delusional; tore tendons in between ribs; They are tender(ribs); hurting all over; Cannot walk or lift anything; chest pain; his arm was sore a little; Left arm injection site pain; Disoriented; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 03Feb2021 (batch/lot number and expiration date not reported) at the age of 49 years old, as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, vascular disease, bilateral stents placement, cataracts since he was born. Concomitant medication included gabapentin taken for an unspecified indication from an unspecified start date and ongoing. On 04Feb2021, the patient experienced left arm injection site pain. The patient experienced dizziness, falling, and couldn't go to work on unspecified date. He was treated by his (MD) physician, was given a CT scan, echocardiogram, and found to have some clots. He stated he has a history of vascular disease and had bilateral stents placed a year ago. He was placed back on an aspirin/Plavix regimen and referred to a neurologist because he has no motor skills anymore. He stated he failed all the tests for motor skills for his arms and legs. He was advised not to take the second dose of the vaccine and was diagnosed with neuropathy and autoimmune disorder (caller does not specify which disorder). He reported being positive for Covid-19 in Dec2020. He wanted to know what else he can do for his symptoms and is offering to be tested by Pfizer for treatment. The symptoms come in really hard seven days later. He actually had to go to the (ER) emergency and they worked on him and a whole string of doctors. He went to the emergency room and something was going on and wanted him to go to a family practitioner. They sent him to vascular, neurological and now they want to send him to a research center. It was a whole week after receiving vaccine before he began having symptoms. With the neuropathy and autoimmune, he cannot work like he did. He can hardly walk. Unspecified autoimmune was diagnosed last week. He can't remember the name of it. They told him not to take second one because the first one did what it did to him. It hurt a little and it was quick. The next day (04Feb2021), he said his arm was sore a little. He is only taking 4 medications and they looked it up. He did not think they were relevant. He was disoriented and fell and hit his head a couple of times. They ran an MRI on his head trying to figure that part out. That was done last week. He doesn't know the date and said it may have been on Friday. Results were good. The date he was disoriented was Wednesday 03Feb2021, when he took the shot. He has been disoriented and has been that way ever since. They kept him for 15 minutes to make sure no one passed out. He has been disoriented since then. He could not think clearly, and he could not do his job. He tore tendons in between ribs. He first thought he actually broke his ribs, but did not. There were two different falls. He cannot feel feet or anything. His motor skills are OK but when they did neuropathy test, they put needles in and shocked him to make his motor fire. His reflexes were really bad. He fell and hit elbow to keep from falling on face and twisted going down hitting 3-4 ribs on left side. It has been over 3 weeks now for his ribs. They are tender but they are not like the initial blow. It feels like they are healing. He fell and hit head a week ago. He was unsure of the exact date. He did not go to the emergency room with this one because the bed caught him. He fell and hit his head. All he has left is scabs. He cannot walk or lift anything (11Feb2021). That next Wednesday, he got ready to go to work and was so delusional and could not go in. He slept from 5:30 all that day and all that night. Then Thursday, he gets up and goes to work and goes slower, just to see what happened on Wednesday. He had fatigue and was disoriented. He did not provide start date or outcome for fatigue. He walked in and said either call an ambulance or he would go home. He went home and that was the last day of work. He then stated he laid in the car for 30 minutes and he said he is going to the emergency room. He went straight there that day. He had stents put in lower part of his body a year before. The neuropathy and the autoimmune kicked in 7 days later after the shot. The reason he went to the ER is because he thought it was his stent. He had bilateral, 4 of them. He was having chest pain and hurting all over on 11Feb2021. He thought he was having a heart attack. He was seen in the emergency room and released. It depends on how far he goes, how the chest pain worsens. Right now, he is ok, but when he gets up and moves around, it does the same thing. Within 2 months, he has lost 47 lbs and eats all the time and is still losing weight. He was about 200 something and was kind of built and now is skin and bones. He lost 6 (lbs) pounds within a week and is eating like crazy. Sensory nerves are all gone. If hit with a baseball bat and he would not feel it. It came on slowly almost that he did not know it was happening. That is why they want to send him to Privacy for a research center and he does not want to go. He never had this happen before. ER or physician's office required: 1st date was on Thursday, 11Feb2021, when he went to Privacy. He was having chest pain and hurting all over. He thought he was having a heart attack. He was released. The patient stated he wanted to change the information he had provided since he was not in his right mind since he had taken the wrong medication dose than the doctor had given him. He stated the medication dosage he wanted to change was for Amiripyin. He stated he wanted to say he told the representative the symptoms he had experienced was enhanced which they were yesterday because he was trying to fight everything and stay awake. COVID 19 vaccine: he stated the doctor did not want him to take the second dose of the vaccine. He stated one of the symptoms he had experienced after the vaccine that he wanted to change the outcome for is the neuropathy. He stated he is back to where he used to be and yesterday it was bad he could hardly walk or talk. He stated also the other symptoms he wanted to change the outcome for is the autoimmune. The patient has not recovered from neuropathy, autoimmune disorder, disoriented, can't walk or lift anything, chest pain, and sensory nerves all gone; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
49 2021-05-14 fatigue 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 2... Read more
23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. No follow-up attempts are needed. No further information is expected.
49 2021-05-16 sweating Patient complained of Flushing/sweating, Nausea, and dizziness. BP 143/97, HR 76, RR 18 -- > 137/91... Read more
Patient complained of Flushing/sweating, Nausea, and dizziness. BP 143/97, HR 76, RR 18 -- > 137/91, 75, 18. Pt A&O x4, VSS, no Resp distress. Water/juice given. Pt states symptoms resolved and released from vaccination site.
49 2021-05-16 sweating Five minutes after receiving vaccination patient off from his chair. he was diaphoresis & hypotensiv... Read more
Five minutes after receiving vaccination patient off from his chair. he was diaphoresis & hypotensive. RN checked VS( BP 56/30)
49 2021-05-18 fatigue, cough, headache Diagnosis Plan 1. Exposure to COVID-19 virus COVID-19 PCR COVID-19 (SARS CoV-2,RNA Molecular Ampl... Read more
Diagnosis Plan 1. Exposure to COVID-19 virus COVID-19 PCR COVID-19 (SARS CoV-2,RNA Molecular Amplification) See patient instructions. MDM: Patient is a 49-year-old male presenting to the urgent care today requesting COVID-19 testing. The patient started with fatigue last night and has developed a cough and headache over the course of the day. He currently lives with 2 family members who are Covid positive. On exam today the patient's vital signs are stable. His resting pulse ox is 97%. He does not report shortness of breath. The patient has a reassuring physical exam at this time. Today COVID-19 PCR swab was collected and sent to the lab. We will call him with results. I discussed with him the need to quarantine 10 days from the start of his symptoms in the event that he is positive. I have also encouraged him to be rechecked if he would develop shortness of breath or chest tightness over the course of the next couple of days. Patient is agreeable with the plan.
49 2021-05-18 fatigue, fever Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. ... Read more
Zero arm pain until around 8PM. Then came on and intensified for next two hours. Became very tired. Went to bed at 10PM. Woke up at 12;30AM with a 101 degree fever and intense pain in lower back/upper buttocks. Fever/pain persisted and worsened throughout the night. Aches spread to other areas of my body but still centralized to back/buttocks. Headache introduced in the AM. Fever bounced all day between 102 and 104.2 degrees all day until about 8:30PM on Sunday. Tried ibuprofen to manage pain and temperature but had minimal effect. General tingly and buzzy feel after 8:30PM and into Monday. Headeache reappeared on Monday evening with cold sweats. Strange calf ache in right leg Monday night into Tuesday AM that consistently woke me up. Tried massage, stretching, to no avail. Tuesday AM most everything dissipated with just a bit of fogginess throughout Tuesday (though less than Monday).
49 2021-05-19 fatigue Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). ... Read more
Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 49-year old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 (Lot Number: EL3247) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history included asthma. Patient received first dose of bnt162b2 (BNT162B2) on 26Jan2021 at 12:00 PM in Left arm (at age of 49-year-old) for covid-19 immunisation, lot number: EL3247. Concomitant medications in two weeks included ubidecarenone (COQ10), ergocalciferol (VIT D), glucosamine (GLUCOSAMINE). Patient did not receive any other vaccine in four weeks. On 18Feb2021 patient experienced arm pain, aches, tiredness. Patient was able to perform work but at a reduced pace. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report. No follow-up attempts are possible. No further information is expected.
49 2021-05-20 sweating Pt c/o flushing/sweating and dizziness. BP 131/84, HR 71, RR 14. Pt stable and released from the v... Read more
Pt c/o flushing/sweating and dizziness. BP 131/84, HR 71, RR 14. Pt stable and released from the vaccination site.
49 2021-05-20 sweating dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute rega... Read more
dizziness. Had syncope episode, was snoring and twitching. Very diaphoretic. Less than 1 minute regained consciousness. Patient was assisted to floor on his side. Patient able to answer questions.
49 2021-05-20 sweating Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotensi... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Weakness-Severe, Additional Details: Shortly after receiving his first shot the patient started to feel severely light headed while being observed. He was not able to walk over to the bench from his seat, so I had to help him from his seat onto the floor to lay down. After laying down and drinking water, he started to regain color to his face. After laying down for roughly 30 minutes he felt strong enough to stand up and walk to the bench where he then sat for an additional 20 minutes.
49 2021-05-20 fever Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, ... Read more
Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.
49 2021-05-22 fatigue, chills, fever Fever, chills, injection site pain, nausea, and fatigue. Fever, chills and nausea lasted for 1 hour... Read more
Fever, chills, injection site pain, nausea, and fatigue. Fever, chills and nausea lasted for 1 hour 20 minutes. Fatigue the evening before and the following day.
49 2021-05-22 pneumonia Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fat... Read more
Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fatigue. Symptoms worsened and he was admitted to ICU on May 21st via the ED for multiorgan failure including respiratory failure with R pneumonia, Shock, Renal failure, Disseminated intravascular coagulation, shock liver failure requiring invasive vent support and treatment for septic shock including vasopressor support and antibiotic therapy. He was started on CRRT on the 22nd. His INR continues to rise and Hb dropping consistent with worsening DIC. Blood cultures are positive for MRSA. He will likely die from progressive septic shock and MSOF.
49 2021-05-25 fatigue, headache, chills, fever Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea... Read more
Dizziness and weakness, injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea
49 2021-05-25 sweating, fever sweating; Fever; This is a spontaneous report from contactable consumer. A 49-years-old male patient... Read more
sweating; Fever; This is a spontaneous report from contactable consumer. A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 9:45 (at the age of 49-years-old) as first dose, single for COVID-19 vaccination. Medical history of the patient was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. It was not known whether the patient was enrolled in clinical trial. The patient neither received any other vaccines within 4 weeks prior to the COVID vaccine nor other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient experienced fever and sweating on15March2021 at 02:00. No therapeutic measures were taken for the events. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot/Batch Number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 9:45 (at the age of 49-years-old) as second dose, single for COVID-19 vaccination. The clinical outcome of the adverse events fever and sweating patient was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
49 2021-05-26 fatigue Dizziness, Nausea, Fatigue, Light Diarrhea and stomach feels empty and uneasy all the time. These ... Read more
Dizziness, Nausea, Fatigue, Light Diarrhea and stomach feels empty and uneasy all the time. These symptoms have been around for a long time over 3 weeks and do not seem. to go away.
49 2021-05-27 fatigue, chills diarrhea with blood; Extreme fatigue; Severe gastrointestinal problems; severe body aches; joint pai... Read more
diarrhea with blood; Extreme fatigue; Severe gastrointestinal problems; severe body aches; joint pain; Painful diarrhea; bloating; abdominal pain; chills; soreness at injection site; This is a spontaneous report from a 49-years-old male contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729), intramuscularly administered in Arm Left on 20Apr2021 10:00 as single dose and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732) intramuscularly, administered in Arm Left on 11May2021 10:00 as single dose for covid-19 immunisation. Vaccine was administered: Workplace clinic. Concomitant medications included chlorthalidone for unknown indication and start stop date not reported. Medical history included drug allergies to Ibuprofen and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measurements included Tylenol, rest, pepto bismol. On 12May2021 11:00, the patient experienced severe body aches, extreme fatigue, soreness at injection site, severe gastrointestinal problems, joint pain, painful diarrhea, diarrhea with blood, bloating, abdominal pain, chills. The outcome of events was not recovered. On (17May2021) clarification was received from a Pfizer colleague with regards to the previous report received. The following was reported: Patient was self , Non- HCP, In sales.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.
49 2021-05-27 fever Herpes Zoster (Ocular) with a fever of 104. Treatment is antivirals until his appointment with Ophth... Read more
Herpes Zoster (Ocular) with a fever of 104. Treatment is antivirals until his appointment with Ophthalmologist on Tuesday 6/1/2021. Currently still symptomatic. Outcome in eye is uncertain.
49 2021-05-28 chills, fever, headache Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the p... Read more
Upon waking up the morning following the injection, a ~2 inch diameter erythema was present on the patient's upper arm at the injection site. In the center was a ~1 inch raised bump, painful and hot to the touch. Later in the day, corresponding to ~24 hours post injection, the patient developed 101 degree fever, an unusually strong headache, chills and myalgias. The symptoms peaked ~28 hours post injection. The patient took 1,000 mg of acetominophen which didn't appear to have an impact. Before going to bed that day, the patient took a full dose of Nyquil liquid. The fever, headache, myalgias and chills resolved overnight. The arm was painful and the myalgia/bump persisted for 4 additional days.
49 2021-05-28 fever, fatigue Gland swollen, fatigue , fever, hives
49 2021-05-29 chills, fatigue, headache Chills. Headaches, stomach pain, nausea, fatigue, and back pain. Symptoms have been 15 days now.
49 2021-05-30 sweating, headache, fatigue Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. ... Read more
Odd taste in mouth, heart racing, sweating. Next day developed tinnitus and pain in right ear/eye. Fatigue and brain fog. Severed headache. Felt like stabbing pain in head. Saw ENT 6 days later. Was prescribed steroids and ear drops. Have hearing loss in right ear and tinnitus
49 2021-05-31 fatigue, headache 4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, ... Read more
4/21: Felt "explosion in head," lightheaded, poor focus, vision off, felt like concussion, fatigue, "my computer short circuit", spinning, dizzy, anxiety, "eyes darting", racing thoughts at night while trying to sleep. 4/26: light sensitivity, new onset sciatica, hypersensitivity, inability to focus, spinning. 2nd phase: right posterior occipital pain (neuralgia). 3rd phase: moving eyes, felt crunching noise. Vertigo treated with vestibular therapy. Anxiety/insomnia treated with Xanax.
49 2021-05-31 fever Fever and aches
49 2021-06-01 chills, fever, pneumonia, headache, sweating Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever l... Read more
Headache; hurt right below my chest and in stomach; skin became extremely prickly; Low grade fever like 99; Dimer test showed kind of high levels with mainly blood clot; some fiber or Fibrogen which was for thickening of blood/ supposed to be between 400 and 420, his was 879; have COVID, it was positive COVID antigen test; have COVID, it was positive COVID antigen test; felt pressure in his back almost like pneumonia; Chills; sweat; Hot flashes; Stomach was cramping/ hurt right below my chest and in stomach; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right shoulder single dose for COVID-19 immunization; second dose with lot number: EV10161 on 22Apr2021, first dose with lot number: EP7533 on 01Apr2021, at 49-year-old. Medical history and concomitant medication were not reported. The patient was non-smoker, non-drinker. The patient had a little headache with the second shot but 2 weeks later on 03May2021 started having chills every night and would sweat. He was having chills and hot flashes and stomach was cramping and when inhaled like taking a deep breath, felt pressure in his back almost like pneumonia like lungs were filling with fluid or clotting. On the 07May2021, he took a little flu medication Theraflu over the counter (treatment) thinking that'd clear it up. Every time he took a deep breath, it'd just hurt right below my chest and in stomach and skin became extremely prickly. He'd have like a low-grade fever like 99. This was 2 weeks after the second shot, so he went to the ER on 07May2021 and was given a COVID test, a fluid test and lab work trying and figure what he was having. One of his blood test - Dimer test showed kind of high levels with mainly blood clot so they gave him a CT scan, scan showed no blood clots, no kidneys stones or anything like that should had any sweating. ER doctor gave him an antibiotic (ciprofloxacin) for infection like diverticulitis or diverticulosis. The doctor said the patient did not have a stomach infection, his tests showing such high levels for clots so the doctor did more lab work a PRC, CRT, TRP or CPR, a CRT lab work and some fiber or Fibrogen which was for thickening of blood. Those numbers are supposed to be between 400 and 420, his was 879 today (17May2021). The patient did have COVID, it was positive COVID antigen test, I got those results today (17May2021). Outcome of the events was unknown.
49 2021-06-01 fatigue Rheumatoid arthritis flare-ups; Fatigue; Off-balance/equilibrium is off; This is a spontaneous repor... Read more
Rheumatoid arthritis flare-ups; Fatigue; Off-balance/equilibrium is off; This is a spontaneous report from a Program received from a contactable healthcare professional and consumer. A 49-year-old male patient received bnt162b2 (BNT162B2), dose 2 at vaccination age of 49-year-old via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation; and tofacitinib citrate (XELJANZ XR; strength: 11 mg), oral from Dec2020 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE) at vaccination age of 49-year-old on an unspecified date for Covid-19 immunization. The patient's concomitant medication was not reported. The patient reported that after he completed the second dose of covid 19 vaccine weeks ago on 31Mar2021, he experienced fatigue and rheumatoid arthritis flare-ups (swelling and joint pain) with no missed doses while receiving the vaccine on an unspecified date in 2021. MD was aware & prescribed him with prednisone 5 mg. The patient also reported his feeling off-balance from laying down too much because of "equilibrium is off" (2021) which was unknown if MD was aware. He mentioned that his left knee has "no cartilage & bone in bone," and swollen improved when using cbd oil (cannabinoid oil). The patient has a scheduled appointment with a rheumatologist next month. The patient was encouraged to call MD. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on a temporal association , a causal relationship between the reported events and suspect drug is assessed as possible. The underlying medical conditions could have contributed.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-06-01 fatigue Irregular heartbeat started shortly after the vaccine and continued from then until now and is still... Read more
Irregular heartbeat started shortly after the vaccine and continued from then until now and is still occurring. Comes with occasional fatigue and several episodes of afib
49 2021-06-01 headache Blood pressure spike, took a month to get back to normal with meds. Stuffy ears/constant headache/ti... Read more
Blood pressure spike, took a month to get back to normal with meds. Stuffy ears/constant headache/tinnitus, still on-going.
49 2021-06-01 sweating Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to w... Read more
Patient was given the second dose of Pfizer Covid 19 vaccine on 6/2/21 at 12:29pm and was asked to wait for 15 minutes to watch how the patient reacts with the vaccine. He didn't have any side effect on his first dose. After 3 minutes of getting the vaccine, his wife notified me that she needs assistance. He was sweating profusely and was about to lose consciousness. His wife and I kept saying his name to check his response. He could not response or was about to faint. His pulse is slow, and his face is red. Since there was other customers waiting for shots in the clinic, I asked the technician to ask for pharmacy manager assistance. He came in the clinic, and checked patient's pulse and blood pressure. The blood pressure was high (170/89). We checked his blood pressure again, and it was lower after couple minutes. Patient started to have consciousness and understand what we are talking. He told us that he always had the same reaction after getting his blood drawn. We asked him to sit down and was monitored by us in the clinic. After 30 minutes, he said that he was feeling fine without any problems and decided to leave. He can breathe ok and didn't have any adverse reactions such as swelling of throat and lip or hives. His wife and he didn't eat anything before getting the vaccine. I checked his blood pressure again, and it was 130/80. Will follow up on him this evening and tomorrow.
49 2021-06-01 malaise, nasopharyngitis, lethargy, fever titers before the vaccine and they were 4400, after the vaccine they were 275; titers before the vac... Read more
titers before the vaccine and they were 4400, after the vaccine they were 275; titers before the vaccine and they were 4400, after the vaccine they were 275; vaccine put his Lupus in remission; Low grade fever; feel he had sickness; Lethargic; felt he had a little cold; feeling achy; felt Bleh; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 49-year-old on 31Mar2021 15:00 (Lot Number: EP6755) as 2nd dose, single dose; and dose 1 on 10Mar2021 (Lot Number: EN6206) as 1st dose, single dose, both via an unspecified route of administration for covid-19 immunisation. Medical history included ongoing systemic lupus erythematosus (diagnosed lupus diagnosed 15 years ago [2006]), antiphospholipid syndrome which is also called hughes syndrome and he was diagnosed 15 years ago [2006] (his numbers are so high that University came over and taken his blood samples as he is a unique case. It is on the national order of rare diseases), ongoing overweight, tachycardia, thyroid under-productive, ongoing neuropathy peripheral, lupus anticoagulant, ministrokes and 2 massive strokes that affected his left side. It was reported that his blood was clotting in his veins and he was having mini strokes and then he had 2 massive strokes. He has a lot of joint and RA factor in his blood. In his back, he had L4-5 disc removed in January and he has stiffness and pain from Lupus. He mentioned that his family has many autoimmune disorders. His son has the worst case of Grave's disease. Concomitant medications included gabapentin (GABAPENTIN) taken for neuropathy peripheral from Feb2021 (reported as taken a month before the first vaccine) to unknown date; iron oxides taken for an unspecified indication from an unknown date in 2021 (reported as few months before the first vaccine) to an unknown date; and propranolol to keep away tachycardia. The patient did not receive other vaccines on the day of covid-19 vaccination. The patient narrated that his plasma was high that he sells his plasma and they make test kits out of his antiphospholipid titers and he never runs under 4,000 on any of those. The patient mentioned that he has been 15 years they have been checking his titers. They checked his titers before the which was 4400 and after the vaccine (07Apr2021), they were 275. The patient mentioned that he has taken the 2 shots and the vaccine put his Lupus in remission (07Apr2021). The patient added that it knocked his titers for anticardiolipin IgM, and alphaglycoproteins IgM down (2021). The patient stated that it has been going on with him for 15 years, and nothing else has brought them down like that. The only new medications he started this year (2021) were Gabapentin and Iron pill so nothing else could have affected his titers except for the Covid vaccine. They checked his titers again (unknown result) so they could do his draws, they could not believe it. The patient further stated that he got a hold of the CDC and health department and they are supposed to be getting ahold of Pfizer. The patient stated that this is a good thing, the vaccine basically put his Lupus in remission and mentioned that he does not know the correlation. The patient has had no rashes, boils, hives, his joint pain has greatly decreased. The vaccine is suppressing all of those antiphospholipids that cause all of those problems. He does not know how close to a cure for Lupus the vaccine is, but this happened a week after the second shot. This has never happened before, so the patient thinks there has to be something there and Pfizer may have stumbled onto something amazing. The patient stated that every medicine he has been on for Lupus, and nothing has controlled his Lupus and Antiphospholipid syndrome. He further added that he has connective tissue pain, it is still there but not near as much as it was and his back was messed up and now that the Lupus is under control his back does not have real pain, just discomfort. In his back, he had L4-5 disc removed in January and he has stiffness and pain from Lupus and now it is not anywhere near as bad. He mentioned that after that it seems like once they got his results, they could not believe it. He has never been turned down for draws before and this was the first time that it was normal. He further mentioned that it is as if the Lupus has gone away. He stated that he had very little side effects from shots which included he felt Bleh and had a low-grade fever on 01Apr2021. The patient added that after the first shot, he had no problems. After the second on 01Apr2021 to 02Apr2021, he felt like he had a little cold or sickness, achy and he was lethargic for a couple of days, and then after that, he was normal again. The patient stated that he has not been having the flare ups that he usually has with Lupus. The inhibitors are what causes his Lupus and APLS which he has had them for 15 years, with no relief. The first time he has relief, was getting a vaccine for a Covid strain. The patient did not received treatment for the adverse events. The patient contacted the main guy that makes the test panel kits, and all they can think of is there is something in the vaccine that is suppressing his immune system. He does not know how long it will last but so far it has lasted about 4 weeks. He feels way better than before, and he will know if it wears off because his symptoms will start. The adverse events did not result in emergency room or physician office visit. The outcome of the events 'titers before the vaccine and they were 4400, after the vaccine they were 275' and 'vaccine put his Lupus in remission' were unknown while the outcome of the other events was recovered on 02Apr2021. No follow-up attempts are needed. No further information expected.
49 2021-06-01 throat irritation Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1... Read more
Client (received the COVID vaccine (Pfizer dose 2, lot # EW0187, expiration 6/28/2021) at 1800. At 1829, the client reported itching on his skin and in his throat. EMT, EMT #2, PHN, and RN responded at this time. The client was sitting comfortably in his chair, alert and oriented x4. The client's vital signs were as follows: heart rate 57, O2 97, respiratory rate 14, blood pressure 150/92. The client's skin was pink, warm, and dry. The client denied any shortness of breath or chest discomfort. The client was able to speak in full sentences and had no visible swelling on his face or tongue. The client declined Benadryl at this time. The client stated he has environmental allergies and has had an anaphylactic reaction to trees in the past. The client stated he has a medical history of anxiety, acid reflux, migraines, and hay fever; he takes antacids, sumatriptan, and allegra. The client stated that he took 1 allegra at 1816, but stated he didn't know the exact dosage and did not have the medication bottle with him. The client was able to speak in full sentences. At 1835, the client identified a small, red, erethematous area approximately 1 centimeter in length on the left medial area of his elbow, which he stated itched. He also stated his eyes were itching; neither eye or eyelid appeared red. The client stated his throat was dry and was offered and accepted water. The client declined Benadryl again at this time. The client was transferred to the zero gravity chair at this time, denied any dizziness during ambulation or transfer. At 1839 the client's vital signs were as follows: blood pressure 142/84, heart rate 74, O2 97%. The client stated "I had an itchy throat this morning" and said that he had a migraine that morning but did not remember if he had taken any medication for the migraine. At 1849, the client's vital signs were as follows: blood pressure 122/84, heart rate 73, respiratory rate 16, O2 99%. At 1853, the client stated "I feel less itchy." At 1900, the client initially requested Benadryl, but then refused both the medication and vital signs when offered. The client stated that his arm "still itched" but denied that it was getting worse. The client stated "I wanted a Benadryl for the road but now I think I'm going to wait." The client denied shortness of breath, chest tightness or pain, or any difficulty breathing. The client did not appear to be in any distress and had no swelling visible on his face or tongue. The client continued to chat with staff and spoke with a pleasant demeanor. Education provided by PHN, EMT, and RN regarding primary care follow up and when to seek medical care. At 1915, the client requested Benadryl and stated "I think my rash is growing." The client's vital signs at that time were as follows: blood pressure 138/92, heart rate 88, O2 99%, respiratory rate 12. At 1922, the client was given 50mg Benadryl orally. At 1927, the client stated "my wife is here, it's time for me to go." RN reiterated the importance of staying for a 30 minute observation time, but the client continued to leave the building. EMT accompanied the client outside, where he ambulated with a steady gait. He walked to the outdoor observation area and then sat down, requesting to be evaluated by EMS. EMS was called by RN at 1933. The client was sitting comfortably and denied any shortness of breath or chest pain. EMS arrived on scene at 1936. At 1938, the client's vital signs were as follows: blood pressure 140/90, heart rate 60, and O2 100%. The client stated at that time that he "felt better" and declined transport to the hospital. The client signed AMA paperwork at 1945 and ambulated to his car with a steady gait, accompanied by his wife, who he stated was going to drive him to an urgent care.
49 2021-06-02 sweating Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw the... Read more
Anaphylactic reaction; skin was on fire; sweating; stomach cramps; throwing up; his arms and saw they were solid red; inflamed; hands swelled up; itchy; sore; sore where injected the Testosterone into left arm.; sore where injected the Testosterone into left arm.; This is a spontaneous report from a contactable consumer (patient). An 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 16:45 (Lot Number: EW0182; Expiration Date: 31Aug2021) as 1st 0.3 ml single dose at the age of 49-years-old for covid-19 immunisation; testosterone cipionate, via an unspecified route of administration from 2020 (Lot Number: 88945; Expiration Date: 30Sep2021) and ongoing, at 150 mg, 2x/week (150 mg injection bi weekly ) for gonads, low testosterone. The patient medical history included low testosterone, gastrooesophageal reflux disease, COVID in the past (He did not know initially he had it, he had lost of taste and smell). Concomitant medication included dexlansoprazole (DEXILANT) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. None prior vaccinations (within 4 weeks). No family medical history relevant to AEs. No additional vaccines administered on same date of the pfizer suspect. The patient experienced anaphylactic reaction (medically significant) on 17May2021. Time of onset (24-hour clock): Roughly 18:00. Usually he took the testosterone in the morning, but he forgot. He was wrapping up the day, took the testosterone and by 18:02 he was on the ground, cold. The patient got his vaccination last Tuesday (11May2021). He was also on testosterone for gonadism. He usually administered the vaccine in his shoulders. He took the testosterone bi-weekly. On Monday he administered it his left shoulder and on Thursday it is in his right shoulder. After getting the vaccine he administered testosterone in his right shoulder on Thursday and had no issues. The patient mentioned everyone else who got the COVID Vaccine he knows had sore arm, nausea, but he did not have any of that. On Monday (17May2021) he injected his testosterone into the same arm/location, left arm, where he got the COVID vaccine and had an anaphylactic reaction. He contacted his doctor and went to the emergency room. The patient confirmed he felt like he had recovered completely from the anaphylactic reaction. Caller clarified the anaphylactic reaction. He did the testosterone injection in the same spot he had the COVID injection. Within 5 minutes it was like his skin was on fire. He was sweating, had stomach cramps, and was throwing up. Once he stopped throwing up he looked at his arms and saw they were solid red. They were all inflamed. His legs were inflamed. His hands swelled up. They were red. He had to take his wedding ring off. He was itchy. It was like he was on fire. He was sore, and sore where injected the Testosterone into left arm. He confirmed he had no problems swallowing or breathing. Based on the symptoms he was experiencing he realized these were things listed to be aware of when getting the COVID shot and to seek medical attention for. He went to the ER and they verified it was an anaphylactic reaction. Treatment included: He was given an Epi-Pen. It made him feel like off, like he had too much coffee or something. he was also given Benadryl and some Anti-Inflammatory to calm his body down. Investigations: He had blood drawn at the ER. However, he does not know if was actually tested. He was informed when the nurse drew blood it would be up to the doctor, but he has no knowledge if anything was done. Action taken of testosterone cypionate was dose not changed. Outcome of the events was recovered on 17May2021.
49 2021-06-03 chills, malaise, fever Fever; Chills; body aches; nausea; feeling unwell; This is a spontaneous report from a contactable c... Read more
Fever; Chills; body aches; nausea; feeling unwell; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, expiration date not reported), via an unspecified route of administration, administered on the left arm on 04Mar2021 12:45 (at the age of 49-years-old), as first dose, single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included buspirone (manufacturer unknown) taken for an unspecified indication, start and stop date were not reported. Patient has no reported allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, body aches, nausea, and feeling unwell on 04Mar2021 15:00. Events did not result to physician office visit and emergency room visit. No treatment was given as a result of the events. The outcome of all events reported was not recovered. No follow-up attempts are possible. No further information is expected.
49 2021-06-03 fatigue, cough, sinusitis, fever By the second day of ?second shot all of my symptoms from being sick (previously cured by 1st vaccin... Read more
By the second day of ?second shot all of my symptoms from being sick (previously cured by 1st vaccination shot) returned with a vengeance. fatigue, shortness of breath, cough, sinus infection, ear infection, swollen lymph nodes, dizzy spells, fever off and on, muscle and joint pain.
49 2021-06-03 headache, fatigue, respiratory tract congestion started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is w... Read more
started getting dizzy about a week after the shot. about two weeks after the shot the dizziness is worse. I fell at work when I was just standing by my desk when I suddenly became extremely dizzy. At home I am having to hold onto things to help with balance. I am also having headaches, tinnitus, confusion, some mild congestion, and extreme tiredness. The vaccine is the only thing thing that is different the last couple of months. None of my medications have changed. I am due for the second shot next week, but I am not getting it due to the side effects I am experiencing.
49 2021-06-05 cough, chills, fever After first shot- racing heart, fever, severe shortness of breath. 2nd shot - fever, chills, nausea... Read more
After first shot- racing heart, fever, severe shortness of breath. 2nd shot - fever, chills, nausea 3 Weeks out, sight of injection is suddenly painful - 3 days later- fever, cough, light-headed
49 2021-06-07 chills, fever hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for... Read more
hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine. She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine). A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
49 2021-06-08 fever, chills Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with him today to... Read more
Patient was given undiluted Pfizer vaccine straight out of the vial. When I spoke with him today to let him know, he had severe chills and a fever of 101 degrees F
49 2021-06-10 fatigue wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30... Read more
wife is reporting that his right arm felt like it was on fire and like he had hot fingers. About 30 hours after taking the vax he felt hot at the core and felt like his breath was hot when he was breathing out. He went to PCP. had blood work with normal results. He has not developed chest pains and a feeling of heaviness on the left side of this body. He is feeling weak, tired and BP is elevated. He went to medical facility. He had a CTA. He was discharged to go home and FU w/ PCP where the test results were sent.
49 2021-06-16 chills, fatigue, fever, sweating, sleepiness fever; body aches; Exhausted; alternating sweats; slept all day; Like having covid again; Little sor... Read more
fever; body aches; Exhausted; alternating sweats; slept all day; Like having covid again; Little soreness; chills to the point of body shaking some/chills; some nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 10:15 (at the age of 49-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) and received medications in two weeks included liraglutide (VICTOZA); metformin. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies. On 21Mar2021 12:00 am, the patient reported with little soreness during day as expected. About midnight chills to the point of body shaking some, some nausea, then around 4 am fever, body aches. Exhausted, alternating sweats and chills slept all day. Like having covid again." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are needed. No further Information is expected.
49 2021-06-16 headache, fatigue Fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient) via... Read more
Fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on 08Jun2021 (at the age of 49-years) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Jun2021, the patient experienced fatigue, dizziness and headache. The clinical course included: the patient received the second dose on 08Jun2021 and called to report the adverse reactions he had felt, especially after the second dose. He felt a lot of fatigue, dizziness, was ongoing since yesterday (10Jun2021), even talking was causing fatigue and had a headache. The outcome of event headache was unknown and for other events it was not recovered. Information on Lot/Batch number was not available. Additional information has been requested
49 2021-06-17 fever, chills, headache Fever; Aches; Chills; Headache; Injection site pain; This is a spontaneous report received from a co... Read more
Fever; Aches; Chills; Headache; Injection site pain; This is a spontaneous report received from a contactable health care professional, the patient. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 17Mar2021 at 01:30PM (at the age of 49-year-old) as single dose for COVID-19 immunisation. The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 25Feb2021 at 01:30PM as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient not had any allergies to medications, food or other products. Concomitant medications were not reported. On 18Mar2021 at 12:00AM, the patient experienced fever, aches, chills, fever, headache, injection site pain (vaccination site pain). The events were treated with tylenol (MANUFACTURER UNKNOWN). The clinical outcome of the events aches, chills, fever, headache, injection site pain (vaccination site pain) was recovering at the time of this report. No follow up attempts are possible, information about lot number cannot be obtained.
49 2021-06-23 throat pain, productive cough, fatigue After the vaccine I waited 15 minutes before returning to my desk. After sitting at my desk for 10-... Read more
After the vaccine I waited 15 minutes before returning to my desk. After sitting at my desk for 10-15 minutes I began to feel light headed/dizzy. I was having a difficult time concentrating and my immediate supervisor noticed right away and sent me home. Walking out of the workplace I was extremely dizzy and dropped my bag once, but thankfully didn't break my laptop. That evening I began to feel an extremely sore throat and nausea. For the next several days 7-8 days I had a wet cough with thick yellow mucus, and fatigue. After 2 weeks I slowly began to have less of a cough. 15 days (day of this report) my cough is minimal but still present. Symptoms are continuing to lessen daily.
49 2021-06-24 fatigue, fever, lethargy Extreme exhaustion, high fever (topped at 105.2). Fever continued at a lower temp through most of Ma... Read more
Extreme exhaustion, high fever (topped at 105.2). Fever continued at a lower temp through most of May 5. Started taking Tylenol and Ibuprofen on morning of May 5 which helped. Lethargy continued until morning of May 6 after which I felt fine, almost immediately.
49 2021-06-24 sweating "Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, car... Read more
"Pt w/ allergy to Penicillin (hives). PMH Psoriasis, HTN, HLD, GERD, CAD (NSTEMI 1/20), anxiety, carpal tunnel. PSH Nerve repair Left index finger, Cardiac Cath. 1/2020 hospitalization for NSTEMI: s/p cardiac cath on 1/30/2020, which showed dominant RCA with proximal 70% lesion followed by 99% mid RCA lesion (LM/LAD/LCx without significant CAD) now s/p PCI of mid RCA with 3.0 x 15 mm Onyx DES and PCI of proximal RCA with 3.5 x 22 mm Onyx DES. Today, via Spanish interpreter) , he reports that he has localized right chest discomfort 2/2 right arm tingling and pain when he received the vaccine today. Pt also has flushing/sweating. He is alert and oriented x 4. He was very ""anxious"" and tears in his eyes. He states that he has ""panic attacks"" in the past and he feels very ""anxious"" after getting the shot. C/o tingling and pain right arm. Pt given 2L O2 via NC. Slowly sx of chest discomfort resolved after 5 min. Pt stable and released from the vaccination site. Pt verbalized ""he feels fine now"". VSS. His is back to baseline. Right arm pain resolved, tingling improved. Denies CP, dizziness, HA, or palpitations. His son is driving him home. Instructed patient to rest at home. He has NTG prn for CP. ED precautions discussed. If CP recurs, he agrees to call 911. FU with PCP if right arm numbness and tingling are worsening or persist after 3 days or CP/pain/palpitations/HAs/syncope. Current medications: acetaminophen (TYLENOL) 500 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Pain. adalimumab (HUMIRA) 40 mg/0.8 mL subcutaneous injection pen kit Inject 0.8 mLs into the skin every 14 (fourteen) days. aspirin 81 MG EC tablet Take 1 tablet by mouth daily. atorvastatin (LIPITOR) 40 MG tablet Take 1 tablet by mouth at bedtime. carvedilol (COREG) 6.25 MG tablet Take 2 pills by mouth in the morning and 1 pill in the evening famotidine (PEPCID) 20 MG tablet Take 1 tablet by mouth 2 (two) times daily. gabapentin (NEURONTIN) 300 MG capsule Take 1 capsule by mouth 3 (three) times daily. For hand numbness hydrocortisone 2.5 % cream Apply to affected areas 2 (two) times daily. lisinopril (PRINIVIL,ZESTRIL) 10 MG tablet Take 1 tablet by mouth daily. loratadine (CLARITIN) 10 mg tablet Take 1 tablet by mouth daily. nitroglycerin (NITROSTAT) 0.4 MG SL tablet Dissolve 1 tablet under tongue every 5 minutes as needed for chest pain, max 3 tablets. If pain continues 5 minutes from first dose call 911 "
49 2021-06-24 lethargy, fever, headache Body aches (across entire body); Lethargy/Need to sleep; Fever (100-101F); Pain at injection site; H... Read more
Body aches (across entire body); Lethargy/Need to sleep; Fever (100-101F); Pain at injection site; Headache; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247] via an unspecified route of administration in left arm on 16Mar2021 at 08:30 (at the age of 49-year-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension, since unknown dates. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 23Feb2021 at 08:30 as a single dose for COVID-19 immunisation. The patient experienced fever (100-101F), body aches (across entire body) (general body pain), pain at injection site (vaccination site pain), lethargy/need to sleep, headache and nausea on 17Mar2021 at 08:00. The patient underwent lab tests and procedures, which included body temperature on 17Mar2021 and the result was 100-101F. The patient did not receive any treatment for the events. The clinical outcome of events fever, general body pain, vaccination site pain, lethargy, headache and nausea were recovering. No follow-up attempts are needed. No further information is expected.
49 2021-06-25 fatigue, sweating, fever Massive heart attack; Diabetes; High blood pressure; High cholesterol; Achy; Fever; slight pain wher... Read more
Massive heart attack; Diabetes; High blood pressure; High cholesterol; Achy; Fever; slight pain where the shot was given; after the second one he was very tired; he was sweating; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 at 10:15 (at the age of 49-years-old male) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Vaccine was not administered at military facility. History of all previous immunization with the Pfizer vaccine was not considered as suspect. Patient had no other vaccine prior this vaccinations within 4 weeks. Patient had no medical history including any illness at time of vaccination. No family medical history relevant to AE. The patient had received dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 at 15:10, for covid-19 immunisation and experienced diabetes and extreme tiredness. 07May2021, the patient experienced massive heart attack, diabetes, high blood pressure, high cholesterol, on 28Apr2021 slight pain where the shot was given, achy and fever, on an unspecified date "after the second one he was very tired" and "he was sweating ". The patient was hospitalized for massive heart attack from 07May2021 to 09May2021. Reporter (patient's wife) stated her husband had no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Fever was overnight and did break in the morning all for the COVID vaccine. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. The patient is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are tying to adjust his blood pressure medication as it is a little low at this time and trying to see what might happen. Reporter stated they do not know what diabetes was caused from. The patient had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. The event caused emergency room visit. Reporter stated her husband went to the cardiologist the week after and he just went to the endocrinologist yesterday for diabetes. Reporter stated extremely tired started immediately after the second vaccination. The patient after the second one he was very tired and he went to lay down and she noticed he was sweating because he had a temperature. A couple of days after the second dose of the vaccine it stopped and her husband was getting better each day and was not taking naps as often. Patient was given a lot of water and refueled and he slept through the night. He experienced slight pain where the shot was given in his arm but that was nothing that alarmed them. It stopped a couple days after. The reporter wanted feedback. The reporter has seen on the news how there are issues and heart issues and is there any feedback or any other contact she needs to make. NDC Number and expiry date was unknown. The patient underwent lab tests and procedures which included blood test: on May2021. He still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack. Treatment was given for the event hypertension. outcome of the event heart attack, pain, fever, vaccination site pain was recovered. Blood pressure high, High cholesterol ,Diabetes was not recovered. Outcome of the event fatigue and sweating was recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-06-25 fatigue, fever This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male p... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: ED6955), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 15:10 as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.Reporter stated on 03Apr2021 her husband had his first shot and on 28Apr2021 he had the second shot, then on 07May2021 he had a massive heart attack husband was hospitalized for three days and has not recovered completely also her husband is 49 years old with no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. Reporter stated her husband is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are trying to adjust his blood pressure medication as it is a little low at this time and trying to see what will happen. Reporter stated they do not know what this was caused, had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack, couple of days after the second dose of the vaccine it stopped, and her husband was getting better each day and was not taking naps as often, slight pain where the shot was given in his arm: Reporter stated this was just a couple of days after the first dose and then it happened again after the second dose on 28Apr2021 but stopped a couple days after. On 7May2021,The patient experienced massive heart attack, high blood pressure was unknown, Diabetes, High cholesterol not recovered, extremely tired, achy and slight pain where the shot was given in his arm was resolved. Follow-up attempts are needed. Additional information has been requested.
49 2021-06-25 headache just a sore arm at injection site---BUT CONSTANT HEADACHES SINCE GETTING THE SHOT-in varian degrees ... Read more
just a sore arm at injection site---BUT CONSTANT HEADACHES SINCE GETTING THE SHOT-in varian degrees mild to borderline migrans not going away and its been a month now
49 2021-06-26 cough Sore left arm at injection site for about a day. On Jun 8th, I, his fiancee who lives with patient, ... Read more
Sore left arm at injection site for about a day. On Jun 8th, I, his fiancee who lives with patient, started to develop a cough that worsened throughout the week. At first I thought it could be allergies since it was accompanied by congestion, but OTC allergy medication did not help. He also had some alergy symptoms but they cleared with OTC allergy medication. Because my coughing was so bad, we decided to sleep apart so he could sleep. When sleeping apart my cough got better. When sleeping together my cough got worse again. I noticed the correlation and we are choosing to sleep apart for a period of time and check to see if the correlation is still there. As of the date of this entry when I am in close contact with him for over 20 min my cough gets worse, and clears when we are apart. Note: we are both teachers and neither of us has had any respiratory issuse throughout the school year even when stidents were back in building. I have not recieved the Vaccine. There has been no changes to detergent, soap, or cleaning supplies.
49 2021-06-26 sweating Syncope symptoms; became pale; sweating; dizziness. Recovered in 15 minutes. Fire department came to... Read more
Syncope symptoms; became pale; sweating; dizziness. Recovered in 15 minutes. Fire department came to check all the vitals. Patient and his wife declined to go to the hospital. His wife reported that he ate the night before and was on empty stomach. The same symptoms occurred when patient received the tetanus vaccine before.
49 2021-06-27 cough 50-year-old male status post heart transplant on 02/08/2017. He developed antibody mediated rejecti... Read more
50-year-old male status post heart transplant on 02/08/2017. He developed antibody mediated rejection in June, 2020. He received multiple sessions of plasmapheresis and IVIG. Last echocardiogram in March 2021 revealed normal LV systolic function with an EF of 60%. He presented to the ED on 6/10 with cough and dyspnea. Labs revealed lymphopenia, neutropenia, and leukopenia and tested positive for COVID. He is s/p Pfizer vaccination on 2/22 and 3/15. He received casirivimab, imdevimab on admission. Before this admission, he was taking tacrolimus 4/3.5 mg twice daily, Rapamune 1.5 mg daily, MMF 1000 mg twice daily, and prednisone 5 mg daily.
49 2021-06-27 fatigue About a week after shot 1 I started to feel very fatigued and run down. I was able to function but ... Read more
About a week after shot 1 I started to feel very fatigued and run down. I was able to function but got tired easily. On May15, I received shot 2 and my fatigue got worse. I started to get tremors and shakes in my hands and arms. Legs felt weak, its difficult to hold my arms up at times. I felt hyper, yet weak. Unable to stay asleep. On June 6 I took a hot shower and barely made it out before collapsing. I went to the emergency room .
49 2021-06-29 chills, fever Vomiting; Diarrhea; High fever; Body ache; Chills; This is a spontaneous report received from a cont... Read more
Vomiting; Diarrhea; High fever; Body ache; Chills; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM6204) via an unspecified route of administration in the left arm on 18Mar2021 at 15:30 as a single dose (at the age of 49-year-old) for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. The patient medical history included hypothyroidism. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN, fish oil (MANUFACTURER UNKNOWN, vitamin D (MANUFACTURER UNKNOWN and turmeric (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 17:00, the patient had experienced vomiting, diarrhea, high fever, body aches, and chills. The patient did not receive treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, diarrhea, high fever, body aches and chills was recovered. No follow-up attempts are possible. No further information is expected.
49 2021-06-29 fever, sweating, fatigue Starting at about 3 AM the next morning after my 2nd vaccine, I woke up sweating, hurting all over, ... Read more
Starting at about 3 AM the next morning after my 2nd vaccine, I woke up sweating, hurting all over, and running fever. Symptoms continued for over 24 hours. I woke up the second morning after symptoms started and was sweating so much that my clothes & bedsheets were soaking wet. As that day progressed, I began feeling better. By that evening & the next day, I was more or less back to feeling normal, except for continuing to feel very fatigued. The fatigue lasted for a few weeks.
49 2021-06-30 headache Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Head... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: Patient recieved covid shot, and fainted within 8-15 minutes. He bumped his head while falling and had redness at the site. We called the ambulance to make sure patient will be okay. Paramedics mentioned that his blood pressure was low.
49 2021-06-30 fever, fatigue Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contac... Read more
Nausea; Fever; Fatigue; Chest pain; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: Er2613) via an unspecified route of administration administered in Arm Right on 24Mar2021 and second dose (#lot: Er8629) via an unspecified route of administration administered in Arm Right on 14Apr2021 as single dose (at the age of 49-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea, fever, fatigue, chest pain and difficulty breathing on an unspecified date. The patient did not report this because he didn't think it was relevant until recent media about myocarditis. He was close 3x to dialing 911 thought was having heart attack. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
49 2021-07-01 fatigue tired; tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; T... Read more
tired; tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 49-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, Expiration Date: unknown, Age at Time of Vaccination: 49-year-old), via left upper arm, on 26Mar2021 15:00 as dose 1, single for covid-19 immunisation. Medical history was not reported. The concomitant medications included vitamin D as 50 mcg every day and vitamin C as 282 mg every day, both ongoing from an unspecified date for immunity and to support immune system (Patient started taking vitamins since Covid started, for a year now). It was reported to ask if the patient needed to test negative before getting the second dose of the Pfizer Covid-19 vaccine on 16Apr2021. Reporter was a woman calling on behalf of husband to inform that her husband had his first dose of the Pfizer COVID-19 vaccine on 26Mar2021, and was tested positive for covid-19 on 03Apr2021. Patient has not yet received the second dose of the product. He went to an Urgent Care where they did the test. Patient was not hospitalized. Patient took no prior vaccinations (within 4 weeks). Patient experienced no adverse events prior vaccinations, he was tired after the covid-19 vaccine. Lab test included COVID-19 Test positive on 03Apr2021. The outcome of events were unknown. No follow-up attempts are possible. No further information is expected.
49 2021-07-01 sweating 49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aorti... Read more
49yom with PMH HTN presents with CP and SOB. Ddx includes but is not limited to: ACS, PE, PNA, aortic dissection, pericarditis, myocarditis. On arrival, patient appeared critically ill with cool, clammy skin, diaphoretic, complaining of chest pain. Patient initially able to answer simple questions, however quickly became unconscious, witnessed having tonic colonic seizure activity. Patient given 2 mg of lorazepam which aborted the seizure, however he remained unresponsive. IV fluids were started, and patient remained hypotensive after 3 L of fluids. Bedside cardiac ultrasound was performed which showed a large pericardial effusion with tamponade physiology. We continued fluid resuscitation and patient was intubated, while stat Cardiology consult was called. Patient suffered a cardiac arrest shortly after intubation. Cardiology performed emergent pericardiocentesis at the bedside which showed hemopericardium with output of greater than 500 mL of blood. ROSC was achieved following pericardiocentesis, and we continued resuscitative measures. Emergent arterial line and central venous lines were placed. Patient began to have profuse bleeding from all orifices, and massive transfusion protocol was initiated. Patient was stabilized enough to be taken to CT scanner which showed an extensive aortic dissection extending into the RCA, abdominal aorta, brachiocephalic artery, common carotids, and into the abdominopelvic vasculature. Cardiac and vascular surgery were consulted stat, and the decision was made to take the patient emergently to the OR. We were informed shortly after that the patient had expired en route to the operating room and they were unable to obtain ROSC. Final impression: type A aortic dissection, cardiac tamponade. Second dose of mRNA vaccine (unknown if Pfizer or Moderna) received two days prior to event.
49 2021-07-04 headache Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. ... Read more
Headache began at 3:00pm. Woke up at 11:00 pm violently shaking all over. I was not hot or cold. Woke up several times after the 11:00 pm also violently shaking. Seemed to have stopped by 3:00 am.
49 2021-07-04 sweating While getting my hair cut the following day I was sitting in my chair and started to feel intoxicate... Read more
While getting my hair cut the following day I was sitting in my chair and started to feel intoxicated for about 2 minutes and then started to sweat, I then passed out and started to shake as if I were having a seizure. This went on for about a minute I was told.
49 2021-07-05 fatigue, cough AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REF... Read more
AFTER 2-3 WEEKS AFTER THE SECOND DOSE, STARTED FATIGUE, SOB, COUGHING CAME TO SEE ME, HAD CHF , REFERRED TO A CARDIOLOGIST DR, MD, WHERE HE HAD ECHO DONE WITH NML CHF AND SEVERE LVH. HE HAD A COVID TEST NEGATIVE.
49 2021-07-07 dehydration, throat pain, headache, fatigue, cough SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021 SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) ... Read more
SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021 SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) on 4/15/2021 Symptom onset 06/10/2021 (same day as admission to inpatient) of sore throat, fatigue, cough, nausea/vomitting, and headache. Hospital records request shows treatment for DM2 uncontrolled with hyperglycemia, AKI, Dehydration, and uncontrolled hypertension. COVID Pneumonia listed as active diagnosis: 1 dose of dexamethasone on June 11, 2021 and then dexamethasone was discontinued. Patient is also not on remdesivir. Patient denies shortness of breath or cough.
49 2021-07-08 chills, fatigue, fever That night I had chills and fevers which lasted all night. The next day I was tired and got a rash o... Read more
That night I had chills and fevers which lasted all night. The next day I was tired and got a rash on my leg. By Thursday, I had little red dots all over the bottom half of my legs. That cleared up a couple days later. Since then, I have had spots on my leg that itch all the time. About 2-3 weeks ago I began experiencing pain in my pinky finger. Also, my index finger began getting stiff with pain. I went to see a doctor, where they did some blood work and Xrays. Both were normal. I am scheduled to get an ENG done next.
49 2021-07-08 cough, pneumonia 04/17/2021 Chronic cough, especially at night. I am a former smoker. I went to doctor and had x-rays... Read more
04/17/2021 Chronic cough, especially at night. I am a former smoker. I went to doctor and had x-rays. Was diagnosed with pneumonia.
49 2021-07-08 fatigue, chills, fever body ache; Fever; chills; fatigue; This is a spontaneous report from a contactable consumer. A 49-ye... Read more
body ache; Fever; chills; fatigue; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included amlodipine besilate (NORVASC) and cetirizine hydrochloride (ZYRTEC) for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 10:00, the patient experienced fever, chills, fatigue and body ache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, chills, fatigue and body ache. The clinical outcomes of the events fever, chills, fatigue and body ache were recovering at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-08 fatigue, fever Pain at injection site; Fatigue; Joint pain; Low-grade fever; This is a spontaneous report from a co... Read more
Pain at injection site; Fatigue; Joint pain; Low-grade fever; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 22Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, GERD, peripheral neuropathy and allergy to shellfish. Unspecified concomitant medications were taken by the patient. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced pain at injection site, fatigue, joint pain, and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes of the events pain at injection site, fatigue, joint pain, and low-grade fever were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
49 2021-07-10 sweating, fatigue, chills, headache, cough, fever headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, r... Read more
headaches, fever, heavy sweats at night, chills (which lasted for 8 days), shortness of breathing, red patches spread over cheeks, neck and body (which started on the 5th day and most visible on the 8th day). Up to today (July 11th), still experiencing shortness of breath, fatigue, lack of focus, and mild coughing
49 2021-07-12 cough, fatigue +COVID presenting with cough, shortness of breath, fatigue after returning from travel
49 2021-07-12 fatigue extreme fatigue, decreased lung capacity, irritability, difficulty concentrating
49 2021-07-12 headache, fever Extreme abdominal pain, seemingly in lower intestine. Headache. Fever.
49 2021-07-15 chills, cough, fever developed Fever, chills, Cough, and Body ache. Got tested for Covid-19 with Rapid Antigen and came b... Read more
developed Fever, chills, Cough, and Body ache. Got tested for Covid-19 with Rapid Antigen and came back POSITIVE.
49 2021-07-15 fatigue Started at about 6PM on 2/6/2021, I felt pain throughout my whole body. All of my muscles ached. I w... Read more
Started at about 6PM on 2/6/2021, I felt pain throughout my whole body. All of my muscles ached. I was very tired. It got worse through 2/7, so I went to the doctor on 2/8. The doctor tested me for COVID, and the results were negative. My symptoms began to subside on 2/9, and I was able to go to work on 2/9.
49 2021-07-17 chills, lethargy, fatigue Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilir... Read more
Significant fatigue; Extremely Lethargic; Erratic heart rate; No appetite; Chills; Glucose and bilirubin slightly elevated; Glucose and bilirubin slightly elevated; Extremely rapid heart rate; Elevated blood pressure; Dry mouth; Lightheaded; Shakes; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of BNT162B2 via an unspecified route of administration at arm left on 25Mar2021 13:15 (age at 49 years old, Batch/Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC); vitamins nos (MULTIVITAMIN); fish oil; all as supplement. About 5 mins after injection (25Mar2021 13:30), the patient developed extremely rapid heart rate and elevated blood pressure, dry mouth, lightheaded and shakes. The patient went to emergency room (ER), heart rate stabilized after about 60 mins. Blood work and EKG were normal on 25Mar2021. Next day on 26Mar2021, the patient developed extremely lethargic, erratic heart rate, no appetite. The following evening, the patient had another the same episode as post injection, rapid heart rate, chills, elevated blood pressure. The patient went to ER, EKG/Chest x-ray/blood tests all normal (glucose and bilirubin slightly elevated) on 26Mar2021. 4 days post injection (29Mar2021), heart rate still erratic and significant fatigue, heart rate spiked with little effort. The events required Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received iv fluids as treatment. All events were not recovered.
49 2021-07-17 headache, malaise, pneumonia pneumonia; valley fever; diabetes; shortness of breath/difficulty breathing; body aches; headache; g... Read more
pneumonia; valley fever; diabetes; shortness of breath/difficulty breathing; body aches; headache; got sick; hadn't been well enough; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years, via an unspecified route of administration, administered in right arm on 23Apr2021 at 02:11 at single dose for COVID-19 immunisation. Medical history included he and his family did have the COVID-19 virus in Nov2020 (with the COVID-19 virus in Nov2020 his fever had reached 103 degrees Fahrenheit). Concomitant medications were not reported. He was calling about the vaccine. He was scheduled for his second dose on 14May2021 but between his first and second dose, he developed pneumonia. He reported he and his family did have the COVID-19 virus in Nov2020. He was the only one that got sick after receiving the vaccine. He didn't know if it was coincidental or happenstance. He had been taking medication and hadn't been well enough to get his second dose. His primary care doctor and the doctor he saw at the urgent care both told him not to get the second dose until he was well. Now several weeks had passed and he wanted to know if he was ok to get the second one or will he have to restart and get the first vaccine again. The type of pneumonia that he had was called Valley Fever. He had been told it was because of the dry climate. He did have a chest x-ray and that was who the doctor knew he had pneumonia. He also had a blood test to confirm that he had the Valley Fever. He also had a COVID-19 virus test and that was negative. He actually thought he had the COVID-19 virus for a second time. The symptoms were exactly like the COVID-19 virus. He had a low grade fever, body chills, body aches, a cough developed and a really intense headache. He went to the urgent care with those symptoms and tested him and found out he did have the Valley Fever, a type of pneumonia. The doctor ordered the blood test to confirm the Valley Fever. His fever didn't get as high this time like it did when he had the COVID-19 virus. This time with the Valley Fever his fever was about 100 degrees Fahrenheit. He definitely had body aches, chills, shortness of breath and difficulty breathing. Since Nov2020 when he had COVID-19 he can say his lung capacity wasn't what it used to be pre COVID-19 virus. He was just able to go out and walk his dog and felt like he was breathing normally. Then he received the first dose and a week and a half later he got sick with the Valley Fever. He would like to get the second COVID-19 vaccine but wanted to know if he had to start the process over. He didn't take any medications and considers himself healthy. He would like to add that when he went for his follow up for the Valley Fever he had a complete blood work and urinalysis and interestingly enough his numbers came back that now he was in the diabetic range. He didn't know if it was related to the COVID-19 vaccine or not but thought that he should add it. He wasn't prescribed any medications for the diabetes he was told to change his diet. His blood sugar came back normally and his doctor told him when people have diabetes their blood sugar gets out of whack. He was going to change his diet for the next couple months. He went to the urgent care on 14May2021 with his symptoms, that was the same day he was supposed to get the second COVID-19 vaccine. He was asking if he was outside the window and need to start over or just need to get another shot. He said that he wants to get the vaccine. The events shortness of breath, difficulty breathing result in physician office. Outcome of the events was unknown. Information about lot/batch number has been requested.
49 2021-07-17 headache Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massi... Read more
Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massive headache; This is a spontaneous report from a contactable physician. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:00 (age at the vaccination 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation at Doctor's office/urgent care. Medical history included prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0185), via an intramuscular, administered in Arm Left on 15May2021 12:00 PM date as 1st dose, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath on 05Jun2021 12:45, daily severe headaches /massive headache on 05Jun2021 12:45, upper and lower gi side effects on 05Jun2021 12:45, slowed mentation on 05Jun2021 12:45. Every afternoon patient had massive headache which patient had never before, shortness of breath and had digestive problems every night, digestive problem like patient can have days of digestive problems upper GI and Lower GI. Adverse event (AE) required visit to the Physician Office. It was getting worst. Therapeutic measures were taken as a result of daily severe headaches/massive headache. Patient took Motrin for headache. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Dyspnea cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
49 2021-07-17 headache Headache; Loose stool; This is a spontaneous report from a non-contactable other non-healthcare prof... Read more
Headache; Loose stool; This is a spontaneous report from a non-contactable other non-healthcare professional. A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) dose via an unspecified route of administration on 22Mar2021 (at the age of 49-year-old) as a single for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to any medications, food, or other products. The patient did not receive any medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced headache and loose stool. The patient did not receive any treatment for the events of headache and loose stool. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events headache and loose stool was resolved on an unknown date in Mar2021. No follow-up attempts are possible; information about lot number cannot be obtained.
49 2021-07-17 sweating, fever, headache, fatigue, cough, chills redness; feeling very weak; he couldn't, his speech was because he was shivering so much that he cou... Read more
redness; feeling very weak; he couldn't, his speech was because he was shivering so much that he couldn't fully speak; dry cough; his pupils dilate; gets bit of a blurred vision; Fever; sweats; chills; throbbing headaches; rash that looks like bruising spread over the body; fatigue; shortness of breath, he wasn't breathing fully; kind of look like bruises; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 15Jun2021 17:30 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation. The patient's Medical history was not reported. The patient's Concomitant medication included collagen (COLLAGEN) taken for an unspecified indication, start and stop date were not reported. On 16Jun2021 17:30 patient experienced fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises and On an unknown date patient experienced redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. The patient underwent lab tests and procedures which included blood test: unknown result on 23Jun2021 "He underwent taking blood test on June 23". Patient was treated with "Antibiotics, tylenol, motrin" for the events fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises, redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision. Patient experienced Fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, difficulty breathing for 8 days, and some of the symptoms still ongoing past 8 days. Currently on 10th day. Symptoms started day after vaccine. Reporter stated, "If you are asking, is he suffering from medical condition, he did after taking the vaccine but before that he did not have any other medical condition". Reporter stated, "A week later, on June 23rd (not clarified) he went to see a doctor and he prescribed him antibiotics and before that he was taking Ibuprofen, he was taking Advil and then they told him not to take Ibuprofen but to take Tylenol and Motrin. So, since June 23 (not clarified) he has been taking Antibiotics, Tylenol and Motrin." (later clarified that patient was taking Antibiotics, Tylenol and Motrin as treatment). Reporter stated, "He underwent taking blood test on 23Jun." (not clarified further). Reporter stated, "So, he was taking Advil and then since 23Jun, he has been taking Antibiotics, Tylenol and Motrin". Reporter further stated, "He had severe headache and even when he took Advil sometimes it would not go away and it would get worse when he was just lying down and he would get headache that would come and go. He would wake up in the middle of the night sweating. He would have to (voice breaking) many times and then after that he would get chills and get very cold and he would shake, he was very cold. He had shortness of breath, he wasn't breathing fully and then on June 23rd (not clarified) which was a week later, he started having this rash all over the body and on his face specifically, they kind of look like bruises. So, when it was like pressed too long like when he had contact and it was pressed too long, it did developed redness and the redness is starting to go away, now it has gone away and he was feeling very weak and then he couldn't, his speech was because he was shivering so much that he couldn't fully speak and he was getting a little bit of dry cough. But mostly, it was the headache that would not stop and then yesterday, he is getting better and now, he is now able to breathe fully, he is able to walk around with more energy, he has less of a temperature fluctuations and but he still sweats at night but not as much and then sometimes he gets like his pupils dilate and he gets bit of a blurred vision but the shivers have gone away now". The outcome for the events "fever, sweats, chills, throbbing headaches, rash that looks like bruising spread over the body, fatigue, shortness of breath, he wasn't breathing fully, kind of look like bruises" was recovering and outcome for the events "redness, feeling very weak, he couldn't, his speech was because he was shivering so much that he couldn't fully speak, dry cough, his pupils dilate, gets bit of a blurred vision" was Unknown. No follow up attempts are possible. No further information is expected.
49 2021-07-17 fever, chills 12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontroll... Read more
12 hours after receiving my second dose I became very ill.; skin hurt; I became to shiver uncontrollably and could not get warm enough; I developed a fever of 101.4; My muscles ache. Instead of feeling "sick"this was more painful than "ill".; it is difficult tosleep.; I'm in somuch discomfort; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, sleep apnea and pre-diabetes. Concomitant medications included propranolol 120 mg (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and armodafinil (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation and morphine on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 00:30 after 12 hours of second dose, the patient experienced illness, skin hurt, shivered uncontrollably and was not getting warmed enough, fever - 101.4 (unspecified unit), muscle ache, hurt to move, discomfort and difficulty sleeping. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of illness, skin pain, shivers, fever, muscle ache, sleep difficult and discomfort were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
49 2021-07-17 fever, headache Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactab... Read more
Fever (102.5F); Headache; Muscle pain; Fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 18:00, the patient experienced fever (102.5F), headache, muscle pain, fast heartbeat. On an unknown date, the patient underwent body temperature measurement and the result was 102.5F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures taken for the events. The clinical outcome of the event fever (102.5F), headache, muscle pain and fast heartbeat was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
49 2021-07-17 fever, sinus congestion Slight fever of 99.8 the evening of the shot; Sinus congestion; This is a spontaneous report from a ... Read more
Slight fever of 99.8 the evening of the shot; Sinus congestion; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6199) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient medical history included irregular heartbeat. The patient previously had drug allergy while taking diclofenac sodium (MANUFACTURER UNKNOWN). Concomitant medications included mirtazepine (REMERON), metoprolol (MANUFACTURER UNKNOWN) and krill oil (MANUFACTURER UNKNOWN) all used for an unknown indication and were started on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, the patient had sinus congestion almost immediately and on the same day in the evening at 19:00, the patient had a slight fever of 99.8 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events fever and sinus congestion were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-18 fatigue It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, star... Read more
It started with just extreme exhaustion. Within about an hour I had extreme pain in both legs, starting from my waist all the way down to my toes. It was not a "coming and going" type of pain. It was constant, and severe. It was so painful that I could not walk. The pain was not relieved by lying down and elevating my feet. It was so painful that I could not really rest or sleep. It lasted about 48 hours before it started getting a little better. It has been nearly 72 hours now, and I'm starting to feel a bit normal again. I did not seek treatment because I did not think there was anything a doctor could do to help me.
49 2021-07-19 cough First 3 weeks I experienced a mild constant cough. Then (after 4 weeks) I experienced vertigo and de... Read more
First 3 weeks I experienced a mild constant cough. Then (after 4 weeks) I experienced vertigo and developed a an ear infection with pulsatile tinnitus since. 3 weeks later I still have it.
49 2021-07-19 fatigue, headache Headache; site soreness; site swelling; nausea; tiredness; This is a spontaneous report from a conta... Read more
Headache; site soreness; site swelling; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: eR8727) via an unspecified route of administration in the arm right on 30Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, site soreness, site swelling, nausea and tiredness. The patient did not receive any treatment for the events. The clinical outcome of the events headache, vaccination site pain, vaccination site swelling, nausea and fatigue was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-20 chills, malaise Started with metallic taste in mouth that evening after 2nd shot, then chills for a solid couple of ... Read more
Started with metallic taste in mouth that evening after 2nd shot, then chills for a solid couple of days. Metallic taste came back and chills went away. On Saturday, June 19th I got violently sick throwing up with diarrhea. The next week I had same event. I have since dealt with a metallic taste in my mouth again and gallbladder pains and pains in my intestines, with issues having bowel movements. When I eat the metallic taste increases and have more severe pains. I'm currently involved in a CT scan, Ultrasound, and now waiting to schedule a nuclear med test. I have been researching now that more people have reported gallbladder issues as well as the metallic taste.
49 2021-07-21 chills, fever Fever; Dizziness; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the pa... Read more
Fever; Dizziness; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient was not allergic to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, at 03:00 the patient woke up in middle of the night with fever, dizziness, it progressed to vomiting for the last four hours and chills. Event fever and chills continued. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, dizziness, vomiting and chills was not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.
49 2021-07-21 fatigue Body ache; Fatigue; Soreness at injection site; This is a spontaneous report from a non-contactable ... Read more
Body ache; Fatigue; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 01Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 16:00, the patient experienced fatigue, body ache and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The patient did not receive any treatment for the event. The clinical outcome of the event fatigue, body ache and soreness at injection site were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-25 throat pain Sore throat, loss of smell
49 2021-07-27 fatigue Fatigue; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 49-... Read more
Fatigue; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 05Apr2021 at 19:45, the patient experienced fatigue and loss of taste. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events fatigue and loss of taste was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-27 sweating, headache, cough, chills, nasal congestion Congestion; Body Aches; Cough; Severe sweats; Severe headache; Chills; This is a spontaneous report ... Read more
Congestion; Body Aches; Cough; Severe sweats; Severe headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left leg on 31Mar2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 18:00, the patient experienced severe sweats, chills, severe headache, body aches, congestion and cough. It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events severe sweats, chills, severe headache, body aches, congestion and cough was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
49 2021-07-28 fatigue Severe increased joint and muscle pain that has lasted for several months and is still ongoing. The... Read more
Severe increased joint and muscle pain that has lasted for several months and is still ongoing. The severity worsened with the second dose which was taken on 02/19/2021. There has also been crepitus, popping, and instability in my joints that wasn't previously there. This is also ongoing. Increased fatigue which has been ongoing.
49 2021-07-28 headache, fever, malaise, fatigue Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Fever; Injection site swelling; F... Read more
Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Fever; Injection site swelling; Feeling unwell; Difficulty breathing; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the arm left on an unknown date in 2021 (at the age of 49-year-old) and the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0175) via an unspecified route of administration in the arm left on 26Apr2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00, the patient experienced dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell. The clinical outcome of the events dizziness, difficulty breathing, injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, fever, injection site swelling (vaccination site swelling) and feeling unwell were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-01-01 chills, fever Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Sym... Read more
Had chills, body aches, and low grade fever starting approximately 14 hours after vaccination. Symptoms continued off/on for approx. 16 hours. Treated with Tylenol and Ibuprofen without any further issues. Arm was quite sore also for a day and a half.
50 2021-01-01 chills extremely Dizzy with chills and still dizzy after almost a week
50 2021-01-03 sneezing, headache, fatigue, cough, upper-airway cough syndrome, fever Fever 102.9, fatigue, headache, ache, cough, nasal drip, sneezing
50 2021-01-04 chills, fever fever spiking to 101.8 orally, chills and aches lasting 4 days
50 2021-01-04 headache, body temperature increased, fatigue Body aches, severe fatigue, Temp 101.2F, persistent head ache, slight nausea. Symptoms resolved by p... Read more
Body aches, severe fatigue, Temp 101.2F, persistent head ache, slight nausea. Symptoms resolved by post-vaccine day 3.
50 2021-01-04 headache, chills Severe headache, chills through the night. First episode occurred second night following the shot. S... Read more
Severe headache, chills through the night. First episode occurred second night following the shot. Second episode, same symptoms, occurred on the 8th night following the shot. Symptoms lasted until 6am.
50 2021-01-04 sweating, fatigue 2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness b... Read more
2 min after shot became dizzy, flushed, sweaty. Lasted 6-7 min. Arm soreness and extreme tiredness both for two days. Next day developed itching that progressed over several days. Rash/hives to upper chest, arms, and back started on day 3 after injection. Had to take Benadryl and vistaril initially then Doctor prescribed Prednisone on day six.
50 2021-01-05 chills, fatigue Tiredness, chills
50 2021-01-05 cough, nasal congestion, influenza like illness Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; P... Read more
Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown. Information on Lot/batch number has been requested.
50 2021-01-06 chills, fever Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills inje... Read more
Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; Fever 37.8 chills injection site pain; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 31Dec2020 at 08:15 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included Type2 DM (diabetes mellitus), hypertension, obesity, gout and Covid-19. Concomitant medications included unspecified medication(s). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was previously diagnosed with COVID-19. On 01Jan2021 at 14:00, the patient experienced fever 37.8, chills and injection site pain. Treatment was provided for the events fever, chills and injection site pain included acetaminophen (TYLENOL 650mg). The outcome of the events fever, chills and injection site pain was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
50 2021-01-06 fatigue, throat pain, headache, fever Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up... Read more
Headache, Fever, fatigue, weakness, sore throat Narrative: 12/29 - received vaccine. 12/30 - woke up with a fever and scratchy throat and headache. Since then the symptoms have lingered. Jan 2- 3 he developed more fatigue. Jan 4 - fever to 101 and headache. He also feels weak and has intermittent scratchy throat. Also had injection site soreness. He has Rheumatoid Arthritis for which he's taking actimira, and methotrexate (immunesupressants). Will test him today (1/4) for COVID-19. 1/5 - COVID-19 test is negative. Employee reports resolution of all symptoms.
50 2021-01-06 headache Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lighthea... Read more
Patient received Pfizer Covid 19 vaccine at 1400. He felt fine initially. At 1600 developed lightheadedness, slight headache and intermittent tingling to his left fingers. He reports itching to his extremities. He has not noticed a rash. He denies syncope, nausea, vomiting, sore throat, congestion, chest pain, SOB, palpitations, weakness, slurred speech, abdominal pain, diarrhea. He denies history of prior allergic reactions. No new medications. he is not anxious. Denies rash likely related to vaccine administration at 1400; seen in the urgent care at 1600 and discharged after treatment and evaluation at 1858. Inventions: ekg no acute findings; methylPrednisonolone 125 mg IV; diphenhydramine 25 mg IV; famotidine 20mg po; odansetron 4mg IV home with Benadryl 25 mg Q6 hours for 5 days.
50 2021-01-07 chills, fatigue, headache Minor nausea; Mild Headache; Tiredness; Chills; This is a spontaneous report from a contactable cons... Read more
Minor nausea; Mild Headache; Tiredness; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), via an unspecified route of administration in the left arm on 18Dec2020 07:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a facility. Medical history included histoplasmosis, degenerative disc disease, and penicillin allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included diclofenac sodium, methocarbamol, diphenhydramine hydrochloride (BENADRYL), and atorvastatin (LIPITOR). The patient did not receive other vaccine in the last four weeks. On 18Dec2020 16:00, the patient experienced minor nausea, mild headache, tiredness, and chills for about 18 hours. The patient did not receive any treatment for the reported adverse events. The outcome of the events was recovered on 19Dec2020 10:00. The report was considered non-serious.
50 2021-01-07 chills, fever Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body ac... Read more
Sore arm for day and a half; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; onset of chills, body aches, low grade fever.; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL0142), via an unspecified route of administration on the right arm on 31Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. There were no concomitant medications. It was reported that the patient was the patient diagnosed with COVID-19 prior to vaccination on 12Dec2020 (pending clarification). On 31Dec2020 22:00 (approximately 14 hours after vaccination), the patient had a sore arm for day and a half and onset of chills, body aches, low grade fever were noted. It was mentioned that the symptoms were treated with acetaminophen (TYLENOL) and ibuprofen. The patient was not tested for COVID-19 since the vaccination. The patient recovered from sore arm on 02Jan2021 10:00 (day and a half) and from the remaining events on 01Jan2021 14:00 (lasted for approx. 16 hours off/on).
50 2021-01-07 lethargy, body temperature increased, chills, malaise, throat pain Temperature of 100°F, bodyaches, chills, lethargic, some back pain, not feeling well overall, sore ... Read more
Temperature of 100°F, bodyaches, chills, lethargic, some back pain, not feeling well overall, sore throat
50 2021-01-08 fatigue, headache Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 4... Read more
Left sided facial numbness 36 hours Dizzy spells 36 hours Fatigue 58 hours and counting body aches 48 hours headache 36 hours stabbing pain 36 hours
50 2021-01-08 fatigue, headache Headache Fatigue, injection site sore Narrative:
50 2021-01-08 headache Headache, NauseaVomiting, Arm soreness at injection site, neck tightness Narrative:
50 2021-01-08 headache headache and nausea for 12 houre
50 2021-01-08 sweating, fatigue 12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt ... Read more
12 minutes after receiving the 2nd covid vaccination, I felt flushed and became diaphoretic. I felt heart palpitations and checked my heart rate which was 117, increasing to a max of 123. I was placed on a pulse ox monitor, which showed 93%, BP was elevated at 146/85. I was not given any medical treatment, and was placed on a monitor for one hour. Once my hr and 02 stas were at my baseline, I was allowed to be discharged. I went back to my department and decided to go home, as I felt tired and was mildly nauseous.
50 2021-01-09 chills Chills nausea aches
50 2021-01-09 fatigue Severe fatigue, malaise, myalgia which lasted for 18 hours Ibuprofen helped significantly reduce the... Read more
Severe fatigue, malaise, myalgia which lasted for 18 hours Ibuprofen helped significantly reduce the symptoms
50 2021-01-09 headache, chills Massive headache and chills!
50 2021-01-10 chills, headache Noon on Saturday, January 9th, just felt achy, a slight headache, and chills.
50 2021-01-10 sweating, chills, malaise Malaise, alternating sweats and chills, and 1.5cm left axillary tender lymphadenopathy persisting > ... Read more
Malaise, alternating sweats and chills, and 1.5cm left axillary tender lymphadenopathy persisting > 72hrs after vaccination without any evidence of erythema, edema at administration site
50 2021-01-10 fever, headache nausea, headache, fever. called in sick to work.
50 2021-01-10 throat irritation Developed scratchy throat 20 minutes post injection. Transferred to ED for evaluation.
50 2021-01-11 chills, fatigue Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that c... Read more
Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
50 2021-01-11 fatigue, chills, fever For Vaccine Pfizer-BioNTech COVID-19 Vaccine: I'm experiencing extreme tiredness, light headed and ... Read more
For Vaccine Pfizer-BioNTech COVID-19 Vaccine: I'm experiencing extreme tiredness, light headed and dizziness, body aches especially on my back, loss of appetite, chills and a mild fever. Have rested for 2 days in bed and no change in the tiredness.
50 2021-01-11 headache Headache from 11:00pm Sunday night to 10:30am Monday.
50 2021-01-11 throat clearing 0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted... Read more
0811 - pt c/o lightheaded and flushing. Pt reports I feel like I am going to pass out. Pt assisted to stretcher. BP - 131/83, hr 87, rr 22, sats 100. Pt given water. 0813 - Pt reports "I am feeling normal.: 0814 - 120/79, p 74, rr 20, sats 99 0818 - Pt clearing throat. Pt states this happened with first vaccine. Pt states "I feel a tickle in my throat." Pt unable to take Benadryl pills. 0820 - Pt given 25 mg liquid Benadryl 0828 - bp 137/85, hr 67, rr 18, sats 98.. Pt reports I feel better. Pt assisted to chair. 0835 - Walked in hallway with patient. Pt reports I feel normal. 0840 - Pt walked to door. Denies throat tickle, being lightheaded or flushed.
50 2021-01-12 chills, body temperature increased, fatigue, headache INJECTION SITE SORENESS, FATIGUE, JOINT MUSCLE PAIN, CHILLS, TEMPERATURE ELEVATION 99-99.8, HEADACHE... Read more
INJECTION SITE SORENESS, FATIGUE, JOINT MUSCLE PAIN, CHILLS, TEMPERATURE ELEVATION 99-99.8, HEADACHE, BACK PAIN
50 2021-01-12 chills, fatigue, sweating Vaccine received at 5:00 pm on 1/12/21. Around 2:00 am on 1/13/21 I experienced chills and profuse s... Read more
Vaccine received at 5:00 pm on 1/12/21. Around 2:00 am on 1/13/21 I experienced chills and profuse sweating which lasted for about 3 hours. Thereafter I have fatigue and generalized aching.
50 2021-01-12 fatigue, fever, headache Headache, Fever, fatigue Narrative:
50 2021-01-12 headache Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache,... Read more
Dizziness, Headache, numbness of tongue, then fogginess in head, then at 1pm started with headache, the arm soreness; transient 1/6/2021 light headeness and weakness; all resolved Narrative:
50 2021-01-12 malaise, cough, throat pain, fever Positive COVID-19 rapid test; Positive COVID-19 rapid test; Positive COVID-19 rapid test; Patient go... Read more
Positive COVID-19 rapid test; Positive COVID-19 rapid test; Positive COVID-19 rapid test; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Patient got sick; 2 weeks of on and off fever and unproductive cough; Lost sense of taste and smell; Lost sense of taste and smell; sore throat; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 16Dec2020, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. On 17Dec2020 patient got sick; 2 weeks of on and off fever and unproductive cough. In Dec2020 the patient also experienced lost sense of taste and smell. On 20Dec2020 the patient underwent COVID-19 rapid POC test and was found positive. The events required emergency room visit. Therapeutic measures were taken as a result of the events and included treatment with Tylenol 650 every 4 hours. The events recovered on unspecified date except unproductive cough and sore throat that were recovering. The information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19 rapid POC test) with BNT162b2 can not be completely excluded.
50 2021-01-12 fever, chills, lethargy Fever, chills, nausea, lethargy
50 2021-01-13 headache, chills 2nd vaccine received at 0930 1/13 Around 1300: 1/13-1/14 Body aches, chills, headache, nausea/vomi... Read more
2nd vaccine received at 0930 1/13 Around 1300: 1/13-1/14 Body aches, chills, headache, nausea/vomiting
50 2021-01-13 headache, chills Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me i... Read more
Moderate severe headache, chills, muscle aches and muscle spasms/cramps. Severe enough to keep me in bed the following day.
50 2021-01-13 lethargy, fever, chills ok directly after...about 1800 on the 12th...started to experience chills, body aches, lethargy, low... Read more
ok directly after...about 1800 on the 12th...started to experience chills, body aches, lethargy, low grade fever and injection site pain(to be expected)
50 2021-01-13 fever, chills Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 10... Read more
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later. Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin. I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains and tightness.
50 2021-01-14 fever, malaise, fatigue, chills 1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body... Read more
1/12/2021 @ 2200hrs - Muscle/body aches, injection site tenderness 1/12/2021 @ 2300hrs - Muscle/body aches, chills 1/13/2021 @ 0300hrs - Muscle/body aches, chills, fever of 99.0, general malaise 1/13/2021 @ 0600hrs - Muscle/body aches, chills, tired, no energy, difficult to get out of bed. Did not go to work. 1/13/2021 @ 1000hrs - Symptoms continued. Advil 600mg PO taken. Allowed sleep from 1030-1230hrs. 1/13/2021 @ 1230hrs - Woke up feeling damp as if having had night sweats. Rested the entire day. 1/14 to 1/15/2021 - Left arm site tenderness with raised hard area at site of injection. Left armpit raised/swollen, appears as lymphadenopathy.
50 2021-01-15 chills, fatigue, fever After 2nd vaccine i experienced side effects starting 24 hrs. After injection. Expierenced fever of... Read more
After 2nd vaccine i experienced side effects starting 24 hrs. After injection. Expierenced fever of 101 f. With chills and body aches. Extremely fatigued. Lasted about 6-7 hours before fever went away along with all other symptons. I took ibuprofen for the fever and aches. Spent several hours in bed!
50 2021-01-16 influenza like illness, malaise, fever, chills, fatigue [BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccin... Read more
[BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.
50 2021-01-19 chills, malaise Chills, Injection Site Pain, Muscle Pain, Feeling Unwell
50 2021-01-19 chills, fever, headache The day after my vaccination, I dealt with a killer headache, body aches, a low grade fever & chills... Read more
The day after my vaccination, I dealt with a killer headache, body aches, a low grade fever & chills. I also had a bout of diarrhea.
50 2021-01-19 chills body aches, sore and chills
50 2021-01-19 fatigue, headache on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting starte... Read more
on the night of 1/5/2021, headache and right arm pain. starting in the pm on 1/16/21 vomiting started and lasted through Tuesday 1/19/21. As of today lasting symptom is fatigue.
50 2021-01-19 fatigue, headache the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and las... Read more
the night of the vaccine, headache and arm pain started. On Saturday 1/16/21 vomited started and lasted until Tuesday 1/19/21. Continues to feel fatigue today on 1/20/21.
50 2021-01-20 chills, headache Severe headache 8/10 unrelieved by OTC acetaminophen, nausea, dry mouth, chills without fever
50 2021-01-20 chills, fever, headache fever,chills,headache for 24 hours
50 2021-01-20 chills, fever, sweating 130 Per Minute Heart rate , Diagnosed with tachycardia Muscle Aches , chills 103.1 Fever Pain at th... Read more
130 Per Minute Heart rate , Diagnosed with tachycardia Muscle Aches , chills 103.1 Fever Pain at the injection site Sweats
50 2021-01-20 headache I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was... Read more
I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was very stift/sore till next day, approx 18 hours. Mild headache
50 2021-01-20 fever, fatigue, chills, headache 130 Per min heart rate , was diagnosed with tachycardia Chills, headache, fatigue 103.1 Fever
50 2021-01-20 fever, headache DOLOR DE CABEZA ARDOR EN AMBOS OJOS DOLOR EN EL CUERPO INAPETENTE FIEBRE
50 2021-01-22 fatigue, headache, fever, chills Headache, body aches, nausea and vomiting, chills, fever, and pain/soreness at injection site. All s... Read more
Headache, body aches, nausea and vomiting, chills, fever, and pain/soreness at injection site. All started day of vaccination; and, continued through next day. Increased fatigue started day of vaccination; and, is still ongoing. Is getting better every day.
50 2021-01-24 fever 100.4 F temperature; swollen lymph node in armpit of injection arm; This is a spontaneous report fro... Read more
100.4 F temperature; swollen lymph node in armpit of injection arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at right arm on 11Jan2021 at 07:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 11Jan2021 at 23:30, The patient experienced 100.4 F temperature and swollen lymph node in armpit of injection arm. The patient outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-01-24 upper-airway cough syndrome, throat irritation Scratchy throat and post nasal drip developed within 15 mins of vaccine administration. VS remained ... Read more
Scratchy throat and post nasal drip developed within 15 mins of vaccine administration. VS remained stable. 1700 Diphenydramine 25mg IM administered. 1723 Epineprine 1 mg IM administered. Patient monitored, VS remained stable. Symptoms improved. Patient discharges at 1743. Patient was driven home.
50 2021-01-25 headache, fatigue Moderately severe headache with significant fatigue. Headache caused minor nauseating feeling. Adv... Read more
Moderately severe headache with significant fatigue. Headache caused minor nauseating feeling. Adverse symptoms lasted about 8 hours but wasn't severe enough for emergency medical care.
50 2021-01-25 headache Sore muscles; Slight headaches; This is a spontaneous report from a contactable consumer (patient). ... Read more
Sore muscles; Slight headaches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 13Jan2021 (13:30) at a single dose on the left arm, with route of administration unspecified for COVID-19 immunization at the workplace clinic. Medical history included high blood pressure (HBP); and high cholesterol. Concomitant medications included atorvastatin, citalopram, metoprolol and fenofibrate. The patient previously took dextromethorphan, and had drug allergy. On 13Jan2021 (15:00), the patient had sore muscles and slight headaches. The patient had not received any treatment for the reported events. The outcome of the events, sore muscles and slight headaches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
50 2021-01-26 malaise, fatigue Malaise, weakness, muscle cramps fatigue.
50 2021-01-27 chills, fever, headache, runny nose Chills; headache; muscle pain; fever; nausea; running nose; This is a spontaneous report from a cont... Read more
Chills; headache; muscle pain; fever; nausea; running nose; This is a spontaneous report from a contactable other hcp. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:El3246, expiry date unknown), via an unspecified route of administration on 23Dec2020 at a SINGLE DOSE then (lot: El3246) via an unspecified route of administration on 13Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient experienced chills, headache, muscle pain, fever, nausea and running nose on 14Jan2021. Treatment was not received for all events. The outcome of the events was not recovered.
50 2021-01-27 fatigue, headache, chills, fever 101 Temperature; Headache; Chills; Fatigue; This is a spontaneous report from a contactable healthca... Read more
101 Temperature; Headache; Chills; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 50-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his right arm, via an unspecified route of administration on 13Jan2021 09:15 at a single dose for COVID-19 immunization. Medical history included covid-19. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced 101 Temperature, Headache, Chills, Fatigue; all on 13Jan2021. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
50 2021-01-27 fatigue, headache Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and sl... Read more
Date these symptoms started was 1/27/2021: About 12 hours after injection, developed fatigue and slight nausea as expected. Oral temperature 98.0. Commuted to work without issue. ~ 1400: As day progressed, nausea subsided, but fatigue grew more profound and developed pain in the right subscapular area with exertional shortness of breath walking any length of time. (Injection of initial and second doses were both in right deltoid). 1540 - 1800: Fatigue increased, developed a burning/tearing pain with every yawn and deep breath from the top of my trachea into both left and right mainstem bronchi and radiated to right arm. It literally felt like someone was trying to tear out my bronchial tree with each breath. 1800: Arrived home and medicated self-medicated with Motrin 400mg. 1800 -2030: rested at home with still some breathing pain, no shortness of breath, but incredibly tired. 2045: Went to bed and slept for the next 12.5 hours without any issued during the night. 0800: Woke up nearly all symptoms were gone, only some minor residual fatigue. No breathing pain, no nausea, no subscapular pain. I did not seek medical attention for symptoms, nor did I contact my provider. I experienced fatigue and a headache with the first dose, but no other symptoms. I never experienced fever or chills
50 2021-01-27 headache Red sore arm, body aches, and head ache
50 2021-01-27 nasal congestion, headache, fatigue Headache, Diarrhea, congestion, fatigue Narrative:
50 2021-01-28 chills, fatigue, headache Chills; minor headache; tiredness; This is a spontaneous report from a contactable consumer (patient... Read more
Chills; minor headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on 08Jan2021 at 17:00 at single dose on left arm for COVID-19 immunisation. Medical history included penicillin allergy, histoplasmosis and degenerative disk disease. Historical vaccine included 1st dose of BNT162B2 (Lot number=EK5730) administrated on 18Dec2020 at 7:00 am on left arm for COVID-19 immunisation at age of 50-year-old. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), diclofenac sodium (DICLOFENAC NA), atorvastatin (LIPITOR [ATORVASTATIN]) and methocarbamol, all from unknown date for unknown indication. The patient experienced chills, minor headache, tiredness, all on 09Jan2021 at 04:00 with outcome of recovering. No treatment was received.
50 2021-01-28 headache, body temperature increased, fatigue, chills I had a positive Covid test on December 16th with mild symptoms (Headaches, fatigue and loss of smel... Read more
I had a positive Covid test on December 16th with mild symptoms (Headaches, fatigue and loss of smell only). Day after vaccine i had severe chills, body ache and 101 temperature. following morning i was fine except for lingering COVID fatigue, and headaches. I am only sharing this for your records/study so you have it. otherwise I am fine.
50 2021-01-28 fever fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fille... Read more
fever; my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); my lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers); numbness in both hands; This is a spontaneous report from a contactable pharmacist (patient). A 50-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176, expiration date not reported), intramuscular on the left arm, on 07Jan2021, at 11:30 at a single dose for Covid-19 immunization. The patient has no medical history and no known allergies . There were no concomitant medications. The patient previously took the first vaccine of bnt162b2 on 18Dec2020, at 12:00 PM, Intramuscular, on the Right arm for Covid-19 immunization, he had numbness in his right hand x2 days. On 09Jan2021, following second dose, he has had numbness in both hands x2 days and on 10Jan2021, day 2, he ran a fever and his lighter weight facial fillers swelled and were painful (around the eyes - not my lip fillers). His eyes have a mix of Juvaderm products. It spontaneously resolved after 1 day with a subjective loss in overall volume. Density of the product used seemed to be a factor in the response. He knows this has been reported with the Moderna product, but he does not believe is has been reported with our product. It appears the response may not be product specific, but more specific to the type of vaccine. The patient has no Covid prior vaccination and not covid tested post vaccination. No treatment was received for the events. Outcome of the events was recovered in Jan2020.
50 2021-01-31 fever, chills, headache, malaise Injection site pain for 3 days, headach 24 hours, chills 24 hours, fever 24 hours 101.8, Nausea 24 h... Read more
Injection site pain for 3 days, headach 24 hours, chills 24 hours, fever 24 hours 101.8, Nausea 24 hours, feeling unwell 24 hours
50 2021-01-31 fever, fatigue severe Fatigue/Myalgia/fever/Dizziness/Abd. Pain - s/p Kidney transplant - on immunosupp. Recommend... Read more
severe Fatigue/Myalgia/fever/Dizziness/Abd. Pain - s/p Kidney transplant - on immunosupp. Recommend Emergency Dept.
50 2021-02-02 chills, influenza like illness, fatigue Sore arm day after shot, mild flu like symptoms, tired, chills, body ache, feel like on the edge of ... Read more
Sore arm day after shot, mild flu like symptoms, tired, chills, body ache, feel like on the edge of getting real sick.
50 2021-02-02 sweating At 10:35am patient received Pfizer vaccination , Patient ambulated to the chair and at approximatel... Read more
At 10:35am patient received Pfizer vaccination , Patient ambulated to the chair and at approximately 10:40 am patient was sitting in chair appearance pale, diaphoretic, with complaints of dizziness , Patient remain Alert and oriented x 3 no loss of consciousness . Patient stated he have history of known needle phobia . Denies any past medical history. Patient also stated did not receive adequate breakfast or sleep. Water was given and also candy to increase blood sugar. Patient blood sugar and color improved after 10 minutes and also stated to feel back to his normal . Patient able to stand and walk on his own . EMS arrived on scene at 1050 am. Patient RMA. Vital signs 97.4 , 98, 74,112/74.
50 2021-02-02 fever, influenza like illness 6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mo... Read more
6 hours after shot, arm was in pain where i could hardly move, by morning felt like i had flu, by mon afternoon temperature went up to 101.8 before dropping tues evening.
50 2021-02-03 cough, throat pain, fatigue Ectopy with skipped heart beats/Ectopy; myalgias; Fatigue; cough; Sore throat; This is a spontaneous... Read more
Ectopy with skipped heart beats/Ectopy; myalgias; Fatigue; cough; Sore throat; This is a spontaneous report received from a contactable physician (who is also the patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date unknown), via an unspecified route of administration in the left arm, on 21Dec2020 10:00, at single dose, for COVID-19 immunization, in the hospital. There was no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. There were no concomitant medication/other medications in two weeks. On 22Dec2021, the day after vaccination, the patient experienced ectopy with skipped heartbeats/ectopy along with myalgias, fatigue, cough and sore throat. The events resulted to "Doctor or other healthcare professional office/clinic visit". No treatment was provided for the events. The patient underwent COVID-19 test (nasal swab) on 25Dec2020 and was negative. The patient had not recovered from ectopy with skipped heartbeats/ectopy but recovered from myalgias, fatigue, cough, sore throat on an unspecified date (reported as "everything but ectopy has resolved").
50 2021-02-04 chills, fatigue, sweating Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive dia... Read more
Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on bloody stool-diarrhea reported cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-02-04 headache, chills Severe headache; nausea; dry mouth; chills without fever; This is a spontaneous report from a contac... Read more
Severe headache; nausea; dry mouth; chills without fever; This is a spontaneous report from a contactable pharmacist. A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3246), intramuscular on 19Jan2021 on the right arm at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. It was unknown if the patient had COVID-19 prior to vaccination. It was unknown if the patient had other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 post vaccination. It was reported that the patient experienced severe headache, nausea, dry mouth and chills without fever all on 20Jan2021. Treatment for the events was acetaminophen and diphenhydramine. The outcome of the events was recovering.
50 2021-02-04 headache Really bad headache/it has worsened; This is a spontaneous report from a contactable consumer (patie... Read more
Really bad headache/it has worsened; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 14:15 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medication included fluoxetine hydrochloride (FLUOXETINE). The patient had a small headache in the morning on 22Jan2021, he ignored it, but now it was getting worse. The outcome of event was not recovered. Information on the lot/batch number has been requested.
50 2021-02-06 head discomfort Pressure in my head, muscle pain all over body
50 2021-02-08 fever, headache, fatigue, chills Extreme body aches, joint paints, fever, fatigue, headache, chills, and nausea. Test positive for CO... Read more
Extreme body aches, joint paints, fever, fatigue, headache, chills, and nausea. Test positive for COVID 01/09/2021
50 2021-02-09 chills, headache, fever Headache; Muscle pain for 36 hours; Fever over 100; chills; joint pain for 36 hours; This is a spont... Read more
Headache; Muscle pain for 36 hours; Fever over 100; chills; joint pain for 36 hours; This is a spontaneous report from a contactable consumer reporting for himself. A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 21Jan2021 11:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included ulcerative colitis and lactose intolerance, both from an unknown date. Concomitant medication included minerals nos, vitamins nos (CENTRUM) daily vitamin received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Ded2020 10:30 AM in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Fever over 100, chills, muscle and joint pain for 36 hours after second dose on 21Jan2021 10:00 PM. Headache has persisted and not subsided since second dose on 21Jan2021 10:00 PM. The patient underwent lab tests and procedures which included body temperature: over 100 on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The treatment was not received for the adverse event. The outcome of the events was recovering. The case was reported as non-serious.
50 2021-02-09 chills, sweating, headache, fatigue Second dose, massive diarrhea; severe fatigue; chills; diaphoretic; neck pain.; headache; This is a ... Read more
Second dose, massive diarrhea; severe fatigue; chills; diaphoretic; neck pain.; headache; This is a spontaneous report from a contactable Nurse (patient). A 50-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunisation. He received the first dose (EL 3248) at age if 50-year-old on 28Dec2020 10:00 AM Intramuscular in Left arm for COVID-19 immunisation, and after first dose experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis, and bloody stool-diarrhea. Medical history included hypertension. There was no known allergies. Concomitant medication included acetaminophen. After the second dose, on 20Jan2021 10:00 PM the patient had massive diarrhea, severe fatigue, chills, diaphoretic, headache and neck pain. No treatment received for events. Events outcome was recovering.
50 2021-02-09 fatigue Fatigue; nausea; light headedness; pain at injection site; This is a spontaneous report from a conta... Read more
Fatigue; nausea; light headedness; pain at injection site; This is a spontaneous report from a contactable other healthcare professional reported for a 50-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported) intramuscularly on 28Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, nausea, light headedness, pain at injection site after vaccination on 28Jan2021. No treatment received for the adverse events. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since having the vaccine. The outcome of events fatigue, nausea, light headedness, pain at injection site was recovering. No follow-up attempts are possible, Information on the lot/batch number has been requested.
50 2021-02-09 headache sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable co... Read more
sore arm; lack of energy; Headaches on occasion.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: El1283), via an unspecified route of administration in the left arm on 18Jan2021 14:00 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 19Jan2021 06:00, the patient reported sore arm, noticeable lack of energy and headaches on occasion. The patient does not have covid prior vaccination and had not tested positive post vaccination. The patient did not receive treatment for the events. The outcome of the events was not recovered.
50 2021-02-10 headache On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of ap... Read more
On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown. Information about Lot/ Batch has been requested.
50 2021-02-11 headache Patient describes strong headache on 01/29/21-01/30/2021 to right side of head, behind right eye and... Read more
Patient describes strong headache on 01/29/21-01/30/2021 to right side of head, behind right eye and down into neck. Took some ibuprofen with some effect but not completely resolved.
50 2021-02-14 headache, chills body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of sign... Read more
body aches/chills/headache/lymphadenopathy L sided (side of injection) - all resolved except of significant Left axillary lymphadenopathy - swelling was the size of small melon, non-tender, rather uncomfortable. Next day, it got a bit smaller - about size of large fist, but still present, day 4. Post auricular and posterior cervical Left lymph nodes were also enlarged and tender, but not to the same extend.
50 2021-02-17 chills, fever delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous rep... Read more
delirium; Fever of 100.8; chills; flushed; overall soreness; deltoid pain; This is a spontaneous report from a non-contactable consumer. A 50-year-old male patient received BNT162B2 (lot# unknown) on 03Feb2021 01:30 PM at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Fever of 100.8, chills, flushed, overall soreness, delirium, and deltoid pain on 04Feb2021 04:00 AM with outcome was Recovering. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
50 2021-02-17 fatigue, headache, chills body aches, chills, fatigue, headache, dizziness--lasted approximately 36 hours
50 2021-02-17 fever Feverish, nausea
50 2021-02-21 fever, runny nose, throat pain I had body aches, fever, sore throat and runny nose.
50 2021-02-22 sweating Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with ... Read more
Flushed, pale, diaphoretic, bradycardic. Epi administered and RRT called. Admitted to hospital with cardiac cath - likely unrelated.
50 2021-02-23 sweating dizziness, sweatiness, mild throat tightness
50 2021-02-25 chills Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurt... Read more
Little back problems, lower back; hurts(Back); My arm is hurting; my arm was killing me; my arm hurts; I throw up twice yesterday; I got a little sick; I just got a little chill; I got chills on the lower part of my back; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration at the age of 50 years, on 25Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient stated, "Yesterday I took my second vaccine shot and my side effects this morning was a little back problems, lower back, my arm is hurting, and I throw up twice yesterday, I got a little sick. So, I just wanted to call and let somebody know." It was also stated, "Yesterday when I got home after the shot, I just got a little chill and then I laid down, I throw up twice and I just laid down and laid down. And when I woke up I was calling you all since 1 in the morning because my arm was killing me." It was stated, "Yes, my arm hurts and my back, I am in my house and I got the back thing on for, the heating pad (treatment), just for my back." The consumer stated, "I took aspirin because I throw up twice yesterday so I just took aspirin. And then I was laid down and I woke up this morning and I took one in the morning. I have been trying to call you all morning, all morning I just got, just to let you know that my arm is hurting and I got a chills on the lower part of my back." Therapeutic measures were taken as a result of little back problems, lower back; hurts(back) (back pain), i throw up twice yesterday (vomiting). The outcome of the events was not recovered.
50 2021-03-01 fatigue Dizzy; nauseous; exhausted; soreness; This is a spontaneous report from a contactable consumer (pati... Read more
Dizzy; nauseous; exhausted; soreness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient, who is 50-year-old the date of vaccination, received bnt162b2 (BNT162B2), lot number: EL8982, via an unspecified route of administration on Arm Left, on 28Jan2021 12:00 as SINGLE DOSE (second dose) for COVID-19 immunization. Medical history included High Blood Pressure. The patient received first dose of bnt162b2 (BNT162B2), lot number=EL3248, on 07Jan2021 at 12:00 on left arm. Concomitant medication included hydrochlorothiazide. On 28Jan2021 12:15, the patient experienced dizzy, nauseous, exhausted, soreness. The outcome of the events was not recovered. No treatment was received for the events. The patient did not have COVID prior vaccination. The patient was not tested post vaccination.
50 2021-03-02 fatigue Excessive tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).... Read more
Excessive tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL34264-21) in the right arm, at single dose, on 25Jan2021, at 06:00 PM, for COVID-19 immunisation. COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Relevant medical history was unknown. Allergies to medications, food, or other products was reported as none. Concomitant medications included loratadine (CLARITIN) and paracetamol (TYLENOL), both from an unspecified date (within 2 weeks of vaccination), for an unknown indication. On 26Jan2021, the patient experienced excessive tiredness, and body aches. No treatment was received. Clinical outcome of the events was recovering at time of this report. Post the vaccination, the patient has not been tested for COVID-19. The case was assessed as non-serious.
50 2021-03-03 headache, fatigue, runny nose Significant Fatigue; headache; runny nose; slower cognition. Aches and pains,
50 2021-03-03 headache The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. The... Read more
The evening of the 2nd vaccine started having numbness in left shoulder and progressed to hand. Then numbness also affected left side of face and neck and left anterior chest wall. Intermittent pain in chest wall with intermittent resolve of numbness. The worst of it lasted a week. After a week, numbness started to resolve, but still have residual numbness in left hand. Did have headaches as well for that week and then headaches resolved after a week.
50 2021-03-04 throat pain, influenza like illness, fatigue, nasal congestion About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensat... Read more
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot. Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started. Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020. The flu-like symptoms were all basically gone except the stuffy nose. I still have a slight stuffy nose, and the strange smell issue. I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now. It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
50 2021-03-05 fever, chills Mild fever and chills for 2.5 days.
50 2021-03-06 fatigue, headache, chills fatigue, chills, headaches, joint pain in shoulders.
50 2021-03-07 chills Extreme chills and body aches.
50 2021-03-07 throat irritation Slight difficulty swallowing, then disappeared at time of injection. Within the hour, tongue felt sw... Read more
Slight difficulty swallowing, then disappeared at time of injection. Within the hour, tongue felt swelled, irritated. Within a couple of hours had intermittent trouble swallowing again. Irritated, itchy tongue and throat to date.
50 2021-03-08 malaise Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. ... Read more
Friday at 1:30 (3/5 my husband received the first shot. That evening he wasn't feeling well at all. Went to sleep in the morning on 3/6 he still was feeling horrible. Looked gray in color- thought he was getting the flu. At 2AM I woke to him having a seizure. Followed by another seizure at 10AM ( 3/7) followed by another seizure at 3PM (3/7) followed by another seizure at 3AM (3/8) and another seizure at 6:30 AM on (3/8).
50 2021-03-10 headache Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger fel... Read more
Within 5 hours of receiving the shot my entire right arm was numb and tingly and my pinky finger felt like it wasn?t there. I also has the worst headache of my life, ibuprofen didn?t help it. The next morning (Friday) I felt somewhat better but by noon, I felt just as bad as the night before and the horrible headache was back. Saturday and Sunday were exactly like Friday. Monday morning, my arm was back to normal and the horrible headache was gone. Since them I?ve had headaches on and off, but not as horrible as Thursday thru Sunday. This afternoon marks 1 week since my first of 2 doses. I?m not sure at this point if I want to get the 2nd dose or not when it?s due.
50 2021-03-11 headache Patient received dose 1 of the Pfizer vaccine at a clinic. After the dose was administered the patie... Read more
Patient received dose 1 of the Pfizer vaccine at a clinic. After the dose was administered the patient experienced tachycardia (pulse 110), elevated BP (measured with arm cuff at ~180/120), headache, and warmth. The patient was offered a cold pack, given water, and was taken away to a secluded room to relax under supervision. After about 1.5 hours the patient improved (BP 120/76 and pulse 85). The patient informed me that his rheumatologist recently had him stop his treatments for Crohn's disease in preparation to receive the vaccine. He stated that he had similar symptoms before when trying different treatment regimens for his underlying condition. The patient left on his own and no further adverse effects were reported.
50 2021-03-14 sweating At 09:21 am Stated tightness in throat, diaphoresis, and nausea. At 09:24 am was given; 1 ml Benedry... Read more
At 09:21 am Stated tightness in throat, diaphoresis, and nausea. At 09:24 am was given; 1 ml Benedryl IM left deltoid. Started feeling relief at 09:30 am, then approximately 14 minutes later had tightness in throat again, stated having no difficulty breathing or swallowing. Called 911 at 09:45 am. O2 sat and heart rate were within normal range, elevated BP 153/93 lying and 163/103 sitting left arm. Agreed to go to ED with medical team at 09:55 am. walked out with paramedic.
50 2021-03-16 sweating Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for... Read more
Client had syncopal episode, diaphoretic, n/v assessed by Lead RN & EMS , EMStransported client for hypotension and weakness.
50 2021-03-18 sweating, fever Flushed, sweating, ?fever feeling?, altered vision, weakness
50 2021-03-18 sweating I received the shot around noon on Tues March 16. I was fine until 3am Wed March 17 when I woke up ... Read more
I received the shot around noon on Tues March 16. I was fine until 3am Wed March 17 when I woke up general body soreness and sweats. I had Covid in March 2020 and the feeling was similar without the coughing and much shorter timeframe. That continued until about 3am on Thursday March 18 when I thought I was almost back to normal. When I woke up at 6am I thought I was ok but then I realized I had a lump under my left armpit on my side seemingly like my lymph node is swollen. That continues as I write this at 341pm on Friday March 19. I also developed hives on my right bicep and on my left and right buttocks and left and right hamstrings. this is itchy. I no longer have the soreness, sweating or fatigue but i have the swollen and what seems to be allergic reaction symptoms of hives.
50 2021-03-19 headache, chills, sweating Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 ... Read more
Started with sore arm 10 hrs after shot, then body aches, headache, chills started around 11pm(12 hrs after) My normal temp us about 97.8 it was up to 99 at 1am Nausea started around then. Dry mouth, by 3am temp was 99.9, vomited 3 times by 4am and temp went to 100.3 20 min later it was 99.6 at 8am i still had massive headache, temp iup to 101, still chills and sweats, nauseous Well it was 101, now 99 in just 20 min Nausea subsided enough to take Acetaminophen Temp around 100 till mid afternoon. Headache continued. Was able to eat dinner. Around then most symptoms stopped except headache and itchy skin Btw i had covid 7/2020
50 2021-03-19 headache Light headed Stomach upset Headache Passed out and shook on the ground Called paramedics
50 2021-03-20 fever, chills, headache, sweating nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hour... Read more
nausea; Headache; Mild muscle soreness at injection site; alternating chills/sweats starting 12 hours post-2nd dose; alternating chills/sweats starting 12 hours post-2nd dose; fever (100.3) taken under arm; restlessness preventing sleep most of the night; restlessness preventing sleep most of the night; periodic dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:00 PM, (lot number: EL3247), at the age of 50-year-old at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of the vaccine on 21Jan2021 01:30 PM (lot number: EL3247) on Left arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 00:00, 12hours post vaccination of second dose, the patient experienced mild muscle soreness at injection site within a couple hours; alternating chills/sweats starting; Fever (100.3) taken under arm; restlessness preventing sleep most of the night; periodic dizziness and some nausea; and headache. The outcome of the events was recovering. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.
50 2021-03-21 sluggishness I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started ... Read more
I got my first Pfizer covid shot around 3:30 PM on March 16, 2021. Around 10:00 PM, my arm started to get some soreness. I also noticed that I started feeling really sluggish with some muscle pains. Approximately 11:30 PM, I attempted to go to sleep and noticed that I started having a minor respiratory distress where I could hear myself wheezing. The wheezing only lasted about one hour. All the symptoms disappeared after 36 hours without any treatments or medications. At this point, I'm not sure If I should get my second vaccine shot.
50 2021-03-21 throat irritation Immediately following vaccine administration patient claimed had throat closing but upon further que... Read more
Immediately following vaccine administration patient claimed had throat closing but upon further questioning, patient had a tickly throat and patient claimed tongue felt enlarged. Gave patient 10ml of children's benadryl (25mg) and patient felt better. Waited in store 45 minutes following vaccine but symptoms disappeared 10 minutes following shot. Patient left pharmacy feeling fine with wife who was home with him all day to monitor symptoms. Told patient to use benadryl throughout day.
50 2021-03-22 headache March 15: 2:45pm Pfizer COVID vaccine 1 March 16; 6am - severe headache: treated with two Excedrins ... Read more
March 15: 2:45pm Pfizer COVID vaccine 1 March 16; 6am - severe headache: treated with two Excedrins at 8am and then two more Excedrins at 6pm. March 17: 10am - severe headache: treated with two Excedrins at 10am March 18: Upper neck and shoulder pain: untreated March 19: Upper neck and shoulder pain and hearing loss (approximately 50% hearing loss): untreated March 20: Upper neck and shoulder pain: treated with Arnicare Cream, hearing loss continues, untreated March 21 - 22: Upper neck and shoulder pain: treated with Arnicare Cream: hearing loss continues. March 23: Upper neck and shoulder pain improved. Hearing loss continues. Notified Dr. (my primary physician)
50 2021-03-22 malaise, fatigue, fever, chills Chills, fever, fatigue, injection site pain, body aches, tiredness, nausea, feeling unwell. Injecti... Read more
Chills, fever, fatigue, injection site pain, body aches, tiredness, nausea, feeling unwell. Injection site pain started approximately 12 hours after shot and was significant through 36 hours, then slowly went away and was gone by 72 hours after shot. Nausea started approximately 12 hours after shot and was gone by 18 hours after shot. Chills, fever and body aches started approximately 13 hours after shot. Body aches ended by 24 hours after shot. Chills and fever (102 degrees F) continued significantly for 36 hours post shot and then periodically at night until 60 hours. Significant fatigue and tiredness 12 hours post shot until 48 hours after shot. Took Tylenol (2 pills) at 18 hours post shot, reduced fever for 1 hours. Alternated Advil and Tylenol starting 24 hours post shot for next 48 hours.
50 2021-03-23 fatigue, fever Dizziness, Myalgia, Fever, Diarrhea, FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS ... Read more
Dizziness, Myalgia, Fever, Diarrhea, FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS Narrative: FEVER 100.1, ARM PAIN, DIARRHEA,BODY ACHES, FATIGUE, DIZZINESS following 2nd Pfizer COVID Vaccine. Other Relevant History:
50 2021-03-23 headache, sweating Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had... Read more
Patient received his first dose of Pfizer COVID-19 vaccine on 3/15/21, administered by store. He had the following reaction within minutes of receiving the vaccine. States he was still under the watch of the clinical team who administered it: Turned red, and got really hot. He tried to stand up, he felt fine but was sweating terribly. He developed a rash on the middle of his back 6-7 inches red rash, it did not itch. Reactions resolved within that same day. However, had a severe headache for about 24 hours.
50 2021-03-23 headache Every since getting my vaccine I have been having these symptoms. I received my first dose of phize... Read more
Every since getting my vaccine I have been having these symptoms. I received my first dose of phizer on 1/22/21 and a second dose 21 days later but was given Moderna not phizer. I continue to have headaches on and off all day, they are short but intense lasting about 5-10 minutes, sometimes hour or two between. Also shortness of breath and increased heart rate with just slight activity. Going up a flight of stairs my heart rate will quickly increase to 130-140 BPM which has never happened before. I have a fitness tracker on my watch so I watch it closely every day and it was never that high. My heart rate will recover fairly quick if I sit and it will come down to 80-90 BPM, at night when relaxed for a while the lowest I see it is about 70-75 BPM, sleeping it will be around 65 bpm.
50 2021-03-23 sweating Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what l... Read more
Extreme sweating, especially under the armpits. I've never had this before. Both armpits have what looks like a red skin rash. Also, my toes are extremely cold.
50 2021-03-24 fatigue, fever, sweating, headache Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatig... Read more
Severe sweating; fever; weakness; Worst headache of my life/daily headaches; searing eye pain; fatigue; This is a spontaneous report from a contactable physician (patient). A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration in left arm on 05Jan2021 16:00 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) in the right arm on 16Dec2020 12:00 PM. The patient had no other vaccine in four weeks. The patient had not been diagnosed with COVID prior vaccination. The patient experienced severe sweating, fever, weakness, "worst headache of my life," searing eye pain for the last 2 months, daily headaches and fatigue on 06Jan2021 12:00 AM (also reported as first 48 hours). The events resulted in disability or permanent damage. Treatment was administered for the reported events. Outcome of events was unknown. The patient underwent Covid nasal swab test post vaccination on 27Jan2021 with negative result.; Sender's Comments: Based on temporal association and known drug profile a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
50 2021-03-24 throat irritation Client verbalized feeling itchy throat after receiving the vaccine. Client was evaluated by onsite ... Read more
Client verbalized feeling itchy throat after receiving the vaccine. Client was evaluated by onsite Fire Rescue. Client was released to go home at 12pm. Per Fire Rescue no additional evaluation needed.
50 2021-03-25 fatigue, fever, chills Chills started about 18 hours after vaccination Body Aches, Joint Pain, Diarrhea, Injection Site Sor... Read more
Chills started about 18 hours after vaccination Body Aches, Joint Pain, Diarrhea, Injection Site Soreness, Tiredness, Muscle Pain, Fever 99.8, Chill stopped about 28 hours after vaccination. Fever, body Aches, Joint Pain, Muscle Pain pretty much gone 40 hours after vaccination.
50 2021-03-25 fatigue 30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fat... Read more
30 minutes after receiving Pfizer COVID vaccine #1 pt reports he became very flushed and hot and fatigued. Itching started later that night. Face felt swollen but no difficulty breathing, swallowing. I saw him the following day via telehealth and he reported generalized redness was improving but not resolved and pruritis persisted but was improving but the hour.
50 2021-03-25 headache Sore arm, body aches, nausea, severe headache
50 2021-03-25 malaise, influenza like illness he started feeling sick day after vaccine with flu like symptoms, seen in ED 5 days after vaccinatio... Read more
he started feeling sick day after vaccine with flu like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19, About 1 week after that, he was found dead at home on his couch.
50 2021-03-26 headache, fever Fever, body aches, headache, stomach ache, diarrhea
50 2021-03-27 fatigue Swelling in Left Underarm area, slightly painful to touch. Tiredness
50 2021-03-28 chills Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was j... Read more
Part of the face started to clench a little, don't know if that's part of Bell's palsy or that was just; Heart palpitations; Chills; This is a spontaneous report from a contactable consumer, who reported for himself. A 50-years-old male consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6206), via an unspecified route of administration, on 03Mar2021 at 3:15 pm (at the age of 50-years-old) as a single dose for COVID-19 immunization, in left arm. Relevant medical history included cholesterol. Concomitant medications included: Rosuvastatin 20mg, once a day for cholesterol, started a year ago and Vitamin C. On 03Mar2021, the patient had heart palpitations that lasted multiple days. I went to a cardiologist and he wasn't sure whether I should do a second vaccine dose, given that was one of the side effect. He gave me metoprolol which took down the heart rate. But I had the chills, I had part of the face started to clench a little. I don't know if that's part of Bell's palsy or that was just, I just don't know. It wasn't strong, it went away relatively quickly, within 4 hours. Treatment for heart palpitation: Metoprolol Tartrate, 25 mg, one. No treatment received for chills. The clinical outcome of the events Heart palpitations and chills was recovered on 11Mar2021, the outcome of the event face started to clench a little was recovered on 03Mar2021.
50 2021-03-28 fatigue Thurs: Shot 7pm, no adverse effects Friday: Face very red, allergic/histamine type reaction; begin O... Read more
Thurs: Shot 7pm, no adverse effects Friday: Face very red, allergic/histamine type reaction; begin OTC antihistamines Saturday: Massive facial and genital swelling Sunday: Same, PCP prescribed 4mg Prednisolone; symptoms lessen after 4 hours, most symptoms unnoticeable by 7pm Monday 7am; Less intense, but significant facial swelling, no genital swelling Fatigue during entire episode Antihistamines seem to yield little to no improvement Steroids help but it is now a tennis match overnight
50 2021-03-28 fever, fatigue after vaccine pt started having diarrhea, myalgias, fevers, fatigue. All symptoms improving except p... Read more
after vaccine pt started having diarrhea, myalgias, fevers, fatigue. All symptoms improving except persistent fevers
50 2021-03-29 headache Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then R... Read more
Reported being hot and having a headache. No sign or symptoms of distress. Client monitored then Released.
50 2021-03-29 headache Upset stomach, diarrhea, headache
50 2021-03-29 sweating Flushing/sweating, dizziness. BP 106/60 (pulse 63). Final BP 120/82 (pulse 75).
50 2021-03-30 chills Chills, muscle cramping
50 2021-03-30 fatigue 2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested fo... Read more
2 days after 1st shot I felt extreme fatigue and shortness of breath for several days. Got tested for COVID with negative results. Went to hospital on 16th of February and was admitted due to heart condition and recent heart attack. I told them my next vaccine was due on the 18th and they gave it to me while I was admitted. Within 24 hours I had another heart attack. I was sent to another hospital for an Angiogram where they expected to find blockage and prepared to install a stint. They found no blockage. There is no medical explination.
50 2021-03-30 fatigue Soreness at the site of injection; fatigue; This is a spontaneous report from a contactable consumer... Read more
Soreness at the site of injection; fatigue; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL3247), via an unspecified route of administration on 12Feb2021, 10:00 AM as single dose at Right arm for covid-19 immunisation. The patient medical history and concomitant medications included none. On 22Jan2021 patient taken the first dose. On 13Feb2021, the patient had Soreness at the site of injection and fatigue for 24-48 hours after administration. The outcome of event was Recovered. No follow up attempts are possible. No further information is expected.
50 2021-03-30 headache, malaise, fever, chills Low grade fever 99.2 (lasted 6-8 hours) Took Tylenol twice. ( 1 every 4-5 hours) Chills Feeling unwe... Read more
Low grade fever 99.2 (lasted 6-8 hours) Took Tylenol twice. ( 1 every 4-5 hours) Chills Feeling unwell Headache
50 2021-03-30 fever, chills, headache, cough Swollen lymph node in left arm pit; Fever; cough; headache; body aches; chills; This is a spontaneou... Read more
Swollen lymph node in left arm pit; Fever; cough; headache; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the second dose of BNT162B2 (Solution for injection, lot number: EL3248, Expiration date; unknown), in the left arm on 08Feb2021, 05:00 AM at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL3248) left arm on 30Jan2021, 05:45 AM at single Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not have allergies. The patient experienced fever, cough, headache body aches and chills on 08Feb2021 at 12:00 AM. The patient was recovering from the events. On the next day, patient reported swollen lymph node in left arm pit on 09Feb2021 at 05:00 PM, the outcome of event were not recovered. Adverse event resulted in emergency room/department or urgent care. The patient performed ultrasound blood tests and received Motrin prescription for the adverse event another event fever, cough headache, body aches chills on 08Feb2021 at 12:00 AM. Patient did not receive any vaccine in four weeks. and did not have covid prior to vaccination. No follow-up attempts are possible. No further information is expected.
50 2021-03-31 fatigue, chills 1day- fatigue,chills, body aches
50 2021-03-31 fatigue I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping ... Read more
I experienced muscle soreness at the injection site (upper-left arm) around 9P followed by cramping of my left calf. I went to bed and work up at 2A with body aches, stiffness, and joint throughout my body. The next day I continued experiencing the cramp in my leg and body aches, stiffness, and joint pain throughout my body, and general fatigue. The symptoms were mostly gone after my second night's sleep. I am still feeling lingering (mild) soreness and fatigue today, 4/2/2021.
50 2021-03-31 fatigue Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approx... Read more
Intense pain in upper arm and shoulder, staying about an hour after injection and laying for approximately 36 hours. Also fatigue that continues to now.
50 2021-03-31 headache, lethargy Nausea, headache, muscle ache, lethargy. For about 16 hours starting 10 hours after the vaccination.... Read more
Nausea, headache, muscle ache, lethargy. For about 16 hours starting 10 hours after the vaccination. Side effects lessened and after another 24 hours were completely gone.
50 2021-04-01 chills, fever, fatigue first 72 hours after first dose - fever, chills, extreme fatigue and body aches first 48 hours after... Read more
first 72 hours after first dose - fever, chills, extreme fatigue and body aches first 48 hours after second dose - fever, chills, extreme fatigue and body aches 72 hours after second dose - extreme fatigue and body aches days following second dose - still extreme fatigue, feels not 100%
50 2021-04-01 fatigue, headache, fever Body ache at the start as all through Headache all day the second day Fever bad the night of shot Na... Read more
Body ache at the start as all through Headache all day the second day Fever bad the night of shot Nausea started the night of the shot and continued to next day Tiredness on day two Just took Advil as treatment
50 2021-04-01 headache, fever, fatigue, chills Fatigue, low grade fever, headache, chills
50 2021-04-01 fever, malaise, headache, cough, chills Patient reports feeling unwell for approximately 2 weeks, but began having fevers, body aches, and c... Read more
Patient reports feeling unwell for approximately 2 weeks, but began having fevers, body aches, and chills about 5-6 days prior to ED presentation. Also reports cough and headache. Patient hypoxic to 87% requiring 2L O2 via nasal cannula. Patient febrile at 101.4 F. Patient to be admitted to the hospital. The patient has received dexamethasone, along with medications for symptom management including acetaminophen, ketorolac, and benzonatate.
50 2021-04-02 fatigue, chills, headache Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium);... Read more
Major (extreme) chills (almost uncontrollable chills and coldness, teeth rattling, slight delirium); body aches, major headache. Couldn't get warm despite spouse providing me with multiple blankets that night. Took tylenol to help with headache through the night. Woke up the next day with major body aches throughout my body. Continued headache and fatigue like symptoms along with the pain. Used tylenol PM the second night to combat continued headache but no chills the second night. Started to feel better today, April 3rd, which is 48 hours since my 2nd Pfizer vaccination.
50 2021-04-02 headache, chills, fatigue Headaches, chills, fatigues
50 2021-04-02 headache, fever Headaches Bodyaches Vomiting Fever Shakiness Heart racing
50 2021-04-02 headache Headache
50 2021-04-03 fatigue, headache, fever, chills Starting at 11:00 am (the day after the vaccine) I started developing cold chills and body aches. H... Read more
Starting at 11:00 am (the day after the vaccine) I started developing cold chills and body aches. Headache started to persist. As the day proceeded, I continued with those symptoms and a fever spiked up to above 102 degrees Fahrenheit. I also had no energy. I just kept hydrated and rested. The fever broke today and body aches and headaches have subsided by 4:00 pm (2 days after vaccine). These are very similar to the symptoms I experienced when I had Covid 19 back in early December of 2020.
50 2021-04-03 fever, chills Had Body Pains, arm pain at the site of vaccine, and EAR ACHE in both the ears at once lasting more... Read more
Had Body Pains, arm pain at the site of vaccine, and EAR ACHE in both the ears at once lasting more than a day, fever and chills
50 2021-04-03 fever, fatigue, headache Headache for approximately 16 hours, fever between 99-100, fatigue Took Tylenol to limit symptoms
50 2021-04-04 body temperature increased, headache, fatigue The day after receiving the 2nd Covid Pfizer-BioNTech dose I began to feel fatigued, had an elevated... Read more
The day after receiving the 2nd Covid Pfizer-BioNTech dose I began to feel fatigued, had an elevated temperature of 99.5, and soreness at the injection site. It has been 4 days since the 2nd dose and my temperature is still elevated at 99.5, I have a persistent headache and soreness of the muscles between my shoulder blades.
50 2021-04-04 fatigue, headache, nasal congestion, chills, fever, cough Nothing super severe, but the following side effects for about 48 hours: low grade fever, muscle ach... Read more
Nothing super severe, but the following side effects for about 48 hours: low grade fever, muscle aches, fatigue, headache, nasal congestion, dry cough, some nausea, chills.
50 2021-04-04 headache THE PATIENT ONLY EXPERIENCED HEADACHES AND BODY ACHES SO FAR.
50 2021-04-04 fever, headache Body ache, fever, and headache started on the 1st WO weeks after vaccination.
50 2021-04-05 chills, headache 4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared ... Read more
4-Apr, 20:00 - pain at injection site, numbness in right ring and pinkie fingers. Numbness cleared after vigorous flexing of hand. Repeated symptom and solution throughout night. Treatment: see above 5-Apr, 02:30 - pronounced pain at injection site and right hip (site of existing injury) radiating to groin, nausea (without vomiting), alternating hot flashes and chills, generalized muscular discomfort. Treatment: OTC painkiller (Tylenol) 5-Apr, 04:00 - Headache, sound of rushing blood in right ear. Treatment: none
50 2021-04-05 fatigue, chills I received my shot on Wednesday, March 24th at 2 pm. On Saturday, March 26th , I woke up to stomac... Read more
I received my shot on Wednesday, March 24th at 2 pm. On Saturday, March 26th , I woke up to stomach cramps, chills, and fatigue which lasted throughout the day on Saturday and subsided by the next morning. However, the tinnitus in my left ear had increased to a more noticeable and distracting noise level. Previously, I would describe my tinnitus on a scale of 1-10 (with 10 being most severe) as a "2". Since Saturday, March 26th at noon the tinnitus has reached a level of 4 or 5. It can be distracting when I am in a quiet environment trying to work, something I have never experienced before. I am concerned that this will continue to worsen.
50 2021-04-05 fatigue significant fatigue on day after receiving 2nd vaccination (Pfizer)
50 2021-04-05 fever, headache T+6hrs, aches and joints hurt. Fever started T+8hrs, continued to T+36. Severe headache T+8 to T+20,... Read more
T+6hrs, aches and joints hurt. Fever started T+8hrs, continued to T+36. Severe headache T+8 to T+20, then tapered off. Mild aches continued to 3rd day following shot. Back to preshot normal by 4th day. The night and day following shot were worse than my covid symptoms in January.
50 2021-04-05 fever, headache Headache and fever of 102 F. Took Advil which relieved the headache. Fever subsided in about a day.
50 2021-04-06 headache Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, hea... Read more
Flushing, headache, and hypertension Treated with intravenous ketorolac and famotidine Flushing, headache, and hypertension improving
50 2021-04-07 chills, fever, headache, fatigue Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all ... Read more
Fever and chills beginning approximately 14 hours after second shot. Insomnia and racing heart all night. Body felt extremely cold, and I had to add three layers of sweatpants/sweatshirts/socks to stay warm. Headache and fatigue lasted approximately 48 hours. Took 72 hours to feel back to 100%
50 2021-04-07 chills, fever, lethargy, fatigue First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. ... Read more
First dose, next morning. Slight body aches low fever (below 100), lethargy and foggy headedness. Arm hurt at injection site and pain spread slightly. All symptoms seemed worse day 2 post shot (3/17/2021). Persisted for about 4 days, gradually getting better. Went to work but was pretty miserable. Took Tylenol and Ibuprofin alternating every 2 hours for fever. Second dose next morning. Higher fever (topped at about 101 and change), severe fatigue, slept 18 hrs and took off work. Alternated tylenol and ibuprofin every 2 hours. Also chills, heavy night sweat body aches.. Next day, sub 100 fever that "rollercoastered" all day. Alternated tylenol and ibuprofin every 2 hours. Body aches, arm ached at injection site. Worked from home. Day 3 post injection (4/8/21) felt better, went to work, fine in the am, slight fatigue towards shift's end.
50 2021-04-07 fatigue In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which cont... Read more
In evening severe left arm and neck soreness, very tired, followed by prolonged diarrhea which continued until next day.
50 2021-04-07 headache Initially slight headache which went away with Tylenol. However, about 4:30 that morning awoke with... Read more
Initially slight headache which went away with Tylenol. However, about 4:30 that morning awoke with severe stomach cramps and diarrhea. Intestinal cramps and diarrhea continued intermittently for 4 days total.
50 2021-04-08 chills, fever, headache Side effects were low grade fever, chills, body aches, headache. Lasted 24 hours
50 2021-04-08 chills, fever, headache 2nd phizer vaccine- normal side effects started around 9-10 am but progressively got worse during da... Read more
2nd phizer vaccine- normal side effects started around 9-10 am but progressively got worse during day and into evening. Aches, chills, fever, headache- around 5:30 pm had an issue with blurred vision in my left eye for approx 15 mins, similar to a migraine apparently (never had one before)- blood pressure spiked to 164/104 and resting heart rate was between 90-104, normally 52-60. Headache persisted for nearly 9-10 hours and all symptoms improved dramatically after two Tylenol
50 2021-04-08 chills Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mi... Read more
Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: patient described as an almost panic attatck reaction - shakiness, dizziness, blurry vision, nausea. Blood pressure and heart rate not elevated. SAt for 20 minutes and started feeling better then got the chills and more shakiness
50 2021-04-08 headache, chills Injection 4/8/21 12:40pm. 4/9/21 3:00am: Severe headache , while first dose did not generate side ef... Read more
Injection 4/8/21 12:40pm. 4/9/21 3:00am: Severe headache , while first dose did not generate side effects, 4/9/21 6am: Chills, backaches. Aches and chills persisting thru early afternoon 4/9/21
50 2021-04-08 sweating, runny nose, fever Fever, sweating, runny nose, pain in injection area, diarrhea, vomiting & still sick but not as bad ... Read more
Fever, sweating, runny nose, pain in injection area, diarrhea, vomiting & still sick but not as bad as yesterday. Also for question # 20 "Has the patient recovered from the adverse event(s)? I answered no Because I still have these symptoms but not as bad as yesterday.
50 2021-04-08 influenza like illness, fever, chills, lethargy Fever Chills Joint pain Lethargy Felt like I had the flu
50 2021-04-09 chills, headache, fatigue fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50... Read more
fatigue; chills; hot flashes; headache; insomnia; This is a spontaneous report from a contactable 50-year-old male consumer reported that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Age at vaccination: 50 Years), dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included amlodipine besilate (NORVASC); telmisartan (MICARDIS); zinc; VITAMIN C [ASCORBIC ACID]; vitamin d nos. The patient previously received first single dose of bnt162b2 on Right arm on 21Jan2021,11:00 single (Age at vaccination: 50 Years) for Covid-19 immunization. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; List of any other medications the patient received within 2 weeks of vaccination: Norvasc, Micardis, multivitamin, vitamin C+D+zinc. On 11Feb2021 21:15, patient had fatigue, chills, hot flashes, headache, insomnia. Patient received treatment with Advil. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
50 2021-04-09 fatigue I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out... Read more
I am dizzy and can't hardly stand up, having severe hot flashes, throwing up, gagging, fatigue , out of it and dry mouth. I need help. The room keeps spinning!
50 2021-04-10 chills, fever, headache Severe Headache for 20 hours, Nausea, Vomiting, Chills, Felt feverish.
50 2021-04-10 fatigue, chills following day,2nd shot. i had chills,no fever,spine hurts along my whole back, exhausted .
50 2021-04-10 headache, fatigue, chills, fever Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoo... Read more
Vaccine administered 9.20am. Fatigue shortly after vaccine was administered - slept most of afternoon. Injection site pain - feels like been punched in arm. Headache in the evening. Night chills and complained of "tight" (not acute) chest pain... but no breathing problems. Morning fever of 101F. Headache, Dizzy, Fatigue, Muscle Pain (esp in legs, asif he had "run a marathon"). He spent most of the day "resting". Evening on day two, we noticed a large bump under his vaccinated arm. Radius about 5cm - larger than what I know swollen lymph nodes to look like - almost looks like a bicep between his armpit and nipple. Tender to touch. Morning of day three (48 hours after vaccine) bump under his arm remains and all other symptoms seem milder.
50 2021-04-10 headache, fatigue April 10: stomach cramping in the late afternoon/evening. diarrhea in the evening throughout the n... Read more
April 10: stomach cramping in the late afternoon/evening. diarrhea in the evening throughout the night. April 11: no more diarrhea, but general fatigue and muscle ache. slight headache
50 2021-04-10 fever, fatigue Fatigue and slight fever lasting 72 hours first onset 24 hours after injection. Swollen lymph node u... Read more
Fatigue and slight fever lasting 72 hours first onset 24 hours after injection. Swollen lymph node under right collar bone starting 24 hours after injection and lasting 72 hours.
50 2021-04-11 chills, fatigue After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site.... Read more
After dose 1 on 3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site. After dose 2 on 4/8/21, weak, chills and body aches all over for one day on 4/9, and arm hurt for a couple days at shot site.
50 2021-04-11 fatigue Soreness and stiffness in upper left arm Soreness and stiffness in left side of neck Fatigue and los... Read more
Soreness and stiffness in upper left arm Soreness and stiffness in left side of neck Fatigue and loss of appetite
50 2021-04-11 fever 3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and ... Read more
3 days after shot I developed a rash on my neck, torso ,arms and hands. My thumbs where swollen and numb. I developed a fever ranging from 101 to 104.4 for 48 hours. intense body achs.
50 2021-04-12 fatigue, headache, sleepiness Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(... Read more
Weakness, headache, nausea, exhausted, wanting to sleep constantly, trouble breathing when sleeping(wife noticed this). These symptoms although getting better have lasted six days.
50 2021-04-12 sweating Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my ho... Read more
Roughly 30 mins (10:30am) after I received my 2nd Pfizer vaccine shot, I was about 5 mins from my home and began to feel tingling/numbing in my mouth and tongue. I got in my house and told my wife I was not feeling right and started to notice a dizziness coming on. I was to call the pharmacy to find out what I should do, but noticed my heart rate was up, I looked at my Apple watch monitor and my BPM was 164. I felt flush and told my wife to call 911. Ambulance arrived and took my vitals and ( I do not recall the blood pressure, but it was high for me) when they put me into the ambulance I began to shake uncontrollably and then began to sweat profusely. They took me to the emergency room, but did not administer any drugs. The Dr. came in and said he did not think it was related to the vaccine, but my personal Dr. agreed with me based on my medical history that it had to be related to the vaccine. My resting heart rate (I monitor this daily) is between 45 - 60 and my last blood pressure reading at my yearly physical on April 2nd, 2021 was 100/70.
50 2021-04-12 nasopharyngitis About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy ... Read more
About 6.5 hours after vaccination my throat got a bit dry and feeling like a start of a cold /raspy feeling and I felt two spots on the front of my neck itching. I looked in mirror and saw two pimple size type spots itchy. over the neck 30 mins another itchy pimple grew and neck got a bit red and under an ear got red and itchy. over the next hour my breathing felt a little more difficult, though oxygen level oximeter reading still good. 8.5 hours after vaccination both sides of my upper back/shoulders were covered in hives. I felt a bit foggy also. I administered epinephrine pen to my thigh. Over next few minutes the hives disappeared (except for a few pimple size spots though they basically disappeared)and the itch was gone. My breathing felt fine. I monitored signs and symptoms with no noticeable issues for the next day+. This was the 1st time I ever used an epi pen.
50 2021-04-13 headache, runny nose Patient had 2nd COVID vaccine 2/4/21. On 4/3/21 developed headache and rhinorrhea. Tested positive... Read more
Patient had 2nd COVID vaccine 2/4/21. On 4/3/21 developed headache and rhinorrhea. Tested positive for COVID.
50 2021-04-13 sweating Patient had a syncopal episode post vaccine, as well as dizziness, diaphoresis.
50 2021-04-14 head discomfort Dizziness, heavy feeling in head, panic attack.
50 2021-04-14 throat pain, cough Breakthrough COVID-19 + . Known unprotected exposure at home, developed sore throat, congestion and ... Read more
Breakthrough COVID-19 + . Known unprotected exposure at home, developed sore throat, congestion and cough. Pfizer COVID-19 vaccine received 1/6/21 and 1/29/21.
50 2021-04-14 throat irritation, throat pain 50 y/o male with history of Asthma who presents with itchy, sore throat post vaccination administrat... Read more
50 y/o male with history of Asthma who presents with itchy, sore throat post vaccination administration. Patient denies SOB, chest pain or difficulty breathing. Patient vitals within normal limits and lungs clear. Benadryl 25 mg PO x1 given and patient observed by the NP and Paramedics. After 20 minutes of observation patient reported that he felt better, no issues with swallowing and was comfortable being discharged home. Patient discharged home in stable condition.-------------------------------END
50 2021-04-15 headache Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches... Read more
Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite
50 2021-04-16 chills, headache, fatigue Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Se... Read more
Shot was received at 6:15pm and symptoms started at 7:30am. I had a soar arm at injection site. Severe dizziness to the point I could not walk, headache and joints pains started around 10am while at work. I left work at 1:30pm When I got home around 2:00pm, I felt tremendous amount of fatigue. I slept from 2pm until 5:00pm. I went back to bed at 6:30pm. During the night I had cold chills and sweated all night until my sheets were drenched. I slept until 9:30am. I felt much better after taking a shower. I would not have the second dose!!
50 2021-04-16 headache, chills, fever, fatigue Low grade fever, chills, headache, fatigue, and body aches
50 2021-04-16 headache, fatigue, chills, fever Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours a... Read more
Had soreness and tenderness at injection within one hour of vaccination. Approximately 13-15 hours after Vaccination, woke from sleep with fever and chills. Fever was 100 as measured using oral digital thermometer. Experienced mild body muscle aches and stiffness, especially in the upper back, shoulders and neck. Had mild to moderate fatigue and persistent headache at base of skull. Also experienced muscle twitching within 2 hours of vaccination through the lower limbs and torso, with more activity concentrated in the legs and feet. Was not painful, but strange. Some of this muscle fluttering and twitching preceded muscle cramping in the feet. Frequency was almost continuous with short, 60 second pauses between twitches. The moved and we?re not in the same exact location. We?re especially active when when lying flat, relaxed in bed. All symptoms aside from the twitching subsided fully by the following Morning (April 15th 2021). Took body temp that morning and had returned to 98.7 f. Muscle twitches have continued five days beyond vaccination, although they have grown milder and less frequent.
50 2021-04-16 sweating syncopal episode 1 minute after receiving second Covid vaccine dose. Patient had head down and slump... Read more
syncopal episode 1 minute after receiving second Covid vaccine dose. Patient had head down and slumped over, was diaphoretic. Patient also had a syncopal episode after his first dose at the end of March, and at that time fell and hit his head, requiring a CT head. Additionally at that time patient continued to have persistent nausea and vomiting afterwards requiring numerous antiemetics and IV fluids. He also had a full work-up, which did not reveal any concerning signs in relation to his syncopal event. Before syncopized today, patient denies experiencing any chest pain, palpitations, shortness of breath, nausea. He said he began to experience some lightheadedness, and then lost consciousness. This was witnessed by his husband, who is with the patient today. Denies any head trauma, neck trauma. He spontaneously regained consciousness shortly after, and felt clammy, however was not experiencing any other symptoms. Patient currently denies any symptoms. Endorses compliance with his medications.
50 2021-04-17 fever, headache, dehydration High fever of 102 degrees. Took 2 caplets of Tylenol at 9pm on 04/09/2021 that had little to no eff... Read more
High fever of 102 degrees. Took 2 caplets of Tylenol at 9pm on 04/09/2021 that had little to no effect. At 3am on 04/10/2021 took 2 gel caplets of Advil hoping to do better. The Advil brought the fever down to 100-101 for several hours but the fever went right back up. Arm was sore and had headache. My fever went down to 99 degrees 48 hours after taking the shot on 04/11/2021 at 3pm. Later on 04/11/2021 around 9pm my temperature went back to normal including any pain or swelling at the injection site. I had to re-hydrate myself but felt better. Overall I would do it again to protect my family from this virus.
50 2021-04-18 cough Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (s... Read more
Shortness of Breath with cough , generalized weakness, left rib pain radiating to upper back pain (sharp in nature)
50 2021-04-18 headache Slight stomach pain began 7 hours after injection. As the night progressed, I felt the pain getting ... Read more
Slight stomach pain began 7 hours after injection. As the night progressed, I felt the pain getting stronger. After eating dinner, I was expecting the pain to subside, but that did not happen. As the pain became more intense, I decided to lay down for the night. I was awaken in the middle of the night with several bouts with sharp abdominal pains. I took (2) Tylenol for the pain in the middle of the night. The next morning, the pain was still there, and more intense. The day after I continued to experience constant sharp abdominal pains. Again, I took another (2) Tylenol for the pain. As the day progressed I continued to experience sharp abdominal pains. I thought it might have been trapped wind, so I took Miralax. Unfortunately that did not help. Again, I went to bed the second evening with concerns this may be a reaction to the virus. On the third day, I started to feel slightly better. I the sharp abdominal pains were subsiding from a level 10 down to a level 8. As the day progressed, down to a level 6. However, I began to feel a headache in the front right lobe. So, I took (2) Tylenol and went to bed. On day four, I woke without any abdominal pains, however I still had a headache and it was non-stop. This continued through day four and through the evening. On day five I still had a headache, but was feeling slightly better. By end of day five the headache stared to subside. On day six, I was feeling back to normal.
50 2021-04-18 fever fever and vomiting for 3 days
50 2021-04-19 sweating Was flying on 2 Apr 21 at cruise about 1 hour into flight, experienced loss of color in vision, went... Read more
Was flying on 2 Apr 21 at cruise about 1 hour into flight, experienced loss of color in vision, went from full color to red and gray, somewhat washed out, experienced lightheadedness and a bit of disorientation but not dizziness. Needed to use the bathroom and try to move to improve circulation and had to think about moving my body. I was not uncoordinated but my steps and balance were deliberate vs. unconscious and automatic. I was able to walk down the aisle to the lavatory without any problem but my vision did not immediately improve as I had hoped. I went into the lavatory and leaned against the side (I'm 6'4" and it was the rear lavatory on a 737). I was not dizzy and my lightheadedness began to clear up slowly as I urinated. The color was also coming back slowly as I finished up and walked back to my seat, again, I had to think about each step and my balance, although I was okay walking back. As soon as I sat down, I began sweating profusely. It lasted about two minutes or less, not long at all and I didn't get wet from the sweat. As suddenly as the sweat came, it went. My eyesight went back to normal and I felt nothing had happened. I am sure I was awake, aware and lucid the entire time, although it felt like what I imagine a psychedelic episode would be like (I've never used any form of hallucinogen, however). I was back to normal when I disembarked the aircraft, felt no adverse or lingering effects either. Nothing to report since.
50 2021-04-21 headache, fatigue Light headed, headache, joint pain, fatigue, no fever
50 2021-04-22 chills 4 hours shivering, joint and muscle pain, 24 hours weakness
50 2021-04-22 fatigue Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappe... Read more
Shortness of breath, heart palpitations, vertigo/dizziness, phantom body pains appearing and disappearing in various places, occasional itching sensation, numbness, brain fog, double-vision, extreme tiredness. Symptoms tapered off over 3-5 days. Similar experience with 2nd vaccine but less pronounced with a shorter timeframe, tapering off after 2-3 days. Strongest side effects after first vaccine, symptoms did not become noticeable until a couple of hours after it was administered, increasing next 24 hours before lessening over time. Basically identical to long covid symptoms but lasting only for a few days after vaccinations and not before.
50 2021-04-22 headache, fatigue Fatigue; headache; rash on both legs with blisters, itching, pain, burning sensation appeared to be ... Read more
Fatigue; headache; rash on both legs with blisters, itching, pain, burning sensation appeared to be shingles (I have had shingles previously but no shingles vaccine) Lasted a total of 2 weeks until all symptoms were gone.
50 2021-04-22 headache Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation... Read more
Headache 2-3 days; Day 3 the rash began on both legs with blisters, itching, pain, burning sensation appeared to be shingles (I have had shingles previously but no shingles vaccine) Lasted a total of 2.5 weeks until most symptoms were gone. Still have occasional nerve pain and burning.
50 2021-04-22 fever, cough Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough ... Read more
Pt received his first dose of Pfizer COVID vaccine on 4/10/21 and started having myalgias and cough on 4/14. He was tested for COVID on 4/16 and received the positive result on 4/19. He then developed fever, loss of taste, nausea, and shortness of breath which prompted him to present to urgent care, and they told him to go to ED on 4/22/21. Patient was found to be hypoxic and was admitted to the hospital for COVID treatment.
50 2021-04-23 headache, chills, fatigue 2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite ... Read more
2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite arm that the shot was administered. The rash was red in color, raised skin and was located near my right bicep, inside elbow area. This rash subsided for most part the day after. Also had the chills for over 48 hours, slight headaches on and off and was extremely tired with low energy. It felt like I was in a fog for a couple of days.
50 2021-04-23 headache at 5am this morning i woke up with a severe headache and feeling nauseous. I sat at the end of my b... Read more
at 5am this morning i woke up with a severe headache and feeling nauseous. I sat at the end of my bed and then do not remember anything until my head hit the bathroom floor. My wife said i stumbled across the bedroom into the bathroom and it looked as if i just passed out and fell to the ground.
50 2021-04-23 sweating Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: anxious before the shot. started sweating and felt dizzy 2-3 minutes after the shot. gave water to patient and asked them to take deep breaths. patient then started to become unresponsive,pale with no blood flow to face. no improvement was seen and then epinephrine shot (adult) was administered. patient started to regain consciousness and became slightly responsive after a couple minutes. had the patient sit down and put theit legs up on a chair. EMT arrived and out of caution took them to ER.
50 2021-04-24 headache, cough, fatigue, fever sick; have symptoms of covid-19 was tested on 3 Apr 2021 and received positive results for Covid 19;... Read more
sick; have symptoms of covid-19 was tested on 3 Apr 2021 and received positive results for Covid 19; her husband all of a sudden coughed up a bunch of gunk, but he was not congested; Headache/ his head still hurts/headache; Low grade fever; her husband was really tired; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 first dose of (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension, blood cholesterol increased, body mass index increased from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced have symptoms of covid-19 was tested on 03Apr2021 and received positive results for COVID-19. Also reported headache/his head still hurts on, low grade fever, tired on 30Mar2021. It was reported her husband got all of sudden coughed up a bunch of gunk, but he was not congested on 02Apr2021 and sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 29Mar2021, sars-cov-2 test as positive on 03Apr2021. She said her husband would really like to have the second COVID-19 Vaccine for protection against the COVID-19 Virus. Treatment as reported her husband took Mucinex, Ibuprofen, and drank a lot of tea with honey in it. She said her husband had the Mucinex and Ibuprofen with him in isolation, so she couldn't provide the NDC, Lot, and Expiration Dates. She clarified her husband took generic brand Ibuprofen, and Mucinex. She said her husband had been on a statin for a while. She said the only other medicine her husband took was Vyvanse, and he had been on Vyvanse forever. She said her husband had a second COVID-19 Virus test on 03Apr2021, and he was told on 04Apr2021 that he was positive for the COVID-19 Virus. She said her husband had his temperature checked on Saturday (03Apr2021) and it was 98.5 degrees. She said when her husband got home last night (05Apr2021), he had a fever of 101 degrees. She said her husband had been sleeping since. The outcome of the event was unknown for cough and illness and not recovered for the other events. No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
50 2021-04-24 headache headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his ... Read more
headache; unable to maintain an erection/ some issues with maintaining an erection; soreness in his arms/ soreness was on both shoulders; real soreness" in his arm where he got the injection/ injection site had pain; developed a "large lymph node under that arm", which he "feels internally"/ lymph node he could feel internally/ internal bone like pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE at the arm right (reported as right shoulder) for covid-19 immunisation (reported as he is trying to avoid serious illness). The patient medical history includes sleep from unknown date and if ongoing. Concomitant medication included zolpidem (reported as generic ambien) taken for sleep, start and stop date were not reported and added that he has been taking it for years but he hasn't taking it since he got the vaccine but thinks he took it the day before. The patient previously took bnt162b2 first dose on 10Mar2021 (roughly two weeks before the second dose) at the left shoulder for covid-19 immunisation. It was reported that the patient had no reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine, and he received the second dose on 31Mar2021. He explained following the second dose, his first issue was a "headache", then he had "real soreness" in his arm where he got the injection. He added he developed a "large lymph node under that arm", which he "feels internally". He specified he still feels it a week later. He also explained he is "unable to maintain an erection". He described himself as "athletic" and specified not having erectile problem in the past. He asked if his current symptoms have been reported as side effect to the vaccine. It was also added that after the second dose he appeared to have some issues with maintaining an erection on 04Apr2021. It was stated he is fairly active with a muscular build and could be a result after an exercise injury but this did happen after his second shot. Caller states he also had soreness in his arms and an enlarged lymph node under his arm that he could feel with his hand but that went away yesterday (from 01Apr2021 to 07Apr20210). The soreness was on both shoulders but he thinks the soreness on the other shoulder is from lifting weights and the shoulder from the injection site had pain, internal bone like pain (from 01Apr2021 to 07Apr20210). It was stated that the lymph node he could feel internally but didn't protrude through skin and went away yesterday and lasted 6-7 days. It was also reported that the soreness and lymph node went away yesterday and believes everything will get back to normal, he expected soreness to last a couple of days and it lasted a week. The patient stated he took some sleep medication after the second injection. He doesn't remember if it was the night before the injection. He took Ambien, a higher dosage. States maybe issues with maintaining an erection are beginning to improve. It was also stated the soreness and lymph node he noticed it the day after the injection, by the evening of 01Apr2021 and as of yesterday 07Apr2021 evening it feels like its completely back to normal. It was noted for the treatment that he didn't take anything but bought a gripper where he squeezes it and builds strength in his hands to give him some relief. The patient added that he's pretty active, he works out 4-5 days a week, including running. The outcome of the event some issues with maintaining an erection/ unable to maintain an erection was recovering; for the event headache was unknown, for all other events was recovered on 07Apr2021. Information about the Lot/batch number has been requested.
50 2021-04-24 influenza like illness Flu like , muscle ackes everywhere, no energy, and no hunger only for one day.
50 2021-04-25 fever, fatigue, chills, influenza like illness, sneezing, cough Flu like systems, started with soreness in the morning, than escalated to chills, fever, hypertensio... Read more
Flu like systems, started with soreness in the morning, than escalated to chills, fever, hypertension.. A couple of coughs and sneezes and overall fatigue and eventual exhaustion all signs were present on the Friday throughout the day, by Saturday morning, all but the soreness cleared up.
50 2021-04-26 fatigue Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain ... Read more
Lower back pain (continuous as of today however less than before), fatigue (7 days), mid-chest pain (1.5 days), intermittent dull pulse pain?right leg calf (continuous)
50 2021-04-26 headache, fatigue, chills Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Ti... Read more
Pain on left arm for 1 day, Headaches 6 days, bodyache 6 days ,chills ,soft stool for 2 days and Tiredness 6 days.
50 2021-04-26 sweating Vasovagal episode Pt became pale bradycardic and diaphoretic He responded with juice and crackers R... Read more
Vasovagal episode Pt became pale bradycardic and diaphoretic He responded with juice and crackers Repeat vital signs BP 124/64 P 74 97% on RA
50 2021-04-26 throat pain The lymph nodes in my neck have swollen. I have been experiencing a very sore throat. It is hard to... Read more
The lymph nodes in my neck have swollen. I have been experiencing a very sore throat. It is hard to swallow. I was diagnosed today with strep throat and prescribed amoxicillin-clavulanate to address the strep throat.
50 2021-04-26 fever 42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomit... Read more
42-43 hours after receiving the first dose of the Pfizer vaccine, patient starting projectile vomiting, approx. or 10 times, every hour from 10am Sunday, 4/25 until approx. 2pm 4/25. Patient also had extreme abdominal pain (score of 10 on a 10 point scale) , showed signs of extreme agitation, discomfort , weakness, mild disorientation. no fever at this time nor diarrhea . Due to extreme abdominal pain and vomiting, patient was taken to Emergency Room where he was given medications to stop the vomiting, cramping . Tests run: EKG, CAT scan and blood work. Blood was normal, and EKG. CAT scan showed extreme swelling and inflammation to the entire abdominal cavity. Patient was discharged after pain was brought under control . Within hours of coming home the patient started to experience sever diarrhea, (watery discharge every hour for about 6 hours - patient estimates at least a gallon or more of liquid loss). Patient was on Gatorade, water intake , as much as he could take , continuously. No vomiting was experienced, but at this point patient was on the medications to control symptoms given at ER discharge. Patient experienced intermittent sharp pain despite medications to stop cramping and coat stomach and nausea continued despite nausea medication . on Monday, April 26th, around 3pm the abdominal pain increased, and by 10pm a high fever was present: 102.8 without ibuprofen, 101.4 with ibuprofen, and at this writing, Tue 4/27/21 at 2:30pm, the fever continues at 101.4 with continuous ibuprofen. The patient has not eaten solid foods and is now on Pedialyte, He has vomitted twice since 7am and is currently experiencing diarrhea .
50 2021-04-27 chills Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased b... Read more
Awoke to uncontrollable spasmatic shivering, ice cold feet, increased heart rate of 110, increased blood pressure 151/84. Worst of it lasting over 1 and a half hours before extreme shivering subsided with continued stress.
50 2021-04-27 cough, fever, pneumonia I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and wa... Read more
I received the Pfizer vaccine on 21 December 2021. On December 27 I developed a fever, cough and was diagnosed with Covid-19. About 14 days later I started to get a rash on hands and feet with burning sensation. I was evaluated and diagnosed with Covid toes. About 1 week later I developed a fever and was evaluated and diagnosed with pneumonia, pulmonary embolism, and a DVT. I continue to get worse to include arthritis in hands, wrists, feet and ankles. I was admitted to the hospital with worsening pneumonia, reactive arthritis and a rash on elbows, knees, hands and feet. I was in the hospital for about 5 days. I have been evaluated by rheumatology, pulmonary and dermatology since. The ongoing theory is I have a reactive arthritis from COVID and may have developed psoriasis/psoriatic arthritis.
50 2021-04-27 fatigue General fatigue- Only symptom
50 2021-04-28 headache Headache and overall mild body aches on the first day post-vaccination. Treated with fluids, ibuprof... Read more
Headache and overall mild body aches on the first day post-vaccination. Treated with fluids, ibuprofen, and rest. Resolved after one day. Swelling and tenderness in left underarm lymph node noted two days post-vaccination. Tenderness increased on day three. Managed with fluids and ibuprofen.
50 2021-04-28 sweating Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/... Read more
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Patient reported feeling dizzy and was found on floor after the vaccine. He was asked to wait for about 30 minutes for extra monitoring. Called patient after he arrived home and reported feeling okay.
50 2021-04-28 throat irritation On April 1, 2021, I received my 1st dose of the Pfizer vaccine at the Center and the only side effec... Read more
On April 1, 2021, I received my 1st dose of the Pfizer vaccine at the Center and the only side effect from the vaccine at that time was localized soreness at the injection site of my left shoulder. On April 2, 2021, earlier that day the soreness at the injection site began to dissipate after doing push-ups and massaging my left arm. After going to bed last night and that night is when the additional side effects started. I was awakened by itching on both arms which had formed whelps from my shoulder to my forearm. For the next 13 days, the whelps and itching were sparsely during the day (which had consumed my legs, upper torso as well as arms) as they presented the illusion to be getting better but would flare up at night while sleeping. I attempted to do home remedies from Calamine lotion, Benadryl and cold showers but nothing seemed to effectively work against the itching and the whelps that resembled Hives. On April 13, 2021, while at work a new side affect began which was the swelling of my bottom lip (particularly the right half) along with itching in my throat. The swelling reduced itself as I continued to work through the night but the discomfort in my throat continued. The whelps and itching were still sparsely present as well. On April 14, 2021, later that morning, post work, the reduced swelling of my lower lip and throat discomfort I decided to go to the ER. While enroute to the ER, my top lip began to tingle and swell. These events made me more concerned about the severity I was experiencing since receiving the vaccine. After checking into the ER and being triaged, the doctor informed me that I would be hospitalized overnight due to the swelling of my upper lip, elongated tonsils, elevated blood pressure and the diagnosis of whelps as Hives. For the next three nights I was intravenous administered Epinephrine, Benadryl and Prednisone. On April 16, 2021, the third night I was discharged from the hospital with the same medications and informed to follow up with an allergist.
50 2021-04-29 chills, runny nose, throat pain, headache, cough, fatigue Had normal side effects for 24 hrs after vaccine(pain, chills, headache, tiredness). 2 days after va... Read more
Had normal side effects for 24 hrs after vaccine(pain, chills, headache, tiredness). 2 days after vaccine, starting with significant runny nose, mild cough, mild sore throat, and some mild chest discomfort during physical activity.
50 2021-04-29 headache, sleepiness Pain in arm muscles pain drowsy headache
50 2021-04-30 chills Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer s... Read more
Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program support. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 at age of 50 years old at single dose for COVID-19 immunization. Medical history included he ate spinach which caused him to have loose stools on 05Apr2021. Concomitant medications were not reported. On 08Apr and 09Apr, he began to experience diarrhea. He took pepto-bismol, which didn't help him so he had been following the BRAT diet and drinking coconut water. He went to an acupuncturist who prescribed Plum Flower curing pills. He asked how long this was going to continue. He also reported having chills after the vaccine. The 2nd dose would be on 29Apr2021. Patient experienced diarrhea and chills the next day after taking the 1st dose. He would like to know how long the diarrhea extended to last. As per the patient he took an anti-diarrhea curing pill which was a Chinese herbal. He would also like to take the 2nd dose a week after the 29Apr2021, which would be on 06May2021. Outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
50 2021-04-30 fatigue 1st Pos. COVID-19 test, resulted on 7 Dec 21 Symptomatic. Second COVID -19 pos. resulted on 29 APR... Read more
1st Pos. COVID-19 test, resulted on 7 Dec 21 Symptomatic. Second COVID -19 pos. resulted on 29 APR 21, s/s: fatigue, difficulty breathing , SOB w/ exertion Onset 29 APR 21. fullness in the trhroat, COPD Chronic Glaucoma, GERD. 1st COVID vac,14 Jan 21, 2nd 6 Feb 21. Since the second onset of symptoms was more than 90 days from the first infection and more than 14 days after the second COVID vaccination. This is considered a new case.
50 2021-04-30 nasopharyngitis, cough, nasal congestion, fatigue Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a conta... Read more
Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021. No follow-up attempts are needed. No further information is expected.
50 2021-04-30 fever Fever spike to 101.5.; This is a spontaneous report from a contactable consumer(patient). A 50-yea... Read more
Fever spike to 101.5.; This is a spontaneous report from a contactable consumer(patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age of 50 years old, administered in Arm Left on 05Apr2021 08:30 am (Lot Number: ER8727) at single dose for covid-19 immunisation. Medical history included allergies: Sulfa Based. There were no concomitant medications in two weeks. The patient got Vaccine on 05Apr2021 started having fever 09Apr2021 03:00 PM. Fever spike to 101.5. Had Fever on 10Apr2021 and 11Apr2021. Body temperature returned to normal on 12Apr2021. Event resulted in Doctor or other healthcare professionaoffice/clinic visit. No treatment received for event. Patient had negative Covid test(Nasal Swab) on 11Apr2021 and negative Flu test on 12Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for the event was recovering. No follow-up attempts possible. No further information expected
50 2021-05-01 chills Body aches and chills for eight hours.
50 2021-05-01 lethargy, body temperature increased, chills, headache 103 TEMPATURE for 4 straight days, chills, pain at injection sight, swelling and redness at injecti... Read more
103 TEMPATURE for 4 straight days, chills, pain at injection sight, swelling and redness at injection sight, debilitating headache, nausea, sore joints, no energy
50 2021-05-02 headache, fever, chills Beginning on 4/29/21: Fever (reaching 105.2*), headache, and chills. Lasted for 4 days. Contacted M... Read more
Beginning on 4/29/21: Fever (reaching 105.2*), headache, and chills. Lasted for 4 days. Contacted MD by phone. Informed to treat with Acetaminophen and hydrate with water.
50 2021-05-02 nasal congestion, cough, fever, chills, headache body aches, headache, cough, chills, fever and nasal congestion Advised patient to hydrate, Tylenol... Read more
body aches, headache, cough, chills, fever and nasal congestion Advised patient to hydrate, Tylenol for fever body aches
50 2021-05-02 fever High fever for two days. First day could not get out of bed to get water to drink. Followed by half ... Read more
High fever for two days. First day could not get out of bed to get water to drink. Followed by half day of moderate fever. One week later very itchy rash appeared on left armpit, left groin and left hand. This was accompanied with slight fever and general weakness. Rah eventually resolved a week after four days of Valacyclovir therapy. The Valacyclovir helped with to reduce the itching. Viral cause of the rash suspected.
50 2021-05-03 lethargy, influenza like illness, fever About 7 hours after receiving the shot, I did feel quite sore in my left arm (where the shot was adm... Read more
About 7 hours after receiving the shot, I did feel quite sore in my left arm (where the shot was administered) About 21 hours after receiving the shot, I started feeling very "Fluish", meaning lethargic, feverish and achy but without registering an actual fever about 28 hours after receiving the shot, I felt the symptoms escalate and felt even worse and remained bed ridden until about 44 hours after receiving the shot (started feeling better at about 11am on 4/2/21)
50 2021-05-03 fever, body temperature increased About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was g... Read more
About 4 hours after receiving the 2nd dose, my left arm started to become sore (where the shot was given) About 10 hours after receiving the 2nd dose, I started feeling "fluish" (achy, feverish, nauseous) All throughout that evening, the symptoms became worse and worse where I repeatedly took my temperature thinking I had a very high temperature only for it to read "below" normal at 97.3. The symptoms continued to get worse, without much sleep throughout the night and into the next day and evening. I almost scheduled an appointment with my primary care physician on 4/24 because I felt so horrible. It wasn't until about 11 am on the 2nd day after receiving the shot (4/25) that I felt somewhat better and by that evening around 6pm, felt normal again. The 2nd dose was absolutely, without a doubt, MUCH worse of symptoms than the first dose. I hope this helps and please contact me with any questions or to help further.
50 2021-05-03 fever, fatigue 8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the n... Read more
8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs. Over the next few days developed increased fatigue, severe joint pain, fever and worsening rash. Was seen in ER on 4/23/2021. Extensive work up showed increased CRP, Eosinophilia, increased LFTs, increased WBC. Skin biopsy was taken and revealed Superficial and deep perivascular and interstitial dermatitis, histiocyte-predominant and with eosinophils. ANA was positive 1:640, Ferritin was elevated. The patient was admitted. . Patient had CT scan of the chest on 4/28/2021 which showed bilateral pulmonary embolism and possible mass in the right side of the liver. Patient was started on anticoagulation. Next day, patient had severe abdominal pain with pain in the right lower quadrant. He as found to have Ogilivie's Syndrome with colon ischemia and peritonitis. Now s/p resection with septic shock. The patient is in the ICU and intubated.
50 2021-05-04 chills, headache Symptoms started about 8 days after receiving first vaccine. The first symptom to present was Tinni... Read more
Symptoms started about 8 days after receiving first vaccine. The first symptom to present was Tinnitus started light then went to SEVERE. About 6 days after onset of tinnitus I started with cold sweats, chills, BAD vertigo, Nausea, headaches around my head (not just in one spot) and no appetite. In the following days symptoms have not subside .....going on 2 weeks now.
50 2021-05-04 chills, headache Chills, severe myalgias, headache, multiple shingle eruptions within 7 days(R abdomen and Left wais... Read more
Chills, severe myalgias, headache, multiple shingle eruptions within 7 days(R abdomen and Left waist), right occipital neuralgia/allodynia, costochondritis, flank discomfort, and sensation of weakness in legs associated with myalgias.
50 2021-05-04 headache, sluggishness, chills, fever 1st dose- I did not have a reaction other than sore injection site 2-nd dose- I had fever/chills, vo... Read more
1st dose- I did not have a reaction other than sore injection site 2-nd dose- I had fever/chills, vomiting/diarhea, strong headache, sluggish, muscle aches, joint aches, confussion or foggy thoughts
50 2021-05-04 sweating Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 1... Read more
Was feeling fine and health when prior to the shot. We were directed (wife and I) to sit down for 15 minutes before leaving. For the first 13 minutes I was talking to my wife, joking, etc. I felt fine. However, after 13 minutes or so, I started to felt light heading and week. Then started to sweat and then I couldn't speak. I felt like passing out. My wife told me that the a man was trying to told we up and prevent me from falling. I could hear what others were saying. My wife states I turned pale, eyes looked stright ahead, and my mouth was distorted. This came all at once and within a minute experienced all these symptoms. The pharmacy staff gave me an eppy shot to get me back, then I was told to lay down on the floor. I came to withing a minute or two and felt much better. They had called 911 for an ambulence to come out. The responders checked me out (vitals) and all looked fine, but I was highly advised to go with them to the ER to get checked out.
50 2021-05-04 malaise, chills Significant bruising and pain at injection site, chills, bloating, malaise
50 2021-05-06 fever, chills, fatigue, influenza like illness Flu-like symptoms (chills, joint pain, low grade fever, fatigue), vertigo, tinnitus, moderate hearin... Read more
Flu-like symptoms (chills, joint pain, low grade fever, fatigue), vertigo, tinnitus, moderate hearing loss. Flu symptoms resolved within 24 hours but hearing loss remains. Using OTC hearing aid until I can schedule appointment with PC and ENT
50 2021-05-08 fever, chills, headache I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever st... Read more
I felt well for the 8-9 hours after the shot, around 8pm that evening, a headache and mild fever started. By 1am, fever, chills, increased headache, severe joint pain were in full swing, muscle almost felt like they were on fire. Even rolling over in bed HURT. Fever got as high as 101.8 (I usually am around 97.6 or so). Symptoms started to abate by mid morning, but I was essentially useless until that evening. By May 6, I felt like I had a really bad hangover all day, then was mostly recovered by that evening. It is now May 9. I have a long history of knee/arthritis pain, and am generally a rather active person, but since the second dose, my knee pain as well as my hands to a large degree, have been extraordinarily sore and painful. My knees in particular, while the symptoms were really peaking, I experienced some very acute,atypical pains a couple times in both knees that seem to keep recurring 2-3 times per day, as well as exacerbated, continual soreness and general pain when I am active.
50 2021-05-08 fever, chills aches, chills, fever
50 2021-05-09 fatigue, headache, chills, fever Pfizer-BioNTech COVID-19 Vaccine EUA. 1st dose. Injection site pain, tiredness, headache, muscle pai... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. 1st dose. Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, vomiting and feeling unwell. Took 2 extra-strength Tylenol at 12:15 pm on 5/9/21. I vomited them up less than a half-hour later. Also vomited a second time an hour later. Started feeling symptoms on 5/9/21 at 1 am and lasted a little over 24 hours. On 5/10/21, symptoms are gone except for tiredness. I tested positive for COVID-19 twice. First time was 11/17/20 - 12/7/20. Recovered fully. Had COVID-19 a second time on 3/20/21. This time a mild case with symptoms lasting only 4-5 days.
50 2021-05-09 fever, fatigue Fatigue, Muscle Ache, Pain at injection Point with mild fever (99.1 to 99.7) Saturday 5/10/2021 fati... Read more
Fatigue, Muscle Ache, Pain at injection Point with mild fever (99.1 to 99.7) Saturday 5/10/2021 fatigue, mild fever continued, pain at injection site, 5/10/2021 11PM fever hit 101.3 all symptoms gone Sunday 5/11/2021 morning with some mild injection site pain
50 2021-05-10 chills I was just falling asleep when my body started shaking. It was not violent, but enough to wake me a... Read more
I was just falling asleep when my body started shaking. It was not violent, but enough to wake me and confuse me. I would call them tremors or convulsions but not sure if there's a better description. It lasted about 1 minute. The "tremors" were at a rate of roughly 2.5 per second somewhat like a very rapid heartbeat almost. In fact, I checked my pulse with my watch thinking it may be a heart issue but it only registered 58 bpm.
50 2021-05-10 cough, fatigue, nasopharyngitis This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male pati... Read more
This is a spontaneous report from a contactable consumer (patient's spouse). A 50-year-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:45 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No Prior Vaccinations (within 4 weeks). No AE following prior vaccinations
50 2021-05-10 fatigue, cough, headache, chills Upon return from the vaccination I experienced no ill effects until that night. The symptoms were th... Read more
Upon return from the vaccination I experienced no ill effects until that night. The symptoms were then similar to when I had Covid in December of 2020. Chills, headache and body aches. This lasted overnight and the next day I only felt the aches and fatigue, which have lingered, slowly improving for the past several days. Three days after the shot, I experienced some respiratory issues, shortness of breath during certain activities and occasional coughing. This lasted about two days. Now, six days after the vaccination, the remaining symptoms are minor aches and fatigue, these seem to be waning.
50 2021-05-10 fever Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal... Read more
Presented to ED today with complaint of right-sided CP onset yesterday. Patient has history of renal cell carcinoma with metastatic disease to the liver. He has had recurrent pleural effusions involving the right lung. Has worsened pain with breathing. Had a R tube placed due to pleural effusion and last week when the tape was taken off it pulled and caused pain. Endorses SOB. No significant cardiac history. No h/o DVT, PE. Has renal CA and had L kidney removed. Patient admitted. Pulmonary/critical care was consulted regarding Pleurx catheter. It is felt that his pleural effusion had decreased in size, and the catheter was likely contributing to his right-sided pleuritic chest pain. Catheter is removed with good results of his pain. Patient however did have recurrent fevers. Empirically placed on Rocephin. With this, he did improve. He was discharged in stable condition.
50 2021-05-11 chills, fever, fatigue mild dyspepsia; bloating; loose stools; mild bilateral LBP; Fatigue; chills; body ache; low grade fe... Read more
mild dyspepsia; bloating; loose stools; mild bilateral LBP; Fatigue; chills; body ache; low grade fever; This is a spontaneous report received from a contactable physician. A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in arm left on 15Jan2021 at 12:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 28Dec2020. The patient medical history was not reported. Concomitant medications included varicella zoster vaccine rge (SHINGRIX) taken for an unspecified indication from 14Dec2020 to an unspecified stop date, Escitalopram (ESCITALOPRAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), MVI, ergocalciferol (VIT D) and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 16Jan2021 at 11:00 patient experienced fatigue, chills, body ache and low-grade fever. Symptoms were significant enough that he remained in bed and missed planned activities. Second set of symptoms began on 06Feb2021. Patient says the second set of symptoms is most likely unrelated to his Pfizer COVID vaccine. However, sharing this might be helpful in the event other recipients describe similar symptoms and timing. Symptoms began at 03:00 AM as mild dyspepsia, bloating and loose stools and mild bilateral LBP. Pepcid relieved my dyspepsia which slowly resolved over 24 hours. The bloating has resolved but I have persistent loose stools and mild LBP. During this time patient have had no fever or symptoms of URI. All the symptoms have been mild and have not prevented him from participating in planned activities. Again, doubtful this is related to vaccine but curious to know if anyone else has reported this. The outcome of the events was not recovered with diarrhea and backpain whereas recovered for the other events.
50 2021-05-11 fatigue, fever, sweating He got his vaccine, he felt tiredness but nothing major. The next day he started feeling nauseous a... Read more
He got his vaccine, he felt tiredness but nothing major. The next day he started feeling nauseous and really out of strength. His muscles were tired, and he got a strange bump under his right armpit, and had a mild fever. He also had little bumps around the vaccine site. The arm is red, but not itchy but does hurt upon touching the arm. It's beginning to get better. He did run fever, and had fever blisters in his mouth that are still there, and he has a lot of pain on the right arm, and on the shoulder blade area. He has taken Ibuprofen for these symptoms. He did not call his doctor.
50 2021-05-11 fatigue allergic to something in the shot./systemic histamine reaction; swollen lips; lips were flaking, ski... Read more
allergic to something in the shot./systemic histamine reaction; swollen lips; lips were flaking, skin flaking; lips were flaking, skin flaking; massive facial angioedema/complete relapse of allergy/angioedema; fatigue; penis redness/penis was also "sheet red" and swollen; penis was also "sheet red" and swollen; itching; very very red face; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 50-year-old, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 19:00 (Lot Number: ER8730; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunisation. Medical history included known allergies to spring pollen, oak birch, and ash. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and levocetirizine dihydrochloride (XYZAL) taken as allergy medication. On 25Mar2021, the patient got the shot, waited 15 minutes, no problems. On 26Mar2021, woke up to a very very red face. On 27Mar2021, massive facial angioedema, fatigue, itching, notable penis redness, his penis was also "sheet red" and swollen. The patient started 4mg prednisolone on 27Mar2021, kept facial swelling and allergies at bay, mostly, but a very close rate to not keeping up. On 02Apr2021, swelling subsided and mostly was getting back to "normal", however lips were flaking, skin flaking. On 04Apr2021-week of, things got better, very swollen lips but everything reasonably in check. On 12Apr2021, the face re-firing red at approx 1pm, slept until 6pm, and complete relapse of allergy/angioedema. Trip to Emergency room (ER), given shot of Kenelog in the arm, released. On 13Apr2021, no improvement, steroids ended 6 days after the patient started taking them, 2nd trip to ER with epinephrine shot, no improvement; blood taken, white blood cell count normal. On 14Apr2021, allergist appointment and he was told that he was allergic to something in the shot triggers pollen allergies, rosacea, etc. 50mg prednisone 5 days, 40mg 5 days, etc. He states that it was a systemic histamine reaction. On 26Apr2021 starts up again, mild, contact me. The patient doesn't know what to do with the second vaccine in general and he had called and they say no on him getting number 2. He was terrified of vaccines now because of his reaction. He also says that he was not hospitalized but he went to the emergency room twice. The patient would like to know if there have been any reports of those who had a similar reaction to this getting the second dose of the vaccine and how they reacted. He states that he has been told that he should not get the second dose but wonders if he were to get another COVID-19 vaccine other than Pfizer, if he would have the same reaction. The event allergic to something in the shot/systemic histamine reaction resulted to doctor or other healthcare professional office/clinic visit. The event massive facial angioedema/ complete relapse of allergy/angioedema resulted to emergency room/department or urgent care. The patient was treated with steroids for the events. The outcome of the event massive facial angioedema/complete relapse of allergy/angioedema was not recovered while for the rest of the events was recovering.
50 2021-05-14 chills, fatigue severe fatigue and body pain. chill, cold sweats. no fever.
50 2021-05-14 fatigue, chills, fever Fever, chills, achy muscles, fatigue
50 2021-05-14 headache Severe headache, Swollen throat. Twitching.
50 2021-05-15 head discomfort Severe persistent dizziness, nausea, and vomiting, Taken to Emergency Room on 5/2, diagnosed with BP... Read more
Severe persistent dizziness, nausea, and vomiting, Taken to Emergency Room on 5/2, diagnosed with BPPV (Vertigo), discharged the same day, Severe dizziness continues for 3 more days, then additional symptoms show up - heavy pressure in the ears and in the back of the head, few days later left ear pops, and the right one clogs even further. On 5/6 visited PCP, no blood nor EKG issues detected, referred to ENT. Visited ENT doctor on 5/12, diagnosed with partial hearing loss in the right ear.
50 2021-05-17 lethargy, chills, headache Profound headache, muscle soreness, lethargy and chills
50 2021-05-17 fever, headache, nasopharyngitis Patient medical history and concomitant medications were not reported. Patient stated, on 07Apr2021,... Read more
Patient medical history and concomitant medications were not reported. Patient stated, on 07Apr2021, he received his first dose of the COVID vaccine and approximately four days after that, he showed symptoms of having COVID, had cold and tested positive for COVID. He was dealing with that for a couple of weeks and on 28Apr, he was supposed to get the second dose but never did because I was dealing with COVID and its his understanding that once you have COVID, you are basically free from getting it for 90 days. So, somebody recommended not to get the second shot and so, he is not sure when he should be getting that. When questioned whether still experiencing the side effects, patient stated that he did not experience any side effects, he just got COVID and he was just having fever and headache. Patient asked if someone was going to tell him if he needs to get the second shot or when he should. The lab tests included SARS-CoV-2 test on an unspecified date in Apr2021 with result as positive. There is a product complaint component. Patient did not receive any treatment for the events headache and fever. Reporter seriousness for the events was unspecified. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
50 2021-05-18 chills, fever, headache, fatigue Chills Fever of 100.5 F Muscle Aches and Pains Fatigue Headache Used Ibuprofen to aid/alleviate symp... Read more
Chills Fever of 100.5 F Muscle Aches and Pains Fatigue Headache Used Ibuprofen to aid/alleviate symptoms. All symptoms dissipated after 32 hours.
50 2021-05-18 head discomfort, headache Server headaches and head pressure. Sudden hearing loss in right ear and ringing in both ears for ov... Read more
Server headaches and head pressure. Sudden hearing loss in right ear and ringing in both ears for over four weeks. My doctor has put me on steroids. Ringing in my ears has not stopped
50 2021-05-18 throat pain 2 days after my 2nd shot my throat started to hurt and lymph nodes on my neck got very swollen. The... Read more
2 days after my 2nd shot my throat started to hurt and lymph nodes on my neck got very swollen. The issues continue for 10 days at which point I went to urgent care and they prescribed antibiotics. My test for strep throat and mono came back negative.
50 2021-05-19 chills, sweating, fever Chills started evening of. Progressed into fever (101), shivering while sweating, extreme loss of en... Read more
Chills started evening of. Progressed into fever (101), shivering while sweating, extreme loss of energy, dizziness, and lack of cognition
50 2021-05-19 headache Bellls Palsey and headaches developed 21 days after administration
50 2021-05-19 sweating 50 YEAR OLD MALE FELT NAUSEAUS AND DIAPHORETIC AFTER RECEIVING TODAYS DOSE. ON SITE EMS RESPONDED AN... Read more
50 YEAR OLD MALE FELT NAUSEAUS AND DIAPHORETIC AFTER RECEIVING TODAYS DOSE. ON SITE EMS RESPONDED AND VITALS ARE BELOW. HE WAS MONITORED, FELT BETTER AND RELEASED TO HOME
50 2021-05-20 runny nose, fever, fatigue, cough, chills, respiratory tract congestion Fever or chills; cough; fatigue; new loss of taste or smell; congestion or running nose.
50 2021-05-21 fatigue, headache nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or sca... Read more
nurse stated it could possibly be blood clots; Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines; blurred vision in right eye that comes and goes; ringing in his left ear; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Very fatigued throughout the day, sleeping a lot/tired and sleeps a lot; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Date received First dose: Third Friday in Feb2021/Received second dose on 12Apr2021, six weeks after first dose; Fullness in face; Body aches; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; headache all over the back of his head/Affecting his balance. In back of head, moves around, sometimes the front; feeling dizziness/had to stop driving; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (may have been in morning) (Batch/Lot Number: Unknown; Pfizer COVID-19 vaccine) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 50 years old. The patient's medical history and concomitant medications were not reported. History and Investigations: Doesn't take any medications. Has no medical conditions, unless age was considered a medical condition. Historical vaccine included first dose of COVID-19 Vaccine reported as on Third Friday in Feb2021 (First dose: between 1430-1530), and experienced AEs: Brain fog; Headache: Thinks in the back of the head, but moved around too, sometimes in the front. Has affected his balance. Dizziness: Had to stop a couple times while driving home from vaccine facility. Aches and pains. All symptoms from the first dose went away within 3-4 days. Caller would say patient recovered completely from symptoms associated with first dose. The patient experienced nurse stated it could possibly be blood clots on an unspecified date with outcome of unknown, patient is afraid he is going to have a stroke or scared he had one after the covid-19 vaccines on an unspecified date with outcome of unknown, brain fog: at times he can't do the simplest things. he will look at the clock on the wall and says he knows what it is, but can't find the words to say. cannot carry on a conversation intelligently on 12Apr2021 with outcome of not recovered, headache all over the back of his head/affecting his balance. in back of head, moves around, sometimes the front on 12Apr2021 with outcome of not recovered, feeling dizziness/had to stop driving on 12Apr2021 with outcome of not recovered, blurred vision in right eye that comes and goes on an unspecified date with outcome of not recovered, ringing in his left ear on an unspecified date with outcome of not recovered, fullness in face on 12Apr2021 with outcome of not recovered, body aches on 12Apr2021 with outcome of not recovered, very fatigued throughout the day, sleeping a lot/tired and sleeps a lot on an unspecified date with outcome of not recovered, date received first dose: third friday in feb2021/received second dose on 12apr2021, six weeks after first dose on an unspecified date with outcome of unknown. Patient was caller's husband. Had both doses and had the same problem. His experience is very bad with the second dose and has had it for a month. Within a day after the first dose, had brain fog, headache, and dizziness where he had to stop driving a couple times. This went away within a few days. Patient and caller were concerned about the second dose. They spoke with patient's doctor and the local Health Department, both said it couldn't be from the vaccine. Patient was advised to get the second dose. Had the same symptoms with second dose, but occurred within an hour of received second dose. Symptoms have continued. Also experiencing blurred vision in right eye that comes and goes. Patient had an appointment with his doctor this week, but the doctor basically didn't look at him. Doctor advised patient to see a neurologist. Another nurse stated it could possibly be blood clots. Caller is trying to find help. Caller wanted to add with the second dose, patient experienced ringing in his left ear, fullness in his face, and headache all over the back of his head. Was feeling dizziness after second dose and had to stop driving. Patient is afraid he is going to have a stroke or scared he had one after the COVID-19 Vaccines. If the COVID-19 Vaccines woke up some other health issues, patient wants to get it taken care of. Received second dose on 12Apr2021, six weeks after first dose. Got second dose at a different location. Second dose COVID-19 Vaccine AEs: Started experiencing symptoms within an hour. Headache: Affecting his balance. In back of head, moves around, sometimes the front. Comes and goes. Brain fog: At times he can't do the simplest things. He will look at the clock on the wall and says he knows what it is, but can't find the words to say. Cannot carry on a conversation intelligently. Dizziness. Blurred vision in right eye: Doesn't know if this started on 12Apr2021 or a couple days after. States as the day goes on and he gets tired, it will worsen. It comes and goes. Ringing in left ear: Began on 12Apr2021 or a few days after. Fullness in face: Stated this comes and goes, but has stayed the same. Documented as provided. Body aches: Comes and goes. Seems to worsen as the day goes on. Very fatigued throughout the day, sleeping a lot: He's tired and sleeps a lot. It was hard for him to get out of bed. Caller stated patient's symptoms worse as the days goes on. Patient never experienced pain at the injection site. Guesses patient received COVID-19 vaccines in his left arm because the county was doing a dive-thru clinic. Since he didn't get out of his car, she believed patient would have received the vaccines in the left arm. The events REQUIRE A VISIT TO Physician office: Doctor doesn't think anything is wrong. ER: Not yet. Is considering going to the ER today. PRIOR VACCINCATIONS WTIHIN 4 WEEKS was None. RELEVANT TESTS: None. Events Clot blood and stroke considered medically significant. Follow up attempts are needed. Information of Lot/Batch number has been requested.
50 2021-05-23 headache Patient complained of a headache after receiving the second Pfizer vaccine. Vitals stable. Given jui... Read more
Patient complained of a headache after receiving the second Pfizer vaccine. Vitals stable. Given juice, water and crackers. Moved to a safe environment. Continuing to monitor.
50 2021-05-23 sinus congestion, body temperature increased, throat pain Copied from Database. Topic: Acute Illness >> Apr 26, 2021 8:30 AM wrote: POS SCREEN Pt started hav... Read more
Copied from Database. Topic: Acute Illness >> Apr 26, 2021 8:30 AM wrote: POS SCREEN Pt started having Sx on 4/23, sinus congestion. Pt stated yesterday he had a temp of 101F and sore throat and crackling in ears. Pt stated he has received both Covid Vaccine injections. Please advise. Thank you
50 2021-05-24 chills, headache, fever Headache, Chills, Fever, Nausea, Left Hallux Pain for 2 days (Gout)
50 2021-05-25 chills, fever strong covid sysmtoms; fever; chills; body ache; This is a spontaneous report from a contactable con... Read more
strong covid sysmtoms; fever; chills; body ache; This is a spontaneous report from a contactable consumer (Patient herself). A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6205), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:00 (age at the time of vaccination was 50-year-old) as single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing i have had covid already (11 days) so it was exact same,. Other medications in two weeks Concomitant medications included bupropion hydrochloride (WELLBUTRIN); fluoxetine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. The patient has no other vaccine in four weeks. The patient has no covid test prior vaccination. The patient has no covid test post vaccination. No treatment for AE. On 14Mar2021 02:00 The patient experienced strong covid sysmtoms, fever, chills, body ache. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.
50 2021-05-25 fatigue body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and o... Read more
body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and other healthcare professional. A 50-year-old Male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 11Mar2021 at 1300 hours (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. Concomitant medications included Zyrtec and multi vitamins (manufacturer unknown), for an unspecified indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 the patient experienced tiredness and on 16MAR2021, the patient's body felt cold, however patient did not have any fever and was able to maintain his normal schedule of work and exercise. The clinical outcome of the event tiredness was recovering. The clinical outcome of the event felt cold was unknown. No follow-up attempts are possible. No further information is expected.
50 2021-05-25 fever, chills, cough, fatigue Fever, Chills, Body Ache, Fatigue, Cough
50 2021-05-25 fever, chills chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, th... Read more
chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, the patient. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9266) as a first dose in the left arm on 15Feb2021 at 10:30 am and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) as a second dose in the right arm on 08Mar2021 at 13:30 pm via an unspecified route of administration for COVID-19 immunization(age at the vaccination: 50 years). Medical history and concomitant medications are not reported. Prior to the vaccination the patient was not diagnosed with COVOD-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a Clinic. On 15Feb2021, the patient experienced Fever, chills, extreme body aches, nausea for first dose and no side effects for second dose. No therapeutic measures were taken for the events fever, chills, extreme body aches and nausea. The clinical outcome for the events fever, chills, extreme body aches, nausea are recovered on an unknown date. The patient feels like he didn't get a second dose or something was wrong with the second dose as he did not experience with any events. No follow-up attempts are needed. No further information is expected.
50 2021-05-26 fever, chills, headache, fatigue High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and ... Read more
High fever 103.5 for about 15 hours then low grade fever 100+ for the next 24 hours with chills and shakes. Headache for 5 days and fatigue for 4 days.
50 2021-05-26 fever, chills sore, stiff shoulder; sore, stiff shoulder; chills; fever; This is a spontaneous report from a conta... Read more
sore, stiff shoulder; sore, stiff shoulder; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient (also reported as 50 months) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) as a first dose, single on 16Mar2021 at 11:00 Am in the right arm for COVID-19 immunization at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Medical history was not reported. Concomitant medication includes atorvastatin (LIPITOR) and lisinopril within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 23:00, the patient experienced sore, stiff shoulder and 12 hours after vaccine fever and chills lasting 6 hours. No treatment received for the adverse event. Outcome of the events fever and chills was reported as recovered on 17-MAR-2021 05:00, outcome of events sore, stiff shoulder was recovered on an unspecified in Mar2021. No follow-up attempts are possible; no further information is expected.
50 2021-05-27 fatigue Tired, nauseous and slight body aches. These went away about after a few hours maybe three of taking... Read more
Tired, nauseous and slight body aches. These went away about after a few hours maybe three of taking over the counter pain reliever acetaminophen.
50 2021-05-27 fever I developed a fever of 103 the evening of May 26 and had to use tylenol, ibuprofen, ice packs, and p... Read more
I developed a fever of 103 the evening of May 26 and had to use tylenol, ibuprofen, ice packs, and popsicles to bring my fever down to 99. I developed a fever of 103 the evening of May 27 and had to use tylenol, ibuprofen, ice packs, and popsicles to bring my fever down to normal.
50 2021-05-28 influenza like illness Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations b... Read more
Flu like symptoms for two days once those subsided then shortness of breath and heart palpitations began and have not subsided.
50 2021-05-29 fever, fatigue, sleepiness Fever up to 101.4, left arm soreness, fatigue, drowsiness
50 2021-05-29 sleepiness On 5/30/21, the day after vaccine administration, around noon hives appeared over entire body. No o... Read more
On 5/30/21, the day after vaccine administration, around noon hives appeared over entire body. No other symptoms reported. Patient self medicated with OTC diphenhydramine and hives improved but did not completely resolve. Hives flared up agian on 5/29/21 around noon. Patient did not want to continue with diphehydramine due to sleepiness. Patient instructed he could take a nonsedating antihistamine but would likely have less effectiveness and to keep diphenhydramine close by to use if needed. Patient instructed to seek medical attention if symptoms worsened, swelling or tingling in the lips tongue or throat, or a fever greater than 101. Patient contacted for follow up on 5/30/21 reported hives did reappear around midnight, he took diphenhydramine and they seem to have resolved. Instructed patient may need to speak with his PCP if this continues. Patient reports symptoms improvng and is not concerned at this time and aware of when to seek medical attention.
50 2021-05-31 fatigue Two weeks after the vaccine, I started to have stomach cramps. I also had loose stools. I noticed bl... Read more
Two weeks after the vaccine, I started to have stomach cramps. I also had loose stools. I noticed blood in the stools and I went to urgent care on 01/20/2021. Tests confirmed a lower bowel inflammation which I had never had an issue with before. I was advised to eat crackers and water for four days. The bowel issues lasted for two weeks. I was also experiencing tiredness even when I woke up in the morning which lasted for about two months. I have not had any more problems since that time.
50 2021-06-02 chills, fatigue, headache Fatigue; Chills; Headaches; Joint pain in shoulders; This is a spontaneous report from a contactable... Read more
Fatigue; Chills; Headaches; Joint pain in shoulders; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 50-year-old) as unknown, single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included known allergies: shellfish. The concomitant medications for patient included men's multi vitamins (unspecified). The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. On 02Mar2021, the patient experienced fatigue, chills, headaches, and joint pain in shoulders. No treatment was received for the events. The patient was tested with nasal swab (rapid test) for COVID, post vaccination, the test result was negative on 02Mar2021. The outcome of the events was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
50 2021-06-05 fatigue I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Inje... Read more
I had experienced several Adverse Events after getting the Covid 19 Vaccine. I had Pain at the Injection site on my Left arm a few hours after receiving the vaccine at 11:00 am on 6/5/21. Initially I did not feel anything. However the Pain got worse thruout the day until I went to bed at night. The Injection site also was a little swollen after a few hours of getting the vaccine. I had experienced some fatigue and tiredness on 6/5/21 after getting the vaccine. When waking up in the morning on 6-6-21 I must of had fever at night because in the morning I was sweaty. I also felt tired and fatigued when waking up. The pain at the injection site seems to have gotten a little better. Also there is no fever or sweating after i woke up.
50 2021-06-07 head discomfort, fever BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; ... Read more
BPPV; burning sensation; partial loss of hearing; fullness and burning sensation in ears; tinnitus; brain fog; pressure in the back of my head; severe vomiting; shortness of breath; Pyrexia; Mental status changes; This is spontaneous report from contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 (Batch/Lot Number: EWO161), at the age of 50 years, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 on 30Mar2021, at the age of 50 years, Time: 03:45 PM, Lot no. EW8730, anatomical location: Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021 19:30 the patient experienced Benign Paroxysmal Positional Vertigo (BPPV) (hospitalization, life threatening). On 30Apr2021 19:30 the patient experienced fullness and burning sensation in ears, tinnitus, brain fog, pressure in the back of head, severe vomiting, shortness of breath, pyrexia, mental status changes. On 12May2021 the patient experienced partial loss of hearing. On 28May2021 the patient experienced burning sensation. Clinical course: Nine days after taking a second dose of the Pfizer vaccine it started with multiple episodes of vertigo for 2 days, followed by severe vomiting, non-stop vertigo, shortness of breath. Taken into Emergency Room (ER) by ambulance on 02May2021, multiple tests performed (CT scan, blood, EKG) diagnosed with BPPV. Discharged the same night. The symptoms escalated into fullness and burning sensation in ears, partial loss of hearing, tinnitus, brain fog, pressure in the back of my head. Went to primary care physician on 05Jun2021, again multiple tests (blood, urine, EKG). Referred to ENT. Visited ENT on 12May2021, audiology test confirmed partial hearing loss. On 28May2021 the patient was still suffering with burning sensation and fullness in the right ear, as well as loss of hearing (high frequencies) and tinnitus. Periodic episodes of brain fog and severe vertigo. The patient underwent lab tests and procedures which included blood test: diagnosed with BPPV on 02May2021, blood test: unknown results on 06May2021, CT scan: diagnosed with BPPV on 02May2021, electrocardiogram: diagnosed with BPPV on 02May2021, electrocardiogram: unknown results on 06May2021, audiology test: partial hearing loss on 12May2021, urine output: unknown results on 06May2021. The patient received treatments due to the events: Diazepam, Meclizine, Potassium Chloride, Metoclop. The outcome of the events was not recovered.
50 2021-06-07 headache, fever fever, 101 degrees; head congested; headache; body aches; This is a spontaneous report from a contac... Read more
fever, 101 degrees; head congested; headache; body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the right arm, on 09Mar2021 at 11:00 (at the age of 50 years old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. The patient had no known allergies. The patient's concomitant medications were not reported. On 09Mar2021, 10:00 PM, the patient experienced fever, 101 degrees, head congested, headache, and body aches. The patient reported that the events lasted for about 5 hours then he felt fine and they started 10 hours after he received the shot. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on 09Mar2021. No treatment was received for the events. The outcome for the events was recovered on 10Mar2021, at 03:00. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
50 2021-06-08 headache Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain,... Read more
Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain, headache, neck pain, weakness in lower extremities. BP 220/112, HR 86, O2sat 99 RA. Pt escorted to ER via wheelchair.
50 2021-06-08 pneumonia Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hem... Read more
Pneumonia, unspecified organism Non-ST elevation (NSTEMI) myocardial infarction Gastrointestinal hemorrhage, unspecified Thrombocytopenia, unspecified
50 2021-06-09 lethargy Swollen Lymph Node-Right Supraclavicular. Lethargic, loss of sleep and restlessness.
50 2021-06-10 fatigue, malaise, headache, cough Transient memory loss--unable to find way to daughter's school or back home. Doesn't know what time... Read more
Transient memory loss--unable to find way to daughter's school or back home. Doesn't know what time school starts. Mild headache, occasional shortness of breath, cough, fatigue, generalized malaise. Neurology consult and examination--- normal. Patient treated with diazepam. Patient discharged home
50 2021-06-12 headache, fever, chills, fatigue major fever (no temp taken) and chills at 430 am. Headache, dizziness, light headedness all day. Fat... Read more
major fever (no temp taken) and chills at 430 am. Headache, dizziness, light headedness all day. Fatigue all day as well.
50 2021-06-14 sweating Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Sy... Read more
Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: at 5:15 pt was sweating through shirt, put on fan took bp1:80/60 pulse 70, had pt elevate legs, also had visual changes bp2: at 5:25pm 195/126 pulse 73, bp3: 185/124 pulse 79, pt has history of high bp, told pt to follow up with md if bp is elvated later today and tomorrow
50 2021-06-15 headache Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal i... Read more
Pt received vaccine on 6/14 at 2 pm. Pt woke up that night with arm pain but thought it was normal injection site reaction. She woke up 6/14 with a swollen arm, unable to lift or move arm, wit radiating pain to the head, neck, and chest.
50 2021-06-16 chills Body aches; chills; This is a spontaneous report from a contactable consumer (patient) A 50-year-ol... Read more
Body aches; chills; This is a spontaneous report from a contactable consumer (patient) A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in Arm Left on 16Mar2021 at 11:00 (at 50 years)as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No allergies to medications, food, or other products . Prior to vaccination and since the vaccination the patient was not diagnosed with COVID-19. Previously on 25Feb2021 at 13:00 (at 50 years)patient took first dose of the vaccine (lot EL3247 ) in right arm for covid-19 immunisation.On 16Mar2021 at 22:00 the patient experienced body aches and chills. No treatment given. The outcome of the events was recovered on an unknown date in 2021.No follow-up attempts are possible. No further information is expected.
50 2021-06-16 nasopharyngitis kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness i... Read more
kidney issues/ Is that possibly his kidney?; cold; numbness of left upper arm/He also had numbness in his arm.; lower back pain/but started hurting again.; difficulty walking/He was also unable to walk the first week.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 14:00 (Lot Number: EW0176) (at the age of 50-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 administered in left arm on 21Apr2021 (lot number: ER8731) for COVID-19 Immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Illness at time of vaccination was reported as none. On 13May2021, the patient complaints of lower back pain, difficulty walking, and numbness of left upper arm. The patient was wondering how the pain can be resolved. The patient was asking and wanted to know if he was having kidney issues due to his lower back pain. On reply Pfizer did not provide any recommendations regarding the management or treatment of potential adverse events. The patient was advised healthcare provider was in the best position to provide appropriate action to take as healthcare provider was most familiar with medical condition, clinical history and treatment and any relevant information to specific case. He had lower back pain. He didn't know that this was a side effect at the time. The pain was in in his left lower back, and he was also unable to walk the first week. After receiving the second dose the patient started to feel something but didn't know exactly what it was. A few days ago, he found that it was cold be a side effect. He also had numbness in his arm. For that he requested that he receive the vaccine in his left arm. He had numbness for 2-3 days that he remembered. It did not bother him after 7 days. He took Advil or Ibuprofen. He has not gone for treatment. He thought it was something else. He went back to where he received the vaccine. They were unable to tell him anything. Outcome of the event for difficulty walking/He was also unable to walk the first week was recovered on 15May2021, for numbness of left upper arm/He also had numbness in his arm was recovered on an unknown date in 2021, for lower back pain/but started hurting again was not recovered, while unknown for rest of the events.
50 2021-06-16 fever, chills, malaise general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a con... Read more
general malaise; general weakness; fever; chills; body ache; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received his second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 01May2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The patient's medical history includes hypertension but it is under control with medication (not mentioned). Concomitant medications included unspecified hypertension medication. Historical vaccine includes first dose of Pfizer COVID vaccine on 08Apr2021 (at the age of 50 years old), for COVID-19 immunization and no reported issues. On an unspecified date, while the reporter was playing cricket with his teammates against another team, he overheard the patient talking about general malaise and weakness. The patient also mentioned how he feels exactly how he felt after the 2nd shot of vaccine, which was the Pfizer COVID vaccine. The patient had body ache that night (01May2021) but took paracetamol (TYLENOL) and even played cricket the next day. On 03May2021, the patient had chills and fever, took paracetamol again and then no issues afterwards. On 12May2021, the patient had chills and general weakness but no fever and continued until 14May2021. On 15May2021, the patient was starting to feel better, no fever or chills but slight weakness. On an unspecified date, the patient experienced malaise. The reporter was not sure if the most recent malaise was vaccine related, but he figured he should err on the side of too much information. The outcome for general weakness was recovering; outcome for body ache, fever and chills was recovered on an unspecified date; outcome for malaise was unknown. No follow-up attempts are needed. Information about lot/batch number can not be obtained.
50 2021-06-16 fever, chills Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness o... Read more
Reports onset of "return of Covid symptoms" almost immediately (fever, chills, diarrhea, shortness of breath, loss of taste and smell, jaundice). Followed by extreme symptoms as of May 7th including fever above 104 degrees Fahrenheit. Pt first seen by medical professional on May 11. Patient was hospitalized May 15 and remained hospitalized until June 1 and was treated for multiple infections and sepsis during hospital stay.
50 2021-06-17 fever Pt in to have a port placed for chemotherapy, spiked a fever to 39.8 C
50 2021-06-18 chills, fever, sweating High fever (reduced to 100.6 degrees F); Aches; Chills; Sweats; This is a spontaneous report receive... Read more
High fever (reduced to 100.6 degrees F); Aches; Chills; Sweats; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in right arm on 16Mar2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route of administration in right arm on 23Feb2021 at 12:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. On 17Mar2021, patient experienced High fever (reduced to 100.6 degrees F), sweats, chills and aches at 02:15. Therapeutic measures were taken as a result of fever and included treatment with repeated Tylenol doses six hours apart. The clinical outcome of the high fever, sweats, chills and aches was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-06-20 malaise Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on... Read more
Pt received his 1st Pfizer vaccine on 3/31/21 and presented to the emergency room with chest pain on 4/16/21 that was ongoing x 1 week. he also reported some shortness of breath. he reported a cold feeling on the side of his chest as well. he also was feeling his heart racing at times. he denied any recent illness, fever or chills or hx of covid 19 infection, he was evaluated and sent home to follow up with his primary care and cardiology if his chest pain returned. He then received his 2nd pfizer COVID-19 vaccine on 4/21/21 and called the hospital on 6/18/21 reporting that since the second vaccine he was experiencing a weird feeling of coldness to his ears, vertigo and dizziness and has suddenly developed a fixed, hard, kidney bean sized lymph node to the r side of his neck. he now has to have imaging and work up with possible biopsy of the lymph node. He reported he has not felt right since his vaccines were given .
50 2021-06-23 malaise HE HAD CHEST PAIN AT THE NIGHT OF VACCINATION AND IT WENT THROUGH FOR 6 HOURS. FELT BAD FOR 2 DAYS,... Read more
HE HAD CHEST PAIN AT THE NIGHT OF VACCINATION AND IT WENT THROUGH FOR 6 HOURS. FELT BAD FOR 2 DAYS, AND STILL FEEL BAD
50 2021-06-24 headache swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swe... Read more
swelling of tongue; difficulty breathing; headache (bad one); numbness in right side; confusion; swelling of face; slurry words; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9810, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Feb2021 at 09:00 am (age at vaccination was 50 years) as 1st dose, single for COVID-19 immunization. Medical history included asthma. The patient had known allergies to iodine, shrimp and iodide (like the CATSCAN contrast fluid). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) and One-A-Day Mens over 50 vitamin. The patient previously received first dose of flu shot in upper right arm on 12Jan2021. The facility where the most recent COVID-19 vaccine was administered was Hospital. On 10Feb2021 at 15:00 pm, the patient experienced swelling of tongue, face, confusion, slurry words, difficulty breathing, no pains though, headache (bad one) and numbness in right side. The patient received treatment with DECADRON (steroid) and Diphenhydramine (Benadryl). Since the vaccination, the patient has been tested for COVID-19. The patient underwent Nasal Swab COVID test (COVID Nasal/Nasopharynx COVID test) on 28Feb2021 and the result was negative. The outcome of the events was resolved on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
50 2021-06-26 fever, chills First: I had the coronavirus infection at the end of December/beginning of January. Second: I recei... Read more
First: I had the coronavirus infection at the end of December/beginning of January. Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th: T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet) T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil. T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously. T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds) T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.
50 2021-06-27 chills, fever The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a... Read more
The morning after the vaccination I began feeling fuzzy headed. As the day progressed I developed a mild fever, chills and muscle aches similar to a severe flu throughout my body (arms, legs, back). This lasted through the night and into the next day, slowly subsiding from mid-day of the second day fading to only general weakness the second evening (48 hours after the vaccination).
50 2021-06-27 fatigue, headache, chills Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the inj... Read more
Initially I had a more severe pain than i had with the first dose. Swelling and Soreness at the injection site was worse than the first dose. Later at night when trying to go to sleep I felt a SUDDEN Onset of CHILLS. I then had Muscular Pain thruout various parts of my body. I had Headache. I felt cold thruout the first night after I got the vaccine. I felt tired and unable to do day to day tasks the following day.
50 2021-06-27 throat pain sore throat that feels like glass with 6/10 pain
50 2021-06-28 fever, chills Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the fa... Read more
Pt.'s friend stating 06/11/2021 after receiving vaccination difficulty breathing, swelling of the face, dizziness/weakness, on/off fever, chills. Edema of both legs (Left more swollen), no seeping. No physician seen.
50 2021-06-28 fever Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and ... Read more
Extreme Convulsions (uncontrollable shaking); Fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours; extreme pain in the hips to where he could not move; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Jun2021 17:00 (Batch/Lot Number: EW0187) (at age 50 years old) as dose 2, single for COVID-19 immunization. The patient's medical history. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient previously received the first dose BNT162B2 on 19May2021 16:00 (lot number: EW167) (at age 50 years old) in left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 11Jun2021 21:30, the patient experienced extreme convulsions (uncontrollable shaking), fever spiked from no fever to 102 w/in 30 minutes and lasted for about 8 hours, extreme pain in the hips to where he could not move, and shortness of breath. The events were reported as non-serious. Treatment was not given. The patient was recovering from the events.
50 2021-06-29 fatigue Having a minor respiratory issue where I could hear myself wheezing; Soreness around the site of the... Read more
Having a minor respiratory issue where I could hear myself wheezing; Soreness around the site of the shot; Feeling tired; Muscle soreness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: 6205), via an unknown route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included allergies. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ZYRTEC. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 16Mar2021 at 22:00, the patient experienced some soreness around the vaccination site of the shot, felt really tired along with muscle soreness. At 23:30, the patient experienced a minor respiratory issue, where patient could hear wheezing. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the vaccination site pain, tiredness and muscle soreness was resolved on 18Mar2021 (All the symptoms disappeared after 36 hours); while that of the wheezing was resolved on 17Mar2021 (this lasted about 1 hour). No follow-up attempts are possible. No further information is expected.
50 2021-06-30 chills, fatigue, fever Fever; Chills; Body ache; Fatigue; This is a spontaneous report from a contactable consumer, the pat... Read more
Fever; Chills; Body ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 19:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) 40 milligram (mg) for an unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5502) via an unspecified route of administration in the left arm on 24Feb2021 at 19:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, at 12:00 (17hrs after the vaccination) the patient experienced fever, chills, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, chills, body ache and fatigue was resolved on 20Mar2021 at 12:00. No follow-up attempts are needed. No further information is expected.
50 2021-07-01 cough, sneezing, runny nose I've never had seasonal allergies or hay fever before in my life. A month or so after getting the p... Read more
I've never had seasonal allergies or hay fever before in my life. A month or so after getting the phizer vaccine, I had a strong allergic reaction to high grass pollen count in my area. So much so I missed a day of work, had to buy Zertec for first time in my life... same arwa and house I've lived in for 20 years. Cauging, sneezing,, runny nose was so bad I though I might have gotten covid, and the vaccine was keeping the symptoms mild with not fever, but I got tested and it was covid negative. Zyrtec helped for a few days, but then I reacted to pollen again after stopping zyrtec for a day, so indication is I've developed new allergies where I didn't have any before.
50 2021-07-02 sleepiness Pressure in eyes; Pressure in ears; soreness in complete body; sleepy; restless; bad dreams; diarrh... Read more
Pressure in eyes; Pressure in ears; soreness in complete body; sleepy; restless; bad dreams; diarrhea; This is a spontaneous report from non-contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) in the right arm on 22Mar2021 at 14:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patients medical history included penicillin allergy, grass allergy and tetracycline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. THE patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not received medication within 2 weeks of vaccination. The past drug history included codeine (CODEINE). On 22Mar2021 the patient experienced pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures and treatment were not taken as a result of the events. The clinical outcomes of the events Pressure in eyes and ears, soreness in complete body, sleepy, restless, bad dreams and diarrhea were recovering at the time of report. No follow-up attempts are possible; Information about batch cannot be obtained.
50 2021-07-05 sweating, fever Developed symptoms after 2nd Covid vaccine dose: dry mouth, fever, sweats, thirst, dizzy. Symptoms p... Read more
Developed symptoms after 2nd Covid vaccine dose: dry mouth, fever, sweats, thirst, dizzy. Symptoms persisted for over 3 weeks.
50 2021-07-07 chills, headache Achiness, chills, headache over several days, resolved in part by Tylenol 1000mg, q 4 hr p.o. daily
50 2021-07-08 chills Chills; Achy; Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the pat... Read more
Chills; Achy; Severe diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 18Mar2021 at 08:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient was allergic to codeine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 25Feb2021 at 11:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 07:00, the patient experienced chills, achy and severe diarrhea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the chills, achy and severe diarrhea were not resolved at the time of this report. No follow up attempts are possible; information about lot number cannot be obtained.
50 2021-07-08 sweating Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/coul... Read more
Chest pain; Shortness of breath/could not breathe while sweating profusely; Shortness of breath/could not breathe while sweating profusely; He turned white as a ghost; The patient all of the sudden didn't feel right; troponin was elevated; The patient's blood pressure has never been high but it was high when he got to the hospital; The doctors are leaning more toward myocardiopathy; This is a spontaneous report from a contactable consumer (wife of the patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8737; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in left arm on 31Mar2021, as dose 2, single (age at vaccination: 50 years), for covid-19 immunization. Medical history included type 2 diabetes mellitus which was diagnosed about 3-4 years ago and sleep apnoea which was diagnosed about 10 years ago and the patient sees a lung doctor for this yearly and uses CPAP machine (both are unknown whether ongoing or not) and the patient has never smoked or done drugs. The patient did not administer any vaccinations within four weeks prior or on same date of the Pfizer Suspect. There was no family medical history relevant to adverse events. The patient concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, expiration date 30Jun2021) on 10Mar2021, administered on right arm muscle as dose 1 single, (age at vaccination: 50 years), for covid-19 immunization and had no adverse effect. Patient's wife said that nothing like this has happened in the past. The patient was sitting at the kitchen table at about 5:30 pm and it was about an hour since they ate. The patient all of the sudden didn't feel right, couldn't breathe, was having chest pains, and was white as a ghost, started sweating profusely. The reporter and the patient got in the car and went to the hospital and they did a cardiac work up on him, they gave him nitro paste on his chest and was hospitalized or admitted because of the events. All the symptoms started at the same time. On 26Jun2021, they did an electrocardiogram/EKG which was fine (normal) but the patient's troponin was elevated. They transferred the patient to another hospital. The patient had a stress test on 27Jun2021, which was normal (They took pictures of the patient's heart during the stress test). Reportedly, the patient's blood pressure had never been high but it was high when he got to the hospital. The patient is not back to normal but was not complaining of anything. They put the patient on a heparin drip at the hospital for the troponin levels. The doctors are leaning more toward myocardiopathy and think it was related to the vaccine. The hospitalization duration was of 2 days, i.e., from 26Jun2021 to 27Jun2021. The patient was going to see a cardiologist on Tuesday. The outcome of the events: The doctors are leaning more toward myocardiopathy, blood pressure has never been high but it was high when he got to the hospital and troponin was elevated reported as unknown and the outcome was assessed as resolving for rest of the events. Information on Lot/Batch number was available. Additional information has been requested.
50 2021-07-08 fever Low grade (99.9*) Fever; Injection Site pain; This is a spontaneous report from a non-contactable co... Read more
Low grade (99.9*) Fever; Injection Site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248); via unspecified route of administration in the left arm on 25Mar2021 (at the age 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955); via unspecified route of administration in the left arm on 04Mar2021 (at the age 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other vaccine within four weeks prior to vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 01:30, the patient had experienced low grade fever (99.9) and injection site pain. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of low-grade fever and injection site pain. The clinical outcome of the events low grade (99.9) fever and injection site pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-10 malaise, chills, headache, fever Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on lef... Read more
Arm felt dead with pain at injection site; Low grade fever; Chills; Body aches; Migraine pain on left side of head and neck; General malaise; Lingering headaches; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney stone and liver issues. The patient did not had allergies to any medications, food, or other products. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced dead arm pain at injection site (for 3 days), low grade fever with chills and body aches, migraine with pain on left side of head and neck (for 3 days), general malaise. The patient experienced lingering headaches. The patient was definitely not looking forward to another shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, low grade fever, chills, general body pain, migraine, general malaise and headache were resolved with sequelae (recovered with lasting effects) on an unknown date of Mar2021. No follow up attempts are needed. No further information is expected.
50 2021-07-11 fever, chills, bronchitis Severe bronchitis with fever, chills, and muscle aches
50 2021-07-12 sweating, fever, chills Dose 1 at 11Mar2021 and Dose 2 at 25Mar2021; Chills; Fever; Aching legs; sore arm where shot was giv... Read more
Dose 1 at 11Mar2021 and Dose 2 at 25Mar2021; Chills; Fever; Aching legs; sore arm where shot was given; sweating; This is a spontaneous report from a contactable consumer. A-50-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: er8727) via unspecified route of administration in the left arm on 25Mar2021 at 10:45hrs (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies to medications, food or other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6205) via unspecified route of administration in the left arm on 11Mar2021 at 10:30hrs(at the age of 50-years-old) as a single dose for COVID -19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. The patient received first dose on 11Mar2021 and second dose on 25Mar2021 (inappropriate schedule of vaccine administered). On 26Mar2021, at 02:00, the patient experienced chills, fever, aching legs, sweating and sore arm where shot was given. The patient underwent lab tests and procedures, which included body temperature and the temperature was 99.2 F. Therapeutic measures were taken and included treatment himself with Tylenols . The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the chills, fever, aching legs, sore arm and sweating was recovered on unknown date and of the inappropriate schedule of vaccine administered was unknown. No follow-up attempts are needed. No further information is expected.
50 2021-07-13 headache, cough cough,loss of taste/smell, body aches,headache
50 2021-07-16 fatigue, fever Fatigue, body ache, light headed, fever (103), diarrhea
50 2021-07-17 fatigue, headache Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; ... Read more
Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; Fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:45 (at 50 years old) as Single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There were no medical history and concomitant medications. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue and headache in first 24 hours followed by a tightness in my chest and shortness of breath which continued from 19Mar2021 to 30Mar2021. Start date of the events was reported as on 17Mar2021 at 18:00. No treatment received for the events. Outcome of the events was not recovered. Information about Lot/Batch number was requested.
50 2021-07-17 headache, chills, fatigue, fever flu symptoms; headache; body aches; slight fever; chills; extreme fatigue.; This is a spontaneous re... Read more
flu symptoms; headache; body aches; slight fever; chills; extreme fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications was not reported and known allergies were reported as no. The other vaccination within four weeks prior to the COVID-19 vaccine was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 02Mar2021 at 12:30 (at the age of 50-years-old) for COVID-19 immunisation. Facility where the COVID-19 vaccine was administered was at the hospital. On 24Mar2021at 08:00, the patient experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events experienced flu symptoms, headache, body aches, slight fever, chills and extreme fatigue was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
50 2021-07-17 headache, fever This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 12:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication since an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 01:00, the patient experienced 18-hour fever (101.00 degrees), headache and muscle aches. Lab data on 27Mar2021 included body temperature (reported as fever 101.00 degree) and result was 101.00 degree at 01:00. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken for the adverse events. The clinical outcome of the event fever was recovered on 27Mar2021 at 19:00, while that of the events headache and muscle ache were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-18 malaise First aches in prior injury sites: Right Rotator Cuff ( surgery 1989) Lumbar spine ( strains off/on)... Read more
First aches in prior injury sites: Right Rotator Cuff ( surgery 1989) Lumbar spine ( strains off/on) left 5th MTP ( fracture 2014) Progressed to general malaise with increased pain at left midfoot and 5th MTP along with lateral ankle pain. No recent trauma to any areas noted. Currently still suffer from lack of energy and intermittent left foot pain.
50 2021-07-18 fever Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the ... Read more
Approximately 18 hours post 1st injection of Pfizer vaccine, patient developed 103.5 fever with the following additional symptoms which lasted approximately 24 hours: numbness tingling in toes teeth and gums hurt blood vessels in eyes felt like they were spasming felt brief momentary pains up through legs and in chest
50 2021-07-19 fatigue Ongoing Dizziness Ongoing lightheadedness Ongoing face numbness Ongoing face tingling Ongoing fatigu... Read more
Ongoing Dizziness Ongoing lightheadedness Ongoing face numbness Ongoing face tingling Ongoing fatigue
50 2021-07-21 headache swelling in right hand.; headache; This is a spontaneous report from a contactable consumer, the pat... Read more
swelling in right hand.; headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history reported as cancer survivor. The patient's allergies to medications, food, or other products were reported as nine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:00 the patient experienced swelling in right hand and had headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of events swelling in right hand and headache were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
50 2021-07-21 sweating Patient stated feeling nauseated within minutes of receiving first dose of Covid19 Pfizer-BioNTech v... Read more
Patient stated feeling nauseated within minutes of receiving first dose of Covid19 Pfizer-BioNTech vaccine. Patient simultaneously presented pallor and diaphoresis. Patient consumed apple juice, received ice compress, was placed in the supine position to prevent vasovagal syncope and was monitored. No dyspnea, urticaria or anaphylaxis present. No other therapy administered. After 20 minutes patient was able to sit and walk unassisted.
50 2021-07-22 malaise He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy... Read more
He is currently 203 pounds; it is starting to work on him mentally; He has not felt well; His energy levels are terrible; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0180; Expiration Date: 30Sep2021, NDC: unknown) via an unspecified route of administration, administered in arm right on 07Jun2021 14:00 (at the age of 50-year-old) at dose 2, 0.3 ml single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0182; Expiration Date: 31Aug2021, NDC: Unknown) via an unspecified route of administration, administered in right upper arm on 07May2021 14:00 (at the age of 50-year-old) at dose 1, 0.3mL single for covid-19 immunisation. On an unspecified date the patient experienced he is currently 203 pounds, it is starting to work on him mentally and on 10Jun2021 he has not felt well, his energy levels are terrible. Patient is calling about the Pfizer covid vaccine. He received the second dose of the covid vaccine on the afternoon of 07Jun2021. He has not felt well since 10Jun2021. He is going to see a doctor on Tuesday. He has not seen his doctor recently because of covid. He had to find a new doctor. His energy levels are terrible. He wishes he did not take the covid vaccine. He drives for a living. He feels terrible. He did not get a fever. He has not felt this way in years. He is currently 203 pounds. He is normally 215 pounds. He has lost 12 pounds. He does not know how common this is. He really does not want to make conversation with people, because people will be scared to take the covid vaccine. He started to feel terrible three days after the covid vaccine, and it is starting to work on him mentally. This has been going on for a month now. His energy levels are terrible: Whenever he eats something, he feels a little better. He does not feel terrible whenever he wakes up. He goes through the stresses of the day and started to not feel well around noon. He will eat lunch and fell and little better. Then start to feel bad again, and then eat again and feel better. Indication: He lives with his elderly mother and has two older sisters. He has to be as healthy as possible to be around his 84-year-old mother. Outcome of the events he has not felt well, his energy levels are terrible was not resolved and he is currently 203 pounds, it is starting to work on him mentally was unknown.
50 2021-07-23 headache over the last 2 months i have noticed mild headaches maybe once or twice a week in localized areas ... Read more
over the last 2 months i have noticed mild headaches maybe once or twice a week in localized areas of my forehead either left or right side of the forehead that last for a few minutes and are not very painfull but very noticeable.
50 2021-07-27 fatigue, chills Chills, fatigue, began during evening time (evening of vaccination day), lasted during the night. Ch... Read more
Chills, fatigue, began during evening time (evening of vaccination day), lasted during the night. Chills went away in the course of the following day, as did fatigue. Unable to work much that day. Anecdotal evidence from others suggests that these are common side effects for second Pfizer Covid19 shot.
50 2021-07-28 nasal congestion, cough, chills, fatigue, fever, runny nose Positive COVID PCR test on 7/28/21. Patient with tactile fever, body aches, chills, cough, nasal co... Read more
Positive COVID PCR test on 7/28/21. Patient with tactile fever, body aches, chills, cough, nasal congestion, runny nose, fatigue.
51 2021-01-01 fatigue Injection site pain.. extremely tired fell asleep at 1130am awoke at 3:55 pm
51 2021-01-01 fever, fatigue Fatigue on 12/28/2020, Fever (101.4F) on 12/30/2020, positive COVID test results on 01/2/2021, loss ... Read more
Fatigue on 12/28/2020, Fever (101.4F) on 12/30/2020, positive COVID test results on 01/2/2021, loss of smell on 1/2/2021.
51 2021-01-04 chills, fever, headache Fever 100.2, chills, headache and body ache.
51 2021-01-04 chills 12hrs after vaccination I got chills and muscle aches and headache that necessitated remaining in be... Read more
12hrs after vaccination I got chills and muscle aches and headache that necessitated remaining in bed for the next 16hrs. All of my colleagues that had previously had covid and then got vaccinated suffered similar SEs
51 2021-01-04 cough, malaise Contracted Covid after receiving the first vaccine; Contracted Covid after receiving the first vacci... Read more
Contracted Covid after receiving the first vaccine; Contracted Covid after receiving the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history included asthma, dry cough due to inhalation from fires over the years. The patient's concomitant medications were not reported. Contracted Covid after receiving the first vaccine was reported. The patient received the first dose of the Covid vaccine, then contracted Covid. He now had the option to receive antibodies through plasma. Since he had the vaccine, was that still an option? Or was that a no-no? He received the vaccine at work on 21Dec2020. He got sick on 22Dec2020 and he was at home. He didn't feel like eating, and can't lay down because it made it worse to cough. He didn't know what vitamins they were giving him. The patient probably should be in a hospital, but was not. The outcome of events was not recovered. Information on Lot/Batch number has been requested.
51 2021-01-04 headache headache; arm soreness under injection; This is a spontaneous report from a contactable nurse (patie... Read more
headache; arm soreness under injection; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), intramuscular on 28Dec2020 12:00 in left arm at single dose for COVID-19 immunization. Medical history included depression, osa (obstructive sleep apnea syndrome) and obesity from an unknown date and unknown if ongoing. Concomitant medication included escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), clarithromycin (CLARITIN [CLARITHROMYCIN]) and losartan potassium (COZAAR). The patient had arm soreness under injection and slight headache on 28Dec2020 21:00 and took Tylenol and aleave as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovering.
51 2021-01-04 influenza like illness, fever Patient has had a fever and flu like symptoms for over 3 days; Patient has had a fever and flu like ... Read more
Patient has had a fever and flu like symptoms for over 3 days; Patient has had a fever and flu like symptoms for over 3 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: Ek5730, via intramuscular, on 18Dec2020 at 09:15 (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included other vaccine (not specified) on 03Dec2020. The vaccine was given at a hospital. On Dec2020, the patient experienced had a fever and flu like symptoms for over 3 days. The event resulted in emergency room visit. No treatment was received for had a fever and flu like symptoms for over 3 days. The clinical outcome of had a fever and flu like symptoms for over 3 days was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
51 2021-01-04 fever, cough positive COVID-19 antigen test with symptoms (ache, cough, fever); positive COVID-19 antigen test wi... Read more
positive COVID-19 antigen test with symptoms (ache, cough, fever); positive COVID-19 antigen test with symptoms (ache, cough, fever); This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 17Dec2020 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included borderline diabetes, ongoing hypertension, ongoing hyperlipidemia, ongoing rhinitis allergic, and currently ill. Concomitant medication included ongoing fexofenadine hydrochloride (ALLEGRA, strength: 180 mg) at 180mg once daily by mouth for Rhinitis allergic taking for years, ongoing lisinopril (strength: 40 mg) at 40 mg once daily by mouth for hypertension taking for two or three years, ongoing atorvastatin (strength: 40 mg) at 40 mg once daily by mouth for hyperlipidemia taking for a year. The patient experienced positive covid-19 antigen test with symptoms (ache, cough, fever) from 19Dec2020. Event details: The patient received the COVID 19 Vaccine on 17Dec2020 10:30AM in the left arm. Tested for COVID 19 with the antigen test, on 20Dec2020 and his result was positive, he experienced ache and cough on 19Dec2020. Clarified he started having symptoms in the evening (19Dec2020) and then tested in the morning (20Dec2020). He experienced the low grade fever on 20Dec2020. His maximum temperature was 100.4 fahrenheit. He had only been treated with over the counter products. No further information provided for the over the counter products. He was not hospitalized. He will take the second dose of the COVID 19 vaccine on 07Jan2021. The patient didn't have SARS-CoV2 antibodies at diagnosis. The patient was not admitted to an Intensive Care Unit. The patient didn't display clinical signs at rest indicative of severe systemic illness. The patient didn't require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient didn't have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient was not treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome of all his symptoms was resolving.; Sender's Comments: The reported events drug ineffective and COVID-19 are likely intercurrent and are unrelated to suspect drug BNT162B2 based on short temporal relation between vaccination and onset of events.
51 2021-01-05 headache Myalgias Headache Arthralgias
51 2021-01-05 fever Fever of 100.6
51 2021-01-06 headache HEADACHE, GENERALIZED ACHES AND PAINS Narrative:
51 2021-01-06 fever Vaccine received on 1/6/2021 at 0810. Symptoms of fever (tmax 102.5) and body aches began at 18:00 ... Read more
Vaccine received on 1/6/2021 at 0810. Symptoms of fever (tmax 102.5) and body aches began at 18:00 on 1/6/2021. Still has fever but improves with tylenol.
51 2021-01-07 headache, fatigue, chills, fever I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Ch... Read more
I am still sick; Fever/my fever was up to 101.7. It is down to 99 now but I still have the fever; Chills; Aches; joints ache; Some muscle pain; Headache; Tiredness; Injection side swelled up; feeling poorly; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: 28Dec2020 (as reported)), via an unspecified route of administration, on 28Dec2020, at single dose, as a preventive measure for Covid. Medical history included blood pressure abnormal (reported as blood pressure). Concomitant medication included amlodipine besilate and amlodipine besilate (NORVASC 5 mg) both for blood pressure. The patient reported, "I received my first dose of Covid19 vaccine on Monday (28Dec2020) and it is now Friday and I am still sick and I am wondering how long these symptoms typically take to get better from because it seems like it is day 5 now so". When probed for events the patient stated, "Everything on the list, fever, chills, aches, my joints ache, some muscle pain, headache, tiredness, injection side swelled up. I was not nauseas or anything like that. I still have fever today. I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever." The patient mentioned, "I kind of like started feeling poorly on the 29th (29Dec2020) late at night but on the 30th (30Dec2020) I had fever and everything." The patient underwent lab tests and procedures which included blood pressure measurement: is always good on an unspecified date, body temperature: 101.7 on 30Dec2020, body temperature: 99 on 01Jan2021 (reported as "I did not get symptoms till like 2 days later and then my fever was up to 101.7. It is down to 99 now but I still have the fever"), and laboratory test: unknown results on Dec2020 (reported as "I did go for full series of stuff, checkup but that was more than 2 weeks ago"). The outcome of the events was not recovered.
51 2021-01-07 headache Mild headache, vision spotty. BP 146/86 SpO2 97% pulse - 92
51 2021-01-07 headache Dizziness, Headache, Nausea, NauseaVomiting, swelling pain at injection site
51 2021-01-07 malaise He is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 51-yea... Read more
He is not feeling well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. He has been participating in the clinical trial for the COVID-19 vaccine and he has been calling his clinical trial site since Tuesday with no response. The patient was not feeling well on an unspecified date. Therapeutic measure was taken as a result of the event and included treatment with ibuprofen (ADVIL). Outcome of the event was unknown. Information on the lot/ batch number has been requested.
51 2021-01-08 headache Employee reports 20-25 min after receiving the vaccine he developed a headache. He took tylenol at f... Read more
Employee reports 20-25 min after receiving the vaccine he developed a headache. He took tylenol at first. Then he took his imitrex which he has for his usual migraine. The imitrex didn't help. 1/5 mid-day the headache resolved.
51 2021-01-09 fatigue, chills, fever Fever close to 102, rigors, aches, fatigue, overwhelming weakness
51 2021-01-09 fatigue, chills Myalgia chills, fatigue Narrative:
51 2021-01-09 fatigue, headache Headache, NauseaVomiting, fatigue Narrative:
51 2021-01-09 headache, chills 3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel ache... Read more
3 hours after 2nd dose almost fainted when exercising. 4 hours after injection started to feel achey, headache, and stiff neck. 12 hours after injection started shivering and increased heart rate. Took advil which helped, but shivering resumed 18 hours later. Took more advil. Body aches, sore arm, and headache continued for 48 hours. I still don't feel great 48 hours later but much better
51 2021-01-10 chills, sweating Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over... Read more
Very hot, flush, stomach upset, sweating, increased respiratory rate, slouched in chair, chills over face/neck
51 2021-01-10 fatigue, cough, chills After the vaccine, I was tired and slept with chills. On Saturday I developed a cough. I went to my ... Read more
After the vaccine, I was tired and slept with chills. On Saturday I developed a cough. I went to my PCP on Dec 28, 2020 where they performed a FLU /COVID swab. The flu was NEG and the COVID 19 was POS. I had an elevated BP & heart rate.
51 2021-01-10 fatigue, influenza like illness, chills, headache Extreme soreness to injection site, Flu-like symptoms including nausea, headache, fatigue, body ache... Read more
Extreme soreness to injection site, Flu-like symptoms including nausea, headache, fatigue, body aches, chills (during the evening), and mild diarrhea. Most symptoms were better by 6 PM on 1/9/2021. Diarrhea better by 1 PM 1/10/2021. (I had NONE of these after the first vaccination.)
51 2021-01-10 headache, chills, malaise I am a front line physician and got my first dose of Pfizer vaccine on 12/21/2020. For the first t... Read more
I am a front line physician and got my first dose of Pfizer vaccine on 12/21/2020. For the first two days after the shot, I had only injection site soreness and mild headache, but nothing serious (Grade 1 effects). was able to go to work with that easily. On the tenth day (December 31, 2020) after dose 1 of Pfizer vaccine, I started to get severe myalgias, headache, chills, neck and back pain, mental fogging, malaise, altered taste, and fever spiking up to 101.2. I took Tylenol and tried to sleep. Woke up at 2 am with worst chills of my life, not improved my several blankets. My initial thought was that I have gotten COVID 19 before vaccine could take effect. I got 3 negative PCR tests done at hospital, first one on 1/2/2021 (day 3 of symptoms and day 13 after vaccine), second one on 1/5/2021 (Day 6 of symptoms and day 16 after vaccine), and third one on 1/8/2021 (Day 9 after symptoms and day 19 after vaccine). My symptoms are still persisting (today is Day 12 of symptoms and Day 22 after vaccine), but have slightly improved in last few days. I have not been able to do any activities of daily life (Grade 3). Have been taking Tylenol 3 times a day, bed rest, hydration. I have been the biggest supporter of the vaccines, but now totally unsure. I have talked to several ID and Immunology colleagues and nobody can explain it. I reviewed Pfizer EUA document, and on page 41, a subset of people have been described who had COVID type symptoms but negative tests. May be I have a n atypical delayed and prolonged systemic reaction to dose 1. I have decided not to take the Dose 2 and wait for a more traditional vaccine like Jonson and Johnson.
51 2021-01-10 fever, headache Low grade fever(100.3), body aches, joint pain, rash, headache, swollen lymph nodes(left shoulder)
51 2021-01-10 fever, malaise feel like somebody hit me with a baseball bat, body ache low grade fever for 5 days
51 2021-01-11 headache Headaches , body and back ache, nausea, nausea started about 10 hrs after the second Pfizer covid va... Read more
Headaches , body and back ache, nausea, nausea started about 10 hrs after the second Pfizer covid vaccine dose , lasted almost 72 hrs. Took tyelenol, zofran to help
51 2021-01-12 headache, fatigue, chills Headache, Myalgia, Arthralgia, Fatigue and Chills but no elevated temperature. Narrative:
51 2021-01-12 headache Headache, Myalgia & Nausea Vomiting Narrative:
51 2021-01-12 headache Symptoms - ?approximately 1 hour after vaccination, mild HA. Approximately 3 hours after vaccinatio... Read more
Symptoms - ?approximately 1 hour after vaccination, mild HA. Approximately 3 hours after vaccination, worsening HA and generalized body aches. Approximately 7 hours after vaccination: chest soreness and achiness, denies airway issues or SOB. Last day of work and shift ? currently at work Home remedies? - naproxen 500 mg at 0730 Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to call vaccine support line with further questions or concerns. EE verbalized back understanding and denied further questions at this time.
51 2021-01-13 body temperature increased, chills, headache temp (100.3) chills, body ache, headache
51 2021-01-14 body temperature increased, chills fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms laste... Read more
fluctuating Temperatures up to 103.7 Painful Body aches throughout all joints Chills Symptoms lasted 36 hours Right leg fluctuating tissue/faccia pain lasting 2+weeks, MD states related to virus/vaccine
51 2021-01-14 chills, headache Recipient was seen one day after the 2nd dose of vaccine was received and complained of Headache, Sw... Read more
Recipient was seen one day after the 2nd dose of vaccine was received and complained of Headache, Swollen lymph node, and Chills
51 2021-01-14 chills, fever Whole body aches from head to toes, chills , flushing, diarrhea, low grade fever
51 2021-01-14 malaise General malaise and body aches.
51 2021-01-15 chills Chills, myalgias. Did not treat. Resolved spontaneously overnight.
51 2021-01-15 chills Chills, myalgias. Strong, rapid onset over 15 minutes. Chills resolved spontaneously overnight (6 ho... Read more
Chills, myalgias. Strong, rapid onset over 15 minutes. Chills resolved spontaneously overnight (6 hours). Myalgias persisted 36 hours. Myalgias resolved spontaneously after the next night sleep.
51 2021-01-15 headache Symptoms: headache, pain at injection site, nausea and shooting pains o. Neck.
51 2021-01-17 fever Nausea Vomiting 101.8 Fever Severe Joint Pain in multiple sites All symptoms resolved in 24 hours.
51 2021-01-18 headache, malaise General malaise about three days after vaccination; moderate soreness at left deltoid running down t... Read more
General malaise about three days after vaccination; moderate soreness at left deltoid running down thru left shoulder and mid back.; moderate soreness at left deltoid running down thru left shoulder and mid back.; moderate soreness at left deltoid running down thru left shoulder and mid back.; experienced headaches off and on for about three days; This is a spontaneous report from a contactable pharmacist reporting for himself. A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot EJ1685, intramuscularly on 21Dec2020 (Dose 1) as a single dose, left arm (age at vaccination: 51 years) for COVID-19 immunization. Medical history was none. There were no known allergies to medications, food, or other products. He was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included multivitamins, krill oil (KRILL OIL). No other vaccines were received in the 4 weeks prior to COVID vaccination. Starting 21Dec2020 at 18:00 after the first vaccine, the patient experienced headaches off and on for about three days, usually at night especially while trying to sleep. General malaise about three days after vaccination (on 24Dec2020) which lasted about four days. Also had moderate soreness at left deltoid running down thru left shoulder and mid back (onset 21Dec2020 18:00). There was no treatment received or hospitalization for the events. The events were reported as non-serious. The outcome of the event headaches off and on was recovered in Dec2020, for the event general malaise was recovered on 28Dec2020 and for the event moderate soreness at left deltoid running down thru left shoulder and mid back was recovered on an unknown date. The patient was not COVID-tested post-vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018615 same patient/drug, different dose/event
51 2021-01-18 headache headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to... Read more
headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to right shoulder blade; This is a spontaneous report from a contactable pharmacist reporting for himself. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular (right arm) on 08Jan2021 07:15 at SINGLE DOSE for COVID-19 immunization. The patient's other medical history was not reported. The vaccine was given at hospital. No other vaccines in four weeks. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EJ1685) on 21Dec2020 07:15, left arm at single dose and experienced headaches, general malaise, moderate soreness at left deltoid running down thru left shoulder and mid back on 21Dec2020 18:00, with no treatment given. Concomitant medication included krill oil and an unspecified multivitamin; unspecified dates and indication. On the second vaccine, patient experienced same headaches starting the evening of after getting second vaccine on 08Jan2021. Patient also experienced headaches feel exactly the same as before, seemingly in the middle, top half of head, right deltoid is very tender to touch at injection site, and a little weak feeling running to right shoulder blade all on unspecified date in Jan2021. No treatment was given. Outcome of the events was unknown. The reporter assessed the events as non-serious.
51 2021-01-19 headache 2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. Afte... Read more
2 days after 1st dose: severe headache and body aches. Severe tinnitus. Insomnia, constipation. After 3 days tingling numbness and weekends in extremities. Loss of appetite. Weight loss. Symptoms persisting for 3 weeks.
51 2021-01-20 fatigue, fever, chills Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This ... Read more
Uncontrollable rigors; profound fatigue; weakness; achiness; nausea; fever (up to about 102).; This is a spontaneous report from a contactable physician reporting for himself. A 51-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3246, expiry date not reported) on 09Jan2021 at 08:30 via an unspecified route of administration in the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. No other medical history. The patient had not had COVID prior to the vaccination and had not been tested post the vaccination. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 at 16:30 via an unspecified route of administration in the left arm for COVID-19 immunization. No other vaccine received in four weeks. Concomitant medication included paracetamol (TYLENOL). On 09Jan2021 at 23:30, the patient experienced uncontrollable rigors, profound fatigue, weakness, achiness, nausea, fever (up to about 102). The events were non-serious. The patient took over the counter paracetamol (TYLENOL) and ibuprofen for the events, and was recovering from the events.
51 2021-01-20 fever, throat pain Fever 101.1, sore throat, congestion, body aches
51 2021-01-21 chills, fatigue pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dy... Read more
pt had severe, non-hospitalized covid infection late August: fever, loss of taste/smell, fatigue, dyspnea, cough; recovered all except smell /taste loss has improved but not normal; covid Ab positive in November; After the injection he began with chills that night around 3 am. The next day he felt ataxic, hit a curb twice while driving, was slurring speech; those sx's resolved over the next few hours; fatigue persisted for the next 48 hours.
51 2021-01-21 fatigue HAD NAUSEA, FATIGUE, AND DIARRHEA
51 2021-01-22 fatigue, chills, fever fever, chills, arm pain, fatigue but mainly swollen lymph nodes continuing to swell for two days
51 2021-01-24 body temperature increased, fatigue I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd ... Read more
I had a sore arm for about two days after receiving my second shot with mild tiredness. On the 22nd of January I work up around 2:30 with severe cramp and joint. I could even close my hands because my nuckles were so sore. I hand a temperature of 101 degrees. On the 25 I?m moving around but very sore but is getting better everyday. I spent the entire day though resting in bed.
51 2021-01-25 fatigue, chills Nauseous ,shivers, and very tired.
51 2021-01-26 chills, headache Day 8, I woke with a headache, chills, vomited 4 times, muscle aches, and heart palpitations all day... Read more
Day 8, I woke with a headache, chills, vomited 4 times, muscle aches, and heart palpitations all day until around 8 pm. I couldn't keep food down until then. From Day 8 until yesterday (Day 11), I have been having intermittent episodes of heart palpitations, which is my only serious concern. I have had a declining number of heart palpitations today, Day 12, but felt I should report these heart palpitations in case this is a sign of a serious complication. Should I avoid receiving the second dose?
51 2021-01-26 fatigue, chills, body temperature increased, malaise he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ear... Read more
he had 102.1 temp; he started not feeling well; chills; ringing in ears/ The ringing was in both ears; body aches; joint aches; fatigue; lymphadenopathy/had swollen lymph nodes like the size of an apple; he was uncomfortable; His eyes were also hurting; The light bothered his eyes; This is a spontaneous report from a contactable Other HCP (patient) and a contactable Nurse (patient's wife). A 51-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EL3246, Expiry Date Apr2021) at single dose at left arm on 11Jan2021 18:00 for Covid-19 immunisation, administered at hospital as being a certified registered nurse anesthetist (CRNA). The patient medical history was none. There were no concomitant medications. The patient received the 1st dose of bnt162b2 (BNT162B2, lot # EK5730, expiry: 31Mar2021) at single dose at left arm on 23Dec2020 for Covid-19 immunisation and he has been fine, no adverse effect occurred. No additional vaccines administered on same date of BNT162B2. The patient experienced lymphadenopathy which is a size of tennis ball under my left armpit /had swollen lymph nodes like the size of an apple in his left arm in the axillary area, where he received the vaccine on 12Jan2021, he started not feeling well on 12Jan2021 around 9.00, he had 102.1 temp Fahrenheit on 12Jan2021 17:00, chills on 12Jan2021, ringing in ears/ the ringing was in both ears on 12Jan2021, body aches on 12Jan2021, joint aches on 12Jan2021, fatigue on 12Jan2021, his eyes were also hurting on an unspecified date in Jan2021, the light bothered his eyes on an unspecified date in Jan2021. The patient underwent lab tests and procedures which included body temperature: 102.1 fahrenheit on 12Jan2021, he was uncomfortable on 12Jan2021, body temperature: 100 and something fahrenheit on 13Jan2021. The outcome of lymphadenopathy/had swollen lymph nodes like the size of an apple was worsened, of he had 102.1 temp, ringing in ears/ the ringing was in both ears was not recovered, he started not feeling well, his eyes were also hurting, light bothered his eyes was unknown, chills, body aches, joint aches, fatigue was recovered on 13Jan2021. Course of events: Around 9AM on 12Jan2021 he started not feeling well. By the time he got home from work he had 102.1 temp Fahrenheit around 5PM. Temp was ongoing. His eyes were also hurting. The light bothered his eyes. He can't put his arm down. His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple. He had chills, ringing in ears, body aches and joint aches, and fatigue 12Jan2021. He was uncomfortable. The ringing was in both ears. On 13Jan2021 his temp was one hundred and something. What is concerning was the swelling in the armpit in the arm he received the vaccine in. It was very painful. It was starting to radiate up his arm. He did not go to the doctor, since he was relatively healthy. No event required a visit to Emergency Room or Physician Office. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple as serious as medically significant. The reporting Nurse assessed the events he had 102.1 temp, His left arm in the axillary area, where he received the vaccine, had swollen lymph nodes like the size of an apple, chills, Ringing in ears, body aches and joint aches, and Fatigue as related to BNT162B2.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between events lymphadenopathy and fever and BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-01-26 influenza like illness, fever 1st dose: No symptoms. 2nd dose: Body/muscle aches, dizziness, low-grade fever (flu-like symptoms).
51 2021-01-27 fever, chills Fever, chills, body ache
51 2021-01-28 malaise I got the first shot on 1/22/21. This was exactly one week ago. This morning my arm has a large ra... Read more
I got the first shot on 1/22/21. This was exactly one week ago. This morning my arm has a large rash and has been a bit itchy. I also do not feel the greatest today.
51 2021-01-29 lethargy, chills, headache, fever Fever 102-103 with fever reducing meds Severe Headache , chills, lethargy and pain in hips Skin/tou... Read more
Fever 102-103 with fever reducing meds Severe Headache , chills, lethargy and pain in hips Skin/touch painful All symptoms started at 6pm 1/28 till now 11:39am Fever down to 101 as of 9:30am with fever reducing meds/ Ibuprofen 800mg taken at 5am
51 2021-01-29 malaise, headache Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left ... Read more
Began with a slight headache that eventually got worse. Started, when treated, at a 5 of 10. Left facility with a 7 of 10 headache. Then I had a weird taste in my mouth (metallic like). My tongue started to tingle and was a bit numb. Eventually after Doctor at facility took me in, I was given benedryl 50 mg and an antacid. After a few minutes the right side of my mouth became itchy but the tingling stopped. The itch was not unbearable but it was getting there. I was already having a slight difficulty breathing but that was from the morning even with inhalers. As an instrument player a doctor said I have super lungs so my results would be skewed due to how much air I take in. But any loss of air, although in the safe range for others, is like breathing through a straw for me. My blood pressure was 139/90 at the time. My normal blood pressure is 117/70. I went home feeling cold and just not feeling well, relatable to flu symptoms. This is the next day after taking benedryl every 6 hours at 50mg/dose. My breathing is slightly labored. I feel ok but my arm hurts, I have been moving it around a lot just to get it mobile. My chest feels like there is a slight weight on it which is weird for me. At the moment my pulse is 81bpm and my oxygen is at around 96. My norm is around 70bpm and oxygen at 99. No temperature is consistent at 97.3. I feel a little weird today. I am stiff all over as well. Little aches here and there but that is a norm. Doing my stretches and exercise is not a go today. Can't breathe as normal.
51 2021-01-30 body temperature increased, chills, fever High fever (+5*) aches, chills, nausea. Treated with OTC Tylenol and ibuprofen. These helped with ... Read more
High fever (+5*) aches, chills, nausea. Treated with OTC Tylenol and ibuprofen. These helped with fever but recurring after time. Continued OTC tx and prolonged rest. Lasted approximately 60 hours. Intermittent mild temp elevation last 5 days
51 2021-02-01 headache A couple days after I begin experiencing general body aches, headache and nausea which lasted about ... Read more
A couple days after I begin experiencing general body aches, headache and nausea which lasted about 10 days after. I got a COVID swab which was negative.
51 2021-02-02 respiratory tract congestion, fever Congestion, Fever, Body aches,
51 2021-02-03 fatigue, lethargy Lethargy, fatigue, dry mouth, muscle aches
51 2021-02-03 headache, fatigue developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan; site injection ... Read more
developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan; site injection pain; headache; muscle pain; joint pain; nausea without vomiting; fatigue; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot No. EK9231), via an unspecified route of administration at site of left deltoid on 13Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had developed non-resolving significant tinnitus after his second Pfizer Covid on 13Jan, sudden onset tinnitus at 11:30am. Stated that he had other symptoms that resolved. Stated that on Friday that the tinnitus was continuing. The other symptoms that resolved were site injection pain, headache, myalgia, muscle and joint pain, queasy stomach, nausea without vomiting and fatigue on 13Jan2021. Stated they were more severe the first day and resolved by Friday night. Stated that the was fine Saturday morning. Stated that they all had acute onset. The outcome of event tinnitus was not recovered. The outcome of rest events was recovered in Jan2021 Information on the lot/batch number has been requested.
51 2021-02-05 fever, headache fever 102, headache, muscle aches, chest pain
51 2021-02-09 sweating Severe bloody nose, diaphoresis, dizziness. No history of nosebleeds. Occurred 7 hours after recei... Read more
Severe bloody nose, diaphoresis, dizziness. No history of nosebleeds. Occurred 7 hours after receiving 1st dose of Phizer vaccine. Presented to ER. EKG and bloodwork within normal limits.
51 2021-02-09 influenza like illness, fever GI upset, spiked fever after the first shot. Was ten days before I could leave the house. After sec... Read more
GI upset, spiked fever after the first shot. Was ten days before I could leave the house. After second shot had flu like symptoms( 2 days after) Had hives and had angioedema event.
51 2021-02-09 runny nose runny nose with thin mucous; muscle pain in right arm; muscle pain in right arm; This is a spontaneo... Read more
runny nose with thin mucous; muscle pain in right arm; muscle pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 11:00 at a single dose for Covid-19 immunization. Medical history included diabetes and chronic kidney disease. Concomitant medications included calcitriol, fluoxetine hydrochloride (PROZAC), and labetalol. The patient experienced runny nose with thin mucous and muscle pain in right arm on 23Jan2021. Patient did not received any treatment for the events. Outcome of the events was recovering. No follow-up activities are needed. No further information is expected.
51 2021-02-10 chills, fatigue, headache Testicular ache; chills; headache; SI joint pain bilaterally; Fatigue; This is a spontaneous report ... Read more
Testicular ache; chills; headache; SI joint pain bilaterally; Fatigue; This is a spontaneous report from a contactable 51-year-old male Health care professional reported for himself. A 51-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration from 24Jan2021, 14:00 at SINGLE DOSE (second dose, left arm) for covid-19 immunisation, administered on a hospital. Medical history included history of chronic hives; no issues x 1 year from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 03Jan2021 at 12:00 PM on the right arm for Covid-19 Immunization (Age of vaccination was 51 years old). The patient previously took Asa and experienced drug hypersensitivity and hives (known allergies: Asa - hives). Concomitant medication included celecoxib (CELEXA), and cetirizine hydrochloride (ZYRTEC), therapy dates and indication unspecified. The patient experienced testicular ache, chills, headache, si joint pain bilaterally, and fatigue on 25Jan2021 04:00. No treatment was given. Outcome of the events was recovered. Seriousness criteria was reported as non-serious. Information on the lot/batch number has been requested
51 2021-02-10 chills Pfizer E18982 Vaccine adverse reaction. Hives over 90% of body, severe itching, short term chills, ... Read more
Pfizer E18982 Vaccine adverse reaction. Hives over 90% of body, severe itching, short term chills, joint pain and teeth chattering. No fever or breathing issues. Vaccine on 1.30.21, doctor visit on 1.31.21eceived IM dexamethasone shot. Symptoms (hives/itching) not resolved. Went to PCP steroid changed to Prednisone twice a day x 5 days. My Allergy doctor advised nothing different however has advised not to get regular allergy shots this week until symptoms subside. The reaction did not occur after injection during the Employee Vaccination visit, it occurred later that evening.
51 2021-02-10 nasal congestion, fatigue, throat pain got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; T... Read more
got positive with Covid Virus; he tested positive for the COVID; sore throat; stuffiness; fatigue; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer reported for himself. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration in the left arm on 16Jan2021 16:00 at SINGLE DOSE for covid-19 immunization. Medical history included ongoing Ulcerative colitis, ongoing Allergy and "had close contact with someone who was positive". Concomitant medication included ongoing mesalazine (taking for over 20 years) for Ulcerative colitis and ongoing allergy medicine (taking for two years, thinks it is Claritin grocery brand) for Allergy. Caller received first Pfizer vaccine on 16Jan2021. He was performed the nasal test at 11: 40 AM yesterday (25Jan2021) and received positive results for Covid 19 today (26Jan2021). Adds he had no symptoms after the vaccine. But he has sore throat, stuffiness, fatigue that started the 23Jan2021 with the COVID 19. All of these are getting better as of today (26Jan2021). The event did not require a visit to physician or ER. The patient stated "I had close contact with someone who was positive." He was supposed to receive his second vaccine dose on 06Feb2021. The patient stated "they told me to quarantine for 10 days from the time I was exposed and that would be until 02Feb2021. Is there any reason I shouldn't get my 2nd dose?" The outcome of the event COVID 19 was unknown, of other events was recovering.
51 2021-02-12 chills, fever, headache headache, fever, chills
51 2021-02-15 fatigue, throat pain ON 2/10/21, DEVELOPED LOOSE STOOLS, BODY ACHES, SORE THROAT, AND FATIGUE.
51 2021-02-15 malaise, fever, headache, fatigue, cough, chills He received his 1st dose vaccination 2/3/2021 and he began feeling sick on Sunday night 2/7/2021. H... Read more
He received his 1st dose vaccination 2/3/2021 and he began feeling sick on Sunday night 2/7/2021. He had pain and swelling along with an infection in his teeth and ears, cough and fever. No appetite, no smell, some chills, body aches and headaches. This past Saturday the 13th he said that he was having bad headaches and fatigue. He did also say that he was having vomiting but that had been after taking his antibiotic and medications for the shingles, basically his right side of his body.
51 2021-02-18 cough, throat clearing After 30 mins walking to my car profusely coughing, able to drink however couldn't clear my throat. ... Read more
After 30 mins walking to my car profusely coughing, able to drink however couldn't clear my throat. I thought about getting Benadryl and going home. I went back in the facility to get observed for 2 hours and I was given Benadryl then I was fine.
51 2021-02-20 chills, headache, sweating Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of ... Read more
Systemic: Chills-Mild, Systemic: Ringing in ears, chills,then feeling flushes. No obvious signs of diaphoresis-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Tinnitus-Mild, Additional Details: Report. 20 min post admin, Aid ckd BP and reported 204/134. Rpt ringing in ears, chills, then warm sensation all over. BP 5-10 min later in other arm, reported 213/162. Gave Pt water. COO at facility to call paramedics to assess. Lied pt down for 5 min, rck BP 180/117. Pt reported feeling fine w/ occasional chill. Waiting on Paramedics. Approx 5 min, pt sat up complaining of headache. Paramedic arrived about 5 minutes later, assessed pt, bp 232/120?. To Hospital
51 2021-02-23 body temperature increased temp 100.5 chills, muscle pain, injection site pain radiating to left armpit which last for 2 weeks
51 2021-02-23 chills, fever 3 days of fever 102.5-101.8 , chills, muscle pains, injection site ,took Tylenol and advil
51 2021-02-23 fatigue Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stay... Read more
Started being more fatigue and right arm stays sore everyday in the bend shoulder on right side stays sore
51 2021-02-23 throat pain Sore throat
51 2021-02-25 body temperature increased At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially ... Read more
At about 2am on 2/10/21, Patient got up from bed and fell down a flight of stairs. He was initially bleeding and unconscious and was brought by EMS to the hospital. Upon arrival at the hospital he had a temperature of 40 C. He was found to have 2 small left temporal hemmorhagic contusions on CT scan. He had a seizure during the hospitalization. He was initially treated for HSV encephalitis but it is not clear if that was confirmed. The hospital team may not have known of the recent vaccination. He improved during the hospitalization, but remained with a very unsteady gait. He could not return to the group home. He was transferred to a rehab facility to receive PT on 02/16/2021. He remains at rehab. Prior to the fall, on the 3rd day after vaccination, on 2/8/21 at about 10 am, the patient coughed and had a small blood on the inside of his face mask while at his day program. He was seen by his PCP and had no abnormal findings. He had a CBC, BMP and CXR and all were unremarkable.
51 2021-02-25 throat irritation Received 2nd dose of Pfizer on January 19, 2021. 3 days post vaccination (January 22, 2021) I deve... Read more
Received 2nd dose of Pfizer on January 19, 2021. 3 days post vaccination (January 22, 2021) I developed right eye discomfort/irritation, prickly sensations in throat. On Jan 25, 2021 I developed tinnitus in right ear which has still not resolved. On January 30, 2021, went to ED with elevated BP 170/110, abdominal pain and tinnitus. Had an abdominal CT scan with contrast which showed mesenteric inflammation (idiopathic etiology). Was seen and evaluated by GI and had colonoscopy and endoscopy with no significant findings. Took solu-medrol dose pack and abdominal pain symptoms improved, but still not fully resolved. On Feb 16 was seen by PCP for persisting, unilateral tinnitus. Sent for MRI Brain which was normal . Referred for further evaluation by audiologist and otolaryngologist . Was seen on February 25, 2021 for right ear fullness, tinnitus. Hearing test normal. Diagnosed with right sided tinnitus.
51 2021-02-26 throat irritation Approximately one hour after the injection he developed hives on his face and ear, and felt a little... Read more
Approximately one hour after the injection he developed hives on his face and ear, and felt a little irritation in his throat, noticed some difference when swallowing.
51 2021-02-28 malaise, fatigue With first dose given on 02/04/2021 there was mild soreness at injection site. With second dose give... Read more
With first dose given on 02/04/2021 there was mild soreness at injection site. With second dose given on 02/27/2021 there was only mild soreness at the injection site until the morning of 02/28/2021. At this time I started to experience fatigue and malaise. This gradually worsened throughout the day although no additional symptoms developed until the following day. When I awoke at around 7:00 am on the morning of 03/01/2021 the feeling of fatigue and malaise were gone however, I noticed significant swelling with minor discomfort in my left armpit area. At 8:00 pm on the same day only mild swelling persists, without discomfort.
51 2021-03-02 headache, fatigue Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatig... Read more
Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatigue; Joint pain; Neck pain; This is a spontaneous report from a contactable consumer reporting for himself. A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Concomitant medication included unspecified drug. On 09Jan2021, the patient experienced blurry vision, headaches, left ear pain, loss of taste and smell, insomnia, fatigue, joint pain and neck pain. The patient received meloxicam as treatment medication. The events were considered as non-serious. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
51 2021-03-02 headache, sweating, chills Chills; Sweating; Headaches; Muscle aches; Pains; This is a spontaneous report from a contactable co... Read more
Chills; Sweating; Headaches; Muscle aches; Pains; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EL3247), via an unspecified route of administration on 16Feb2021 10:00 in right arm at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication within 2 weeks of vaccination included venlafaxine hydrochloride (EFFEXOR XR), amlodipine besilate (NORVASC), atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (PFIZER, lot# EL3247) on 27Jan2021 13:00 in right arm for covid-19 immunization. The patient previously took sulfur and experienced allergies: sulfur. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, sweating, headaches, muscle aches and pains on 16Feb2021 16:00. No treatment was received for events. This case was reported as non-serious. Outcome of events were recovered in Feb2021.
51 2021-03-03 fatigue, lethargy Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a... Read more
Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.
51 2021-03-03 head discomfort, headache, lethargy Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up... Read more
Dizziness/felt woozy/light headed; Weakness; vision changed; increased heart rate/heart rate went up slightly; had pressure in his head; pressure in his hands and feet like he could not move his feet; pressure in his hands and feet like he could not move his feet; headache; muscle tightness/muscles tightened in his back and in his calf muscles/tightness in his neck; he felt like he was just not himself; lethargic; lump in his throat; lymph nodes got tight on the same side as the vaccine/lymph node on his left side was tight throughout his neck; cringing in his stomach muscles; kind of like a muscle spasm in his stomach; didn't sleep that well last night; wobbly; back was hurting; muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9261, expiry date: unknown), via an unspecified route of administration, from 01Feb2021, at single dose, for COVID-19 immunization. Medical history included anemia (anemic), inflammation, acid reflux (esophageal), pain, on blood thinner, high cholesterol, sinus disorder (sinuses), overactive bladder/bladder control, acid reflux, stools hard (to soften stool), nerves, blood pressure high (high bp), car accident, and costochondritis in chest. Concomitant medication included atorvastatin calcium for high cholesterol from an unspecified date and ongoing; docusate sodium to soften stool; famotidine to soften stool from an unspecified date and ongoing; garlic [allium sativum] as blood thinner from Nov2020 (3 months ago) and ongoing, gabapentin for nerves from an unspecified date to an unspecified date and from Nov2020 (got back on this 3 months ago) and ongoing; hydrocodone for pain; iron for anemia from Nov2020 (been taking this for the last 3 months) and ongoing; meloxicam for inflammation, omeprazole (PROTONIX) for acid reflux from an unspecified date and ongoing; tadalafil for overactive bladder/bladder control from an unspecified date and ongoing; vitamin c (ascorbic acid), colecalciferol (VITAMIN D), vitamin b for trying to build up his immune system; ranitidine hydrochloride (ZANTAC) for sinuses; "One a Day Men's" from 2016 and "50+" (as reported, pending clarification). On 01Feb2021, after the shot, the patient experienced dizziness/felt dizzy and had weakness. When he walked to the desk to check out he felt his vision changed and his heart rate went up slightly but it did go down once he sat down but he felt woozy and had pressure in his head and pressure in his hands and feet like he could not move his feet. He was kind of like dizzy and light headed. He walked somewhere to sit down, he stayed 30 minutes and left after and sat 30 minutes in the car and he got a headache and his muscles tightened in his back and in his calf muscles and he felt like he was just not himself. He felt lethargic and felt like his lymph node on his left side was tight throughout his neck. He felt like his lymph node was getting tight and he just sat until he felt like his symptoms had dissipated. He also had lump on his throat. He had stuff going on with his stomach like cringing in his stomach muscles, it was kind of like a muscle spasm in his stomach. He didn't sleep that well last night (01Feb2021) as he felt some symptoms come on again, the tightness in his neck again and when he sat up, he got dizzy and wobbly, his back was hurting, his calf muscle was tight. He felt more muscle pain. He checked his blood pressure and it was good, but he just felt a little dizzy on 02Feb2021. The patient stated that all his symptoms have improved since 01Feb2021. The patient also mentioned that the girl looked really young (referring to the person who administered the vaccine), "maybe she jacked it up, he knows it supposed to be a very little bit, maybe she put more in him than she was supposed to". He went back to his doctor as he wants to come off of some of his medications because he is supposed to have another shot and he want to take the second shot. He wanted to stop taking all the medications around the second shot in case it was his medications that caused it. The patient asked since he had complications with the fist dose, should he still take the second dose. The patient was recovering from the events.
51 2021-03-04 fatigue (Nurse Practitioner) Family Medicine at 3/1/2021 10:50 AM Pt called to follow up on covid-19 vac... Read more
(Nurse Practitioner) Family Medicine at 3/1/2021 10:50 AM Pt called to follow up on covid-19 vaccine done on 02/24/21. She reports that she got home that day and slept until the next day. Fatigue resolved. No other issues noted with vaccine otherwise. Denies any further questions or concerns. Pt is appreciative of phone call. Progress Notes 2nd Attempt to call patient for follow up via phone. No answer. Progress Notes ? Family Medicine at 2/28/2021 7:28 AM Attempt to call patient for follow up via phone. No answer. Progress Notes (Physician Assistant) ? ? Family Medicine Cosigned by: MD at 2/28/2021 7:29 AM STORMONT VAIL COVID VACCINE CLINIC Patient: Date: 2/24/2021 Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, vision changes and increased respirations. She denied rash, hives, difficulty swallowing, wheezing, throat tightness and hoarseness. She has a history of asthma often triggered by stress. She does have albuterol inhaler on hand, but has not used today. Denies frequent use of albuterol inhaler. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath, dizziness and headaches Patient denies chills, fever, facial swelling, cough, chest tightness and wheezing Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1155 BP: (!) 126/92 Pulse: 64 SpO2: 100% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: water and Tylenol 1000mg Follow up response to treatment: good. Patients symptoms all resolved prior to discharge. Her O2 remained 99-100% and she denied difficulties breathing. Her respirations decreased while she was in the bay. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Electronically Signed 2/24/2021 12:31 PM
51 2021-03-05 headache frequent headaches that fades away but it comes back, the worst was 10 days after the 2nd dose i was... Read more
frequent headaches that fades away but it comes back, the worst was 10 days after the 2nd dose i was so sick that i was nauseated and vomited several time with dizziness. it originated from the left frontal side of my head with dizziness and now the whole frontal area of my head. when the worse time i have to take tylenol but it does not help much. my dr ordered EKG, Blood test and CT Scan and all the results are normal. this is unusual for me.
51 2021-03-06 fatigue Swelling and pain at site of injection lasting 3-4 days Fatigue on day after injection.
51 2021-03-06 headache, fatigue Headache, fatigue, rash
51 2021-03-07 fatigue Mild Fatigue, pain in right aram and foreign body sensation
51 2021-03-07 fatigue Sore right arm, foreign body sensation, mild fatigue
51 2021-03-07 fever Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain ... Read more
Fever started 2 days after vaccination, followed by shortness of breath, dyspnea, weakness and pain and edema in both legs. edema was traveling up and reached umbilicus. Weakness in both legs. Started to improve with steroids. When steroids were starting to taper, symptoms worsened again. Patient was seen in ED.
51 2021-03-08 headache, fatigue, fever The night after receiving the second dose of the Pfizer Covid , the patient developed severe headach... Read more
The night after receiving the second dose of the Pfizer Covid , the patient developed severe headache, who body myalgias, severe fatigue, and fevers. The next day he also developed pleuritic chest pain and shortness of breath. He described the chest pain as like a heart burning sensation, worse lying down and better sitting up. He documented a fever to 100.8 deg F. By the thord day the fever had resolved but the chest pain persisted, leading him to present to the emergency department. On exam he had BP 113/84, HR 95, RR 18, O2Sat 95% on RA, Temp 97.5 F. His lungs were clear to auscultation. Heart was RRR, S1, S2 WNL without MGR. ABD was soft, without tenderness, masses or HSM.
51 2021-03-08 fever, chills 20 hours after the vaccine, at 3:00 PM on 16th I had small a fever and chills. Those symptoms laste... Read more
20 hours after the vaccine, at 3:00 PM on 16th I had small a fever and chills. Those symptoms lasted until 05:00 PM on 17th. I had a sharp pains in my chest that would come and go. That lasted for three to four days. Then they just went away. I just kept taking my meds. It wasn't clear if it was a muscle pain or inside my chest - it wasn't bad enough to hinder me or for me to see a doctor.
51 2021-03-08 fever, fatigue Onset of fever (101 degree Fahrenheit occurred at approximately 3:30 pm (3.5 hours following vaccina... Read more
Onset of fever (101 degree Fahrenheit occurred at approximately 3:30 pm (3.5 hours following vaccination. The fever was accompanied by significant fatigue and joint discomfort. Over the counter analgesic (acetaminophen) was taken. The symptoms lasted until approximately 8:30 pm, when the fever broke. Joint pain and fatigue remained through evening and night. No symptoms were present the following morning.
51 2021-03-09 headache, fever Fever; joint pain; body aches; throwing up; headache; This is a spontaneous report from a contactabl... Read more
Fever; joint pain; body aches; throwing up; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EC3246), dose 1, single dose via an unspecified route of administration in the left arm on 22Jan2021 at 14:30 (at the age of 51 years-old) for COVID-19 vaccination. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included zolpidem (AMBIEN) and lisinopril. On 22Jan2021 at 16:45, the patient experienced fever, joint pain, body aches, throwing up and headache. The events resulted in a physician's office visit. Treatment was not received for the events. The clinical outcome of fever, joint pain, body aches, throwing up and headache was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 on 27Jan2021: polymerase chain reaction (PCR) nasal swab and was negative.
51 2021-03-10 fatigue Extreme exhaustion Aching joints Aching stomach Diarrhea
51 2021-03-10 sweating Had a high heart rate at rest. While sitting, not moving, I recorded 160 BPM and it would go as high... Read more
Had a high heart rate at rest. While sitting, not moving, I recorded 160 BPM and it would go as high as 178 BPM. Periodically sweating, dizziness and sick to my stomach. This lasted until 0830 the next day. I had no other issues. For most of this period my heart rate was around 120-140. If I just stood up, it would go right up to 160-170. This lasted approximately 19 hours...
51 2021-03-10 malaise, fatigue fatigue, malaise, severe nausea. Nausea progressed and became debilitating. Missed two days of wor... Read more
fatigue, malaise, severe nausea. Nausea progressed and became debilitating. Missed two days of work. Given Zofran to return to work. resolved after 7-10 days. lost 5 lbs.
51 2021-03-11 headache I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and h... Read more
I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and had to have my wife come get me because it was so bad. It lasted 3 days. I had some arm soreness.
51 2021-03-11 headache I had to wait for 15 min and was released. I started getting a really bad headache about 5 min later... Read more
I had to wait for 15 min and was released. I started getting a really bad headache about 5 min later above my ear. I then got nauseous. I went back to vaccination location and was given a cold compress. I was taken to the ER and given Benadryl and multiple nausea meds. I was there for about 5 hours. I was released and instructed to drink lots of water. I was told by the doctor that my body was doing what it was supposed to do, but to come back if I got worse. I took 2 days off and returned to work with no remaining complications.
51 2021-03-11 malaise, fatigue Malaise, fatigue, injection site pain, intestinal distress in the form of constantly feeling like I ... Read more
Malaise, fatigue, injection site pain, intestinal distress in the form of constantly feeling like I need to have a bowel movement or am having gas but not really needing necessarily to do either.
51 2021-03-11 nasal discomfort After second covid shot about a week later sensation of ulcer in nasal passages that moves around da... Read more
After second covid shot about a week later sensation of ulcer in nasal passages that moves around day to day. Irritating, almost feels like a zit expanding inside the nose but then next day in a different area of nose Continues still
51 2021-03-14 headache, chills Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful... Read more
Warm left arm at the injection site after 4 hours. Both shoulder joints and hip joints were painful about 8 hours after injection. Took Tylenol. Light headache and tingling under hairline on the back of the neck. 8 hours after injection. 2:30am chills until 3:00am. Fell back to sleep. 8:00 am - 9:30 am. Sore muscles and bones from head to toe. 9:45am took Motrin and Tylenol seems to work. I feel better.
51 2021-03-14 sweating Diaphoretic, syncope, unresponsive, evaluated by EMS, transported to ER
51 2021-03-15 sweating Patient became dizzy and suffered from diaphoresis after vaccination. Reclined patient, gave HiC, vi... Read more
Patient became dizzy and suffered from diaphoresis after vaccination. Reclined patient, gave HiC, vitals taken and stable throughout. After 15 minutes patient was able to walk and leave clinic.
51 2021-03-16 chills, fever, sinus headache Chills, fever, aches and pains, sinus headache
51 2021-03-16 fatigue, runny nose, chills, headache 1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21,... Read more
1st Shot on 2/22/21, no adverse reaction aside from injection side muscle pain. 2nd Shot on 3/15/21, vaccine administered at 15:15EST, after going home, became very tired around 17:30, took nap, woke up at 21:30 with pounding headache and the "chills." Went to bed at that time, took ibuprofen for headache, Slept through morning alarm on TUE 3/16 at 05:15, woke up at 08:45, in to work by 10:30. Left work at 13:30 due to continued headache & body aches, chills, (had to turn a space heart on in my office), hands were cold. Took nap from 16:00 - 19:00. Still had headache, body aches, and chills. Went to bed around 21:15. Woke up on WED 3/17 at 01:30, had the chills, and was shivering, still had head ache. Turned up the thermostat from 70 to 75. Put an extra blanket on the bed. Woke up at 03:30, t-shirt and blanket soaked in sweat. Woke up for day at 05:45. Right underarm swollen, (lymph gland/nodes). Experiencing runny nose, body aches, headache continues.
51 2021-03-16 headache, fever Extreme headache, fever, nausea, leg cramps
51 2021-03-16 sweating Patient noticed his left arm & about 6" below his left arm was sweating profusely 15 minutes after r... Read more
Patient noticed his left arm & about 6" below his left arm was sweating profusely 15 minutes after receiving the vaccine .Shirt on the left side was noticebaly wet (Not Right side) ."Feeling totally normal" and not noticed anything else. Patient would like to leave facility and willcall us if he feels '"off"
51 2021-03-17 cough Pt c/o difficulty breathing, esophageal spasms, severe coughing for hours during the night; resolved... Read more
Pt c/o difficulty breathing, esophageal spasms, severe coughing for hours during the night; resolved by 1400 on 3/15/21. 98% sat on ra; increased RHR of 86 bpm (normal is 48-52bpm) -
51 2021-03-18 sweating 3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN ... Read more
3-17-21 1:10PM PT STATES HE 'DOESN'T FEEL WELL'. SYNCOPE APROX 1 MIN - WIFE HELD PT IN CHAIR. RN X3 AND MEDIC ASSISTED PT TO FLOOR AND ELEVATED LEGS. PT BECAME RESPONSIVE. PT PALE AND DIAPHORETIC. 1:16PM ASSISTED PT TO CHAIR 'FEELS BETTER NOW'. A/O, PINK, W/D, RESP REG WITH EASE. WIFE HERE TO DRIVE PT HOME. 3-19-21 3:30PM TC: PT STATES 'FULL RECOVERY'.
51 2021-03-19 headache, chills Headache, chills
51 2021-03-19 sweating Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minute... Read more
Systemic: Flushed / Sweating-Medium, Additional Details: patient became flush approximately 5 minutes into his 15 minute observation period. Placed patient on floor and elevated legs. Patient was able to return to a sitting position in a chair approximately 8 minutes later. BP during epidose was 130/88 and pulse was 60 per automatic blood pressure cuff machine. Patient also stated he was light-headed as well. Patient was doing much better when he left the observation area.
51 2021-03-20 chills, headache, fever all muscles in body seized, couldn't breathe, body aches, fever, chills, headache
51 2021-03-20 headache, sweating About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and the... Read more
About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and then I passed out walking to get help. I hit my head on a chair when I was falling and cut my head. I stayed laying down because I was still dizzy and hot. They called the squad and did vitals and I was fine. I sat there for about another half an hour and I went home. I have felt fine ever since. Only thing that hurt was my head from the fall.
51 2021-03-21 nasal congestion, headache, fatigue, runny nose, influenza like illness Flu-like symptoms. Running nose, congestion; headache, noticeable fatigue.
51 2021-03-22 head discomfort, fatigue, fever, chills soreness at site of injection (1 to 48 hours), mild chills (24 to 48 hours), mild fever (from 24 to ... Read more
soreness at site of injection (1 to 48 hours), mild chills (24 to 48 hours), mild fever (from 24 to 48 hours), mild fatigue (from 24 to 48 hours), mild pain in shoulder joints (24 to 48 hours), heavy headedness (36 to 48 hours). No treatments taken. All resolved completely within 48 hours after injection.
51 2021-03-23 fever, headache 1pm Sunday received dose 1 then 14 hours later awoke at 3am with a pretty solid headache and feeling... Read more
1pm Sunday received dose 1 then 14 hours later awoke at 3am with a pretty solid headache and feeling warm. Headache lasted until I went to bed that night took Tylenol throughout the day with occasional mild help but not much. Took my temperature it was 98.8 I usually run around 96/97 It got up to 98.8 later that morning. As the day progressed my muscles ached and I had very little energy. I napped a little but otherwise was just planted on the couch. The headache was the most annoying and steady. All symptoms were gone when I woke the next morning. My temp today is 97.7 and that?s a little higher than normal and my head still feels a little warm when someone else feels it and I feel still a tad warmer than normal. Otherwise I feel pretty good.
51 2021-03-24 headache swollen arm pit and headache
51 2021-03-24 headache Headache. Dizzy. Itching on right side. Rash on right cheek. Aching In upper back right side. Errati... Read more
Headache. Dizzy. Itching on right side. Rash on right cheek. Aching In upper back right side. Erratic racing pulse.
51 2021-03-24 fever After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morn... Read more
After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er. Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy. Still not recovered.
51 2021-03-25 headache, fever, sinus congestion, chills Headache, muscle aches, sinus congestion, fever, chills. Headache and muscle aches began at 3 AM on ... Read more
Headache, muscle aches, sinus congestion, fever, chills. Headache and muscle aches began at 3 AM on March 23. Sinus congestion began at approximately 9 AM on March 23. Fever and chills began after 5 PM on March 23. All symptoms persisted until approximately 9 AM on March 25. Fully recovered by March 26.
51 2021-03-25 sweating 1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patien... Read more
1055: Patient in 15 minute observation called for medical with c/o dizziness and diaphoretic. Patient taken to first aid station for further assessment by Physician and EMS on Duty. Patient denies eating an AM meal. Patient given water 8oz able to drink water without issues. VS: 182/90 patient states that his pressure normally runs high. EMS on duty rechecked b/p-190/102. Patient requested CBG check once EMS on duty went to take CBG patient "I think were making too much of a fuss" Patient refused further treatment and left AMA.
51 2021-03-27 lethargy, chills Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately nigh... Read more
Very Lethargic late in the night. Went to bed and had really bad chills, shakes, and ultimately night sweats. This lasted essentially through the night, into the late morning, and early afternoon. Started to fell normal late afternoon, 24-26 hours after the shot.
51 2021-03-27 fever, chills, headache Low grade fever (99.9 F), chills, headache, body aches
51 2021-03-28 fatigue, headache Headache for ~48 hours (ibuprofen taken without relief) Sleeplessness Fatigue
51 2021-03-28 headache, chills chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and fe... Read more
chills, shivers, cold sweats, dizziness, headache, joint and nerve pain above baseline, hands and feet completely numb more than baseline, chest (rib cage) pain when breathing, weakness, fell several times, LOC x 1, gas, crawled instead of walked at times, bloating, abdominal cramps, diarrhea every 1-3 hours, slept the rest of the time, was able to drink Gatorade, pedialyte, water, ginger ale for hydration, no vomiting,
51 2021-03-28 throat irritation, nasal discomfort, nasal congestion ALOPECIA AREATA UNIVERSALIS: I have complete hair loss of my entire body. Head/ scalp, eyebrows, e... Read more
ALOPECIA AREATA UNIVERSALIS: I have complete hair loss of my entire body. Head/ scalp, eyebrows, eye lashes, nose hairs, mustache, some armpits, chest hair, pubic/ groin hair, arm/ legs. 1. DEPRESSION/ sadness with no head/ scalp hair, eyebrows, eyelashes. Dramatic change of identity. I am BALD and my family/ friends/ patients think I have cancer b/c I have a CHEMO HEAD/ SCALP. 2. EYES/ NOSE/ THROAT irritation due to NOT having eyelashes or nose hairs. Watery eyes/ eye sensitivity due to dust/ environament, nasal congestion and irritation due to NO nose hairs. Time: 1st injection Dec 20, 2020 noticed some hair loss but after 2nd dose Jan 8, 2021 -> ALL HAIR GONE AFTER 1 WEEK. HAD PRIMARY CARE PHONE CALL JAN 27, 2021 TO REPORT W/ LABS (SEE BELOW) AND EARLIEST APPT WITH DERMATOLOGIST Feb 8, 2021: DX of alopecia areata universalis . TREATMENT AND STILL ON TREATMENT: 1. VITAMIN D2 1250 MCG WEEKLY, 2. 300 MG PREDNISONE PO EVERY 30 DAYS, ALLEGRA 120 MG DAILY, MINOXIDIL 5% TWICE DAILY
51 2021-03-29 chills, headache Developed chills, muscle aches and headache approximately 12 hours after receiving vaccine and laste... Read more
Developed chills, muscle aches and headache approximately 12 hours after receiving vaccine and lasted about 24 hours.
51 2021-03-29 chills At 36 hours after the injection, I began to develop a skin rash, initially only on the underside of ... Read more
At 36 hours after the injection, I began to develop a skin rash, initially only on the underside of my right forearm. Over the following hours, the rash covered the entire underside of both forearms, from elbow to wrist; rash also extended from armpits down the side of the ribcage on both sides. Some rash also appeared across the ribcage and on the back, at the base of the spine down to the sacrailiac. Currently nearing 72 hours after injection. I also experienced considerable chills and muscle/joint aches, which has improved, but which has not yet disappeared.
51 2021-03-29 headache, fever, fatigue Sore arm at injection site, Headache, Fever of 100F-101F, Fatigue until end of next day.
51 2021-03-29 sweating 2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine ... Read more
2.8kg 51 yo M with hx of hypothyroidism and allergy to pencillin was given his first Pfizer vaccine around 0915 3/27 at Medical Center (lot # not reported). Within 5 minutes he states he felt a "jolt" throughout his body and became very nervous and had sweaty hands. Patient reported symptoms at the vaccination location. Blood pressure was reportedly "low" and patient was told he could leave if he felt better. After about 30 minutes from the injection, patient decided to go home but continued to feel nervous and was twitching all over and decided to come to urgent care. He presents with chest pressure (4/10), muscle tremors, mouth dryness and mild dizziness. Denied any history of Covid.Denied any previous reactions to any vaccines. Denied any shortness of breath/trouble breathing, lightheadedness, nausea, or vomiting. No history of high blood pressure or high cholesterol. Denies any history of anxiety or nervousness. States he felt fine prior to the vaccine. Patient did drink his coffee and have a flour tortilla along with a breakfast bar today. HR 82 but BP elevated 199/122.at 1125. BP treated with SL nitroglycerin and four 81mg aspirin. Chest pain improved 1/10. EKG showed inverted T waves V4-V6 with no ST elevation or depression. Sent to ED where EKG was repeated. Incomplete right BBB. BP 128/73 and pulse 47. CXR negative. Unknown if patient was admitted. ED was at Medical Center.
51 2021-03-30 chills I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my f... Read more
I had a tingling/numbness feeling in my face similar to Novacaine. It was only in the areas of my face where my beard and mustache were. It dissipated in about 30 minutes. Then I had chills at about 1.5 hours.
51 2021-03-30 headache, fatigue Pain at injection site; fatigue; headache; chills
51 2021-03-30 headache Really Sore Injection Site (Right Arm); Headache post-injection; This is a spontaneous report receiv... Read more
Really Sore Injection Site (Right Arm); Headache post-injection; This is a spontaneous report received from a contactable consumer (patient himself). A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247) via an unspecified route of administration on 10Feb2021 12:30 to the right arm at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT). Patient received Zoloft 200mg daily within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (Pfizer COVID 19, Solution for injection, lot number: EL3247 via an unspecified route of administration on 20Jan2021 at 11:00 AM on the right arm as a single dose). Patient did not receive any other vaccine in four weeks. On 10Feb2021 at 13:30 PM, patient had really sore injection site (right arm) and headache post-injection. No treatment was provided for the event. Outcome of the events was reported as recovering.
51 2021-03-30 fever High fever and passing out
51 2021-03-31 chills, fatigue, fever Fever, Severe chills, aches, dizziness, fatigue, vomiting
51 2021-03-31 chills, fever Fever, chills, body aches - over the course of 36 hours
51 2021-03-31 dehydration Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontane... Read more
Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 06Mar2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included heart attack 3 years prior and a prior kidney stone event. The patient had no known allergies. Concomitant medication included atorvastatin. On 06Mar2021 at 12:30 PM, the patient experienced soreness in left arm starting about 2 hours after administration of the vaccine. On 06Mar2021 at 18:30, the patient experienced dehydration and pain in kidney area on left side starting about 8 hours after vaccination, lasting through the next day. Felt similar (though not as intense) to a prior kidney stone event, but slightly higher and in front left side. Costochondritis flare up overnight after the vaccine on 06Mar2021. There was no treatment given for the events. The patient was recovering from all events.
51 2021-03-31 fatigue, chills Extreme stiffness, soreness and pain at the injection site 7 hours after injection. Body aches with ... Read more
Extreme stiffness, soreness and pain at the injection site 7 hours after injection. Body aches with chills 14 hours - the next 48 hours. Nausea and tiredness.
51 2021-03-31 fatigue, fever Fever, headache, body ache, fatigue
51 2021-03-31 headache, fever Fever (101.5) that lasted about 6 hours a severe headache the occurred simultaneously and ended simu... Read more
Fever (101.5) that lasted about 6 hours a severe headache the occurred simultaneously and ended simultaneously
51 2021-03-31 headache I suffer from Tinnitius, and my tinnitus has doubled in severity since receiving the vaccine; I also... Read more
I suffer from Tinnitius, and my tinnitus has doubled in severity since receiving the vaccine; I also experienced a number of non-headache migraine symptoms, including aura, eye strain, head, neck and eye strain, scalp sensitivity, light sensitivity, spotty and blurry vision, difficulty focusing and brain fog
51 2021-03-31 influenza like illness, chills, headache, fever Flu like. Body/head aches. Chills. 102 fever. Took ibuprofen. Lasted approx 24 hrs.
51 2021-03-31 throat irritation Pt arrives to the observation are after his injection feeling a little dizzy and experiencing scratc... Read more
Pt arrives to the observation are after his injection feeling a little dizzy and experiencing scratchiness in his throat. He arrives via wheelchair eating gold fish and drinking water. 1338 BP 144/97 HR 78 Oxygen room air 98% 1345 pt states he is feeling better "back to normal" 1350 pt released from observation to exit with wheelchair
51 2021-04-01 fatigue Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and sw... Read more
Sore arm for two days, mild general fatigue, but at -37 hours post-vaccine, upper lip itched and swelled slightly. Went down after taking a Benadryl.
51 2021-04-01 headache has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringin... Read more
has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
51 2021-04-01 fever, chills, fatigue Extreme tiredness. Minor Chills. Minor fever.
51 2021-04-01 fever, chills Pfizer shot at 11:30am, April 1 Reactions 3:30am, April 2: chills, fever, body aches, dry mouth
51 2021-04-01 fever, headache, chills, fatigue Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All las... Read more
Pain in left arm. Fever (102.7). Chills. Fatigue. Headache. Dizziness. Light-headedness. ... All lasting at least 15 hours. Cleared upby the next morning.
51 2021-04-02 body temperature increased, fatigue Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 tempera... Read more
Severe pain in shoulder, to where I could not lift arm, Felt like 20 hornets stung me, 100.4 temperature, fatigue, and had the shakes. This was from Wednesday night through Thursday. Felt better on Friday.
51 2021-04-02 headache, chills mild hives/rash on upper chest and back, itchy; no rash on right arm where shot was given. Hives wit... Read more
mild hives/rash on upper chest and back, itchy; no rash on right arm where shot was given. Hives with itch appeared about 3 hours after the shot was given, along with an itchy feeling in mouth and on tongue and feeling of strangeness in throat. I felt mostly normal during the 30 minutes after the shot, but developed a headache, chills, mildly upset stomach. I have anxiety issues and was nervous about getting shot so was hesitant to label anything as a side effect as it could be anxiety/panic disorder etc. But the rash/hives are itchy - I showered which made them itchier. I'm submitting this @ 10:30pm EST, my shot was @ 2pm EST - I have taken more zyrtec worried I am having an allergic reaction. I am filing this because I am worried about the 2nd shot - I do not want to have a worse allergic reaction after the 2nd shot. I will call my allergist. He manages my allergies and advised me to continue taking my seasonal allergy meds and zyrtec as normal during the shot today. Presently there are no hives/itch on any other parts of my body except my upper chest and upper back.
51 2021-04-02 influenza like illness, fever, sweating, chills after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking... Read more
after 4 hours - sore arm - this was expected. After 10 hours - body cold - skin dry - severe shaking / teeth chattering - uncontrollable - then sweating / cycle hot & cold. Cannot stop shaking. Severe lower body aches - from hips down - bones aches. After 30 hours - fever of 102.1 for around 2 hours. seems like a sever flu. After 48 hours - feeling much better - low fever - 100 all day Friday April 2nd. Good nights sleep - feel great Saturday April 3rd - temp at 99.
51 2021-04-03 headache, chills Note: These symptoms are from the second injection of the vaccine; first was March 11...no problemat... Read more
Note: These symptoms are from the second injection of the vaccine; first was March 11...no problematic symptoms from that one. Symptoms started at midnight on April 2 (10 hours after injection) with chills, not sure if accompanied by fever. By 8:00am, chills subsided, but had body aches and headache the rest of the day and though the night. Ended by 8:00am on April 3.
51 2021-04-05 fatigue, headache Tachycardia, hypertensive spike with dizziness lasting approximately one hour. Extreme nausea and ac... Read more
Tachycardia, hypertensive spike with dizziness lasting approximately one hour. Extreme nausea and acute headache lasting two hours after onset. Extreme fatigue lasting 4 hours with moderate headache and fatigue lasting into the night.
51 2021-04-05 fever, influenza like illness Mild flu-like symptoms: aches, mild fever, nausea, vomited once, the worst symptom was lower back pa... Read more
Mild flu-like symptoms: aches, mild fever, nausea, vomited once, the worst symptom was lower back pain, it was pretty bad. I had covid last year but didn't have any issues with lower back pain then.
51 2021-04-05 fever muscle pain, joint pain, fever
51 2021-04-06 fatigue, fever Body aches, fatigue, and low grade fever (99.2 to 101.2) for 24 hours. Symptoms started about 12 h... Read more
Body aches, fatigue, and low grade fever (99.2 to 101.2) for 24 hours. Symptoms started about 12 hours after vaccination.
51 2021-04-06 headache Left arm extremely sore at injection site, very strong nausea and headache
51 2021-04-06 fever Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to ... Read more
Sore arm that developed into very painful area on left side of ribs as well, fever for 3 days up to 101 degrees
51 2021-04-07 headache Started with dizziness in the morning around 7 AM when woke-up and then nausea and vomiting till app... Read more
Started with dizziness in the morning around 7 AM when woke-up and then nausea and vomiting till approx. 4 PM. No other medicines were taken to treat these symptoms. Due to minor to moderate to headache, took extra strength Tylenol around 4 PM. After 7 PM, felt better and no signs of these symptoms.
51 2021-04-07 throat pain, fatigue, headache, fever First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101... Read more
First symptom was weakness and fatigue approximately 8 hours after injection. Onset of fever of 101? F approximately 12 hours after injection, 24 hours after onset still had 100? F temperature, gone by beginning of day 3. Headache and body aches that lasted about 3 days. After fever was gone the weakness/fatigue/headache/body aches lasted an additional 12 hours or so. Approximately a day after all these symptoms disappeared I got a very minor sore throat and some congestion that has lasted a couple of days. Treatment was Alleve every 8 hrs, lots of fluids and rest.
51 2021-04-08 chills, fever 101.2 deg fever, chills, muscle ache, joint pain lasting ~18 hours. Significant elevated tinnitus s... Read more
101.2 deg fever, chills, muscle ache, joint pain lasting ~18 hours. Significant elevated tinnitus symptoms. See also temporary VERS #414207
51 2021-04-08 malaise, fatigue, chills I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I ... Read more
I received the vaccine at 12:15 PM. I was a little tired but generally fine the rest of the day. I woke up at 2:30 and didn?t feel well. I got up to go to the bathroom. I started getting the chills and feeling dizzy. I passed out. My wife found me passed out on the ground and bleeding. I needed six stitches in my head and have a black eye as well as other facial lacerations. I have no recollection of anything until my wife woke me. I have never passed out in my life prior to this.
51 2021-04-09 headache, chills, fatigue About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, h... Read more
About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, headache, tired, chills. During the course of about 4-5 hours after the vaccination, I had other symptoms such as an urge to urinate, accompanied by pain and burning. Pain in the ribs, back, left arm, diarrhea, felt like inflamed lungs and shortness of breath. Today and 3 days later I still have diarrhea, headache, fatigue and pain when urinating.
51 2021-04-10 fatigue I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for tw... Read more
I had the usual sore arm, fatigue, and body aches. But the one side effect I had was insomnia for two days. I missed work the day after receiving the shot (Wednesday). Went to work on Thursday with no sleep. Missed on Friday due to not being able to sleep.
51 2021-04-11 body temperature increased, fatigue, chills SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT... Read more
SORE ARM, EXHAUSTED ON SATURDAY. SUNDAY MORNING TEMP OF 102, NAUSEA, CHILLS, JOINT PAIN ITCHING LEFT NECK AND LEFT FACE FAST HEART RATE (102 AT REST NORMAL IS 60 AT REST) CONTINUED TO MONDAY MORNING.
51 2021-04-11 chills, fever, headache From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alter... Read more
From 4pm Saturday including all day Sunday I had fever and chills, low energy, and headache. I alternated between Tylenol and Advil to treat fever symptoms.
51 2021-04-11 chills, fever 9 days after vaccine mild fever jumped to 101.9. fluctuated between 100.5 and 103.1 for 7 days. Feve... Read more
9 days after vaccine mild fever jumped to 101.9. fluctuated between 100.5 and 103.1 for 7 days. Fever also brought Diarrhea, severe nausea, muscle aches, chills and stomach pain. Took Tylenol, Ibuprofen, Nyquil and nothing broke the fever. Today, day 8 fever is starting to break but still have other symptoms.
51 2021-04-11 chills It started feeling current in the posterior part of the body, then it started pain in the whole body... Read more
It started feeling current in the posterior part of the body, then it started pain in the whole body that continued to increase and burning sensation in the skin, chills, felt like was burning, marked respiratory difficulty, sensation of asphyxia, pain in the ribs, urinary retention, hematuria, liquid diarrheas, trembles, pain in the ribs and pain in the left arm (contrary to the one injected). Took Tylenol 500 mg 2 tabs q 4 hrs
51 2021-04-12 cough, fatigue Vomit, cough, tired, diarrhea for 3 days. Edema, hospital ization
51 2021-04-12 sinus headache awoke this morning with ringing in right ear, ear clogging (same ear), minor right side sinus headac... Read more
awoke this morning with ringing in right ear, ear clogging (same ear), minor right side sinus headache,
51 2021-04-14 chills, fatigue, headache, fever High fever, chills, headache, nausea, tiredness, overall bad feeling
51 2021-04-14 headache Light Headache followed by mild nausea.
51 2021-04-14 nasopharyngitis DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3/... Read more
DEVELOPED BELL?S PALSY - DIAGNOSED 4/14/2021 COLD SYMPTOMS DEVELOPED 8 DAYS AFTER SECOND SHOT (4/3//2021), AND THEN FACIAL PARALYSIS WITH BELL?S DIAGNOSED ON 4/14
51 2021-04-14 fever, chills fever and chills with severe shaking that lasted for about three hours
51 2021-04-15 headache Approximately 2 hours after the injection i developed a headache which became very severe and lasted... Read more
Approximately 2 hours after the injection i developed a headache which became very severe and lasted for seven and a half hours. The headache the became moderate and lasted for two more days. I self treated and used Tylenol to manage the headache.
51 2021-04-15 headache The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with head... Read more
The day after my vaccination I felt like I had mild to moderate flu symptoms, achy, stuffy with headache. The day after that the flu like symptoms abated, but then were replaced with muscular and joint soreness, especially in the lower legs. It felt like my calf muscles were going to charlie horse at any moment. Also, I experienced random muscle twitches throughout my body, but mostly in the calf region. This muscular twitching has continued for two weeks now, though it has abated to some degree in terms of frequency and intensity. The muscle twitching is the reason that I'm writing this report. I expected that I might have flu like symptoms, but not twitching muscles all day and night.
51 2021-04-15 malaise, body temperature increased Felt horribly ill for two days, as if I had the flu. Very painful body aches and 102 degree fever.
51 2021-04-16 headache Vision impairment after about 60 minutes of receiving the shot that lasted for 6 hours; Blurred visi... Read more
Vision impairment after about 60 minutes of receiving the shot that lasted for 6 hours; Blurred vision, unable to read.; soreness; light headedness; I had the expected symptoms of headache; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732), at right arm via an unspecified route of administra-tion on 27Mar2021 10:30, as SINGLE DOSE for COVID-19 immunisation. Medical history included low iron and anemia. Concomitant medications included montelukast sodium (SINGULAIR) and omepra-zole (PRILOSEC [OMEPRAZOLE]), patient received these medications within 2 weeks of vaccination. Patient was allergic to IV contrast dye and salicylates. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. After about 60minutes of receiving the shot (27Mar2021 11:30) the patient had vision impairment lasted for approximately 6 hours. Patient had blurred vision and unable to read. Patient had the expected symptoms of headache, soreness, light headedness, etc. But was not expecting vision to be decreased. Patient not received treatment for the adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the event visual impairment was recovered and for the other events its recovering.
51 2021-04-17 headache, sleepiness headache, severe drowziness. i couldnt get out of bed for 2 days.
51 2021-04-18 fatigue I was extremely fatigued with muscle soreness especially in my left arm pit. As of 4/18/2021 I notic... Read more
I was extremely fatigued with muscle soreness especially in my left arm pit. As of 4/18/2021 I noticed a large knot/lymph node in my arm pit and the soreness was constant.
51 2021-04-18 fatigue Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve sw... Read more
Fatigue, weakness, achiness- especially in legs Now is in the hospital due to severe optic nerve swelling behind both eyes
51 2021-04-18 fever, chills, headache, influenza like illness Herpes-type cold sores around mouth and anus and ulcer on tip of tongue. Along with flu-like sympto... Read more
Herpes-type cold sores around mouth and anus and ulcer on tip of tongue. Along with flu-like symptoms including fever, muscle aches, chills, headache, stomach pain, diarrhea, nausea
51 2021-04-18 fever Body Aches, onset: 4/17/2021 Body Aches, continues 4/18/2021 Fever Onset: 4/18/2021 Fever (back to ... Read more
Body Aches, onset: 4/17/2021 Body Aches, continues 4/18/2021 Fever Onset: 4/18/2021 Fever (back to normal) 4/19/2021
51 2021-04-19 chills, malaise Patient described body aches, chills and general unwell feeling beginning the evening after vaccinat... Read more
Patient described body aches, chills and general unwell feeling beginning the evening after vaccination and lasting for about 3 days. Patient self treated with OTC medications. Patient was covid positive last fall.
51 2021-04-20 fatigue Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brai... Read more
Become so forgetful since I had the injection that it feels like I have Alzheimer's; brain fog; Brain fog and fatigue is unreal/fatigue; chilling pain; it feels like I have Alzheimer's; Arm is till really hurting; Hematoma; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included ongoing hypertension, anxiety, blood cholesterol increased, hypertriglyceridaemia, covid-19 from Sep2020 ("My wife was tested positive, I had it back in September, my wife was tested positive in January and that's when I started experiencing loss of smell and taste). Concomitant medications included lisinopril taken for hypertension, propranolol taken for hypertension, alprazolam (XANAX) taken for anxiety, atorvastatin calcium (LIPITOR) taken for blood cholesterol abnormal, bacopa monnieri, eleutherococcus senticosus root, rosmarinus officinalis essential oil, schisandra chinensis fruit (BACOPA COMPLEX) taken for hypertriglyceridaemia. On unknown date patient experienced "become so forgetful since i had the injection that it feels like I have Alzheimer's", fatigue, brain fog, chilling pain and on 01Apr2021, arm is till really hurting and hematoma (described as I went to ER last night and he said that the pharmacist might have punctured a vain or a capillary). Patient had no temperature, blood pressure is normal, patient stated he never had anything like that from other vaccines.
51 2021-04-20 fatigue Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired... Read more
Really sore arm all the way to my hand, around my neck and shoulder where the shot was given. Tired and fatigued really bad. Barely get moving every day since shot.
51 2021-04-20 headache Severe body aches. Pain in the injection site. Extreme body shakes. Headaches and back pains.
51 2021-04-21 chills, headache, fatigue Woke up feeling tired with mild body aches. Chills began at 10AM and lasted four hours. When the ch... Read more
Woke up feeling tired with mild body aches. Chills began at 10AM and lasted four hours. When the chills stopped the headache began and felt like a vise on the side of my head. Advil helped a little. The aches and headache continued until approximately 11PM the same day. Then suddenly everything faded away. This episode felt very similar to an illness I had in November 2019 when I also had a bad cough that lingered for four weeks. This was a month before the first public reports of COVID. The headache during both events is so distinct. I have never felt anything else like it. During the post 2nd dose of vaccine event I needed only a few tablets of Advil to control the headache and body aches. I drank plenty of water and rested. My appetite was not affected and I was able to rest and sleep. Overall the event last approximately 12 hours and disappeared as quickly as it began.
51 2021-04-21 influenza like illness, fatigue Severe fatigue. Arm soreness. Light nausea. Flu-like symptoms
51 2021-04-21 malaise i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccina... Read more
i experienced cold sweats and an unwell feeling shortly after injection. I passed out at the vaccination site and was taken by ambulance to the medical center yesterday, april 21st around 356pm.
51 2021-04-22 chills, headache, throat pain Day 7, intense headache for no reason that lasted for 3 hours, with chills. 3-4 hours later experien... Read more
Day 7, intense headache for no reason that lasted for 3 hours, with chills. 3-4 hours later experienced tingling on lip and within 15 minutes a large cold sore developed on the lip, along with a tender node under chin beneath the sore, leading up to a sore throat. Also noticed the day after both shots I was highly sensitive to the sun and my forehead got discolored blotchy red/brown (similar to a bad sunburn but without the pain) that took a day to mostly go away, but still has hints of it. Cold sore is subsiding but expect it to last at least a week. Haven?t had them in a long time, but recognize it.
51 2021-04-22 fever, fatigue, headache, lethargy 102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced w... Read more
102 degree F Fever - 4 hours reduced with Advil Mild 99 - 100 degree F fever for 1.5 days, reduced with Advil Severe headache for 4 hours followed by mild headache for 3 days reduced with Advil Sore achy muscles in arms and legs - 2 days Sore joints, knees, elbows shoulders - 2 days Tired and lethargic for 2 days.
51 2021-04-23 chills, headache severe chills, severe body aches, headache, loss of sleep night following shot used ibuprofen took s... Read more
severe chills, severe body aches, headache, loss of sleep night following shot used ibuprofen took several days to be back to normal
51 2021-04-23 fatigue, headache, fever Feverish, muscle & joint aches, headache, fatigue
51 2021-04-23 fatigue, nasal congestion, runny nose joint pain; tired; congestion; body aches; Runny nose; This is a spontaneous report from a contactab... Read more
joint pain; tired; congestion; body aches; Runny nose; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received first dose of BNT162B2 (Pfizer Covid Vaccine, solution for injection, Lot# unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 14:00 (at the age of 51 years-old) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 at 14:00, patient experienced joint pain, tired, congestion, body aches, runny nose. The patient had no known allergies. The outcome of all the events was recovering. Information on Lot/Batch number has been requested.
51 2021-04-24 fatigue Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Pati... Read more
Patient had first dose on 4/1/21 he developed fatigue and muscle cramps lasting about 36 hours Patient had second dose 4/22/21 and once again developed muscle cramps. He also started to have vision changes, increase thirst, and blood sugar spikes between 400-500. He is not a diabetic
51 2021-04-25 chills Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to ... Read more
Migraine headache that persisted the entire day. Took a Bayer Back & Body Extra Strength (500mg) to attempt to get rid of itarround noon. Headache only lessened slightly but persisted. Cold chills began in the late afternoon and persisted into the evening. No fever was detected when checked. Took a second Bayer Back & Body Extra Strength around 8pm before bed. Fell asleep about 10pm. Woke up with alarm at 2am. Clothes had a feeling of having absorbed a cold sweet while asleep. Cold chills no longer present, migraine headache no longer present.
51 2021-04-25 fatigue, headache Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode ar... Read more
Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like just got over a chest cold or bronchitis or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.
51 2021-04-25 sweating, fatigue syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migr... Read more
syncope, followed by profuse sweating, patient fainted twice., very low blood pressure, severe migraine and vomiting EMS called after prolong time of syncope and vomiting. Patient refused travel to ER. I followed up a call to the patient later in the day and patient was tired but had fully recovered.
51 2021-04-25 sweating, headache patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to... Read more
patient having reaction to pfizer shot given on april 11th. patient states symptoms from numbness to extremities, shortness of breath, sores on lip, headache, yellow eyes, weakness. on 4/25 Overnight he felt very "hot", like he was breaking a fever, but was not febrile per vital signs. He sweated and then noticed bubbling of his skin on both hands and feet and then those bubbles popped and his skin is peeling now.
51 2021-04-26 lethargy, fever, chills Symptoms began with soreness, redness, and swelling at injection site. Symptoms progressed to low gr... Read more
Symptoms began with soreness, redness, and swelling at injection site. Symptoms progressed to low grade fever, chills, and lethargic. All symptoms except arm soreness gone within 24 hours. Arm soreness persisted for almost 48 hours.
51 2021-04-27 lethargy Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen... Read more
Swollen glands in neck at collarbone, arm pit and groin area upon awaking on day three. All swollen glands were on the side the injection was given, and are visible to the naked eye. Physician advise taking Benadryl and consult them in 24 hours if effects continue. First dose side effects were shaking, rapid heart rate, and lethargic, lasting 2 weeks. These side effects were not present with second vaccine at this time.
51 2021-04-28 headache, sinusitis Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side we... Read more
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS. Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
51 2021-04-28 sweating, chills 50 y/o male, with past medical history of HTN, who presents with dizziness, palpitations and diaphor... Read more
50 y/o male, with past medical history of HTN, who presents with dizziness, palpitations and diaphoresis onset post vaccination. Patient states that this is his first vaccination in the two-dose series. Patient received the vaccination to his R arm. NP and Paramedics at patient side. Patient provided with bottle of water and legs were elevated. Patient initial BP was elevated, 159/96, but states that is normal for his history of Hypertension; all other vitals within normal limits (97% RA, 78 HR, Resp 14). Patient glucose was 131 but states that he had a protein shake prior to arrival. Approximately after 10 mins of observation patient stated that he was getting better but then developed chills and palpitations continued. Patient at this time placed on stretcher and was moved to a private area. EKG was obtained and patient noted to be Sinus Tachycardia with HR of 111. Patient with diaphoresis again and BP increased to 158/104. It was determined at this time by the NP that patient needed to be transported to the ER. Fire rescue arrived at site. Patient was evaluated, EKG was obtained and normal. Patient stated that he felt better, and all symptoms resolved. Patient stated that he did not wish to be transported to the ER. Patient signed out AMA with Fire Rescue as well as with the NP. CNO and PM aware.
51 2021-04-28 sweating, nasopharyngitis PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS... Read more
PATIENT FELT DIZZY, FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS, FELT COLD , CONFUSED AND WAS SWEATING. CALLED EMS AND THEY DID A ROUTINE CHECK, ALL VITALS WERE NORMAL AND PATIENT REFUSED HELP
51 2021-04-28 sweating Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; P... Read more
Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
51 2021-04-29 fatigue, influenza like illness, chills Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints,... Read more
Within a day of 2nd Pfizer dose (intramuscular, left shoulder) had flu-like symptoms (aching joints, tired, chills, swelling under jawline, metallic taste in mouth) but they disappeared by third day from date of vaccination. By the 10th day after vaccination had developed intense shoulder pain radiating from shoulder to mid-arm (left arm) and upper back (trapezius/neck). Went to local Urgent Care next day and was X-rayed and given the following: Methylprednisolone - 4MG (tapered dosage) ? Shoulder/trapezius muscle pain/inflammation Cyclobenzaprine - 10MG ? Muscle relaxant for shoulder/trapezius muscle pain/inflammation. By end of tapered does still feeling intense ache/throb and pain in same areas.
51 2021-04-29 influenza like illness I have a gastric band. After my perfectly ordinary flu like symptoms cleared up, I found myself unab... Read more
I have a gastric band. After my perfectly ordinary flu like symptoms cleared up, I found myself unable to eat or drink, even clear fluids. It seemed as though I was more inflamed due to the vaccine at areas where there are medical devices implanted - such as my gums around a crown. I was unable to drink or eat for a total of six days.
51 2021-04-30 headache, fatigue Received the shot around 10:15 am on 30 April 2021 at a public vaccination clinic at a community cen... Read more
Received the shot around 10:15 am on 30 April 2021 at a public vaccination clinic at a community center. I didn't expect any side effects as no one I know has had any from the first shot. However, within about 2-3 hours started to feel mild body aches similar to when you have the flu coming on and minor fatigue. Nothing debilitating. Ended up taking a few long naps during the day and not getting much work done. By the evening I had a very slight headache at the base of my neck which was probably related to the sore muscles. Also noticed that the soles of my feet were a little sore which seemed unusual. Went to bed around 11:30 pm on 30 April. Woke up around 3 am on 1 May and just felt "off." I could still feel body soreness but also had developed a strong metallic taste at the back of my mouth and into my throat. Drank a lot of water to try to see if that changed anything but it didn't. Woke up around 7 am on 1 May. Body was very sore (like from a major workout), bottoms of feet still tender, minor headache and strong metallic taste. Tried to work on some things but ended up going back to bed around 8 am for a few hours. Woke up around 10 am and feel much better. Minor body aches (including the sore feet, which is weird) and just a minimal metallic taste.
51 2021-04-30 sleepiness 04/05/2021 - Inflamation in neck and shoulders. 04/06 to 04/09/2021 - Began experiencing double visi... Read more
04/05/2021 - Inflamation in neck and shoulders. 04/06 to 04/09/2021 - Began experiencing double vision and felt pressure behind right eye. Slept nearly all day during this time frame. 04/12/2021 (12:20pm) - Phone appointment with primary care doctor to discuss symptoms experienced after receiving Pfizer vaccine. Office vist scheduled for 04/22/2021. 04/22/2021 (11:50am) - Office visit to Dr. Continued to experience double vision and pressure behind right eye in the interim. Referred to opthamologist and ordered MRI. 04/27/2021 (3:15pm) - Office visit to Dr. No evidence of detatched retina, eye pressure normal. Agreed that MRI needed.
51 2021-05-01 headache, chills At 7:30 p.m. on the day of the vaccine, I started to feel chills, which steadily increased throughou... Read more
At 7:30 p.m. on the day of the vaccine, I started to feel chills, which steadily increased throughout the evening. My temperature increased from 97 to 104.4 over the next 6 to 7 hours and stayed above 100.4 until about 24 hours after initial symptom onset. The chills subsided as my temperature declined. I felt drained, had no appetite, and had a low grade headache that intensified on movement, particularly bending over. The headache, lack of appetite and energy, lingered after the chills and fever had subsided into the following day (5/1). On 5/2, I felt much better and was up and about at 80% of normal activity. I expect to be fully back to normal tomorrow.
51 2021-05-01 headache, fatigue Approximately 24-36 hours after receiving my second dose of the Pfizer COVID-19 vaccine I started ha... Read more
Approximately 24-36 hours after receiving my second dose of the Pfizer COVID-19 vaccine I started having three noticeable side effects: pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds. These symptoms have not subsided and the arrhythmia became persistent enough last night that it required a trip to the local ER. The first doctor I spoke to, informed me that he had been out of work for a week following his second dose of the Pfizer vaccine due to transient, but consistent, heart palpitations, which ultimately brought him into the ER to take his own EKG. He advised me that a number of other patients with identical complaints had come to the ER over the last 4-5 weeks. Ultimately he referred me to a local cardiologist and told me not to worry about the arrhythmia, that it would clear up in a few days. I?m curious why this isn?t listed as a common side effect of the vaccine, had it been, I would not have been so concerned about it.
51 2021-05-03 sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Mediu... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Anixety-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Additional Details: Patient discussed vaccination with immunizer for a few minutes before injection was given. After the injection was given, patient experienced brief syncope episode with brief 2-3 seconds of "seizure-like" activity. Patient woke back up and was pale and diaphoretic. EMS services were activated and patient rested, given water and orange juice. Maintained a slow, steady heart rate of 48 bpm while awaiting EMS. EMS evaluated patient and transported to hospital
51 2021-05-04 fatigue, headache on same day: headache a 10 hours after application small left arm pain... Read more
on same day: headache a 10 hours after application small left arm pain next day: morning ok after 34 hours heavy headache, nausea, strong left arm pain two days later: morning ok 60 hours mild headache, mild left arm pain three days after: tiredness at the end of the day Fourth day: back to normal
51 2021-05-04 fever, chills, headache High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminoph... Read more
High fever, chills, nausea, headache, during 12-24 hrs after injection. Treated with (1) Acetaminophen (500mg) every 6 hrs (2x total) . Periodic sharp pains in legs (calves) about 25-27hrs causing awakening from sleep. Took 320 mg aspirin, symptoms alleviated.
51 2021-05-05 cough, headache, chills, fatigue Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, ... Read more
Since my 2nd Pfizer vaccination, I have been experiencing consistent fatigue, weakness, body aches, chills, headaches, brain fog, and an itchy cough.
51 2021-05-06 headache Headache, Injection Site Pain, Diarrhea, Headache, Minor Muscle Pain (Legs)
51 2021-05-06 headache Mild headache following second shot that has lasted 3 months. Dreams more frequent, vivid, very diff... Read more
Mild headache following second shot that has lasted 3 months. Dreams more frequent, vivid, very different than prior to vaccine.
51 2021-05-06 throat pain, nasal discomfort, fatigue, paranasal sinus discomfort, upper-airway cough syndrome, cough Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burnin... Read more
Post nasal drip, sore throat, cough, sinus pressure, nasal irritation, fatigue, night sweats, burning in chest stay well-hydrated and well-nourished while resting appropriately For cough: honey 1 to 2 teaspoons every 4 hours can help to quiet a cough buPROPion SR (WELLBUTRIN SR)
51 2021-05-07 chills, fatigue, headache woke up to severe chills and body aches, headache and extreme pain at both injection sites. fatigue.
51 2021-05-07 headache, cough, fever Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Sk... Read more
Symptoms: Headache: stabbing pain headache especially right temple Tinnitus: ringing in right ear Skin: rt ear red, swollen & bumpy. hair / scalp pain sensitivity Dizziness / Vertigo: Equilibrium and balance are off, walking like a drunk. Vision swims on head turn, phone appears to rotate in dark. Slight associated nausea. Occasional dry cough causing headache to explode. Progression SUNDAY 4/18/21 Second shot pfizer COVID-19 vaccine Gradual onset starting Thursday 4/22/21 (Day 4 since vax) or Friday (day 5 since vax.). SATURDAY 4/24/21- day 6 (since vax) , 0 (since full onset) - sharp stabs of headache every once in a while, noticed at game & really set in in evening. Feverish at night. SUNDAY - day 7,1 - low energy, body aches, difficult to get out of bed, 3 hour nap, severe headache. MONDAY - day 8,3 - Dr 9:45. 185 lbs, 97.8. Flu, strep, COVID negative. 5 day course of steroids, Start Flonase, Still fairly dizzy TUESDAY - day 9,4: Significant headache still but manageable with acetaminophen. Balance issues, vertigo? WEDNESDAY day 10,5 - 5:30am - Awakened by splitting headache. feverish. 1 acetaminophen, 1 chlorphenirmine @ 6am. By 10 AM, headache is back, high sensitivity to loud noise. Difficulty walking straight. THURSDAY day 11,6- 5:30am - awakened by splitting headache, 99.9 deg. 2 x acetaminophen. FRIDAY- calls back, Will call in a prescription for anabiotic, meclizine. SATURDAY 4:30am 2 x Acetaminophen 4am. first antibiotic @ noon , Diarrhea & cramping 7pm. Probiotic. 11 PM: 2X acetaminophen, anabiotic. SUNDAY- antibiotic 8, probiotic 10, Meclizine noon. TUESDAY- day 11 - Didn?t sleep well; 1x acetaminophen @ 5am. Headache pulse WEDNESDAY- Day 12 - 1x acetaminophen @ 1am, Headache seems just enough to prevent sleeping well without meds. Dizziness continues at same level. Meclizine doesn?t work. THURSDAY - Second visit with Dr : might be shingles based on lesions on ear, will prescribe anti-viral. Less likely: Ménière?s, something else. Call on for MRI Monday if symptoms not resolved. SATURDAY 5/8/21 - Day 15-still on antibiotic and antiviral, neither seems to be doing anything. Headache mostly gone, but dizziness /vertigo persist. Can not successfully walk heel to toe without falling over.
51 2021-05-07 malaise Pharmacist came to observation area noticed MD and EMT with client. Client reportedly per OBservati... Read more
Pharmacist came to observation area noticed MD and EMT with client. Client reportedly per OBservation Lead was complaining of not feeling well, feeling dizzy and having blurred vision. Client was intially refusing to provide us with his information. Per EMT clients BP 202/127 oxygenation 97% HR 85, client declined Blood Sugar check. MD advised client to go to ER due to BP, EMT called paramedics at approx 350pm. Paramedics arrived at 4pm repeat BP 200/130 agreed to transport to hospital. TRansferred to doctors hospital at 0405pm
51 2021-05-08 headache, fever, chills, fatigue I received my first Pfizer Covid-19 vaccine shot on March 5, 2021, and my second shot on March 26, 2... Read more
I received my first Pfizer Covid-19 vaccine shot on March 5, 2021, and my second shot on March 26, 2021. After my first shot, I had minor chills, no fever, and was a little tired for two days. However, approximately 12 hours after my second shot, I had a 101.0 F fever, with a heart rate of 105. I did not take any fever reducing medicine. I had a fever for two days, and slight elevation in my temperature on the third day. My heart rate decreased over the second and third day, and went back to my normal 50s-60, four days after my second shot. I had slight nausea the first day, and a loss of appetite two additional days. My appetite is now back to normal. Furthermore, I had a lot of soreness in my lower back, neck, shoulders, and knees that lasted 5 or 6 days after my second shot. Also, I had a low-level intermittent headache the first day after the second shot. In addition, I had significant chills that lasted 10 days after the second shot. My chief complaint is feeling very lightheaded / unsteady when in a standing position. Also, my exercise routine has suffered the past month. I only walk 15 to 20 minutes and feel very tired. Certainly, not a normal feeling for me. I feel very tired over the past month and a half since my second shot. I have checked my EKG a few times over the past 6 weeks. It is my normal EKG, (RBBB and LAFB) and remains unchanged.
51 2021-05-09 runny nose, nasal congestion Sinus issues since 2 days after first shot. Been almost 2 months of congestion/ runny nose. daily OT... Read more
Sinus issues since 2 days after first shot. Been almost 2 months of congestion/ runny nose. daily OTC medicine including Zyrtec, day-quil sinus helps for a little while but have to keep taking it. Never had allergies last this long. EVER..
51 2021-05-10 fatigue, headache, cough, dehydration, chills, fever, pneumonia dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat an... Read more
dehydration; low blood sugar; fatigued; Appetite; Pneumonia; Night sweats; Headache; Couldn't eat anything; Wheezing; migraine; Light, hacking cough; Fever/ 103.9 degrees; Chills; No more than 2-3 hours of sleep per night for 5 nights; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received the second dose of BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration, administered on left arm on 14Apr2021 10:45 (Batch/Lot number was not reported) at age of 51 years as single dose. The patient medical history and concomitant medications was reported as none. Historical v for covid-19 immunisation accine included the first dose of BNT162B2 administered on left arm on 24Mar2021 at age of 51 years for covid-19 immunisation and experienced no issues. Patient reported that after the second dose of the Covid-19 vaccine, he had a fever for 8 days and was diagnosed with pneumonia on 21Apr2021. Patient reported that he was tested for both Covid-19, Influenza A, and Influenza B twice on 19Apr2021 and 21Apr2021 and tested negative for Covid-19 and influenza both times. Patient reported that he had no pre-conditions and that he was feeling great the night before he received the second dose of the Covid-19 vaccine, 13Apr2021. Patient reported that he was planning to go to work following the second dose of the Covid-19 vaccine on 14Apr2021. He began running a low-grade fever (102 degrees) on 14Apr2021 after receiving the Covid-19 vaccine and then his temperature flared up to 103.5 degrees on 15Apr2021. Fever: He received the second dose of the Covid-19 vaccine at 10:45 on 14Apr2021 and about 2:00 in afternoon on 14Apr2021 was the first fever that was significant. The last fever he had on 21Apr2021, his temperature was 103.9. He was put on antibiotics for pneumonia. He contacted the on-call nurse for his company. The on-call nurse advised him to see a doctor on Saturday, 17Apr2021.He went to the doctor on Monday, 19Apr2021. The doctor only ran a Covid-19 swab for testing and a flu swab. His doctor did not do blood work and stated that the patientwas experiencing an ill effect of the Covid-19 vaccine and sent the patient home. He went back to the doctor on Wednesday, 21Apr2021. When he went back to the doctor, the staff performed a chest X-ray and ran 4 different blood works to see what the patient had. The second Covid-19 test that he received on 22Apr2021 was performed with both the rapid test and the test that was sent off. Both Covid-19 tests came back negative. SARS test on 22Apr2021 was negative. 508-3 High Sensitivity CRP: One of his numbers that was parts per liter, 3 is considered to be high risk and he had 300 (300+) of whatever it was on 21Apr2021. He went back to the physician and was given another steroid shot an additional prescription. He had been back to the doctor 3 times since then. Fever: His fever was 103 consistently after 15Apr2021. 508-3 High sensitivity CRP: This value showed abnormal. The results said that relative risk was greater than 1 mg/liter and high was greater than 3. 1000 CBC with auto differential on 21Apr2021: The abnormal results were red blood cells measured at 4.38; hematocrit measured at 13.82; MCHC measured at 36.4; Neutrophils measured at 84; Lymphocytes measured at 12; and absolute Lymphocytes measured at 0.57. He wore a Garmin and that it recorded that he received no more than 2-3 hours of sleep per night for 5 nights. He didn't know anything about pneumonia previously and that he had specifically told his physician's office everything about what he was experiencing. He told his physician about the wheezing in his chest (on 17Apr2021), cough (on 16Apr2021), fever, and chills (on 14Apr2021). His physician told him it was a normal reaction to the Covid-19 vaccine and sent him home on 19Apr2021. He then consulted Google and started to realize that his side effect were very atypical. Wheezing: When he breathed really light, the crackling would continue. If he breathed shallow, the wheezing was audible but if he breathed deeply, it was not. The pneumonia was in the left side of his chest. He was still being treated for the pneumonia. He has his last dose of medication tomorrow, 27Apr2021, and that he was also being released to go back to work tomorrow. Cough: He had a little cough that would then go away. The cough began late Friday, 16Apr2021. It was interesting because it wasn't a main part of the illness. The cough was just kind of a hacking cough every once in awhile. The cough was not continuous like go and go and go and stop. The cough came, went away for awhile, then came again.The cough being worse was relative. He was coughing more than he did on Wednesday 21Apr2021, Thursday 22Apr2021, and Friday 23Apr2021. The cough was consistent more so at night when he laid down. He would probably say that it was a different feel towards the cough but it was still a cough. The cough was still the same volume but not the same effect. Headache (on 18Apr2021): He had been waking up with headaches in the morning and going to bed with them at night. On Wednesday, 21Apr2021, the headache was due to dehydration from the fever and night sweats. Once he got away from the dehydration headaches, the headache got better but he had woken up with a headache the last few days and had a headache at bedtime a few nights in a row. The headache was usually a frontal headache and this morning, 26Apr2021, the headache was toward the back of his head. The headaches last a few hours until he started moving around. On Saturday, 17Apr2021 he experienced a migraine that would not go away. He didn't usually get migraines. The migraine lasted hours if not for a day and that the headache was something furious. Sunday 18Apr2021 was pretty much the same thing with the headache. Because of the massive fever, he couldn't eat anything at all (17Apr2021). The headache was mostly due to low blood sugar and dehydration. Appetite: His appetite improved after his second doctor's appointment on 21Apr2021. The second provider was a lot more straightforward and advised the patient that he needed to start taking care of himself and trying to force himself to eat. He forced himself to eat on 21Apr2021 and by Thursday 22Apr2021, he had a full appetite and was craving food again. Shortness of breath (Apr2021): Patient reported that the shortness of breath was just from being fatigued. Patient reported that he got out of breath from going up and down the stairs. He was unsure when the shortness of breath began because he was moving very little, but that he noticed the shortness of breath on Monday, 19Apr2021 when he got up to go to the doctor.On Friday 16Apr2021 and Saturday 17Apr2021, he had a really good break.On Friday 16Apr2021 from 9 AM to 1 PM, he had no fever and it was like the sun was coming out, then the fever hit really hard. The same thing happened on Saturday, 17Apr2021, but the fever free period lasted maybe a little longer. His fever returned and that the afternoon of Saturday 17Apr2021 was the worst he had been the entire time. On 13Apr2021 to get away from arm soreness, he did a few laps in the pool. On 13Apr2021 he had a new best time on the 100 in freestyle in the pool and that he felt really strong going into 14Apr2021 to get his second dose of the Covid-19 vaccine. There was nothing that would have indicated that he had anything going on before getting the second dose of the Covid-19 vaccine. Up until Saturday, 17Apr2021, he had only been taking Motrin and just taking 2 tablets. He had no break in between fevers and chills and was not able to get ahead of the fever with the Motrin. There was a long stretch where the Motrin wasn't working and his temperature didn't get below 100 for several days. He tried to cycle acetaminophen in beginning Saturday 17Apr2021 to try to get the acetaminophen in between the Motrin doses. When he went back to the doctor on 21Apr2021, the provider told him that he could take 3 to 4 Motrin tablets at a time but not to exceed 4 doses per day. He never took more than 3 tablets. Motrin was generic ibuprofen. Night sweats (on 21Apr2021): The last couple of nights have been the same. He had a fan on to keep a little cooler and that it was 61 degrees outside and he felt the night sweats. He had a buckwheat mat that was cool that he put on the floor to stay cooler with the night sweats. Come Thursday, 22Apr2021, he said we're done with this and he couldn't sleep from it (Apr2021). Last night, 25Apr2021, he knew that he had night sweats because he was sweating at night and the temperature in the room was 64 degrees. AEs did not require a visit to Emergency Room. AEs required a visit to Physician Office for fever, wheezing, cough, shortness of breath, chills. Outcome of events was unknown.
51 2021-05-10 headache, malaise Joint Pain; joint pain felt low; Headache; headache wasn't down; Nausea; Feeling unwell/I feel lous... Read more
Joint Pain; joint pain felt low; Headache; headache wasn't down; Nausea; Feeling unwell/I feel lousy; Muscle Pain; muscle pain is much worse; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: ER8731; Expiration Date: 30Jul2021) as single dose for COVID-19 immunisation. The patient medical history included a back issue, but nothing really, overall, patient was pretty healthy. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) for back pain (pain reliever for back) and the dose was 5 to 325 mg. It was reported that possible side effects were muscle pain, joint pain, feeling of unwell, headache, all of those symptoms applied to patient. Patient had not taken anything. Patient just woke, yesterday (14Apr2021) patient felt lousy, the pain in the muscle drop (voice breaking) and he woke up this morning (15Apr2021) and that was when the headache was not down and the muscle pain was much worse, the joint pain felt low, nausea. No treatment was received for the events. Outcome of the events was unknown. No follow up attempts are needed. No further information is expected.
51 2021-05-10 pneumonia N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmol... Read more
N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
51 2021-05-10 fever gums are sore and hurt; can hardly eat anything or hard foods; arm was sore; roof of his mouth and h... Read more
gums are sore and hurt; can hardly eat anything or hard foods; arm was sore; roof of his mouth and his gums hurt and had a burning sensation; got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip.; mouth started itching and weirdness; fever 103-104; woke up shaking really bad; felt hot; This is a spontaneous report from a contactable consumer. This consumer reported that the 51-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer Covid Vaccine, quantity 0.3 and RX7546, NDC number of Covid Vaccine: 59267-1000-01), via an unspecified route of administration, administered in Arm Right on 09Apr2021 15:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included dry age-related macular degeneration from an unknown date and unknown if ongoing, he had appendicitis as a kid and has never smoked and doesn't drink and he goes to the gym and he put on weight after his carpal tunnel surgery. States he body builds all his life and after the surgery he went 3-4 years and stopped working out. States he gained 70-80 pounds and he is back at the gym getting in better shape as he had gotten thicker. The patient's concomitant medications were not reported. The patient experienced arm was sore on an unspecified date with outcome of unknown, fever 103-104 on 10Apr2021 with outcome of recovered on 11Apr2021, got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip on 11Apr2021 with outcome of unknown, gums are sore and hurt on an unspecified date with outcome of unknown, can hardly eat anything or hard foods on an unspecified date with outcome of unknown, woke up shaking really bad on 10Apr2021 with outcome of unknown, felt hot on 10Apr2021 with outcome of unknown , mouth started itching and weirdness on 11Apr2021 with outcome of unknown, roof of his mouth and his gums hurt and had a burning sensation on an unspecified date with outcome of unknown. The clinical course was reported as follows: Caller states he has a question, he had the shot on 9Apr2021 and didn't have problems, his arm was sore and that was a little worse Saturday and Sunday. States Friday into Saturday he got a fever 103-104 all day and it broke Sunday afternoon. States then he got massive blisters all over his mouth inside and out, it was red and irritated bubbles on the roof of his mouth and blisters on his top and bottom lip. States his gums are sore and hurt and he can hardly eat anything or hard foods. Caller is asking is this something normal that happens. Caller provides that he has gotten blisters with high fevers before but nothing like this before. Caller states he is scheduled for the 2nd dose 7May2021 and is wondering if he should take the 2nd part and if he will get a high fever. Caller relays he is prone to fevers since he was a kid. States at 4am into Saturday morning he woke up shaking really bad, his girlfriend took his temperature in his ear and said he had no fever it was 99 but he was shaking. States about an hour later he felt hot and had a fever 103-104, the highest was 104. States he was taking Extra Strength Tylenol and switched off with Ibuprofen until Sunday. States he took Ibuprofen last at 10pm Saturday into Sunday and the fever didn't come back Sunday. States his mouth started itching and weirdness and he figured he would get a blister, didn't get 1 it was the side, top lip, half the bottom lip, inside his mouth, around the edge of his mustache, and was feeling raw on top of his mouth and his gums started to hurt on 11Apr2021. States this is bad, he didn't get blisters really before and now it's a bunch everywhere and he doesn't know if it's from the 104 fever or if it is a combination of the vaccine and the fever he doesn't know. Caller relays that his doctor gave him cream for the inside of his mouth and has stuff for the outside of his mouth, states by Monday it was all over. States he got the cream yesterday, 14Arp2021 for inside his mouth. Provides that it is Triamcinolone 0.1% instructions say don't rub in, take cotton and slowly tap inside mouth where bubbles are. Caller states it creates a paste and doesn't hurt as bad to put something inside his mouth. Caller relays he also got Abreva for the blisters on the outside of his mouth. Caller relays they are getting better and are drying up and falling off. States when he brushes his teeth his says oh my God because the inside is sore so he brushes slow and rinses slow. States the Abreva works really well and the blisters are falling off slowly and he has raw spots on his lips that need to seal up because the skin comes off with the blisters and it's a little raw and he has to be careful with things like citrus. States he had a turkey wrap he had to throw out he couldn't eat it and had tried and his mouth was killing him, the roof of his mouth and his gums hurt and had a burning sensation. Caller relays that the outside of his mouth is getting better faster than the inside because that stays wet and is taking a little longer. Caller states he had coronavirus last Sep2020 and had a fever for 3 weeks straight and got maybe 1-2 blisters, not like now. States he had it for a month and a half. Caller states to prevent from catching it again, it was horrible and he has heard if it comes back it can be worse and kill you. States he had a heavy cough and lost 22 pound when he had it. Caller states he had appendicitis as a kid and has never smoked and doesn't drink and he goes to the gym and he put on weight after his carpal tunnel surgery. States he body builds all his life and after the surgery he went 3-4 years and stopped working out. States he gained 70-80 pounds and he is back at the gym getting in better shape as he had gotten thicker. Caller states he didn't see his healthcare provider, he was able to call in and explain what was happening and she prescribed the medication and how to apply it. History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks was none. AE(s) following prior vaccinations was none. Relevant Tests was none. Caller states he wants the other dose and he may be feeling better when it comes time but he is scared about taking it and maybe he should take half of it. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-05-10 runny nose, fatigue runny nose; Covid-19 vaccine cured allergies; Pain in arm; Little fatigue; This is a spontaneous rep... Read more
runny nose; Covid-19 vaccine cured allergies; Pain in arm; Little fatigue; This is a spontaneous report from a contactable consumer or other non-healthcare professional. Follow-up (PRD 23Apr2021) received from a contactable consumer was processed together with initial information. A 51-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EB8731), via an unspecified route of administration in left arm on 21Apr2021 at 12:00 as single dose for COVID-19 immunization. Medical history included ongoing allergic to dust, ongoing allergic to dust mites, ongoing allergic to cold air and ongoing allergic to pollen. Patient reported that he has been suffering from allergies every single year for many years. Patient reported that 10 years ago, he started having flu shots. Patient reported that they worked on his body for a few years then came back. Patient reported that flu shots made patient sick, ever since then, he had not gotten any vaccines at all. Patient reported that he doesn't get the flu. Patient also reported that his son has had the flu and he had been in close contact with his son when his son had the flu and the patient did not get the flu. Concomitant medication(s) included ongoing cetirizine hydrochloride (ZYRTEC ALLERGY) 10 mg, one pill every 2 days as needed for allergies. Patient did not take it for 2 days before getting vaccine. On 21Apr2021, patient experienced pain in arm (8 hours after the vaccination), patient reported that the place on his arm where the needle went in for the Covid-19 vaccine had pain. Patient reported that the pain was getting better and that if he pressed on the injection site there was not much pain and experienced little fatigue (at night). Patient reported that he played badminton on the night of 21Apr2021, (6 hours after the vaccination), played badminton for 2 hours and stopped. Patient reported that he thought that he might have been a little fatigued because he lost 2 badminton games. On 22Apr2021, patient experienced COVID-19 vaccine cured allergies. On an unspecified date, patient reported that when he woke up in the morning and came downstairs, he had a runny nose. Patient reported that he usually jogged daily and brang tissues with him because his nose would be running. Patient also reported that he really enjoyed walking outside with the sunlight and the air. Patient reported that yesterday on 22Apr2021, when he went jogging, he didn't have any runny nose at all. Patient reported that he was not having any problems with a runny nose at all, 23Apr2021.Patient mentioned that when he smells something or if he smells soap, later clarified as detergent or any fragrance, the runny nose will usually come right away. Patient also mentioned that he had not experienced this since getting the Covid-19 vaccine. Patient wanted to know the fundamental or principle behind Pfizer vaccine cured allergies. Patient also wanted to know if Pfizer had done any research on allergy cures or something that boosts the immune system. Patient reported that he told people on social media that the Covid-19 vaccine cured his allergies. Patient reported that he had so many friends that replied that had the same benefit from the Covid-19 vaccine. Patient reported that he was not a fan of taking medicine. Patient reported that even sometimes if he had a cold, he didn't take medication. Patient reported that instead of taking medication for a cold, he would eat spicy food to make himself sweat and drank lots of water. For LOT# Patient reported that the handwriting on his vaccine card was very bad, especially the second letter of the lot number. Patient reported that the letter looked like a B, but could be a P or an R (could be EB8731, ER8731 or EP8731). Patient reported that the lot number could be ER8731. Outcome of Covid-19 vaccine cured allergies was not recovered, pain in arm was recovering, little fatigue was recovered and runny nose was recovered on 22Apr2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460544 same reporter, product and AE, different patient
51 2021-05-10 throat irritation After being vaccinated at the off -side clinic , the patient had itchy throat . The staffs gave him ... Read more
After being vaccinated at the off -side clinic , the patient had itchy throat . The staffs gave him Benadryl for the sympstom
51 2021-05-11 headache, fatigue Some tiredness for a day. Light headache at times
51 2021-05-12 cough, dehydration ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Princ... Read more
ED to Hosp-Admission Discharged 2/23/2021 - 2/25/2021 (2 days) Treatment team Costochondritis Principal problem Discharge Summary (Physician Assistant) ? ? Internal Medicine Cosigned by: MD at 2/27/2021 4:06 PM Discharge Summary Hospitalist Medicine Admission Date: 2/23/2021 Length of Stay: 0 Days Discharge Date: 2/25/2021 Admission Diagnosis Hospital Problems POA * (Principal) Costochondritis Yes COVID-19 Yes Problem List Resolved POA Resolved Problems Atypical chest pain 2/25/2021 Yes SIRS (systemic inflammatory response syndrome) (CMS/HCC) 2/25/2021 Yes Hyponatremia 2/25/2021 Yes Dehydration 2/25/2021 Yes Home Or Self Care CODE STATUS: Full Code Active Issues Requiring Follow-up Test Results Pending at Discharge Pending Labs Order Current Status Blood culture x 2 SETS Preliminary result Blood culture x 2 SETS Preliminary result Hospital Course Hospital Course: Please refer to the admitting providers H&P for full history. Patient is a 51-year-old male with a PMHx significant for hemochromatosis, sarcoidosis and morbid obesity who initially presented to the ED for evaluation of chest pain, cough and shortness of breath. On presentation, vitals were mostly unremarkable other than some mild tachycardia and tachypnea. Patient was able to maintain adequate oxygenation on room air but was placed on supplemental oxygen for comfort. Blood work was mostly unremarkable. ABG was not particularly concerning. Troponin was negative x3. Patient underwent chest CTA which showed basilar atelectasis bilaterally and scattered groundglass opacities and scattered borderline size hilar and mediastinal lymph nodes consistent with patient's known sarcoidosis. Patient was treated with supportive care and monitored overnight. He was able to maintain sufficient oxygen levels. On the time my evaluation, patient continues to complain of bilateral rib pain worse with deep breaths consistent with costochondritis. I discussed with the patient that he will need to continue to take NSAIDs on a scheduled basis to help with his discomfort. Additionally I offered to prescribe cough medicine. I discussed possibly discharging the patient on steroids however he states that he makes a point to avoid taking steroids due to his history of hemochromatosis. At this point, patient no longer requires care in the hospital and can be discharged home. Patient is agreeable with the plan and all questions have been answered appropriately.
51 2021-05-12 fever, chills Covid infection 5/6(fever,chills) Covid positive 5/13
51 2021-05-13 fever, headache Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a sp... Read more
Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a spontaneous report from a contactable other health care professional (Patient, self-reported). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 27Jan2021 07:30AM, as second dose, single, dose 1, (Batch/Lot Number: EJ1686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 07:30AM, as first dose, single for covid-19 immunization. Reportedly other medical history was none. Patient did not have allergies to medications, food, or other products/known allergies. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (MOTRIN [IBUPROFEN]) received in two weeks of vaccinations. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 28Jan2021 02:45AM, the patient experienced intense headache 7-10 of 10, low grade fever 100.4, significant body aches and cold sweats. The patient underwent lab tests and procedures which included pain assessment: 7-10 of 10 and pyrexia: 100.4 on 28Jan2021. Treatment was not received for adverse events. Outcome of the events was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
51 2021-05-14 fatigue, headache transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild hea... Read more
transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild headaches; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 26Apr2021 17:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient medical history included insomnia. The patient had no known allergies. Concomitant medication included mirtazapine taken as sleep aid. The patient previously received the first dose of BNT162B2 (Lot Number: ER8734) administered in left arm on 05Apr2021 18:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 19:00, the patient experienced pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds. These symptoms have not subsided, and the arrhythmia became persistent enough last night that it required a trip to the local ER. The consistent heart palpitations which ultimately brought him into the ER. The patient was referred to a local cardiologist and was told not to worry about the arrhythmia, that it would clear up in a few days. The reported events resulted in Emergency room/department or urgent care. There was no treatment received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
51 2021-05-16 fatigue Injection site has developed a raised welt and very itchy. Noticeable increase in fatigue
51 2021-05-16 fatigue Full body muscle ache (lasted 24-48 hours) Fatigue (lasted 24-48 hours)
51 2021-05-16 sweating, chills, cough, fatigue, headache, fever Chest cough Chest pain - mild Headache Fever Sweats Chills Aches Fatigue
51 2021-05-17 headache, fatigue Shot 1 taken on 4/22/2021. Shot 2 taken on 5/13/2021. (side effects) (both shots) ? Extreme Dry Mo... Read more
Shot 1 taken on 4/22/2021. Shot 2 taken on 5/13/2021. (side effects) (both shots) ? Extreme Dry Mouth for approx. 24-36 hours ? Headache (top of the head only) for approx. 7 hours. intermediate ? Arm pain at the injection spot (onset occurred 8 hours later) (side effects) (2nd shot only) ? Extreme exhaustion and tiredness (felt like I could sleep for days) ? Elevated Sugars (bgs) for 13 hours (could have impacted the sleepiness feeling above) ? Palpitations (still ongoing) but Sinus Pause only ? micro events ? Tinnitus (very loud ringing in my ears) ? loudness comes in waves but is constant now and won't go away.
51 2021-05-17 sleepiness he had bowel movement and it came out red; feeling drowsy from the shot; This is a spontaneous repor... Read more
he had bowel movement and it came out red; feeling drowsy from the shot; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0171) via an unspecified route of administration on 01May2021 13:00 at first dose, single for covid-19 immunisation. Medical history included Diabetes mellitus, High blood pressure, Blood cholesterol increased, back disorder. Concomitant medications included fenofibrate; metformin; gabapentin for his back; losartan; empagliflozin (JARDIANCE); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); atorvastatin; fish oil; glimepiride, acetylsalicylic acid (ASPIRIN CHILDREN) (St. Joseph Children Aspirin) and multivitamin once a day. patient stated he went to get the first vaccine shot yesterday around 1 O'clock in the afternoon and then late at night on around 8 O'clock he had bowel movement and it came out red and that's never happened to him before. And he have been feeling kind of, every time he sit up for he go for a walk he feel drowsy. He was still, its the next day and he was still feeling drowsy from the shot. He went through this pamphlet they gave him after the shot and it didn't say anything about having any effects on his bowel movement. he want to know if there is something he should worry about. Consumer stated, Blood work was couple of months before. He had a Cologuard test recently. And the test came back positive. He called last night when he was on the phone for like almost two hours and nobody picked up and he felt asleep. No treatment received for the events. Outcome of feeling drowsy from the shot was not recovered and outcome of the other event was unknown. No Follow-up needed; information about lot/batch no. cannot be obtained. No further information is expected.
51 2021-05-18 chills Chills and tremors two weeks after vaccination. Possible aggravation of underlying psychiatric diso... Read more
Chills and tremors two weeks after vaccination. Possible aggravation of underlying psychiatric disorder including anxiety, desire for a drink and additional anxiolytics medication, suicidal ideation. Sleeplessness. Not absolutely certain these were related to the vaccine although I was doing well before it. Dr. suggested it might be an allergic reaction or unspecified cause.
51 2021-05-20 body temperature increased 4/14/2021 I received 2nd Pfizer at 8 am, but around 10 am I started to feel my left leg tighten up. ... Read more
4/14/2021 I received 2nd Pfizer at 8 am, but around 10 am I started to feel my left leg tighten up. In two days I could not walk. They tried to give me muscle relaxants and pain meds. But It did not cure anything. I have had a low-grade temperature(usually exactly 99.5 but sometimes higher ) for 38 days and does not go away. I felt inflammation and at the hospital, they did a C-Reactive Protein (CRP) and it showed 144 mg/L. I entered the hospital from 5/21/2021 till 5/25/2021. They ran many tests but found no infections. They did possibly find some preexisting condition that I might have had all along. The only problem I have is I was completely healthy per se (even with the preexisting condition that I didn?t know about) right before the vaccine I was able to exercise, able to lift weights, good energy level, and eating properly. I feel like the vaccine is still somehow working in my body even that is not supposed to be the case. I feel like my body is still in a state of hyper inflammation and it killing me.
51 2021-05-21 headache General weakness; lightheaded; muscular pain; light headache.
51 2021-05-22 fatigue recommended emergency room evaluation . which the caller has refused
51 2021-05-23 influenza like illness, fatigue, headache Flu-like symptoms: weakness, fatigue, soreness, headache. Began 16 hours after vaccine and lasted ap... Read more
Flu-like symptoms: weakness, fatigue, soreness, headache. Began 16 hours after vaccine and lasted approximately 36 hours. Treated with bedrest. However, tiredness/fatigue still continue 12 days after vaccination, and have not subsided.
51 2021-05-24 throat pain pain in left arm (side of injection) but also pain in left neck, left ear, sore throat, pain and thr... Read more
pain in left arm (side of injection) but also pain in left neck, left ear, sore throat, pain and throat congestion continues 3 days later
51 2021-05-24 fever heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly... Read more
heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown. Follow-up attempts are completed. No further information is expected.
51 2021-05-25 fatigue, fever, pneumonia, paranasal sinus discomfort, nasal congestion, cough, runny nose fever , cough, tiredness , body aches Office Visit 4/30/2021 Urgent Care CRNP Family Medicine COVI... Read more
fever , cough, tiredness , body aches Office Visit 4/30/2021 Urgent Care CRNP Family Medicine COVID-19 Dx Cough Reason for Visit Progress Notes (Nurse Practitioner) ? ? Family Medicine ? ? Encounter Date: 4/30/2021 ? ? Signed Expand AllCollapse All History Chief Complaint Patient presents with ? Cough Lingering fatigue, fever Positive Covid test 4-26-21 Patient is a 51 y.o. male HPI Patient is a 51-year-old male who presents with continued Covid symptoms. Patient was diagnosed on April 26. He is currently on day 9 of symptoms. Patient continues to have low-grade fevers. Wife and patient would like the cough is worse. He has been taking over-the-counter medications with minimal relief. He denies history of pneumonia or asthma. Symptoms started suddenly and have been persistent. Tmax at home = 100.4 F Admits to nasal congestion, rhinorrhea, sinus pressure, nonproductive cough Denies ear pain, sore throat The cough is worse at nighttime. Admits to occasional mild chest tightness.
51 2021-05-25 sweating AE: Diaphoretic( at 12pm). patient is Type II diabetic and has not eaten today. Treatment: no medica... Read more
AE: Diaphoretic( at 12pm). patient is Type II diabetic and has not eaten today. Treatment: no medication was given. patient was under observation. Graham crackers and water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
51 2021-05-30 headache, chills, fever on the day of the 2nd injection i had pain from the injection site up to the left side of my head. h... Read more
on the day of the 2nd injection i had pain from the injection site up to the left side of my head. had chills and a slight fever that went away by the next day. however the shooting pain in my arm and in my left side of my neck has returned and there seems to be no way to relieve it.
51 2021-05-30 headache, nasal discomfort Neurological: dexterity in fingers/arms impaired, balance affected, sensation in nasal bone area. ... Read more
Neurological: dexterity in fingers/arms impaired, balance affected, sensation in nasal bone area. Feeling off, mild headache.
51 2021-05-30 sluggishness Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd... Read more
Very sluggish,cold not chills no fever,out of sorts feeling,lasted only 1 day,feeling better on 2nd day
51 2021-05-31 fatigue, fever, malaise, chills (5/28) - Fatigue, chills, fever (100.3), aches, general malaise lasting approximately 24 hours. (5/2... Read more
(5/28) - Fatigue, chills, fever (100.3), aches, general malaise lasting approximately 24 hours. (5/29) - lingering aches but everything else had passed (5/30) - back to normal
51 2021-05-31 headache, fatigue constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spont... Read more
constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6202; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Feb2021 15:00 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient received the historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: el9269; Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 17:00 (at the age of 51-year-old) as 1st dose, single dose for COVID-19 immunization. The patient had no other medical history. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN 81) at a dose of 81 mg, atorvastatin (ATORVASTATIN), multi vitamin. There was no other vaccine on same date or in four weeks of product. The patient did not had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. On 25Feb2021 12:00, the patient experienced constant headache, body pain and aches, extreme fatigue, pain in entire upper arm. Reportedly, constant headache, started 25Feb2021 12pm still present (26feb2021), had body pain & aches, extreme fatigue, pain in entire upper arm until 26Feb2021 06:00, headache still present 26Feb2021 at 20:00. No treatment was given for adverse event. The clinical outcome of the events was not recovered. Follow-up attempts completed. No further information expected.
51 2021-06-01 fatigue, headache Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactab... Read more
Dose 2. Sore arm; Headache; Fatigue; Vertigo; This is a spontaneous report received from a contactable consumer (reporting on himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0167 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 19May2021 18:30, as 2nd dose, single dose for COVID-19 immunization. Medical history included, vertigo from 2019 to an unknown date. The patient's concomitant medications were not reported. Patient did not have known allergies. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ek8735 or ER8735 and Expiration Date was not reported) via an unspecified route of administration in Arm Right on 24APR2021 04:00, as 1st dose, single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 08:00, patient experienced dose 2. sore arm, headache and fatigue first 48 hours; vertigo and significant fatigue began at 48 hour point has continued for two days. Has a bout of vertigo around 2019 that lasted weeks. Patient did not received any treatment for adverse events. Since the vaccination, the patient has tested for COVID-19. The outcome of the events was not recovered.
51 2021-06-01 headache, sweating, chills Heavy chill headache; Heavy chill headache; sweetness; This is spontaneous report from a contactable... Read more
Heavy chill headache; Heavy chill headache; sweetness; This is spontaneous report from a contactable consumer (patient, self-reported). A 51-year-old male patient (age at vaccination: 51 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 13Mar2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 17Mar2021 at 05:00 PM, he had heavy chill headache and sweetness. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. Outcome of the events was unknown. Information about the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
51 2021-06-01 fever Patient is experiencing fever and myalgias one day after receiving the vaccine.
51 2021-06-03 chills, fatigue, sweating, headache, fever Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized ... Read more
Fatigue; muscle pain; low grade fever; chills; excessive sweating; headache; back pain; generalized weakness; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route and administrated in the left arm on 16Mar2021 at 16:45 hours (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension which was controlled. Patient was not allergic to medications, food, or other products. Concomitant medication included amlodipine besylate 10mg (MANUFACTURER UNKNOWN) and hydrochlorothiazide 25mg (MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17March2021 at 14:00 hours, patient experienced fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. Patient did not receive any treatment for the reported events. On an unknown date in Mar2021, the patient was recovered from the events fatigue, muscle pain, low grade fever, chills, excessive sweating, headache, back pain and generalized weakness. No follow-up attempts are needed. No further information is expected.
51 2021-06-03 headache Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spont... Read more
Vomiting; Massive Migraine; Pain in neck; Dizziness; Headache; Nausea; Made me sick; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0167; Expiration Date: 31Aug2021), via an unspecified route of administration on 20May2021 at 16:30 (at the age of 51-year-old) as 1st dose, single dose in right arm for COVID-19 immunisation at Public Health Department. The patient's medical history included arthritis and gout. The patient had known allergies to amoxicillin. Concomitant medications within 2 weeks of vaccination included allopurinol (ALLOPURINOL) taken for gout, celecoxib (CELEBREX) taken for arthritis, gabapentin (GABAPENTIN), and buprenorphine (BUPRENORPHINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021 at 22:30, after the first shot of vaccine, the patient experienced massive migraine, pain in neck, dizziness, vomiting, headache, and nausea. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included Sumatriptan Succinate 50mg and then 100 mg (Manufacturer: Aurobindo). On an unspecified date in May2021, the patient reported that the Pfizer shot had made her sick. The patient underwent lab tests and procedures on Apr2021 which included blood test: unknown results and patient had several blood test over the last month. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event made me sick was unknown and clinical outcome of all other events was not resolved.
51 2021-06-07 fatigue Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; ... Read more
Slight dizziness; a slight breathing difference; heart palpitations; soreness in arm and shoulders; soreness in arm and shoulders; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration: not reported), via an unspecified route of administration, administered in arm right on 06Mar2021 10:45 as single dose for covid-19 immunisation (at the age of 51-year-old). The patient's medical history was none. Concomitant medication(s) included nortriptyline (as other medications in two weeks) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks, no covid tested post vaccination, no covid prior vaccination and no known allergies. Previously, the patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration, administered in arm right on 13Feb2021 10:45 as single dose for Covid-19 immunisation (at the age of 51-year-old). On 06Mar2021 11:30, the patient experienced slight dizziness, a slight breathing difference and heart palpitations, and soreness in arm and shoulders, with tiredness. Not major issues but the patient thought should report them. No treatment taken. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
51 2021-06-07 malaise, influenza like illness, fatigue, throat pain axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blow... Read more
axillary lymphadenopathy/Lymphadenopathy was evident in the left axilla/large lymph nodes; full blown flu like syndrome with headache, body ache and flu like chills, nasal drainage and eyes watery/ congested, nose running like a faucet non stop; sore throat; severe right deltoid pain; arm very tender and swollen; fees like crap and is hard to get out of bed every morning; rhinitic, congested, draining like a faucet; severe pain in left foot and right hand; Has been fatigued and his body aches and he is exhausted.; He couldn't even walk, it was completely painful.; This is a spontaneous report from a contactable physician (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04May2021 (at age of 51 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history included flu, has gotten the flu before but has never gone on this long. The patient's concomitant medications were not reported. Clinical course as reported: He is a practicing physician who has been providing vaccinations to patients all of his life. He ended up with severe right deltoid pain. It is usually not a problem, he has dealt with this with other shots. By the second or third day, it was very tender and swollen and had axillary lymphadenopathy on the same side he re-ceived the vaccination. It persisted the next day until day 5 or 6. He then started to get worried. He went to the hospital. They did a CT scan which noted there was notable lymphadenopathy. They thought it was a reaction to the Covid vaccination. 2 days later, he went home and he kept taking Motrin and Tylenol on board. Lymphadenopathy was evident in the left axilla, inguinal nodes, and is still there now. On day 7, he went into full blown flu syndrome, had a headache, body aches and flu like chills, the whole thing. Is still a little bit rhinitic and is very congested, and is draining like a faucet. It has all been happening since he got vaccinated. He was told he was either exposed to covid or it is from the vaccination. He went to urgent care yesterday (20May2021) and they did a Covid test which was negative. He hates to point fingers but this fatigue has been overwhelming and is never ending. He called withheld where he got the vaccination. He said the pharmacist has been hearing this from a lot of patients. He reported for 7 days straight the clinical events as they were happening. Nobody has contacted him, they said some-one would be contacting him the next day and he has not heard from anyone. This laid him up for 5 days. The last 4 days, he had severe pain in the left foot, and the right hand. It was out of the blue like someone whacked him with a hammer. He couldn't even walk, it was completely painful. He hasn't worked out since he got the damn shot. In 15 days, he has not gone to the gym. They did an X-ray which didn't say anything. He was in immense pain. They gave him prescription for Prednisone 50mg and he hasn't been able to get to the pharmacy to get it yet but will head over shortly. Has been taking Motrin and Tylenol around the clock. Has been taking antihistamines because his nose has been running like a faucet non stop and he has a sore throat. Sore throat has gotten better in the last 5 days. The pain was really bad. The sore throat has subsided. The nasal drain-age and his eyes are watery are still there. Has been fatigued and his body aches and he is exhausted. The second vaccination is due 25May2021 and he is absolutely not getting the second one. When having other viral syndromes, he has never felt this sick. Has gotten the flu before but has never gone on this long. He is just feeling like crap. Can barely even get out of bed every morning. It is unbelievable. He hasn't had any true positive exposure. Has not been exposed to other family members with Covid/ coronavirus. Have practices strict isolation in their home. They have 5 kids and they did not go near anyone or go to any public places. For this to happen, it has to be because of the vaccine. Nothing else could have caused this. No one else around him has been sick. Is not sure if they are getting a lot of reports. When going on line to the Pfizer vaccine reporting, it took him a while to get a number to contact Pfizer directly. He called (Withheld) and they gave him 2 wrong numbers. It took 4 people to get the number to report this to Pfizer. He thinks there is a lot of under reporting. If he has a deductible, he would like Pfizer to take care of the cost for his ER visit. On 21May2021, reported that Beginning 05/04 when received vaccine, experienced Very large lymph nodes and Flu syndrome. Outcome for events sore throat was recovered on May2021, for other events was unknown. The lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
51 2021-06-08 fatigue All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excru... Read more
All over body rashes; Shortness of breath; Dizzy; Foggy head; Nausea; Tired/ Fatigue; horrible excruciating migratory arthritic pain; Have variety of symptoms very painful; Areas of my body have been in serious pain; I couldn't walk for days and it affected my right foot and right hip; Really been destroying my health; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 51-years, and administered in left arm on 02Apr2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient was completely heathy before this vaccine. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient stated that she was having really horrible excruciating migratory arthritic pain and all over body rashes on 07Apr2021 since she took the Pfizer vaccine. it was reported that she had went emergency twice and she had been to the doctors going back to the doctors again and she was going to ask him can she see rheumatologist, they're taking blood test and urine test and she had variety of symptoms very painful. Areas of her body have been in serious pain like it felt like a migratory arthritis kind of pain that just moved area to area every three to four days and twice it got her unable to walk. The patient couldn't walk for days and it affected her right foot and right hip and she was unable to walk since in two instances she was left unable to walk for a few days and it was very painful but she also had like all over body rash, shortness of breath from time to time, dizzy, foggy head, nausea, tired, fatigue. The patient was completely heathy before this vaccine. It had really been destroying her health basically. The patient had been taking pain pills and Benadryl(Treatment) because of the rash and stuff, pain pills for pain but it had not really helping a lot it was just she had been taking like generic Tylenol(Further not clarified). And patient stated above symptoms still happening. The patient underwent lab tests and procedures which included blood test and urine test: normal on Apr2021 (They couldn't find anything wrong with patient). No follow-up attempts needed. No further information expected.
51 2021-06-08 pneumonia Pneumonia, unspecified organism
51 2021-06-09 cough, fever The patient presented to the ED or fever, cough and ostomy evaluation (infection at site?). This vac... Read more
The patient presented to the ED or fever, cough and ostomy evaluation (infection at site?). This vaccinated nursing home patient tested positive for COVID-19. The patient received a 5 day course of remdesivir but no steroids. Maximum O2 flow rate via NC was 2L. IV ceftriaxone, and azithromycin given for possible superimposed bacterial pneumonia Both set of blood cultures grew gram-negative rods (Proteus mirabilis). Repeat blood cultures done on 5/31/2021 shows no growth. Completed 7 days course of IV cefepime. Source of bacteremia unclear. Possible urine versus infected ulceration This is a nursing home resident and he was required to remain hospitalized until testing negative. Patient is stable for discharge.
51 2021-06-09 fatigue Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lu... Read more
Extreme fatigue; Lower back pain is now moderate but currently ongoing; I had severe back spasms (lumbar region); Tightness in upper back; Hamstrings; This is a spontaneous report from a contactable (Patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN 6203 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Mar2021 at 01:45 PM as single dose for COVID-19 immunisation. The patient medical history included suspected allergy of penicillin and allergic to wasps. The patient not received other vaccine in four weeks. The patient concomitant medications included loratadine (CLARITIN) and omeprazole. The patient did not have COVID prior vaccination. On 06Mar2021 at 08:00 AM (18-hours after the vaccination), patient had severe back spasms (lumbar region) along with tightness in upper back and hamstrings, followed by extreme fatigue after 48 hour (morning of 07Mar2021) lasting until Tuesday (09Mar2021). Lower back pain was now moderate but currently ongoing. The patient visited doctor or other healthcare professional office/clinic as a result of events. The patient received treatment with Ibuprofen and Acetaminophen and electrolytes. The patient not tested for COVID post vaccination. On 09Mar2021, the extreme fatigue was resolved. The outcome of all other events was recovering. No follow-up attempts are possible. information about lot/batch number cannot been obtained.
51 2021-06-09 headache, chills Chills, body aches and headache on 6/9 The above symptoms subsided but I have soreness under my left... Read more
Chills, body aches and headache on 6/9 The above symptoms subsided but I have soreness under my left armpit
51 2021-06-13 fatigue Vaccine administered on 5/24/21, patient reports feeling very fatigued from 6/8 to 6/11 as well as m... Read more
Vaccine administered on 5/24/21, patient reports feeling very fatigued from 6/8 to 6/11 as well as moderate diarrhea on 6/11 and 6/12.
51 2021-06-14 body temperature increased, headache, fatigue In the evening of the vaccine shot, I felt a slight body temperature rise and a dull headache, these... Read more
In the evening of the vaccine shot, I felt a slight body temperature rise and a dull headache, these lasted throughout the next. By the next day (two days after the shot), these effects were gone. The subsequent day I also felt fine. But on the next day (the fourth day since the shot), I felt very tired, slightly nauseated, and had a mild headache. These are all not normal and very strange. The next day, these effects were still present but less so. The next day (6 days since the shot), they were diminished again and almost gone. It seemed very strange that I had side effects that started on the day of the shot, but then these were resolved within 48 hours. However, two days later, side effects returned and new effects came.
51 2021-06-14 cough Have persistent cough, eye burn frequently, blurry vision,.
51 2021-06-15 lethargy, sweating patient complained of dizziness, patient became lethargic, diaphoretic, patient complained of nausea... Read more
patient complained of dizziness, patient became lethargic, diaphoretic, patient complained of nausea vomit, chest pain, shortness of breath. PATIENT TAKEN TO HOSPITAL .
51 2021-06-16 headache, fatigue Fatigue and headache; Fatigue and headache; This is a spontaneous report received from a contactable... Read more
Fatigue and headache; Fatigue and headache; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 14:30 (Batch/Lot Number: EN6203) age at vaccination of 51-years-old, as single dose, for covid-19 immunisation. The patient medical history was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 16Feb2021 14:30 (Batch/Lot Number: EL3247), for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue and headache on 17Mar2021 14:30. No treatment was given for the events. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
51 2021-06-16 sweating, malaise, fatigue, sleepiness violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm go... Read more
violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178. Information on the lot/batch number has been requested.
51 2021-06-17 sweating, malaise, cough Onset 1-2 days after second vaccine (on 4/27/2021), has felt ill, has difficulty breathing, cough - ... Read more
Onset 1-2 days after second vaccine (on 4/27/2021), has felt ill, has difficulty breathing, cough - deep and strangling, N/V, no fever, but is sweating, out-of-breath with little exertion. No history of heart or lung problems. Has not seen a doctor. Referred to the ER today (6/18/2021).
51 2021-06-17 sweating, throat pain rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was rep... Read more
rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was reported as worsened; sweating; shaking; weakness; pain around the kidney; Pain around back; muscle pain in his back; a little scared.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: FW0187) as 1st dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient experienced the following symptoms: weakness on 29May2021, pain around the kidney on 29May2021, muscle pain in his back in 2021, sweating on 29May2021, shaking on 29May2021, rash around the body on 30May2021/rash all around body was reported as worsened and sore throat on 30May2021/sore throat was reported as worsened, a little scared in 2021, pain around back on 29May2021. Clinical course: A couple hours after the first vaccination, he started to feel weakness and pain around his kidney and back part. Also, some symptoms that are very common. He felt sweating and shaking and stuff like that. That night he noticed he started to have a rash all around his body and day by day it has been getting worse. On 01Jun2021, he went to the hospital emergency room and they gave him some medicine. He received a shot of diphenhydramine hydrochloride (BENADRYL) in the hospital. They also gave him an IV to flush out his body. Then the doctor gave him three prescriptions. He was released from the emergency room yesterday as well. 1. Aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) 20 mg Expiration- Nov2022 in a pharmacy bottle, No lot number; 2. diphenhydramine hydrochloride (generic one) 25mg Expiration- Nov2023 in a pharmacy bottle, no Lot number; 3. Methylprednisolone tablet 4mg (NDC: 68001-005-01; Lot number: 20P0432, Brand: Bluepoint). Dose details: 6 days- First day to take 6 together, second day to take 5 together, fourth day to take 4 and so on for 6 days. So far, he has just taken the first dose which is 6 together. When he woke up today, he noticed that his rash was even worse. He didn't know how far the rash will go. The rash was like a burn and watery. The rash was all around his body. It started on his head; under his head and all around his face, then stomach, back and legs. His primary doctor and the emergency doctor suggested for him to not get the second dose because the second dose of BNT162B2 was going to have a stronger reaction. Some event details described as follows: weakness: Experienced 5 hours after receiving the shot. Considering how it has worsened his daily activities, from zero to 10, was like a 4. Pain around kidney: Like a muscle pain around kidneys that started about 8-10 hours after the shot. That pain came and went. It's not that much pain but still with him. Zero to 10 is like a 4 or 5 on pain level. Pain around back: pain was like a muscle pain. He experienced this 10 hour after vaccine. The pain has sort of improved. It was almost resolved. Sweating: He experienced on first night. 12 hours after. It came and went, but still ongoing. It was not that much, but still he still had it. Shaking: He experienced this on same night as the sweating. 12 hours after. It was almost recovered. It has happened one or two times over the past two days. Rash all around body: He noticed this a day after his shot. It was a couple of them around his body. It started from his head and spread all around body, but it was not that much at first. Day by day it has been getting worse and today is the worst day so far. The emergency room doctor checked his kidneys just in case. They told him everything was fine with the kidneys. It seems like it is a problem with the muscle. Also, he had a sore throat. It started 3 days ago. When he drinks or eat something, he felt burning. He noticed it the first time at nighttime. The emergency room doctor is assuming he had a vaccine reaction. Reporter seriousness for events weakness, pain around kidney, pain around back, sweating, shaking, rash all around body and sore throat was provided as unspecified. The outcome of event muscle pain in his back and a little scared was unknown; of event shaking and pain around back was recovering; of rest events was not recovered.
51 2021-06-17 sweating He also reports his right leg and foot started swelling; He also reports his right leg and foot star... Read more
He also reports his right leg and foot started swelling; He also reports his right leg and foot started swelling; Sweating; feels weird; Shaking; Later that day he states his left arm (injection arm) started twitching; he vomited; and his left pinky and ring fingers were numb; right leg blew up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0181), via an unspecified route of administration in left arm on 28May2021 as single dose for covid-19 immunization. The patient's medical history included alcohol use stated that all he does was drink some liquor and beer. No medications or surgeries. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient stated that after he received his first Pfizer COVID-19 vaccine dose on 28May2021, later that day he states his left arm (injection arm) started twitching, he vomited, and his left pinky and ring fingers were numb, and the patient felt nervous like he was shaking. On 14Jun2021, the patient also stated that he got the shot and the band aid that they cover the injection area with, it was branded in his arm and he got the shot 3 weeks ago and it looks like a band aid is on his arm. He thought it would be gone and it stayed. On an unknown date, the patient reported that his right leg and foot started swelling. The patient's right leg blew up. He reports the band aid to his injection site looks like it "burned" into his arm. He states his right/foot leg swelling and left arm twitching have continued and wants to know if this is a reported side effect. Now after he got the shot his arm has been twitching, he's sweating and vomiting all morning. His right leg blew up and he feels weird. He just doesn't feel like himself. Right after the shot, the patient felt like there's a bunch of fluid. It's ongoing, it has gone down a little bit. It's improved a little, very irritating when it does happen. He can't eat. It won't stay in his stomach and he can't hold water. It has improved but when it happens, he feels terrible. There was no emergency or physician room visit for the events. The clinical outcome for the events was unknown, the other events muscle twitching, and shaking was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
51 2021-06-18 chills, body temperature increased, malaise Slight malaise went getting ready for bed at 11pm Ache in legs Woke at 12:50am with the worse case o... Read more
Slight malaise went getting ready for bed at 11pm Ache in legs Woke at 12:50am with the worse case of the chills I can remember. Room was 75F, I went into another room to get a blanket. Woke at 3:00am with slightly less chills; took my temperature, it was 100F (digital thermometer runs a little cool on me, normal is ~98F) Felt better by 10am (fever gone)
51 2021-06-18 chills, fatigue, headache, fever Fever; pain at injection site; joint pain; chills; tiredness; nausea; muscle pain; feeling bad; head... Read more
Fever; pain at injection site; joint pain; chills; tiredness; nausea; muscle pain; feeling bad; headache; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 13:00 (Batch/Lot Number: EN6207) (at the age of 51) as single dose for covid-19 immunisation. Medical history was not reported. No concomitant medications in two weeks. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever on 20Mar2021 01:00, pain at injection site on 20Mar2021 01:00, joint pain on 20Mar2021 01:00, chills on 20Mar2021 01:00, tiredness on 20Mar2021 01:00, nausea on 20Mar2021 01:00, muscle pain on 20Mar2021 01:00, feeling bad on 20Mar2021 01:00, headache on 20Mar2021 01:00. The events were not treated. The events outcome was not recovered. No follow-up attempts are possible. No further information is expected.
51 2021-06-21 fatigue, influenza like illness After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu sympt... Read more
After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu symptoms passed, but continued to have problems with lymph nodes. Fatigue set in just after flu symptoms, have never recovered. In June, I started having pain in my upper maxillary. Saw my dentist, who sent me to a dental surgeon. They determined that it was wire from a jaw surgery 30 years ago. They removed the wire, but all of the other wires are giving me pain, and may need to be removed. They had not bothered me prior to the vaccine. Mental health has also declined and not recovered. My medications are now higher than pre vaccine. Fatigue is still a major problem.
51 2021-06-22 runny nose Runny nose and eyes, itch deep in left palm, stroke and loss of use in left hand
51 2021-06-23 cough Symptoms: rapid, pounding heartbeat when lying down; occasional cough at night; shortness of breath ... Read more
Symptoms: rapid, pounding heartbeat when lying down; occasional cough at night; shortness of breath when trying to sleep.
51 2021-06-24 chills chills; I felt some body aches; This is a spontaneous report from a contactable consumer (patient). ... Read more
chills; I felt some body aches; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration, administered in arm left on 03Feb2021 at 14:30 (at the age of 51-years-old) as unknown, single for COVID-19 immunisation. Medical history included COVID-19 (if Covid prior vaccination: Yes). The patient had no known allergies. Concomitant medication(s) included zinc, vitamin C [ascorbic acid], vitamin D3 and multivitamins. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 04Feb2021 at 03:00, the patient experienced chills but he felt none by the next morning. The next day the patient felt some body aches which only lasted that day. The outcome of the events was recovered on 04Feb2021. Follow-up attempts completed. No further information expected.
51 2021-06-24 fatigue Heart pain, tiredness, dizziness. I had a stress test and have scheduled a CT scan of the heart for ... Read more
Heart pain, tiredness, dizziness. I had a stress test and have scheduled a CT scan of the heart for July 17.
51 2021-06-24 sweating WHEEZING, DIAPHORESIS, RESPIRATORY DISTRESS
51 2021-06-26 fatigue, cough, bronchitis The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, ne... Read more
The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, nervousness, anxiety and irritability. Unintentional severe weight loss and imsomnia. Coughing, and bronchitis
51 2021-06-30 headache Diffuse headache of moderate strength aggravated by visual sensitivity to light; Loose stool; Faint ... Read more
Diffuse headache of moderate strength aggravated by visual sensitivity to light; Loose stool; Faint nausea; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the right arm on 22Mar2021 at 11:45 (at the age of 51-years-old) for COVID-19 immunisation. Medical history included hypertension and anxiety. The patient had a history of allergy to sulpha drugs, possibly imaging agents and mild reaction to some shellfish. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), quetiapine PRN (MANUFACTURER UNKNOWN), lorazepam PRN (MANUFACTURER UNKNOWN) on an unknown date for unknown indication. The patient had not received any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021, the patient experienced diffuse headache of moderate strength aggravated by visual sensitivity to light, loose stools (but not diarrhea) and faint nausea. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of diffuse headache of moderate strength aggravated by visual sensitivity to light, loose stools (but not diarrhea) and faint nausea was resolving at the time of report. No follow-up attempts are needed; information on lot/batch number has been requested.
51 2021-07-01 fatigue Hives, itchiness all over body, general fatigue
51 2021-07-01 headache Body aches and pain; headache; joint pain; pain at injection site; This is a spontaneous report from... Read more
Body aches and pain; headache; joint pain; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 11:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, obesity and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN), NEXIUM, LIPITOR, allopurinol (MANUFACTURER UNKNOWN) and MICARDIS. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP3247) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced body aches and pain, headache, joint pain, pain at injection site on 23Mar2021 at 23:45. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the general body pain, headache, joint pain and vaccination site pain was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
51 2021-07-01 sweating Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe, Additional Details: Fully recovered
51 2021-07-01 malaise I tried to think maybe I am infected with covid, see if I got it or; I got sourness in my arms.; I g... Read more
I tried to think maybe I am infected with covid, see if I got it or; I got sourness in my arms.; I got soreness and I am sick ever since; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0191), via an unspecified route of administration on 10Jun2021 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included hypersensitivity from an unknown date and unknown if ongoing. The concomitant medications of the patient included paracetamol, pseudoephedrine hydrochloride, triprolidine hydrochloride (SUDAFED SINUS PAIN & ALLERGY RELIEF) taken for hypersensitivity, start and stop date were not reported, dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported and mesna (MESNEX) taken for an unspecified indication, start and stop date were not reported. It was reported that patient had been taking some allergy medicines (unspecified medication), It never worked it never working, he was taking over the counter cold medicines like Sudafed, NyQuil, mesnex and he took two pills every four hours, 10 mg (unspecified pills) he donot know it was confusing. On 13Jun2021 the patient reported i tried to think maybe i am infected with covid, see if i got it or, i got sourness in my arms, i got soreness and i am sick ever since and just have been taking some allergy medicines. The patient stated he donot know what the shot did to him but he was sick that he wanted to report what kind of medical guidance can he get, do his event and asked to inform him if is there anything else he can visit to hospital. Therapeutic measures were taken as a result of AE. The outcome of the events was reported as unknown. Follow up attempts are needed; Additional information has been requested.
51 2021-07-01 fever fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my bod... Read more
fever; sore arm in the location of the injection.; hoarse throat & raspyvoice; aches all over my body.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and suspected COVID-19 on 22Dec2020. The patient was non-allergic to medication, food or other products. Concomitant medications included Flovent diskus of 250 microgram (mcg) and albuterol (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 19:00, the patient experienced sore arm in the location of the injection, very sore/aches all over body and fever/aches had lasted approximately up to 36 hours. The patient experienced hoarse throat raspy voice, which patient had assumed due to it. The patient had not received any treatment for the events. On an 22Dec2020, the patient had tested for COVID-19 which resulted in positive and on 21Mar2021, the patient had tested for body temperature which resulted in 100.3-degree Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever and general body pain were resolved with sequelae on 23Mar2021 at 07:00 whereas that of the events sore arm in the location of the injection, hoarse throat & raspy were resolved with sequelae on an unknown date. No follow-up attempts are possible; No further information is expected.
51 2021-07-02 headache Body aches; joint pain; severe headache; This is a spontaneous report from a non-contactable consume... Read more
Body aches; joint pain; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3247), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at an age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified anatomical site on an unknown date as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced body aches, joint pain, severe headache. The clinical outcome of body aches, joint pain, severe headache was unknown at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.
51 2021-07-04 lethargy, fatigue Fatigue, lethargia
51 2021-07-05 fatigue Fatiuge, and left arm muscle pain
51 2021-07-05 fatigue Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When ... Read more
Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours. When I awoke, I had soreness in my muscles and cramps. The cramps migrated to my chest area and I have had severe chest pains, soreness in the back of my neck on the left side and in my left chest with occasional tingling in my right arm. The pains have slowly subsided and went away for about 5 days and returned fiercely last Friday in the middle of the night. It hurt so bad I couldn't sleep, so I took an Advil and after 30-45 minutes, the pain subsided. When the Advil wore off, the pains returned, so I attempted to contact a walk in clinic, they referred me to an urgent care facility. The urgent care facility took my vitals, asked about my symptoms and then hooked me up to an EKG. They told me I have an abnormal T-wave and sent me to the emergency room. The emergency room triaged me, took blood samples, reviewed my EKG and took chest X-rays. After several hours, they ruled out heart conditions and sent me home with a prescription for heartburn medicine. I do not have heartburn, I have symptoms that mirror Myocarditis/Pericarditis.
51 2021-07-05 headache, fever, cough, fatigue On 7/3/21 in early morning, case was hospitalized due to Covid symptoms including Shortness of Breat... Read more
On 7/3/21 in early morning, case was hospitalized due to Covid symptoms including Shortness of Breath, Fever, Cough, Nausea, Vomiting, Diarrhea, Headache, Fatigue.
51 2021-07-06 cough, headache, chills weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, y... Read more
weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, yellowing of eyes, nausea, intermittent cough
51 2021-07-07 cough, headache, fever, respiratory tract congestion Fever, coughing, body ache, head ache, congestion, chest pain, death
51 2021-07-08 body temperature increased, headache sore left arm; severe itch whole body; headache; slightly elevated temperature; low energy; This is ... Read more
sore left arm; severe itch whole body; headache; slightly elevated temperature; low energy; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route in the left arm on 03Mar2021, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 20:00, the patient experienced sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took ibuprofen as a treatment for the reported events. The clinical outcomes of the events sore left arm, severe itch whole body, headache, slightly elevated temperature, and low energy were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-08 cough DEVELOPED DIVERTICALITIS, DRY COUGH, VERTIGO,
51 2021-07-09 body temperature increased Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/... Read more
Household contacts had covid 4/15/21 (PCR+) when pt had cough/fatigue. He got 1st Pfizer dose 5/11/21. 5/24 he develops abdl pain, nausea, vomitting; seen in ED 5/28 w/ WBC cnt 17k CRP 197 but neg CT abdomen. Our ED on 5/31—hypotensive, temp 101.8, pulse 130s, COVID PCR neg, CXR normal. Despite fluids, needed pressors. Next day, still on pressors, new CHF, pulmonary opacities on XR, Echo with severe biventricular hypokinesis(EF 20%). Inflamm markers elevated: WBC 19k , 92% polys, hgb 11, plts 73k, CRP 334 mg/L, COVID spike Ab 1568, COVID NP index 233. Rx with IVIg for MIS x 1 dose, steroids, rapidly improved. On 6/11, 6/24 EF 60%, inflamm markers, CBC normalized. Now well, off steroids. MIS likely due to vac
51 2021-07-09 fever, fatigue, headache Took shot early that morning and by 9:30-9:45pm the same day, very tired , exhausted. Went to bed an... Read more
Took shot early that morning and by 9:30-9:45pm the same day, very tired , exhausted. Went to bed and fell asleep . Woke up in 1/2hr with: Fever , chills , hot /cold, body aches , head aches
51 2021-07-10 headache, malaise right hand finger tingling; Headache, Right sided.; body muscle aches; overall feeling of being sick... Read more
right hand finger tingling; Headache, Right sided.; body muscle aches; overall feeling of being sick; This is a spontaneous report from a contactable other healthcare professional. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 25Feb2021 09:00 am (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. Medical history included high cholesterol, heart disease, diabetes from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; carvedilol (COREG) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 04Feb2021 09:00 am (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. On 25Feb2021 16:00, the patient experienced right hand finger tingling, headache, right sided, body muscle aches, overall feeling of being sick. No treatment was taken as a result of events. The outcome of the events were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-11 chills, headache, fever Swollen face; severe head and body aches; severe head and body aches; fever; chills; muscle weakness... Read more
Swollen face; severe head and body aches; severe head and body aches; fever; chills; muscle weakness; joint pain; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via unspecified route of administration in left arm on 19Mar2021 12:15 PM (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included anxiety and depression from unspecified date. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO) 20 mg, losartan 50 mg, fish oil and beet root, all from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took niacin and he experienced allergy. On 21Mar2021 05:00 AM the patient experienced swollen face, severe head and body aches, fever, chills, muscle weakness and joint pain. Fever and swollen face only occurred for 24 hours (22Mar2021). All other symptoms persisted for 6 days (27Mar2021). The case was reported as non-serious. The events resulted in emergency room (ER)/department or urgent care. Treatment received due to the events included ER visit on 25Mar2021, intravenous (IV) (as reported) and Zofran was given. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved on 22Mar2021 for swollen face and fever and on 22Mar2021 and resolved on 27Mar2021 for all other events.
51 2021-07-11 fatigue Brain Fog, Long Fatigue,
51 2021-07-11 fever body itchy; Fever; watery eyes; has been working with a person that found out that he is positive fo... Read more
body itchy; Fever; watery eyes; has been working with a person that found out that he is positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 08Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had a vaccine yesterday and after that the patient experienced body itchy, fever and watery eyes on unspecified date. The patient Wanted to know if this is normal if the vaccine does this. The patient takes care of an elderly person and before he got the vaccine that the person had a Covid test which he got back and they told him that it was positive on an unspecified date. The patient reported he is a provides care to this elderly person that is 86 years old and Wanted to know if he can still work with him. The events outcome was Unknown. Information on the lot/batch number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
51 2021-07-12 cough, head discomfort, malaise, runny nose runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is n... Read more
runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; I have been generally not feeling well compared to before the vaccination; cough; head congestion; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 51-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 59267-1000-01/EW0161), via an unspecified route of administration in left arm on 19Apr2021 12:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient neither received other vaccine in four weeks nor other medications in two weeks. He had no known allergies. It was unknown if covid prior vaccination. Not tested covid post vaccination. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had been not tested for COVID-19. The device date was 02May2021. On 19Apr2021 12:00, the patient experiencing some health issues after taking the first dose of the Pfizer COVID-19 vaccine. Not sure if he should go for the second dose scheduled for 10May21. He took the first dose on 19Apr2021, since 19Apr2021 12:00 (then) he had been generally not feeling well compared to before the vaccination, did experience cough, head congestion, and runny nose. On 19-APR-2021 12:00, lymph nodes in his left armpit were sore, he was vaccinated in the left arm. It was getting better but not his normal self. Typically, when he was physically active his blood pressure stayed under control, but he noticed that his diastolic blood pressure had gone up and it was now mostly around 100, and systolic ranges from 130 to 160 (start date: 19-APR-2021 12:00) whenever he took readings at home after the vaccination. The patent had started taking AMLODIPINE 2.5MG tablet since 01May2021 but it was not helping much (corrective for blood pressure up). No treatment for all other events. The outcome for all the adverse events was unknown. No follow-up attempts are needed. No further information is expected.
51 2021-07-14 fatigue, sweating 5 minutes after the shot, dizziness, sweating underarms, hot, nausea. Rested for 30 minutes at the ... Read more
5 minutes after the shot, dizziness, sweating underarms, hot, nausea. Rested for 30 minutes at the pharmacy. 4 hours later. 9:30 PM. Fatigue EXTREME, dizziness when turning head quickly.
51 2021-07-17 fatigue, headache Sore arm; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, th... Read more
Sore arm; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: unknown) via an unspecified route of administration in the right arm on 19Mar2021 at 09:30 (at the age of 51 years) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, at 15:00 hours, the patient experienced events sore arm, headache and tiredness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sore arm, headache and tiredness were recovering at the time of reporting. No follow-up attempts are needed; Information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Age and age at vaccination updated from 52 years to 51 years per DOB and event onset time. Final sentence updated as no follow-up attempts are needed; Information about lot/batch number cannot be obtained.
51 2021-07-17 fatigue, fever This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, male patient r... Read more
This is a spontaneous report from a contactable consumer, the patient. A 51-year-old, male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (age at vaccination 51-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure, sleep apnea and COVID-19. The patient had history of allergy to bone. Concomitant medications included losartan (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), advair inhaler (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown date. Prior to vaccination the patient was diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 22:00, the patient experienced dizziness, fever (101.9), tiredness, nausea and ringing in ears. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event dizziness, fever, tiredness, nausea and ringing in ears were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-17 headache, sinusitis Mild to sever headache; Sinus infection like symptoms; This is a spontaneous report from a contactab... Read more
Mild to sever headache; Sinus infection like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in right arm on 10Mar2021 at 15:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On 11Mar2021, patient had experienced mild to severe headache and sinus infection like symptoms. It was unknown if therapeutic measures were taken for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache and sinus infection was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-17 headache Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer... Read more
Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204), via an unspecified route of administration in the left arm on 09Mar2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to guaifenesin (MANUFACTURER UNKNOWN) and BENEDRYL. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lansoprazole (PREVACID 30 mg), cetirizine hydrochloride (ZYRTEC) 10 mg and fluticasone propionate (FOLNASE) spray received on unspecified dates for an unknown indication. On 09Mar2021 at 17:45, the patient experienced, mild nausea, pain in arm and intense headache while driving home from office. The headache on left side to left temple was painful, different type of pain which was consistent, pain emitted from the inside out and lasted for more than six hours. The patient did not receive any treatment for the events. The clinical outcome of the events intense headache was resolved on 09Mar2021, however mild nausea and pain in arm were resolved on unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-18 chills, fever, headache, fatigue Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss o... Read more
Two days of severe body aches, chills, mild fever. Five additional days of severe leg cramps, loss of strength, headaches, disorientation, extreme fatigue.
51 2021-07-19 fever, headache Night/sleep sweats; Fever; headache; This is a spontaneous report from a contactable consumer, the p... Read more
Night/sleep sweats; Fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm (also reported as left shoulder) on 28Mar2021 at 15:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 09:00, within 48 hours of the vaccine, the patient experienced fever that went away on 31Mar2021 (reported as next day). The patient also experienced night/sleep sweats and headache within the 48 hours which were still present. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, night/sleep sweats and headache. The clinical outcome of the event fever was resolved on 31Mar2021 while that of night/sleep sweats and headache was not resolved at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
51 2021-07-20 headache LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH... Read more
LEFT SIDE OF FACE WASSWOLLEN; Headache; Pain; LEFT EYELID DIAGNOSED WITH BLEPHARITIS; GUM AND TEETH PAIN.; GUM AND TEETH PAIN.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955), in the right arm on 22Mar2021 at 10:30 (at the age 0f 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced face swelling on left side with headache and pain and also diagnosed with blepharitis in left eyelid. The patient had also experienced swelling in upper eyelid and itchy and also gum and teeth pain. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as result of events which included antibiotics and ointment for both eyes. The clinical outcome of the events left side of face swollen, headache, pain, left eyelid diagnosed with blepharitis, gum and teeth pain was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
51 2021-07-20 influenza like illness, fatigue, fever Onset was almost exactly 12 hours after getting second Pfizer injection. Exhaustion hit all of the s... Read more
Onset was almost exactly 12 hours after getting second Pfizer injection. Exhaustion hit all of the sudden (had to hold self up) fever of 100+ degrees, bones felt like they were breaking, would describe as worst flu like symptoms ever had for approximately 48 hours after 96 hours felt like returning to work.
51 2021-07-22 fatigue Dizziness; Nausea; Vomiting; Fatigue; This is a spontaneous report from a contactable consumer, the ... Read more
Dizziness; Nausea; Vomiting; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the right arm on 01Apr2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and sulfa since childhood. The patient had no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 11Mar2021 at 12:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 02Apr2021 at 02:00, (also reported as approximately 10 hours after vaccination) the patient awoke with dizziness and nausea. This had been ongoing and was increased to vomiting and had included fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events dizziness, nausea, vomiting, and fatigue were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
51 2021-07-22 sweating sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain ... Read more
sweaty hands and feet/his hands and feet were sweating and really clammy; tingling in tongue; brain fog for two months; losing weight/States he was 220 pounds. States not he is around 160-170 pounds; Was walking 5-10 miles a day, has not been; Caller states the she feels her husband is handicapped from this; now introverted where previously he was the life of the party; he's not speaking much; The patient states he feels like he's dying on the inside/She says some doctors say he is depressed but he has never had any kind of mental health disorders; Says his mentality is not right; Abdominal Pain; Says his voice went from being vibrant to low and monotone; flat affect; irregular bowel movements; double vision; Caller says her husband has a small appetite, but he had always previously been an avid eater; This is a spontaneous report from a contactable nurse (patient's wife) and consumer (patient's sister). A 51-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Feb2021 (Batch/Lot Number: EQ3249) and dose 1 administered in Arm Right on 29Jan2021 (Batch/Lot Number: E19263) as single dose for covid-19 immunisation at the age of 51-year-old. Medical history included ongoing type 2 diabetes mellitus which was diagnosed 2-3 years ago, the patient was not on insulin or anything, unspecified Allergy, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. There were no concomitant medications. The patient experienced losing weight in Feb2021, flat affect in 2021, sweaty hands and feet on 20Feb2021, tingling in tongue in Feb2021, brain fog for two months in Feb2021, irregular bowel movements in 2021, double vision in 2021, small appetite in 2021, was walking 5-10 miles a day, has not been in Feb2021, handicapped from this in 2021, now introverted where previously he was the life of the party in 2021, not speaking much in 2021, feels like he's dying on the inside/she says some doctors say he is depressed but he has never had any kind of mental health disorders in 2021, his mentality is not right in 2021, abdominal pain in 2021, his voice went from being vibrant to low and monotone in 2021.The patient was hospitalized from 07May2021 to 09May2021.The patient underwent lab tests and procedures in 2021 which included colonoscopy: normal, computerised tomogram: normal, echocardiogram: normal, endoscopy gastrointestinal: normal, magnetic resonance imaging: normal, weight: 160-170 pounds, blood test: normal. The outcome of the events was not resolved. The nurse reported that her husband received his second dose of the Pfizer BioNtech covid 19 vaccine on 19Feb2021. The next day he woke up with the following symptoms: sweaty hands and feet, tingling in tongue, brain fog for 2 months, irregular bowel movements, double vision, and flat affect. The nurse reports he was now introverted where previously he was the life of the party, he's not speaking much, not doing things he previously enjoyed such as previously doing yard work, driving, and walking 5-10 miles every morning. He is losing weight without trying 220 lbs to 160-170 lbs now. The nurse reported they have been in and out of the emergency room and sought medical care from many different people including a psychiatrist. The nurse reported they have had labs and bloodwork drawn that all resulted normal. The patient states he feels like he's dying on the inside. The nurse was seeking treatment recommendations as one doctor suggested that these reported symptoms could be caused from the Pfizer BioNtech covid 19 vaccines. He has been losing weight and his affect and demeanor are different since he got the second vaccine. They have been to every doctor and specialists. His blood work is perfect, and they cannot find out what is wrong with him. The nurse says that her husband was happy and jovial. he was 220 pounds and now is around 160-170 pounds. his mentality is not right; he has no affect. he used to be cutting grass and gardening. Now he is not speaking to family and friends; he is not even speaking to her as much. no one knows what is wrong. The nurse states that several doctors believe it to be from the vaccine because nothing happened until after the second dose of the vaccine. The nurse is uncertain about this. He has lost weight quickly. On 20Feb2021: He woke up and his hands and feet were sweating and really clammy. States she could touch them and feel the moisture. He went to the (privacy) and they gave him a roll-on for his hands. The following week he kept saying that his tongue was tingling; like as if he had bit it. He started seeing the dentist about it and they prescribed medications. A week after the tongue tingling he started experiencing brain fog. She states this brain fog lasted for 2 months. Along with the brain fog, he started to lose weight and complain of intense abdominal discomfort, Abdominal pain. He said that his bowel movements were not regular. He went to a gastroenterologist and they did a colonoscopy and EGD and found nothing on these tests. He kept the gastrointestinal issues for a long time. he has been wearing glasses because he is nearsighted. After the vaccine he complained of double vision. He saw his optometrist who said everything was fine. He has been in and out of the emergency room. Everyone says that he is fine. All of his labs are within normal limits; blood work, urine tests, and stool. He is steadily losing weight; he was 220 pounds, now he is 160-170 pounds. He was bright and affectionate. And he loves the outdoors and would walk 5-10 miles a day. But he has not been walking since Feb2021. He has a small appetite, but he had always previously been an avid eater. He was admitted into the hospital around 07May2021-09May2021. She had to push for that admission. her husband would wake up every morning saying he felt like he was about to die. she has been taking him to the emergency room about twice a week since February. While hospitalized he had CT Scans, MRI, Echocardiogram, and nothing was found on these tests. she feels her husband is handicapped from this. Their daughter is getting married, they are about to be grandparents, and her husband's affect is just flat. She says some doctors say he is depressed but he has never had any kind of mental health disorders. she has not seen her husband smile since February or March. his voice went from being vibrant to low and monotone. Patient's sister reported Her brother was fine, he had the first one then he got the second one and after the second one he is now having these foggy brain, mental kind of stuff happen. He got it in February and it started right there after, this is still going on and she wants to know how long it may last. No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on close temporal association there is reasonable possibility of causal association between the reported serious events and the suspect drug Comirnaty. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
51 2021-07-26 cough, fatigue, headache, chills, fever 51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, head... Read more
51yo Male, received 2nd COVID pfizer vaccination 6/17, since then has had chills, fatigue, DOE, headaches, body aches, dry cough, random easy bruising. Had been ruled out for ACS 6/18 in ED, CXR neg. Many of symptoms typical post-vaccination symptoms, but cough/DOE atypical. Patient also tested neg for COVID 6/22/21. Afebrile (fevers only lasted first 2 days after vaccination). 1 month later, symptoms are unchanged. I am repeating a D-dimer, CXR, CBC, INR. Patient has been unable to keep his job due to his ongoing symptoms. Patient has been very worried about symptoms, likely strong anxiety component contributing as well, but etiology of symptoms still unclear. consulted ID, recommended further labs. Repeat CXR 7/26 clear, repeat D-dimer neg.
51 2021-07-27 fatigue, chills chills; tiredness; joint aches; left side of face tingle; This is a spontaneous report from a contac... Read more
chills; tiredness; joint aches; left side of face tingle; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 16:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had intermittent shellfish allergies and only certain shellfish trigger allergic reactions but it's very rare. Concomitant medications included famotidine (MANUFACTURER UNKNOWN) 20 mg taken once daily from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 10:00 the patient experienced chills, tiredness, joint aches and left side of face tingle. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, tiredness, joint aches and left side of face tingle were recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-28 fatigue Abdominal pain; Extreme Nausea; Vomiting; Diarrhea; Fatigue; This is a spontaneous report from a con... Read more
Abdominal pain; Extreme Nausea; Vomiting; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30(at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 03:00 the patient experienced extreme nausea, vomiting, diarrhea, abdominal pain and fatigue. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme nausea, vomiting, diarrhea, abdominal pain and fatigue were resolving at the time of this report. No follow-up attempts are needed, information about lot number cannot be obtained.
51 2021-07-28 influenza like illness, fever Mild flu like symptoms; Body aches; Fever; Nausea; Vomited; Painful lower back pain; This is a spont... Read more
Mild flu like symptoms; Body aches; Fever; Nausea; Vomited; Painful lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 09:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) positive and COVID-19 in 2020. The patient was allergic to shellfish. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), cromoglicic acid (CROMOLYN), cetirizine hydrochloride (ZYRTEC) and pea protein. The patient previously took sodium valproate (DEPAKOTE) and experienced specific allergy (drug). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:00, the patient experienced mild flu like symptoms, body aches, mild fever, mild nausea, vomited once and the biggest issue was painful lower back pain. The patient had contracted COVID-19 in 2020 ( last year) and it did not bother his lower back but this vaccine really messed with his lower back for a full day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of the event mild flu like symptoms, body aches, fever, nausea, vomited and painful lower back pain was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
51 2021-07-28 fever, throat pain a mass under my right neck area, this has developed into a solid mass which has ever since extended ... Read more
a mass under my right neck area, this has developed into a solid mass which has ever since extended downwards towards my sternum and clavicle area; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; It is ejecting pains into my middle right ear which has caused a partial deafness in that ear; had issues with swallowing anything, including my own saliva; fever; body aches; sore throat; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 51-year-old), dose 1, single for COVID-19 immunisation. Medical history included allergy and there were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On an unspecified date, the patient got fever, body aches, sore throat. Five days after that he observed a mass under his right neck area, this had developed into a solid mass which had ever since extended downwards towards his sternum and clavicle area. The mass felt tender with protruding ends. It was not very painful; however, it was ejecting pains into his middle right ear which caused a partial deafness in that ear. Initially, the patient had issues with swallowing anything including his own saliva, the problem of swallowing had ever since dissipated. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
51 2021-07-29 chills Threw up; started chilling; Started burning up late in night or early morning on 5/4.; Hot and cold ... Read more
Threw up; started chilling; Started burning up late in night or early morning on 5/4.; Hot and cold through out the morning; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 03May2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 on an unspecified date. Concomitant medications included ramipril (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 the patient experienced started burning up late in night or early morning. On the same day around 06:45 started chilling and on the same day around 09:15 threw up. On the same day hot and cold through-out the morning. The clinical outcome of the events feeling hot, chills, vomiting, feeling hot and cold was not recovered. No follow-up attempts are needed. No further information is expected.
52 2021-01-03 fatigue Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization ... Read more
Patient experienced shaking, nausea, vomiting, and diarrhea beginning the night of the immunization (12.17.20). Patient had "extreme" fatigue and weakness for 2 weeks. Went to urgent care on 12.28.2020, no medications or treatment given. Resolved as of 1.4.21 with continued "slight" weakness. Patient also reports to have lost a considerable amount of weight.
52 2021-01-03 fatigue extreme fatigue that lasted 48 hours
52 2021-01-05 fatigue Moderate ankle pain left x 1.5 days Hamstring cramping moderate x 1 day Fatigue - moderate x 1 day
52 2021-01-05 sweating Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stat... Read more
Employee became diaphoretic, stated he felt his heart was racing, and that he was very anxious. Stated he has history of fear of needles. He also does extreme exercise program. Evaluated by EMT's BP 152/97, HR 56, SpO2 100% After 15 extra minutes observation employee stated he felt fine to go to work.
52 2021-01-06 cough CoughWheeze Narrative:
52 2021-01-06 headache Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual m... Read more
Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual migraines 12/19,12/20,12/21 with loss of vision/aura for about 30m-1h, mild headache followed. -numbness, intermittent in left ring and pinky finger 12/19,12/20,12/21
52 2021-01-06 headache Headache, NauseaVomiting, Hypertension, lightheadedness Narrative: 51 year old female presented to ... Read more
Headache, NauseaVomiting, Hypertension, lightheadedness Narrative: 51 year old female presented to ED post first dose of COVID-19 vaccine on 12/28/20. Sxs reported include feeling lightheaded, mild nausea and headahce. Nausea resolved 45 minutes after injection, but headache persisted, no facial swelling or difficulty, swallowing, no continued nausea or abdominal pain. Patient was administered a one-time dose of ibuprofen 800mg in the ED at 1510, recovered, and was discharged from ED on 12/28/20 at 1535.
52 2021-01-06 malaise, fever I started feeling bad in my body. This morning when I was come home and go to bed to sleep, I had a ... Read more
I started feeling bad in my body. This morning when I was come home and go to bed to sleep, I had a fever. I do not know which Covid vaccine I received. Today when I go to work, I am going to go to the ER.
52 2021-01-07 headache Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccinatio... Read more
Patient spoke to me this morning regarding some symptoms he had after his Pfizer COVID 19 vaccination yesterday. He said he had some pain at the injection site and mild headache in the afternoon; however, around 12 to 1 am in the morning, he was feeling heart palpitation and he felt his muscle twitching from his upper torso which went down to his thigh and no loss of consciousness. He said he checked his heart rate and it was 70 and he did not have any problems breathing. He said his heart palpitation felt better after taking some deep breaths. He said he no longer had heart palpitations or muscle twitching any more. He denied any other symptoms. Generally, he appeared well, no facial drooping, awake, alert, oriented, speech clear, and normal gait. (Today)
52 2021-01-07 nasopharyngitis, throat pain covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; ... Read more
covid 19 test result came up positive; covid 19 test result came up positive; severe left arm pain; This is a spontaneous report from a contactable unspecified Healthcare professional reporting for himself. This 52-year-old male patient received on 20Dec2020 02:30 PM first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) at single dose intramuscular in the left arm for COVID-19 immunization. No allergies to medications, food, or other products. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Concomitant medications (all started on an unknown date and received within 2 weeks of vaccination) included buspirone hydrochloride (BUSPIRON), atorvastatin (manufacturer unknown) and acetylsalicylic acid (BABY ASPIRIN). On 21Dec2020, 10 hours after getting vaccine the patient had body aches, cold and severe left arm pain. 4 days after getting vaccine again the patient had cold, body aches and sore throat for couple of days. On 28Dec2020, covid 19 test (nasal swab) result came up positive. The patient went to Emergency room. Outcome was recovered on an unknown date. It was unknown if a treatment was performed.; Sender's Comments: The association between the event lack of effect (COVID 19 nasal swab test result came up positive) with BNT162b2 can not be fully excluded.
52 2021-01-07 throat pain, cough The Patient present Sore throat , cough ,hoarseness . the doctor gave him Benadryl 50 mg IM now
52 2021-01-07 fever, chills, headache 24 hours after injection fever began. Also Experienced chills and headache. 36 hours after injection... Read more
24 hours after injection fever began. Also Experienced chills and headache. 36 hours after injection fever peaked and then broke. 40 hours after injection symptoms subsided.
52 2021-01-08 fatigue, headache Headache tremors, fatigue Narrative:
52 2021-01-08 fatigue, headache Myalgia & Arthralgia Narrative: reports feeling fatigue, myalgias, arthralgias and h/a one day post ... Read more
Myalgia & Arthralgia Narrative: reports feeling fatigue, myalgias, arthralgias and h/a one day post vaccination
52 2021-01-08 fatigue fatigue Narrative:
52 2021-01-08 headache Headache Narrative:
52 2021-01-08 headache Soreness at injection site for 24 hours. Headache for 48 hours.
52 2021-01-09 chills, body temperature increased Woke in pain and shivering body temp 89.4 axillary, oral, and non-contact forehead
52 2021-01-09 headache, fatigue received his first dose of the Covid vaccine 1/6. Since that time he has endorsed fatigue, body ach... Read more
received his first dose of the Covid vaccine 1/6. Since that time he has endorsed fatigue, body aches, headache, and nausea.
52 2021-01-09 malaise, chills Severe chills, general malaise Narrative: 12/19/20 Shift note at12:10: c/o chill. Vital sign check ... Read more
Severe chills, general malaise Narrative: 12/19/20 Shift note at12:10: c/o chill. Vital sign check was normal. Covered with blankets. 12/19/20 OT Unable to Treat note at13:47: Pt reporting severe chills and general malaise, possibly as a side effect to COVID-19 vaccine. Pt deferred therapy until next week, requesting to sleep. 12/19/20 Shift note at17:45: no c/o chill at this time.
52 2021-01-09 fever, headache Severe HA with mild myalgia. Felt feverish but temp never exceeded 98.6.
52 2021-01-10 headache, chills, fatigue The day following my second vaccination I had body aches, headache and chills that lasted for approx... Read more
The day following my second vaccination I had body aches, headache and chills that lasted for approximately 3 hours. In addition, on this same day I experienced mild tiredness for most of the day.
52 2021-01-10 sinusitis, throat irritation Inflammation of mucosal linings in body. Diarrhea, throat burning when eating, burn when urinatin... Read more
Inflammation of mucosal linings in body. Diarrhea, throat burning when eating, burn when urinating, sinuses burning, bronchospasm.
52 2021-01-11 headache Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 day... Read more
Headache, Myalgia, Arthralgia, Angioedema, Nausea Vomiting & HYPOtension Narrative: Extensive >4 days symptoms, lost work time
52 2021-01-11 headache body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored progr... Read more
body ache; Headache; soreness in his arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician reported for himself. A 52-year-old male patient intramuscularly received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730), first dose on 15Dec2020 21:00 and second dose on 05Jan2021 09:00 at single dose at deltoid left for preventative. Medical history and concomitant medications were reported as none. The patient experienced body ache on 06Jan2021 with outcome of unknown, soreness in his arm on 05Jan2021 with outcome of recovering, headache on 06Jan2021 with outcome of not recovered. He was asking if he can take paracetamol (TYLENOL) for body ache and soreness in his arm following administration.
52 2021-01-12 chills Systemic: Chills, Systemic: pale in color, increase hr; symptoms lasted 1 day
52 2021-01-12 fatigue, headache, chills lightheaded right after shot for 30 ninutes, then chills for the whole night after. The next day, he... Read more
lightheaded right after shot for 30 ninutes, then chills for the whole night after. The next day, headache and then respiratory symptoms with dry cough and 02 sat down to 93%. More headache and body aches/fatigue that day. Insomnia for two nights after the injection.
52 2021-01-12 sweating About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating do... Read more
About 10minutes post vaccine, he started c/o tingling to the right side of his neck and radiating down to his fingers. Vital signs were stable: BP 129/87, 97% RA, temp 97, HR 75, respirations 20, denies pain. Also c/o sweating palms, nausea but no emesis, mild dizziness, no SOB/difficulty breathing. Stated he did not eat anything this morning. Provided with crackers and water. At 0839, re-evaluated, nausea improved VS 132/88, hr 73, 98% RA, denies pain, continues to have tingling but not worsening, sweaty palms improving. At 0905 tingling and nausea have improved no longer c/o dizziness, vs 130/95, hr 81, 98% RA, RR 18, denies pain. Felt good to go home. Total time of about 30 minutes wait.
52 2021-01-12 influenza like illness, sinus pain seeing kind of blurry; flu like side effects; sinus aches; This is a spontaneous report from a conta... Read more
seeing kind of blurry; flu like side effects; sinus aches; This is a spontaneous report from a contactable consumer (patient himself). A 52-year-old male patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 05Jan2021 in left arm at single dose for prevent getting COVID-19. There were no medical history and concomitant medications. Consumer said he took the COVID-19 vaccine yesterday for where he worked, and had flu like side effects and would like to make sure they are normal. Caller clarified that he got the vaccine on Tuesday, 05Jan2021. He said that the side effects were his body and head hurts. He said that the side effects started yesterday, like the flu, he had body and sinus aches, and was like coughing a little bit with a low fever last night that went away. He said that this morning (06Jan2021) he woke up the same way, then went outside and he was seeing kind of blurry, but not much. He said he came inside and sit down, and was ok again, he felt like he had a big flu in his head. Caller said that he took a picture of the vaccine card, where they kind of wrote on it and it said Pfizer EL0140. Caller said that yesterday and today he woke up the same, so no change to events, he just took over the counter pills for sinus, he didn't want to drink nothing. No further information was provided about the over the counter pills for sinus. Caller said he had no new medications and received no other vaccines when he got the COVID-19 vaccine. Caller said for his fever his wife put her hand on him and said he was kind of hot, but it was nothing big. Temperature was not taken. Outcome of events were unknown.
52 2021-01-12 fever At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with ... Read more
At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with a really high fever. My fever was 102.8 when I first woke up. I was very nauseous and my fever felt worse. My thermometer would not read any more until my temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I was actually scare for my life. In March I actually caught coronavirus and developed anti bodies for Covid. I can only guess my body was fighting for it's life.
52 2021-01-12 fever Starting in the middle of the night feeling feverish, sore left shoulder. Checked temp at 6AM was 1... Read more
Starting in the middle of the night feeling feverish, sore left shoulder. Checked temp at 6AM was 101.4 I believe this is normal but was told to report any symptoms
52 2021-01-12 fever Fever & Nausea Vomiting missed one day of work following second dose vaccine
52 2021-01-13 chills, fatigue Left Deltoid injection sight with increase redness, warmth, and itching. Aprox. 4 1/2 inches width. ... Read more
Left Deltoid injection sight with increase redness, warmth, and itching. Aprox. 4 1/2 inches width. Complaints of fatigue, muscle aches, chills for first 24hrs.
52 2021-01-13 fatigue Fatigue; lymph node swelling; This is a spontaneous report from a contactable nurse. A 52-year-old m... Read more
Fatigue; lymph node swelling; This is a spontaneous report from a contactable nurse. A 52-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular from 06Jan2021 10:45 to 06Jan2021 10:45 at single dose for COVID-19 vaccination. Medical history included idiopathic epilepsy. Concomitant medication included carbamazepine. On 06Jan2021 at 17:00, the patient had fatigue two days after as well lymph node swelling in armpit of arm where second dose administered. The patient also stated that with first dose from 15Dec2020 to 15Dec2020 for COVID-19 vaccination, the patient had soreness in his arm with no other symptoms. Outcome of the events was not recovered. Information on the lot/ batch number has been requested.
52 2021-01-13 throat irritation, fever, fatigue, cough A PCR test was done and received results Monday (4th) as positive; A PCR test was done and received ... Read more
A PCR test was done and received results Monday (4th) as positive; A PCR test was done and received results Monday (4th) as positive; Had some scratchy throat late friday night; Saturday called out sick to work as the cough started; Saturday called out sick to work as the cough started.; Lost taste and smell monday; Lost taste and smell monday; Running fever; fatigue; This is a spontaneous report from a contactable Pharmacist (the patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1686, expiration date unknown) via an unspecified route of administration on 28Dec2020 at 12:00 PM (at the age of 52-years-old) via an unspecified route of administration at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included hypertension, high blood cholesterol from unknown dates. Allergy information was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was administered the vaccine at a Nursing Home/Senior Living Facility. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN/HYDROCHLOROTHIAZIDE), atorvastatin (LIPITOR), fenofibric acid (FENOFIBRIC ACID), amlodipine besilate (NORVASC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine on Monday 28Dec2020. A PCR test for COVID was done on Tuesday and a rapid test on Wednesday both of which were negative. The patient experienced some scratchy throat late Friday night on Saturday, 02Jan2021 the patient called out sick to work as a cough had started. A PCR test was done on 02Jan2021 and he received results Monday (4th) as positive. The patient continued to say that the cough had subsided, as he took Delsym. He lost taste and smell on Monday. He reports running a fever that varies from 99-101.5. He took Tylenol and Motrin to control the fever. In addition he has experienced fatigue. It was also reported, in contradiction of the above reported chronology of events, that the onset date of events was 25Dec2020 (CONFIRMATION PENDING for onset date of events relative to vaccine administration). The patient experiences of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue resulted in a physician office visit (date not specified). The patient underwent lab tests that includes a PCR test on 29Dec2020 which was negative, a rapid test on 30Dec2020 which was negative and a PCR test on 02Jan2021 which was positive. Treatment for the events was reported as Motrin and Tylenol for fever and Delsym. for cough. The clinical outcome of COVID 19 positive test, scratchy throat, sickness, cough, loss of test and smell, fever and fatigue was reported as not recovered.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and COVID-19 PCR test positive on 02Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.
52 2021-01-14 chills, headache Chills, body ache, headache. Resolved.
52 2021-01-14 chills, sweating, fever fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance... Read more
fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown. Information about lot/batch number has been requested.
52 2021-01-14 headache, chills Started with chills, then severe headache, body aches, and ETOH like withdrawals (mind racing, delus... Read more
Started with chills, then severe headache, body aches, and ETOH like withdrawals (mind racing, delusional thoughts), nausea, tossing and turning unable to get comfortable (Though I spent 18 hours in bed, Fitbit recorded only 3.5 hours of sleep). Please note this writer has never experienced etoh withdrawal personally, however he has taken care of many patients requiring hospitalization for the same. The bulk of all simultaneous symptoms occurred from 0200 on 1/14 to 1030 hours of same day. Headache unrelieved by Tylenol (500mg at 2230 on 1/13, 1000mg at 0245 on 1/14, then Advil 400mg at 0945 on 1/14).
52 2021-01-17 fatigue, sleepiness I felt fine until 2 hrs after shot. Then became very drowsy. Needed 3 hr nap. Then got up for a few ... Read more
I felt fine until 2 hrs after shot. Then became very drowsy. Needed 3 hr nap. Then got up for a few hours. Went to bed 2 hrs early. Slept very soundly that night. For the rest of the week, I needed a 5 to 6 hrs extra sleep every day. I missed a week of work because of fatigue. On 3rd and 4th days after shot I had diarrhea. On 3rd and 4th days after shot I had slight nausea. Slight ringing in ears on days 2, 3, and 4 after shot. Only slight fatigue on 5th day after shot. All other symptoms gone. 6th day after shot all symptoms gone. I feel fine. I'm glad I was vaccinated.
52 2021-01-18 fatigue, fever low grade temp, sore muscles, fatigued, loss of appetite
52 2021-01-18 fatigue fatigue, shortness of breath and measured low pulse ox
52 2021-01-19 fatigue, headache, cough Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and litt... Read more
Soreness in arm about 8 hours later; December 26 I started to have congestion, and headache and little bit of a cough. Some body aches, loss of taste and smell, as well. 27th - Covid test - Pos-tive (notified on 28th). Symptoms lasted for about 7 days except loss of taste and smell was only 5 days and it resolved. Took Tylenol and Mucinex D. Went to Urgent Care. Still having lingering congestion and fatigue.
52 2021-01-19 headache Staff member notified DON of Hypertensive state at 0830 on 1/20/2021. Staff member has no PMH of HTN... Read more
Staff member notified DON of Hypertensive state at 0830 on 1/20/2021. Staff member has no PMH of HTN and does not take any Rx medications for any disease processes. Staff member checked BP with multiple cuffs which were consistently read in the range of 160-180 SBP, 98-104 DBP with an elevated pulse >100 as well. Staff member reported an accompanying mild headache and lightheadedness. Sent to ED for evaluation of new onset HTN per Medical Director advice. Staff member was released from ED with orders to f/u with PCP for further evaluation of HTN persists
52 2021-01-20 headache, fever Body ache starting 11 hours after vaccination; headache shortly after, then fever 99.5, up to 100.9;... Read more
Body ache starting 11 hours after vaccination; headache shortly after, then fever 99.5, up to 100.9; insomnia; aches lasted ~14 hours
52 2021-01-20 nasal congestion, headache Cold sweats, shaking, headache, congestion., joint soreness, muscle soreness
52 2021-01-21 throat irritation, throat clearing Per the patient: "I waited approximately 25 minutes. As I drove home. I started to experience a scra... Read more
Per the patient: "I waited approximately 25 minutes. As I drove home. I started to experience a scratchy throat and broke out in hives. The reaction started approximately 40 minutes are the injection. By the time I had an increase in the scratchy throat, with constant clearing of my throat. I administered my epi pen and continued on, due to being closer to. I was observed (in the ED) and discharged home with a prescription for Prednisone."
52 2021-01-24 fatigue, throat pain, sleepiness, headache Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat... Read more
Headache, diarrhea, fatigue, Pounding Heart, Muscle/joint pains, stomach cramps, sore/swollen throat, difficulty swallowing, trouble staying awake, gassy
52 2021-01-24 headache, fatigue Upper back pain which progressed to severe neck pain and headaches, fatigue, mild nausea, all of the... Read more
Upper back pain which progressed to severe neck pain and headaches, fatigue, mild nausea, all of the symptoms tended to get wax and wean for the next 2 weeks.
52 2021-01-24 malaise, fatigue sick; With the first dose he got tired and had malaise, and body aches for two days; With the first ... Read more
sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself). This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
52 2021-01-25 fever his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 p... Read more
his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
52 2021-01-26 fatigue, nasopharyngitis he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; ... Read more
he got real cold and shaky and couldn't get warm; he got real cold and shaky and couldn't get warm; temperature was low at 96 degrees Fahrenheit; He got nauseous with it; He had severe fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140) via an unspecified route of administration on left arm on 11Jan2021 at 9:15 at single dose for COVID-19 immunization. The relevant medical history included Covid-19 from 17Jul2020 to 14Aug2020, he didn't get hospitalized but was pretty sick. He had circulation issues with it. He had numbing and tingling in his left three fingers (clarified left three fingers as his middle finger, index finger, and ring finger) and numbing and tingling in his toes as well. Concomitant medications included ubidecarenone (COQ-10), acetylsalicylic acid (BABY ASPIRIN), rosuvastatin and monascus purpureus (RED YEAST RICE). The patient previously received the first dose of BNT162B2 at the age of 52 years old on 23Dec2020 at single dose for COVID-19 immunization. With second dose the patient thought he would be better, but about 12 hours later he got real cold and shaky and couldn't get warm. He checked his body temperature and he didn't have a temp. His temperature was low at 96 degrees Fahrenheit. He tried to keep himself warm. He got nauseous with it. Basically he looked on line and was having them. Today he started to feel better, but still a little nauseous. He had severe fatigue. He didn't realize he could go fill out something on the website for CDC. He knew he had wanted the vaccine because he had some severe symptoms when he had COVID. He didn't want to get COVID again. His hospital frustrates him sometimes. They didn't put the date on there when he was to come back for the second dose. They didn't tell him to come back on the 13th. He had to figure the dates from the website and emails. He talked it over with his wife. He came in contact with it every night. He was taking care of people that were critical. He worked in the intensive care unit. Even the people he took care of that didn't have it, ended up with it. He wore a mask. He used hand sanitizer. He didn't want to get it again. People were shocked when he got it the first time. He did verify that he got the second dose one day sooner, instead of the three day window. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. He had a couple of emails where they discussed increasing the window to do it a day sooner. He was going to have to go an hour an half a way to get the second dose and he didn't want to do that. The patient underwent lab test included height was approximately six two, weight was about 194 lbs on an unspecified date, and body temperature showed 96 degrees Fahrenheit in Jan2021. The outcome of the event he got real cold and shaky and couldn't get warm, temperature was low at 96 degrees Fahrenheit was recovering, for the events he got nauseous with it and he had severe fatigue were not recovered.
52 2021-01-26 fatigue My arm was really sore at the site of injection; Developed body aches similar to the flu; Nauseous; ... Read more
My arm was really sore at the site of injection; Developed body aches similar to the flu; Nauseous; Fatigued; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 12Jan2021 at a SINGLE DOSE (30mcg) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 23Dec2020. The patient stated, "I received my second vaccine shot on Tuesday, 12Jan2021. On Wednesday (13Jan2021), my arm was really sore at the site of injection and I developed body aches similar to the flu. I was also nauseous and fatigued (Jan2021). Thursday I started to feel better. I am 95% better today on Friday." The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number could not be obtained.
52 2021-01-26 headache Extremely achey Muscles & Joints ALL over with a pounding Severe Headache & Dry Mouth
52 2021-01-27 fatigue generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowin... Read more
generalized itching, maculopapular rash, lips, face, neck, tongue swelling, difficulty of swallowing, left wrist swelling, generalized weakness, fatigue. 2nd dose of vaccine received on 01/11/21, first was on 12/22/20. Symptoms started on 01/16/21 between 1 and 2 am. First day symptoms were mild resolved after taking allegra and benadryl. On 01/17/21 between 2 and 3 am started again, and got worse, did not improve after taking allerga and zyrtec. Later in the day started on prednisone daily, allegra daily and one dose of benadryl. Symptoms lasted for few more days
52 2021-01-27 malaise, fever Mild fever; Injection site pain; Feeling a little unwell; This is a spontaneous report from a non-co... Read more
Mild fever; Injection site pain; Feeling a little unwell; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 1284, expiry date not reported), via an unspecified route of administration on the left arm on 13Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior to vaccination). There were no concomitant medications. The patient experienced mild fever on second day, injection site pain, feeling a little unwell; all unspecified dates. The outcome of the events was unknown. The patient was not covid tested post vaccination. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
52 2021-01-28 chills Whole body itching; severe lip swelling; chills/rigors; body aches; This is a spontaneous report fro... Read more
Whole body itching; severe lip swelling; chills/rigors; body aches; This is a spontaneous report from a contactable Physician (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 11Jan2021 13:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced whole body itching, severe lip swelling, chills, body aches, rigors 14Jan2021 16:00. Treatment received for the events included Allegra and Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.
52 2021-01-28 fatigue, fever, chills, headache trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ whe... Read more
trouble breathing; severe body aches; fevers and chills; extreme fatigue; headaches; passed out/ when trying to return to bed, passed out a second time; This is a spontaneous report from a non-contactable physician. A 52-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 07:30 at a single dose for COVID-19 immunization at the workplace clinic. The patient's medical history was not reported. Patient has no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR). Patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date. On 15Jan2021 04:00, patient had severe body aches, followed very quickly by fevers and chills. At 4:45am started to have trouble breathing. Patient was concerned about respiratory symptoms, and woke his spouse, then stood up to try and breathe better, took a couple steps, and passed out. When the patient woke, when trying to return to bed, passed out a second time. Over the next few hours respiratory symptoms improved. Remainder of day characterized by extreme fatigue, body aches and headaches. Patient had an unspecified over the counter anti-inflammatory medication. The patient has a negative COVID 19 test via a nasal swab on an unknown date. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported passed out and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
52 2021-01-28 headache, chills, fatigue, fever redness at injection site measuring 4cm lasting for 5 days. fever, chills, myalgia, fatigue and mil... Read more
redness at injection site measuring 4cm lasting for 5 days. fever, chills, myalgia, fatigue and mild headache beginning around 20 hours after vaccination and lasting around 15 hours.
52 2021-02-01 body temperature increased, throat pain, chills, cough, fatigue, nasal congestion, pneumonia At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. I... Read more
At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. It was mostly body aches, chills, sore throat, stuffy nose/congestion and a cough. I got released to go back to work on Jan 26 and I worked all day and that night I woke up with serve shortness of breathe and a temp a 103. I went to the ER and had pneumonia. I tested positive on Jan.11 for Covid, I tested on Jan. 4 and it was negative. I still have not went back to work.
52 2021-02-01 fever On the evening following COVID-19 vaccine, patient had mild fever and experienced mild epigastric an... Read more
On the evening following COVID-19 vaccine, patient had mild fever and experienced mild epigastric and bilateral upper quadrant pain. Pain continued and patient presented to the ED on 1/31/2021 with epigastric pain. Final diagnosis appears to be acute diverticulitis with microperforation and early abscess formation. No physician notes document that the two events are related; however timing is close. Patient does not have a history of gallbladder disease, abdominal disease, etc. Patient is currently admitted and followed by general surgeon.
52 2021-02-02 headache Patient complained of headache 15 minutes post vaccination. He stated he has a history of migraines.... Read more
Patient complained of headache 15 minutes post vaccination. He stated he has a history of migraines. After additional 15 minutes of enhanced observation headache abated,
52 2021-02-03 cough positive for COVID; positive for COVID; This is a spontaneous report from a Pfizer Sponsored Program... Read more
positive for COVID; positive for COVID; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EH9899, on 28Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient took the first dose of the Pfizer COVID Vaccine on 28Dec2020. After that he showed positive for COVID. He was scheduled for the second dose today (18Jan2021). He had taken a COVID test and tested positive for COVID. He was trying to re-schedule an appointment. They told him to contact his doctor, which he did. His doctor had suggested that he took the second booster on 24Jan2021, instead of today. The patient took a covid test Last Friday (15Jan2021) and tested positive also, He didn't believe the results so he tested again today (18Jan2021) and the result was also positive. Both tests were rapid tests. What made him take the test, the following Wednesday, he had a dry cough. He took OTC cough medicine and it stopped the dry cough. No other symptoms, not coughing today. The outcome of the events was unknown.
52 2021-02-04 body temperature increased, sweating, cough On set of substernal chest pain and sweating 2 hours after administration of the vaccine. Patient re... Read more
On set of substernal chest pain and sweating 2 hours after administration of the vaccine. Patient returned to clinic 24 hours later with continued pain . Reported mild cough. Vitals stable except for mild tachycardia at 109 and temperature of 100.3. Normal EKG except for sinus tach. Patient transferred to ER via EMS due to chest pain with risk factors including positive cardiac family hx, age and male.
52 2021-02-04 headache, chills, fever Fever, chills and headache; Fever, chills and headache; Fever, chills and headache; This is a sponta... Read more
Fever, chills and headache; Fever, chills and headache; Fever, chills and headache; This is a spontaneous report. A contactable consumer (patient) reported that a 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EKZ421 or EXZ421) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes, psoriasis. Concomitant medication included metformin for diabetes, secukinumab (COSENTYX) for psoriasis. The patient previously received the first dose of BNT162B2 (lot # EL1284) for COVID-19 immunization. The patient experienced fever, chills and headache in Jan2021. No treatment was received for the events. The outcome of events was not recovered.
52 2021-02-04 headache, fever Headache; Body aches; Fever; Insomnia; This is a spontaneous report from a contactable healthcare pr... Read more
Headache; Body aches; Fever; Insomnia; This is a spontaneous report from a contactable healthcare professional (reported for himself). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), intramuscular in the left arm on 19Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 29Dec2020 16:30 in the left arm for COVID-19 immunization. No other vaccines received within prior to COVID vaccine and no other medications received within 2 weeks of vaccination. The patient experienced headache, body aches, fever, and insomnia on 21Jan2021 07:30. The reported events were non-serious. No treatment received for reported events. The outcome of the events was recovered on 21Jan2021. Information on the lot/batch number has been requested.
52 2021-02-05 fever Fever
52 2021-02-07 headache The patient's concomitant medication included adalimumab (HUMIRA); The patient's concomitant medicat... Read more
The patient's concomitant medication included adalimumab (HUMIRA); The patient's concomitant medication included adalimumab (HUMIRA); 24hr headache occurred after each vaccine dose; This is a spontaneous report from a contactable nurse (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH1284), intramuscular at deltoid right on 07Jan2021 at 10:30 at single dose for COVID-19 immunization. The patient medical history included mild coronary artery disease (CAD), allergy to sulfa and seasonal allergy, all from an unknown date and unknown if ongoing. The patient's concomitant medication included finasteride at 1 mg, clonazepam at 0.5 mg, cetirizine hydrochloride (ZYRTEC) at 10 mg, aspirin at 81 mg, fremanezumab (AJOVY) at 125 g monthly and adalimumab (HUMIRA) twice weekly. The patient previously received MMR/Flu vaccine for immunization and experienced brachial plexus neuritis (parsonage Turner syndrome). The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at deltoid right on 17Dec2020 at 10:30 at single dose for COVID-19 immunization and experienced tachycardia, elevated blood pressure (BP), headache and flushing face turned into red. In Jan2021, the patient experienced 24 hours headache. The patient outcome of the event was recovered.
52 2021-02-10 chills Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is ... Read more
Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.
52 2021-02-16 chills, fever On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Ac... Read more
On 1/18 developed fever 102.5, upon waking, around 8am. Fever climbed to 103.5 in the afternoon. Acetaminophen 1000mg taken and fever dropped to 102.5 in evening of 1/18. Severe night sweats and chills at night of 1/18 and 1/19, 1/20. Was advised by employer to go to ED due to elevated fever >12hrs. Pt declined due to cost of ED visit.
52 2021-02-17 headache This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown), via an unspecified route of administration right arm on 04Feb2021 07:45 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3248; expiration date: unknown) at the vaccination age of 52-year-old via an unspecified route of administration left arm on 14Jan2021 08:45 AM at a single dose for covid-19 immunization. On 04Feb2021 04:45 PM, the patient reported that he believed he experienced an ocular migraine in his left eye approximately 9 hours after getting the second shot. He took 2 acetaminophen 500 mg tablets and the symptoms cleared up in 20-30 minutes. He has never experienced this sort of sensation before so he figures it could possibly be related. He woke up with a mild headache at the start of this second day (05Feb2021), as well. The events were non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event ophthalmic migraine was recovered on 04Feb2021 while headache was recovered on Feb2021.
52 2021-02-19 sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Seizure-Medium, Systemic: Shakiness-Severe, Additional Details: About 5 minutes after receiving vaccine, patient was seated in observation area and notified facility staff member who was in charge of observing patients that he felt faint. Staff member reported patient quickly turned extremely red and was showing seizure-like activity, unconscios. She alerted the pharmacists to come over I came over and patient appeared bright red, pupils extremely dilated and was not conscious, grabbed pt arm he woke up and then showed typical vasovagal symptoms thereafter.
52 2021-02-21 chills, fatigue, headache Nausea, vomiting, headache, chills, fatigue
52 2021-02-21 chills, influenza like illness Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of inten... Read more
Slightly sore arm for a day. Starting ten hours and lasting maybe thirty hours was a series of intense chills and strong, flu=like weakness. From about 24 hours for maybe the next 4 days, significant aggravation of legacy rashes from my chronic skin conditions. After 4 days, they reverted to normal.
52 2021-02-21 headache, malaise I contracted Covid 19 in mid October 2020 and I lost my sense of smell and taste. It took a long ti... Read more
I contracted Covid 19 in mid October 2020 and I lost my sense of smell and taste. It took a long time to start coming back and was at about 60% of normal when I received the 2nd dose of the Pfizer vaccine. Four days after the shot my sense of smell and taste changed. From that day until present almost everything I smell and taste has a "chemical" taste and smell. Nothing smells normal and very few things taste good. Animal proteins are especially bad as well as some fruits and vegetables. Most foods make my stomach so upset that it is nearly impossible to eat. All smells are the same, nothing smells pleasant and most smells give me a light headache. I have lost over ten pounds since this started and I have general malaise.
52 2021-02-24 headache Diarrhea sharp pain on the left side of the temple of my head, and head ache loss of appetite for a ... Read more
Diarrhea sharp pain on the left side of the temple of my head, and head ache loss of appetite for a day localized pain near injection site on left arm (expected and not too bad)
52 2021-02-24 malaise nausea, joint pain, feeling unwell, hard to swallow
52 2021-02-25 fatigue, headache mild headache; tiredness; This is a spontaneous report from a contactable other healthcare professio... Read more
mild headache; tiredness; This is a spontaneous report from a contactable other healthcare professional reported for himself (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5130) into right arm on 17Dec2020 10:00 AM at single dose for covid-19 immunization in Public health. Medical history was not reported. Other medications in two weeks included irbesartan (AVAPRO), amlodipine besilate (NORVASC) and HCTZ. No other vaccine in four weeks (Also reported "other vaccine same date product was PFIZER, other vaccine same date lot number was 1600, other vaccine same date dose number was 2, other vaccine same date vaccine location was Right arm", pending clarification). Patient experienced mild headache and tiredness on 17Dec2020 07:00 PM. No covid prior vaccination. Covid test post vaccination via Blood test with unknown results. No treatment received. outcome of the events was unknown.
52 2021-02-26 body temperature increased, nasal congestion, chills Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after inje... Read more
Left jaw pain & soreness near left ear (difficult to open mouth, chew food) from 7 am day after injection (current as of 10pm, same day), mild nasal congestion (starting around 6pm day after injection, current as of 10pm), chills (lasted about an hour 6-7pm day after injection), flush (about an hour after chills ended). AM temp 97.7 (9 AM), PM temp 101.1 (10 PM).
52 2021-02-27 chills About 11 p.m. that night I got extreme chills and some aches in my upper back. I was in bed the next... Read more
About 11 p.m. that night I got extreme chills and some aches in my upper back. I was in bed the next day until about 7 p.m. that night when the symptoms ceased. I just found this reporting site or I would have sent this sooner.
52 2021-02-28 headache, fever, sweating, chills Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightm... Read more
Fever; Chills; Body Ache; Pain in face; Pain in back; pain in hip; Headache for 2 days; Vivid nightmares; Sweats; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL3249, expiry date: not reported), via an unspecified route of administration, on 25Jan2021 03:00 PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. Medical history was none. The patient was not diagnosed with covid prior to vaccination. He had no known allergies. Concomitant medications were not reported. On 26Jan2021 01:15 AM, the patient experienced fever, chills, sweats, body ache, pain in face, pain in back, pain in hip, headache for 2 days, vivid nightmares. 2 days later (at the time of report, 27Jan2021), the patient still had low grade fever, sweating, body ache and headache. No treatment was received for the reported adverse events. Outcome of the events was reported to be recovering. The patient was not tested for covid post vaccination.
52 2021-02-28 influenza like illness, chills Flu-like symptoms: Achiness (whole body), Chills - Time course: Symptoms appeared 12 hours after v... Read more
Flu-like symptoms: Achiness (whole body), Chills - Time course: Symptoms appeared 12 hours after vaccine administration. Symptoms started diminishing 24 hours after onset (36 hours post-vaccination). Symptoms totally gone 48 hours after vaccination.
52 2021-02-28 runny nose, cough, sneezing, upper-airway cough syndrome Consumer reports that 2 weeks following 1st vaccine, he began to experience post nasal drip, sneezin... Read more
Consumer reports that 2 weeks following 1st vaccine, he began to experience post nasal drip, sneezing, cough, runny nose. These symptoms are still persistent and he believes might be vaccine related.
52 2021-03-02 headache, fever 52-year-old male reports developing multiple HSV simplex lesions around his upper lips within 24 hou... Read more
52-year-old male reports developing multiple HSV simplex lesions around his upper lips within 24 hours of receiving the second Covid 19 vaccine. Patient has had HSV-1 lesions before but never to this extent; patient is otherwise stable and afebrile. He has no radicular pain. Labs are ordered for CBC and a CMP. The vaccine support center was called at approximately 3:35 PM and message left. The vaccine support center was called again on February 26, 2021 at approximately 9:20 AM. Provider spoke with NP for consultation. VAERS CDC report advised. No further action required. Antiviral medication was not offered due to the fact that patient was on day 6 post outbreak and out of the window of opportunity to treat acutely.
52 2021-03-02 headache, runny nose runny nose, metallic taste in mouth, headache, nose bleed
52 2021-03-04 fatigue, headache, fever, chills Severe Headache Random Severe Muscle Pain Fatigue Joint Pain Chills/Feverish Minor Disorientation
52 2021-03-05 fatigue Injection site soreness, fatigue and bodyaches
52 2021-03-05 head discomfort Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date.... Read more
Heart fluttering/skipping beats shortly after receiving and periodically continuing up to this date. Numbness feeling in face and jaw several hours after receiving that continues today. Feel pressure on forehead and nostril area.
52 2021-03-05 fever The following evening after receiving second dose, I had swelling under left arm and fever.
52 2021-03-07 head discomfort Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting ... Read more
Goosebumps tingly sensation in head; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher.; feeling weak; Heaviness in the head; Feeling anxiousness in the brain; Localized soreness and pain; This is a spontaneous report from a contactable consumer reported for himself. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 18:00 (Lot number: EL9263) via unspecified route of administration in the left upper arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included ongoing diabetes (Due to diabetes has low testosterone), High cholesterol both from 2005, Colitis ulcerative from 1999, Glaucoma from 2010, Enlarged prostate gland from 2018 and Chronic sinus infection, Acid reflux and GERD from an unknown date and unknown if ongoing. The concomitant medication included Janumet (Metformin hydrochloride/sitagliptin) ongoing for diabetes mellitus at (50/1000 one tablet twice daily), amoxil (amoxicillin) for low testosterone via topical route at 4 pumps, azelastine at two sprays twice a day for chronic sinus infection, crestor (rosuvastatin calcium) ongoing at 5 mg once a day blood cholesterol increased, tamsulosin ongoing at 0.4mg once a day for enlarged prostate gland, dexilant (dexlansoprazole) at 30 mg once a day for acid reflux and GERD, lialda (mesalazine) ongoing at 4.8 mg, once a day (1.2gram 4 tablets once a day) for colitis ulcerative, canasa (mesalazine) ongoing 1 g once a day (at night time) for colitis ulcerative, timolol ongoing at one drop both eyes at once a day for glaucoma, lumigan (bimatoprost) ongoing for at one drop both eyes once a day for glaucoma, melatonin ongoing at 5mg once a day for insomnia, zyrtec (cetirizine hydrochloride) ongoing at 10 mg (on of them) for insomnia, xanax (alprazolam) 1 mg at 1mg at night time and 1 mg as needed for generalized anxiety and blood pressure, 5-hydroxytryptophan ongoing at 100mg for anxiety, carvedilol ongoing at 25 mg, once a day (12.5mg in the morning 12.5 at night) for blood pressure measurement, valsartan ongoing at 160 mg, once a day (160mg one tablet once day in the morning) for blood pressure measurement, hydrochlorothiazide tablet ongoing at 12.5 mg, once a day for blood pressure measurement, Vitamin E at 400 international units; one capsule once a day, ongoing ambozil for low testeterone, clonidine ongoing at 0.1 mg as needed for blood pressure measurement. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. No other vaccine administered on the same date. The patient had no events prior vaccination within 4 weeks. In all his life. He had vaccines that received and had no adverse event or side effect whatsoever. He had had the regular flu vaccine early November. The patient experienced feeling anxiousness in the brain, Heaviness in the head, feeling weak in Feb2021, Localized soreness and pain in Jan2021, Goosebumps tingly sensation in head, Blood pressure and palpitation/heart rate/heartbeat is getting higher and higher on 04Feb2021. The patient could not take Benadryl as he cannot tolerate Benadryl. With Zyterc he does not have secondary effects like he does with Benadryl. The first week after getting the vaccine he only had kind of had localized soreness and pain in the area. He later clarified it was in the area where got the injection, vaccine. He just had pain soreness in that area. Other than that he had no side effects at that time. The third week, initially stated as, about 5-7 days ago he started to have a feeling of anxiousness in the brain. He could feel anxiousness and sensation in his brain that he did not feel before. It was like he had the flu kind of thing, but he did not have a temperature. However, the feeling is in his head. It is like heaviness feeling from the flu in his head. He has been having the heaviness in the head feeling for 4-5 days. He later further clarified and initially clarified the localized pain and soreness was noticed the second day, the day after getting the vaccine. This only lasted a few days. He does not remember exactly when this ended. He did not take anything for the localized pain and soreness in the same area as the injection. He confirmed he has recovered completely from this event. Caller further clarified the feeling of anxiousness started Thursday or Friday of last week, maybe 05Feb2021. Stated it was like this feeling is getting worse and worse. Stated it was hard to explain, but he started to feel a goosebumps tingly sensation in his brain in head, in scalp Thursday of last week first. It started with that and slowly over the past few days it has changed and transformed into this heaviness feeling that one would feel from the flu, but he has no fever or anything; it is just in his head. Also, along with that feeling at the same time his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. His blood pressure typically ranges in the 130/85 or less range with all the blood pressure medications he was taking. Once he started having this tingling sensation in his head he had the higher blood pressure and higher heart rate. Now his blood pressure would average being about 170/110 to 180/115. This was like the upper and lower range. His heart rate was typically around 70-75 and now it goes about 80-85. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. He further explained it would bring it down for some time, but then it would go back high. The Clonidine is no longer working for the last six days. When probed for labs/testing he sated he could not work anymore due to the events reported. He was feeling weak. He could not really walk. He took time off from work. He went to see his primary care provider on Monday. On Monday the doctor doubled the dose of Carvedilol. Since then instead of taking 12.5 twice a day, he is now taking 25mg twice a day. On Tuesday, yesterday, he went to get blood work done. Blood was drawn but has no results yet. Localized pain and soreness time of onset didn't remember, stated he may have had a little pain right after getting the vaccine, but it was around 21:00 25Jan2021 he really noticed the soreness and pain. The following morning around 9 AM it woke him from his sleep and he could feel it more compared to the first day. Anxiousness in the brain around 16:00. The patient had no emergency visit. Stated he almost felt like going when his blood pressure was 182/116 on Saturday night of last week. He was about to go to the ER but decided not to. He ended up taking two Clonidine and one Xanax, laid down, and eventually his blood pressure came down a little. Therefore, he did not go. The patient had physicians office visit. After getting the vaccine he mentioned started to have a feeling of anxiousness in the brain that was getting worse. He could feel anxiousness and sensation in his brain that he did not feel before. Also, his blood pressure and palpitation/heart rate/heartbeat was getting higher and higher. His regular blood pressure medications won't work anymore to bring it down. Later during call, he also added, every six months or so his blood pressure may be elevated on these medications. Sometimes his blood pressure was not maintained by the three different blood pressure medications he takes. He was also prescribed two other medications for emergent use Clonidine and Xanax. Clonidine: 0.1mg only during times he has episodes of high blood pressure. Usually every six months he would have to take Clonidine and Xanax and typically in an hour to two hours the blood pressure would come down and it's good. However, this time, he took two Clonidine and Xanax starting last Thursday when had the high blood pressure episode and they were failing to bring the blood pressure down. It would bring it down for some time, but then it would go back high. The Clonidine was no longer working. The patient experienced side effects on the 3rd week after getting vaccinated and had already made a report. The patient's second dose was scheduled for 21Feb2021 which was 28 days after the first dose. The outcome of the event Feeling anxiousness in the brain was not recovered, Localized soreness and pain recovered in 2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.;
52 2021-03-07 headache No immediate affects after first several hours. The next morning, I woke up with extreme dizziness ... Read more
No immediate affects after first several hours. The next morning, I woke up with extreme dizziness and vertigo like symptoms, nausea and a headache. The nausea continued for 24 hours. The dizziness/vertigo continued for 48 hours after vaccine administration. Headache continued for 72 hours after vaccine administration.
52 2021-03-07 fever light fever, aches, muscles sore, loss of energy
52 2021-03-09 fever Fever, aches, joint pain, and nausea
52 2021-03-10 fatigue, chills Started feeling dizzy and nauseas within five minutes of getting the shot. Vitals were fine and I ha... Read more
Started feeling dizzy and nauseas within five minutes of getting the shot. Vitals were fine and I had to stay longer to be watched by RN. Symptoms Days 1-3: dizzy, light-headed, nauseas, muscle aches, fatigue, pain at site of injection, extreme chills.
52 2021-03-11 fatigue, chills Aches Chills Tired
52 2021-03-14 fatigue, body temperature fluctuation, fever, throat pain, chills within two hours of the second dose, the patient experienced red skin in face and hands, muscle ache... Read more
within two hours of the second dose, the patient experienced red skin in face and hands, muscle aches and fatigue. After four hours the patient experienced swollen lymph nodes. Although his lymph nodes were swollen on his left and right side, the lymph nodes on the patients left side (same side as the injection) were more swollen and sensitive to the touch. The next day, joint pain and muscle fatigue persisted, the patients also experiences chills and small blemishes on his face and left arm. On the night of 13 March 2021, patients experienced fever of approximately 99.5 degrees Fahrenheit (F). After taking 1000mg of Acetaminophen, the fever was reduced to 89.9 F. Two hours later, patent's temperature rose to 101.5 F. Patent then took 800mg of Ibuprofen. This brought the patient's temperature down to 99.5. Then he went to sleep. The next day 14 March, the patent experienced a sore throat and higher fever. He went to the urgent Clinic for examination.
52 2021-03-14 headache vomiting, diarrhea, headache, nausea
52 2021-03-15 sweating After receiving the vaccination, he started feeling lightheaded, then started sweating. He asked for... Read more
After receiving the vaccination, he started feeling lightheaded, then started sweating. He asked for water and drank water prior to a brief episode of syncope. He denies any trauma to his head or any part of his body. No mental status changes. He was assisted to the supine position on the floor, then was able to ambulate to a private section of the area and lay recumbent on an EMT gurney. He has a history of syncope with needlesticks.
52 2021-03-15 fever, headache Headache, nausea, 99.5 fever, mouth sores, knee pain
52 2021-03-16 headache, chills, fever, cough Fever, chills, whole body aches, headache, cough
52 2021-03-17 sweating Profuse sweating and dizziness
52 2021-03-18 fatigue Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips a... Read more
Redness, prickly/itching sensation over face, arms, legs, chest/abdomen, burning sensation on lips and around eyes, pressure/fullness in back of throat, pain in infections site, fatigue, muscle aches.
52 2021-03-18 fever, chills Aches Chills Fever
52 2021-03-18 fever, fatigue moderate pain at injection site on up into neck area, slight case of the runs severe nausea loss ... Read more
moderate pain at injection site on up into neck area, slight case of the runs severe nausea loss of appetite slight fever moderate to severe fatigue Took first dose of phizer vaccine at around 1530hrs on March 7th 2021, started experiencing symptoms at around 0130hrs on 8th March 2021. By March 11th 2021 pain at injection sight, loose bowel movements, and fever were gone. Nausea and fatigue lasted up until March 14th 2021.
52 2021-03-19 headache, throat pain, nasal congestion Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known... Read more
Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known soreness of the injection site in right arm.
52 2021-03-20 chills, headache After the injection, local soreness but not noticeable unless moving my arm. Day 1 after the shot h... Read more
After the injection, local soreness but not noticeable unless moving my arm. Day 1 after the shot had no symptoms. Woke on Day 2 around 5am, with chills, nausea, dizziness, vomiting, shortness of breath, severe headache. Symptoms persisted until approximately 2pm the same day. Headache was persistent, as was dizziness, but nausea and chills were intermittent. 4 incidents of dry heave vomiting.
52 2021-03-20 chills, fever fever 102- 103 for 6 days aches chills sweating intermittent diarrhea Take Tylenol and cold comp... Read more
fever 102- 103 for 6 days aches chills sweating intermittent diarrhea Take Tylenol and cold compress when fever high lots of fluids Currently 7th day just aches and diarrhea
52 2021-03-22 nasal congestion Received Pfizer COVID-19 vaccine 12/26/2020. On 1/2/2021 developed congestion, tested positive for ... Read more
Received Pfizer COVID-19 vaccine 12/26/2020. On 1/2/2021 developed congestion, tested positive for COVID.
52 2021-03-24 chills, throat pain Sore throat, chills
52 2021-03-25 chills, sweating Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: purfuse sweating, lose of sight left eye, dizziness, nausea-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient began to fell better about 5 minutes after epinephrine was administered. EMS was called but did not transport.
52 2021-03-25 headache Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in... Read more
Patient was diagnosed with Bells Palsy. On 3/15/21, patient noticed loss of taste and a sensation in his tongue. On 3/16/21, patient had right sided facial paralysis with some right ear discomfort, right eyelid drooping, right upper temple headache, sensitivity to sounds, and right eye only able to be open halfway. Patient also states that his right eye was watery. He denies a mouth droop. Patient went to urgent care on 3/16 and he was prescribed Prednisone. On 3/18, patient went to see his primary care physician and was prescribed an antiviral. He has not had any new or worsening symptoms since 3/18 pm, but he has not seen much improvement in symptoms either. He describes a small improvement in taste.
52 2021-03-25 lethargy, fever, fatigue, headache On the day after shot, starting at 2am, I ran a fever of 100.3. Headache, soreness, and really tire... Read more
On the day after shot, starting at 2am, I ran a fever of 100.3. Headache, soreness, and really tired. Tylenol seemed to keep symptoms at bay, but felt very lethargic, and needed to sleep. By day 2, fever had diminished. But had swollen lymph nodes (lymphodemenopothy) in left arm pit.
52 2021-03-26 chills, body temperature increased Dizziness body aches chills temperature to 104.0 nausea. 3/26/202- and 3/27/2021
52 2021-03-26 chills, fever, influenza like illness, headache 1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle ... Read more
1. Headache within 1 hour after shot. Severe after 12 hours. Still light at 48 hours. 2. Muscle aches within 8 hours. Still light at 48 hours. Peaked at 24 hours after shot. 3. "Glans/local ache' (lower back/kidneys and testicles) within 8 hours. Testicle ache stopped with 36 hours after shot. Kidney/lower back ache still lightly present at 48 hours. 4. Shaking/Chills. Started 12 hours after shot. Went from light to extreme within 30 minutes. Shaking and shivering uncontrollably. To the point I would not have been able to dial 911 for help if I had needed. No matter what I did I could not get warm or stop shaking. Extreme shaking lasting about 2 hours. In about 2 more hours shaking subsided and stopped. So shaking stopped around 16 hours after shot. Chills continued until around 36 hours after shot. 5. Cold sweat/Fever. Sweating starting 11 hours after shot. Lasting until about 36 hours after shot. For fever, Unknown how high it was as I was too busy uncontrollably shaking to take my temperature. Fever remained for about 48 hours in low grade form EXCEPT for hours 11 through 18 after shot - I am sure it was very high due to headache, chills, shaking, etc at that time. Basically, for most of the 2 days, it felt like the flu. But for 6 hours, (hours 11 through 17 after receiving the shot), it was the sickest I can recall beings in decades. Will 'click' I have recovered below in item 20. But not 100% back to normal yet. 90% back to normal would be a good current 'level'. Expect to feel 100% again tomorrow or the next day based on recovery rate.
52 2021-03-26 headache Pfizer-BioNTech COVID-19 Vaccine EUA: injection site soreness; joint pain (elbow); headache; nausea;... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: injection site soreness; joint pain (elbow); headache; nausea; muscle pain
52 2021-03-26 sweating Patient displayed bruise and swelling at injection site immediately after shot. Patient became limp ... Read more
Patient displayed bruise and swelling at injection site immediately after shot. Patient became limp and eyes rolled back and he collapsed to the floor. Epi pen admitted at that time. Patient immediately regained consciousness and said he felt ok. He was sweating heavily. Paramedics arrived and took him to hospital after taking vital signs and interviewing him.
52 2021-03-26 fever, chills Achey, chills, fever, general feeling poorly approx 22 hrs after vaccination
52 2021-03-27 fatigue Swollen lymph node on left side (same as injection side) Dizziness Fatigue
52 2021-03-27 fever, headache Fever Muscle aches Headache
52 2021-03-28 chills None stated.
52 2021-03-29 fatigue, chills, fever Fever, chills, severe joint pain, severe fatigue causing me to sleep 32 hours in a 36 hour period
52 2021-03-29 fatigue, chills Head ache Muscle pain Chills Tiredness
52 2021-03-29 headache, fatigue, chills, fever chills; fatigue; headache; 102 fever; The initial case was missing the following minimum criteria: T... Read more
chills; fatigue; headache; 102 fever; The initial case was missing the following minimum criteria: This case has been considered invalid as unspecified adverse event. Upon receipt of follow-up information on 02Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient (also age at vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 1:30 PM (Batch/Lot Number: CL1964) as SINGLE DOSE for covid-19 immunization. Medical history included chronic respiratory disorder (Fumes/vapour), Chronic rhinosinusitis (Sinus surgery) from 07Jan2021, Observance sleep apnea from 16Sep2019 (CPAP machine), and Sinus condition for years from unspecified date; all unknown if ongoing. For the sinus condition for years a surgery was needed and was recommended between 1st & 2nd vaccine shots (on 04Feb2021) and the surgery were planned prior to taking the vaccine. The types of surgery recommended were septoplasty, functional endoscopic and turbinectomy. The patient also had family history which includes Heart diseases and High blood pressure from unknown date and unknown if ongoing. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 52-years-old at the time of vaccination Lot: EL3247 administered in Arm Left on 16Jan2021-1:30 PM for Covid 19- immunization and experienced GERD on 17Jan2021 (Pertinent Details: Endoscopy). Concomitant medication included cefuroxime axetil (CEFUROXIME AXETIL ZHIJUN, 500mg tab) taken for an unspecified indication from 08Feb2021 to 16Feb2021; oxycodone hydrochloride, paracetamol (OXYCODONE AND ACETAMINOPHEN, 5-325) taken for an unspecified indication from 05Feb2021 to 05Feb2021 (also reported as (Only one tab). The patient experienced 102 Fever, chill (reported onset from last dose was 7 minutes), fatigue, Headache on 06Feb2021. The patient was not admitted hospital due to the events. The outcome of the events was recovered on 07Feb2021. No Treatment were received. Information about lot/batch number has been requested.
52 2021-03-29 lethargy, fatigue Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pron... Read more
Severe back muscular and intestinal cramping lasting for about 8 hours. Abdomen distention was pronounced. Also very fatigued and lethargic for over 24 hours.
52 2021-03-30 headache, malaise Armpit lymph node swollen. Feeling unwell. Mild Headache
52 2021-03-30 headache having headaches.Patient took one tablet of Advil, and still has ongoing headache, advised patient t... Read more
having headaches.Patient took one tablet of Advil, and still has ongoing headache, advised patient that he can take 2 tablets of Advil every six hours as needed. If headache gets worse recommended for him to see primary provider.
52 2021-03-31 chills, headache, fatigue Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no... Read more
Mild symptoms including chills, headache, fatigue, arm soreness more intense than first shot (but no problems with mobility).
52 2021-03-31 headache, fever, chills beginning 10hrs after injection: chills from 12-28hrs after injection: chills, INTENSE headache, mu... Read more
beginning 10hrs after injection: chills from 12-28hrs after injection: chills, INTENSE headache, muscle aches throughout body, hypersensitive skin - the hair on my legs felt like metal spikes when rubbing against each other; occasional, slight fever. from 28-36hrs after injection: gradual diminishing of headache to zero; on and off chills; muscle aches replaced by stiffness. from 36hrs - finally slept. 46hrs after injection - awoke with zero adverse symptoms remaining.
52 2021-03-31 fever, chills, headache, respiratory tract congestion Swelling, pain in arm, joint pain, chills, slight fever, congestion, headache.
52 2021-04-01 malaise, headache, lethargy, dehydration heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm in... Read more
heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
52 2021-04-01 fever, chills, headache Headaches body ache. Chills. Fever
52 2021-04-02 fatigue, fever, chills, malaise Started feeling "off" almost right away. Tinitus and feeling like my ears were clogged began within ... Read more
Started feeling "off" almost right away. Tinitus and feeling like my ears were clogged began within 30 min, but subsided in a few hours. About 6 hours later I felt like I was getting sick, and by 12 hours I had a fever, chills, headache, body aches. It felt like I had the flu. Fever spiked to 100.5 but tended to stay around 99.5-100. Worst of symptoms lasted 36 hours before beginning to subside. Most symptoms subsided in two days, with some lingering fatigue for another day or two.
52 2021-04-03 sweating Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%... Read more
Flushing/sweating, dizzy. History of fainting with shots. BPs 154/92, 121/74 (pulse 52). O2 sats 97%, 100%.
52 2021-04-03 lethargy Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as... Read more
Woke up around 4 AM the morning after the vaccine. Had pains are crossed my entire trust and felt as if I was having a heart attack. Got up I had a couple glasses of water and a couple of ibuprofen and it seem to clear up after about 30 minutes. Next day I was very lethargic and had increased stomach issues. Injection site very sore
52 2021-04-04 sweating, chills Pfizer-BioNTech Covid-19 Vaccine. I received the 1st dose at approximately 11am on April 2nd. I we... Read more
Pfizer-BioNTech Covid-19 Vaccine. I received the 1st dose at approximately 11am on April 2nd. I went to sleep and woke at approximately 4am on April 3rd with a sharp pain/ache in my side. I went to the bathroom and began to experience chills and started sweating. I was sitting on the toilet and passed out. My wife heard me hot the ground and I came to. I had had another experience passing out while on the toilet a month earlier, for which I went to the ER and was discharged. Test run on the early occasion were all negative. I did not seek any medical attention immediately following this event but will be following up with my primary physician.
52 2021-04-04 runny nose, throat pain Woke up with severe sore throat and developed stuffy/runny nose later that day. Felt weirder (off ba... Read more
Woke up with severe sore throat and developed stuffy/runny nose later that day. Felt weirder (off base / not normal). No headache / fever or chest congestion or ill feelings (stomach).
52 2021-04-05 cough, fever Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms ab... Read more
Patient presented 4/3 stating received Pfizer COVID-19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he should have production but is not able sputum out. The pain is chest is described as not being able to fully expand his lungs when he tries to inhale. Patient presented 4/6-DOA
52 2021-04-06 fatigue, fever Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (... Read more
Swollen lymph node (in arm pit, same side as shot). Diarrhea. Fatigue. Muscle soreness. Mild fever (100F) w/ brain fog.
52 2021-04-06 headache Dizziness, weakness, feeling faint, disoriented, headache, some shortness of breath
52 2021-04-06 sweating, nasopharyngitis, fatigue anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd co... Read more
anaphylactic shock Began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at me in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. went unconscious, - after recovery I had tremors for a few hours such that I could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired.
52 2021-04-07 chills, fatigue Chills, fatigue and hives
52 2021-04-08 fatigue, headache Began with tiredness and mild headache Progressed to intense diarrhea and vomiting
52 2021-04-08 fatigue, influenza like illness patient felt "flu like symptoms" as described by fatigue and dizziness. Resolved with lying back in... Read more
patient felt "flu like symptoms" as described by fatigue and dizziness. Resolved with lying back in seat and drinking water, 30 minute obs and back to baseline.
52 2021-04-08 sweating Syncope, Diaphoretic, Flush, arrhythmia
52 2021-04-08 sweating Patient began to feel lightheaded, diaphoretic, vital signs: 94/60, hr 48, saturation 94%. Paramedic... Read more
Patient began to feel lightheaded, diaphoretic, vital signs: 94/60, hr 48, saturation 94%. Paramedics called to assess for low heart and low blood pressure.- Patient feeling better, encouraged to call family or friend for drive home, patient insisted on driving self home. Patient encouraged to follow up with primary MD.
52 2021-04-08 fever, lethargy Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature... Read more
Severe vertigo with onset approximately 8 hours after injection. Mild fever symptoms but temperature wasn't measured. Lethargy and weakness accompanied other symptoms. Symptoms cleared after 48 hours.
52 2021-04-08 fever Hives followed by a fever which began at 8:30am in 04/09/2021. Highest measured fever was 103.4 at... Read more
Hives followed by a fever which began at 8:30am in 04/09/2021. Highest measured fever was 103.4 at 2:30pm. Took 3 200mg ibuprofen liquigel capsules. Fever dropped to 101.4 at 4:14pm.
52 2021-04-08 fever High fever 100 plus. Highest has been 100.5 at 5:00PM today. Took 3 reading today 99.5 in the morn... Read more
High fever 100 plus. Highest has been 100.5 at 5:00PM today. Took 3 reading today 99.5 in the morning, 100.2 this afternoon and 100.5 at 5:00PM.
52 2021-04-09 headache injection site pain; joint pain; headache; dizziness; This is a spontaneous report from a contactabl... Read more
injection site pain; joint pain; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm Left on 25Mar2021 09:30 (Lot Number: EN6207) as single dose for covid-19 immunization. Medical history included overweight. There were no concomitant medications. The patient did not receive other medications within 2 weeks of vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced injection site pain, joint pain, headache, dizziness on 27Mar2021 12:00. No treatment received for the events. The report was non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
52 2021-04-10 lethargy, fever Fever around 101 lasted for 12 hours, lethargy and body aches lasted for 24-48 hours. Treated with A... Read more
Fever around 101 lasted for 12 hours, lethargy and body aches lasted for 24-48 hours. Treated with Acetaminophen and Ibuprofen. All symptoms resolved within 48 hours
52 2021-04-10 fever, fatigue, sweating, headache Symptoms included: headache, body aches, particularly in lower back and upper back, tenderness at in... Read more
Symptoms included: headache, body aches, particularly in lower back and upper back, tenderness at injection site, fever and sweating, and extreme fatigue. Patient took ibuprofen (200 mg) 3 times over the course of 24 hours. Symptoms subsided after about 36 hours. Patient had to stop working for the day on 4/8/2021 due to symptoms.
52 2021-04-11 chills, fatigue, fever, headache March 6, 2021. - side effects began - tiredness, headache, fever, chills, muscle pain, joint pain Ma... Read more
March 6, 2021. - side effects began - tiredness, headache, fever, chills, muscle pain, joint pain March 14, 2021 - rash appeared on both arms, high fever persisted, muscle pain, fatigue March 16, 2021 - high fever persisted, severe muscle pain, fatigue
52 2021-04-11 chills, fever, lethargy Blood sugar readings have increased 15% since having COVID-19 vaccine. Have not returned to normal. ... Read more
Blood sugar readings have increased 15% since having COVID-19 vaccine. Have not returned to normal. Severe symptoms lasted 48 hours High fever Chills Aches Lethargy
52 2021-04-11 headache, fever fever over 102.3 for 4 days, headache for 2 weeks, broke out in a rash with red spots 9 days later, ... Read more
fever over 102.3 for 4 days, headache for 2 weeks, broke out in a rash with red spots 9 days later, skin on both hands had sever peeling, lost of taste and smell... misses 3 days of work due to in the bed with high fever
52 2021-04-11 headache Severe ringing in ears (tinnitus) since the day after 2nd dose. Causing headache and some dizziness
52 2021-04-11 fever, headache body aches, diarrhea, headache, fever 101 degrees F
52 2021-04-12 fatigue, sweating tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went ... Read more
tremors; legs felt hot; legs felt hot to the touch and ached; weak; tired; anaphylactic shock; went unconscious; neck pain; heavy dry mouth; profuse sweating; saw odd colors and dashboard of car coming at me in design; very cold; light headed; trouble breathing; throat felt swelled; bowels and bladder felt they were going to let loose; bowels and bladder felt they were going to let loose; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 02Apr2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies (sometimes seafood and some fresh fruits) from an unknown date and unknown if ongoing. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), lisinopril and lamotrigine (LAMICTAL), all taken for an unspecified indication, start and stop dates were not reported. The patient experienced anaphylactic shock which began with neck pain on left side, heavy dry mouth, profuse sweating, saw odd colors and dashboard of car coming at him in design, very cold and light headed, trouble breathing, throat felt swelled, bowels and bladder felt they were going to let loose. The patient then went unconscious. After recovery, the patient had tremors for a few hours such that he could not hold a glass of water, legs felt hot to the touch and ached for several days. Still feel weak and tired. Reaction began about 18 minutes (also reported as 14:15) after the shot. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering. The events were assessed as serious and life-threatening by the regulatory authority. Information on the lot/batch number has been requested.
52 2021-04-12 fatigue The feeling intensified further over the next 20 minutes until the feeling became almost a psychedel... Read more
The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience.; About 30 minutes after the second shot I began to get very light headed.; My pupils were tiny; the my perceptions were off any my "way of thinking" had changed.; The only other effect was I would get an uncontrollable tired feeling once a day for about 10 days.; This is a spontaneous report from a contactable consumer (patient). This 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in right arm on 09Mar2021 at 09:00 as a single dose for COVID-19 immunisation. The patient medical history included High blood pressure (had a history of drugs having unusual reactions in his system). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in the right arm on 16Feb2021 at 10:00 for COVID-19 immunisation and had light head. the patient not receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications the patient not received within 2 weeks of vaccination; 30 minutes after the first shot he felt light head. Not too bad but a bit concerning. About 30 minutes after the second shot (09Mar2021 09:30) patient began to get very light headed. The feeling intensified further over the next 20 minutes until the feeling became almost a psychedelic experience. his pupils were tiny, the my perceptions were off any his "way of thinking" had changed. he had take psychedelics in my youth (but not in 30 years) and it were not for that previous experience and ability to stay calm he was very well may have ended up in the emergency room. The whole experience lasted till he went to bed but the "peak high" lasted about an hour. The next morning he again felt like someone who had done a psychedelic drug the night before. The only other effect was he would get an uncontrollable tired feeling once a day for about 10 days. No treatment received for the adverse event; Prior to vaccination, the patient not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19; The outcome of all the events was recovered in 2021. Information on the lot/batch number has been requested.
52 2021-04-12 fever, headache I got a headache within 15 minutes, which progressed. I was able to drive home, but by the time I go... Read more
I got a headache within 15 minutes, which progressed. I was able to drive home, but by the time I got there is was very distracting. The next day I had a fever and muscle soreness. After about 33 hours, I felt recovered and had no further issues other than soreness in my arms.
52 2021-04-12 fever Within moments of injection experienced metallic taste in mouth that lasted several days. Day after ... Read more
Within moments of injection experienced metallic taste in mouth that lasted several days. Day after vaccine experienced fever up to 100.5 (even with 400 mg ibuprofen every 6 hours) that lasted 18 hours. Substantial pain that traveled from shoulder down the left arm. Very large swelling of the lymph node in left arm pit three days after injection. (not recovered from this yet)
52 2021-04-13 fatigue, chills Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feel... Read more
Patient received his second vaccination 2 days prior to presentation. States he woke yesterday feeling tired with associated chills, nausea, decreased appetite and hoarse voice. He was able to go to work as usual. He came home and ate some fish and clam chowder for dinner. Around 7pm that evening, his voice became muffled. Symptoms progressed to difficulty swallowing and sensation of throat swelling so he came to the emergency department for evaluation. On arrival to the ED, he was noted to have water bag edema of the uvula. O2 sats 98% on room air, no respiratory distress. He was treated with diphenhydramine, famotidine, and methylprednisolone and observed. No progression of symptoms noted.
52 2021-04-13 sweating 52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving... Read more
52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving the Covid vaccine (2nd dose). He LOC for 10 seconds. He became diaphoretic and pale. Denies headache, vertigo, seizures/PMHx of seizures, numbness/tingling/parasthesias, throat irritation, throat tightness, SOB, dyspnea, palpitations, chest pain, chest tightness/heaviness, hives, rash, peripheral or facial edema, nausea, vomiting. Patient was immediately assessed by EMT and clinical leads. Vitals were taken immediately. Given oral fluids (water/orange juice) and cookies.
52 2021-04-13 sweating 52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving... Read more
52 y/o (M/F) with PMHx of chronic lower back pain began to feel lightheaded 1 minute after receiving the Pfizer vaccine (2nd dose). He LOC for 10 seconds. He became diaphoretic and pale. Denies headache, vertigo, seizures/PMHx of seizures, numbness/tingling/parasthesias, throat irritation, throat tightness, SOB, dyspnea, palpitations, chest pain, chest tightness/heaviness, hives, rash, peripheral or facial edema, nausea, vomiting. Patient was immediately assessed by EMT and clinical leads. Vitals were taken immediately. Given oral fluids (water/orange juice) and cookies.
52 2021-04-13 nasal congestion, fatigue I have had mild tinnitus (ear buzz) in my left ear from 2014. The onset of that had coincided with a... Read more
I have had mild tinnitus (ear buzz) in my left ear from 2014. The onset of that had coincided with a flu shot I had taken then on the left arm. Since then the tinnitus had subsided to a tolerable level. I took the Pfizer Covid 1st shot on the right arm on 04/07/2021 9am. Other then mild fatigue, I was fine through the day. But that night at 3am, I woke up with significant tinnitus in my right ear. Over the next day it went away from the right ear but the tinnitus still lingered overall and was a little aggravated. Since then, it has now settled back in the left year but still at the aggravated levels it was back in 2014. Also, the left ear feels stuffed up as do my sinuses.
52 2021-04-13 throat pain, fatigue sore throat fatigue feels like I am coming down with a cold
52 2021-04-14 lethargy, cough Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt... Read more
Received a Janssen product 3 weeks earlier. His wife had received the Pfizer and she had a 2nd appt and he thought he needed one as well. Cough, generalized soreness, lethargy, shortness of breath, joint pain, watery diarrhea, night sweats.
52 2021-04-14 fever, headache, malaise Medical Decision Making 52-year-old male with past medical history of HIV, fibromyalgia, status ... Read more
Medical Decision Making 52-year-old male with past medical history of HIV, fibromyalgia, status post VP shunt, presenting to the emergency room with chief complaint of fever, headache, nausea, generalized malaise and body pain after receiving the 2nd Kaiser COVID vaccine yesterday morning. Patient is hemodynamically stable on arrival and afebrile. He is well appearing on examination without any acute neurovascular deficits on examination. He is placed on cardiac monitor and IV access was established. He was given symptomatic treatment with IV fluids Toradol and Zofran as well as a 25 mg IV dose of Benadryl. No evidence of anaphylaxis or concerning vaccine reaction, likely side effect. EKG was reviewed and grossly unremarkable. Patient was signed out to oncoming ED physician Dr. pending reassessment for symptom control. No further interventions while under my care in the emergency room. Patient was in agreement with plan of care and all questions and concerns were answered best my ability.
52 2021-04-15 headache headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), ra... Read more
headache, body aches, very large swollen lymph nodes under arm (swelling is the size of my fist), racing heart
52 2021-04-16 chills, malaise I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped ... Read more
I work 3rd shift Started with chills about 11pm same day as shot, then by 3am my heart rate dropped to 48 bpm and extreme shivering. (My normal resting rate is about 80 bpm). Heart rate came back up shortly but still below my normal bpm. When I got home at 7am was very weak and chilled, and on both hands my fingers turned completely white like they wasn?t getting circulation and were very cold.. I went to bed feeling horrible hoping it wasn?t serious and after I slept more than normal, I feel good now. Can?t say my heart rate going that low wasn?t kinda scary.
52 2021-04-17 malaise Tested positive for Covid-19; Tested positive for Covid-19; Not feeling very well; This is a spontan... Read more
Tested positive for Covid-19; Tested positive for Covid-19; Not feeling very well; This is a spontaneous report received from a contactable consumer or other non hcp and from a Pfizer Sponsored Program. A 52-years-old male patient received bnt162b2, Solution for injection (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 17:45 (Batch/Lot Number: EP7534) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia from Oct2019 and ongoing. The patient's concomitant medications were not re-ported. The patient was tested positive for covid-19 on 30Mar2021 and not feeling very well in Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 30Mar2021. He was given a steroid and an albuterol inhaler. Therapeutic measures were taken as a result of, covid-19 and not feeling very well. Patient got his first dose of the COVID Vaccine on 16Mar2021 and a few days later started not feeling very well and it has continued since then. He went to the doctor today and tested positive for COVID 19. His second dose is scheduled for 06Apr2021. He asks if a positive test has any effect on if he should follow through with the second shot or should he reschedule. Physician said he does not have a PCP right now and he went to Urgent Care. Within a couple of days patient did not feel well. It was probably the 17th or 18th. His symptoms are lingering. He tested positive today. He was taking over the counter stuff until today, he got prescribed a steroid for his symptoms. How he feels depends heavily on if he was taking medicine or not. He does not have product information for the over the counter medications taken available. No further details provided. There was not a date on the card, not an expiration date, but there was a date for his second vaccination. His employer gave him a letter that said he was eligible for it. He had avoided getting COVID for a year. Patient received his first COVID vaccine two weeks ago, went to urgent care today and has tested positive for COVID and would like to know if he should still take the second COVID vaccine or wait until his symptoms are gone. Transferred to public service due to having side effects and getting COVID. Due to their being a few callers ahead asked him if he would mind waiting in the waiting que and the next available medical professional from public service will be happy to answer your question. The outcome of the event was not recovered for malaise and unknown for other events.
52 2021-04-20 chills, headache, fever Severe headache, chills and oscillating fever (100-101) for 24 hours
52 2021-04-21 headache, lethargy, fever 2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no notic... Read more
2:30pm - Vaccine administered. Some muscle soreness at the vaccination site, but otherwise no noticeable side effects. 1am - 10 hours after vaccine. All over body shaking. Not unlike "chills" but didn't have the cold feeling with it. No accompanying fever at the time. Lasted until 5:30am. 6am - 15 hours after vaccine . Shortly after the shaking stopped, spiked a 101.5 degree fever. That continued until approximately 5am the following day. Took 500mg acetaminophen at 7am, and again at 4pm, and again at 12am. Throughout the following day - 15 hours to 36 hours after vaccine - general body aches (most noticeable in the back), lethargic - but that could have been a result of no sleep the night prior due to shaking. 5pm following day - 27 hours after vaccine - bad headache. That lasted until midnight 5am the next morning - most all side effects gone. Some lethargy but temperature at 98.6 degrees, body aches no longer apparent, headache gone.
52 2021-04-22 fatigue, headache 4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient wit... Read more
4/15 immediate post-injection reaction: "Patient evaluated for chest pain after vaccine. Patient with L sided chest pain and back pain immediately after vaccine. Patient had identical reaction after first dose. When patient was laid in bed and given oral hydration, pain resolved. Patient felt confident that this was anxiety as with his first vaccine. VS and exam WNL. 2 lead EKG showed NSR with no clear ST changes. Patient was returned home with wife as driver. " 4/16 reaction: patient contacted PCP with complaints of "Nausea, stomach ache, headache, injection site discomfort, fatigue, some diarrhea." Patient requested something for nausea. Provider prescribed ondansetron. 4/22: patient contacted PCP with complaints that since 2nd dose, he has felt "Fatigue and feet pain with swelling and intermittent numbness . Also since then has not been able to control CBG, in AMs >200, using medications as prescribed." PCP monitoring; no medication treatments.
52 2021-04-22 head discomfort, chills, fatigue, headache It?s been over 2 weeks & right eyelid STILL swollen & looks very bad!! Had chills, fatigue, head fel... Read more
It?s been over 2 weeks & right eyelid STILL swollen & looks very bad!! Had chills, fatigue, head felt real heavy & almost fell to floor when using bathroom the next morning 4-8-21 after 2nd dose 4-7-21, had severe headache all day (took 2 Tylenol every 4-6 hours. Headache finally went away the next day.
52 2021-04-22 headache Constant ringing in left ear, tinnitus. So bad on one day it gave me nausea and severe headache, di... Read more
Constant ringing in left ear, tinnitus. So bad on one day it gave me nausea and severe headache, dizziness. Tried a round of steroids (Methylprednisolone) from doctor, did not improve.
52 2021-04-23 fatigue I would describe symptoms as ?mild?, but as this was only the first shot, I thought they were worth ... Read more
I would describe symptoms as ?mild?, but as this was only the first shot, I thought they were worth reporting. From 12 hours after my shot to about 48 hours afterwards, I experienced extreme fatigue, irritating rashes on the backs of my hands (which now went away), stomach pain, and a racing heart beat. All of which are also symptoms of mild covid. I seem OK 2 days afterwards.
52 2021-04-23 lethargy, fever, headache 4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills,... Read more
4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills, muscle aches, diarrhea, lethargic - first 3 days, then next 4 days - intermittent fever - low grade, muscle aches, very lethargic, and diarrhea. (7 or a few more in total) 4/20/21 - 2nd shot - 36 hours of low grade fever, 100 or less, headache, chills, muscle aches and diarrhea.
52 2021-04-23 fever, fatigue, chills, headache Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swo... Read more
Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The patient Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on 06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired. Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered. Follow up (15Feb2021): This follow up report contains no new medically significant safety information. Follow up (17Feb2021): This follow up report contains no new medically significant safety information.
52 2021-04-24 fatigue, chills chills; fatigue; sore joints and muscles; sore joints and muscles; This is a spontaneous report rece... Read more
chills; fatigue; sore joints and muscles; sore joints and muscles; This is a spontaneous report received from a contactable consumer (patient's wife). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:30 (Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Patient took the first dose of vaccine in Arm Right on 17Mar2021 11:30 AM (Lot Number: EP6955) for covid-19 immunization. Medical history included hypertension. Concomitant medication included amlodipine taken for hypertension, start and stop date were not reported. The patient experienced chills, fatigue, sore joints and muscles on 08Apr2021 08:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. Patient was not diagnosed with COVID-19 prior vaccination nor tested COVID-19 post vaccination. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The case was reported as non-serious. No follow-up attempts are needed. No further information is expected.
52 2021-04-24 fatigue, headache aches shoulder and neck mild headache extreme fatigue constant ringing in ears
52 2021-04-24 fatigue, headache Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms... Read more
Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
52 2021-04-24 sweating, fatigue, headache, fever, chills Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fe... Read more
Side effects: light chills, strong headache (3 days, after now 9 days still coming back briefly), fever (37.8C), muscle pain, body joint pain for 3 days, left arm pain (3 days), sweating (2nd night), fatigue for ~2days, and most importantly: for over 9 days/nights swollen nymph knot under left arm, was as big as a full hand full (like a full bar of soap), has meanwhile improved daily, but I can still sense a small (wallnut size) under the arm now, 9 days after the shot. It's important to inform because the media and the doctors are not reporting how bad and lasting the side effects are and it is important to be transparent to patients what to expect, otherwise trust is eroded and people stop getting vaccinated.
52 2021-04-26 chills, fever, headache Approximately 4 hours after the shot, my vace and head broke out in with what look like "in grown ha... Read more
Approximately 4 hours after the shot, my vace and head broke out in with what look like "in grown hairs". The next morning, 4/23, my lymph nodes on the side of my neck, and under the tip of my chin swelled up significantly. Still there... Then the headache started (4/23), and is still ongoing. This is accompanied with major body aches, a very low grade fever, and occasional chills. Today, 4/27 at approximately 6:30pm, I started puking. I'd rather roll the dice with Covid then get a second shot!!!!!!
52 2021-04-26 headache Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. Apr... Read more
Vaccine April 24th 9:15 am, by afternoon was feeling tingling and numbness in left side of face. April 25th, arm hurt, headache (typical), but tingling and numbness was increasing. It felt like I had a novocaine shot. April 25th Doctor said to got to ER. At ER they had me take an EKG, Full Blood Work, CT Scan and CTA Scan. MRI to be determined in a couple days.
52 2021-04-28 sweating Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: C... Read more
Pt received vaccine, wife was receiving her vaccine and pt became unresponsive, diaphoretic. 1150: Code Medical called immediately. Car seat reclined.. BP 92/50, HR 40, RR18. Pt pale and diaphoretic. 1152: Pt arousing but unable to communicate clearly. BP 98/48, HR 40, RR1. Able to drink OJ, small sips. 911 activated. 1154: Pt removed from car and placed on cot awaiting EMS. 1156: Pt answering questions, remains pale and diaphoretic. BP 102/62, HR 54. Alert & Oriented X3. 1202: EMS arrived and walked pt to ambulance. BS 102, BP 114/68, HR 51. Skin warm and dry. Alert & Oriented. Pt to be transported to ED secondary to decreased Heart Rate.
52 2021-04-28 fever First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoi... Read more
First vaccine was 3/1/21. 3/2/21 had muscle & joint aches, weakness, low grade temp, swollen lymphoid under arm until 3/3/21. Second vaccine was 3/22/21. Had same symptoms only more severe & higher temp. This time I was sick 4 days & unable to work. I was not better until 3/26/21
52 2021-04-29 chills, fever soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. t... Read more
soon after shot, pain in muscle area ...around 11 hrs later,very bad chills, body aches started.. then as time went on nausea, weakness and running low grade fevers..symptoms getting better and worse over a period of time thru late Sunday morning when started to feel like myself..by the end of the day, felt better..
52 2021-04-29 fatigue, chills Joint and muscle aches, approx. 24 hours Chills, approx. 2 hours Exhaustion, approx. 36 hours
52 2021-04-29 fever, cough cough and fever
52 2021-04-30 chills, fever, fatigue Fever; Chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). ... Read more
Fever; Chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 52-Year-old male patient received second dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Batch/Lot Number: EL3247; Expiration Date: unknown), via an unknown route on 16Feb2021 at 11:00 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included marginally high blood pressure. Patient's concomitant medications included (medications in two weeks) lisinopril. The patient received first dose of BNT162B2, Solution for injection, Lot number: Batch/Lot Number: EL3247), via an unknown route on 26Jan2021 at 09:30 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 16Feb2021 at around 10pm (on the same day of vaccination), the patient reported fatigue, fever, and chills. It was reported that, patient did not take any treatment medication for the events. The outcome of the events was resolving.
52 2021-04-30 fatigue Fatigue for 48 hours; This is a spontaneous report from a non contactable consumer (patient). A 52-y... Read more
Fatigue for 48 hours; This is a spontaneous report from a non contactable consumer (patient). A 52-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot number was not reported) at age of 52-year-old, as single dose for covid-19 immunisation. Medical history was none. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) taken at age of 52-year-old, via an unspecified route of administration, administered in arm left on 22Mar2021 10:30 (Batch/Lot number was not reported), as single dose for covid-19 immunisation. The patient experienced fatigue for 48 hours on 12Apr2021 16:00. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-04-30 headache, throat pain 3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On... Read more
3/31: earache, headache 4/1 ? 4/4: earache, headache, sore throat, vertigo, vomiting, brain fog. On 4/4, doctor prescribed Amoxicillin 125 MG 2x/day 4/5 ? 4/7: sharp earache with pressure, loss of hearing in left ear, sore throat, brain fog, headache 4/8 ? 4/11: noticed Ptosis, numbness left side of face, persistent headache. Went to Emergency Room, performed CT scan, blood test, confirmed there is no stroke, DIAGNOSED FOR BELLS PALSY. Prescribed Prednisone and Valacyclovir for 7 days. 4/12 ? 4/22: Treated by NP for Bells Palsy, referred for rehab/therapy. 4/23: symptoms clear, Bells Palsy 95% return to normal 4/30 : received 2nd Pfizer vaccine dose Lot # ER8737
52 2021-04-30 fever, fatigue, chills fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3... Read more
fever, chills, joint and muscle aches, night sweats, fatigue, lightheadedness, foggy headedness, - 3 days in a row starting April 8 then subsided and started again a few days later
52 2021-05-01 fatigue, headache, chills Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and ... Read more
Upper arm soreness started at about 8:30 pm, about 10 h after injection. Went to be like normal and arm was just sore, but nothing else at that time. At 1:10 am, patient woke up with horrible shakes, verging on convulsions, and the feeling of freezing to death. Uncontrollable shivers/shaking. At around 1:40 am, patient was able to move enough to get out of bed to find a second blanket and extra strength Tylenol and took the Tylenol with some seltzer water and hid under blankets to get warmer. After about an hour, around 2:30 - 2:40 am, the shaking was reduced enough that the patient was able to relax and try to get to sleep. At 5;30 am, the patient woke up with much the same symptoms, but with the addition of the worst headache he had had since he stopped having migraines in his mid 20s and also his whole body ached like he had been hit by a truck (that [getting hit by a truck] had happened to him once about 15 years ago, so he has the actual reference to compare against). This experience was worst overall body aches/pains ever experienced by the patient. He took additional Tylenol at 6 am and about 30 minutes later, the chills subsided and the pain was reduced enough that he could go to sleep again. Shortly before 10 am the symptoms started to get worse again and he took ibuprofen (400 mg) at 10 am, after the shakes started to come back. He has traded off every 4 hours taking tylenol and ibuprofen, which keeps the temperature perception swings to a minimum and overall body aches lower, but the headache does not go away. He feels exhausted, and has slept for spurts of 15 - 30 minutes on and off all day. He was able to each crackers at around noon and some homemade chicken vegetable soup at about 1 pm as the nausea had subsided. Prior to that, he could only drink water and Gatorade. He is hoping that within 24 - 48 h he will feel much better, without having to take Tylenol or Ibuprofen.
52 2021-05-01 headache, fatigue Headache, foggy, tired Next morning or 40 hours after vaccine back to normal
52 2021-05-01 headache, nasopharyngitis Patient traveled to Tennessee for son's college visit 4/22/21-4/24/21 and started getting headache a... Read more
Patient traveled to Tennessee for son's college visit 4/22/21-4/24/21 and started getting headache and head cold after returning. Got positive COVID19 test one 4/27/21. Patient in quarantine but feeling better. Postponing second dose vaccine by 2 weeks.
52 2021-05-01 malaise Patient was traveling and got mildly ill, tested positive for COVID19 two weeks after getting first ... Read more
Patient was traveling and got mildly ill, tested positive for COVID19 two weeks after getting first shot
52 2021-05-03 chills, cough, fatigue, headache, fever The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have dev... Read more
The first 2 days had fever chills fatigue teeth hurt headache tiredness. 4 days after shot have developed a cough left side chest pain at times twitching in left shoulder area headaches and now have a difficult time doing anything physical like simple walking feel out of breath.
52 2021-05-03 cough, fatigue, nasal congestion fatigue, cough, generalized body aches, nasal congestion
52 2021-05-04 cough, chills, fatigue Cough Fatigue chills, muscle/body aches nausea Finish Valtrex Tylenol prn Inc fluids / plenty o... Read more
Cough Fatigue chills, muscle/body aches nausea Finish Valtrex Tylenol prn Inc fluids / plenty of rest Netti pot Check COVID PCR Rx: Doxycycline
52 2021-05-04 fatigue cerebral edema; diarrhea; fatigue; nausea; vomiting; This is a spontaneous report from a contactable... Read more
cerebral edema; diarrhea; fatigue; nausea; vomiting; This is a spontaneous report from a contactable pharmacist. A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly administered in left deltoid on 18Apr2021 (at age of 52 years old, Lot Number: EW0161) as single dose for covid-19 immunization. Medical history included hypertension, hyperlipidaemia, depression, anxiety. Concomitant medications included amlodipine, baclofen. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 28Mar2021 (at age of 52 years old) as single dose for covid-19 immunization. The patient not took any other vaccine. The patient took some medication (prescribed regularly) for there disease state prior to the event being reported. No allergies reported. Pharmacist stated, "Cerebral edema following within less than 24 hours of the second dose of vaccine. There was no anaphylactic reaction reported. The patient had fatigue, nausea, vomiting, diarrhea. Patient enter ER and was now requiring ICU level of care, intubated for respiratory support. They came in overnight emergency, they do have lab. He had done a whole work up he came in to the ICU. Pharmacist stated, "He did not take anything and ended up into the hospital. So they are requiring antibiotic and they also require intubation. So he needs to be intubated for respiratory support. Duration of stay was undefined and they arrived to the ER at 9:11 AM today (19Apr2021) this morning. That is the time of admission. Before 19, today's date. The events required the initiation of new medication or other treatment or procedure. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Cerebral edema and other reported events due to temporal relationship. However, the reported event of Cerebral edema may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
52 2021-05-04 headache Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till ... Read more
Evening symptoms, injection site pain, mild headache, sleeplessness caused by mild limb spasms till 1:00 am. Spasm symptoms seem to have subsided, headache remained mild. able to fall asleep. Awoke at 5:30 (normal time) seemed good other than arm soreness. By 8 am I developed Vertigo like symptoms. 48hrs after injection this morning, the headache is gone but vertigo symptoms remain however lesser than the previous day.
52 2021-05-04 fever, malaise ill; not feeling well; body aches; fever; flu; This is a spontaneous report from a contactable consu... Read more
ill; not feeling well; body aches; fever; flu; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 (at the age of 52-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was due for his second dose of the vaccine on 21Apr2021; but was ill on 20Apr2021; not feeling well with body aches and fever, but stated he doesn't have COVID, just a flu. The patient was asking if he could receive the second dose of vaccine on the next day. The events had not resolved at the time of the report. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
52 2021-05-06 sweating Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood... Read more
Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood pressure medications.
52 2021-05-07 fatigue, chills Migraine, chills, body aches, very tired feel, strong body pain all over
52 2021-05-07 fatigue Evening of 4/30/21 - dizziness. increased appetite and food intake 5/1/21 - fatgue during the day t... Read more
Evening of 4/30/21 - dizziness. increased appetite and food intake 5/1/21 - fatgue during the day then sleptat least 16 hours straight, increased food intake
52 2021-05-07 lethargy Moderate-to-high energy in the first 24hours. Lethargy accompanied by significant body (joint) ache... Read more
Moderate-to-high energy in the first 24hours. Lethargy accompanied by significant body (joint) aches afterward for approximately 24 hours. Interesting was that I noticed a 1" stain on my white t-shirt exactly over the injection site 48-72 hours after the injection, as if the vaccine was "oozing" out of the injection site.
52 2021-05-08 chills, fever, headache, fatigue vomiting, nausea, fever, chills, joint pain, aches, fatigue, headache
52 2021-05-08 headache The day after vaccination I had significant headache.. I have measured my blood pressure and it show... Read more
The day after vaccination I had significant headache.. I have measured my blood pressure and it showed 200/107.. My usual blood pressure baseline at that time was ~130/~87
52 2021-05-08 fever, sweating "I watch a customer get his Vaccine at 1:13pm while I waited for mine at 1;35. He seemed happy and... Read more
"I watch a customer get his Vaccine at 1:13pm while I waited for mine at 1;35. He seemed happy and moved to the recovery area allowed for 20 minutes rest to see if there were any reactions. He complained after 10 minutes of having a fever and asked for cold, cold water. He was sweating and his T-shirt looked very wet, At this point the pharmacist attended him and called 911. I heard a staff member of the Shop say that was the 6th one to have a reaction that week that they knew about. I got up and left and did not get my vaccine. "
52 2021-05-09 chills, fatigue Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning... Read more
Pt vaccinated on 5/5/21. On 5/6/21 he developed fatigue, body aches and chills. In the early morning of 5/8/21 (around 3am), he woke up from a sleep in his armchair and stood up, at which time he lost consciousness and passed out, hitting his head. He does not recall anything after that until he woke up in bed in the morning.
52 2021-05-09 sweating, headache, chills Chills and sweating occurred around 4:00 AM on 4/24/2021. Bad headache occurred around 2:00PM that s... Read more
Chills and sweating occurred around 4:00 AM on 4/24/2021. Bad headache occurred around 2:00PM that same day.
52 2021-05-10 headache blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all... Read more
blurry eyes; Headache; numb face and arms; Felt dizzy; Had to call out of work to rest and sleep all day; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 16:00 as single dose for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medication was not reported. The patient received second dose of Pfizer BioNTech Covid 19 vaccine on Monday 19Apr2021 around 4pm. The next day the patient experienced numb face and arms, felt dizzy, and had to call out of work to rest and sleep all day. Today he felt okay but started feeling dizzy with a headache and blurry eyes. He has diabetes but has been taking his blood sugar in the morning and they have been okay. He has been taking tylenol for the headaches. The patient said he was driving to work next day and face and arm went numb. Had to turn around and go back home. Next day tried going to work again, face and arm went numb also was dizzy and slight headache. Wants to know if this side effect has been reported and what do we suggest. It was reported that the patient went to see his animals and I (sentence incomplete). I am calling you because of the side effects that I am having from the vaccine. Also, I want to know if this was the part of the side effects that was going on with me. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-05-10 sleepiness, headache eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and fac... Read more
eyes kind of cloudy; dizzy and off balance; Headache; dizzy and off balance; whole right arm and face numb; Drowsiness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8734, on 19Apr2021 16:00 at single dose in left arm for COVID-19 immunization. Medical history included ongoing Diabetes mellitus since 2011. Concomitant medication was none. The patient previously received first dose of BNT162B2, Lot: GR8735, on 28Mar2021. The patient received his second dose of the Pfizer Covid-19 vaccine at 1600 on Monday (19Apr2021). Yesterday (20Apr2021), he went to work to feed his horses and he couldn't work. He was drowsy, his whole face and right arm was numb, he rested all day. Today (21Apr2021) as he was driving to work he pulled over. He had a headache and was drowsy and his eyes were kind of cloudy. The patient was drowsy early this morning again, it came back like yesterday morning. He laid down in his truck and rested and he got better. His arm and face being numb started yesterday around 9am and stopped between 1800 to 1900. At the jobsite, it was lunchtime and he drove the employees, reported his eyes bring kind of cloudy was better now. This morning he was drowsy and dizzy, off balance. He stayed in his truck. His balance was getting back to normal again. He had been taking Tylenol for his headache. The outcome of Drowsiness, eyes kind of cloudy, dizzy and off balance was resolving. The outcome of whole right arm and face numb was resolved on 20Apr2021. The outcome of Headache was unknown. No follow-up attempts are needed. No further information is expected.
52 2021-05-11 fatigue Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection. Approximately 74... Read more
Virtually no symptoms from first vaccine or in first 72 hours after 2nd injection. Approximately 74 hours after 2nd injection I noticed some slight nausea and body aches. Within a few hours I was severely tired, weak stomach, had short, shallow breathing, tight chest and body aches. This has gone on continuously until this morning, 5 days after vaccine.
52 2021-05-11 malaise Patient stated he didn't feel well 2 days after receiving the vaccine and he went to hospital next d... Read more
Patient stated he didn't feel well 2 days after receiving the vaccine and he went to hospital next day. He was diagnosed for blood clot in lung, treated in the hospital and discharged home. Patient stated the doctor was not sure what has caused the blood clot in lung.
52 2021-05-11 pneumonia, fever, cough Pneumonia, unspecified organism FEVER COUGH GENERALIZED BODY ACHES
52 2021-05-12 fatigue, nasal congestion, fever, cough, chills body aches, loss of taste and smell, tired, congested, shortness of breath, fatigue, cough, chills, ... Read more
body aches, loss of taste and smell, tired, congested, shortness of breath, fatigue, cough, chills, fever, chest pain
52 2021-05-12 nasal congestion, fatigue Body aches, loss of taste and smell, achy, tired, congested, shortness of breath
52 2021-05-12 runny nose, headache, nasal congestion Muscle or body aches Headache New loss of taste or smell Congestion or running nose
52 2021-05-13 fever Dizzy after the first dose of the vaccine; Felt very sick/Sick as a dog; 102 degree fever after firs... Read more
Dizzy after the first dose of the vaccine; Felt very sick/Sick as a dog; 102 degree fever after first dose of the vaccine; He felt dizzy and thought he was going to fall over; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732 ), at single dose via an unspecified route of administration on 29Mar2021 for covid-19 immunization (at the age of 52 years). Medical history included ongoing asthma (had for 20-30 years), diabetes (from 2018 and ongoing but on and off since 2018), covid-19 from Jan2021 to an unknown date (No Investigation Assessment), motor vehicle accident he had in 2002- took Naprosyn and it helped. States that before all of this he had lost (weight) pounds and been eating very well. The patient's concomitant medications were not reported. Previously, the patient had flu vaccine and he got the flu every time he got it (Vaccination Date: 2002 or 2003). No other products. After the first dose of the vaccine, on 29Mar2021 he had a 102degree fever a few minutes after the shot and was dizzy. He felt dizzy and thought he was going to fall over on an unspecified date in Mar2021. On 29Mar2021 he felt very sick; dizzy after first dose of the covid vaccine and stated that he sat for a bit after his shot. Paramedics there who took his temperature and that it was 101 point something; close to 102. They told him to go home and relax and take Tylenol. States he went home and took Aleve as therapeutic measure and felt better. It lasted one more day then went away. The patient underwent lab tests and procedures which included body temperature: 102 on 29Mar2021 it was 101 point something; close to 102. Rest relevant tests were none. The Outcome for fever, dizzy and felt sick was recovered on 30Mar2021; for going to fall over was unknown. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-05-14 fatigue This is a spontaneous report received from a contactable consumer. A 52-year-old male patient receiv... Read more
This is a spontaneous report received from a contactable consumer. A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number : EM9810, expiry date: unknown) via unknown route of administration on 15Feb2021 as single dose for covid-19 immunisation. The patient's medical history included asthma, diabetes, anxiety and depression. Concomitant medications included metformin, glipizide, steglatro (: ertugliflozin pidolate), wixela Inhub (fluticasone propionate, salmeterol) (indication for use: Asthma), Effexor (venlafaxine hydrochloride). On 16Feb2021, the patient experienced body aches and fatigue. It was reported that patient know that in the fact sheet, said could take Tylenol or see the medicine for the body aches. The patient had taken Aleve (as patient don't have Tylenol) and was just wondering if patient could take Aleve instead of Tylenol." . The patient confirmed that he had not taken any medication yet after receiving the first dose. Outcome of events was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
52 2021-05-14 headache, fever, chills I Have injection site pain, headeche, muscle pain all body, chills, fever over 100.54
52 2021-05-14 fever Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Prog... Read more
Blood Clot in right leg; Severe pain in leg; cry; This is a spontaneous legal report (Marketing Program) from a contactable consumer (patient himself). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection) dose 2 (Batch/Lot Number: EW0770) via an unspecified route of administration, on 21Apr2021 11:30, as single dose for covid-19 immunization. Medical history included Asthma ongoing, Diabetes had been on and off since 2018, Covid-19 in an unspecified date in Jan2021. The patient received dose 1 (Batch no/Lot Number: ER8732) via an unspecified route of administration, on 29 Mar 2021, as single dose for covid-19 immunization. The patient's concomitant medications were not reported. On 21Apr2021 around 11:30-12:00 in the night the patient experienced Blood clot in his right leg, had a severe pain and cannot walk, feels like he's being stabbed in the leg every time he gets up. He had to keep his legs up all the time and not put them down. He stated that his life was going to be upside down for 6 months because of the Covid vaccination. Stated that was unacceptable. Reporter also said that if the blood clot breaks off it could be dangerous. Said it was substantial; it was all the way up to his groin, not its down almost to his knee and goes all the way down to his ankle. Patient went to the hospital last Saturday due to pain in the back of his leg. The pain started 12 hours after the second Covid vaccine. He wanted to cry he was in so much pain. He could not take anything for it. Patient stated that if the clot breaks off, he was dead. So, he had to put everything on hold because he did the right thing which ended up being the wrong thing. Patient stated that the pain in his leg was a 13 or 14 on a scale of 1-10. Patient took Tylenol and Pain patches did not work on a blood clot. Patient stated that when he was in the hospital, 4 different doctors, told him the event was at least 50 if not 100 percent caused by the Covid dose of vaccine. Patient stated that after the first dose of vaccine he was sick as a dog and he said that the clot may have started with the first dose of vaccine, stated that he had a 102 degree fever a few minutes after the vaccination, felt dizzy and thought he was going to fall over. Patient stated that he got the vaccination dose to get his life back and now he could not, that what about in 6 months if he had to get a booster vaccine and probably go through it all over again; or to be on quarantine. Patient stated that he went with his 84-year-old mother to get the vaccine. Patient said that the only reason she didn't get a blood clot was because she was already on blood thinners and said that he is the one who takes care of his mom and now he cannot walk barely, he had Covid in January and that people who had Covid shouldn't be taking these vaccinations because they have immunity, he talked to a doctor and a woman yesterday who still have their antibodies a year after having Covid. He said that the vaccine was injuring people. He was hospitalized related to his leg pain and diagnosed with the blood clot from 24 Apr 2021 to 27 Apr 2021. In the hospital he was told to him take Oxycontin or Morphine. He said that he did not want to take those and end up addicted. He said after a motor vehicle accident he had in 2002 he took Naprosyn and it helped, he said could not take that now because he was on a blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had tested COVID-19 positive prior to vaccination. This is to notify that potential legal action from a reporter in the attached source document booked into AER 2021506757 and 2021506972. The outcome of the event Blood Clot in right leg and Severe pain in leg was not recovered, feels like he's being stabbed in the leg was recovered and cry was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
52 2021-05-16 chills, sweating, fever, headache - fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more tha... Read more
- fever and chills during overnight hours the past 2 nights after shot, unable to sleep for more than an hour at a time. - headache most of the day on Sunday, headache area more so on top of head and some tingling in head at times. - worse chills overnight the 2nd night, had to change pajamas due to chills and sweating 2nd night. - 2nd shot given in left arm, 2 mornings later (Monday), excessive swelling in left armpit and pec muscle, swelling almost size of baseball and protruding, no bruising or pain, just very tender and uncomfortable, feels tight and can certainly feel skin stretched due to swelling.
52 2021-05-16 headache Patient developed frequent headaches starting a day after receiving first dose of vaccine. Patient ... Read more
Patient developed frequent headaches starting a day after receiving first dose of vaccine. Patient then developed daily headaches after he got the second dose. Patient was hospitalized for his headaches and had to be started on medication.
52 2021-05-16 fever, fatigue, malaise Fatigue, weakness, general ill-feeling, fever measured at 101.5 on Saturday, May 8. Fatigue continu... Read more
Fatigue, weakness, general ill-feeling, fever measured at 101.5 on Saturday, May 8. Fatigue continued until May 13.
52 2021-05-17 chills, respiratory tract congestion, fever, malaise, headache Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nos... Read more
Began with 7 hours of deep chills, fevers beginning 10 hrs after shot. Strange metallic smell in nose for one hour. Some tender mild swelling of lymph nodes for next 10 hrs, headache persisted 6hrs, , then mild congestion for 24 hrs. Malaise persisted throughout 24 hours even with bed rest.
52 2021-05-17 cough, sleepiness, fever, chills, body temperature increased On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir ... Read more
On 11/08/20 the client had symptoms of fever up to 103.5 F, chills tachycardia 117 bpm, O2Sat nadir of 85%, respiratory rate 22, development of hypotension with BP 85/55 bpm with weakness, drowsiness, chills, flushed skin, bilateral edema both lower extremities with wheezing and rhonchi throughout both lungs and was sent to a local medical hospital for treatment where he tested positive for COVID and was returned to the psychiatric hospital after a 3 day stay and 2 administrations of remdesivir on 11/09/20 and 11/10/20 improved. The client subsequently received the Pfizer COVID19 vaccinations on 12/29/20 and 01/19/21 from different lot numbers noted above. On 5/16/21 the client began to have respiratory symptoms including temp of 99.5, pulse 103 O2 Sat of 85% with rhonchi responsive to albuterol inhalation and subsequently albuterol nebulizer treatment; however the following day symptoms progressed with weakness, wheezing, cough, shortness of breath, pallor and O2 saturation 77% unresponsive to albuterol nebulizer treatment. He was was transferred to a local medical hospital for treatment of severe respiratory symptoms and tested positive for COVID a second time and after the complete Pfizer COVID19 vaccination series approximately 4 months prior. He is still hospitalized at the medical hospital at the time of this report (2 days).
52 2021-05-17 headache, fatigue He got his vaccine, he felt fine after it for the rest of the day. The next morning he woke up with... Read more
He got his vaccine, he felt fine after it for the rest of the day. The next morning he woke up with dizziness, headache and vision/near sighedness was impaired. He has some emotional issues that have been corrected but they seemed to have returned. Also had fatigue that was fairly mild at first, and over the next 3 days got worse, and has remained the same since that time to present. About a week some of the dizziness and headaches are not as often, but the headaches have become more severe. Before it was a low grade migraine that was constant, but other times it is horrific and others not too bad. No predictability. No fever, no chills, no sore injection site. He has notified his doctor who tested his electrolytes which came back normal. He ended up falling getting out of the shower and hurt his back and shoulder and prescribed him Hydrocodone which did not help the headache.
52 2021-05-17 pneumonia, headache, fatigue headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- a... Read more
headaches, stiffness, dizzyness, fatigue, loss of appetite pnuemonia including a stay in hospital- antibiotics x 3 types, oxygen, steroids
52 2021-05-19 cough, chills, nasal congestion, fever Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason fo... Read more
Clinical Support 3/31/2021. Exposure to SARS-associated coronavirus +1 more. Dx Labs Only. Reason for Visit ED Discharged 4/30/2021 (2 hours) Treatment team. Providers COVID-19 Clinical impression, Fever, Generalized Body, Aches, Chills. Chief Complaint Patient presents with Fever, Generalized Body Aches, Chills. HPI: 52-year-old male with history of diabetes, hypertension, obesity presents the emergency department with gradual onset of moderately severe generalized nasal congestion with associated cough unproductive of sputum and fever, T-max 103.8 at home the patient states began approximately 1 week prior to arrival. The fever worsened today and he decided to be seen at that time. He states he had his first dose of Pfizer COVID-19 vaccine 3 weeks ago. Denies sick contacts, chest pain, shortness of breath, syncope, dizziness, lightheadedness, numbness, focal weakness, abdominal pain, nausea, vomiting or diarrhea, changes in bowel or bladder habits or other complaint. No other signs or symptoms and no treatment prior to arrival. ED Discharged 5/1/2021 - 5/2/2021 (5 hours). Last attending Treatment team COVID-19 +1 more. Clinical impression, Chest Discomfort, Chief complaint. ED Provider Notes. Expand AllCollapse All. HPI. Chief Complaint Patient presents with. Chest Discomfort. Patient History. 52-year-old male with history of asthma, diabetes, heart murmur, hypertension, obesity, sleep apnea and was seen in the emergency department yesterday complaining of generalized nasal congestion, fever and cough and was discharge with a diagnoses of COVID-19 4/30/2021 presents to the emergency department with complaint of chest tightness. The patient states that tonight he developed chest pain which woke him from sleep. He describes the pain as burning. He states the pain is similar to the pain he had when he had a gallbladder attack. He also states the pain is well localized and does not radiate. Initially the pain was 10/10 initially and is currently a 4/10. He took his temperature and states he had a fever of 101.6 and took 1,000 mg of tylenol just prior to arrival. His O2 saturation today has not gone under 90%. Medical History. Past Medical History: Diagnosis Date Asthma 5/29/2017, Diabetes mellitus, Heart murmur, Hypertension, Obesity, Sleep apnea, obstructive. APAP 8-20CM WME AIRVIEW. Surgical History. Past Surgical History: Procedure Laterality Date CARDIAC CATHETERIZATION 03/2004. OTHER SURGICAL HISTORY ear surgery as a baby. STRABISMUS SURGERY repair of congenital strabismus-childhood. Family History. Problem Relation Age of Onset. Hypertension Mother. Diabetes Father. Hypertension Father. Hearing loss Other. Kidney disease Other. Social History. Tobacco Use. Smoking status: Never Smoker. Smokeless tobacco: Never Used Vaping Use. Vaping Use: Never used. Substance Use Topics. Alcohol use: No. Drug use: No. Review of Systems. Constitutional: Positive for fever. Respiratory: Positive for chest tightness. Cardiovascular: Positive for chest pain. All other systems reviewed and are negative. ED to Hosp-Admission. Discharged 5/4/2021 - 5/6/2021 (2 days) Hospital. Last attending Treatment team Acute hypoxemic respiratory failure due to COVID-19. Principal problem. Presenting Problem/History of Present Illness/Reason for Admission. Acute hypoxemic respiratory failure due to COVID-19. Hospital Course. Patient is 52 yo BMI around 40, presents to the hospital with severe sepsis secondary to COVID-19 pneumonia. He was first positive on 04/30, had progressive shortness of breath with weakness and worsening cough. He presented to the hospital originally on 05/04, and desaturated to 85% on room air. He admitted to the medicine service, pulmonology was consulted. Severe sepsis (tachycardia, tachypnea, and fevers with acute hypoxemic respiratory failure) secondary to COVID-19 pneumonia. He was started on dexamethasone IV, and transition to oral dexamethasone. He will continue 7 more days at home to complete 10-day therapy. He was started on remdesivir therapy and received 3-day treatment. Pulmonary consulted, as he was a possible candidate for Actemra, however his inflammatory markers including D-dimer, ferritin, CRP improved, and his oxygen requirements also improved. On discharge, he will continue with oxygen supplementation 2 L with rest, 4 L with activity, 2 L with sleep to be infused into his CPAP therapy. Hyperlipidemia. Continue rosuvastatin 10 mg Monday, Wednesday Friday. Benign essential hypertension. Holding hydrochlorothiazide Continue lisinopril and metoprolol.
52 2021-05-19 fatigue Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It cont... Read more
Brain fog, fatigue, loss of coordination, mood swings. Symptoms have persisted for 16 days. It continues to affect my ability to perform daily work/home activities. I have not sought treatment yet
52 2021-05-19 sweating Within one day of receiving the 2nd shot started having heart palpitations in the middle of the nigh... Read more
Within one day of receiving the 2nd shot started having heart palpitations in the middle of the night, Went to Urgent care, not help. Went back to hospital and a got a heartmonitor and wore that for a week. Thenon Friday, May 7th went to the emergency with sweats and almost passed out. They kept him there for over a day, ran tests, etc. Blood work came out fine. He was released the following day. No answers. One doctor there admitted that he believed it's related to the vaccine. Now here we are, May 20th, no answers and feeling the same, but now chest pain, shortness and breath. Never had ANY HEART PROBLEMS BEFORE THIS!
52 2021-05-21 fever Woke up in the middle of the night with 100.5 fever, cold sweats, aching all over and blurry vision
52 2021-05-22 fatigue I had the shot on the 8th, The first 24 hours I was tired and had some injection site soreness. Da... Read more
I had the shot on the 8th, The first 24 hours I was tired and had some injection site soreness. Day 2 until now I have had numbness in legs and feet. A huge lump appeared a few inches from injection site. My whole body feels swollen and tender. My eyes are swollen and my vision is blurry. It feels like someone is poking my internal organs. I am tired all the time and I have pain in back. I am scheduled for second shot in a week and now I am very afraid that the side effects will be worst after the second shot or possibly permanent.
52 2021-05-23 sweating RN responded to a call for help in the observation room at about 1115. The pt was found to be on th... Read more
RN responded to a call for help in the observation room at about 1115. The pt was found to be on the ground next his chair and diaphoretic. Someone was supporting his head and his eyes were open. The pt was was responding and A&Ox4. His initial vitals were 96/49, 42bpm, 96% on RA. The pt remained alert and said that he was trying to sit down in his chair, and then found himself on the ground. He had recently walked over from getting his Pfizer covid vaccine. He was unsure he if he had LOC or hit his head. The pt said he felt "a little dizzy," but he denied any pain, including head, neck, back, and chest. He denied feeling SOB. The pt was able to sit up with minimal assistance, and then was able to get himself on to a cot that was placed next to him. He vitals were checked and can be found below. He continued to remain alert and respond appropriately. He said he "felt better." EMS was called due to the pt's dizziness, 61/40 BP, and 31 bpm pulse. AMR and a fire crew arrived at 1131, placed the pt on their gurney and monitoring equipment, and brought the pt in to the ambulance. The pt remained alert and was able to transfer himself to their gurney. Report and care of the pt was given to EMS personal. 1117: 96/49, 42bpm, 20RR, 96% RA 1120: 81/31, 47bpm, 18RR, 95% RA 1123: 61/40, 31bpm, 18RR, 95% RA 1125: 110/53, 53bpm, 18RR, 94% RA 1127: 100/61, 57bpm, 16RR, 94% RA 1131: 113/62, 66bpm, 16RR, 95% RA
52 2021-05-24 sweating, fatigue Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturda... Read more
Received fax on Thursday. Had ?normal? fatigue next day. On Saturday woke up feeling better. Saturday evening aroun 7:30pm felt hot flash and had sweats and my back started to ache. Pain continued and also radiated from center abdomin and left side and intensified. No sleep as I has fairly severe pain all night. Sunday consulted with nurse and was advised Togo to the ER. Went to ER at Hospital around 5:07pm. Had several tests conducted including CT SCAN which revealed bloackage in the splenic vein. Admitted and started me on morphine and also started Heparin blood thinner. Many many blood tests and additional CT scan conducted. Released on Tuesday around 12:30pm. Still have painful spasms as a result of the damage done to spleen. According to Dr, it may take 2-3 weeks before spleen is healed and spasms are gone. Follow up visit TBD in 2 weeks.
52 2021-05-24 fever I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day o... Read more
I had COVID in early December 2020. I waited a few months to get the vaccine. I was fine the day of the vaccine 16 MAR. I took the next day off 17 MAR because I was running a fever and and had body aches. I did not have any alcohol on St Patty's day. I pretty much slept the whole day. I went back to work on 18 MAR and was feeling better with only a mild ever. The night of 18 MAR I began to run a fever and had body aches. The body aches worsened during the night I could not sleep. The body aches became centralized in my upper back and shoulders, My neck was hurting too. I began to feel chest pains. The chest pains increased in intensity. I researched the symptom's which suggested I was having a heart attack. I took some aspirin to try to alleviate the pain. The pain continued and more severe so I drove myself to hospital. The staff gave me an EKG and took blood samples for testing. The EKG was normal. The blood test came back with elevated levels of Troponin. The Dr. advised that the Troponin level indicated that I probably had a heart attack. the first hospital did not have a cardiac unit so I was transferred to downtown location. The staff there ran more test. The EKG was again normal and the Troponin elevated so a Coronary angiography was conducted with catheter and dye. The angiography was also normal with no sign of a heart attack the doctor said I probably had a reaction to the vaccine. He suggested that I still get the second vaccine. I did get the second vaccine. After the second vaccine I only had fever and body aches, I pre0-gamed with aprin and plenty of rest for the second vaccine.
52 2021-05-26 fatigue, headache, chills Bone Aches; headache; Muscle Aches; chills; fatigue; This is a spontaneous report from a contactable... Read more
Bone Aches; headache; Muscle Aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration in the left arm, on 07Mar2021 14:30 (at 02:30 PM) (Lot number: EN6205), at the age of 52-years-old, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ondansetron (ZOFRAN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On 10Mar2021 12:00 PM, the patient experienced muscle aches, bone aches, chills, headache, and fatigue. The patient did not received any treatment for the events. The clinical outcome of muscle aches, bone aches, chills, headache, fatigue were recovering. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up is being submitted to amend previously reported information: in corresponding data fields, patient age was added, stop date of BNT162B2 was populated as 07Mar2021 14:30, reporter details (first and last name and email address) were updated, past drug Zofran was coded appropriately and suspect vaccine BNT162B2 was recoded as a company product.
52 2021-05-26 fever, headache This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received seco... Read more
This is a spontaneous report from a contactable other hcp. A 52-years-old male patient received second vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, expiration date not reported), via intramuscular, administered in left arm on 30Jan2021 08:30 (at the age of 52-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first vaccination dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via intramuscular, administered in left arm on 09Jan2021 09:00 AM (at the age of 52-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks. On unspecified date in 2021, 24/48 hours after the second shot, patient experienced major headache, sore and achy all over, fever around 100 and little nauseous. Patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was tested for COVID-19 (Aegis) nasal swab which showed negative on 29Jan2021 and on 01Feb2021, patient tested sars-cov-2 test with pending result. Patient did not receive treatment for the adverse event. Reporter assessed the case as non-serious with no seriousness criteria (results in death/ life threatening/ caused/prolonged hospitalization/ Disabling/Incapacitating/ Congenital anomaly/birth defect). At the time of report, patient was recovering from all the events. Follow-up attempts are completed. No further information is expected.
52 2021-05-28 headache, fatigue, chills, fever Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Fev... Read more
Full blown flu symptoms; Severe headache; Random sharp muscle pain; Fatigue; Joint pain; Chills; Feverish; Sore arm; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration (at the age of 52-year-old), administered in right arm on 02Mar2021 10:15 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Medical history included hypertension and gerd. Concomitant medications included daily multivitamin, atenolol, chlortalidone and lansoprazole (PREVACID). The patient had known allergies chantix and prozac. Patient not diagnosed with COVID-19, prior to vaccination. Patient not tested for COVID-19, since the vaccination. The patient experienced severe headache, random sharp muscle pain, fatigue, joint pain, chills and feverish on 03Mar2021 10:30. On 02Mar2021, the patient had sore arm. On 04Mar2021, patient had full blown flu symptoms. No other vaccines within 4 weeks prior to the COVID vaccine. He returned to work on 05Mar2021 with just minor fatigue. The outcome of the events was recovered with sequelae while sore arm and full blown flu symptoms were unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
52 2021-05-28 headache, malaise Headache - shooting pain in the back of head; Feeling unwell; This is a spontaneous report from a no... Read more
Headache - shooting pain in the back of head; Feeling unwell; This is a spontaneous report from a non-contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, administered in Arm Right on 04Mar2021 at 08:45 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included had issue with knee pain in both knees. Patient's concomitant medications included meloxicam at 7.5 mg once daily and gabapentin; both were taken for an unspecified indication, start and stop dates were not reported. On 04Mar2021 at 09:00, the patient experienced headache - shooting pain in the back of head and was feeling unwell. It was reported that no other vaccine taken in four weeks of vaccination. Patient not had COVID-19 prior vaccination; not tested for COVID-19 post vaccination. Patient was not received treatment for the events. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-05-28 headache diarrhoea; Searing headache; This is a spontaneous report from a contactable consumer (patient).A 52... Read more
diarrhoea; Searing headache; This is a spontaneous report from a contactable consumer (patient).A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Expiration date: Unknown; Lot Number: EL3247), via unspecified route of administration in the right arm On 01Mar2021 at 09.00 (at the age of 52-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccination included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Lot Number: EL3247; Expiry date: Unknown), via an unspecified route of administration in the left arm on 08Feb2021 at 09:00 as single dose for COVID-19 immunization. On 01Mar2021 (at 20:00), after 11hours from vaccination, the patient experienced Searing headache, diarrhoea. The patient did not receive any treatment.The outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
52 2021-05-28 sweating Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, sh... Read more
Numbness/tingling right arm since vaccine. Sweaty palms since vaccine. Chest pain starting 18MAY, shortness of breath associated with it 20MAY, continued chest pain with relief when leaning forward- concern for pericarditis
52 2021-05-30 fatigue, cough, sleepiness, fever * Fever and coughing, which is very rare at the first shot. My temperature was 38.3 C. The fever las... Read more
* Fever and coughing, which is very rare at the first shot. My temperature was 38.3 C. The fever lasted for two days. But the coughing stayed for over a month. As of today (5/31/2021), I still cough occasionally. * Fast heart beat. My normal heart beat is 57-60 per min. After the first shot, my heart beat went to 70 above, some times 80 and above. The fast heart beat stayed for weeks. That was why I was hesitant to take the second shot. Eventually I took the second shot on 5/26/2021, 33 days after the first shot. I did not have much side effect for the second shot, except sleepiness. Ironically, on 5/30/2021, I suddenly felt much better after getting up from the bed. I measure my heart beat, it was below 60, back to normal. Fatigue. I did not feel the same as before after the first shot. I felt fatigue. Un thet weenkend after my second shot, I was back to normal. No fatigue any more.
52 2021-05-31 fatigue The day after receiving the shot i was very tired. Slept part of the day. I am a runner and was un... Read more
The day after receiving the shot i was very tired. Slept part of the day. I am a runner and was unable to run that day but could tell i was very winded even going up and down stairs. The rest of the week was unable to run from being winded. Then after a week was able to slowly get back to my normal routine. I had a calcium score scheduled for 7:00 am on May 19th. I was called into my doctors office to be given the results the next week because my calcium scan came back fine...but doing the scan they found a 3mm nodule on my lung. I have never had any type of lung issues. I do not know that this is related to the shot. But because of how my lungs felt for a week after the shot, i feel this could be related. I am not a smoker and never have been. They say the majority of these type nodules are formed from inflamation or infection. At the time they told me about the nodule they also did my yearly physical. Since i know some are getting inflamation around the heart...i'm curious if there can also be inflamation around the lungs which would have given me the nodule. At this point..the doctor plans to do a ct scan in one year to see if the nodule has grown. I felt like i should report this since this may not be discovered by many others unless they just happen to go from some type of scan of the lungs.
52 2021-06-01 fatigue feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eye... Read more
feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump appeared a few inches from injection site; Numbness from his ankle to his feet and from his knees to his feet/numbness in legs and feet; feels like it's cold and tingly; feels like it's cold and tingly; ringing ears; pressure in his neck to his injection site; back pain/pain in back; vision is blurry; throat was swollen.; Toes locking up; Really dizzy and really lightheaded; Mind has been foggy; Glands were swollen; Arm soreness; Nose is bone dry; tiredness/tired; injection site pain/injection site soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 02:38 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included Bug bite (happened 5 days prior to 30Apr2021 and regimen of an antibiotic). He was completely done with the rotation for a least 8 days before he got the vaccine. It might have something to do with this. concomitant medication included dicloxacillin (started it on 30Apr2021 and it was for 5 days. He did not know what it did was). The patient reported that on 08May2021, day one, he experienced, tiredness and injection site pain. On day 2, until now side effects which had not gone away. It hadn't gotten worse, but it was not any better. The patient felt like congestion, but his nose was bone dry, like crusty dry. It hurts a little bit because it was so dry and he had arm soreness, nothing out of the ordinary. The arm soreness was just normal injection stuff. At first it was a little tender on the injection spot. It went away after about a day. On 10May2021, the patient felt like there were little, tiny baby hands pinching his internal organs randomly throughout his abdomen. It was not a sharp pain, more like a little squeeze all through his abdomen. It felt like his whole throat was swollen. It was not visually swollen, it more felt like a football in his neck. Stretching it was helping. His toes have been locking up like a pre-clamping. He had numbness from his ankles to his feet for 8 days, and now he has numbness from his knees to his feet. It was not completely numb, but it was not normal. The feeling of baby hands pinching his internal organs started the second day after the vaccine and has stayed consistent. The patient's eyes swollen, and his vision was diminished. Day 2 through today, it felt like his eyes were swollen, his vision was seriously diminished, he had a golf ball sized welt on his arm not at the injection site but 2 inches from it, and he was really dizzy and really lightheaded and almost fainted at the corner store. The feeling like his eyes were swollen started on day 3 after the vaccine. The crease of his eye be-low the eyebrow and on top of the socket got red and puffy and looked like sunburnt skin does. It was at the point that now it feels swollen all the time almost like he had pink eye and his vision has been diminished about 30%. He had a test done yesterday and his vision was 20/25. Some-times he could not even read a text and had to stare at his phone for 10 minutes to make out words. He did not have these issues before. The feeling of his eyes being swollen was a little better in the mornings and about 1300 it gets worse when he gets lightheaded to where was when it started. His vision became diminished about day 3 after the vaccine. It was a little better in the morning, but in the afternoon, it goes to exactly the same as when it started. He noticed the golf ball sized welt on his arm about 3 days ago. The doctor seemed to think a drop of the injection might had travelled from the injection site and his body was creating a defense to it. It was scary to take a shower and then see that. It didn't hurt. It was not painful, but it was a weird foreign entity. The cramping in his toes started probably day 3 and was consistent. The numbness started on day 2 after the vaccine, and up until 3 days ago it was just his ankles and feet. 3 days ago, it got to the point where it was from his knees to his feet. It has gotten worse since it was now travelling up his legs. On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball - when asked with his doctor he said that he thinks that a drop of the vaccine travelled and his body building a reaction to it and it was very abnormal. The patient also had numbness from his ankle to his feet worsened and from his knees to his feet- almost feels like it was cold and tingly. The patient also had dizziness and lightheaded about day 2 after the vaccine and it was the same. It came in waves but was consistent throughout the day. He would be fine then had a wave of dizziness. He has been laying down so much because he was so tired, ringing ears, felt like his glands were swollen, pressure in his neck to his injection site, and back pains. The patient stated that his doctor was only form urgent care. The patient Felt like whole throat was swollen, toes locking up, really lightheaded, mind has been foggy, and arm soreness. The patient had bizarre side effects from the Covid Vaccine for 11 days now. He thought it was the smart thing to report them to Pfizer. He didn't like to give personal information. He declined to give his mailing address or his email address. He hated when asked for race, but he guessed it might be important. He did not have a mailing address, phone number, or email address handy for his physician. He went to Urgent Care yesterday to have it checked and they did an EKG and said he had to be sent by ambulance to the ER. The doctor did bloodwork, and she said everything looked alright and to rest a few more days and keep hydrated. The patient underwent the lab work and procedures which included chest X-ray with unspecified result. He thinks it was on 18May2021. His mind has been foggy with all of that. It was yesterday or the day before. He could not be sure. He has been sleeping so much and was in a complete daze. The fogginess he had the whole time as his other symptoms, and it was the same. He has been eating well and hydrating and taking a multivitamin and Gatorade, all the things' people say to do. He asked if Pfizer has heard of this before. He was panicked it might be chronic, and he worries about the safety of the second shot for him. He was sure many people haven't reacted, but these are freaky side effects. He asked for advice and if Pfizer had heard of this before or if he was some weird anomaly. On his way to get the vaccine he asked 2 people at the city health line if they had taken it and they both said no. He asked 3 other patients and they said they took the Pfizer. One woman said she will take it when they make her. The guy who gave him the shot lied and said he wasn't eligible. It might have been his way of not having to discuss it. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not diagnosed with Covid prior vaccination. The patient was tested for Covid post vaccination with Nasal Swab on 18May2021. The outcome of the events was not recovered. Device Date: 23May2021,Additional information has been requested.
52 2021-06-02 malaise dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; de... Read more
dizziness; nausea; He did not feel well at all and was not able to feel well enough to stand up.; definite lack of coordination; he vomited on himself; his cholesterol was high at 208.; had very little strength; started feeling like something was wrong; just had sort of a feeling like being really drunk; passed out (fainted) in his car 3 times; He was told he had a vasovagal reaction; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15May2021 10:50 (Lot Number: EW0173; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included vasovagal reactions in high school. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. Within 2 minutes of receiving the Covid 19 vaccine he started feeling like something was wrong. He pulled to the side in the parking garage and as soon as he stopped the car he passed out. He woke back up and was able to put the car in park and he passed out a second time. He woke up again and his foot was on the gas pedal and he tried to roll down the window. He was able to roll down the window but he wasn't able to get anyone's attention. He passed out a third time. When he woke up again he wasn't able to get the door open and he was nauseated. He basically had nausea, dizziness, and a definite lack of coordination. He just had sort of a feeling like being really drunk. He doesn't drink. He had very little strength but he was able to push his car horn. He was out of it. He could see someone in his car mirror a little ways behind his car and the horn didn't get the person's attention so he honked a second time and someone came to help him, maybe from the fire department and maybe some emergency medical technicians. He was placed on a golf cart or ATV to be transported downstairs to a waiting ambulance and while on the ride he vomited himself. He mentioned that the EMTs called it a vasovagal reaction. He was brought to the hospital in which he had a lot of tests done. He did not feel well at all and was not able to feel well enough to stand up. He had tests done at the hospital, a chest x-ray and his blood was drawn. He had a cardiac ultrasound later in the afternoon the next day on 16May2021. The doctor's didn't find anything wrong other than his cholesterol was high at 208. He was admitted to the hospital on 15May2021. He continued to have his blood drawn through the night and the next morning, on 16May2021, he had a CAT scan. For his cholesterol he was told to eat better and maybe follow up with a doctor in a couple months to check his cholesterol again. No one had any answers to the effect of what happened to him. Everything was fine, his tests were normal. He was told he had a vasovagal reaction. He's had vasovagal reactions before and he can tell this was much different than the vasovagal reactions he's had before. In the past when he's had vasovagal reactions the world went black like looking through a small circle, his vision got blacker and blacker and then he'd pass out. He did not have this feeling with the Covid 19 vaccine. He can only describe this feeling that he had like an occasion in his past when he's drank to much and he's stumbling around. He may have passed out briefly to someone helping him move to a bed and his arms are weighted and he can't lift them and he's disoriented but still has a sense of what's going on but he feels like he could vomit at any second. He's comparing his experience to the Covid 19 vaccine to drinking to much alcohol and then falling asleep or passing out. He was pretty much out of it for 5 hours. Between the fourth and fifth hours after receiving the Covid 19 vaccine he was comfortable enough to stand on his own for brief moments. He was feeling better and was able to use the restroom. By the next day, around the 24 hour period after the vaccine he was feeling almost normal. He was released from the hospital the next day, 16May2021 at around 4:00PM. He was maybe in the hospital for about 27 to 28 hours. At the hospital he had all these tests and he was found to be healthy with no problems. He also had a Covid 19 virus test, he never asked what the results were but he's going under the assumption that if he was Covid 19 virus positive the hospital staff would have told him. Passing out, nausea, dizziness required a visit to Emergency Room. The outcome was unknown.
52 2021-06-03 fatigue I have always loved beer but since the second COVID shot had zero desire to drink it; I felt drunk a... Read more
I have always loved beer but since the second COVID shot had zero desire to drink it; I felt drunk after only a few beers; very tired; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old (adult) male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 14Feb2021 at 11:00 hours (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Jan2021 at 11:45 hours (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient reported that he always loved beer but since the second COVID shot have had zero desire to drink it on 14Feb2021. On an unspecified date in 2021, in two occasions when he drank, he felt drunk after only a few beers and very tired. The clinical outcome of the events I have always loved beer but since the second COVID shot I had zero desire to drink it, I felt drunk after only a few beers and very tired was unknown at the time of report. Information about lot number cannot be obtained. No further information is expected.
52 2021-06-03 headache Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21).... Read more
Patient presented symptoms of high blood pressure three days after receiving the vaccine (05/31/21). Seven days later, the wife tells the pharmacy that she has a headache in the left back, has a droopy eyelid on the left side and numbness in the left area of ??the face. He was advised to visit his doctor, and his wife indicated that the patient was going to go that same day (04/06/2021).
52 2021-06-07 fever, chills, fatigue, headache Injection Site pain about one day, A little bit of tiredness about a day. Headache after 12 hours an... Read more
Injection Site pain about one day, A little bit of tiredness about a day. Headache after 12 hours and lost about 4 hours. Chills after 12 hours and lost for 2 hours. Starting have fever after 9 hours and getting fever around 99.7 F after 16 hours. Getting better after one day.
52 2021-06-08 pneumonia J18.9 - Pneumonia, unspecified organism
52 2021-06-08 fever, chills, headache Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cyc... Read more
Severe headache; Whole body pain; All day Vomiting; Nausea; Muscle Spasms; Intense Chills; fever cycle; Very High blood pressure; This is a spontaneous report from a contactable patient. A 52- year-old male patient received first dose of BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot no.: EN6207) via an unspecified route of administration in right arm on 12Mar2021 at 12:00 PM (at the age of 52-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure and thyroid disorder. He also thought he had a false negative covid test in Jul2020, and actually did have covid in Jul2020. The patient did not have any allergies to medications, food and other products. Concomitant medication lexapro, losartan, DIM (as reported, unspecified), retinol (vitamin A), vitamin d and phytomenadione (VITAMIN K), trazadone within 2 weeks of vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient was not tested positive for COVID-19. On 13Mar2021, patient trip to the emergency room (ER) for severe headache, whole body pain, muscle spasms, intense chills and fever cycle, very high blood pressure, all-day vomiting and nausea. Nothing they tried eased any of the symptoms. There is no amount of ibuprofen or acetaminophen. He threw up nausea medicine. Two doses of morphine at the ER took the pain from a 10 to a 7. He had never, ever felt this badly. The clinical outcome of the events severe headache, body pain, muscle spasms, intense chills, fever, very high blood pressure, vomiting and nausea was not resolved. No follow-up attempts are possible. No further information is expected
52 2021-06-09 headache, fatigue, throat pain, fever, cough, chills weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; co... Read more
weakness; fatigue; body aches; headache; sore throat; chills; fever; slight arm pain; chest cold; cough; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0183), via an unspecified route of administration in left arm on 20May2021 at 00:45 (at the age of 52-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. He has no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included sertraline hydrochloride (SERTRALINE). He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at an urgent care center. On 21May2021, the patient experienced slight arm pain for the first 2 days after the shot. On 23May2021, 3 days after the shot, he experienced weakness, fatigue, body aches, headache, sore throat, chills, and slight fever. On May2021, 4 to 5 days after the shot, cough and sore throat became more severe. He still had some fever, but it was reduced by ibuprofen. On 25May2021, 5 days after the shot, he still has cough like he has a chest cold. He also reported that all symptoms started to decrease. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measure was taken as a result of fever and included treatment with ibuprofen. He did not receive any treatment for all other events. The outcome of the event "slight arm pain" was recovered on 23May2021 and recovering for all other events.
52 2021-06-10 head discomfort Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a ... Read more
Caller stated he got the second shot two days ago and that next day he had a rash.; when he is in a hot room like 78 degrees with the window open he can not take the heat like he used to; Hot flashes; rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing; Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging; felt like he was drugged; pulse rate has been a little elevated; Palpitations: Caller stated this started the same day 10 to 12 hours after getting the first shot. Caller stated it was getting somewhat better but after the second shot it got worse.; getting out of breath was reported as worsened; felt like there was pressure in his skull; he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall ove; Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine; This is a spontaneous report from a contactable consumer (patient, self-reported). A 52-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0183; expiry date: 31Aug2021) via unspecified route of administration in left arm on 01Jun2021 as single dose of COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0173; expiry date: 31Aug2021) via unspecified route of administration in left arm on 11May2021 as single dose of COVID-19 immunization and experienced palpitations, felt like he was drugged, felt like there was pressure in his skull, getting out of breath, rash got bright pink, respiratory rate was somewhere around 16, blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle. On an unspecified date in Jun2021, after second dose of vaccination, the patient experienced palpitations, getting out of breath like when he was walking up and down the stairs especially when carrying laundry or a garbage can and he never had this problem doing that unless he had an upper respiratory infection and prior to the vaccine he was perfectly fine, palpitations was reported as worsened, getting out of breath was reported as worsened, rash on his left side where he got the shot on his hand, specifically the top of hand and on his first, second, third, fourth, and fifth finger was reported as worsened, on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle was reported as worsened, crack in the knuckle area on the second finger was reported as worsened, rash got bright pink was reported as worsened, felt like he was drugged, Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine, pulse rate has been a little elevated, felt like there was pressure in his skull, felt like he was going sideways, and on 01Jun2021 experienced hot flashes. On 02Jun2021, he was in a hot room like 78 degrees with the window open he cannot take the heat like he used to. On an unspecified date in Jun2021, patient stated that palpitations got worse after the second shot it was started on the same day of first shot of vaccination, 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse. On 03Jun2021, that next day of vaccination, patient had a rash and explained that on his first finger, the thumb, there was a rash that started bubbling up below the middle knuckle, this stopped a week to ten days after the first dose and then it came back after the second. Patient had a crack in the knuckle area on the second finger: patient stated he was scheduled for the dose around 12:20 and they had to get more vaccines and so he had to get it around 3:00pm. The patient stated this started to feel bad in the first two hours. For the event of rash got bright pink, patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing. Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging. For the event "felt like he was drugged" patient stated this started within 4 hours of first dose, he started to feel better in 5 days and then 10 days after he was completely better and stated he got this again from the second shot and it was getting better but the more he exerts himself the slower he feels but he does not feel like he is on anesthesia. The patient stated that his pulse rate has been a little elevated, stated on the following day after first dose his pulse rate was 114 and 120 was the highest. He stated after the first dose it was between 116 to 120 and after the second dose it was slightly elevated like 90 or something. The patient stated but his pulse rate has been 86, 87, 90 so the pulse rate has been a little elevated. The patient reported he also had hot flashes. He felt like there was pressure in his skull, 10 to 12 day after the first vaccine and this got better, then within 7 to 10 days after the second shot he got it again and he anticipates that for 7 to 10 days he will have to deal with the same crap. The patient felt like he was going sideways, this stopped within two days after the first dose and then it happened within one day or a day in half after the second shot. The patient stated that hot flashes lasted a day or day in a half. The other problem he had noticed is when he is in a hot room like 78 degrees with the window open, he cannot take the heat like he used to. Reportedly, after the second shot they had the patient sit for 15 minutes and so he went to the hospital main area after to get a pass to eat and he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over. He stated the first hour or so after the vaccine he felt like he was drug and he even had caffeine and got his car cleaned, but he felt like his body was behind him like woozy to stomach like in slow motion with exertion and it felt like he was drugged. The patient stated he just wished the vaccine dosage had a high of like if it was 0.3 maybe should be 0.2. The patient stated there should be a different regimen based on height and weight. The outcome of the event "hot flush" was resolved on 01Jun2021, for the event "Palpitations: The patient stated this started the same day 10 to 12 hours after getting the first shot. The patient stated it was getting somewhat better but after the second shot it got worse", "getting out of breath was reported as worsened", "The patient stated he got the second shot two days ago and that next day he had a rash", "he felt like he was going sideways and had to grab onto rail for 30 seconds to a minute so would not fall over", "felt like there was pressure in his skull", "Blood pressure went down to 124/78 and so his blood pressure has been better since the vaccine", "felt like he was drugged", "pulse rate has been a little elevated", "when he is in a hot room like 78 degrees with the window open he cannot take the heat like he used to" was not resolved and for the event "Scrapes in hands little dots now and skin peeled away got worse. Still a little pink on pinky but have little scabs. Last time felt tight but not it is stinging" was unknown, for the event "rash got bright pink, the patient stated within that second day of getting the first dose it was pink, then it came back again after the second dose and now the rash was healing" was recovering.
52 2021-06-10 headache pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection p... Read more
pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.
52 2021-06-13 fatigue After 2nd shot, I began having a noise in my left ear, for 3 day's it would come and go, on the 4th ... Read more
After 2nd shot, I began having a noise in my left ear, for 3 day's it would come and go, on the 4th day it just stayed on and has been making the noise in my ear at all times. Once or twice a day when I stand up I get dizzy or wobbly feeling, sometimes it is bad enough I have to sit back down. I no longer sleep well. I used to just lay in one spot all night, barely making a dent in the covers. My dog slept in bed every night for over 7 years. But after vax, she stopped sleeping on bed and I wake up to a trashed bed and the covers all balled up on my head. How or what I eat has changed, I no longer like most of the stuff I always liked. I no longer feel right, just always feel off, tired and by the end of most days the noise in my ear is driving me insane. I have never experienced the ear noise or the getting dizzy ever in my entire life until the Govt stuck poison in my arm.
52 2021-06-14 fever, fatigue, headache Headache, Fever (100.4°F), light-headedness, tired. After two days, resolved.
52 2021-06-15 fever After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course o... Read more
After receiving the vaccine I had the soreness in my arm and a small fever of 99. Over the course of the next few weeks I was experiencing severe eye pain which caused me to start losing site in my right eye and also microclots in my eyes, my eye doctor stated that the vaccine was not the cause of my conditions with my eye. But other than the soreness of my arm where the vaccine was administered and a slight fever I really didn't have any other problems.
52 2021-06-16 headache, chills headaches; body aches; chills; joint pain; This is a spontaneous report received from a contactable ... Read more
headaches; body aches; chills; joint pain; This is a spontaneous report received from a contactable consumer (Patient). This 52-Year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, on 08May2021 as first dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 30May2021, the patient experienced headache, body pain, chills and joint pain. The Patient was denied to receive the second dose. It was reported that the patient asked if those symptoms have been reported this late after the first dose. The patient asked if the fact that his symptoms started 22 days after first dose, does this mean his symptoms are not related to his Covid vaccine. The patient also asked if data on side effects was collected from the clinical trial only or it was based on real world data, like people like him calling and self reporting about the events. The outcome of the events was not recovered. Information about batch/lot number has been requested.
52 2021-06-16 influenza like illness flu like symptoms x 48hrs after receiving the 2nd dose of the COVID vaccine.; This is a spontaneous ... Read more
flu like symptoms x 48hrs after receiving the 2nd dose of the COVID vaccine.; This is a spontaneous report from a non-contactable pharmacist. A 52-years-old male patient received BNT162B2, (Solution for injection, Batch/Lot Number and Expiration Date was not reported) via an unspecified route of administration on 03Feb2021 05:00 as second dose, single dose for COVID-19 immunization. The patient medical history was not reported. Patient previously received BNT162B2 vaccine. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if covid tested post vaccination. It was unknown if other vaccine given in four weeks. The patient experienced flu like symptoms x 48hrs after receiving the 2nd dose of the covid vaccine on 03Feb2021 12:00. It was unknown if treatment was given. The outcome of the event was recovered on Feb2021. No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
52 2021-06-17 headache Two days after the second dose, started to experience headaches, lightheadedness and nausea pretty m... Read more
Two days after the second dose, started to experience headaches, lightheadedness and nausea pretty much constant for the next 6 weeks. Went to primary care physician the 2nd week and he thought it was vaccine related. One week later it had got worse so went back to other primary care physician in the same office who thought I had vertigo and an ear infection. I then followed up with an ENT who said I did not have an ear infection but thought my symptoms were vaccine related and stated she had seen multiple other patients with same symptoms. At one point the headache and nausea was so bad I went to an urgent care clinic who did a CT scan thinking it might be a stroke but later ruled that out. the initial primary care physician had ordered some blood tests which then prompted a referral to a hematologist/Oncologist who did more testing and concluded that thought my issues were vaccine related. Can provide additional detail around physicians and dates if needed
52 2021-06-23 lethargy, sleepiness about 2 weeks after the 2nd dose became lethargic, no appetite, sleepy, swelling in feet, painful to... Read more
about 2 weeks after the 2nd dose became lethargic, no appetite, sleepy, swelling in feet, painful to walk, hands occasionally also hurt, nausea on/off, diareaha
52 2021-06-24 sleepiness, fatigue Fatigue; He feels drowsy whenever he wakes up; This is a spontaneous report from a contactable consu... Read more
Fatigue; He feels drowsy whenever he wakes up; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 01Jun2021 at 11:00 (52-year-old of age at vaccination) as a 2nd dose, single for COVID-19 immunization. The patient's medical history included mononucleosis from 1996 (he had heard that mono virus remains in a body dormant). He was not fatigue like this since 1996.The patient's family history was reported as none. The patient's concomitant medication was reported as none. The patient was not related to a study or program. Vaccination facility was reported as pharmacy. The patient was not administered with any additional vaccine on same date of the Covid-19 vaccine. The patient was not administered with any other vaccine within 4 weeks prior to Covid-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiration date: Unknown), via an unspecified route, administered in Left Arm on 11May2021 at 11:30 (52-year-old of age at vaccination) as a 1st dose, single for COVID-19 immunization. On unknown date in Jun2021, the patient experienced fatigue. He stated that, he still had fatigue. He was not depressed and was eating well. He had a fair amount of daily activity. Two times a day (time not specified by reporter) was whenever it suddenly comes over him, and he takes a nap. He felt drowsy whenever he wakes up, like he was coming off a sleeping pill: Began two or three days after the second dose of the Covid-19 vaccine. It was about the same, but not as strong as two weeks ago. Two hours ago, he fell asleep and took a nap. He took vaccine as he thought it was smart thing to do on a society level. The patient had neither visited physician office nor emergency room. The patient had neither undergone any relevant test and procedure not any investigation assessment. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information had been requested.
52 2021-06-26 chills, fatigue cold sweat, shivering, tiredness long term effect: Mucus build up in throat
52 2021-06-29 fatigue, chills Hives; Rash; Chills; Fatigue; Itchy tongue; Itchy lips; This is a spontaneous report from a contacta... Read more
Hives; Rash; Chills; Fatigue; Itchy tongue; Itchy lips; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medication included metformin 1000 mg/day from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 20:00, the patient experienced hives, rash, chills, fatigue, itchy tongue and lips. The patient was treated for the hives, rash, chills, fatigue, itchy tongue and lips with BENADRYL. The adverse events resulted in a visit to doctors or other healthcare professional office/clinic visit. The clinical outcome of the hives, rash, chills, fatigue, itchy tongue and lips was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
52 2021-06-29 sweating, fever, chills My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up m... Read more
My body started shivering uncontrollably/feel extremely chilled; I had trouble sleeping and was up most of the night; high fever/I checked my temperature last night ranged from 101.8 to a high of 103.7; I woke up soaked in sweat; severe migraine; I felt dizzy all through the night; This is a spontaneous report from a contactable other health care professional. A 52-years-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248, age at vaccination 52 years), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:00 as dose 2, single for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, Low lung input and output, covid-19 covid prior vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient previously took BNT162B2, dose1, single (lot number EL3248) for covid 19- immunization on 14Jan2021, 11:00. The patient's concomitant medications were not reported. On 04Feb2021 22:30, the patient started to feel extremely chilled. He went to bed and covered up with 2 blankets. patient body started shivering uncontrollably. Patient normal temperature fluctuates from 94-95 degrees. He checked temperature last night ranged from 101.8 to a high of 103.7. patient had trouble sleeping and was up most of the night due to the high fever. He woke up soaked in sweat. He also had a severe migraine and he felt dizzy all through the night and into 05Feb2021. The patient underwent lab tests and procedures which included body temperature: ranged from 101.8 to a high of 103.7 on 04Feb2021. Seriousness was not serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Non-Allergies to medications, food, or other products. No treatment was received for the adverse events. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
52 2021-06-29 nasal congestion, chills, cough, fatigue, sneezing, sinusitis, runny nose, headache, sweating, fever, sleepiness Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt... Read more
Fever, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt horrible, second vaccine; left side of his body was very sweaty; Chills, second vaccine; sneezing; headache; stuffy nose; loss of smell; Felt knocked out; fatigue, Tiredness; Sleepy, sleepiness, slept for very long hours, second vaccine; Nose running; Sinuses, stopped up, second vaccine; Aches, second vaccine; Did not eat much; he was shaking; coughing; weakness; pain to his left arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 26Mar2021 at 10:00 AM to 10:30 AM as a dose 2, single for COVID-19 immunisation. No family medical history relevant to ae(s). The patient's medical history included prostate and bronchitis, the caller stated that, he had a history of Bronchitis since he was small. The Bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. Past drug event included Tamsulosin for prostate, started about a year and a half ago for his prostate 0.4mg capsule, once a day and Finasteride for prostate, started about a year and a half ago for his prostate 5mg tablet, once a day. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration in the left upper shoulder on 05Mar2021 at 11:00 AM to 11:30 AM as a dose 1, single for COVID-19 immunisation. The patient's concomitant medications were not reported. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as no. Age at time of vaccination was 52 years. Enquired, the caller was a 53 y/o male. The patient received his first Pfizer Covid dose on 05Mar2021 and his second dose on Friday, 26Mar2021. The first and second vaccine both were given in the left upper shoulder. Stated that, his job offered to schedule his vaccines. After his second dose he developed pain to his left arm, which resolved on 28Mar2021. Stated that, on 26Mar2021, he sat down for 10 minutes after the dose and then drove home. Stated that, he drove the home on streets instead of the highway in case he started feeling bad so he wouldn't have to leave his vehicle on the highway. He kind of resisted being dizzy and sleepy, he was not that dizzy. The patient started feeling dizziness, fatigue, weakness a few hours after receiving the vaccine. Stated that, the second dose knocked him out. Stated that, he had a swift reaction about an hour after receiving his second dose, he was very tired, sleepy and sweating a lot and shakiness. The night he received the vacccine, he woke up at 3 AM and stated that, his left side of his body was very sweaty and he was shaking, coughing and sneezing. The patient reported that, a headache, stuffy nose and loss of smell. The patient wanted to know whether these were expected side effects. Response included referred to healthcare professional for further discussion and treatment recommendations. Informed the caller that, Pfizer cannot make treatment recommendations. It was reported that, the caller wanted to know whether the symptoms were immediate or took longer to effect someone after their second vaccine dose. Stated that, he knew everyone's reactions were different, he just wanted to know. Stated that, the patient was drinking a lot of water mixed with sprite to keep hydrated. The patient was sneezing a lot, had a stuffy nose, aches, fever but he could not find his thermometer. Stated that, he felt weird, bad, horrible and it hit him hard. Stated that, he did start to feel a lot better and on Saturday 27Mar2021, the patient thought he had improved. That morning he was ok to eat breakfast and able to smell his breakfast. In between 02:00 PM to 03:00 PM on Saturday, he was sleepy, slept very long hours, sweating on his left side a lot and some on right side of his body. On Friday and Saturday evening, the patient felt the same things, he was thirsty, sweating had chills all through night, was knocked out, had headaches, felt like the room was moving like in hyperspace, anytime he walked he felt like a guy on moon, like the ground was soggy underneath his feet. He stated he was not lethargic and kept his balance but like he was stepping on something soggy underneath him, he was dizzy. He had pain on his left side, his head, his arm as well and the left side of his face. The pain in his arm on Friday was so bad that he felt the pain in his face as well. The caller stated that, he had much less pain in his arm the next day on Saturday. Stated that, he heard the symptoms would start the next day after the shot. His nose was still stuffy. Stated that, the caller did not provide a healthcare professional for the report. Stated that, he had not seen a doctor for 10 years. The caller stated that, he was fine whether safety needed to clarify any documentation from the report. Stated that, his card does not have the Lot or Expiry date of the first dose and second dose. Stated that, with his first vaccine on 05Mar2021, he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things. By Tuesday/Wednesday the patient was fine. The adverse events did not require a visit to emergency room and physician office. The reporter seriousness for other events was unspecified. Treatment received for the events was not provided. The relevant tests were reported as no. The outcome of the events pain to his left side was recovered on 28Mar2021 while for the other events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
52 2021-06-29 fever This is a spontaneous report from a contactable consumer. A 52-year-old male patient received First ... Read more
This is a spontaneous report from a contactable consumer. A 52-year-old male patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 27Mar2021 17:00 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history and known allergies were reported as no. Concomitant medications included atorvastatin (LIPITOR), amlodipine (NORVASK), omeprazole (PROTONIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lipitor, Norvask, Protonix. The patient experienced fever 101 on 28Mar2021 at 12:00. Seriousness of the event was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The patient did not have covid prior to vaccination and has not been tested for Covid-19 post vaccination. The patient did not receive any treatment for the adverse event. The outcome of event was recovered on an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.
52 2021-06-30 chills, body temperature increased, headache 24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), ... Read more
24 hours: Chills and mild tachycardia (HR 111) 48 hours: Continued mild tachycardia (HR 105-117), tmax 100.2,chilles, headache and bodyaches 72 hours: tmax 102.4, tachycardic (HR 141), hypotensive (low SBP 73), sepsis trigger from MEWS 7 at 0545 on 6/21, procalcitonin increased to 111.66 ng/mL right upper quadrant pain. Blood cultures drawn. 96 hours: ongoing hypotension, lactic acid increased to 4.0. Admit to hospital for pressor support. Suspected cholecystitis w/drain placement. Blood cultures drawn at 72 hours showing GNR. Eventually confirmed as Klebsiella oxytoca
52 2021-06-30 fatigue, headache BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; ... Read more
BP shot up to 197/130; Throbbing headache; Nausea; Tingling in both arms and fingers; Itchy tongue; Iitching all over body; Clamminess; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021, 15:30 (age at vaccination was 52-year-old) as single dose for covid-19 immunization at hospital. Medical history included hypertension. The patient concomitant medication included Hydrochlorothiazide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 18Mar2021 at 15:45 Within 60 seconds of vaccine, I got an immediate throbbing headache, nausea, tingling in both arms and fingers, itchy tongue, itching all over body, BP shot up to 197/130, clamminess, and fatigue. Patient received a treatment with Antihistamine given during episode for the events. The patient underwent lab test and procedures which included blood pressure measurement: 197/130 on unspecified date in Mar2021. The outcome of the events was not recovered. Additional information is excepted. Follow up is requested.
52 2021-06-30 headache joint pain, head ache, vertigo
52 2021-07-01 fever Patient complained of body aches starting after receiving his vaccine on that day. Throughout the we... Read more
Patient complained of body aches starting after receiving his vaccine on that day. Throughout the weak worsening joint and body pain and after 5 days began form oral lesions. He eventually presented to the ED on 6/11/21 HPI taken from ED Documentation: 52 yo male with no chronic medical problems presents to ED with complaints of body aches, weakness, and mouth sores. Also presents with fever (101.7) Denies any shortness of breath, chest pain, abdominal pain, nausea or vomiting.
52 2021-07-02 fatigue Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ac... Read more
Almost a complete lack of sleep due to ache all over body; Almost a complete lack of sleep due to ache all over body; felt exhausted; arm where the shot was is sore and very tender; This is a spontaneous report from a non contactable consumer, the patient. A 52-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route in the left arm on 23Mar2021 at 15:00(at the age of 52 years old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have any allergies to medications, food, or other products. The patient did not take any concomitant medication and did not receive any vaccination within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 23Mar2021 at 22:00, the patient experienced complete lack of sleep due to ache all over body, felt exhausted, arm where the shot was is sore and very tender, though there are no swelling or shot location issues. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of the lack of sleep, ache all over body, exhausted, pain in arm and tenderness was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
52 2021-07-05 throat pain, sinusitis Sever Symptoms of Sinus infection, resulting in sore throat, sinus drainage, dizziness, loss of apat... Read more
Sever Symptoms of Sinus infection, resulting in sore throat, sinus drainage, dizziness, loss of apatite. symptoms are preistent and ongoing.
52 2021-07-06 chills, fever Patient presented with fevers, chills, then developed generalized tremors which were of unexplained ... Read more
Patient presented with fevers, chills, then developed generalized tremors which were of unexplained etiology, extensive neurological testing included MRI brain, EEG, CSF testing which were unrevealing. a serum autoimmune panel was sent which demonstrated elevated Acetylcholine ganglion Receptor Antibodies but patient's symptoms did not correlate with this finding, and was felt to be a false positive test. his INR values were also significantly deranged on arrival, despite him being on coumadin long term prior to this with stable INR values previously. Further workup revealed evidence of positive cardiolipid IgM and IgG antibodies, which confirmed findings of antiphospholipid syndrome. a follow up MRI also revealed a punctate cerebellar infarct which was not thought to be responsible for his diffuse tremors. His tremors were felt to be related to cardiolipiin antibody positivity (there are case reports/series describing above). The positive anti-cardiolipin antibodies were felt to be related to recent vaccination and potential molecular mimicry. he was treated wit steroids with a tapering dose, with eventual resolution of symptoms. repeat cardiolipin antibody testing has shown normalization of values.
52 2021-07-06 fatigue, sweating, headache On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart ... Read more
On night of April 25th I went to ER with a sudden and intense chest pain that brought on high heart rate, high blood pressure, head ache, dizziness, sweating and nausea. I was admitted into ER and tested for a heart attach which I did not have. I was released from ER in the early morning hours. Since my first dose, I have had persistent brain fog (fuzzy thinking), trouble concentrating, and strange bouts of fatigue. The second dose was a hard recovery with extreme fatigue lasting over 4 days but the strange bouts of fatigue are random and not just after the second dose.
52 2021-07-06 influenza like illness, sleepiness, fatigue, body temperature fluctuation I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had... Read more
I had positive COVID infection 12/13/2019 and was in the ICU and hospitalized multiple times. I had no adverse events or symptoms with the 1st dose (lot ER732 IM RA). The 2nd vaccine 5/24/2021 (lot EW0187 IMLA), the next day my arm was sore. I felt extremely tired all day. The 2nd day, I had extreme fatigue and could not go to work. My arm was still sore and I had flu like symptoms. These symptoms lasted for 5 days. I started to feel better for a couple days and go to bed and wake up still completely exhausted. I just wanted to sleep all the time. Since the 2nd vaccine, I have lost sense of smell and appetite and don't have the energy to do anything else. I have lost a total 25 pounds since getting the vaccine. My initial weight was 175 lb, my weight now is 149 lbs. My other symptoms include: difficulty regulating my body temperature, cold sensitivity, muscle pains in my hands, shoulders, chest and top of legs thighs. "I feel like my body is eating myself away." I also have confusion, depression, difficulty focusing and brain fog.
52 2021-07-06 fever, fatigue Patient experienced fever for two days and patient has had fatigue every since. Patient went out of... Read more
Patient experienced fever for two days and patient has had fatigue every since. Patient went out of town On June 4th and return on June 10th. Since patient has been back from out of town his hearing is damaged. Patient can not hear out of left ear and barley hear out of his right.
52 2021-07-06 runny nose, throat irritation, headache Slight headache, burning in the throat, runny nose constantly.
52 2021-07-07 chills, fatigue Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pr... Read more
Reports hot/cold shivering started 6/25 then started with nausea, vomiting & Diarrhea. Chest pain/pressure started 6/29 and went to hospital. MD reports increasing Troponin so admitted to hospital for ECHO & Cardiac Cath. Discharged on 6/30. Still reports Fatigue
52 2021-07-07 cough That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath... Read more
That night I got night threats, no fever. The next day I started coughing, wheezing, short of breath. The next day I saw my Dr., she listened to my chest, and checked my blood pressure and it was 160/100. I have never had high blood pressure before. She prescribed losartan potassium 60 mg tablet. I take 1 every morning now. And cough medication: benzonatate 200 mg tablets 1 every 8 hour now. The cough and the blood pressure is still ongoing. There is no pneumonia. I had a Bilateral hip replacement, total hip replacement on both legs, it has become very sensitive and painful after the vaccine. I take the 4 Advils for the pain in my hips. The doctor is trying to determine if I'm a long-hauler of COVID related. I have never had Covid-19 virus, not to my knowledge.
52 2021-07-07 lethargy I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all time... Read more
I have severe pain in my leg muscles and bi-ceps in both arms, I'm extremely lethargic at all times of day. I also have burning sensation in my leg calf nerves and forearms. I have also slight pain in my chest. I also have finger cramping when I wake up in the morning. slight lost in memory.
52 2021-07-08 sweating Night sweats.; Extreme sweating during the night to the point of sheets being wet; This is a spontan... Read more
Night sweats.; Extreme sweating during the night to the point of sheets being wet; This is a spontaneous report from a contactable other health care professional, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 14:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin (PCN). The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 13:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 24Mar2021 at 00:00, the patient experienced night sweats, extreme sweating during the night to the point of sheets being wet. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the event night sweats and extreme (excessive) sweating during the night to the point of sheets being wet was recovered on 24Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-08 malaise the covid vaccine made him a little bit sick and more on the second dose; This is a spontaneous repo... Read more
the covid vaccine made him a little bit sick and more on the second dose; This is a spontaneous report from medical information Team. A contactable consumer or other non-health care professional reported that a 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: not reported, Expiration Date: not reported), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, the covid vaccine made him a little bit sick and more on the second dose. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
52 2021-07-10 headache Achy body; Achy body / joints; headache; This is a spontaneous report from a contactable consumer, t... Read more
Achy body; Achy body / joints; headache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the left arm on 23Mar2021(at the age of 52-years-old), at 13:30 hours, as a single dose for COVID-19 immunisation. The medical history was not reported and the patient had no known allergies. The concomitant medications included atorvastatin calcium (LIPITOR) and amitriptyline pamoate, (amitriptyline) (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since having the vaccine. On 24Mar2021 at 06:30, the patient experienced achy body and joints was very tired and had headache. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of achy body and joints, tiredness and headache were recovering at this time of the report. No follow-up attempts are needed. No further information is expected.
52 2021-07-10 fever, influenza like illness Fever; General flu like symptoms; This is a spontaneous report received from a contactable consumer,... Read more
Fever; General flu like symptoms; This is a spontaneous report received from a contactable consumer, for patient. A 52-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and the patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis (MS). The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had taken concomitant medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced fever and general flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events fever and general flu like symptoms were resolved on an unknown date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-11 influenza like illness 1. Persistent viscous mucous accumulating between (what feels like) the back of the mouth and the na... Read more
1. Persistent viscous mucous accumulating between (what feels like) the back of the mouth and the nasal passages. Not relieved by anti-histamines nor decongestants. A much different feeling than seasonal allergic rhinitis, which is easily treatable. 2. Flu like symptoms after vigorous physical exercise.
52 2021-07-13 chills, cough, fever, runny nose, nasal congestion Vaccinated with Pfizer on 1/23/21 and 2/3/21. Symptom onset on 7/10/21 with cough, runny nose, shor... Read more
Vaccinated with Pfizer on 1/23/21 and 2/3/21. Symptom onset on 7/10/21 with cough, runny nose, shortness of breath, chills, fever, nasal congestion. Tested positive for Covid 19 on 7/13/21
52 2021-07-13 sweating, fever, chills 1. Woke up at 2am with sweats and chills (Fever). An hour later had pain on my left flank (seemed l... Read more
1. Woke up at 2am with sweats and chills (Fever). An hour later had pain on my left flank (seemed like pain from the same area that I had previously had a Diverticulitis event. Previous Diverticulitis event the pain gradually increased in that area. This time it was immediate. Chills and Sweats (Fever) lasted until 7-8AM. Started Antibiotics and diet Monday afternoon (2/15/21). Pain on my left flank lasted until I completed my Antibiotics Treatment 8-9 days later. 2. At some point within about 3 weeks of the 2nd Vaccination I noticed I was wheezing at night while I slept (it would wake me up). I was not really short of breath, but while laying down would wheeze. I had asthma as a child, but since I was a teenager, I have not had any Asthma or Wheezing issues. Doctor gave me a course of Steroids and Albuterol which I am still using daily. It has gotten better but I still need the inhaler daily.
52 2021-07-13 sweating Patient received vaccine and seat to wait for 15 minutes, then started feeling dizzy and sweating. T... Read more
Patient received vaccine and seat to wait for 15 minutes, then started feeling dizzy and sweating. Took patient's blood pressure and was slightly elevated, revised blood pressure and after third reading BP was lower and patient started feeling better.
52 2021-07-13 fever, runny nose, nasal congestion, cough, chills Vaccinated with Pfizer on 1/13/21 and 2/3/21. Symptom onset 7/10/21 with cough, runny nose, shortne... Read more
Vaccinated with Pfizer on 1/13/21 and 2/3/21. Symptom onset 7/10/21 with cough, runny nose, shortness of breath, chills, nasal congestion, fever. Tested positive for Covid-19 on 7./13/21.
52 2021-07-14 cough, throat pain, runny nose Patient developed cough, runny nose, loss of smell, disturbing vivid dreams, and sore throat on 07/... Read more
Patient developed cough, runny nose, loss of smell, disturbing vivid dreams, and sore throat on 07/11. Tested positive for COVID on 07/14
52 2021-07-15 cough Persistent, wet cough. .
52 2021-07-17 fatigue, sweating Tiredness (exhausted); sweating but no fever Average temp was between 95.7 and 96.; Aches in joints ... Read more
Tiredness (exhausted); sweating but no fever Average temp was between 95.7 and 96.; Aches in joints (toes, ankles, right rear right shoulder.; Very watery diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot number: ER8733), via unspecified route of administration, administered in left arm on 30Apr2021 at 04:30 PM (at the age of 52-years-old) as dose 2, single for COVID-19 immunization in Hospital. Medical history included right hemicolectomy 1.5 years ago but still have diarrhea, and ongoing burp. Patient had no known allergies. Concomitant medication(s) included omeprazole 20mg taken for burp, hydroxyzine 25mg, and citalopram 40mg; all from unknown start and stop date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, lot number: EW0161), via unspecified route of administration, administered in left arm on 09Apr2021 at 02:30 PM as dose 1, single for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccine within four weeks of vaccination. On 30Apr2021 at 10:00 PM (same day of vaccination), patient experienced tiredness (exhausted), sweating but no fever average temp was between 95.7 and 96, aches in joints (toes, ankles, right and rear right shoulder), and very watery diarrhea (patient had a shortened colon but not usually had diarrhea that bad). Therapeutic measures taken for events included Tylenol 500mg. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
52 2021-07-17 influenza like illness four straight days of moderate flu-like symptoms; This is a spontaneous report from a contactable co... Read more
four straight days of moderate flu-like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 21Mar2021 at 16:30 (age at vaccination 52-years-old) in the left arm as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN) at a dose of 25mg per day taken for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 06:00 since the vaccination, the patient experienced moderate flu-like symptoms for four straight days of moderate flu-like symptoms, minus fever. On the fifth day (26Mar2021) of reporting also he does not know how much these symptoms will be longer and persists. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events of flu-like symptoms was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-17 fever, chills Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches;... Read more
Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 16:00 (at the age of 52-years-old) (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included Pulmonary embolism, Heartburn. The patient had no allergies to medications, food, or other products. Concomitant medication(s) included apixaban (ELIQUIS); dexlansoprazole (DEXILANT), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 18Mar2021 16:00, the patient experienced fever up to 104.4 times 4 days, uncontrolled chills, Weakness, body/ joint aches. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequelae (Recovered with lasting effects). Follow-up attempts are completed. No further information is expected.
52 2021-07-18 fatigue Reported with the first Pfizer COVID vaccine, he had dizziness the next day along with nausea and ti... Read more
Reported with the first Pfizer COVID vaccine, he had dizziness the next day along with nausea and tiredness which lasted for two to three days. He reported he didn't eat with the first dose of Pfizer COVID vaccine. He denied other signs or symptoms of anaphylaxis. He stated he didn't have a follow-up with PCP and denied any known allergies or any chronic health conditions.
52 2021-07-18 fatigue The immediate reaction was severe pain in neck, knees, hand, ankles, nausea and fatigue. This occurr... Read more
The immediate reaction was severe pain in neck, knees, hand, ankles, nausea and fatigue. This occurred for 3 days then on Sunday I was admitted to the hospital. I was given pain medication discharged still exp tiredness and fatigue. The nausea was gradually going away started to loose all functions in hands. As of today my energy level is at at 75% my left hand is better and right hand still experiencing some numbness. I have seen a Neurologist, Rheumatologist and Cardiologist.
52 2021-07-18 fever, chills, fatigue, headache Fever, chills, headache, body aches, fatigue
52 2021-07-19 throat pain Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old ma... Read more
Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Feb2021 at 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR), sertraline hydrochloride (ZOLOFT), ascorbic acid/vitamin C (MANUFACTURER UNKNOWN) and multi vitamin (CENTRUM). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 27Jan2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021, the patient underwent a rapid test (nasal swab) for COVID-19 and tested negative. On 30Mar2021 at 21:00, the patient experienced a sore throat and reported that he would get a COVID-19 test done as a precautionary measure. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event sore throat was resolved on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
52 2021-07-19 fever Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in a... Read more
Vaccinated 7/16, 7/17 developed mild chest pain, fever and body aches. 7/19 developed dizziness in addition to previously reported symptoms. 7/20 developed right leg numbness and reported symptoms to this clinic. Was escorted to ED
52 2021-07-20 fatigue Pain in right shoulder and joints on right side of body; Extreme exhaustion; This is a spontaneous r... Read more
Pain in right shoulder and joints on right side of body; Extreme exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 29Mar2021 at 06:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back, right hip and knee chronic pain. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the right arm on 08Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021 at 18:00, the patient experienced pain in right shoulder and joints on right side of body. On 30Mar2021 at 18:45, the patient experienced extreme exhaustion that began 24 hours after second dose. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events pain in right shoulder and joints on right side of body and extreme exhaustion. The clinical outcomes of the events pain in right shoulder and joints on right side of body and extreme exhaustion were not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
52 2021-07-22 headache I'm going to die; his head is a little dizzy; Dry mouth; Continuous headache; Throwing up; Losing we... Read more
I'm going to die; his head is a little dizzy; Dry mouth; Continuous headache; Throwing up; Losing weight; Taste buds are off; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Apr2021 (at 52-year-old) (Lot Number: ER8732) as dose 2, single in arm left for COVID-19 immunisation. The patient's medical history, family Medical History and other products were reported as none. The patient reported he was perfectly healthy before the COVID-19 shot (he worked out every day and rides his bike). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26Mar2021 (at 52-year-old) (Lot Number: ER8730) as dose 1, single in left arm for COVID-19 immunisation. The patient mentioned that "a week after, his taste buds are off in Apr2021, he had headache began Jun2021 (about a month ago), lost 40 pounds from a week after the second dose (Apr2021) in the last 2 months because he can't eat animals or dry food, he can't eat; and his head was a little dizzy because it made him throw up began maybe 30 days after receiving the Covid-19 vaccine (May2021) and it has stayed the same ". Caller wanted to know if anybody "reported about the loss of sense of taste and dry mouth since he has had a really dry mouth in Jun2021 as well and barely eating anything ". The only thing he is eating right now was tomato juice, yogurt, and soup. Caller mentioned that he was "still losing weight". When returned from hold, caller mentioned he was "taking a headache medicine" and Tylenol 500 mg at the time. Caller mentioned that he was over 200 pounds and after the vaccine, he lost 40 pounds, and weight loss was getting worse and worse. He's already down to 160 pounds. (probably be down to 130). He was going to die/ probably die soon. "Taste buds are off" was reported as worsened. He went to the emergency room 2 weeks ago and a specialist. Emergency room doctor gave him metoclopramide and he was taking 3 per day. He was being sent for a CT scan and was going to the ear, nose, and throat doctor this month (Jul2021). His physician referred him to gastro health and he went there yesterday, 07Jul2021. He still has a little headache, sort of like a 304 on the pain scale with the meds. Tylenol and metoclopramide do bring his headache down some. The outcome of events near death experience, dizzy was unknown; of events loss of taste, headache, weight decreased, vomiting, dry mouth was not resolved.
52 2021-07-23 headache, fatigue Starting at about 14:00 on the day of receiving the first dose of the Pfizer-BioNTech COVID-19 I be... Read more
Starting at about 14:00 on the day of receiving the first dose of the Pfizer-BioNTech COVID-19 I began to feel soreness at the vaccine injection point. After about another hour, I started to feel fatigue; about another hour or two later, headache; about another hour later numbness in my head; and about another hour later achiness in other parts of my body. I am submitting this report on July 24, 2021 at 06:53, about 23 hours after receiving the vaccine, and the numbness in my head has subsided, the headache and body aches have mostly subsided but are still present; and the soreness at the injection point has not yet subsided. I am noticing a little shortness of breath that I did not notice yesterday.
52 2021-07-27 fatigue, fever, headache Fever; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable consumer, the p... Read more
Fever; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO179) via an unspecified route of administration in the right arm on 30Apr2021 at 03:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sickle cell trait. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729), via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021 at 10:30, the patient experienced fever, fatigue, headache and body ache. The clinical outcome of the events fever, fatigue, headache and body ache were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
52 2021-07-27 malaise, headache Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks... Read more
Had 4 strokes/My girlfriend took me to the hospital to find out I suffered 4 strokes. 2 were 2 weeks old.; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; few hours after 1st shot severe headache and vomiting/Didn't feel well for 2 weeks till I got the severe vomiting and headache again; Didn't feel well for 2 weeks; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness; the next day didn't know anything, couldn't speak, shaking, weakness.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunization. Other medical history was none before the covid shot, was healthy and now he lost his business and no income. Not known allergies. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. The patient experienced had 4 strokes/my girlfriend took me to the hospital to find out i suffered 4 strokes. 2 were 2 weeks old, few hours after 1st shot severe headache and vomiting/didn't feel well for 2 weeks till i got the severe vomiting and headache again, didn't feel well for 2 weeks, the next day didn't know anything, couldn't speak, shaking, weakness all on 01May2021. The events were serious per hospitalization, disability. The patient was hospitalized for these events. Had 4 strokes, few hours after 1st shot severe headache and vomiting. Didn't think too much about it since they said 50 + men don't get reactions. Didn't feel well for 2 weeks till he got the severe vomiting and headache again, and the next day didn't know anything, couldn't speak, shaking, weakness. His girlfriend took him to the hospital to find out he suffered 4 strokes. 2 were 2 weeks old. Backing it up till 01May2021 when he has the first covid shot. Therapeutic measures were taken as a result of events (Treatment for strokes). The adverse event result in doctor or other healthcare professional office/clinic visit and a visit to Emergency room/department or urgent care. Duration of Hospitalization was 5 days. Hospitalization was not Prolonged. Facility where the most recent COVID-19 vaccine was administered was hospital. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was resolved with sequelae.
52 2021-07-27 malaise Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not f... Read more
Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not feeling well. My blood pressure was really high 179/about 100 and pulse rate was about 110. I let it go on for a couple of days to make sure it wasn't something> I went to see my Cardiologist and he started me on blood pressure medications. It's gone down. But I've had blood pressure issues before so it's kind of out of the blue. Blood pressure seems to be controlled now.
52 2021-07-27 fever, fatigue, headache I had headache, body ache, serve fatigue, low grade fever, nausea, and difficulty breathing. I went... Read more
I had headache, body ache, serve fatigue, low grade fever, nausea, and difficulty breathing. I went to the Urgent care. They did a Covid-19 test, which came back negative. I did have a repeat of the same symptoms two weeks later.
52 2021-07-28 chills, fever, fatigue I experienced extreme fatigue for two to three days, body aches, low grade fever, and chills. I went... Read more
I experienced extreme fatigue for two to three days, body aches, low grade fever, and chills. I went to the doctor and was told that I the symptoms would subside after a while. After a few weeks, I finally started to feel normal but the fatigue continued for an additional week and a half.
52 2021-07-29 fatigue, chills Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; He... Read more
Dizziness; Brain fog; Tinniutis; Unsure of balance; Disequilibrium almost to the point ofvertigo; Heart Racing; Bizarre nightmares; Benign hypertensive levels; Anxiety; Chills; Fatigue; Muscle Aches; Some burning in leg muscles; Severe joint inflammation in knees and ankles; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included essential hypertension, benign. The patient has taken unspecified concomitant medications. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced severe joint inflammation. On 31Mar2021, the patient experienced dizziness, foggy feeling in head, tinnitus, loss of balance, disequilibrium, heart racing, nightmares, benign hypertensive heart disease, anxiety, chills, fatigue, muscle aches and burning in leg muscles. It was reported that the patient experienced 3 days after vaccination, severe joint inflammation in knees and ankles, like a gout attack starting 7 days after vaccination dizziness, brain fog, tinniutis, unsure of balance, disequilibrium almost to the point of ,vertigo, for example at any time, with eyes closed and head up, my body will rock on his heels noticeably, heart racing, especially at night when trying to sleep or stay asleep, waking up numerous times, bizarre nightmares BP elevated above his essential benign hypertensive levels, anxiety starting 7 days after vaccine, but faded chills, fatigue required 2 days of rest muscle aches, some burning in leg muscles inflammation. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event dizziness, foggy feeling in head, tinnitus, loss of balance, heart racing, nightmares benign hypertensive heart disease and anxiety was not resolved. The clinical outcome of the event chills, fatigue, muscle aches, burning in leg and joint inflammation was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
53 2021-01-04 fatigue achy joints; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-... Read more
achy joints; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection, lot number: EK5730, intramuscular in the left shoulder on 23Dec2020 12:00 at a single dose for covid-19 prophylaxis. The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included Shingrix and experienced weak, tired and achy that lasted for 24 hours, he received this 6 months ago (2020). The patient experienced achy joints and fatigue, both on 24Dec2020 at 10:00 with outcome of recovering. The patient called about the Covid-19 vaccine and reported that he received it last Wednesday on 23Dec2020. He said that since then he has had achy joints and fatigue that started on Thursday 24Dec2020 that has been going on through today. He received the vaccine at the hospital where he works at. His symptoms are persisting, but stated that he does feel a little bit better today. He said that it does not seem to be getting worse. He read achy joints and tiredness were some of the reactions to be expected with the medication, and now he was thinking it was a little more long term than what it should be.
53 2021-01-04 headache, sweating Profuse sweating (20 mins after injection), headache ( like migraine), muscle soreness in left arm, ... Read more
Profuse sweating (20 mins after injection), headache ( like migraine), muscle soreness in left arm, balance off, soreness at injection site
53 2021-01-05 chills This is a late entry note regarding adverse reaction status post Pfizer COVID-19 vaccine which was g... Read more
This is a late entry note regarding adverse reaction status post Pfizer COVID-19 vaccine which was given to the patient yesterday at 9:45. Secondary to the patient's past medical history he was advised that he would wait and observance for approximately 1/2-hour instead of 15 minutes. At approximately 10:15, 30 minutes after receiving his vaccine, the patient did report tingling and numbness in his lips and mouth, this progressed to tightness in his throat at 10:45, the patient denied any shortness of breath or wheezing and was constantly monitored by emergency medical services as a vaccine clinic to take place at our local fire hall. Secondary to throat tightness, and chills, and ongoing tingling numbness in his lips and mouth. #18 IV was started in the right AC, normal saline 1000 cc was up open, the patient received 25 mg of IV Benadryl per protocol, as well as 125 mg of IV Solu-Medrol at 1055. Vital signs at that time 168/95, pulse was 73, and O2 saturation was 100%. Physical exam did not reveal any indication of blockage within the throat, there was no shortness of breath or wheezing. Lung sounds are clear but diminished to auscultation bilaterally, heart rate regular. Temp 98.2. Approximately 10 minutes after receiving medication blood pressure 161/100, pulse-73, sat remained 100. Assessment of patient's symptoms patient does report that the throat feels slightly thicker, he denied any shortness of breath or wheezing, there was no oral or facial edema throughout the entire episode. The patient received 1000 mg of IV Tylenol at 1125. Continued observation for the next hour, the patient did report improvement in his symptoms, lip tingling and numbness dissipated, along with throat tightness. Vital signs at 1236 122/74, pulse 79 oxygen saturation 100%. The patient was placed on a cardiac monitor the entire time of this incident. Follow-up phone call to patient on 01/06/2021 at 8:00 patient reportedam that he did have 1 further episode of tingling in the tip of his tongue and around his lips yesterday afternoon at 16:00 he did take Benadryl as instructed and this dissipated, he reports throughout the night he has had no further episodes of tongue or lip tingling, throat tightening shortness of breath or wheezing difficulty swallowing. He was instructed prior to leaving the vaccine administration site to continue with Benadryl 25 mg every 6 hours, along with Tylenol alternating with ibuprofen per box instructions to aid with chills and rigors for the next 24 hours. He reports that he is had an improvement in his symptoms, We will follow-up again in 1 day.
53 2021-01-05 headache, fever, chills, malaise, influenza like illness Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever... Read more
Extreme Arm Soreness Painful axillary lymphadenopathy on side of injection Flu like symptoms (Fever, HA, Muscle aches, malaise, chills) Abdominal cramping
53 2021-01-05 sleepiness, fatigue Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating visio... Read more
Fairly rapid onset of excess fatigue, difficulty keeping eyes open associated with oscillating vision, near simultaneous distortion of sound (at the time was watching a show using my phone, and the actors no longer sounded like themselves), sense of subtle disequilibrium, and a sense of intense heat involving my upper abdomen and lower chest, centered around my xiphoid process as if being pressed up against a space heater, the latter symptom was non-painful, perhaps the best example is the feeling one has after receiving intravenous contrast dye for CT imaging although more the "warmth" was more intense. Lasted 90-120 minutes before going to sleep, then gone by morning.
53 2021-01-06 fatigue Myalgia, NauseaVomiting Fatigue
53 2021-01-06 fever, headache Headache, Myalgia & Fever
53 2021-01-08 chills, headache, fever Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mo... Read more
Headache, NauseaVomiting, swollen and painful left axilla and left arm; chills, strange taste in mouth Narrative: 1/5 received vaccine. 1/6 woke up with left arm/axilla swollen and painful, severe headache, nausea, and chills. Also has a strange taste in his mouth. He stayed home from work. 1/7 employee reports fever overnight, chills, and lump under his left arm has enlarged. Advised to see his PCP. 1/8 left axillary lump has decreased from softball size to baseball size. It's still tender. His arm pain has improved. Headache, nausea, and chills have resolved.
53 2021-01-08 chills Chills, muscle aches, joint pain
53 2021-01-09 chills, fever Fever to 101.7 with chills and muscle aches
53 2021-01-09 fatigue, fever, headache, chills Headache, chills, fever (101), chills, fatigue
53 2021-01-09 headache, malaise Mild headache x 8 hrs Malaise, myalgias x 48 hrs
53 2021-01-10 fatigue, headache Fatigue, headache, diarrhea, upset stomach
53 2021-01-10 fever severe shortness of breath, tachycardia, fever
53 2021-01-11 sleepiness, fatigue, cough, chills he is also not drinking; pain at injection site; coughing/cough; chills; not wanting to eat and fati... Read more
he is also not drinking; pain at injection site; coughing/cough; chills; not wanting to eat and fatigue; not wanting to eat and fatigue; feeling of being drowsy, like he is going to get a cold; This is a spontaneous report from a contactable consumer (patient himself). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (arm left), on 04Jan2021 at 14:15, at a single dose, for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications included metformin, empagliflozin (JARDIANCE), lisinopril, and pravastatin. Historical vaccine included shingles; and flu shot for flu vaccination both administered in Jan2020. Patient is Behavioral Health Technician. Patient received the first dose of vaccine on 04Jan2021 (Monday) at 14:15 and went through cough, chills, not eating, fatigue. Today (Wednesday) he is better; he asked if he can take ibuprofen after having the vaccine. He also asks how long do these symptoms typically last. All the symptoms he mentioned started around 8:00 p.m. the same day, it was that feeling of being drowsy, like he is going to get a cold. He also had excruciating pain on the arm that got the vaccine, it was pain at the injection site. He added that he was also not drinking, he knows he should drink fluids. His second dose is on 26Jan2021 at 8:45PM. He has no positive COVID test before the vaccine. He did not have antibody test before the vaccine. He has had no issues with vaccines in the past. Outcome of the events not wanting to eat and fatigue was not recovered, for event "he is also not drinking" was unknown, while for other events was recovering. Information about lot/batch number has been requested.
53 2021-01-12 chills, fever Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old ma... Read more
Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730, expiry: 31Mar2021), intramuscular on the left arm on 06Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization It was reported that the patient was visiting COVID-19 patients. There were no concomitant medications. The patient previously received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (lot/batch number: EK5730, expiry: 31Mar2021) intramuscular on the left arm on 16Dec2020 as COVID-19 immunization. The patient reported that he received the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday (06Jan2021) and was having a minor reaction. He has chills and fever and fever this morning (07Jan2021) and wanted to know if it's okay to take over the counter ibuprofen or acetaminophen (TYLENOL). Outcome of the events were not recovered.
53 2021-01-12 chills, fever swelling of the lymph nodes; fever; right arm injection site pain; aches and pains; chills; This is ... Read more
swelling of the lymph nodes; fever; right arm injection site pain; aches and pains; chills; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 53-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 04Jan2021 at 13:00 at single dose in right shoulder for covid-19 prophylaxis. There were no medical history or concomitant medications. The patient experienced fever, right arm injection site pain, aches and pains, and chills on 05Jan2021, swelling of the lymph nodes on 06Jan2021. Event details: On 05Jan2021 in the morning, he started having a fever and chills. He stated that he noticed the injection site pain on the 05Jan2021 and stated that it only hurt at time of reporting if he pushed on it. He stated it did not hurt when he moved his arm around. The patient stated that he noticed the aches and pains on the 05Jan2021 in the morning and it stuck with him throughout the day and was over by the time he went to bed on 05Jan2021. Wednesday 06Jan2021, toward the early morning around 0300 under his arm hurt and the lymph node under his arm was swollen about the size of a baseball. The patient said that his fever was currently 99.5 in Jan2021. The outcome of events fever and swelling of the lymph nodes was not resolved, outcome of right arm injection site pain, aches and pains was resolved in Jan2021, outcome of event chills was unknown.
53 2021-01-12 headache headaches on both sides of his head; This is a spontaneous report from a contactable Physician repor... Read more
headaches on both sides of his head; This is a spontaneous report from a contactable Physician reporting for himself. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 0.3ml single dose on 30Dec2020 in the left deltoid for COVID-19 immunisation at the age of 53-year-old. Lot number was EK9231, expiration date 30Apr2021. Medical history and concomitant medications were unknown. On 31Dec2020, headaches on both sides of his head; the event was considered medically significant. The patient received TYLENOL for the event. The patient did not recover from the event. The physician considered the event was related to suspect vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
53 2021-01-12 headache Headache, NauseaVomiting c/o light headiness. Told to follow up with primary care physician if no im... Read more
Headache, NauseaVomiting c/o light headiness. Told to follow up with primary care physician if no improvement Narrative:
53 2021-01-12 sweating Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle a... Read more
Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.
53 2021-01-12 sleepiness, headache, sweating, fever Mild injection arm soreness for 3-4 hours after injection. Mostly asymptomatic on the day of inject... Read more
Mild injection arm soreness for 3-4 hours after injection. Mostly asymptomatic on the day of injection. No constitutional symptoms until 24 hours later. Then subacute onset of headache, fever 38 C, sweats, sleepiness for approximately 12 hours. Asymptomatic by 48 hours later.
53 2021-01-13 headache, fatigue, sweating Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, ... Read more
Headache; migraine; tenderness at injection site; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias; Fatigue; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on right deltoid on 05Jan2021 07:45 at single dose for covid-19 immunization. Family history included migraine (other family members). Medical history included mild blood pressure and kidney stones, reactive airway disease. Concomitant medication included colecalciferol (VITAMIN D), potassium, allopurinol and hydrochlorothiazide/valsartan for mild blood pressure and kidney stones, fluticasone propionate, salmeterol xinafoate (ADVAIR) for reactive airway disease, atorvastatin, and multivitamins. The patient previously took fluticasone propionate, salmeterol xinafoate (ADVAIR) and experienced dry mouth and lost sense of taste. The patient also previously took Tdap booster on Aug2020, Shingrix on 10Aug2020, and influenza on 12Oct2020; all for immunization; and tetanus injections for immunization and experienced localized tenderness. The patient had the first dose of BNT162B2 (lot number: EH9899) for COVID-19 immunization on 15Dec2020 and experienced localized tenderness at injection point. The received his second dose of COVID vaccine on 05Jan2021. With the first dose he had increased localized tenderness at injection site on 15Dec2020, and he rated it mild to moderate. He would say it was 80% resolved in 24 hours. It had completely resolved in 36 hours. He would say that he has recovered completely form the localized tenderness with the first dose. Then he noted his second dose was yesterday, in the context of not having much sleep the night before. The actual injection was uncommonly eerily painless. The other folks in his department had similar experience. Maybe it was the nurse who gave the injection. Maybe it was because it was the same area and sensitivity was decreased. They had to check the Band-Aid to make sure blood was there. The administration was painless. He was relieved when the arm started getting sore to know he actually received it. He had increased arm tenderness at injection site which he rated as moderate which has now resolved. It got to moderate where lifting the arm up was sore. He definitely knew that he had been vaccinated. He got the vaccine at 7:45AM and now it is 16 to 17 hours later and he would say the pain is mild now. It did persist. The first vaccine hurt a little more. He expects this to go away. Ten hours after injection he had shaking, sweats, hot and cold flashes, and augmentation of myalgias. He had unrelenting headache over night that was moderate to severe. He said it kept him awake. It was exacerbated by lying down. Sitting up helped him. It became a migraine which is something he doesn't often experience. Migraines are pretty rare for him. He took 800mg of Advil at 6AM that helped for headache and migraine. The weight of the patient was 250 to 255 pounds. Shaking, sweats, hot and cold flashes, and augmentation of myalgias have resolved. Everything has resolved except for a little headache. In the background he literally had one or two hours of sleep. He thinks that likely precipitated a migraine was increased. Last night he slept literally an hour. He took 800mg of Advil and fell asleep. He is operating on 2 hours of sleep in 48 hours. Most of the stuff is gone except a little headache and expected fatigue. Headache Seriousness Criteria: he would say that it was relatively disabling. He would not have been able to carry on. He wouldn't have been able to operate last night. It would have interfered. It was dissimilar to others. He gets rare migraines. Everything was amplified with a migraine. He certainly felt that. It was fair to say the vaccine precipitated the migraine that was mild or severe. He doesn't want to falsely attribute these things to the vaccine. Causality Headache: precipitated by the vaccine. In the context that he had not slept the night before. He had a nasopharyngeal COVID test and it was negative. He has been in a COVID study where they are looking at combination. They developed a saliva test at (Name). There is a combination of saliva oropharyngeal and immunoglobins. He has been negative multiple times. The outcome of the events headache and fatigue was not recovered and recovered for the rest of the events.; Sender's Comments: A causal association between BNT162B2 and the reported event headache cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
53 2021-01-14 fatigue, fever, chills 30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever... Read more
30 hours post injection mild weakness and fatigue; Onset began 18 hours after injection. 100.2 fever; chills; body aches; extreme fatigue; Bedridden 8 hours; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via an unspecified route of administration on 07Jan2021 at 15:00 (at the age of 53 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included high blood pressure from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, lot number: EJ1685 on 19Dec2020 at 16:15 in the left arm. On 08Jan2021 at 09:00 (reported as onset began 18 hours after injection), the patient experienced 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours. It was reported that 30 hours post injection (08Jan2021 at 21:00) he experienced mild weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of 100.2 fever, chills, body aches, extreme fatigue, bedridden 8 hours, mild weakness and fatigue was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
53 2021-01-15 chills, headache, fever Headache, Fever, Chills, L arm soreness and numbness Narrative:
53 2021-01-15 headache Myalgias and headache, discharged from ED with tylenol
53 2021-01-16 chills Developed soreness and mild swelling at injection site 8 hrs later. Then 19 hrs later, developed mil... Read more
Developed soreness and mild swelling at injection site 8 hrs later. Then 19 hrs later, developed mild to moderate chills.
53 2021-01-17 fatigue, headache headache; myalgia; fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old adu... Read more
headache; myalgia; fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK923), intramuscular on 08Jan2021 16:15 (reported as "04:15 PM") at single dose on the left arm for COVID-19 immunisation. There were no medical history and concomitant medications. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on 18Dec2020 04:30 PM on left arm. COVID-19 vaccine was administered in the hospital. The patient experienced headache, myalgia and fatigue on 09Jan2021 at 8:00 AM. No treatment received for the events. The events were assessed as non-serious. Outcome of the events was recovered in Jan2021. The patient has not been tested for COVID-19 since the vaccination.
53 2021-01-17 fatigue Muscle/body aches/fatigue
53 2021-01-18 chills, fever, headache Fever / chills Restlessness Vomiting HA
53 2021-01-18 chills, fever Chills Body aches Fever Swollen lymph nodes right armpit
53 2021-01-18 malaise, chills More pronounced pain from IM site; chills after more than 12 hrs; body malaise; This is a spontaneou... Read more
More pronounced pain from IM site; chills after more than 12 hrs; body malaise; This is a spontaneous report from a contactable nurse (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Jan2021 12:00 at single dose (Lot:EK9231) on left arm for covid-19 immunisation. Medical history included none. No Known allergies. No COVID prior vaccination. Concomitant medication included VITAMIN C and multi vitamin. No other vaccine in four weeks. The patient experienced More pronounced pain from IM site, chills after more than 12 hrs, body malaise, all on 09Jan2021. 01:00 Outcome of events was recovering. No COVID tested post vaccination.
53 2021-01-19 nasal congestion, fatigue Same lot number as the first one. With this I had a sore shoulder and I had fatigue and I had a feve... Read more
Same lot number as the first one. With this I had a sore shoulder and I had fatigue and I had a fever about 100.5-101. That was not well controlled with Tylenol - still stayed about 100.5. Also had some gastro-intestinal distress - diarrhea. Lasted for about 36 hours. And then my fever went down and I felt pretty good but still experiencing some low grade fatigue and a little congestion which is lingering from first dose. Lingering effects may be from COVID
53 2021-01-19 fever Developed fever 12/28/20, tested positive for SARS 12/29/2020. Quarantine for 10 days from onset of... Read more
Developed fever 12/28/20, tested positive for SARS 12/29/2020. Quarantine for 10 days from onset of symptoms, returned to work 1/6/2021
53 2021-01-20 chills, fever I was sick all day fevers chills dry heaves no energy
53 2021-01-21 fatigue Diarrhea, stomach pain tired
53 2021-01-23 sweating The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I ... Read more
The injection site seemed inappropriately high in the shoulder/deltoid. No aspiration attempted. I had a dripping sweat occur at the five to fifteen minute range. There was a flushing sensation during this. After a few minutes, it all abaited. The bandaid was saturated with blood. My arm was never sore and I had zero symptoms after the initial reaction. I believe this injection was given intravascularly. I have not been able to find ANY information to address the effectiveness of this route if administration and I seriously fear that I am not covered.
53 2021-01-24 headache, fever Pain at the injection site, headache, fever.
53 2021-01-25 body temperature increased 1/21/2021, blood glucose levels were fluctuating from very low to high, normally stable and consiste... Read more
1/21/2021, blood glucose levels were fluctuating from very low to high, normally stable and consistent. 1/22/2021 spiked a temp of 101.9 that would come and go, nausea with eating, high anxiety with feeling of fatigue and being in a fog. Feels good when first getting out of bed in the morning but about an hour or two he feels tired with his anxiety level rising. PCP contact with new orders to increase daily dose of Prozac to assist with the anxiety and rest. Patient stated that he has been resting and was feeling a little better today.
53 2021-01-25 headache, fever, chills Body aches; Chills; Headache; Pain at injection site; poor appetite; fever; This is a spontaneous re... Read more
Body aches; Chills; Headache; Pain at injection site; poor appetite; fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular (left arm) on 11Jan2021 (16:45) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EL1284) on 21Dec2020 (05:00 PM) intramuscular (left arm) for Covid-19 immunization. The patient's medical history included diabetic and heart disease; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, headache, pain at injection site, poor appetite, and fever on 12Jan2021. There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
53 2021-01-27 chills Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lighthead... Read more
Extreme chills, shaking, shivering x 1 day, loss of appetite, diarrhea x 2 days, weakness, lightheaded x 3 days, shortness of breath x 4 days
53 2021-01-30 throat pain Severe sore throat radiating to the right ear during swallowing With tender thyroid on palpation th... Read more
Severe sore throat radiating to the right ear during swallowing With tender thyroid on palpation the symptoms are not regressing till now
53 2021-02-01 headache patient presented with 2 day history of myalgias and headache, no concerning findings in ED
53 2021-02-02 chills, headache, fatigue, cough Severe headache, severe muscle aches/soreness, severe chills, severe fatigue, mild nausea, mild coug... Read more
Severe headache, severe muscle aches/soreness, severe chills, severe fatigue, mild nausea, mild cough, all lasting several days. Slight fever lasting 1 day.
53 2021-02-02 fatigue, headache, chills Syncope/a complete syncopal episode while standing. Then a 2nd one on return; unconscious approxima... Read more
Syncope/a complete syncopal episode while standing. Then a 2nd one on return; unconscious approximately 30 seconds each time; chills; fatigue; muscle aches; joint aches; headaches; extreme dizziness and nausea; extreme dizziness and nausea; injure a knee when my legs pretzeled on the 2nd syncopal episode.; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 53-year-old male patient received second dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EL3248), via an unspecified route of administration on 13Jan2021 11:00 AM on Left arm at single dose for COVID-19 immunisation. Medical history included Controlled hypertension and known allergies: Hypersensitive to narcotics. Concomitant medications included Amlodipine, Irbesartan and Atoravastin. The patient previously took first dose of BNT162B2 (COVID-19 Pfizer/Biontech, Lot#: EK9231), via an unspecified route of administration on 23Dec2020 11:00 AM on Left arm at single dose for COVID-19 immunisation. Facility type Vaccine was Hospital. No Other vaccine in four weeks. The patient experienced Syncope. He had the most common severe reactions (chillls, fatigue, muscle aches, joint aches, headaches). But when he walked to bathroom, he had extreme dizziness and nausea, then a complete syncopal episode while standing. Then a 2nd one on return. His wife said he was unconscious approximately 30 seconds each time. EMS was called but refused transport since ERs full. The patient did also injure a knee when his legs pretzeled on the 2nd syncopal episode. The events started from 16Jan2021 01:30 AM. The outcome of th events was recovered. No treatment received. No Covid prior vaccination. No covid tested post vaccination.
53 2021-02-02 sweating Pt. had syncopal episode as dose was being administered, became diaphoretic, pale and lost consciou... Read more
Pt. had syncopal episode as dose was being administered, became diaphoretic, pale and lost conscious. transferred to triage area where patient was monitored. Pt. symptoms resolved but then became nauseated. Every time patient sat up he became nauseated and would have a bout of emesis. 1900 patient continues to feel nauseated when sitting up but family here to pick patient up and patient escorted out to wife's car with Dr. approval
53 2021-02-02 fever, headache Headache / Fever
53 2021-02-04 headache Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood c... Read more
Headache the next morning after receiving vaccine that hasn?t gone away, fluid in left lung, blood clots in right lung and leg.
53 2021-02-07 fatigue Sudden onset of dizziness, lightheaded ness, nausea, swollen glands at cervical region, fatigue, bod... Read more
Sudden onset of dizziness, lightheaded ness, nausea, swollen glands at cervical region, fatigue, body aches; lasting 5 hours. Ongoing gland swelling with meals.
53 2021-02-09 headache, fatigue Weak in my legs, headache, and fatigue
53 2021-02-12 headache elevated BP, headache
53 2021-02-13 headache, chills 12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same condition... Read more
12 hours after shot started chills, body aches, severe headache. 24 hours after shot, same conditions, with nausea. 48 hours after shot same conditions, with vomitting. Unable to eat or drink and would just throw it up. 72 hours, severe headache, extreme light and sound sensitivity, nausea. 96 hours finally starting to feel better. Mild symptoms, such as slight headache, weakness.
53 2021-02-13 fever, headache, fatigue Body aches and fatigue set in at approx 15 hours after injection. Took 3 hour nap. Approx 24 hour... Read more
Body aches and fatigue set in at approx 15 hours after injection. Took 3 hour nap. Approx 24 hours after injection, developed fever and headache. Fever lasted approx an hour; headache persisted until asleep for night. Woke up next morning with no symptoms.
53 2021-02-14 sneezing, dehydration, headache, runny nose 30 minutes after vaccination mild headache in temple area. 5.5 hours after vaccination sneezing and ... Read more
30 minutes after vaccination mild headache in temple area. 5.5 hours after vaccination sneezing and runny nose and a feeling of dehydration. Following day minor stomach nausea upon waking up but dissipated after an hour. minor pain in right neck muscle.
53 2021-02-19 fatigue, cough, chills, fever, headache During the night after vaccination the patient experienced chills, severe headache, fever, cough an... Read more
During the night after vaccination the patient experienced chills, severe headache, fever, cough and and fatigue. All abated after 24 hours except the headache, which continue 48 hours later
53 2021-02-20 sweating Systemic: mentioned a fear of needles after talking with the patient-Mild, Additional Details: 2/20/... Read more
Systemic: mentioned a fear of needles after talking with the patient-Mild, Additional Details: 2/20/21 app 11:45am received his second COVID vaccination. He was seated for 20 minutes after his shot. He described himself as feeling nauseous, sweaty, and \"pale\". He went out for 20 seconds, when his coworker called his name. He quickly responded. He was then walked to the RN office of the facility. She took vitals BP 148/82, 58 heart rate, 99% pulse ox. He started back\r\nto work. At 3 pm I checked in and he responded he was feeling fine.
53 2021-02-22 pneumonia, fever, cough, fatigue as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine ... Read more
as I mentioned, he had a fever and aches one day prior to the first vaccine. following the vaccine the fever spiked as high as 103 and fatigue continued. four days later a rash developed on his back, and a dry cough developed. He also is experiencing and continues to experience some numbness/tingling in his legs and arms. Two Saturdays following the vaccine he went to the ER and was diagnosed with pneumonia in both lungs. However, a fourth covid test was given and it was negative like the previous three tests.
53 2021-02-24 headache, fatigue Fatigue, body pain, weakness , headache.
53 2021-02-24 fever, chills Employee reports onset of fever, chills, and dizziness following second dose of vaccine. Employee ha... Read more
Employee reports onset of fever, chills, and dizziness following second dose of vaccine. Employee has taken Motrin and Tylenol and reports mild improvement. Symptoms have not interfered with ADL's.
53 2021-02-28 fatigue After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes la... Read more
After waiting 15 minutes in the observation room, I left as I was feeling fine. About 10 minutes later, as I was driving home, I had an odd taste in my mouth and my right cheek started to go numb. I arrived home and started looking for answers (Pfizer information page that lists side effects). The sensation lasted about an hour or so, then started to subside. By the time I went to bed, there was just a little tingle at the edge of my cheek bone. Other than being tired and a bit woozy, I feel better today.
53 2021-03-01 fatigue, headache, chills Pain at the injection site, tiredness, headache, and chills.
53 2021-03-01 sweating Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sw... Read more
Patient felt flushing across chest, sat down and symptoms resolved, patient then reported feeling sweaty and wanting to lie down. Patient was assisted onto the floor by staff. No Loss of consciousness. Patient transferred to ED for evaluation. Patient received IV fluids and 0.25 mg alprazolam. Patient was discharged home from ED.
53 2021-03-02 fatigue, chills, fever, throat pain, sleepiness, malaise Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report fr... Read more
Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 28Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included open heart surgery and being diabetic. Concomitant medication included metformin, sitagliptin (JANUVIA), acetylsalicylic acid (ASPRIN), atorvastatin, and fenofibrate (TRICOR). The patient previously took moxifloxacin (AVELOX), levofloxaxin (LEVAQUIN), ciprofloxacin (CIPRO), and cloxacillin sodium (LOXACIN) and experienced allergies. The patient experienced light fever, sore throat, chills, feeling unwell, tiredness, and sleepy on 28Jan2021 16:45. The patient did not receive treatment for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
53 2021-03-02 fever Following vaccination, patient felt achy and mildly feverish. During the night, he got up to use the... Read more
Following vaccination, patient felt achy and mildly feverish. During the night, he got up to use the restroom and felt palpitations and lightheadedness, which persisted during the morning. A colleague at work evaluated the patient's pulse, noting it to be irregular and fast, so patient went to the ED for evaluation. EKG was performed and patient was found to be in new onset atrial fibrillation. Patient was given fluid boluses, 10mg IV diltiazem, and a diltiazem infusion, during which the patient converted to normal sinus rhythm. After stabilization, he was discharged with new prescriptions for metoprolol tartrate 25mg BID and apixaban 5mg BID, to follow up with cardiology.
53 2021-03-03 fever, malaise, headache On February 15, 2021, had fever and MASSIVE HEADACHE. Got worse each day. Went to ER on 2/19/21, was... Read more
On February 15, 2021, had fever and MASSIVE HEADACHE. Got worse each day. Went to ER on 2/19/21, was treated and release. Found unconscious in home on 2/20/21. Was hospitalized on 2/20/2021. Was diagnosed with varicella meningitis on 2/22/2021. Hosptalized till 2/25/2021. Still not well
53 2021-03-04 headache Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y.... Read more
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Subjective Pt. is a 53 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience numbness in right forearm and headache. He denied difficulty breathing, difficulty swallowing, itching and lightheadedness. This provider was notified of patient reaction and he was then assessed in the emergency area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, cough, chest tightness, shortness of breath, wheezing, dizziness and headaches Numbness right forearm.: Previous Reactions: None Objective Vitals Vitals: 02/24/21 1208 BP: 124/77 Pulse: 83 SpO2: 95% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Musculoskeletal: General: No swelling or deformity. Comments: No rashes noted on right arm where injection was given. Equal strength in bilateral upper extremities. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol 1000mg and water. Follow up response to treatment: good. Sx completely resolved. Discussed that he may take Ibuprofen this evening if he experiences some numbness in the right forearm or fingers. He denied symptoms of headache and numbness resolved prior to discharge. I walked with patient to exit the facility. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Electronically Signed 2/24/2021 12:09 PM
53 2021-03-05 fatigue, cough I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on T... Read more
I ate nothing that morning of the shot. The first day: I took the covid-19 vaccine Pfizer shot on Thursday the 4th of March; there was pain at the injection site just as any other vaccine I have been administered during military service. After the shot I felt tied, and my left arm did hurt from the shot, I started to feel irritable (angry or even aggressive), my chest became tight and my heart rhyme felt somewhat off causing me to start coughing and sometimes uncontrollable to the point I could not catch my breath I thought about seeking medical attention but did not.. The second day: Pain in my left arm went away at the injection site, tiredness went away, and the feeling of irritable (angry or even aggressiveness) went away, tightness in my chest and coughing went away. I have been having a chronic pain in my left arm for about a year and after the shot the pain was gone I noticed that on the second day. I did notice my body temperature was up and down showing symptoms of histamine reaction but not out of control.
53 2021-03-06 sweating Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to near... Read more
Diaphoretic, syncope for approximately 2 minutes, panic attack, rapid breathing. Transported to nearest ER by EMS.
53 2021-03-07 chills, headache, fatigue, fever, cough Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; ... Read more
Severe chills; entire body muscle aches; mild nausea; extreme fatigue; mild cough; severe headache; Slight fever; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 13:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included dermatomyositis (autoimmune disorder). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown) received at 53 years of age, via an unspecified route of administration on the left arm, on 29Dec2020 09:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 28Jan2021 at 10:00, the patient experienced severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough, severe headache, all lasting several days; and slight fever which lasted for 1 day. The adverse events resulted to physician office visit. The patient underwent lab tests and procedures which included rapid test (nasal swab) on 31Jan2021 with negative result and nasal swab on 01Feb2021 with unknown result (pending). The patient recovered from slight fever on 29Jan2021a at 10:00; and was recovering from severe chills, entire body muscle aches, mild nausea, extreme fatigue, mild cough and severe headache.
53 2021-03-08 fatigue 1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, f... Read more
1st symptom: Within 30 seconds, ache in arm from elbow to wrist. Got worse over next few minutes, fairly uncomfortable for about 45 minutes before subsiding slightly (tried to keep moving arm as recommended). Pain returned when I drove to work and while at my desk. Lasted for approx 4 more hours. Injection at 11:15am, pain mostly ended around 9:30pm (except when reaching or extending arm, pain in shoulder now mostly). 2nd symptom: Mild nausea starting about 5 min after injection, while in waiting room. Passed when laying down at home before work, approx 45 min later.. Started again while driving to work and lasted from about 4pm to 8pm. Subsided about 10pm. 3rd symptom - feel very fatigued.at typing of this report at 10pm - started about 5pm. So far nothing else - no headache or chills for example. No pain at all at the actual injection site - now the pain is mostly above it - from the shoulder joint to near the injection site (maybe a couple inches above.) as well as the forearm, all around. To make coping easier in case the symptoms (arm ache, fatigue, etc) are worse as commonly described from the 2nd dose I put in and was approved for PTO from work for scheduled 2nd date on March 30th. Will allow me to rest (avoid being effected at work with the fatigue and an even more achy arm as expected side effects of 2nd dose)
53 2021-03-11 fatigue Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from usi... Read more
Warm - No fever, just very warm with a red face Muscle fatigue and soreness General fatigue from using any muscle... standing... walking...etc. I have no issues at all with performing any of these activities All symptoms were gone after approximately 36 - 48 hours
53 2021-03-12 headache, malaise, fatigue Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores... Read more
Started with itching burning rashes neuropathy headaches fatigue and dizziness. Now have mouth sores that won?t heal and debilitating malaise fatigue A few days later: Joint pain and air hunger A few days later: Numb extremities Two weeks to date: Body temp regulation issues , heart pounding, face flush. Sleep disturbance entire time. Extreme fatigue.
53 2021-03-12 fever, fatigue Swollen lymph node right arm pit, feverish, tired
53 2021-03-14 cough, sweating second shot on3/8/21 basically fine all day, 3/9/21 630am one hour and half felt slightly beat up th... Read more
second shot on3/8/21 basically fine all day, 3/9/21 630am one hour and half felt slightly beat up then fine, an hour and half later same thing, and then 2pm same thing then fine. on 3/9/21 woke up with finger tips white and cold and arm cold and sweat from shoulders up,i then got up and moving and was fine after that. dry spot in throat with occasional cough once and a while throuout the day, then friday night had sat down to dinner and had a 3 minute vomitting upset stomach (did not vomit), and then went away. mother in law tested positive on 3/10/21 and wife tested positive on 3/13/21 so i went to test on 3/13/21 just to rule out and received positive result call from test site on 3/14/21 at 2pm.
53 2021-03-14 fatigue Woke up on the 4th with still neck and had Vertigo. Saw Dr. about the vertigo on the 8th. Been takin... Read more
Woke up on the 4th with still neck and had Vertigo. Saw Dr. about the vertigo on the 8th. Been taking Meclaziine. Vertigo and pain in joints persisted for 7 days. Until, approximately the 10. Vertigo and pain in joints has seemed to go away. Still feeling HEAD FOGGINESS since. Constantly tired.
53 2021-03-14 headache, runny nose, fever Head ache fever runny nose body aches
53 2021-03-14 throat pain, cough, productive cough, sinus congestion On the 2nd after the shot I had sinus problems with a sore throat. On the 3rd day and for 4 days aft... Read more
On the 2nd after the shot I had sinus problems with a sore throat. On the 3rd day and for 4 days after the violent un-controlled coughing . Coughing up blood and fluid, not food.
53 2021-03-14 runny nose, fatigue, cough COVID-19 breakthrough infection 2 months after second dose of Pfizer series. Symptoms include runny ... Read more
COVID-19 breakthrough infection 2 months after second dose of Pfizer series. Symptoms include runny nose, loss of taste and smell, fatigue, and cough. Tested positive for SARS-CoV-2 via nasopharyngeal PCR swab on 3/12/21.
53 2021-03-15 cough, throat pain, nasal congestion Severe Congestion, diarrhea, cough, body aches, sore throat, difficulty breathing , Nausea
53 2021-03-15 malaise, fever, headache Headache, low grade fever, nausea, vomiting, general malaise
53 2021-03-17 headache, fatigue Mild Nausea, Mild dizziness, Persistent headache, Fatigue
53 2021-03-18 malaise DID NOT FEEL WELL
53 2021-03-19 fatigue, fever, headache Received the vaccine on day 15 after the first vaccine. Experienced pain at injection site. Feve... Read more
Received the vaccine on day 15 after the first vaccine. Experienced pain at injection site. Fever, nausea, severe fatigue, headache and severe body aches. Lasted approx 12 to 14 hours.
53 2021-03-19 sluggishness Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel ... Read more
Felt weird 5 minutes after shot. 10 minutes after shot I called over a tech and said I didn't feel right. The took my vitals and found the my blood pressure had dropped to 85/45. They called 911 and hit me with an EpiPen. I never blacked out. After another 10 minutes the fire department arrived and they took vital signs; all normal. Another 10 minutes and ambulance arrived. Vitals in the back of the ambulance were fine. Got to the emergency room and vitals were fine including ekg. Was released from the hospital about 4.5 hours after the initial shot. I feel a little sluggish today but otherwise fine.
53 2021-03-20 chills, fever Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm ha... Read more
Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm had traveled to his neck.At around 11:45 pm he got out of bed and became FREEZING, started shaking, teeth chattering, fever of 101. I gave him Tylenol pm to halt the fever. He was up all night shaking, teeth chattering, burning with fever. This morning the fever is 100. He had Covid over Thanksgiving which started the same way. He went to the ER with Covid and could not get out of bed for ten days. No additional medical treatment at this time
53 2021-03-21 headache Chronic tinnitus significantly increased in intensity/volume the day following the first injection--... Read more
Chronic tinnitus significantly increased in intensity/volume the day following the first injection--I estimate about double the volume. In both ears. After 12 days it has not subsided at all. The increase in severity is causing secondary headache, jaw clenching, sleeplessness, irritability, hearing issues.
53 2021-03-21 lethargy Patient feels hot, dizzy, lethargic
53 2021-03-23 fatigue, headache, influenza like illness Flu like symptoms, body aches, headache, fatigue, insomnia
53 2021-03-23 headache Mild headache (started hour after injection) became moderate headache about 23 hours after dose of v... Read more
Mild headache (started hour after injection) became moderate headache about 23 hours after dose of vaccine. Treated with 1000mg Acetaminophen orally and sleep for 3 hours. Became mild headache and treated with 500mg Acetaminophen in morning and afternoon.
53 2021-03-23 headache The evening of the vaccine I had minor tongue swelling. The next night after eating Tuna I had the ... Read more
The evening of the vaccine I had minor tongue swelling. The next night after eating Tuna I had the tongue swelling again with some Tachycardia and a severe headache with red welts all over my body. I also had tightness in my throat. I went to the Urgent Care where they gave me Antihistamine, Prednisone, something for headache and IV Fluids. I was discharged after three hours and felt better within a few hours. I took Prednisone for five days.
53 2021-03-23 fever, headache Headache, Myalgia & Fever
53 2021-03-23 throat irritation 20 mins after receving 1st dose pt began to have itchy throat, EMS presented to patient, called medi... Read more
20 mins after receving 1st dose pt began to have itchy throat, EMS presented to patient, called medical. 50 mg Benadryl was given and 1 puff of patients own proair. VSS. After 5 mins, patient began to feel better. Pt informed to call wife to drive him home after receiving the medication.
53 2021-03-25 fatigue, influenza like illness About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face beca... Read more
About 30-45 minutes I began to feel tingling in my tongue and throat. A few hours later my face became numb - it was a circle around my face. The next day (3/7) the right side of my face was numb and showing symptoms of what doctors later decided was Bells Palsy. on 3/7 I had fatigue and general feeling bad like I had the flu. On Monday 3/8, I was feeling worse and I called the advice nurse who advised I go to the Emergency room due to right face partial paralysis, numbness, and face drooping. They diagnosed Bells Palsy and prescribed Valtrex and prednosone. From 3/9-12 the right side of my face was numb, droopy and I had ear pain and a lot of fatigue. By Saturday 3/13 I was feeling better and have gradually gotten better through today 3/26. I still have numbness in my right cheek. and occasional tingling in my lips. My doctor has advised me to go ahead and get the second dose of vaccine tomorrow 3/27. Also, during the week of 3/7 - 3/12 I had some dizziness and a general foggy feeling in my head.
53 2021-03-25 fatigue Insomnia, feeling fatigued and lack of energy all of the time, and periodic sickness or nausea to st... Read more
Insomnia, feeling fatigued and lack of energy all of the time, and periodic sickness or nausea to stomach. Cannot sleep more than 2 hours, awake.
53 2021-03-25 fatigue Injection site sore. No inflammation. Both arms feel heavy. Fatigue.
53 2021-03-25 headache Headaches, low neck pain, base of skull pain, lightheadedness, slightly dizziness, brain fog, tightn... Read more
Headaches, low neck pain, base of skull pain, lightheadedness, slightly dizziness, brain fog, tightness in ears, left ear seems to stop randomly. No treatment assigned beyond neck PT that will start 3/31/21. Condition has been experienced for 2 weeks.
53 2021-03-25 fever Shortness of Breath, fever-ish, muscle aches throughout body. Took ibuprofen, but didn't seem to hel... Read more
Shortness of Breath, fever-ish, muscle aches throughout body. Took ibuprofen, but didn't seem to help. Ice packs on forehead and neck. Sleep
53 2021-03-26 sleepiness, fatigue, lethargy, chills Vaccine Friday morning. Saturday no symptoms other than soreness at injection site. Sunday, started ... Read more
Vaccine Friday morning. Saturday no symptoms other than soreness at injection site. Sunday, started feeling lethargic. Took 3hr nap during the day. Went to bed early Sunday night. Early Monday morning,: nausea, chills, diarrhea, violent vomiting. Monday during work day, very fatigued and sleepy. Had to take another long nap by afternoon. Tuesday, back to normal.
53 2021-03-27 chills, fever Fever, body aches, chills
53 2021-03-28 headache for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morn... Read more
for one day only felt like had the Flu: body aches, low-energy, head ache and left arm sore. By morning of 29th felt better
53 2021-03-30 chills, headache, malaise Side effects: Mild chills, headache, joint pain, nausea, feeling unwell, rash and itching, muscle p... Read more
Side effects: Mild chills, headache, joint pain, nausea, feeling unwell, rash and itching, muscle pain, and difficulty breathing.
53 2021-03-30 fatigue, lethargy Feeling very tired; lethargic; This is a spontaneous report from a contactable consumer (patient). A... Read more
Feeling very tired; lethargic; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration, administered in arm right at the age of 53 years old on 15Feb2021 08:45 at single dose for covid-19 immunisation. Medical history included diabetes diabetes and HBP (high blood pressure). No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247) via an unspecified route of administration, administered in arm left at the age of 53 years old on 26Jan2021 09:45 at single dose for covid-19 immunisation. The patient experienced feeling very tired and lethargic. The patient noticed the symptoms about 2hrs after the second dose on 15Feb2021. On the next day 16Feb2021 the symptoms were worse but later that evening all symptoms were gone on 16Feb2021 and the patient was back to normal. No treatment was received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered on 16Feb2021.
53 2021-03-30 headache Severe Dizziness upon standing - On-going (3 weeks) Lightheadedness - On-going Mild Headache - On-g... Read more
Severe Dizziness upon standing - On-going (3 weeks) Lightheadedness - On-going Mild Headache - On-going (Motrin only slightly relieves the pain) Nausea - Periodically Ringing in ears - On going
53 2021-03-30 sweating, chills, fatigue 3/26/2021 @ 0930 hrs, covid 19 dose 1 Pfizer received. 3/26/2021 @ 1430 hrs; sweats, chills, body a... Read more
3/26/2021 @ 0930 hrs, covid 19 dose 1 Pfizer received. 3/26/2021 @ 1430 hrs; sweats, chills, body aches, fatigue, dizziness, nausea, possible siezure or stroke while driving on I-10; weight loss, loss of appetite, hypertension/hypotension, 3/27/2021 - sweats, chills, body aches, fatigue, dizziness, nausea, weight loss, loss of appetite, hypertension/hypotension 3/28/2021 - sweats, chills, body aches, fatigue, dizziness, nausea, weight loss, loss of appetite, hypertension/hypotension 3/29/2021 - sweats, chills, body aches, fatigue, dizziness, 3/30/2021 - chills, body aches, fatigue 3/31/2021 - body aches, fatigued, dizziness
53 2021-03-30 sweating dizziness, sweat passed out, seizures
53 2021-03-30 malaise Patient complained of prolong adverse reactions including: Malaise, body aches, not feeling well. Th... Read more
Patient complained of prolong adverse reactions including: Malaise, body aches, not feeling well. The symptoms would come and go over a period from time of vaccine 3/18/21 until 3/29/21.
53 2021-03-30 fever, headache, chills, lethargy Severe headache, extreme cycling between high fever and shivering chills - lasting for about 14 hour... Read more
Severe headache, extreme cycling between high fever and shivering chills - lasting for about 14 hours. Continued lethargy.
53 2021-03-31 fatigue, malaise, influenza like illness Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off... Read more
Very sore arm within 12 hours of 2nd shot on Wednesday March 24th. Woke up the next day feeling "off" and irritated. By 9pm Thursday my entire body ached severely as if I had a very bad flu. By 11pm I had very severe cold & hot shakes and felt extremely nauseous until the next morning. I checked my temp every couple hours and never was I above 98.5 but, I felt extremely sick until about 48 hours after the 2nd shot. On Friday, and for the next 2-3 days, I felt fatigued as if I was recovering from the flu. Only a flu that was without fever or any respiratory issues. By Monday I felt normal again.
53 2021-03-31 fatigue, runny nose, throat irritation completed because of being Tested positive for COVID-19 infection 14 or more days after being fully ... Read more
completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/20/2020.pfizer Lot#EK5730 2nd dose:01/10/21.pfizerLot#EL3248 Diagnosed covid positive: 03/30/21 Exposue:Home Exposure Symptoms:Fatigue, Muscle Aches, Runny Nose,irritation in the throat.
53 2021-03-31 headache, sweating 15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness.... Read more
15 minutes after receiving vaccine, client began c/o headache, flushing, diaphoresis, and dizziness. Vital signs were obtained. BP was elevated. Client given oral Benadryl after c/o itching. No rash noted. Obtained VS every 15 minutes while monitoring for 45 minutes post Benadryl administration. VS stabilized. Client stated he was feeling better and was released home with spouse driving.
53 2021-03-31 throat irritation This nurse was called to the monitoring area to assess a patient. Patient was sitting in chair AAO x... Read more
This nurse was called to the monitoring area to assess a patient. Patient was sitting in chair AAO x 3. Stated he felt like his heart was racing and he felt dizzy. RN obtained VS: 158/100, HR 142, pulse ox 98%. This nurse informed patient EMS was going to be called. Patient reports a PMH of COPD and Htn. Stated he did not take his medications this morning which included Lisinopril. He was concerned the medications would interact with the vaccine. Patient had dose #1 of Pfizer Covid vaccine (Lot # EN6207, exp. 7/31/21). Patient was slightly diaphoretic. VS reassessed: BP 160/98, HR 131, pulse ox 99%. Patient denied any chest pain or tightness, no difficulty breathing. Patient reported feeling his throat was itchy. Stated he felt hard to swallow. At that time, this nurse advised she was going to administer the epi-pen. Patient refused. Stated he wanted to wait. Symptoms did not subside. Nurse offered Benadryl to which patient agreed. EMS arrived. They stated they would administer the Benadryl. Final BP was 160/100, HR 114, pulse ox 98%. Patient left without further incident.
53 2021-04-01 fatigue Fatigue starting about 5 hours after the vaccination.
53 2021-04-02 cough Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Cl... Read more
Shot arount 4pm. Couple hours later, a little bit of coughing. Around 8pm, more cough from chest. Close to midnite, wheezing and more cough. Took Xyzal and benadryil. Today (20 hours after the shot), lot of coughing, and weird feeling in chest. May need to goto urgent care today , lets see.
53 2021-04-02 fatigue, fever Fever Diarrhea Fatigue
53 2021-04-02 headache, fatigue Fatigue; Headache; Insomnia; Inability to concentrate.
53 2021-04-04 headache General body aches, mild headache, mild pain behind eyes.
53 2021-04-04 sweating a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered... Read more
a few minutes after receiving the vaccine, the patient became flush and lightheaded. He was lowered to the floor where he never went unconscience, but did get very pale and sweaty. His blood pressure was low at 99/60. He reported he had not eaten. He was given glucose tabs and after 15 minutes began to feel better. he drank water and was observed for 30 minutes. He did not report this had happened previously, but did say he did not like needles or blood.
53 2021-04-04 fever, headache Headache(migraine) & Fever 48 hours
53 2021-04-05 fatigue, chills, fever Fever, chills, fatigue, nausea and rash on left leg.
53 2021-04-07 fatigue Tired, arm pain, cold, dizzy
53 2021-04-07 fever, chills, headache Chills, fever, extreme head ache, insomnia, body aches
53 2021-04-07 fever Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvdi... Read more
Placed follow up called on 4/5/2021 at 1:25pm: Patient reported he is still feeling warm since rcvding 2nd dose on 4/1/2021. Patient also reported on 4/4/2021 there's a sore on the outside of his mouth, and this morning 4/5/2021 the tip of his tongue is red and there is a sore inside his mouth (reporting that there's discomfort inside his mouth when he consume something hard or drink hot beverages). Patient reported on 4/1/2021 in the evening he had high fever (temp 101.9 degree) that occured through Friday morning (4/2/2021), he reported taking Tylenol one time on 4/1/2021 evening and then continued to take Tylenol 3 more times on 4/2/2021. Patient reports that his left armpit is still swollen, and has been swollen for 3 days now, there is pain if pressure is applied to the swollen area. For the swelling in the left armpit patient reported taking Aleve one time on 4/3/2021 but that did seem to help with the swelling. Recommend patient to stay hydrated, and to take Tylenol as need for any fever or pain but not to exceed a dose of 4,000mg per day. Also recommend patient to contact PCP for further evaluation of symptoms. Patient reported will try to get in to see his PCP either 4/5/21 or 4/6/21. Advised will follow up on Wed 4/7/21 after 1pm. Follow up on 4/7/21. Spoke with patient he stated he's feeling a lot better. Fever subsided same day after taking the tylenol. Patient saw PCP on Tuesday 4/6/21 and he was prescribed a steroid. He stated the mouth sores and armpit swelling are 80% better. Patient is overall doing and feeling a lot better. Advised to continue with the medication pcp prescribed and to call if he has any questions or concerns.
53 2021-04-08 headache, fatigue headache; feeling tired; This is a spontaneous report from a contactable consumer based on informati... Read more
headache; feeling tired; This is a spontaneous report from a contactable consumer based on information received by Pfizer. A 53-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy. Concomitant medication included etanercept (ENBREL) taken 50mg weekly for psoriatic arthritis. The patient experienced headache, feeling tired on 18Mar2021. The outcome was unknown. Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained.
53 2021-04-08 headache, fever Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. ... Read more
Slight pain in shoulder several hours after injection. By 7:00 am it felt like I had Covid again. I had a fever of 102.8 cold sweats, muscle aches throughout my body and bad headache. I took recommended dose of Tylenol drank tons of fluids and laid in bed the entire next day. what was mild discomfort in shoulder turned into large pain. after about 12 + hours of Tylenol and fluids the fever broke and was down to about 100.6. As of today (Friday) I am up and about with shortness of breath but no fever and minor aches.
53 2021-04-08 headache At 12:45pm, patient began to have headache. No blurry vision. No N/V/SOB. 7/10 in pain, known to hav... Read more
At 12:45pm, patient began to have headache. No blurry vision. No N/V/SOB. 7/10 in pain, known to have headaches in medical history. Vitals stable 117/52, HR 74, O2 97%, FS 100
53 2021-04-09 fatigue In the last 24 hours and still continuing: Muscle aches Fatigue
53 2021-04-09 lethargy Nausea 36 hours, lethargy 48hrs (still), soreness at injection site 36 hours
53 2021-04-09 fever, fatigue, headache Fever (101 Deg F), fatigue, headache
53 2021-04-10 chills, headache, nasal congestion headache, chills, nausea, nasal congestion, increaced frequency for unrination and bowel movement
53 2021-04-10 fatigue, headache 30 minutes after the injection moderate headache. 8 hours after the injection upset stomach and diar... Read more
30 minutes after the injection moderate headache. 8 hours after the injection upset stomach and diarrhea. Next morning after 8 hours of sleep, I felt very fatigued, dizzy, lightheaded. By 11am the morning after the injection, my adverse reactions had subsided.
53 2021-04-10 headache, fatigue, chills, fever Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, som... Read more
Fever (+2 degrees above normal); very strong headache, body aches, chills, fatigue, hot flashes, some chest congestion, could not sleep due to aforementioned. Symptoms began about 12 hours after second dose. Symptoms subsided about 24 hours after second dose.
53 2021-04-10 headache It's been 6 days and I'm still feeling headache slight and I didn't get it until 3 days after still ... Read more
It's been 6 days and I'm still feeling headache slight and I didn't get it until 3 days after still going during this writing.
53 2021-04-11 headache I woke up around midnight with a headache as bad as I have ever had. Symptom lasted for about 12 hou... Read more
I woke up around midnight with a headache as bad as I have ever had. Symptom lasted for about 12 hours.
53 2021-04-12 chills, headache 1) severe chills but no accompanying fever; covered with blankets to provide warmth; chills began to... Read more
1) severe chills but no accompanying fever; covered with blankets to provide warmth; chills began to subside about 8 am on 4/10 and ended by 5 pm on 4/10 2) headache leading to cluster headache event; no other usual triggers present; symptoms included visual aura/tunnel vision, intense ringing in ears, and pressure/throbbing pain in head; treated with ibuprofen and acetaminophen, rest, fluids; symptoms began about 630pm on 4/9 and finally ended about 7pm on 4/10.
53 2021-04-12 headache Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear ... Read more
Facial paralysis/Bell's palsy/lip and tongue paralyzed; Lip and Tongue Paralyzed; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; reports neck, ear & head pain that started on 21Mar2021; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 13Mar2021 between 15:00-16:00 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2016 and ongoing States it started 5 years ago, and it is under control, hypertension from 2016 and ongoing States it started 5 years ago, and it is under control. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 21mar2021, the patient experienced neck, ear & head pain on the left side. On 24Mar2021, the patient experienced facial paralysis, lip and tongue paralyzed the left side of the face, bell's palsy. The patient states that everything started before on sunday then on wednesday he started to get paralyzed on his face. The patient went to the ER on 24Mar2021 and they thought he was having a stroke, so they did a CT and MRI and his brain is fin and Stated that the Neurologist diagnosed him with Bells Palsy. He was admitted to the hospital on 24Mar2021 and discharge 25Mar2021 at 18:00. The patient enquired about getting second shot and he wants to know what is going to happen if he gets the second shot, was it recommended or not recommended. The patient underwent lab tests and procedures which included computerized tomogram: normal on 24Mar2021 brain is fine, magnetic resonance imaging: normal on 24Mar2021 brain is fine. Therapeutic measures were taken. The patient was treated with Acyclovir and Methylprednisolone. The outcome of the events facial paralysis, lip and tongue paralyzed were not recovered and for neck,ear and head pain was recovering Information on the lot/batch number has been requested.
53 2021-04-12 headache Headache, neck, shoulder and chest muscle aches started about 20 hours after the shot along with swo... Read more
Headache, neck, shoulder and chest muscle aches started about 20 hours after the shot along with swollen lymph node in left arm pit.
53 2021-04-12 fever, chills Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked ... Read more
Shaking Chills Body Ache Rapid Heartbeat, my normal is 56-61, during reaction it was 81-88 checked every hour Fever 99-100.1 Treatment: Fluids, Acetaminophen, Rest
53 2021-04-13 chills, fever, sweating, headache Low fever, cold chills, sweats, headache
53 2021-04-13 fatigue Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have,... Read more
Beginning one day after receiving my second dose of the Pfizer vaccine for Covid-19 I began to have, what I perceived as adverse events different from what is listed as common side effects. 1. Slower heartbeat then what I normally run. 2. Slower breathing and respiratory response 3. Very low energy 4. Loss of appetite 5. Abnormally wide fluctuation of blood pressure while not exerting myself. For example, higher blood pressure readings (155/95) with a slower pulse (60). 6. Difficulty relaxing and sleeping
53 2021-04-13 headache PFIZER 1ST DOSE. DIZZY, HEADACHE VERTIGO.
53 2021-04-14 fever, chills Fever up to 101.8, chills, aches.
53 2021-04-14 fever After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After seco... Read more
After first dose, "normal" side effects of extremely sore arm, headache lasting one day. After second dose, fever to 101.5 at 1:00am after receiving shot at 3:00pm previous day. Extreme arm and shoulder pain. Waking up again at 3:00am experienced FULL BODY paralysis. Estimate fever at 103+ but was unable to move to verify. Eyes were in pain and blurry vision. unable to reach phone to call 911. These symptoms lasted 1 hour and son called to check on me and rushed over. Fever was at 101 but immediate does of motrin and then later tylenol, broke fever. Arm remained immobile for full day. Now it is mobile but still painful to lift overhead. All other symptoms subsided.
53 2021-04-14 sleepiness Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21. Aside from some drowsiness ... Read more
Received the first shot of Pfizer Covid Vaccine at 10:00 AM on 3/21/21. Aside from some drowsiness I felt fine the entire day. Then that night I woke up at 2:30 AM with severe pain in my right knee. I was unable to bend the knee or walk for the next 36 hours. After that the pain transitioned to the back of my calf muscle for the next few days. The pain then went back to my knee for a day and then returned to the back of my calf muscle. On 3/30/21 I saw my primary care physician who then sent me to get an ultrasound which determined that the pain in my knee and calf were caused by blood clots (DVT). I was then prescribed Eliquis 5 mg blood thinners.
53 2021-04-15 fatigue fatigue; general muscle and joint aches/soreness; arthritic pain and weakness in hands, especially l... Read more
fatigue; general muscle and joint aches/soreness; arthritic pain and weakness in hands, especially left hand.
53 2021-04-15 headache, chills, fatigue Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle... Read more
Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle aches developing overnight. Fatigue next day (approx 18 through 36 hrs post vaccination), ongoing muscle aches, low body temperature accompanied with chills (96.7-97.7°F) 30-36 hrs post vaccination.
53 2021-04-15 fever, headache, chills Developed radiating pain from shoulder, up side of my neck causing pain in my teeth and jaw. Pain s... Read more
Developed radiating pain from shoulder, up side of my neck causing pain in my teeth and jaw. Pain started at 1700hrs Wednesday and worsened throughout the day Thursday. Headache, painful joints and fever started Thursday. Fever spiked Thursday evening around 1700hrs to 101.4. I had the chills and diarrhea. Sometime between Thursday and Friday the fever broke. As of Friday at 1000hrs, I no longer have a fever or radiating pain into my jaw and teeth . As of Friday at 2120hrs, my joints still ache (especially my knees), I have a slight headache and diarrhea.
53 2021-04-16 fever, fatigue Tiredness, fatigue, sore in the arm, fever
53 2021-04-17 nasopharyngitis, fever I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across ... Read more
I felt weak/drained within about an hour of vaccination on April 16. On April 17 I felt pain across my body at the level of the skin, including on my scalp. I was extremely cold without a fever, but later developed a fever with e a temperature of 100.7. The symptoms subsided at approximately 5:30 PM on the same day.
53 2021-04-17 fever, headache He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested... Read more
He was hungry all the time and when he ate, he noticed there was no taste at all; When he was tested for covid he thought he was feeling hot; lost sense of smell; He was hungry all the time and when he ate, he noticed there was no taste at all; Tested positive/tested for covid; fever; Headache; Symptoms in my throat ; This is a spontaneous report received from a contactable consumer. This 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration at the left arm on 12Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included high blood pressure (Diagnosed more than 5 years ago and is controlled) and diabetes (controlled). Concomitant medications were not reported. On 16Mar2021, the patient had fever, headache and some symptoms in throat. On 18Mar2021, patient was tested positive for Covid19. On 24Mar2021, the patient had lost sense of smell and lost sense of taste. It was reported that he was hungry all the time and when he ate, he noticed there was no taste at all. It was reported that when he tested positive for covid, the doctor gave him an antibiotic and cough syrup. The patient was taking regular medication for blood pressure and diabetes. He had been taking for years and does not fell it is relevant. Now he is taking a lowered dose of his diabetes medication. When he was tested for covid he thought he was feeling hot but had no temperature when verified. Outcome of fever, headache, symptoms in throat, lost sense of smell, lost sense of taste, covid19 was reported as recovered and outcome was unknown for feeling hot and hunger all the time.
53 2021-04-18 chills Body Chills. Off and on for 16 hours. Body Aches. For 16 hours.
53 2021-04-19 fatigue, fever Muscle aches all over, low grade fever (100), upset stomach, & tiredness. Lasted for 24 hours, then... Read more
Muscle aches all over, low grade fever (100), upset stomach, & tiredness. Lasted for 24 hours, then back to normal
53 2021-04-19 fever Fever for over 24 hours
53 2021-04-20 cough Recent admit for upper GI bleed and pneumonia (3/27/2021 to 4/7/2021), was receiving IV antibiotics,... Read more
Recent admit for upper GI bleed and pneumonia (3/27/2021 to 4/7/2021), was receiving IV antibiotics, seen in the EC 4/15/2021 for cough and not admitted to the hospital, returned to EC 4/19/2021 for cough, now with some tinge and dark blood (streak), discharged home
53 2021-04-21 headache, fatigue Headache Sore arm Nausea Fatigue/Tired
53 2021-04-21 headache Headache, feeling run down
53 2021-04-21 fever, headache Dizzy 2 days and still going on.head ache couple hours .body aches 6to 8 hrs. Fever 2 to 3 hours.
53 2021-04-22 headache Two week later, approximately, I started having real bad headaches. I was having them at least 5 tim... Read more
Two week later, approximately, I started having real bad headaches. I was having them at least 5 times a week. I called my doctor. The headache would last 15 or 20 minutes and then it would go away. Sometimes the pain would wake me up. The headache pain had gone away before I saw the neurologist (the last week of March - maybe the 29th); the doctor had referred me to see a neurologist and they gave me a medication to take: Topiramate. It was a 60 day supply and I'm still currently using it. I have a follow up appt to follow up with neurologist on May 3rd. I've not had the headache symptoms. I had the second dose of the vaccine on January 7th, 2021.
53 2021-04-22 malaise, chills, fever, fatigue, headache Extreme fatigue; achy muscles; chills; 102 degree fever; inflammation under left arm pit; sore joint... Read more
Extreme fatigue; achy muscles; chills; 102 degree fever; inflammation under left arm pit; sore joints; headache; injection site pain; general sick feeling.
53 2021-04-23 headache In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness... Read more
In the late afternoon of April 23rd I started to experience the effects of Bell's Palsy. Droopiness in my lip, eyelid not closing, difficulty in drinking and eating. We went to our local minor emergency center around 4pm and confirmed it was an episode of Bell's Palsy. The Dr prescribed Prednisone and Valtrex. I took the first dose around 6pm. All week long I'd been experiencing a mild headache and had seen the dr the day before. The diagnosis was muscle tension with arthritis in the neck and was assigned to physical therapy.
53 2021-04-24 fatigue, sweating, headache, sinus disorder, chills, fever, dehydration continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and... Read more
continued muscle pain; skin, hair was hurting, couldn't touch skin; muscular pain down to pelvis and knees aching; muscular pain down to pelvis and knees aching; diarrhea; chills; Fever; sweating; inner-skeletal pain; feeling of dry mouth; slight pain at left shoulder where the injection site was at; headache; Fatigue; weakness and dizziness; weakness and dizziness; sinus drainage; feels dehydrated; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in arm left (left shoulder) on 30Mar2021 09:00 (Lot Number: ER8733) at age of 53 years old as single dose for covid-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to events: caller states he don't think so, his father had high blood pressure and diabetes. Concomitant medication included ibuprofen taken for tooth disorder at 600 mg every 8-12 hours, taking it probably a week before receiving the vaccine. No prior vaccinations (within 4 weeks). No events following prior vaccinations. No additional vaccines administered on same date of the Pfizer Suspect. The patient experienced slight pain at left shoulder where the injection site was at on 30Mar2021, chills on 02Apr2021, fever on 02Apr2021, sweating on 02Apr2021, continued muscle pain on 03Apr2021, skin, hair was hurting, couldn't touch skin on 03Apr2021, muscular pain down to pelvis and knees aching on 03Apr2021, diarrhea on 03Apr2021, fatigue in 2021, headache in 2021, weakness and dizziness in 2021, sinus drainage in 2021, feels dehydrated in 2021. The patient was calling to report some long term, severe side effects. He received the Pfizer covid-19 vaccine on 30Mar2021. He didn't have anything then muscle pain for the first two and a half days, no reaction until on Friday 02Apr2021 he had extreme chills, fever, sweating, then that continued on to be muscle pain, his skin and hair were hurting, couldn't touch skin through Sunday 04Apr2021. It dissipated into muscular and inner-skeletal pain. He had muscular pain down to pelvis and knees and things would start aching. Now it was kind of letting up. It was the 4th day now and no one he knows who had gotten it had such a long term reaction to this. Clarified that he had slight pain at left shoulder where the injection site was at and that dissipated on Thursday 01Apr2021 and he had no pain anymore and no other side effects. On Friday 02Apr2021 afternoon when it went haywire and thought he may have to go to the hospital on Sunday 04Apr2021. He had diarrhea and almost had everything on the list except redness at the site injection. He also did not have swollen lymph nodes. He didn't think he needed to go to the hospital, he normally didn't get sick and hadn't been ill for years and this was why he wanted to report it because it seemed that it was pulling for along time. He had been sleeping and drinking a lot of liquids. Headache, joint pain, and diarrhea continued all the way through Monday 05Apr2021 and started to dissipate Monday evening. He had no nausea and vomiting. The muscular pain down to pelvis started Saturday 03Apr2021. His knee would ache and then that would stop and then his other knee would ache then stop. It was like it would transfer around lower part of body, and that dissipated late Monday 05Apr2021 night into Tuesday (06Apr2021). Now he had fatigue was tired and had sinus drainage. He felt dehydrated and couldn't seem to drink enough liquids to get the feeling of dry mouth out. The diarrhea, fatigue and the sinus drainage was still continuing and the other symptoms seem to have dissipated. He still felt so fatigued and didn't feel the other symptoms are there. He hoped they didn't return. It had stayed the same for the diarrhea, fatigue and sinus drainage and he was still tired. Later added he did have weakness and dizziness, but assumed it was fever and chills. Caller states he did have weakness and dizziness and Saturday 03Apr2021 and Sunday 04Apr2021 were the worst two for all of the symptoms at the same time. It had dissipated as of Monday 05Apr2021 evening. Outcome of weakness and dizziness: Caller initially confirmed it had dissipated as of Monday 05Apr2021. However, he later stated he was still experiencing slightness there. He still feels some weakness, and feels about 60% right now. He thought it would be a good idea to get vaccinated because he had family members that had contracted covid-19 and be less weary of the virus. He was hesitant now to get the second shot. He was taking ibuprofen because he had issues with a tooth. He was taking Benadryl for the sinus and hadn't taken it in 36 hours and hadn't taking anything else. He was already taking Ibuprofen for the tooth issue, but was also using it to relieve some of the symptoms and if it was indeed that he may have contracted something after that. He hadn't been to the doctor but for checks ups in years and years. Time of Onset (24-hour clock): Caller stated it started about 1-2 pm in the afternoon on Friday 02Apr2021 and came on very quickly. The events did not require a visit to emergency room or physician office. The outcome of slight pain at left shoulder where the injection site was at was recovered on 01Apr2021. The outcome of diarrhea, fatigue, sinus drainage was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-04-25 fatigue, headache, chills Upset stomach, weakness, tiredness, shivers, headache
53 2021-04-25 throat pain 6 days after 2nd vaccine: 1. Tinnitus - left ear. No treatment. Disappeared after 12 hours. 2. So... Read more
6 days after 2nd vaccine: 1. Tinnitus - left ear. No treatment. Disappeared after 12 hours. 2. Sore tongue, lymph nodes, throat. Gradually subsided after 4 days.
53 2021-04-28 fatigue Tinnitus Nausea Fatigue
53 2021-04-28 headache two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which c... Read more
two days after receiving vaccine arm became really swollen. On day 3 pt. had slight headache which continued. On 4/25/21, headache became worse and on 4/26/21 pt. checked BP and noticed it was rising. On 4/26/21 pt. was sent home from work. Pt. was taken to Urgent Care that evening where BP was recorded as 205/89. Pt. was given unknown shot and instructed to take Ibuprofen. on 4/27/21 pt. followed up with PCP, who prescribed Hydrochlorothiazide daily and Norco prn for pain. On afternoon of 4/27/21 after taking HCT and BP remained elevated at 190/93. Pt. instructed to go to ER. Per wife upon arrival to hospital BP was 129/90. On the morning of 4/28/21 BP was down slightly to 189/90's
53 2021-04-29 chills, fever Chills followed by fever then aches.
53 2021-04-30 fatigue Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from... Read more
Fatigue; Sleeping 10-12 hours most nights; felt cold (not chills); This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm, on 23Mar2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypogammaglobulinemia immunoglobulin A (IGA) (no IGA present in blood). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), and naproxen sodium (ALEVE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) on 25Mar2021 at 09:30. The events were reported as non-serious. The events were described as: The fatigue set in about 36 hours (as reported) after the vaccine and the patient has been fatigued for 6 days. He has been sleeping 10-12 hours most nights and each day gets a little better. He has felt cold (not chills) and so has been wearing additional clothes, blankets at night and turned up heat in the house. The patient did not receive any treatment as a result of the events. The clinical outcome of fatigue, sleeping 10-12 hours most nights, and felt cold (not chills) was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
53 2021-04-30 influenza like illness, fatigue 1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the va... Read more
1. Felt flu-like symptoms (fatigue, weakness, muscle aches) starting around 8:00pm the day of the vaccination. The next morning, after waking and getting out of bed around 6:50am, continued to feel flu-like symptoms. Began feeling light headed and fainted. Fell on bathroom floor and was unconscious for approximately 1-2 minutes. 2. Two days after vaccination (4/23/21 around 7:00pm), developed rash on both feet. Rash improved by next morning and was gone by the day after (4/25).
53 2021-04-30 nasal congestion, runny nose, nasopharyngitis, malaise, head discomfort Congested/stuffy nose; not feeling well; Pressure in the head; Runny nose; a bit of a head cold; Thi... Read more
Congested/stuffy nose; not feeling well; Pressure in the head; Runny nose; a bit of a head cold; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP7534; Expiration Date: 31Jul2021, NDC number: Unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 at 13:30 (at the age of 53-year-old) at single dose for Preventive Care. Medical history included anxiety. Concomitant medications included sertraline taken for anxiety from 2021 (reported as started taking about a week and a half ago to two weeks before 09Apr2021) and ongoing, he also took vitamins but didn't think vitamin c and vitamin d were going to make the list. Patient reported that he was due for second dose of Pfizer BioNTech Covid 19 vaccine on 09Apr2021 but last night (08Apr2021) and this morning (09Apr2021) had a bit of a head cold, and pressure in the head. Patient couldn't make his second dose today (09Apr2021) because he was not feeling well. He was experiencing head cold symptoms now. Patient stated that his runny nose started last night (08Apr2021) around 2100 or 2200 and then he woke up today (09Apr2021) with congestion and a stuffy nose. Patient stated he had not taken anything for it. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional vaccines administered on same date of the Pfizer suspect additional administered vaccines and no prior vaccinations (within 4 weeks). Events were not required a visit to Emergency Room nor Physician Office. No family medical history relevant to AE. No Investigation Assessment and Relevant Tests. No treatment was received for the events. The outcome of the events congested/stuffy nose and runny nose was not recovered, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-04-30 fever, fatigue, chills Fever, chills , extreme fatigue, body aches
53 2021-05-01 fatigue 3.30.21 vasovagal syncope, dyspnea during jiujitsu. General fatigue, thought from vaccine. 4.1.21 s... Read more
3.30.21 vasovagal syncope, dyspnea during jiujitsu. General fatigue, thought from vaccine. 4.1.21 same 4.3.21 same 4.6.21 same 4.8.21 same 4.11.21 same but during boxing 4.12.21 same but during jumping rope 4.13.21 second vaccine Pfizer same clinic at 12:00pm ER2613 4.14.21 same but during boxing 4.15.21 same but during, boxing, jumping rope, and rowing 4.18.21 same but during bike ride and walking 4.19.21 same but during coaching 4.20.21 admitted to ED 4.22.21 diagnosed with third degree heart block and dual chamber pacer fitted 4.23.21 DC
53 2021-05-02 headache Headache,join and muscle pain
53 2021-05-02 malaise Patient received PFIZER vaccine and was in waiting room. He came up to nurse and stated that he was... Read more
Patient received PFIZER vaccine and was in waiting room. He came up to nurse and stated that he was not feeling well as he was stating this, he began leaning over table, then began to fall to floor but was assisted to floor by nurse. Medical alert called. Patient did not bump his head. Patient loss consciousness for about 3-5 seconds, and then began to open his eyes. Patient was able to answer questions regarding his name, the date, and place. Initial vitals (10:00 AM), BP 102/51, HR 55, O2- 96. 2nd set of vitals (10:03 AM) 120/58, HR 84, O2-99. Patient stable and taken to ED via wheelchair.
53 2021-05-03 chills After 18 hours I ( patient) had normal chill/body pain which went away in another 12 hours. However ... Read more
After 18 hours I ( patient) had normal chill/body pain which went away in another 12 hours. However after 70 hours of vaccination, approximately at around 6pm on May 3rd, I have sever rash all over the body. I tried Benadryl and other ani histamines such as Zyrtech / Claritin and saw no remission. At 9am on May 4th, I went to the urgent care where I was given steroids (merit). As of May 4th noon - I still have the rashes. The rashes are red spot all over the body. they are itchy. I do not have any weakness or swollen mouth etc.
53 2021-05-03 cough Heart inflammation When coughing, heart aches.
53 2021-05-03 headache Immediate sharp, non-radiating neck pain after receiving second COVID-19 vaccination. Associated wit... Read more
Immediate sharp, non-radiating neck pain after receiving second COVID-19 vaccination. Associated with headache and weakness. No changes in vision, no chest pain, no syncope. Took ibuprofen 400 mg x1 which provided mild relief.
53 2021-05-03 malaise, sleepiness, fatigue Was ?sick? for 9 days after receiving the Covid shot: Doesn't feel right, Covid Brain, felt like ba... Read more
Was ?sick? for 9 days after receiving the Covid shot: Doesn't feel right, Covid Brain, felt like back of brain was swelling and shaking and would get a head rush when bending over. Felt like he had radiation in his blood like there was amphetamines in it, ?edgy?, fatigue, sleepy. Denies fever or muscle aches. Went to the ER on 4/4 or 4/11 not for sure on date. They didn't do a COVID test and diagnosed him with depression due to his dog dying and divorce.
53 2021-05-03 throat pain Sore throat, COVID symptoms
53 2021-05-04 headache Patient received Moderna Vaccine (lot: 001B21A) on 3/9/21. Patient noted within history form that ... Read more
Patient received Moderna Vaccine (lot: 001B21A) on 3/9/21. Patient noted within history form that he had Pfizer Vaccine as dose #1. Pfizer Vaccine (lot: ER8735) administered as a second dose on 5/5/21. Patient denies any possible Side Effects at time of vaccination. States he had a mild headache on his way to work following 15-minute observation period, which has since ceased.
53 2021-05-04 headache Headache; This is a spontaneous report from a contactable consumer (reporting himself). A 53 -year-o... Read more
Headache; This is a spontaneous report from a contactable consumer (reporting himself). A 53 -year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 26Jan2021 at 12:00 as a single dose for COVID-19 immunization. Patient did not receive other vaccine in four weeks. The patient's concomitant medication included losartan, armodafinil, baby asprin, multivitamin. The patient was not diagnosed with COVID prior vaccination. On 26Jan2021 at 12:30, the patient experienced headache. The patient did not received treatment for the event. The outcome of the event was not recovered. Follow-up attempts are completed. No further information was expected.
53 2021-05-04 sweating, fatigue, headache Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thin... Read more
Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation. Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing. Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230. On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying. He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying. He was very cold, very tired, and not comprehending. Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours. Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now. Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
53 2021-05-04 sweating DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO... Read more
DIZZY, DIAPHORETIC, EYES FLUTTERING, SYNCOPE, SEEN BY PARAMEDICS, BP 171/90 HR 97, BS: 99. PT HAS NO HX OF SYNCOPE, REFUSED TRANSPORT, AMA SIGNED.
53 2021-05-04 sweating Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began ... Read more
Patient stated he felt dizzy after injection. Had the patient take slow deep breaths. Patient began to lightly shake, then patient was unresponsive with blank stare. Pt clammy, pale, and diaphoretic, Pt transferred via w/c and taken to medical monitoring.
53 2021-05-04 throat pain Chest pain; Back pain; The chest and back pain has worsened; Sore throat, like when you get a cold a... Read more
Chest pain; Back pain; The chest and back pain has worsened; Sore throat, like when you get a cold and it's kind of hard to swallow; Came back positive was the inflammation test; Couldn't walk; back inflammation; Diabetes is out of whack; Every joint hurt badly; This is a spontaneous report from a contactable consumer (patient). This 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EW0151), via an unspecified route of administration, on 05Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 vaccination, in left arm. The medical history included: Diabetes. Concomitant medications not reported. The patient reported that he got the first shot on 05Apr2021 and something went wrong. Every joint hurt really bad (From: Apr2021 To: 18Apr2021, duration 17 days), and he couldn't walk. So, he went to the emergency room and the ER people told him he had arthritis and to go home and take Tylenol. He came home, took Tylenol, and then his chest and back started hurting. He went to the doctor and the doctor ran an arthritis test, lupus test, and all these tests, and it came back negative. The only test that came back positive was the inflammation test. He had 3 times the normal amount of inflammation a person is supposed to have. He stated his chest hurts really bad and his back hurts really bad. He keeps going to the hospital and then they keep sending him home. Caller states he is not sure if he's not going to die but all of his other items are out of whack, like his diabetes is out of whack. He can confirm after all the joint pain went away, then the chest and back pain/inflammation popped up. The chest and back pain has worsened. It's worse than yesterday. He has not taken any aspirin or anything. The back pain has worsened. It feels like he did chest exercises. It hurts to the touch. He has back inflammation. Treatment: He clarified that he was instructed to take Tylenol Arthritis and not aspirin. He confirmed he was taking Tylenol Arthritis. No additional details provided. He mentioned that someone told him he could not take Aleve. He does not know what to do and what he can and cannot take also has diabetes and his blood sugar seems to be extremely high, which it never is. They are working on getting his blood sugar under control, but it seems like it's been out of whack for a little bit. He later clarified that he switched medications prior in March and he is on some new stuff and he expected it to be out of whack. He also adds that it's like he has a sore throat but he doesn't have a sore throat, it's like when you get a cold and it's kind of hard to swallow. He explains when arthritis issue/joint stuff cleared up, he had the sore throat, the chest pain and sore throat appeared. It's been 3 or 4 days and it has not gone away. ER Dates - 15Apr2021. Doctor's office - 16Apr2021. Lab tests included: 16Apr2021Test: Muscle enzyme Result: normal; Thyroid test Result: normal; blood cell count result: normal; rheumatoid arthritis test Result: negative; Lupus test Result: negative; Inflammation Marker Blood test Result: High; 3x normal; EKG Result: Fine. The clinical outcome of the event Diabetes is out of whack, chest and back pain has worsened, Came back positive was the inflammation test, Couldn't walk, back inflammation was unknown; Every joint hurt badly was recovered; Chest plates, back pain, sore throat was not recovered. No follow-up attempts are possible. No further information is expected.
53 2021-05-04 fever, fatigue, head discomfort, headache Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower brea... Read more
Strong chest pressure; fluctuating heartbeat; slower breathing and respiratory response; slower breathing and respiratory response; Extreme fatigue; very low energy; Loss of appetite; loss of weight; Abnormally wide fluctuation of blood pressure while not exerting myself; Difficulty relaxing and sleeping; Nausea; dizziness; Stomach pain; diarrhea; Headaches; low grade fever; shortness of breath; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; intense , powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of my head at the cerebellum.; sudden increased heart rates and high blood pressures reading; spikes his heart rate/sudden increased heart rates; intestinal discomfort/strong stomach discomfort; intense chest pressure and some pain; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0151) via an unspecified route of administration in right arm on 09Apr2021 12:30 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, anxiety disorder, known allergies: Clonazepam (KLONOPIN), food allergies: sea bass and orange roughy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date; lovastatin taken for an unspecified indication from an unspecified date; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified date; ibuprofen taken for an unspecified indication from an unspecified date; fluoxetine hydrochloride (PROZAC) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (Pfizer Covid-19 Vaccine, lot number EP7534) via an unspecified route of administration in right arm on 18Mar2021 11:00 AM at age of 53-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was currently 11 days out from receiving his second COVID vaccine and he was still having very strong side effects. This included an emergency room visit on 16Apr2021. He was generally very good health and he exercised regularly including running so these were very abnormal effects for him. Beginning one day after receiving his second dose of the Pfizer vaccine for COVID-19: 1. Strong chest pressure and fluctuating heartbeat. 2. Slower breathing and respiratory response. 3. Extreme fatigue & very low energy (for example, walking up two flights of stairs made him very tired and spikes his heart rate, abnormal for him). 4. Loss of appetite and loss of weight. 5. Abnormally wide fluctuation of blood pressure while not exerting himself. For example, higher blood pressure readings (155/95) with a slower pulse (60) or the opposite scenario, (110/89) elevated pulse 98. 6. Difficulty relaxing and sleeping. 7. Nausea and some dizziness. 8. Stomach pain and diarrhea. 9. Headaches. 10. Low grade fever. As of 26Apr2021, it stated the day after the patient received his 2nd dose of the Pfizer Covid-19 vaccination (10Apr2021 12:00 PM), he began to have side effects which he expected to some extent. However, as of today, he has 17 days straight of side effects or perhaps an adverse event. His symptoms began mildly the day after but suddenly increased greatly within the next couple days and he had been dealing with this ever since. He had made two emergency room visits, seen his general practitioner, and as of today (26Apr2021) a cardiologist who ordered imaging. His symptoms range from, extreme fatigue, nausea, strong stomach and intestinal discomfort, weight loss, shortness of breath, sudden increased heart rates and high blood pressure readings, intense chest pressure and some pain, powerful involuntary shaking of my body that comes in waves, and pressure and pain in the back of his head at the cerebellum. His life was basically come to a screeching halt and he was searching for answers! The doctors he had spoken to were unclear as to what was wrong with him and why. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for the events. COVID tested post vaccination on 17Apr2021 included PCR and Nasal Swab, both showed negative result. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
53 2021-05-04 sleepiness, nasopharyngitis, fatigue, dehydration, chills Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tir... Read more
Arm swollen, pain in arm, cold chills back pain arm pain right toes hurt fatigue could not sleep tired dehydrated sleepy shoulder pain bruising at injection site. Waiting for side affects to subsidize before seeking medical attention
53 2021-05-07 chills, fever Chills; Fever; This is a spontaneous report from a contactable consumer via Pfizer sponsored Program... Read more
Chills; Fever; This is a spontaneous report from a contactable consumer via Pfizer sponsored Program. A 53-year-old male patient received second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Feb2021 at single dose for COVID-19 immunisation at the age of 53-year-old.Medical history was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation. On 06feb2021, the patient experienced chills and fever; the patient was not treated for the events. The outcome of the events was unknown. Follow-up attempts completed. information about batch/lot number cannot be obtained. No further information expected.
53 2021-05-07 fatigue Nausea and fatigue, symptoms faded before 2nd shot
53 2021-05-07 headache The morning after the 2nd shot, I woke to severe tinnitus, hearing sensitivity, headache, earache, a... Read more
The morning after the 2nd shot, I woke to severe tinnitus, hearing sensitivity, headache, earache, and fullness in the ears. I went to my PCP and she said that I had an infection of the middle ear. I took a course of Augmentin. Later, when I sent an ENT, the infection had cleared but the symptoms remained.
53 2021-05-09 throat pain 5 mm purple flat macule on left lower lip edge (non-tender, no symptoms). mild palpitations, upper ... Read more
5 mm purple flat macule on left lower lip edge (non-tender, no symptoms). mild palpitations, upper back pain, and sore throat for a day after vaccination.
53 2021-05-09 fever, headache Fevers and Headache 1d following 2nd dose on 2/25/21. Fevers persisted for 3 weeks. LP showed +VZV P... Read more
Fevers and Headache 1d following 2nd dose on 2/25/21. Fevers persisted for 3 weeks. LP showed +VZV PCR though normal protein, glucose, and WBC. No skin lesions and not immunosuppressed. Treated with 14d of IV acyclovir though headaches and fevers persisted. VZV may have been false positive, though treated regardless. He had 8 weeks of fevers and headaches started 1 day following 2nd dose. Extensive FUO workup has been otherwise unrevealing. Subjectively improved 2 months later.
53 2021-05-10 fatigue, fever I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to t... Read more
I had Covid-19 back in December 2020. On the 10th day I ended up in the hospital for 3 days due to the start of Covid pneumonia. It took me two months to finally feel 100%. I had my 2nd vaccination shot on Friday 5/7/21, I was sick Saturday with a fever of 101.5 and joint pain in fingers, hands and knees and slept all day. The adverse event happened on Sunday. I was still very tired during the day but no fever and felt like I was in a fog. Sunday evening went to bed at 9:30pm woke up at 11:30pm with uncontrollable body tremors. The tremors were muscular twitches from my neck to my feet. Everything was twitching at once. My fiance took my temperature and it was 97.5 so no fever when it started but after 45 minutes of tremors I started burning up, she took my temp again and it was 103.5. She wanted to call 911 or take me to the emergency room but I didn't want to go at that point. I took a baby aspirin thinking about possible blood clots and then 30 minutes later took 2 Tylenol to bring down the fever. The tremors finally stopped and the fever went down to 101. It took me a while to fall asleep and the next morning I woke up still tired and called out of work and slept all day again.
53 2021-05-10 headache, malaise, fatigue This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162... Read more
This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (COVID-19 VACCINE, lot number: EN6203; expiration date: Jun2021), dose 1 via an unspecified route of administration on 27Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included ongoing lyme disease. There were no concomitant medications. The patient went through post- vaccination especially because he has Lyme disease. He has had this pre-existing autoimmune disease for 8, almost 9 years, he wants to add this information to the database. Caller states the first shot he would say was kind of catastrophic, the second shot, he will go into. Caller states the second shot, he showed up at the military vaccination place locally and they actually declined his ability to get it with them because of his first reaction even though he had the go ahead from his Lyme specialist and primary doctors. Caller states because of this, he went after four weeks instead of three and he went to a high risk clinic to protect him from anaphylaxis. He has received both doses, the first dose was horrendous and the second was quite easy. Caller states no reaction whatsoever with the second, though he still has remaining symptoms. Reporter Details: Caller states his legal name is (Name), he goes by (Name). Caller states he would prefer if company contacted him and also so that maybe they can warn people with autoimmune or Lyme that the first one is going to be kind of rough. Caller states he works with the public. Prescribing Healthcare Professional: Caller states unsure of email address. Caller states the only thing missing off the initial story is that all in all, the second shot was really good. Caller states he does have some very lingering issues still that he is going to be seeing the Lyme specialist about. Caller states the first dose, it's pretty intense. Caller states the second one, he had fatigue and neuropathy from the stupid autoimmune stuff. Caller states there is residual symptoms, but nothing like the initial ones. Caller states what he did was he just jotted some notes down about every third or fourth day up until the second shot just to detail each symptom. Caller states he only wrote about 5 days worth of little sentences. Caller states 27Feb2021, the first dose, it was a Saturday so by Monday 29Feb2021, it started with itching, burning rashes, so like a visible rash on his chest with raised bumps, neuropathy- shooting pains in his fingers and toes that feels like bugs are crawling all over him, headache, fatigue, and dizziness. Caller verifies all of these symptoms actually began on 01Mar2021. Itching, burning rashes: Caller states he would say they lasted about 2-3 weeks because he went to the walk-in to have them check and called his primary doctor and went into his primary and had him check. Caller states it ended sometime in Mar2021 and he has recovered completely. Neuropathy: Shooting pains in his fingers and toes: Caller verifies it began 01Mar2021. Caller states he would say he still has about 20% left. Caller states it is hard to sleep at night because he still gets itching and burning and stuff. Caller states it is persisting, but certainly not as bad. Headache: Caller verifies it started 01Mar2021. Caller states it ended Mar2021 and has recovered completely. Fatigue: Caller states began 01Mar2021. Caller states this is one of the bad ones he would say. Caller states he still, he would like to go for a walk or work out and he barely has the amount of energy to work let alone the others. Caller states he can't workout or walk. Caller states if he goes up and down stairs, he's exhausted. Caller states that's definitely a lasting one. Caller verifies it is ongoing, persisting. Dizziness: Caller verifies it began on 01Mar2021 and is ongoing. Caller states when he walks he literally cannot turn his head quickly or he feels like he's going to throw up or pass out. Caller verifies it is persisting. Caller states he would say about 4 or 5 days later from getting the first shot, this was really interestingly weird, he had mouth sores that wouldn't heal and debilitating malaise and fatigue. Caller states malaise so bad he couldn't get through work, he could barely work. Caller states the mouth sores were so weird. Caller states everything he is telling company he has read about online. Caller states he has had canker sores from low immunity, but this was on the tip of his tongue, either side of the tongue tip, it came and went three or four times through the entire month. Caller states it was like his immune system was on the edge of crashing, then he would sleep a lot more. Caller states he would do whatever he could do to make it come back. Caller verifies this debilitating fatigue is different than overall fatigue that began 01Mar2021. Caller states the debilitating malaise began 04Mar2021 or 05Mar2021. Debilitating Fatigue; Debilitating Malaise: Caller states the debilitating fatigue also began 04Mar2021 or 05Mar2021. Caller states it is acute. Caller states ended sometime in Mar2021. Caller states recovered completely but is still left with some fatigue. Caller states recovered with lasting effects maybe. Caller says the other one, he could barely get up, he could barely work, he literally couldn't function. Caller states the overall fatigue has not left, it's ongoing. Mouth sores that won't heal: Caller states began around 004Mar2021 or 05Mar2021 and stopped sometime in Apr2021, it took about a month. Caller states he recovered completely. Caller states he just wrote what happened down about every 2 days up until 14Mar2021. Joint Pain: Caller states literally every single joint in his body was killing him and felt inflamed. Caller states it began around 03Mar2021 or 04Mar2021. Caller states joint pain is ongoing, but has improved. Air Hunger, shortness of breath upon exertion: Caller states if he went up and down a few stairs, he would breathe almost as if he was having an asthma attack, it was shortness of breath upon exertion and started about four days after. Caller states it began around 05Mar2021. Caller states he actually had it this morning, felt like he just walked up a flight of stairs. Caller states he is very physically fit, so that should not happen. Caller states it's ongoing and has improved. Numb Extremities: Caller states a week later from 01Mar2021 he had numb extremities. Caller states he started being very aware of the fact that his fingers and toes were starting to lose feelings on 08Mar2021. Caller states it resolved within a week on 15Mar2021. Caller states it was a weird sensation that happened for a while but is completely resolved now. Body Temperature Regulation Issues: Caller states two days later, he had body temperature regulation issues. Caller states he was cold when he should have been hot and hot when he should have been cold. Caller states began around 03Mar2021/04Mar2021 and is ongoing, but not terrible, it's probably the least of the issues and has improved. Heart was pounding out of his chest; face was flushed: Caller states a day or two later, his heart was pounding out of his chest and his face was flushed to the point where people were asking if he was okay. Caller states he felt like he got a quick burst of a run and then stood still. His face was visibly red and very aware of his heart beating out of his chest and this is with no exertion. Caller states he was laying on the couch and he could feel his face flush while doing nothing basically. Caller states began 02 or 03Mar2021 and just stopped a week ago around 12Apr2021. He recovered completely, for now, it seems. Caller states he went to (Clinic name) on (Address), he doesn't have the doctors name, it was a walk-in. Caller states they literally said no big deal, it's all side effects of the vaccine, they just said he's fine. Caller states they simply recommended anti-inflammatories, Tylenol, which was smart and he wishes he thought about it. They also recommended Benadryl to stop the reaction. Caller states it was very helpful, the Benadryl really helped a lot. Caller states there was also a good amount of insomnia because of all the symptoms, it would be close to impossible to sleep. Insomnia: Caller states it seemed to get worse, started a week later because it was getting disconcerting to him so he couldn't sleep. Caller states it started 08Mar2021 and have had that on and off with Lyme. Caller states has struggled for years, is ongoing and is persisting. Caller states on 14Mar2021, he couldn't sleep, couldn't get out of bed, completely weak and dizzy, his left leg and quad was spasming like when he had Lyme's, left knee itches, tingles, and burns and that's where he got bit by the tick and that's when he had his symptoms when he was acute. Caller states it resolved within 3 weeks after the initial onset of the shot. Caller states when he had Lyme initially, that's what he experienced, his left knee swelled, burned and itched, his left knee cap. Caller states ended 17Apr2021. Caller states its a situation where some of those are still there because of Lyme and some are gone. Caller states the knee cap stuff and can't get out of bed was gone on 17Apr2021. Caller states he has recovered completely. Caller states he still is weak and dizzy and his left leg and quad are still spasming, but it's better and is improved. Caller states on 20Mar2021, his left knee cap hurt, was twitching and tight, his left toe was numb, felt like something is chewing on his toe with a sensation of worms under the skin and sleep disturbances. Caller verifies the sensation of worms under the skin and something chewing on his toe is all related to neuropathy, which is still there. Caller states he had written down that on 20Mar2021, he was supposed to get his second shot at 1800, but was denied due to side effects he was experiencing and was rescheduled for 31Mar2021 at a local high-risk clinic. Caller states on 22Mar2021, he slept good, but was fairly weak all day. caller states he took a shower mid-afternoon, and couldn't get off the couch. Caller states basically all he did was take a shower and threw himself on the cough the whole day. Caller states he has written that he has the sensation of ants crawling over the top of his back, no desires to go outside, and light sensitivity. Caller verifies the ants crawling over the top of his back was also neuropathy, and he recovered completely within 3 weeks. Light Sensitivity: Caller states throughout the whole thing, had it today and is still ongoing and persisting. Caller states began sometime in Mar2021, its been the whole time. Caller states 28Mar2021, he only slept 6 hours and woke up completely fatigued, could not get out of bed until 2:00 in the afternoon, has a complete loss of appetite, had a drink and 2 eggs and laid down, couldn't move until 1930. Caller states got up, had a nutrition shake, he wasn't desiring solid foods whatsoever, had 100% malaise, fatigue, no appetite, and was dizzy. Loss of appetite: Caller states he has lost 7 pounds since the first shot. Caller states he wasn't really interested in eating. Caller states he has a natural desire to eat and nothing sounded good. Caller states started Mar2021, is ongoing, and has improved. Caller states 31Mar2021, he got the second shot, he had a little bit of irritation, tingling and burning at site and definitely a flushed face throughout the day, almost like a sunburn. Caller states he was joking with clients and said the first shot killed him and the second shot cured him. caller states after the second shot, he is 80% better but can list the remaining symptoms. Caller states what he is left with is fatigue, he does not have any energy to do anything other than work, sleep issues, neuropathy, and dizziness. Dizziness: Caller states the dizziness has been consistent and goes with the sleeplessness, ongoing since Mar2021 and is persisting. Irritation, tingling, and burning at injection site: Caller verifies the irritation, tingling, and burning is at the injection site of the second dose. Caller states it happened within a few hours on 31Mar2021 and resolved within a week on or around 07Apr2021. Covid Vaccine: First Dose: Caller verifies he received the injection in his left arm around 1800. Caller unsure of NDC. Covid Vaccine: Second Dose: Caller verifies he received the second dose on 31 Mar2021. LOT: ER8730, Expiry Date: They didn't write that down so caller unsure. NDC: Caller unsure of NDC. Caller unsure of dosage given. Caller states was given via injection in his right arm around 1300 or 1330. Covid Vaccine: Indication: Caller states first off he owns a business, he did it to be responsible to the public. Caller states he wants his business to appear as safe and compliant as possible. Caller states he definitely was afraid because of the Lyme disease. Concomitant Products: Caller states he made sure he did nothing before purposefully. Test Results: Caller states after the first shot, he went to (Name) family physician, they did a lot of blood work trying to make sure his inflammatory markers weren't going up, to make sure he wouldn't have issues. Caller states the good news was he was great, everything looked normal, there was nothing crazy in the blood work. Caller states they though the shots would have triggered an autoimmune response of Lyme. Muscle/Joint: He reports a bit of muscular/joint pain in the area where the shot is, if he goes to reach The outcome of the event "itching, burning rashes, like a visible rash on his chest with raised bumps", "headache", "can't workout or walk", "exhausted", "immune system was on the edge of crashing", "immune system was on the edge of crashing", "face was visibly red" was resolved in Mar2021; the outcome of the event "debilitating malaise" was resolved with Sequel in Mar2021; the outcome of the event "Numb Extremities" was resolved in 15Mar2021; the outcome of the event "mouth sores" was resolved in Apr2021, the outcome of the event "face was flushed" was resolved in 12Apr2021; the outcome of the event "couldn't get out of bed" "left knee itches, tingles, and burns" was resolved in 17Apr2021, the outcome of the event Back disorder was unknown, the outcome of the event "complete loss of appetite", "Joint Pain", "Body Temperature Regulation Issues", "barely has the amount of energy to work let alone the others/Weak" was resolving, the outcome of the other events was not resolved.
53 2021-05-10 headache COVID-19; Headache; This is a spontaneous report from a contactable consumer or other non-HCP. A 53-... Read more
COVID-19; Headache; This is a spontaneous report from a contactable consumer or other non-HCP. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 06Mar2021 as single dose for covid-19 immunization. Patient was 53-years-old at the time of vaccination. The patients medical history and concomitant medications were not reported. On an unspecified date, patient experienced COVID-19 and headache. Patient was given the shot (unspecified) for the headache and was not treated for COVID-19. On an unspecified date (approximately a week after), patient underwent lab tests and procedures which included sars-cov-2 test: positive. Patient mentioned that he was scheduled to get the another shot on 15Apr2021 which was 5 or 6 days ago but he didn't do it. Patient wanted to know that for how long he needed to wait to get the second shot. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
53 2021-05-10 fever DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous repor... Read more
DVT causing Muscle cramps; DVT causing Muscle cramps; fever; chest pain; This is a spontaneous report received from a contactable healthcare professional (patient). A 53-year-old male patient received the second dose of BNT162B2 (lot number: EL9261), intramuscularly in left arm on 03Feb2021 13:00 at single dose for COVID-19 immunisation. Medical history included gout. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EL0142), intramuscularly in left arm on 06Jan2021 13:00 for COVID-19 immunisation. The patient experienced deep vein thrombosis (DVT) causing muscle cramps, chest pain, fever, etc 2-3 weeks after the second dose on 24Feb2021 12:00. Patient did not receive any treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not resolved.; Sender's Comments: Considering a positive temporal association, a causal relationship between the event deep vein thrombosis and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
53 2021-05-12 chills, fatigue CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours... Read more
CHILLS, VERY SHAKY, ANXIETY, VERY TIRED. All began within four hours of injection. Worse 10 hours later Have been persistent the last 48 hours.
53 2021-05-12 chills, fatigue 16 hours after dose (10:15am Tuesday) I was dizzy and felt 'off balance'. This lasted for approxima... Read more
16 hours after dose (10:15am Tuesday) I was dizzy and felt 'off balance'. This lasted for approximately 2 hours. I also endured muscle aches and mild fatigue. 30 hours after dose (10:00pm Tuesday) I began getting the 'chills'. This continued most of the night. I woke up at 6am Wednesday morning and my t-shirt was extremely wet with perspiration. The rest of Wednesday and Thursday I have had mild muscle aches and mild fatigue.
53 2021-05-16 chills 8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated ... Read more
8 hours after shot I became nauseous. Was shaking, major chills, 2 large hives on face, accelerated heart beat and had little bit issue breathing. Took benadryl. Started feel good after 20 minutes
53 2021-05-16 fatigue, headache, fever Slight fever, fatigue, breathlessness, body aches, headache started approximately 24 hours after inj... Read more
Slight fever, fatigue, breathlessness, body aches, headache started approximately 24 hours after injection and lasted for approximately 24 hours
53 2021-05-16 fatigue, headache fatigue, headache, loss of balance, joint and muscle aches
53 2021-05-16 fever, malaise, fatigue Had COVID 19 from July to Oct of 2020. Never had a fever. Received the 1st shot on 04/13/2021 with n... Read more
Had COVID 19 from July to Oct of 2020. Never had a fever. Received the 1st shot on 04/13/2021 with no issues. Received 2nd shot on 05/04/2021 and 12 hours later (in a matter of an hour) went to 101 and felts sick. Fever went away in like six hours and felt tired for the next 48 hours. Just reporting so that folks can be track/see trends for the future.
53 2021-05-17 fatigue, headache, sweating My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extre... Read more
My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My lower extremities, from the knee down, are weak and sometimes it is hard to walk.; My knees also hurt; Dizziness; Skin was very pale and cold to the touch.; Profuse sweating.; Fatigue; Muscle Pain; Fainting 9 hours after administration; I had my first headache.; I had pins and needles in fingers 4 and 5 in the arm of vaccine administration; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 11:30 (Lot Number: EW0170), at age of 53 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took asparagus for Allergy. Reported Event: Immediately after the vaccine, I had pins and needles in fingers 4 and 5 in the arm of vaccine administration. 3 hours after vaccine, I had my first headache. Severe headache, dizziness, fainting 9 hours after administration. During fainting episode, skin was very pale and cold to the touch. Profuse sweating. This was on the same day as vaccine administration. For the next 3 days, I laid in bed with fatigue, severe headache, and muscle pain. After 10 days, I still feel weak, I get tired after walking half a mile, and I have episodes of dizziness during the day. My lower extremities, from the knee down, are weak and sometimes it is hard to walk. My knees also hurt. This is still present 10 days after the vaccine. Outcome for events was unknown. Prior to vaccination, whether the patient was diagnosed with COVID-19 Was Unknown, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.
53 2021-05-17 lethargy Lethargy immediately after injection and arm soreness at injection site. Approximately one week late... Read more
Lethargy immediately after injection and arm soreness at injection site. Approximately one week later I experienced left ear infection/fluid in ear causing hearing loss and mild dizziness. Hearing loss, ringing in ear and dizziness are still on-going.
53 2021-05-17 fever, cough 6 hours after receiving 2nd dose, develped a fever (99.8), dizziness, chest tightness (lungs felt co... Read more
6 hours after receiving 2nd dose, develped a fever (99.8), dizziness, chest tightness (lungs felt constricted), trouble breathing, coughing, and very fast heartbeat. Took Tylenol, the next day fever was gone but chest tightness and cough persisted. On 5/11/21 checked into Urgent Care facility because fast heartbeat and chest tightness did not subside. Dr. checked my pulse (at 99 beats) and gave me a PCR test for Covid. Coved test came back negative. On 5/16/21 at 1:00am, chest tightness felt like it was getting worse. Checked into Urgent Care ficility again. Dr. took a check x-ray and EKG. Both came back normal with nothing unusual found. Dr. prescribed Zithromax and Prednisone in case of bacterial infection and the Sterol to help with my breathing.
53 2021-05-20 chills, fever One day after the second dose I got a fever of 100.5, chills, and bodyaches for about 12 hours. Du... Read more
One day after the second dose I got a fever of 100.5, chills, and bodyaches for about 12 hours. During this time I had quite sever pain behind my knees whenever I bent my leg very far. At one moment the pain was really sharp when I bent down to pick something up. This pain behind my knees decreased a few days later, but never totally went away. It is now 6 or 7 weeks later.....and I still have soreness behind my legs, especially when stretching them. Somewhat concerned it is not going away and may get worse.
53 2021-05-21 chills, headache, fatigue 4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset suma... Read more
4/22/21 about 1:55 pm I got the shot, 2:45 got a bad headache, dizzy, feeling flush and upset sumac I left work at 4 pm and when home. around 6 pm i started to get joint pain in my arms, legs and hip. by 730 pm I got the chills, shivers and got extremely tired. I when to bed around 8 pm and woke up around 730 am on 4/23/21. I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21). I don't know if this is related but I would like to provided the information. Prior to the shot my blood press was between 112 to 120/ 70 to 80. after the shot my blood pressure has been 140 to 150/ 80 to 93. am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot from 4/19/21 to 4/22/21. .
53 2021-05-21 paranasal sinus discomfort, cough, fatigue This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in arm left on 08Apr2021 14:30 (batch/lot number EW0153 and expiry date unknown) at 53 years of age as 1st dose, single for COVID-19 immunization in other facility. Medical history included known allergies many but did not react to vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included meloxicam, omeprazole, levocetirizine; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he was quite sick after the 1st dose and he suffered from exhaustion and sleeping 15 to 17 hours a day, and a heavy cough, and a minor sinus pressure, for the first 2.5 weeks after the 1st dose. The patient noticed a very faint high pitch in his ears a few days before the 2nd shot but dismissed it as an aberration. The adverse events were reported serious which caused disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
53 2021-05-21 fever, headache Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days... Read more
Pt states that 10 days ago he had his 1st dose of the Pfizer COVID-19 vaccine. He states that 2 days later he had HA, fever, myalgias, weakness, numbness of the hands and fingers, and abdominal pain that lasted a few days. He states the only sx that has persisted is the weakness and numbness of the hands and fingers. The pt states that his arms and legs are equally weak. Pt reports that today he had a fall due to the weakness today, and he denies any head strike or injuries from this fall. MRI of the brain with and without contrast was done showing no acute intercranial abnormality. MRI cervical spine showing no spinal cord abnormality. And MRI T-spine showing no spinal cord abnormality. Lumbar puncture was performed in the emergency room. Protein was found to be elevated at 109. Glucose was elevated at 134 CSF cell count within normal limits. CSF PCR panel within normal limits. Patient continues to complain of weakness. Lumbar puncture was completed showing a protein elevated at 109 likely representing GBS. MRI brain, cervical spine and thoracic spine showing no structural lesion. At this time we will start IVIG 0.4 g/kg daily for 5 days. Patient will be seen by physical therapy and Occupational Therapy. We will also consult inpatient rehab.
53 2021-05-22 fatigue, fever, chills, headache 1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day afte... Read more
1st day after vaccine. Chills, fever, fatigue, headache, 2nd day- stiff neck, headache. 3rd day after vaccine - left side of face sore, headache, earache. 4thday -Chest pains,- very quick, sharp, very tired, had heart skip/ palpations went to ER @ 11:30pm. Had EKG, blood work, stress test from cardio dept. Followed up with Dr. with cardio dept. received Zio patch Heart Monitor and wore for 2 weeks. Currently waiting the results.
53 2021-05-23 headache Developed headache a few hours after receiving first dose. Over the subsequent days and weeks the he... Read more
Developed headache a few hours after receiving first dose. Over the subsequent days and weeks the headaches worsened. Ultimately presented to ER and was admitted with Subdural hematoma and CSF leak. Required blood patch
53 2021-05-24 headache Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
53 2021-05-25 headache, fatigue Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain ... Read more
Caller reports he had stool that was not fully formed/his stool was liquidy/close to diarrhea; pain in the arm; Double Vision , massive headaches; Double Vision , massive headaches; Achy and tired, like exhausted after the 2nd shot; Pain at the injection site.; achy/He was achy from joint pain; crampy; He was a little achy and had a headache after the second shot; double visions very disorienting; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Injection, Batch/lot number: EWO158, expiration date: Jul2021) at left deltoid, in his shoulder on 28Apr2021 15:00 PM at second dose, 0.3 ml single for COVID-19 immunization. Medical history included overweight. Concomitant medication was none. the patient not received other medications within 2 weeks of vaccination. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of covid vaccine (Lot number: EWO158) at Arm Left on 07Apr2021 15:00 PM for COVID-19 immunization and experienced diarrhea (since the first dose), worst headache of his life, Pain at the injection site, pain in the arm. Patient experienced double Vision and massive headaches, both on 05May2021 10:00 AM. patient had double vision about a week after the second dose of Pfizer COVID-19 vaccine (Also reported about 15 minutes after the 2nd COVID Vaccine, pending clarification), he read many times people saying it could be such neurological and/or blood clotting, reporter asked if people died from the vaccine. Caller stated he is overweight and afraid of this possible side effects affecting him even more than COVID-19 infection. He asked what about bowel movements or gastrointestinal side effects. He has had close to diarrhea for about 2 weeks now, since the first dose. Caller stated he does not have a Physician. Patient also reported the Headache after the 2nd vaccine was on 28Apr2021. patient reported he is getting a call. Never mind caller is letting it go to voicemail. Caller reports he was distracted but, he is better now. Caller reports he does not get headaches or neurological issues at all, usually. But after getting the 2nd shot, about a week ago from yesterday, he experienced double vision for about 15 minutes. When he got the 1st shot, the Monday after, he experienced the worst headache of his life worse than any hang over. He never had neurological issues and it terrified him because could not shake it right away, it lasted for about 15 minutes then it was gone. He asked if that is something that is a side effect that could be concern and should he be worried about it. Caller reports double vision for 15 minutes. He got the shot at about 10 am. This happened after the 2nd shot. He got the second shot on 28Apr2021. Caller confirms his first shot was on 07Apr2021. Double Vision: It lasted for about 15 minutes and he waited until it came back. It was scary. The double visions very disorienting, he couldn't see anything, he could not work, he could not do anything. For the double vision he just waited it out, by shutting his eyes and laying his head down, it did not work the first few moments but then it did. He was a little achy and had a headache after the second shot. He was achy from joint pain. He took Tylenol before he to went bed and the headache went away. After the first COVID vaccine he experienced the worst headache of his life: It was so bad it knocked him to knees he took Tylenol and it went away. Pain at the injections site, pain in his arm: Started right away after getting the 1st shot. He could not put weight on the arm or without feeling a little pain. After 09Apr2021 he did not notice much after that. Caller said he was achy all over after the first shot when mentioning the arm pain. He asked if this is all experimental right. He wants to find out as much as he can because he does not trust anything online or anyone that is why he called the source, which is Pfizer. Online there are reports from people against the vaccine and for the vaccine. Headache after the 2nd vaccine: He was achy, not as bad as the 12th. It went away on 29Apr2021 he took to some Tylenol before he went to sleep on 28Apr2021. and it went away in his sleep. The Tylenol took care of it. Achy and tired, like exhausted after the 2nd shot: Caller reports the event subsided on 01May2021. Gastro Issues: patient reports he had stool that was not fully formed, not diarrhea and not normal but, runny. It was not formed. He is feeling like he has to go after the second shot on 28Apr2021. It has not subsided yet, it is still kind of going right now. He is not rushing to the bathroom every 5 minutes, but its not comfortable, so its improved since the first time, he was very crampy and his stool was liquidy and now it is more solid, it is slightly improving. 1st Pfizer COVID vaccine Lot number: EW0158; zero maybe an O. he confirms both vaccines have the same Lot number as far as he knows. It is the same Lot on both cards he got. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for double Vision. Patient was recovered from double Vision on 05May2021, recovered from headache on 29Apr2021, recovered from Fatigue on 01May2021. Outcome of other events was unknown. It was reported as non-Serious, Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all reported as No. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-05-25 headache Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like s... Read more
Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips/ Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Bell's palsy-like symptoms: left eye lid drooping, numbness in left check, lips; Left eye pain and dryness; Left eye pain and dryness; Headache behind eye; Left shoulder, arm hand numbness and tingling/ Left leg numbness and tingling; Elevated blood pressure; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 53-years-old, intramuscular in left arm on 22Apr2021 at 14:00 at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient has no known allergies. It was unknown if the patient has COVID prior to vaccination. Concomitant medication included macrogol 3350 (MIRALAX). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 53-years-old, via an unspecified route of administration on 26Mar2021 at 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a pharmacy/ drug store. On 25Apr2021, the patient experienced Bell's palsy-like symptoms: left eye lid drooping and numbness in left check and lips. He also experienced left eye pain and dryness; headache behind the eye; left shoulder, arm, hand, and left leg numbness and tingling; and elevated blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent lab tests and procedures which included PCR nasal swab for COVID: negative on 15Apr2021 and blood pressure: elevated on 25Apr2021. The outcome of the events was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
53 2021-05-25 runny nose, respiratory tract congestion Muscle or body aches Congestion or running nose CLOSE CONTACT
53 2021-05-26 fatigue, body temperature increased 4/20/2021- I awoke to fatigue, nausea, and a 101.9 temperature. 4/23/2021- After seeing no signs of ... Read more
4/20/2021- I awoke to fatigue, nausea, and a 101.9 temperature. 4/23/2021- After seeing no signs of improvement, I visited my primary care physician, who had blood drawn for tests. Morning of 4/26/2021 ? I was contacted by my primary care physician?s office with results of the blood work. I was referred to a gastroenterologist due to critically high liver enzyme levels. My AST(ASGOT) was shown to be 825. Afternoon 4/26/2021: The gastroenterologist explained that my AST was roughly 40 times higher than normal. He said levels this high could not be caused by hepatitis A, B, C, or Auto-immune hepatitis. More blood was drawn at the gastroenterologist?s office. The results showed: Bilirubin Total of 2.2, Bilirubin Direct of 1.38, Alkaline Phosphate of 360, AST of 1,222, ALT of 2,314, Ferritin, Serum of 737. The gastroenterologist told me to go to the hospital if I developed jaundice or became too fatigued to get out of bed. 4/28/2021? CAT scan. Results were inconclusive. 5/2/2021- Developed jaundice. I spoke with the gastroenterologist?s office and got appointment for 5/4/2021. The gastroenterologist changed his mind and had me admitted to hospital on 5/4/2021. While in the hospital blood was drawn frequently. Peaks levels reached during the hospital stay were as follows: Bilirubin Total of 14.0, Bilirubin Direct of 11.53, Alkaline Phosphate of 346, AST of 1,522, ALT of 2,550. I had an ultrasound and endoscopy performed while in the hospital. The endoscopy looked at my bile duct, liver, and small intestine. Tissue was taken from the small intestine which ruled out celiac disease. Tissue was taken from my liver and biopsied. The gastroenterologist said the liver appeared to have suffered medication induced hepatitis. He said, in his opinion this was caused by the Pfizer COVID-19 vaccine. At the time I was taking no other medicine other than a once a day multi-vitamin. 5/7/2021 I left hospital. 5/18/2021-Latest blood work results: Bilirubin Total of 14.7, Alkaline Phosphate of 369, AST of 268, ALT of 593. Future: I have an upcoming appointment with a hepatologist to determine extent of liver damage.
53 2021-05-28 chills chills; shortness breath; hives on face; dizziness; This is a spontaneous report from a contactable ... Read more
chills; shortness breath; hives on face; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 15May2021 at 11:15 (at the age of 53-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included known allergies: seafood shellfish from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the 1st dose of the Pfizer vaccine, was fine for 8 hours, then had chills, shortness breath, hives on face and dizziness on 15May2021 at 20:00. The patient had shellfish seafood allergies. Last time he had one, that also happened after 8 hours. Therapeutic measures were taken as a result of all events [50mg diphenhydramine (BENADRYL)]. The outcome of the events was recovering.
53 2021-05-29 headache, fever, fatigue severe headache low grade fever extreme tiredness
53 2021-05-30 headache Headaches every day since the first dose. Usually in the afternoon
53 2021-05-30 nasal congestion Swelling of nasal passage and throat. Then swelling of feet, ankles, calves, thighs, genitals, and s... Read more
Swelling of nasal passage and throat. Then swelling of feet, ankles, calves, thighs, genitals, and shortness of breath.
53 2021-06-02 fatigue Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self... Read more
Arm pain; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9766 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 01:15 PM, as a single dose for COVID-19 immunization at hospital. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV, rheumatoid arthritis, asthma, and adrenal insufficiency. The patient did not have any known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021, he experienced arm pain, fatigue, and diarrhea. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unknown date. No follow-up attempts are possible. No further information is expected.
53 2021-06-02 malaise, fatigue He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on f... Read more
He was tired; Felt discomfort; Feel numbness and swelling in his toes and hands/feel a numbness on fingers of hand and feet; Feel numbness and swelling in his toes and hands; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp; Inflammation in the stomach; Abdominal pain; Sometimes his blood pressure increases; couldn't sleep with the symptoms; He was not feeling well; He woke up with inflammation in his fingers and toes; This is a spontaneous report from contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8731 and Expiration date not reported), via unknown route on his right arm on 16Apr2021, (at the age of 53 years) as a 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8733 and Expiration date not reported), via unknown route in left arm on 26March2021, (at the age of 53 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. After the first dose patient had only pain in arm. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced to feel numbness and swelling in his toes and hands, began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensa-tion and transforms into a cramp, he also presents inflammation in the stomach and abdominal pain for which it has already been prescribed with acetaminophen that calmed his symptoms a little, when he gets wet with hot or cold water feels all the discomfort described previously, he had never felt such symptoms, the patient is concerned that sometimes his blood pressure increases. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. The patient states, that the timing was normal, he just had the pain as normal, like everyone else getting the vaccine at that time, but with the second it became stronger, but still common with everyone else. Then he started to feel them with much more frequency. Numbness on fingers of hand and feet: the second dose he felt that, alongside the abdominal pain, he was generally not feeling good. He took Acetaminophen and it decreased, when the medication is active, then he goes back to normal, and it increases. Tingling in back started at the same time. At the time it was like itchiness on the back, at that point he wasn't able to scratch but it was fine, then it became tingling that he was not able to get rid of. Inflammation in stomach started with the second dose. The first dose was no issue, he was feeling the same, second dose he had those symptoms. It increases when he drinks milk and stuff so he would say it's getting worse. Blood pressure rises sometimes: He had felt his blood pressure rise since the second vaccine, but it's normal during the day, it was tested and normal, he gets to exercise, that's fine, he has no issues with blood pressure before the second, but for example, early this morning, 12 in the morning to 6 this morning, he felt it was increasing, and he was tired and stuff. outcome normal, his blood pressure fine during day, he exercises, but he felt it early this morning, felt discomfort, he was uncomfortable and tired and now, normally it's fine, regular pressure. reported. The patient describes the experience as something similar to an allergy to some food that holds up for a long time and feels that its symptoms have increased, the symptoms diminish when performing his normal activities, today he was unable to work because he woke up with inflammation in his fingers and toes. After receiving the second dose of vaccination patient felt all these symptoms, took some medication, Acetaminophen because he was not feeling well, yesterday he couldn't sleep with the symptoms. He would visit his doctor after making the report. Patient was working for a pharmacy for 3.5 years. When asked for consent to contact, the interpreter was no longer on the line. Primary care doctor's declined, caller states he doesn't have a PCP, states he is a tourist now. Card has on the back the date, where vaccine was done, states he didn't take any medication; he is very healthy. He took Acetaminophen, clarifies as he took Tylenol (UPC unknown. Lot: SPA084, expiry is Oct2024; strength is 500mg), verified, and he just appreciates the help. Details for Vaccine Supplemental Form not provided by caller. Patient was working in supermarket with friends, they said they would vaccinate people, so he took advantage. The outcome of the events, numbness localized, feel tingling in his back, stomach inflammation, abdominal pain was not recovered, the event blood pressure increases was recovered on unknown date in 2021, the event couldn't sleep, Feel numbness and swelling in his toes and hands, Began to feel tingling in his back, a sensation that begins as if it were itching becomes a tingling sensation and transforms into a cramp not feeling well, couldn't sleep with the symptoms, inflammation in his fingers and toes, he was tired, felt discomfort was unknown. Product complaint was filled: While providing and AE for the Pfizer COVID 19 vaccine, the caller states he had numbness on fingers of hand and feet: He takes Acetaminophen, later clarified as Tylenol, and it decreased, when the medication is active, then he goes back to normal and it increases. Follow up (26May2021): This is a follow up spontaneous report from contactable consumer. This 53-Year-old female consumer (patient) reported for herself new information included event detail, Batch/lot number was updated
53 2021-06-03 fatigue, headache Fatigue; Mild dizziness; Mlid nausea; Intermittent headache; Body aches; intermittent neck pain, esp... Read more
Fatigue; Mild dizziness; Mlid nausea; Intermittent headache; Body aches; intermittent neck pain, especially on same side as injection site (Left Arm); This is a spontaneous report received from a contactable consumer, the patient. A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in left arm on 17Mar2021 at 13:30 hours (at the age of 53-years) as a single dose for COVID-19 immunisation. The patients medical history included aortic dissection/aneurysm in 2016, hypertension, anxiety/depression. The patient was allergic to latex, artificial sweeteners and artificial cinnamon flavouring agent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients concomitant medications included blood pressure medications (unspecified) and statins (unspecified). The patient received these medications within 2 weeks of vaccination. On 18Mar2021 at 11:00 hours, the patient experienced fatigue, mild dizziness, mild nausea, intermittent headache, intermittent neck pain especially on same side as injection site and body aches (other than injection site). The patient did not receive any treatments for these events. The clinical outcome of the events fatigue, mild dizziness, mild nausea, intermittent headache, intermittent neck pain especially on same side as injection site and body aches (other than injection site) was resolving. No follow-up attempts are needed. No further information is expected.
53 2021-06-03 fatigue with the first Covid shot he got was sick and throwing up; with the first Covid shot he got was sick... Read more
with the first Covid shot he got was sick and throwing up; with the first Covid shot he got was sick and throwing up; tired; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 53-yearsold male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0173), via unknown route of administration in left arm on 04May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included amyotrophic lateral sclerosis from an unknown date and unknown if ongoing, patient has something like ALS or Lou Gehrigs disease, but has not been diagnosed. The patient's concomitant medications were not reported. The patient had no medical history. The patient states that with the first Covid shot he got was sick and throwing up for four days. He was worried about getting second shot because he heard it was stronger. He now feels sick, kind of, not throwing up. He did not file report after the first Covid shot. Confirmed details of being sick as: threw up a lot first day, slept for 17 hours straight, and stayed in bed a total three to four days. He doesnt remember the date on that first Covid shot. He didnt go to the doctor or anything. Two to three hours after he got the first shot the throwing up got to be violent. After that, he was just sick and tired for three to four days. Confirmed he was throwing up for one day only and that he fully recovered on that same day he got the Covid shot. Initially stated he doesnt remember the date he got the vaccine. He guesses it was three weeks before. Dont they say to wait three weeks to get second shot He recovered completely after 4th day and was back to normal self. Commented he has a sickness like does not feel well. No lab tests were done. The clinical outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-06-03 headache Extreme headache; Jaw pain; This is a spontaneous report from a contactable consumer reported that a... Read more
Extreme headache; Jaw pain; This is a spontaneous report from a contactable consumer reported that a 54-year-old male patient that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that his brother received the first dose of Pfizer vaccine and developed extreme headache and jaw pain for 1 week. The outcome of the events was unknown. Information about the lot/batch number has been requested.
53 2021-06-03 malaise Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb... Read more
Whole lip swollen and numb; Whole lip swollen and numb; Nose swollen and numb; Nose swollen and numb/ Some of his cheek under his left eye was numb; Face had swelled/ some of his cheek under his left eye was numb and swelled; Doesn't feel well, sickness like just don't feel well/ feels sick, kind of; This is spontaneous report received from a contactable consumer (patient himself). A 53-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186), via an unspecified route of administration on 25May2021 at 14:10 (at the age of 53-year-old) as a single dose to protect him if he would get the coronavirus/ COVID-19 immunisation. The patient's medical history included has something like ALS (amyotrophic lateral sclerosis) (has not been actually diagnosed. Doesn't have anything to do with his lip swelling and nose going numb). No new meds, not anything new eaten, no new detergents. Noting was different other than he got the shot. Has medical conditions but doesn't have anything to do with swelling in lips or face. Patient states he has something like ALS or Lou Gehrig's disease, but has not been diagnosed. It has nothing to do with the swelling or lips turning numb. Concomitant medications were reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 04May2021 (at the age of 53-year-old) as a single dose for COVID-19 immunization and experienced throwing up four days, sick for four days, slept for 17 hours straight and stayed in bed a total three to four days, tired. Family medical history relevant to adverse events was none. The patient did not administered additional vaccines on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. It was reported that, patient was calling about COVID, the Pfizer shot, the second Pfizer COVID shot. Had gotten the shot on Tuesday, 25May2021 at 14:10. Noticed yesterday (26May2021) around 2'clock half of his lip was swelled, and some of nose, and left side of face, cheek, under eye. As time went on it spread. He later clarified it was more around 14:30 after the 24hr period. He noticed his face had swelled, spread over time, and started with his upper left lip. His wife noticed that. Some of his nose was numb and swelled and some of his cheek under his left eye was numb and swelled. It went to other side of his lip, swelled and numb, and his nose was swollen and numb. Both lips are swelled and numb. He went to doctor yesterday, to walk in clinic that was in his doctor's office. They gave him a steroid shot yesterday (26May2021) and steroid pills today (27May2021). He had just taken his first steroid pill now. Confirmed dates and times, he stated the symptoms started after the 24-hour period. Whole lip swollen and numb: Big enough as of right now, that upper lip covers bottom lip, don't even see the bottom lip. Commented he has a sickness like does not feel well. He now feels sick, kind of, not throwing up. No investigation assessment. No relevant tests. No tests performed. Went to walk-in clinic downstairs from doctor's office. The doctor though his symptoms were from the shot and he got a steroid shot and steroid pills. The adverse events required a visit to physician office. The adverse events did not require a visit to emergency room. The outcome of the events was not recovered. Follow-up attempts needed. Additional information has been requested.
53 2021-06-03 fever, chills, malaise Soreness at injection site; Fever (low grade 100.6); Chills; Nausea; Diarrhea; Feeling unwell; This ... Read more
Soreness at injection site; Fever (low grade 100.6); Chills; Nausea; Diarrhea; Feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, high blood pressure, obese and acid reflux from an unknown date. The patient was allergic to penicillin. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) for an unknown indication, Esomeprazole (NEXIUM) for an unknown indication, famotidine (MANUFACTURER UNKNOWN) for an unknown indication and doxycycline(MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unknown date, the patient experienced soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell. The patient did not receive any treatment for the events The clinical outcome of the events soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell were resolving at the time of report. Information about lot number cannot be obtained. No further information is expected
53 2021-06-03 fever, chills high fever that continued to escalate from Friday night until the Following Wednesday. Intense night... Read more
high fever that continued to escalate from Friday night until the Following Wednesday. Intense night sweats, intense chills. So weak I couldn't even walk my own dog. Very frightening.
53 2021-06-04 sleepiness, headache Stomach cramping; Grogginess; Headache; This is a spontaneous report received from a contactable con... Read more
Stomach cramping; Grogginess; Headache; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955), an unspecified route of administration, administered in right arm on 16Mar2021, at 14:45 as single dose for covid-19 immunization at the age of 53 years old. Medical history included sulfa allergy. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced stomach cramping, grogginess and headache on 17Mar2021, at 08:00. The events were reported as severe stomach cramping started the next morning, followed by a headache and grogginess. No treatments were given for the events. The clinical outcome of stomach cramping, grogginess and headache was recovering.
53 2021-06-06 malaise Patient reported feeling ill within hours of injection, saw PCP that day, was sent home, went to hos... Read more
Patient reported feeling ill within hours of injection, saw PCP that day, was sent home, went to hospital by ambulance next day. Patient reported "blood poisoning," received blood transfusion in hospital and spent 3 days in hospital. Patient could not give name of PCP.
53 2021-06-07 headache, sweating Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
53 2021-06-07 headache Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of f... Read more
Diagnosed as Bells Palsy on right side of face. Started on 5/24/21 with headache in right side of frontal lobe, neck pain slightly below right ear, and right side of tongue being numb. Tongue numbness spread to right, interior side of lips over next few days. On 5/28/2021 I noticed paralysis on right side of face (unable to smile on right side, unable to control direction of spit, unable to wink/close right eye (unless while closing both eyes), unable to furrow brow on right side, unable to keep right side of lips closed when trying to hold breath in mouth (air leakage).
53 2021-06-07 headache Headache, facial drooping, numbing sensation, 7:30am
53 2021-06-07 fever At 5:30 am the day following vaccination woke up with severe new unset right flank pain. Went to ED... Read more
At 5:30 am the day following vaccination woke up with severe new unset right flank pain. Went to ED and was found to have a kidney stone on CT scan. Was treated with hydration and Toradol. However, spiked a fever (possibly due to vaccine) and was pan-cultured (blood x2 and urine) and given IV antibiotics for possible UTI/pyelo. Blood and urine cultures were negative and was discharged after overnight observation. Did not have a history of kidney stones before this event.
53 2021-06-11 cough Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath ... Read more
Started experiencing shortness of breath and coughing on May 27, 2021. Noticed shortness of breath as walking up hill. Breathing issues continues to get worse over time. Went to urgent care doctor on June 4th. They said my oxygen level was low and could hear wheezing in chest. They did a chest x-ray and thought I might have pneumonia. Gave me antibiotics. Recommended to see primary care doctor. Went to HCF on 6/7/2021. Saw FNP. She did blood work. Scheduled me for a cat scan on 6/8. Blood tests indicated d-dimer level was high. Cat scan showed pulmonary embolisms in both lungs. Went to hospital.
53 2021-06-11 fatigue, fever These side effects only started from Shot #2 - 100.5 fever started almost 24 hours later, itching m... Read more
These side effects only started from Shot #2 - 100.5 fever started almost 24 hours later, itching my left wrist and right thumb(assuming poison ivy), softball size lump under left arm where I received the shot. Fever lasted 3 days, lump lasted at least 4-5 days before slowly going back down. Extreme tiredness for almost a week+, no interest in doing anything for over a week. Noticed itchy rash upper thigh. Searched other side effects. Appeared to not be poison ivy but "shingles". Went to the doctor to confirm shingles and immediately went on Valacyclovir HCL 1 Gram tablet every 8 hours for 7 days. Rash on upper thigh still quite visible, hoping that goes away. Hand and wrist 100% cleared up.
53 2021-06-13 influenza like illness, fever, headache, chills Initial adverse event was severe sickness the day after the vaccine. I was extremely ill for 3-4 da... Read more
Initial adverse event was severe sickness the day after the vaccine. I was extremely ill for 3-4 days after the vaccine with flu like symptoms. Fever, chills, body aches, head ache. 1-2 weeks after that I developed extreme joint pain in two specific areas. My left index finger knuckle, and my right knee. My index finger had extreme pain, was sensitive to touch, and would lock into position as I slept requiring me to gradually wiggle it (painfully) to gain function in the morning. My right knee became very sore to the point that it was hard to walk my dog, and the knee felt unstable and painful with any twisting or torquing moves. The two conditions persisted for 2 months before worsening. The specific pain moved from the middle knuckle of my index figure to the base knuckle, the pain in my knee also spread to a sharp pain in my ankle, and I developed a specific pain (exact location) in my head that would hurt when I coughed, bent over or clenched (like when peeing). At that point I went to the doctor to be checked out.
53 2021-06-14 headache Nearly constant headache, back of head, almost a buzzing sensation
53 2021-06-16 fatigue Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active... Read more
Breathing Issues, shortness of breath, fatigue, that has gotten progressively worse. I was an active and healthy person and have been unable to do normal activity and exercise since receiving my second vaccine.
53 2021-06-16 fever, fatigue Fever of 102.5, muscle cramps, loss of balance, weakness, tiredness and blurred vision
53 2021-06-16 throat irritation Pt reports 24 hours after receiving the covid vaccine hives developed on her face, lips, eyes & fore... Read more
Pt reports 24 hours after receiving the covid vaccine hives developed on her face, lips, eyes & forehead. Pt reports swelling ti eyes as well. Pt states the hives resolved on there own w/ out using any OTC medication apprx 12 hrs after they appeared. Pt reports an itchy scratchy throat as well. Slightly swollen eyes & scratchy throat & muscle aches were still reported 3 days post vaccination
53 2021-06-17 headache No effects on first shot in left arm for the Pfizer. Second shot had a lot of muscle aches and pains... Read more
No effects on first shot in left arm for the Pfizer. Second shot had a lot of muscle aches and pains especially on the left side and a headache for about a day and a half. Bad enough to miss work.
53 2021-06-18 fever Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer spon... Read more
Fever; It has not worsened but he cannot go to work; This is a spontaneous report from a Pfizer sponsored program (CEP ID: 159558). A contactable 53-year-old male consumer (patient) reported that: A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWO186), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) on 13Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation (reported as because everybody should take it). The patient's medical history and family medical history relevant to adverse event was reported as none. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient previously received flu shot (unspecified manufacturer) on an unspecified date and experienced itches and fever (anytime when he has the flu shot he had a fever). On 14Jun2021, midnight around 01:00, the patient experienced fever and was suffering. It has not worsened but he cannot go to work. He can't make it to work. It was persisting and staying the same. The patient did not receive treatment and stated he was calling to get treatment for fever. The outcome of event fever was not recovered and the outcome of other event was unknown. Information on Lot/Batch number was available. Additional information has been requested.
53 2021-06-18 runny nose, fatigue, headache runny nose, fatigue, severe headache, loose stools for several weeks.
53 2021-06-19 fever, fatigue Starting on 6/6/21, the patient began to have low-grade fevers (usually ranging 100F to 100.4F), mya... Read more
Starting on 6/6/21, the patient began to have low-grade fevers (usually ranging 100F to 100.4F), myalgias, and weakness. This occurred daily for 2 weeks. It is slowly improving without interventions. His symptoms were improved with ibuprofen.
53 2021-06-20 headache, fatigue Nausea, heartburn, tiredness, dizzyness, urge to lay down, slight headache
53 2021-06-21 chills, fever, fatigue I had my injection on June 18. I started experiencing chills, body aches, fatigue on June 20. Yester... Read more
I had my injection on June 18. I started experiencing chills, body aches, fatigue on June 20. Yesterday morning (June 21) I felt even worse and knew I was running a fever. I went to see a doctor. My fever turned out to be high - 100.4 (oral) and I tested positive for Covid. I wish I didn?t take the vaccine
53 2021-06-21 fatigue Bloody stool; patient was very tired/ he got extremely exhausted; This is a spontaneous report from ... Read more
Bloody stool; patient was very tired/ he got extremely exhausted; This is a spontaneous report from a contactable consumer (patient's wife). A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), intramuscular on the right arm on 04Jun2021 13:00 (at the age of 53-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The reporter didn't know the lot number. The reporter called because last night (on 05Jun2021), at 09:00 PM, the patient was very tired and also had a bloody stool. The patient now hadn't gone to the bathroom again. Since that time, he hadn't had the bloody stool, but he got extremely exhausted after having the bloody stool. The reporter stated that the patient was a healthy person, so they needed to look out for any possible side effects once he got the vaccine. The reporter then added that's everything and they were just following up because the instructions that he was given was to reach out to the company if they had side effects and reiterated that the patient had exhausted and blood stool at 9 pm last night. The outcome of the events was unknown. Information about lot/batch number has been requested.
53 2021-06-21 fever Patient presented to the ED on 4/30/2021 for back pain with sciatica. Patient presented to the ED an... Read more
Patient presented to the ED on 4/30/2021 for back pain with sciatica. Patient presented to the ED and was subsequently hospitalized on 5/1/2021 for fever of unknown cause. These visits are within 6 weeks of receiving COVID vaccination.
53 2021-06-22 cough, paranasal sinus discomfort, headache, fatigue The patient is a 53 yo previously healthy male who experienced GBS temporally associated with receip... Read more
The patient is a 53 yo previously healthy male who experienced GBS temporally associated with receipt of Pfizer BioNTech COVID vaccine (lot # EW0162 )13 APR 2021. He denies any illness symptoms such as fever, malaise, cough, URI symptoms, n/v/d in the preceding month. He denies any immediate reaction suggestive of IgE mediated event. He reports his initial only side effect was local site tenderness. Approximately 11 days after receipt he had been playing basketball with his kids during the. day and he noted unusual fatigue that evening, pain in his shoulders/neck, took ibuprofen and went to be early. In the morning (Day 14), his right leg slipped and he fell when standing after getting out of bed. He took a few steps and discovered he had no balance and fell again. Family brought him to ER. He was evaluated but no definitive diagnosis and discharged home. He reports on 29 APR 21 (day 16) he was brushing his teeth and couldn't retain water in his mouth. He noted facial drooping, his speech was affected and he returned to ER. ER eval was inconclusive but he was admitted for further evaluation. after multiple tests including LP he was diagnosed with atypical GBS. He received IVIG and was transferred to hospital. He states he improved dramatically after a few days. He was transferred back to hospital and then to rehab for one week and then discharged home. He reports currently he estimates strength at about 60%. He is continuing to improve but fatigues easily. . ER note 27 APR documents c/o body aches x2 days, cough, weakness, HA, perioral numbness and sinus pressure. Also states family member had URI symptoms. Diagnostics included ECG (1st degree block), CXR, CT head, CBC, Chem, LFT, Trop and COVID-19 which were are WNL. A UA showed 2+ ketones. Dx was viral syndrome or possible side effects from COVID vaccine and discharged home, but placed on isolation due to concern for COVID because of symptoms. ER note c/o oral and extremity paresthesias for this date. Triage diagnosis was vaccine reaction. ER note documents c/o facial droop, eye lid droop, left arm weakness. Neuro exam documents facial droop, unable to lift left arm above head. Diagnostics included plain films left femur and hip, ECG, CT/CTA head, MRI brain, MR venography were normal. Neuro consult did not think was CVA but he was admitted for further eval. Symptoms continued to progress to include increased weakness, DTR 1+ throughout, difficulty managing excretions. LP 01 MAY 2021 was positive for protein and neg for oligoclonal bands, or evidence of infection. He was diagnosed with atypical GBS, started on IVIG, and transferred to hospital. He was transferred back 06 MAY after completing IVIG and then transferred for rehab therapy x1 week followed by discharge home.
53 2021-06-24 head discomfort Tinatus, started slowly then constant ringing, loss of equilibrium, head and ear pressure that will... Read more
Tinatus, started slowly then constant ringing, loss of equilibrium, head and ear pressure that will not go away.
53 2021-06-25 headache Pt reports severe HA and tinnitus on day 6-9 after immunization. Slowly improving since day 9.
53 2021-06-26 cough Have had joint pain in feet, knees, wrists, fingers, elbows, shoulders, ringing in both ears, dry co... Read more
Have had joint pain in feet, knees, wrists, fingers, elbows, shoulders, ringing in both ears, dry cough
53 2021-06-29 chills, fever, headache Chills; Fever; Aches; Headache; This is a spontaneous report received from a contactable consumer, t... Read more
Chills; Fever; Aches; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on an unspecified date at 07:00 (at the age of 53-years) as a single dose for COVID-19 immunisation. The patient's medical histories were reported as heart disease, appendix out, hernia repair and uvula removed. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), ELIQUIS, LIPITOR, lisinopril (MANUFACTURER UNKNOWN), PLAVIX and CLONAZ. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 at 19:00, the patient experienced chills, fever, aches, pains and headache. It was reported that the patient experienced these events for three days. The patient did not receive any treatment for these events. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 19Mar2021 at 07:15 as a single dose for COVID-19 immunisation. The clinical outcome of chills, fever, aches, pains and headache was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
53 2021-06-29 fatigue, chills, headache, fever First 48 hours fever(102); Chills; Headache; Vomiting; Fatigue; Diarrhea; This is a spontaneous repo... Read more
First 48 hours fever(102); Chills; Headache; Vomiting; Fatigue; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 6203) via an unspecified route, administered in Right Arm on 22Feb2021 at 16:30 (53-year-old of age at vaccination) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, known allergies to amoxicillin. The patient's concomitant medications included Emtricitabine, Tenofovir Disoproxil Fumarate (TRUVADA), propranolol (PROPRANOLOL), Olmesartan (OLMESARTAN) and diltiazem (DILTAZEM). The patient had not received any other vaccine in four weeks prior to covid-19 vaccine. The patient did not have covid prior vaccination. On 22Feb 2021, the patient experienced fever (102) for first 48 hours, chills, headache, diarrhea, vomiting, and fatigue. After day two (unknown date in Feb2021) diarrhea and extreme fatigue through day 6. The patient had not received any treatment medication for the resulted events. The patient was not covid tested post vaccination. The outcome of the events was not recovered. No follow up attempts are possible. No further information was expected.
53 2021-06-29 fatigue Slight palpitations and a little dizziness and tiredness.; Little dizziness; Tiredness; This is a sp... Read more
Slight palpitations and a little dizziness and tiredness.; Little dizziness; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and high cholesterol. Concomitant medications were not reported. The patient was allergic to Gluten. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. The patient had received medications within 2 weeks of vaccination, the details of which were not given. The patient experienced slight palpitations and a little dizziness and tiredness on 20Mar2021 at 02:45. The patient did not receive any treatment for palpitations, dizziness and tiredness. The clinical outcome of the events slight palpitations, little dizziness and tiredness were not recovered. Information about lot number cannot be obtained. No further information expected.
53 2021-06-29 lethargy, chills, headache Lethargy; Mild headache; chills; Mild soreness; Restlessness followed; This is a spontaneous report ... Read more
Lethargy; Mild headache; chills; Mild soreness; Restlessness followed; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via unspecified route of administration in the right arm on 16Mar2021 at 09:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. The patient had no medical and known allergic history. Concomitant medication included glucosamine (MANUFACTURER UNKNOWN), one a day for men at the age of 50 plus. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient had experienced mild soreness, 11 hours later at 22:00 severe chills which were strong enough that the patient could not carry a glass of water without spilling it and restlessness followed. On 17Mar2021, next day the patient experienced lethargy and mild headache which continued in the evenings for 2 days. The Patient did not receive any treatment for the events. Event had not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes for the events chills, was recovered on 17Mar2021 at 02:00, lethargy and mild headache were recovered on 19Mar2021, restlessness and soreness were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 fever, chills Freezing chills; Temperature of 101; This is a spontaneous report received from a contactable consum... Read more
Freezing chills; Temperature of 101; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no any allergies to medications, food or other products. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 23:30, the patient experienced temperature of 101 (units unspecified) and freezing chills. Therapeutic measures included Tylenol pm to keep fever down, however did not know if it would have gone higher. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events temperature of 101 (units unspecified) and freezing chills was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
53 2021-06-29 fever very ill; Fever; no energy; nauseous; This is a spontaneous report from a contactable consumer, the ... Read more
very ill; Fever; no energy; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in the right arm on 16Mar2021 at 00:00, (at the age of 53-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 16Mar2021 at 20:00, the patient experienced fever, no energy, nauseous and very ill. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events illness, fever, loss of energy and nauseous was not recovered at the time of this report. Information about lot number cannot be obtained. No further information is expected.
53 2021-07-01 fatigue, headache, chills Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; diff... Read more
Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
53 2021-07-01 fatigue, headache Fatigue; mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A... Read more
Fatigue; mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration, in left arm on 20Mar2021 at 11:15 AM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was reposted as none. Concomitant medication was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 13:00, the patient experienced fatigue and headache. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for events fatigue and headache were resolved on an unknown date. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
53 2021-07-01 throat pain I believe it was allergy related; therefore, the temperature in the area was in the 70s and 50s at n... Read more
I believe it was allergy related; therefore, the temperature in the area was in the 70s and 50s at night. I woke up with a really swore throat which persists for a couple of days and moved down into my mouth. I called the doctor via telehealth and he prescribed an antibiotic and Claritin from the local drug store and I begin to feeling better after 36 hours (took it on Monday night and started to feel better on Wednesday morning).
53 2021-07-04 fatigue unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two ... Read more
unable to breathe, bed ridden with bouts of unconsciousness and severe chronic fatigue for over two weeks along with heart pains and heart palpitations. The inability to breathe and bouts of unconsciousness have subsided with chronic fatigue and heart palpitations still present. I haven't sought medical treatment because I have no insurance and I can't afford it.
53 2021-07-05 fatigue fatigue and nausea
53 2021-07-05 headache The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, ... Read more
The Second shot the next day my lymph nodes swole up as big a baseballs under my arms, hot flashes, uncontrollable shakes on lefts side. But now I am shaking on both sides, short of breath, and headache
53 2021-07-07 headache 2 week after 2nd shot I started having heart palpitations, headaches, shortness of breath, dizzyness... Read more
2 week after 2nd shot I started having heart palpitations, headaches, shortness of breath, dizzyness. I did not associated these symtoms with the vaccine. These symptoms have continued for 2.5 months. Some days they are stronger, somedays less, but have not gone away. Monitoring show PVCs, but stress test and echocardiagram were unremarkable I have not discussed the vaccine as possible cause with any healthcare provider but did not on V-Safe responses.
53 2021-07-08 cough Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, t... Read more
Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cough, breathing difficult, loss of energy was recovered with sequelae. No follow-up attempts are needed. No further information is expected.
53 2021-07-08 fatigue, influenza like illness Swollen lymph node in right armpit; mild flu like symptoms; body aches; fatigue; This is a spontaneo... Read more
Swollen lymph node in right armpit; mild flu like symptoms; body aches; fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 5318) via unspecified route of administration on 26Feb2021 (at the age of 53-years-old) at 13:30 in right arm for COVID-19 immunisation. Medical history of the patient included pancreatectomy (pancreatic tumor (insulinoma) removed in 2016). The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient received a dose of tetanus vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration on 29Jan2021 in left arm within 4 weeks of COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 at 13:30, the patient experienced swollen lymph node in right armpit, mild flu like symptoms, body aches and fatigue for about 12 to 15 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of axillary lymphadenopathy, mild flu like symptoms, body aches and fatigue were reported as recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
53 2021-07-11 fever, fatigue, cough Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade f... Read more
Within 12 hours, I felt tiredness, fatigue, body was weak. I had loss of appetite. Ran a low grade fever. The cough started 2 days after the vaccine was given. With each day, I felt worse, finally on 5/28/2021, I went to the walk in clinic. They took my vitals and wheeled me to the ER. I had a fever of 101.38, elevated heart rate, high BP. nausea with an upset stomach. Several test were run on me at this time. The ER Dr. said I would feel bad for a week or so, and was put off work for 1 week and a half. My cough got worse each day and I kept that cough for about 4 weeks. The ER Dr. said I should follow up with my regular Dr. I seen Dr. 2 different times during the next few weeks.
53 2021-07-12 fever, fatigue, malaise, nasal congestion, throat pain, runny nose, sinus pain Sore throat, Nasal congestion, Sinus pain, Extreme fatigue, Runny nose, feverish, swollen sore tongu... Read more
Sore throat, Nasal congestion, Sinus pain, Extreme fatigue, Runny nose, feverish, swollen sore tongue w/ red streaks. Took Tylenol on day 3 of symptoms Began Zpac 5-day treatment of antibiotics on day 4 of symptoms Took one dose of guaifenesin and on dose of Flonase on day 4 of symptoms I was quite sick for about one week, then slowly recovered in the next week.
53 2021-07-13 fatigue, cough, respiratory tract congestion Developed cough, fatigue, congestion 7/1/21. Symptoms fully resolved by 7/12/21.
53 2021-07-14 cough, influenza like illness, fever, chills 2 days after the vaccine, developed flu like symptoms including vomiting. Vomiting / symptoms laste... Read more
2 days after the vaccine, developed flu like symptoms including vomiting. Vomiting / symptoms lasted for 36 hours. Fever, chills, dizziness, etc lasted for 5 more days. Persistent cough lasted for a month.
53 2021-07-17 cough, chills Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; As... Read more
Breathing Issue/problems breathing; Felt bad/crappy; Got Covid after receiving the Covid vaccine; Asthma; Cough; He got chills; hand is beginning hurt; Height shrank he thinks; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0150 and expiration date was 31Jul2021) via an unspecified route of administration, administered in arm left on 07Apr2021 at 12:00 or 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. Patient did not receive other vaccinations within 4 weeks prior to vaccination. Medical history included diagnosed allergies (allergy shots from 2019 to unknown date), according to the thing he was obese, and carpal tunnel. No family medical history reported. Concomitant medications included unspecified allergy shots for allergies (he had been taking for two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year). The patient did not receive any vaccine prior vaccinations (within 4 weeks). The clinical course of the events was reported as: he got his first dose on 07Apr2021 and six days later he ended up getting Covid. His healthcare provider advised him to wait two months. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. He went to two locations and they did not want to give him the first vaccine. According to the CDC they were not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they did not care and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they did not care what his doctor says and that they know more than him. He figured he would go directly to the manufacturer and see what Pfizer says. Pfizer would know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he would do. He clarified that he got Covid three days after the vaccine dose 1. He needed to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. Height shrank he thought. But he felt crappy for still another week. For another week he was still coughing and having problems breathing which kind of still lingers, he still has it. He had asthma he guessed now. Asthma was what was diagnosed, but now they were saying it might be cardio. Stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they were saying it might not be asthma, it could be cardio. So he was going through tests right now (as reported). With physical activity he got out of breath and the only thing that did help was his inhaler. His inhaler did help him for now (as reported). He thought he missed his second dose in Apr2021. It was three weeks after his first one. Might be the 21Apr2021 or 28Apr2021. Cough came on the second week. It was the week of 12Apr2021. States it was still ongoing, but he had recovered with lasting effects: He stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there. Breathing issue began on unspecified date (as reported). It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he had not done any physical activity. He was trying to avoid it. He stated he did tech support and R and D for a living and Pfizer was really thorough. It was good, but his hand was beginning hurt. He started feeling bad on the 10th. He got chills. Everything happened in April. He was feeling bad until 24Apr2021 or 25Apr2021. Might be even 01May2021. Asthma: He was feeling crappy for about a week and then he started to walk around his backyard and he was having trouble breathing, but he knew he had Covid. It started then, a week after his first effect. It was 15Apr2021 or 17aApr2021. They were possible cardio issue and they were testing but there was nothing concrete. The events were not resulted into emergency room visit and physician office visit, but he did have a tele visit. He did go get tested as well. The outcome of the events asthma, cough was recovered with sequel and the outcome of dyspnoea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807432 similar report from same reporter
53 2021-07-17 headache Tingling in fingers; Headache for a week.; This is a spontaneous report from a contactable consumer.... Read more
Tingling in fingers; Headache for a week.; This is a spontaneous report from a contactable consumer. A 53-years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in left arm on 19Mar2021 at 15:45 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Allergies to medications, food, or other products was unknown. Concomitant medication included Metformin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 20Mar2021, the patient experienced tingling in fingers and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment received for the events. The clinical outcome of the events tingling of extremities and headache was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
53 2021-07-17 headache Loss of taste and smell.; Severe headache.; Loss of taste and smell.; This is a spontaneous report r... Read more
Loss of taste and smell.; Severe headache.; Loss of taste and smell.; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not have allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200 59267-1000) via an unspecified route of administration in the left arm on 02Mar2021 at 11.00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 24Mar2021 at 06.00, the patient experienced loss of taste and smell and severe headache. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events loss of taste and smell and severe headache was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
53 2021-07-17 malaise, cough, chills He got chills; problems breathing; Got Covid after receiving the Covid vaccine; felt bad; missed sec... Read more
He got chills; problems breathing; Got Covid after receiving the Covid vaccine; felt bad; missed second vaccine dose; Asthma; Cough; felt crappy; This is a spontaneous report from a contactable consumer (patient), from Pfizer sponsored program. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0150, Expiration Date: 31Jul2021), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunisation. Time of the vaccination given was 12 or 1:00 PM. The patient's medical history included diagnosed allergies, obese, hand was beginning hurt, carpal tunnel. Concomitant medications include allergy shots started on an unspecified date of 2019 for allergies. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations received within 4 weeks. 3 days later after receiving the Covid vaccine he got Covid on the 10Apr2021 and was diagnosed positive on the 11Apr2021. HCP advised to wait 2 months and start over with the first vaccine. No clinics want to do that. He went to two locations and they don't want to give him the first vaccine. They only want to give him the second dose. He went to the clinic and they were going to give him a second dose, but he was wanting to know if that was ok or if he would have to start all over. Patient wants Pfizers recommendation. He was way past 21 days. The patient stated he would want to start over if they don't know how good the second vaccine was if given that late. Patient was asking that this Pfizers recommendation. According to the CDC they are not allowed to give him three vaccines. He was not asking for three. He had to start over because this happened. They said they don't care, and they would just give him the second. He said he told them no and that his doctor told him that he needs to start again. They told him they don't care what his doctor says and that they know more than him. He figures he would go directly to the manufacturer and see what Pfizer says. Pfizer will know the vaccine better than anyone else, his doctor or the pharmacist. Whatever Pfizer tells him to do, he will do. He had been taking for allergy shots two years or a year and a half because they closed the offices for Covid and then his serum expired so he was going to have to restart again this year, name of shots unknown. Patient was taking Covid 19 vaccine to protect self and family, he doesn't want to die. End date of adverse event lasted until the 20Apr2021 according to the state. But he felt crappy for still another week and gives you ten days quarantine. For another week he was still coughing and having problems breathing which kind of still lingers, he still had it. He had asthma he guesses now. Asthma was diagnosed, but now they are saying it may be cardio. The patient stated he had recovered with lasting effects. He had never had asthma in his life until after the vaccine. Now they are saying it may not be asthma, it could be cardio. So, he was going through tests right now. With physical activity he gets out of breath and the only thing that does help was his inhaler. His inhaler does help him for now. He thinks he missed his second dose in Apr2021. He got chills. Everything happened in Apr2021. Cough Came on the second week. It was the week of 12Apr2021. It was three weeks after his first one. Maybe the 21Apr2021 or 28Apr2021. The patient stated it was still ongoing, but he had recovered with lasting effects. The patient stated he was definitely not recovered. It was not everything so he ok with the rest of the stuff. It was just the breathing that was still there breathing issue began on Mother's Day. It was the first time he noticed it. He went for a bike ride and he felt it again maybe two weeks after and since then he hadn't done any physical activity. He was trying to avoid it. Patient The patient stated he does tech support and for a living and was really thorough. It was good, but his hand was beginning hurt and he had carpal tunnel. He started feeling bad on the 10Apr2021. It started then, a week after his first effect. It was 15Apr2021 or 17Apr2021. He was feeling bad until 24Apr2021 or 25Apr2021. Maybe even 01May2021. He was feeling crappy for about a week and then he started to walk around his backyard, and he was having trouble breathing, but he knew he had Covid. They are possible cardio issue, and they are testing but there was nothing concrete. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 11Apr2021. Description of product complaint of Pfizer Covid Vaccine includes patient clarifies he got Covid three days after the vaccine dose 1. He got the vaccine 07Apr2021. He needs to take a picture with his phone because the sticker was so small. Then 10Apr2021 was when he got Covid. The outcome of the event COVID-19 was resolved with Sequel on 20Apr2021, outcome of events asthma, problems breathing, cough was not resolved, event felt crappy was resolved with Sequel on an unspecified date and unknown for other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021814814 similar report from same reporter
53 2021-07-18 fever, headache The patient received the wrong second dose vaccine. He received a Pfizer vaccine instead of the Mod... Read more
The patient received the wrong second dose vaccine. He received a Pfizer vaccine instead of the Moderna. His wife requested he get his second dose and told the pharmacy it was Pfizer. Unfortunately, we did not verify this and when we processed his vaccine later in the day, we received a message that we couldn't process because it did not match his previous dose which was Moderna. The patient did not report any side effects except a slight fever, a mild headache and soreness at the site.
53 2021-07-19 fatigue A week or two after the second shot I started filling pain in middle of the chest. It was getting be... Read more
A week or two after the second shot I started filling pain in middle of the chest. It was getting better if I was taking an Aspirin. The pain disappeared two weeks later. The pain appeared again three days ago after I swam for 5-10 minutes at the moment I got tired. Now I have the pain occurring from time to time...
53 2021-07-20 fatigue, sleepiness Extreme fatigue and sleepiness. Numbness in 3 right toes and part of foot.
53 2021-07-20 throat pain, respiratory tract congestion Fri night- stomach pain diarrhea Saturday till present--very sore throat and chest congestion with ... Read more
Fri night- stomach pain diarrhea Saturday till present--very sore throat and chest congestion with yellow phlegm. NO FEVER, NO LOSS OF TASTE OR SMELL
53 2021-07-22 paranasal sinus discomfort pressure in sinus cavity which lead to extreme vertigo and nausea; pressure in sinus cavity which le... Read more
pressure in sinus cavity which lead to extreme vertigo and nausea; pressure in sinus cavity which lead to extreme vertigo and nausea; pressure in sinus cavity which lead to extreme vertigo and nausea; This is a spontaneous report received from a contactable consumer (the patient). A 53-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EW0170, expiration date was unknown) via an unspecified route of administration in left arm on an unspecified date (at the age of 53-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208, expiration date was unknown) via an unspecified route of administration in left arm on 17Mar2020 11:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. On 24Apr2021 at 02:00, next day after vaccination, patient experienced pressure in sinus cavity which lead to extreme vertigo and nausea. Patient was hospitalized for 2 days. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Patient underwent lab tests and procedure which included SARS-CoV-2 test nasal swab and result was negative on 26Apr2021. Patient was tested for COVID-19 since the vaccination. Patient received Meclazine treatment for the events. Outcome of the events was recovered (resolved with sequel) on unknown date in 2021. Follow-up attempts are completed. No further information is expected.
53 2021-07-22 fever, chills, sweating Lost the 30% of the smell; Loss the 30% of the taste; Fever; Chills; Sweats; Nausea; This is a spont... Read more
Lost the 30% of the smell; Loss the 30% of the taste; Fever; Chills; Sweats; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 15:45 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20 mg from an unknown date for unknown indication. The patient previously received Morphine on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 21:00, approximately six hours after receiving the first vaccine, the patient experienced fever of 102, chills, sweats and nausea. On 23Mar2021, the patient had lost the 30% of the smell and taste that had regained over the last 6 months since having the COVID in Oct/Nov, all the smell and taste had gone again. Now two weeks later and still could not smell or taste. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. On 03Apr2021, the patient underwent nasal swab test for SARS-CoV-2 (PCR) and the result was pending. The clinical outcomes of the events fever, chills, sweats, nausea, lost the 30% of the smell and taste were not recovered at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 2021-07-25 cough Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my... Read more
Within several weeks, I started noticing what felt like heart palpitations that caused me to lose my breath and wheeze/cough. I had called my primary care physician and saw them and said I wanted a visit with a cardiologist. Just one week later, during a work call, it the event happened so severely that I started passing out. Thus, I went immediately to the ER and checked myself in. It was not until mid-July that I got to see a cardiologist, and my symptoms were much less frequent or severe by that time. For several weeks though, it was very uncomfortable and unnerving.
53 2021-07-27 chills Chills began on 7/25 afternoon, then on 7/26/21 in the AM he awoke with swollen lymph node in L unde... Read more
Chills began on 7/25 afternoon, then on 7/26/21 in the AM he awoke with swollen lymph node in L underarm the "size of a tennis ball" and tenderness
53 2021-07-27 cough, nasal congestion Cough and nasal congestion developed on 7/25/2021. Tested positive for COVID on 7/26/2021
53 2021-07-28 headache Strong headache; Feeling like throat was closing; This is a spontaneous report from a contactable ot... Read more
Strong headache; Feeling like throat was closing; This is a spontaneous report from a contactable other healthcare professional. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an Intramuscular route of administration in the right arm on 30Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications were not reported. The patient's past drug history included DK (MANUFACTURER UNKNOWN), since unknown date for an unknown indication. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Apr2021, the patient initially experienced a strong headache but then progressed to feeling like the throat was closing. It was reported that the patient went to urgent care for tx. The events resulted in emergency room or department or urgent care. The clinical outcome of the events strong headache and feeling like the throat was closing was recovering at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
53 2021-07-28 influenza like illness, fever initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper bod... Read more
initial flu like aches; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; gave way to extreme muscle weakness in lower extremities moving to upper body weakness; persistent low grade fever; loss of mobility; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 15:00 (at the age of 53 years) (Batch/Lot Number: EW0191) as a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination. Concomitant medication included ibuprofen (other medication in two weeks). On 06Jun2021 07:00, the patient experienced initial flu like aches which gave way to extreme muscle weakness in lower extremities moving to upper body weakness, persistent low grade fever, and loss of mobility. AE resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 2 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has been tested for COVID-19 since the vaccination (nasal swab) with result negative both on 18Jun2021 and 19Jun2021. Patient has no known allergies. Therapeutic measures were taken as a result of the events. The patient has not recovered from the events.
53 2021-07-29 throat pain Slight swollen/sore throat; Slight swollen/sore throat; This is a spontaneous report from a contacta... Read more
Slight swollen/sore throat; Slight swollen/sore throat; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included slight high blood pressure and medicated for hypothyroidism, under control. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 06:45, morning after second dose, the patient experienced slight swollen/sore throat that started getting better after couple hours. The clinical outcome of the events slight swollen/sore throat was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-01-03 body temperature increased Body aches and joint pain, swollen lymph node on right armpit, temperature of 101'F starting on 1/1
54 2021-01-03 headache Patient received the vaccine and had slight chest tightness, had a slight headache and has mild naus... Read more
Patient received the vaccine and had slight chest tightness, had a slight headache and has mild nausea. He worked the day and still has the symptoms at 1:30 pm
54 2021-01-03 sweating Patient experienced hypotension (systolic 88mmHg), diaphoresis
54 2021-01-04 fever, chills On Jan 1 came down with fever, chills, aches and pain.
54 2021-01-05 fever Fever of 101.6
54 2021-01-06 chills, fatigue Generalized pain, fatigue, chills
54 2021-01-06 chills Diarrhea, NauseaVomiting, chills, injection site pain
54 2021-01-06 fatigue, headache I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later ... Read more
I woke up the morning after the vaccine with a moderate headache. Felt very tired, no energy. Later in the day it seemed as though I had COVID again. Winded very easily, no strength, body aches.
54 2021-01-06 fever Cold sweats, fever of 100, pain the my joints
54 2021-01-08 fatigue, runny nose, malaise pain at injection site, tired, malaise, generalized pain, nausea, runny nose Narrative:
54 2021-01-09 headache, fever Red swollen, burning and itchy eyes 10 hours after dose. Benadryl 50 mg taken. Eye swelling, redn... Read more
Red swollen, burning and itchy eyes 10 hours after dose. Benadryl 50 mg taken. Eye swelling, redness, burning, itchy persisting into the next day. Another dose of medicine taken. Low grade fever, headache, fattier Tylenol 1000 mg taken
54 2021-01-10 malaise, dehydration he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless;... Read more
he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes, lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well, ate a bit but not much, kind of pale, vomiting, trouble in breathing, and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021, after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit, which continued throughout the night. He was having trouble in breathing. Emergency services were called, and they took his vitals and said that everything was okay, but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine, but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up, he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning, he was still agitated. The patient stated that he couldn't breathe, and his mind was racing. The patient's other brother went to him and he was not responsive, and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered, the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away
54 2021-01-10 fever, headache Lymph nodes very enlarged in clavicle area on same side of injection with continued constant pain ... Read more
Lymph nodes very enlarged in clavicle area on same side of injection with continued constant pain Severe headache x2 days fever of 100.3 x2 days
54 2021-01-11 fatigue Fatigue
54 2021-01-11 headache, fatigue Dizziness, Headache, fatigue, soreness at injection site Narrative:
54 2021-01-12 chills Myalgia chills Narrative: missed time from work day following second dose due to above symptoms
54 2021-01-12 cough, fever Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except... Read more
Fever around 101, ache all over, cough and sore left arm. All symptoms were gone in 24 hours except a cough which lingered until Monday 1/11/2021. Vaccine was given on 1/7/2021.
54 2021-01-13 chills, fever Fever and chills started at 1:00 AM the next morning
54 2021-01-13 chills woke up with Mild chills; body aches for 12 hours; This is a spontaneous report from a contactable o... Read more
woke up with Mild chills; body aches for 12 hours; This is a spontaneous report from a contactable other healthcare professional, the patient. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via intramuscular on 06Jan2021 at 07:30 (at the age of 54 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included enlarged prostate from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tamsulosin, Vitamin D-3, Vitamin C, and montelukast sodium (SINGULAIR), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2 with lot number: EH9899 on 16Dec2020 at 16:30, intramuscular in left arm. The vaccine was given at a hospital. On 07Jan2021 at 06:00, the patient woke up with mild chills, and body aches for 12 hours. The patient did not receive treatment for the events. The clinical outcome of mild chills, and body aches for 12 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
54 2021-01-13 fatigue When i woke up in morning to go for pee, I start feeling dizziness, so I set on the toilet seat for ... Read more
When i woke up in morning to go for pee, I start feeling dizziness, so I set on the toilet seat for pee. I don't know what happen and I was lying on the floor with my front head hitting the floor, My wife was trying to revive me . I tried to get up but could not walk to my room and laid down back again on carpet floor, one minute later I tried again but could not gather the courage to laid on the bed and again laid on the bed room floor carpet. My wife gave me water and sprite to drink. I start feeling better and after 10 minutes later i could go to bed for rest. I called my doctor at 9:00AM for the appointment and visited doctor at 2:00PM. he checked and took tests and EKG but all the results came out to be fine.
54 2021-01-13 malaise, headache 1. Within 24 hrs post vaccination 1/5/2021 severe headache, malaise symptoms. 2. 1/8/2021 onset of... Read more
1. Within 24 hrs post vaccination 1/5/2021 severe headache, malaise symptoms. 2. 1/8/2021 onset of severe back pain. 3. 1/13/2021 severe back pain continued, unrelieved by NSAIDS and Acetaminophen. 4. 1/14/2021 non-traumatic rhabdomyolysis possibly due to COVID-19 vaccine diagnosis. Diagnosis was made in hospital Emergency Department.
54 2021-01-13 throat pain Soreness at the injection site and sore throat
54 2021-01-13 fever, headache, chills Patient developed fever and chills to 101 at 0200 on 1/14/21. Headache and neckache.
54 2021-01-16 headache 1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot ... Read more
1. The first 24 hours (date of vaccination 12/29/2020: Minor Pain at the injection site, minor Hot flashes, Moderate Headache (took Tylenol 1 gm po x 2 doses), lack of energy, anxiety. 2. 01/16/2021 @ 20:00: Swallen Lynph node in left armpit.
54 2021-01-17 headache, fever, chills Expected side effects of fever, joint pain, chills, and severe headache. Out of work for 48 hours. ... Read more
Expected side effects of fever, joint pain, chills, and severe headache. Out of work for 48 hours. The issue is that the individual received 2nd dose only 14 days after 1st dose. 1st dose given 12/28/2020 @ 10:40 AM
54 2021-01-18 chills, fever Body Aches, chills, slight fever.
54 2021-01-18 headache, fatigue, lethargy, fever 8 hours post dizziness and lethargy. 12 hours post headache, mild aches, dizziness. 16 hours post ... Read more
8 hours post dizziness and lethargy. 12 hours post headache, mild aches, dizziness. 16 hours post headaches, fever, increased body aches and body pain. 24 hours post continued symptoms plus under arm lymph swelling on left arm only. (same side as injection). 36 hours symptoms lessening, 48 hours post symptoms gone, still very tired. lymph swelling remains but less tender and painful
54 2021-01-18 headache, fatigue, fever Headache, Fever, Nausea, Body aches, tired. Took Tylenol
54 2021-01-18 fever Fever 99.5. Weakness. No other symptoms
54 2021-01-20 fatigue vertigo; Extreme dizziness/ vertigo. To the point of falling.; feel lightheaded; extreme exhaustion;... Read more
vertigo; Extreme dizziness/ vertigo. To the point of falling.; feel lightheaded; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek9231) at single dose at right arm on 07Jan2021 12:00 AM for Covid-19 immunisation, administered at hospital. Medical history included non-Hodgkin's lymphoma, allergy to penicillin. Concomitant medication included amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), escitalopram (ESCITALOPRAM). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced feel lightheaded on 08Jan2021 around 4 pm, extreme exhaustion on 08Jan2021 around 4 pm, vertigo to the point of falling on 08Jan2021 around 8 pm and feel lightheaded, and he was still feel lightheaded, not badly. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae (recovered with lasting effects).
54 2021-01-26 fatigue, chills sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach wit... Read more
sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach without true nausea and loss of appetite; upset stomach without true nausea and loss of appetite; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration on 11Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included hypertension, environmental allergies, and COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), cetirizine hydrochloride (ZYRTEC), and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient experienced sig elevation in previously controlled HTN, chills without fever, extreme fatigue, upset stomach without true nausea and loss of appetite on 11Jan2021. No treatment received for adverse events. The outcome of the events was recovering. Facility type Vaccine was Hospital. No other vaccine in four weeks. The patient was not COVID tested post vaccination.
54 2021-01-27 headache, body temperature increased I woke up around 4am and was running 102 temp and body aches with headache
54 2021-01-27 fever, malaise, headache, fatigue, chills Pfizer-BioNTech COVID-19 Vaccine EUA: injections site pain; tiredness; headache; muscle pain; chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: injections site pain; tiredness; headache; muscle pain; chills; fever; nausea; feeling unwell began at 3am on 1/28/2021. Giving Tylenol.
54 2021-01-28 chills, fever, malaise General unwell feeling, chills,slight fever99,diarrhea
54 2021-01-28 fever, malaise, chills shot at 11 pm 12:30 - achey. and BLURRED vision- could see more than 2 feet in front of me. 3:00- a... Read more
shot at 11 pm 12:30 - achey. and BLURRED vision- could see more than 2 feet in front of me. 3:00- achey blurred vision worse. 7:00 - achey. chills. Overnight. sick chills fever, soo much paing blurred vision. 6 am- could barely walk without clutching furniture . Could not move my injection arm more than 2 inches. Whole body and joints in exrtreme pain. Incapacitated all day. By friday. my body felt better. My vision not as blurry. but by the weekend I was back. I still feel like my vision is not quite back.
54 2021-01-29 fever, chills, cough, malaise, pneumonia 9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache r... Read more
9 days after the vaccination, I had fever 102-103 F with chill, malaise, paresthesia and body ache requiring taking Tylenol alternate with Advil every three hours. I tested for COVID-19 (PCR) and it was negative. Fever continued. On day 6, I went to urgent care center and was tested again with PCR for SAR-CoV-2 virus. The result was again negative. On day 7, I started coughing so I went to Hospital ER and was admitted. Chest X-ray and CT scan of chests showed pneumonia. The COVID-19 PCR test was again done and was negative. Respiratory panel PCR was negative. Mycoplasma titer was negative. I was given steroid and fever improved. I continued to cough until now (1/30/2021)
54 2021-01-31 cough, throat pain, headache, fatigue ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY START... Read more
ON THE THIRD DAY POST VACCINATION PT WOKE UP WITH HEAD ACHE, WEAKNESS, BODY ACHES, THE 4TH DAY STARTED DRY COUGHING , SORE THROAT, ON THE 5TH DAY BEGAN WITH COUGH AND YELLOW SPUTUM. BODY ACHES, FATIGUED
54 2021-01-31 head discomfort Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; ... Read more
Uncontrolled short rhythmic breathing; brief electric shock sensation; little sporadic back spasms; strong head pressure sensation; depression symptoms; This is a spontaneous report from a contactable Other HCP reporting for self. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient received first dose of bnt162b2 on 17Dec2020 09:00. The patient's concomitant medications were not reported. The patient experienced Uncontrolled short rhythmic breathing, brief electric shock sensation and little sporadic back spasms, strong head pressure sensation, depression symptoms currently persistent and decreasing gradually on 09Jan2021. Patient had Nasal Swab on 12Jan2021 with negative result. Outcome of events was recovering. Patient received treatment for all events.
54 2021-01-31 fever, fatigue, headache joint pain; difficulty concentrating; severe fatigue; Headache; body aches; low-grade fever; This is... Read more
joint pain; difficulty concentrating; severe fatigue; Headache; body aches; low-grade fever; This is a spontaneous report from a contactable nurse. This 54-year-old male nurse reported for himself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) at single dose for COVID-19 immunization on 15Jan2021 at 15:45. Relevant history included HTN (hypertension), hyperlipidemia, alopecia, seasonal allergies, obese and covid prior vaccination. Relevant concomitant drugs were unknown. No Known allergies. The patient experienced headache, difficulty concentrating to start followed by joint pain, body aches, low-grade fever, and fatigue on 15Jan2021 at 17:30. The next date the patient had severe fatigue. The next 2 days better when first awake then headache, fatigue after about 4 hours. Treatment therapy for the event was received. The outcome of event was recovering. The patient did not have other vaccine in four weeks. The patient did not have covid test post vaccination.
54 2021-02-01 chills, sweating, fever drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which al... Read more
drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which all lasted for 30 minutes; This is a spontaneous report from a contactable physician reporting for self. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included asthma, covid-19 from an unknown date. Patient received first dose of bnt162b2 on 17Dec2020. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), fluticasone propionate (FLOVENT). On 15Jan2021 22:00, 36 hours after second vaccine patient had diarrhea, then rigors, fever to 102.7, tachycardia to 140 which all lasted for 30 minutes. After it stopped had drenching sweated for another 5 hours and more diarrhea. Fever lasted for 1 hour after taking Tylenol and Alleve. Felt back to normal next morning and fine since. No symptoms now. Outcome of events was recovered.
54 2021-02-02 fever Patient is noticed to have generalized weakness, holding his head towards right side, mild right fac... Read more
Patient is noticed to have generalized weakness, holding his head towards right side, mild right facial puffiness with mild left facial droop, and sent to ER, on 1/22/21. Patient also had mild fever for the last two days and was on Tylenol, blood pressure also remained elevated moderately than the usual readings. Patient was admitted through ER for 2 days and was discharged on 1/24/21, with a diagnosis of possible TIA, Todd's paresis post seizure. Patient's CT head and MRI of brain was negative for acute stroke. Patient's left facial droop and right side facial puffiness resolved over a week but noticed to have right sided pronounced weakness with moderate swelling on right arm. Patient used to eat by himself,but now not able to do so and not able to hold cup in the right hand. Patient was again sent to ER for repeat CAT scan of head, further evaluation and management. Not sure if patient had an adverse reaction to Covid-19 vaccination, but definitely these symptoms were developed after 2 weeks of receiving Pfizer vaccination, which may be coincidental. Patient was followed up by the neurologist a week after the discharge from hospital who couldn't rule out adverse reaction of vaccination. Patient is awaiting for an EEG, carotid ultrasound and Echo as an out patient.
54 2021-02-02 fever Fever & Body aches
54 2021-02-03 body temperature increased, bronchitis, chills, headache, throat irritation He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 ... Read more
He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; sore arm; headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in the right arm on 30Dec2020 14:40 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood cholesterol, both ongoing. The patient received the influenza vaccine on 04Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID), eicosapentaenoic acid ethyl ester (VASCEPA). On 31Dec2020 the patient experienced sore arm and headache with outcome of recovered on 01Jan2021. On 02Jan2021 and 03Jan2021 he felt fine. He had a scratchy throat on Monday 04Jan2021. Tuesday 05Jan2021 he felt like he was getting bronchitis which he got sometimes. Later that evening on 05Jan2021 he had a two degree temperature, chills, and achy muscles. He couldn't get in with the doctor on 05Jan2021, so he had to wait until 06Jan2021 when he went to the respiratory clinic. They did the COVID test on 06Jan2021, but the positive result didn't come back until 07Jan2021. He was just now recovering from it. He had a secondary infection of bronchitis and was given an inhaler.
54 2021-02-03 fatigue Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-yea... Read more
Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), at single dose into the right arm on 22Jan2021 at 09:30AM for COVID-19 immunization. The patient medical history was not reported. On 11Jan2021 the patient had a negative nasal swab covid_test. The patient did not receive any concomitant medications. On 23Jan2021 at 08:00AM the patient experienced tiredness and injection site pain. No treatment was received. The outcome of the events was not recovered.
54 2021-02-03 headache, fatigue, fever injection site pain and swelling; extreme fatigue and tiredness; mild fever (101.1); joint pain; hea... Read more
injection site pain and swelling; extreme fatigue and tiredness; mild fever (101.1); joint pain; headache; and basically feels like a severe case of the flu on the first and second day but improving some on the second day.
54 2021-02-03 headache, fatigue Headache, Myalgia, Fatigue, pain/swelling at injection site Narrative:
54 2021-02-05 chills, fatigue Body aches, fatigue, chills, blacked out
54 2021-02-05 chills, headache Chills, muscle aches, headache, diarrhea
54 2021-02-06 chills, fever, malaise, headache Symptoms: fever, chills, body aches, head ache, malaise. Treated with ibuprofen 200mg and acetamino... Read more
Symptoms: fever, chills, body aches, head ache, malaise. Treated with ibuprofen 200mg and acetaminophen 300mg. First broke fever 38 hrs after vaccination. Mild fever returned within 8 hrs but was managed with acetaminophen.
54 2021-02-06 influenza like illness, fever Fever starting about 12 hours after injection. Flu like symptoms for 48 hours
54 2021-02-08 chills, fever Severe Injection site pain. Fever, Body Aches, Uncontrollable Shivering. Dizziness. On the first d... Read more
Severe Injection site pain. Fever, Body Aches, Uncontrollable Shivering. Dizziness. On the first dose I got these Symptoms at 11:30pm then they subsided by 6:30 am with multiple doses of Tylenol. I was able to return to work the next day. The second night the symptoms returned around 11:00 and persisted until morning. They went away with more Tylenol and all but the injection site pain did not return. On the second dose I had the same symptoms The same night as injection. They did not go away with Tylenol, and continued through the entire next day. Fever never broke. Unable to go to work with fever over 100. All symptoms persisted through the next night until morning when fever finally broke, and I was able to go to work. That night the symptoms return overnight, but were gone in the morning, and all but the injection site pain did not return. It has been 5 weeks since the first injection, and two weeks since my second, and I still have injection site pain and weakness in both of my arms. It is not as severe as the first five days following injection, but still persistent and noticeable.
54 2021-02-09 sweating, headache, chills Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body ache... Read more
Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Restless sleep; Frequent urination; Intense chills and sweats; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:1686 (as reported)), via an unspecified route of administration on 05Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 54 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. On 05Jan2021 at 21:00 the patient experienced intense chills and sweats, multiple body aches including joint pain and headache, restless sleep and frequent urination. These symptoms started approximately 12 hours after injection (clarification requested) and lasted for approximately 14-16 hours. The events were non serious. No treatment was received for the events. The events resolved in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
54 2021-02-10 body temperature increased, headache 24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blu... Read more
24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blurred vision - went to Emergency Services at Hospital, admitted. Reports diagnosis of CVA. Reports headache has improved, continues with blurred vision
54 2021-02-10 headache N/V, dizziness, headache
54 2021-02-10 fever, chills, throat pain, productive cough 1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phl... Read more
1/15: Pfizer vaccine dose 1 administered 1/16: Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes, patient said he gets these symptoms annually, requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test, advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic, so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21.
54 2021-02-11 headache, sweating, chills Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by... Read more
Patient woke up at 3:00 AM freezing and sweating with a bad headache. Chills and sweating stopped by 7:00 AM but slept for a majority of the day due to headache persisting.
54 2021-02-12 headache Headache, redness and pain in right eye. Watery
54 2021-02-12 sweating Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a... Read more
Patient received his first COVID-19 vaccine on 2/12/2021 at approximately 11:30am at clinic. He is a resident there. He was initially monitored for 30 minutes without incident. Approximately an hour later (12:30pm) he returned complaining of sweating, feeling warm (no fever, normal blood pressure) and blurry vision. He was monitored for an additional 30mins (approximately 1pm). Symptoms did not resolve. The facilities manager called EMS and patient was taken to Hospital. No further information available at this time.
54 2021-02-13 fatigue, fever Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fev... Read more
Broke out in hives approximately 1 hour 30 minutes after injection. Severe weakness, body aches, fever, and fatigue began approximately 20 hours after injection
54 2021-02-16 lethargy, fever, fatigue 1. General lethargy/tiredness starting 1 hour after injection, continuing 40 hours. Recovered after... Read more
1. General lethargy/tiredness starting 1 hour after injection, continuing 40 hours. Recovered after 40 hours with no treatment. 2. Moderate fever 12-40 hours after vaccination (max 101F 30-40 hours after vaccination). Fever gone after 40 hours with no treatment. 3. Normal level of muscle pain at injection spot. Still ongoing at 48 hours, but not concerning. 4. Entire upper right arm aches, from neck to elbow, 12-36 hours after vaccination. Mostly recovered after 48 hours. 5. Painful swelling of glands in right armpit, with pain extending ~4 inches above and below armpit. Started ~24 hours after vaccination, still ongoing at 48 hours.
54 2021-02-17 fatigue muscle aches; Fatigue; This is a spontaneous report from a contactable consumer (patient himself). A... Read more
muscle aches; Fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EL3302), via an unspecified route of administration in left arm on 21Jan2021 07:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included hypertension, obesity and had PCN Allergy. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carvedilol (COREG), testosterone, valsartan, fexofenadine hydrochloride (ALLEGRA). The patient experienced muscle aches and fatigue on 22Jan2021. No treatment for the events. The outcome of event was recovering.
54 2021-02-20 fever, chills 12/28/20 I woke up with a fever, chills, body ache. I went and got tested for Covid19. 12/29/20, ... Read more
12/28/20 I woke up with a fever, chills, body ache. I went and got tested for Covid19. 12/29/20, I was informed I tested positive. 3 weeks of rest, over the counter medicine- nightquil, cold ez, Mucinex. Prescription inhaler.
54 2021-02-22 cough, runny nose, upper respiratory tract infection, fatigue received 2nd vaccine on 2/14/21, on 2/16/21 started having cough, nasal drainage, fatigue. Went to u... Read more
received 2nd vaccine on 2/14/21, on 2/16/21 started having cough, nasal drainage, fatigue. Went to urgent care on 2/23/21 and diagnosed with URI
54 2021-02-22 headache, fatigue pain at injection site (5 on 0-10 scale) for first 48 hours. no swelling. Headache at hour 6 (5 on 0... Read more
pain at injection site (5 on 0-10 scale) for first 48 hours. no swelling. Headache at hour 6 (5 on 0-10 scale). ibuprofen 400 mg P.O. overall tiredness for first 48 hours
54 2021-02-23 fatigue Arm soreness at injection site; fatigue; slight muscle aches in neck/shoulders; This is a spontaneou... Read more
Arm soreness at injection site; fatigue; slight muscle aches in neck/shoulders; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318 and expiration date unknown), via an unspecified route of administration on left arm at the age of 54 years old on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunisation at the workplace clinic. Medical history included hypertension and pre-diabetic. Allergies to medications, food, or other products was none. Concomitant medications included metoprolol tartrate, atorvastatin and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced arm soreness at injection site, fatigue, slight muscle aches in neck/shoulders on 26Jan2021 at 05:00 PM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
54 2021-02-23 headache, fever, chills, cough 103 fever, severe chills, body aches, severe headaches, wheezing, coughing (x 48 hours)
54 2021-02-24 fever, headache, chills Covid-19 like symptoms for 28 hours after injection. Chills, headache, muscle ache, fever of 101.7. ... Read more
Covid-19 like symptoms for 28 hours after injection. Chills, headache, muscle ache, fever of 101.7. I had COVID in October and this was as bad as the worst day when I was positive.
54 2021-02-27 headache, fatigue Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left t... Read more
Headache 24 hours after injections Overall tired and weak 48 hours after injection Tremor in left thumb at 48 hours and continues currently at about 72 hours post
54 2021-03-05 fatigue, chills Tired. Chills.
54 2021-03-05 sweating Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and... Read more
Heart started to race, face flushed, sweaty forehead and palms, felt hot. lasted approx 1 min, and slowly went away after 5min or so.... I did not notify anyone.
54 2021-03-08 malaise Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had ... Read more
Couple of episodes of feeling like i was getting sick. lasting a hour or so. (run down, warm). Had a rash brake out. Mainly on torso, some on other body areas. Have been on for 6 days now.
54 2021-03-10 fever, chills, sweating Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes;... Read more
Severe stomach cramps; Severe diarrhea; He felt like he was running a fever; Chills; Sweats; Shakes; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular on 02Feb2021 at around 10:00 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had a family history of dementia. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. About 36 hours after getting the vaccination (unknown date Feb2021), the patient experienced severe stomach cramps, severe diarrhea, felt like he was running a fever, chills, sweats, and shakes. The clinical outcome of the stomach cramps, diarrhea, fever, chills, sweats and shakes was recovered on an unknown date in Feb2021 (symptoms lasted about 18-24 hours).
54 2021-03-14 headache Headache Injection site pain Narrative:
54 2021-03-14 runny nose, fatigue, lethargy I felt tired and had a very runny nose the day after the shot. The 2 following days I felt lethargi... Read more
I felt tired and had a very runny nose the day after the shot. The 2 following days I felt lethargic and very tired but was able to go about my daily routine as expected.
54 2021-03-17 sweating, chills, fever 36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS A... Read more
36 hours after the vaccine, I don't know if it was the vaccine or what, but I had BODY PAIN CHILLS AND FEVER OF 99.08 FOR A DAY OF FEVER. FROM MARCH 15 TO MARCH 16. AND FOR THREE NIGHTS IN A ROW I AM SWEATING A LOT OF WET MY T-SHIRTS AFTER SLEEPING 2 OR 3 HOURS I CHANGE THEM FROM 3 TO 4 TIMES AT NIGHT, IT IS ONLY AT NIGHT NOT IN THE DAY, I NEVER SLEEP IN THE DAY. I'M CONCERNED BECAUSE I HAVE AN APPOINTMENT FOR 03/04/2021
54 2021-03-17 fever, fatigue mild fever ache at injection site day of vaccination, lasting two days. Extreme tiredness that has l... Read more
mild fever ache at injection site day of vaccination, lasting two days. Extreme tiredness that has lasted so far 6 days. I have slept 13 of the last 24 hours.
54 2021-03-18 chills BODYACHES, ARM SORENESS, CHILLS
54 2021-03-18 chills Myalgia Injection site pain, Chills Narrative: Other Relevant History:
54 2021-03-18 fatigue Muscle aches Fogginess Fatigue
54 2021-03-18 headache Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-yea... Read more
Sore arm; headache; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 17Feb2021 15:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously had allergies to topical iodine- produces rash. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 16:00, the patient experienced sore arm and headache. No treatment was received for the events. The clinical outcome of sore arm and headache was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
54 2021-03-19 fever stinging in the eyes, fever
54 2021-03-19 runny nose, fatigue, throat pain, nasal congestion, fever Employee/patient reported symptoms starting on 03-16-2021 with a sore throat, which is now gone. The... Read more
Employee/patient reported symptoms starting on 03-16-2021 with a sore throat, which is now gone. Then went into body aches and low grade fever of 100.4. Now it is more nasal congestion, fatigue, runny nose and sneezing.
54 2021-03-19 throat clearing Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec... Read more
Very soon after I left the parking lot after waiting 15 min for observation ( i was literally 15 sec after ) I started to feel an slight painful tingling in the corner of my mouth on my lips I thought it was like a chapped lip it progressed to my full set of lips and it was tingling and slight painful to touch maybe slight swollen but not a lot I then started to clear my throat and felt like my mouth was very dry like a lump in the back of my throat i was slightly having little difficulty in feeling could not catch my breath and considered going to the closest hospital i was getting a little worried so that may have been the cause of resp issue It started to improve and i drove home and in about 10 to 15 mins all the symptoms were gone and i am symptom free now about 24 hours later
54 2021-03-20 chills, headache Chills. Body Aches. Headaches.
54 2021-03-20 sweating, chills, fever Chronic Diarrhea for five days, fever of 102 degrees, severe chills, sweats, severe abdominal pain, ... Read more
Chronic Diarrhea for five days, fever of 102 degrees, severe chills, sweats, severe abdominal pain, dizziness, horrible side effects like I experienced were not listed on any other website. I am fearful now to schedule a 2nd shot. Please advise, thank you.
54 2021-03-21 chills, throat pain, fever Difficulty bre-athing; Swelling of face and throat; A fast heartbeat. Pt went to the ED where he wa... Read more
Difficulty bre-athing; Swelling of face and throat; A fast heartbeat. Pt went to the ED where he was treated with solu-medrol, pepcid & benadryl and monitored over 2 hrs. He continued to report fever, chills, sore throat, mild to moderate difficulty breathing over the next 2-3 days. He refused further recommendations to return to ED and on 3/20/21 admitted to feeling better
54 2021-03-22 fatigue, chills chills, fatigue, weakness, diarrhea cramping swollen glands
54 2021-03-22 fever, headache It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 1... Read more
It feels like I burnt my tongue. Because of that nothing tastes the same Still going on 3/23/21 10:54 AM Low fever 99.9 for a couple of days Headache, on going 3/23/21 10:54 AM Little dizzy and weak on going 3/23/21 10:54 AM Nothing horrible just uncomfortable
54 2021-03-23 fatigue Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began ... Read more
Within minutes of patient receiving vaccine, patient began to feel lightheaded and skin color began to turn white. Patient parked by EMS in observation parking and became unresponsive. EMS began vital signs and tried to get him to wake up. Patient stayed unresponsive and vital signs continued to decline. EMS transported patient to hospital. Upon arrival to hospital, staff conducted EKG, chest x-ray, and blood work. All tests came back normal. Patient began to become coherent, and staff began to try and feed him and get him up. After patient was able to get self up and eat food, he was sent home. Patient is now at home recovering. He states he only feels a sore arm and is fatigued.
54 2021-03-24 headache Injection site pain, headache on and off, muscle stiffness slight pain, Nausea on and off.
54 2021-03-24 fever, fatigue Whole body aches and general tiredness over last 2 days. Now have slight fever...Took Motrin once a... Read more
Whole body aches and general tiredness over last 2 days. Now have slight fever...Took Motrin once at 3am on 3/25 and now taking Tylenol at 4pm on 3/25
54 2021-03-25 headache headache, nausea, vomiting 15 minutes after vaccine. Trouble speaking/remembering -- EMS transfer
54 2021-03-25 sweating Light headed and dizzy, sweating, passed out briefly. 15 seconds. This was 45 minutes after getting ... Read more
Light headed and dizzy, sweating, passed out briefly. 15 seconds. This was 45 minutes after getting injection. I did not have trouble breathing or swallowing. Very similar to what has happened to me sometimes getting blood drawn but happens at time of appointment not after. Reclined, deep breaths and started to feel better within 10 minutes. An hour later feeling much better.
54 2021-03-26 headache Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash... Read more
Starting the following day after the vaccine a rash appeared on the whole body, arms legs feet. Rash was treated with some medication throat started swelling, mild headache and burning sensation all over body.
54 2021-03-26 fever, headache 102 fever, nausea, headache, left swollen armpit (swollen armpit remains into second day)
54 2021-03-27 malaise Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bath... Read more
Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes. Crawled to bathroom on stomach and vomited. After laying on floor, was able to speak and crawled back to bed. Vomited one more time around 10 am. Was in bed until 4:00 pm. Symptoms subsided by then, but I did not feel well until the next morning. The vertigo and nausea were the most severe I have ever had. At no point was I running a fever..
54 2021-03-28 headache, fever, chills Headache, chills, body aches, fever (maxed at 101-degrees Fahrenheit on the second day) lasting 3 da... Read more
Headache, chills, body aches, fever (maxed at 101-degrees Fahrenheit on the second day) lasting 3 days. Lymph nodes very swollen and painful under left arm, lasting 5 days.
54 2021-03-28 lethargy Body aches and Lethargic
54 2021-03-29 chills Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness a... Read more
Pain on the side of the injection, chills, difficulty breathing, palpitations and severe dizziness almost like fainting. Tremors in the hands and arms, these lasted approximately one hour and thirty minutes.
54 2021-03-29 fatigue, headache Headache - fatigue - nauseous Feel bad - stomach in knots
54 2021-03-29 fever, chills, cough Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a ... Read more
Adverse events experienced and are they still occurring now: Had chills, aches, fever of 101 and a cough. She is still feeling weak and has a cough What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Home management and has been taking Tylenol once or twice a day
54 2021-03-29 fever, fatigue, chills Fatigue, muscle/body/joint pain, dizzy, chills & feverish symptoms lasting almost 10 days since 1st ... Read more
Fatigue, muscle/body/joint pain, dizzy, chills & feverish symptoms lasting almost 10 days since 1st vaccine.
54 2021-03-29 sleepiness, headache Head Ache Brain Fog. Drowsiness
54 2021-03-30 headache, fever, chills, fatigue Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/... Read more
Body aches; Chills; Fever of 101; Nausea; Drymouth; extreme fatigue; Rapid heartbeat; mild headache/severe headache; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Feb2021, at 14:00 (at the age of 54-year-old) as a single dose for Covid-19 immunization. The patient medical history included allergies to Penicillin. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and didn't receive any other medications within 2 weeks of vaccination. On 04Feb2021, the patient had mild headache, Injection site pain. On 05Feb2021 at 11:00 the patient had severe headache, body aches, Chills, Fever of 101, Nausea, dry mouth, extreme fatigue, rapid heartbeat. It was reported that the headache subsided on 06feb2021 at 03:00 and the patient was still fatigued. The patient took Tylenol as a treatment for all the events. The seriousness of the events was reported as non- serious. The outcome of the events was reported as recovering. Information about lot/batch number requested.
54 2021-03-30 headache, fever About day nine after the first dose, I had a very quick onset of diverticulitis that hospitalized me... Read more
About day nine after the first dose, I had a very quick onset of diverticulitis that hospitalized me for five days. I had some bouts with it before but nothing that had come on so suddenly. I have had an elevated immune system in the past and it felt like my body just went into an attack mode and previous location for diverticulitis was impacted. It is important to note that my diet had changed to no red meat two years ago and I had no occurrences of DV and was feeling much healthier from a GI perspective. Also, and of equal importance, is that following the second dose at about the exact time frame I got the normal post vaccine symptoms (headache, slight fever, etc.). That nine-ten day mark is what is making me curious given my immune system. Thanks.
54 2021-03-31 chills, fatigue, headache, fever 101.5 fever for 28 hours, chills, headaches and eye strain, and fatigue and joint pain over a 28 hou... Read more
101.5 fever for 28 hours, chills, headaches and eye strain, and fatigue and joint pain over a 28 hour time period.
54 2021-03-31 chills, headache, fever Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after sho... Read more
Sore arm, nighttime chills during sleep, headache, fever (99.7). Sore arm started 3 hours after shot and the others about 15 hours after shot.
54 2021-03-31 cough, fatigue, nasal congestion, headache, chills Report coughing, chest congestion, nasal congestion, HA, chills and fatigue began day 4 post vacci... Read more
Report coughing, chest congestion, nasal congestion, HA, chills and fatigue began day 4 post vaccination. Treatment: PCP tested for COVID-19, Tylenol. Outcome: Waiting on results of PCR test, no improvement of symptoms. Does not interfere with ADLs.
54 2021-03-31 fever received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower b... Read more
received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower bowel or intestine pain. It got worse through the night and had bad cramping in morning. I tried going BM and could not. After getting up and moving around a bit I was able to have a solid stool, but it did hurt a little. It also hurt when I went to urinate. Later that day I had 99 to 100 fever. For the next 2 days I was better but I did have some lower abdominal pain and tenderness.
54 2021-04-01 chills, headache Chills, body aches, headache
54 2021-04-01 fever Low grade fever 24 hours after injection, moving joint aches. Swollen Lymph Node under left (injec... Read more
Low grade fever 24 hours after injection, moving joint aches. Swollen Lymph Node under left (injection) armpit.
54 2021-04-02 chills Chills the second day and a little raised the skin from the injection and muscle aches
54 2021-04-03 sweating, headache, chills, fatigue, fever, malaise I received the first Covid vaccine (Pfizer) on 3/24. A week later I started to feel very ill; chills... Read more
I received the first Covid vaccine (Pfizer) on 3/24. A week later I started to feel very ill; chills, low grade fever, fatigue, sweaty, head ache in the middle of my face, muscle aches, fuzzy thinking, and later a cold sore. I started taking Tylenol and stayed home from work. It has persisted over the past 4 days but I started to feel better yesterday.
54 2021-04-03 fever, lethargy, headache, fatigue, chills During early morning hours I awoke with pain and swelling at injection site, and hand and fingers we... Read more
During early morning hours I awoke with pain and swelling at injection site, and hand and fingers were numb util effectively exercised a few minutes. Shortly thereafter, I developed a sever headache along with fever, chills and lethargy. Sever body aches followed with joint pain throughout entire body. All symptoms lasted 24-36 hours. 48 hours later, still feeling stiff with aching back muscles and feeling tired. Large underarm lumps have developed 72 hours after injection. All of the aforementioned occurred after the second injection.
54 2021-04-04 fatigue, influenza like illness, sweating, chills Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach crampin... Read more
Recv'd first shot 4/3/21, was fine 4/4/21. Early in AM of 4/5/21 I had muscle aches, stomach cramping, and chills. At 1 point I stopped working because I felt tingly, and started to sweat (only happened once). I'm feeling tired, like I have the flu.
54 2021-04-04 fatigue Patient with prolonged fatigue
54 2021-04-04 headache, malaise I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over... Read more
I woke the morning after not feeling the best. About 10:00 am or so, I started getting achy all over my back and shoulders. It got worse over next few hours and stayed with me all evening. Had a headache as well. The next morning I was 80% better and by the next morning I was fine. The pharmacist told me that most people only get sore arm and sometimes can hardly lift the arm. I had sore arm but nothing I couldn't deal with. He also said that second shot tends to make people sick. I guess I wanna be certain I should get second vaccine?! I tested positive for covid on 12/20/20 and negative on 1/8/21.
54 2021-04-04 fever, chills Fever (100.6) and chills next day at 2 AM. Tylenol 1000mg cleared up symptoms. Fever at 4 PM next da... Read more
Fever (100.6) and chills next day at 2 AM. Tylenol 1000mg cleared up symptoms. Fever at 4 PM next day as well. Tylenol cleared symptoms. I had mild case of Covid in July 2020. This seems to be a common response for Covid survivors after first dose. Not looking forward to next dose. CDC should consider recommending Covid survivors receive only one dose and there are plenty of studies supporting this treatment recommendation. My body?s immune response was strong and I don?t think i need second dose.
54 2021-04-05 headache After receiving his vaccine, client stated he have headache, tingling sensation in L side of his fac... Read more
After receiving his vaccine, client stated he have headache, tingling sensation in L side of his face. No vital signs obtained by EMS. Client refuse vital signs as per EMT. Client states he is feeling better. Client discharge home.
54 2021-04-05 fever, headache, fatigue, chills Diaria first dat fatigue 2days head ache first day low fever and chills 2 days
54 2021-04-05 fever, headache Hives/rash on the whole body Fever on second day with headache and weakness
54 2021-04-06 chills Chills
54 2021-04-06 fatigue I took the second Pfizer COVID19 vaccination on 4/2/2021 (Friday). On Sunday evening, I started feel... Read more
I took the second Pfizer COVID19 vaccination on 4/2/2021 (Friday). On Sunday evening, I started feeling ringing in my left ear. I thought I was too tired, just went to sleep. From Monday (4/5/2021) morning, I felt frequently ringing in my left ear. Now (4/7/2021), when I talk to people or watch TV, I hear lots of echoes from my left ear. I also felt ringing inside of my left ear even no sounds outside.
54 2021-04-06 headache, fever, paranasal sinus discomfort Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 ... Read more
Full body aches, arm pain, 100F fever, neck and headache and sinus pressure. All subsided after 16 hrs from onset.
54 2021-04-06 headache c/o light headache after the 2nd dose of Pfizer.
54 2021-04-07 headache, fever Headache, fever...likely due to recovering from COVID less than 60 days prior to Vaccine #1
54 2021-04-07 sweating, lethargy started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat... Read more
started 1pm on 4/7 patient experienced dizziness, shortness of breath, tightness of chest and throat, lethargic, and sweat profusely. PT woke up and bed was soaked. Anxiety and confusion lingers to today 4/8 - today patient still feel lethargic but not nearly as bad - Recommended patient to keep monitoring and proceed to ER if needed
54 2021-04-07 nasopharyngitis Became cold and then violent shaking that lasted 2 1/2 hours
54 2021-04-07 fever, chills, headache Headache, chills, body aches, low grade fever. Increase water intake, ibuprofen, bed rest
54 2021-04-08 chills, headache, fatigue A week after the shot, on Thursday 4/8, I started getting a headache. Overnight, I woke up experienc... Read more
A week after the shot, on Thursday 4/8, I started getting a headache. Overnight, I woke up experiencing sever shivering, aches, and headache. The shivering was so severe it was like all muscles were cramping up. I took a painkiller, and went back to bed. In the morning on Friday 4/9 I awoke very sore and achy and had a bad headache and fatigue. I took more painkiller, had some breakfast, and took the day off to relax.
54 2021-04-08 headache Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable ... Read more
Headache; Body aches; Light headed; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer er8730, Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at 13:00 on left arm at single dose for COVID-19 Immunization. Medical history included Chrones. The concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 16:00 (24-hour clock), patient experienced headache, body aches, Lightheaded and Loss of energy. The patient did not receive any treatment for the events. The reporter assessed the event as non-serious. The events were not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-04-08 lethargy Dizziness, "brain zaps", body aches, lethargy.
54 2021-04-09 chills, sweating, headache Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vacc... Read more
Within an hour started feeling weird. over the course of the next 36 hours, my reaction to the vaccine is awful. Worse than my covid. At least I know my body is doing what it is supposed to be doing. But it is just miserable. Massive headache, soreness, weird shooting pains in my leg, sweats and chills and nausea, and now the racing heart and shortness of breath.
54 2021-04-09 fatigue, headache Mental and physical fatigue, headache, stomachache and vomiting.
54 2021-04-10 chills, fatigue, headache, fever Fever, chills, headache, body ache, severe fatigue. Took Tylenol.
54 2021-04-10 headache, fever starting 12 hours after injection: unable to sleep, low grade fever, headache, body aches. Lasted ... Read more
starting 12 hours after injection: unable to sleep, low grade fever, headache, body aches. Lasted about 20 hours.
54 2021-04-10 headache Headache and nausea.
54 2021-04-10 sweating About 10 minutes after shot was taken I got a sharp pain in my stomach and felt like I had to throw ... Read more
About 10 minutes after shot was taken I got a sharp pain in my stomach and felt like I had to throw up, about the same time I was sweating profusely and felt like fainting, they brought the wheel chair over to me and was going to move me, but the symptoms were improving and I started to feel better, I have never had symptoms appear that fast, very scary stuff for sure.
54 2021-04-11 chills, body temperature increased high temperature and nausea and chills
54 2021-04-11 malaise Patient had general malaise. Onsite EMS was called vitals BP 146/91 99% O2 HR 85. Patient refused... Read more
Patient had general malaise. Onsite EMS was called vitals BP 146/91 99% O2 HR 85. Patient refused evaluation or care. Released to go home against medical advise.
54 2021-04-11 throat pain, chills, fever Slight fever (Lasted one day), Aches, Chills, Sore throat (lasted several days) Severe Joint Pain he... Read more
Slight fever (Lasted one day), Aches, Chills, Sore throat (lasted several days) Severe Joint Pain head to toe, (has lasted for several weeks, still ongoing)
54 2021-04-11 fever, fatigue General fatigue, slight fever, swelling around both sides of my neck/collarbone area. This occurred... Read more
General fatigue, slight fever, swelling around both sides of my neck/collarbone area. This occurred about 10 days after 2nd vaccine.
54 2021-04-13 chills Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium... Read more
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: PT came in for Pfizer shot. 5 min later, pt felt nauseous and light headed. Pt vomited twice and EMT checked pt and he was clear. Pt felt better after 45 min. He later claimed it might be food poisoning from the morning of 4/14, same day of the first dose.
54 2021-04-13 fatigue, chills Fatigue, dizziness, shortness of breath, chills, aches
54 2021-04-13 fatigue Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Conta... Read more
Nausea, diarrhea, fatigue, tingling in hands and arms. Lasted 4-5 days. Caused to miss work. Contacted PCP but did not go in for visit.
54 2021-04-14 chills, headache Headache, chills, body ache,
54 2021-04-14 chills, fever Chills, body aches and fever at night.
54 2021-04-14 headache, fever, cough Fever of 102-105, headache, coughing, weaknesss
54 2021-04-14 headache headache for one day after
54 2021-04-14 fever I started getting hives on my stomach, arm, back and both ankles. I did have a low grade fever the f... Read more
I started getting hives on my stomach, arm, back and both ankles. I did have a low grade fever the first night and then a fever of 100.4 last night.
54 2021-04-15 fever, headache, chills Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil o... Read more
Chills, shake, fever, headache. Shaking stopped by 6 AM. Fever was low stopped by 8 AM. Took Advil once. Constipation 48 hours. Cramps on day 2. Headache continues after 48 hours. Shortness of breath on day 2. Advil taken morning of day 2. Dizziness at times.
54 2021-04-15 fever Nausea, vomiting, diarrhea, fever
54 2021-04-16 fatigue Injection site pain; Body Ache; Tiredness/Exhaustion feeling; This is a spontaneous report from a co... Read more
Injection site pain; Body Ache; Tiredness/Exhaustion feeling; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration in right arm on 17Feb2021 at 08:30 pm as single dose for COVID-19 immunization. The patient medical history included hypertension, blood cholesterol and overweight. There were no known allergies to patient. there was no COVID prior vaccination. The concomitant medications included metoprolol, simvastatin and amlodipine. On 18Feb2021, the patient experienced injection site pain, body ache, tiredness/exhaustion feeling. Patient did not receive any treatment for adverse event. There was no COVID tested post vaccination. It was reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 10Mar2021 at 08:15 am as single dose for COVID -19 immunization. The outcome of the events was not recovered. No follow-up attempts possible. No furthermore information expected.
54 2021-04-17 influenza like illness, cough, fatigue This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male pati... Read more
This is a spontaneous report received from a contactable consumer (patient). A 54-year-old male patient (height: 193cm, weight: 99.79kg) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6207) via an unspecified route of administration at right upper arm on 18Mar2021 18:00 (54-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included blood pressure, teeth cleaned (Shortly before the shot, went to the dentist to have teeth cleaned. Directly from Dentist went to pharmacy. Went to pharmacy's Drive Thru to pick up a little antibiotic from the dentist. It was 4 capsules of Amoxicillin. He was supposed to take the Amoxicillin before the dentist office visit, but he forgot to do that. Therefore, soon as he left the dentist office he went to pharmacy to pick it up so he could take it. While he was there, was offered the COVID 19 vaccine and that it was the last shot). Concomitant medications included atenolol tablet from 2016 (been taking for 5 years) and ongoing for blood pressure, and ascorbic acid/ cyanocobalamin/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine mononitrate (ONE-A-DAY). No additional vaccines administered on same date. No history of all previously immunizations. No prior vaccincations wtihin 4 weeks. He got the shot Thursday and by Sunday, many different side effects were coming in. He has had side effects from the COVID VACCINE, but initially he does not want to file report, just thinks that everyone needs to get the shot. He does not have complaints. He is wondering how long the side effects will last, and when they go away. States that he is being treated as he has gone to the doctor's. Also states that he made an appointment with the doctor and almost went to the emergency room a couple of times. Right after the shot, he was getting in the car and his right leg started hurting (on 18Mar2021). It didn't go away for a couple of days. It went away but then noticed his shoes started feeling funny. He wasn't looking at his feet, put his shoes on they felt tight. Then he started to look at feet more. Below his knees, his legs are swollen. Swelling started within 2 to 3 days after the vaccine. The swelling is really severe when standing. Everybody at work has seen how sick he is and his legs. Swelling in the legs has him concerned, thinking maybe it's a blood clot. He was given medicine and would like to see it go away. He keeps his legs up. He has other side effects (all in Mar2021) and is having flu like symptoms. He basically has the flu. He has never had the flu shot. This is the first flu shot (He referred to the COVID vaccine as the flu shot as documented. However, confirmed suspect product as Pfizer covid vaccine) he has had that he knows of. He is questioning if he should get the second shot. He feels a little dizzy. Quick questions get him confused and that it comes and goes. Lungs felt full, gasping for air: not now but, since the doctor gave him antibiotics (unspecified injections, he was given 2 shots at the doctor's office, one in each arm), his lungs felt full. At times he was gasping for air. It went away but thought he was going to die. Now when he gets winded, it feels like he has a dry cough. Gets winded easily. The doctor ordered him an inhaler, Symbicort, but it was very expensive, so he did not get it at that time. He never picked it up because it was too much money. The fluid is not there anymore and he does not feel like he needs this as does not feel like it needs to be cleared. He is having wheezing. He can now take deeper breaths. Fatigue: initially, that he was feeling tired within 1 or 2 days, but he did not recall the next day feeling that way (later stated it was within 2-3 days he started to feel tired). He is still tired. Unable to clarify time frame of fatigue further. He feels bloated and full. Hasn't really eaten but feels real full and bloated. Hot and cold flashes started occurring about the same time as the other symptoms. He had these last evening. He does not get the flu very often and doesn't take the Flu shot. This is the closest thing he can remember having a pretty good episode with the flu. He was also given prescriptions for 2 new medications: Triamterene 37.5mg daily, for leg swelling; Clindamycin, 300mg, twice a day, an antibiotic. The odd thing is that it seems like his eyes are big, like really, really big, like they are really open. It is like big eye balls. States that he is just sick and his body is reacting to getting better. He has not been to work in the last 3 days. States that he is fine, just worried about work. Patient asked for personal advice about going back to work. The outcome of "his right leg started hurting" was recovered; outcome of "below his knees, his legs are swollen/ swelling in the legs/ put his shoes on they felt tight" and Fatigue/feeling tired was not recovered; outcome of other events was unknown.
54 2021-04-18 cough, chills chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, co... Read more
chills, night sweats, chest pain, body aches, nausea, anorexia, back pain now, 16 lb weight loss, cough when sitting up and moving, peripheral neuropathy, - chest pain resolved but other issues are persistently bad, adv some of the initial symptoms could have been related to the shot, such as initial body aches and chills, but persistent and worsening issues are NOT expected this far out. I adv HCF eval given likely unrelated persistent symptoms, consider ED if effects are severe and worsening. He will likely go in tonight but he isn't sure where he will go. I adv try not to drive yourself call back if issues. PCC will FU tomorrow with patient at home. 4/11-Patient positive for Covid per MD at hospital Follow up call - Patient feeling better today, went to ED at hospital , was prescribed Flexeril, Ibuprofen and ondestron. Second vaccination is next week.
54 2021-04-18 fatigue About a week after my first shot i experienced the start of a rash on my lower back.Did not think mu... Read more
About a week after my first shot i experienced the start of a rash on my lower back.Did not think much of it at the time,assumed contact dermatitis. Rash started to spread slowly,used hydrocortosone daily as needed.Contacted my PCP on 4/09 virtually and he told me to keep an eye on it.After my 2nd shot I experienced the usual fatigue and arm.pain but my rash got worse.,Contacted local urgent care provider on 4/18/2021 @11:25 AM.My provider was Doctor. By this time my rash was all over my back and had travelled to my front.After full mock up she diagnosed me with a pityriays-rosea condition .She prescribed me kenalog 0.1% predisone cream and Benadryl for itching.
54 2021-04-18 fever, fatigue Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 3... Read more
Persistent Increased heart 110-114bpm started 8-10 hours after the injection and continued roughly 30-36 hours. My heart rate while sleeping was over 95+ bpm and 110-114bpm while awake In addition, I had severe joint aches, fatigue, night sweats, fever for 48-72 hours.
54 2021-04-19 fatigue, cough, fever, headache Cough, fever, prostration, headache, rash, muscle pain.
54 2021-04-20 headache, fever, lethargy, chills beginning 4 hours after - lethargy, aches beginning 12 hours after - fever, chills, significant head... Read more
beginning 4 hours after - lethargy, aches beginning 12 hours after - fever, chills, significant headache, took 3 ibuprofen @ 10 pm. slept from midnight till 8:00 AM feeling generally better, sensitivity of skin.
54 2021-04-21 sleepiness 11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue f... Read more
11:39 am stated he was feeling sleepy , Vital sign were done 11:50 patient stated that his tongue felt different , experiencing nausea , clear emesis , Per Dr order , I gave patient benadryl 25 mg po. patient was alert . patient was left for further evaluation . 12:45 pm the patient began to complain about tightness off and on , nausea , emesis continue , whole body felt tingly. 12:47pm per Dr order , i administer the Epi Pen was administer . 911 was called . paramedics was transport to hospital .
54 2021-04-22 chills, headache, fever Chills, Fever (99.2)(took 2 Tylenol at 2:20 pm 04/23/2021), Body Aches, Headache, Nausea
54 2021-04-22 fatigue, headache I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started h... Read more
I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started having headache and nausea and then started having the withdrawal symptoms come back. Insomnia, air hunger, back and shoulder pain after eating and fatigue, burning feet and Tinnitus.
54 2021-04-22 headache, chills, fever Woke up the next morning with shivering and 99.7 fever, headache. Left armpit swollen, possibly lymp... Read more
Woke up the next morning with shivering and 99.7 fever, headache. Left armpit swollen, possibly lymph nodes. Fever reached 103.5 by afternoon. I contacted my primary care who recommended Tylenol and Ibuprofen plus fluids. Fever lessened by night, swollen armpit and headache continues
54 2021-04-22 headache, fatigue Woke up at 4:00 AM on 4/2 with severe headache; took an Excederin Migraine on 4/2 and it helped. He... Read more
Woke up at 4:00 AM on 4/2 with severe headache; took an Excederin Migraine on 4/2 and it helped. Headaches continue daily, nearly constantly with varying intensity; have not taken anything for the headaches Lack energy, continue to be very tired in the afternoon -- not usual for me
54 2021-04-22 headache, head discomfort, chills, fever Extreme Chills, 8 hour fever 102.7, random pains some dull some stabbing all over, severe headache w... Read more
Extreme Chills, 8 hour fever 102.7, random pains some dull some stabbing all over, severe headache with head pressure.
54 2021-04-23 chills, fever, influenza like illness, headache Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tyle... Read more
Flu-like symptoms, fever of 99.6, chills, nausea, headache, arm pain, for about 24 hours. Took Tylenol and Ibuprofen cold and sinus
54 2021-04-25 sweating, fever, chills Fever (101.7 F), chills/sweats, body aches
54 2021-04-26 headache, fever Fever 101F, Headache, Joint Ache Headaches continuing mostly in the morning at waking time.
54 2021-04-27 fatigue Ringing in ears, loss of hearing. Ringing (Tinnitus) in both ears, loss of hearing in and more inte... Read more
Ringing in ears, loss of hearing. Ringing (Tinnitus) in both ears, loss of hearing in and more intense "ringing" in right ear. Fatigue. Have not yet visited a doctor, was hoping symptoms would subside or go away naturally.
54 2021-04-27 headache Patient states that he began having a headache (frontal) that caused him to have some brain fog. It... Read more
Patient states that he began having a headache (frontal) that caused him to have some brain fog. It lasted approximately four weeks. It would wax and wane. Then one morning he woke up without it. He was not seen for this. Just happened to be seen today for his routine physical and mentioned it.
54 2021-04-27 sweating Patient received the vaccine then reported to the observation area. After a few minutes in the obser... Read more
Patient received the vaccine then reported to the observation area. After a few minutes in the observation area the patient stated he was light headed and dizzy and might pass out. A few moments later the patient passed out. He passed out from his chair to the floor where he was assessed by pharmacists and a nurse. He was sweating and was coming in and out of responsiveness. Patient never stopped breathing. 911 was called and patient was taken away by EMS. Patient was still in and out of responsiveness when EMS arrived.
54 2021-04-27 sleepiness, headache, fatigue, chills Dizziness, Pounding Headache, Drowsiness, Nausea, Fatigue, Chills, Ringing In Ears.
54 2021-04-28 body temperature increased, malaise I was very sick with a temperature going as high as 105 degrees and lost nearly 10 pounds in 3 days.
54 2021-04-28 malaise, fatigue I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt ... Read more
I started feeling drugged about 2 hours after the shot. I then experienced extreme fatigue and felt unwell / sick for 6 days. My joints were extremely sore in my back, ankles and wrists. My body felt heavy and it was hard to stand and walk. It felt as if I was losing circulation in my feet. By 5PM each day I was in bed passing out for about 2 hours each day. Most of each day on couch sick. On day 5, I broke out in hives on my face. All symptoms began to clear on day 7. I was almost feeling normal Apr 28. Today, Apr 29 I feel OK.
54 2021-04-28 fever, chills Couldn't get out of bed the next day. Achy, headache, body aches, chills, fever. This lasted through... Read more
Couldn't get out of bed the next day. Achy, headache, body aches, chills, fever. This lasted throughout the entire day.
54 2021-04-29 fatigue, throat pain, malaise Pt with H/O long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropen... Read more
Pt with H/O long-standing ITP, APLABs, VTEs, admitted with exacerbation of ITP and immune neutropenia after first dose of Pfizer COVID-19 vaccine.
54 2021-04-29 influenza like illness, fever, chills About 48 hours after the shot, I developed flu-like symptoms: chills, mild diarrhea, body ache, and ... Read more
About 48 hours after the shot, I developed flu-like symptoms: chills, mild diarrhea, body ache, and low fever. These dissipated in the next 36 hours. HOWEVER, during this time I developed bilateral, persistent high-pitch tinnitus. This problem is significant enough to affect sleep and concentration. The tinnitus remains persistent three weeks later.
54 2021-05-01 chills, headache Chills, strong headache, pain ate the injection site for two days.
54 2021-05-01 throat pain, headache Headache every day since shot wife also..shot injection site sore 10 days..sore throat sinus issues.... Read more
Headache every day since shot wife also..shot injection site sore 10 days..sore throat sinus issues..
54 2021-05-02 fever, chills, headache After 2nd. Vaccine my symptoms were fever, chills, body aches, headache, loss of right side arm and ... Read more
After 2nd. Vaccine my symptoms were fever, chills, body aches, headache, loss of right side arm and leg I?m a high risk and had previous stroke with minor paralysis on right side after shot loss of right side for 1 day slowly coming back
54 2021-05-02 throat irritation Strong throat irritation and wheezing began 5 minutes after administration. Breathing not severely i... Read more
Strong throat irritation and wheezing began 5 minutes after administration. Breathing not severely impacted. Pulse and oxygen saturation remained normal. Throat irritation continued for the rest of the day, wheezing subsided quickly.
54 2021-05-03 fatigue, chills, fever, headache Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Startin... Read more
Vaccinated Weds 4/28/21. Started shortly thereafter with fever Tm 102 F, chills, headache. Starting Thursday with fatigue and metallic taste in his mouth. He has no appetite and reports not eating x 4 days. He has had fever and headache persistent since vaccination. He has not slept x 4 days since vaccination, he reports his mind is racing. He had a syncopal episode x3 night of 5/2/21 back to back. Right before syncope he did not feel lightheaded or dizzy, chest pain, palpitations. He had LOC lasting less than a minute in total.
54 2021-05-03 fatigue No effects for first 4 days. The evening of May 3rd around 7PM PDT I was stuck with severe nausea/ve... Read more
No effects for first 4 days. The evening of May 3rd around 7PM PDT I was stuck with severe nausea/vertigo. This lasted for several hours. Also experienced weakness for duration, cold sweat for first half hour. For first couple of hours any movement caused extreme nausea/vertigo, gradually fading. (my insomnia was not effected!). As I type this, May 4th at 742 AM I feel tired, very slightly nauseous. No other symptoms noted at this time.
54 2021-05-03 sweating Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; ... Read more
Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose
54 2021-05-04 fatigue, fever fever of 99.0; Pain at injections site; fatigue; arm pain; This is a spontaneous report from a non-c... Read more
fever of 99.0; Pain at injections site; fatigue; arm pain; This is a spontaneous report from a non-contactable consumer (Patient). A 54-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 54-years-old, via an unspecified route of administration, administered in Arm Left on 14Apr2021 09:30 AM (Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included myocardial infarction, diabetes mellitus, asthma. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); insulin aspart (NOVOLOG); carvedilol; atorvastatin; lisinopril; colecalciferol (VITAMIN D 3); vitamin E (VITAMIN E NOS); calcium and multivitamin, gummy vitamin. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pain at injections site and fatigue on 14Apr2021. The injection site pain started the same day as the injection but the fatigue was more noticeable the day after the injection. Arm pain on 14Apr2021. Last night (15Apr2021) at approximately 9:00 pm symptoms of fatigue and arm pain continued. However, he started to run a fever of 99.0 given him two regular strength Tylenol and fluids. Today (16Apr2021) the fever was resolved in the morning. Event outcome of Pain at injections site and fatigue were not recovered, of fever was recovered on 16Apr2021, of the remaining was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
54 2021-05-04 fatigue, fever High fever (103 for 3.5 days), sensitive to light, tiredness Same symptoms of FMF disorder
54 2021-05-04 fever, chills 24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. S... Read more
24 Hours after 2nd vaccination came down with fever of 103, shaking chills, and weakness all over. Slept 6 hours and symptoms subsided. 2 days after started having severe numbness in hands and feet. a few days later started having weakness in arms and legs, progressed over next week to the point I was unable to walk. Began steroid infusions on Mon 26 Apr. Admitted to hospital Wed 28 May for assessment and treatment. Released home on 30 Apr and returned 1 May for outpatient steroid.
54 2021-05-05 headache A few days after receiving the first dose I started experiencing body aches, headache and minor back... Read more
A few days after receiving the first dose I started experiencing body aches, headache and minor back pain. The body aches only continued to get worse over time as well as the back pain. I did not have back problems or pain until the vaccine. I contacted my primary physician and explained that I received the vaccine and told her about my symptoms. She asked me to get a Covid-19 test. I did and the results was negative. At his point, May 6, 2021, the symptoms have only become worse. My back pain is so severe I can barely stand it. I have tried ice packs, a heating pad, over the counter pain medication and nothing has made it better. My physician does not know what to do. Another side effect is it has made my fibromyalgia pain much worse. I have had fibromyalgia for about fifteen years and my pain is tolerable but the past few weeks have been unbearable. I may have a weakened immune system due to the fibromyalgia so maybe that could be a explanation for my symptoms. I wanted to know if other people have experienced severe side effects. The only treatment is over the counter pain medication and ice packs and a heating pad. As of today, May 6, the back pain and body aches are still present and I would say severe. The headache is tolerable but still lingers and does not go away. The body aches, headache and back pain is twenty four hours a day and never get better.
54 2021-05-05 fever, cough, throat irritation achiness, a slight cough and scratch throat, and also his fever reached 101 last evening, but w/ Exc... Read more
achiness, a slight cough and scratch throat, and also his fever reached 101 last evening, but w/ Excedrin pt is now in the 99 range.
54 2021-05-06 fatigue, fever fatigue, fever, and body aches. Tested positive for covid19 on 5/7/2021
54 2021-05-07 head discomfort, fatigue Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of h... Read more
Nausea, fatigue, loss of taste, facial tingling and numbness, pain in elbows, pressure to front of head and behind eyes, fogginess, memory loss, lack of concentration, muscle tingling in the middle of the night, numerous cysts in rt. arm, shooting pain in rt. thumb and hand, bone spurs and calciumafication of rt. elbow. No treatment. Schedule to neurologist and orthopedic doctor.
54 2021-05-07 headache, fatigue, chills Fatigue and lymph node pain for several days and s(wollen lymph nodes on left side by chest) I had ... Read more
Fatigue and lymph node pain for several days and s(wollen lymph nodes on left side by chest) I had an episode of lightheadedness and labored breathing for 2 minutes and was unable to think clearly or speak in a sentence for 45 seconds. I had chills and needed to be covered with blankets to feel comfortable again. 2.5 hrs later was feeling better with a mild headache.
54 2021-05-08 fever, headache, fatigue Site injection pain; Body Aches; tiredness;headache; minor fever (2 degrees above normal but below 1... Read more
Site injection pain; Body Aches; tiredness;headache; minor fever (2 degrees above normal but below 100)
54 2021-05-09 fatigue, fever, lethargy, sleepiness The following are descriptions is a synopsis of information provided over the phone by the patient's... Read more
The following are descriptions is a synopsis of information provided over the phone by the patient's wife on 5/10: At time of second dose patient was fatigued, lethargic, hyperglycemic, and experiencing brain fog. She states some of the symptoms started some time after his first dose but couldn't provide a time frame. On 5/6 he answered the Vaccine Questionnaire question of "are you sick today?" as "unsure" and further discussion was had with a pharmacist to verify he was eligible to receive vaccine. Neither the pharmacist or patient remember the details of this discussion. Patient and wife have belief that his ethnicity contributed to dismissing of possible illness during the vaccine screening process, but due to the patient's lethargy and brain fog at the time, he could not provide specifics of the conversation. His wife was not with him during the screening process with the pharmacist or during vaccine administration. The appointment time was 4:55pm. The wife states the patient was so fatigued after the shot was administered on 5/6 that he was asleep in his chair in the observation area. Later that day fever of 100.5 was noted and controlled by OTC ibuprofen 2 hours after the ibuprofen was administered. The wife states that he rapidly declined over the 3 days after second Pfizer vaccine and she called an ambulance on Sunday 5/9. From the ER he was admitted to the ICU with the primary reason for admission listed as hyperglycemia but a COVID was listed as a contributing factor. The COVID test administered Sunday was positive. He had high blood pressure, heart rate, blood sugar, and sodium. Patients vitals have since stabilized other than the sodium is still high. He is in ICU at hospital still very lethargic as of today 5/10.
54 2021-05-09 fatigue Scheduled for second COVID 19 dose. Pfizer Lot # EW0153 vial was reconstituted with .8 mL 0.9% sodiu... Read more
Scheduled for second COVID 19 dose. Pfizer Lot # EW0153 vial was reconstituted with .8 mL 0.9% sodium chloride instead of 1.8 mL. RN withdrew 0.3 mL diluent and administered IM to left deltoid. Pt remained for 15 minutes post injection. Patient reported arm pain at injection site and general tired feeling. Symptoms were resolved within 24 hours. No hospitalization required.
54 2021-05-09 headache, chills, fever The expected side effects on the day after the second shot of headache, muscle aches, chills, fever.... Read more
The expected side effects on the day after the second shot of headache, muscle aches, chills, fever. On May 5, 2021, patient suffered a stroke. Could not control right arm, could not speak. Called 911, taken to ER, and checked into hospital.
54 2021-05-10 fatigue, malaise, headache 1st shot: No side effects after 1st vaccine shot other than slight bruise-like pain at site of injec... Read more
1st shot: No side effects after 1st vaccine shot other than slight bruise-like pain at site of injection (upper left . 2nd shot: 27 hours after, fatigue, general malaise, and light headache noticed. 29 hours after, minor swelling of left armpit with associated minor discomfort. After sleep, all symptoms gone save swelling which has increased. Noticeable overall swelling in the area visibly, inferior of armpit. At time of report (17:30 11 May 2021), swelling persists but pain reduced.
54 2021-05-10 fever caught a fever but got past that; I developed a knot up on my left arm where I got the shot.; develo... Read more
caught a fever but got past that; I developed a knot up on my left arm where I got the shot.; developed a knot under his arm and his arm is sore, like the lymph node is inflamed; reported that his whole arm was sore, but now it is just right under the armpit like a lymph node or cyst.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left as single dose on 16Apr2021 11:30 for COVID-19 immunization. The patients medical history included unspecified blood pressure condition diagnosed probably 10 years ago and is ongoing. The patients concomitant medication included losartan (LOSARTAN, unspecified formulation) 50 mg once daily taken for blood pressure and is ongoing. Complained that they does not have the product with them at the time of call. Patient had not received any vaccines within 4 weeks. On 18Apr2021, the patient experienced fever, developed a knot up on his left arm where he got the shot and experienced a knot under his arm like the lymph node is inflamed. He reported that his whole arm was sore, but now it is just right under the armpit like a lymph node or cyst. Treatment medication for pain in arm included Tylenol. The outcome for all the events was reported as recovering. The seriousness of all the events was unspecified. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Kindly review the events coded, seriousness and listedness.
54 2021-05-10 fever Client stated he felt he had a fever over the weekend but did not take his temperature. Swelling pre... Read more
Client stated he felt he had a fever over the weekend but did not take his temperature. Swelling present in R upper arm down elbow and complaints of pain in right arm. Stated he can feels discomfort in his neck on the right side. Complaint that he has difficulty swallowing. Client sent to ER by APRN. Client went to hospital.
54 2021-05-11 fatigue, headache, fever, chills I felt tired the evening of the shot. The next morning I had fever and chills, body aches everywher... Read more
I felt tired the evening of the shot. The next morning I had fever and chills, body aches everywhere, severe headache, extreme fatigue, and very upset stomach. By the second day following the vaccination I have a very bloated stomach and extreme pain. These symptoms continued with the stomach and headache becoming worse. Entered the Emergency Room the evening of May 7th and admitted into the Hospital.
54 2021-05-12 headache, fever Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentra... Read more
Aches, fluish symptoms, muscle aches, fever (100ish), significant brain fog (confusion, no concentration-still continues), regional shoulder pain, massive headache-several days, significant heart/chest pain upper left quadrant both first and second shot. Went into Atrial fibrillation 4-5 days after first shot. Massive emotional swings from ecstasy to rage and depression starting day after shot and continuing.
54 2021-05-13 body temperature increased Temperature excursion with vaccine administration
54 2021-05-13 headache Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt r... Read more
Had tachycardia and high blood pressure, headaches and some nausea yesterday. Tachycardia hasnt repeated but headaches and queasiness continue intermittently along with possible high BP Never had this before was wondering if possible side effect? EKG came back same as normal for me and bloodwork fine. Still feeling poorly.
54 2021-05-14 chills, fever convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body ache... Read more
convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30 (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.
54 2021-05-16 cough Son came into Health Dept this morning to report that his father began throwing up and having diarrh... Read more
Son came into Health Dept this morning to report that his father began throwing up and having diarrhea Saturday morning(05/15/2021) which progressed through the day. States did not want to go to the Hospital but wanted to wait to see his MD at the Dialysis center on Monday (05/17/2021). On Sunday(05/16/2021) nausea and vomiting and diarrhea was worse and now with cough noted. States was washing his hands and fainted, EMS was called and he died that morning.
54 2021-05-16 head discomfort pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left si... Read more
pt states his head felt like it was 10 x the normal size. There was a lot of pressure on the left side of the head and ear. The left side of his was face numb and he lost all hearing in left ear. He went to ER on 4/22/21. They removed ear wax and was prescribed amoxicillin and Mucinex. His symptoms did not improve so went to his PCP, on 4/29/21( he had to see his assistant ). They prescribed prednisone 40mg. He was referred to ENT. He saw her on 5/3/21. He was then prescribed 60mg prednisone and was given a hearing test. He had lost 20% of hearing at that point. He went back to ENT on 5/10/21 and had another hearing test. His hearing was better and almost back to normal but says he continues to have ringing in his head. He has a MRI scheduled on 5/24/21 further treatment.
54 2021-05-17 chills, fever, headache Fever, chills, muscle and joint pain, massive headache
54 2021-05-19 chills, fever Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4... Read more
Fever and chills Myalgia Viral syndrome ED to Hosp-Admission Discharged 4/18/2021 - 4/22/2021 (4 days) Hospital MD Last attending ? Treatment team Acute respiratory failure with hypoxia (CMS/HCC) Principal problem Presenting Problem/History of Present Illness/Reason for Admission Acute respiratory failure with hypoxia (CMS/HCC) [J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82] Hospital Course This pleasant 54-year-old gentleman with history of hypertension came in with increasing shortness of breath and hypoxia secondary to Covid pneumonia resulting in hypoxic respiratory failure and diffuse pulmonary infiltrates. Patient was hospitalized for management of severe sepsis secondary to Covid pneumonia resulting in acute hypoxic respiratory failure. Patient was also treated for possible secondary bacterial pneumonia given duration of Covid symptoms prior to coming into hospital. Patient made nice recovery and was able to wean off from high flow oxygen down to 2 L with exertion. Patient overall made nice recovery hence he was discharged home. Patient was noted to have rising D-dimers despite clinical improvement in Covid infection. He is at high risk for developing DVTs hence he was recommended to use Xarelto 10 mg daily for 1 month to prevent any risk of DVTs. Patient voiced understanding of this. In he was discharged home with home health care. His readmission potential is low to moderate.
54 2021-05-19 head discomfort After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. H... Read more
After the 15 minute post shot waiting period patient said he felt "confused" with clammy hands. He sat in the chair and was slow to talk. I asked him if he was diabetic, and he responded that he was, but he never feels this way and had eaten before coming in. After talking a while longer, I was going to ask him if he'd like us to check his sugar, he asked me if we had a blood pressure cuff. I said we did, but he wanted to use the machine in front of the store because he felt well enough to get up and wanted to walk. I walked to the machine with him. He sat and answered the many questions tapping on screen with no issues at all. The confusion was not evident. The maching reported 111/68 or very close, with a pulse of 48. He said, "that's the issue, my pulse is down. I need to walk around." I said he could stay back at the pharmacy where we could see him, or we could call someone for him. He said staying back here would not help his pulse. I told him there was no hurry, he'd been here for his 15 minutes, but we could keep an eye on him or help him and call whatever he needed. He said no, he'd be fine, he just needed to walk around. He now had pressure in his head, not really a headache just pressure, he said it was all related to his pulse. He said if he needed help later he could always go to an Urgent Care, I offered again to call anywhere for him or call for assistance, he was not interested.
54 2021-05-19 sweating Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / ... Read more
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild, Additional Details: 5 minutes following second dose of pfizer pt with syncopal episode. LOC for 10 seconds, came to spontaneously without intervention. Pt placed in trendelenburg, regained consciousness. vital signs stable, blood sugar stable, no injury.
54 2021-05-19 fever, cough Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Feve... Read more
Extremely Sore Left arm for 22 days. No treatments. Constipation for 6 days. Enema given. Light Fever on days 3,4, and 6. No treatments. Severe coughing with lung pain from day 7- Present. Treatment is cough drops/Dextromethorphan HBr on Day 26. No male penis erections from Day 10-30. No treatments. Extreme Nausea from Day 14-Present. Feelings of vomiting but never did. 4-6 hours each day.
54 2021-05-21 fatigue The patient came to the pharmacy to get his "second shot" and informed the pharmacy he needed to pfi... Read more
The patient came to the pharmacy to get his "second shot" and informed the pharmacy he needed to pfizer vaccine. The information on his card was verified over the phone. He received a dose of the pfizer vaccine, only to realize 9 days later that his first dose was actually the moderna vaccine. The patient reported having a sore arm and fatigue.
54 2021-05-22 headache Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe,... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Additional Details: patient fainted 7-10 minutes after vaccination. He felt when tried to stand up so he layed down until the help arrives. Patient mentioned about having history of fainting whne he had blood draw years back. Never received any vaccinations. EMS took him to hospital for check up. No allergic reactons noted no breathing issues as well.
54 2021-05-22 fever, lethargy Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech)
54 2021-05-25 fatigue, malaise, lethargy, influenza like illness critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea;... Read more
critical sadness like never before/sadness and depression; Flu like symptoms; terribly sick; nausea; lethargy; body ache; fatigue (he is tired all the time and cannot get off the couch); This is a spontaneous report from a contactable consumer (patient) via a Pfizer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 22Apr2021 (Batch/Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included gabapentin (GABAPENTIN) taken for neuropathy peripheral, start and stop date were not reported. Patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine on 22Apr2021, he has been terribly sick, he feel like his dying. He had nausea, lethargy, body ache, critical sadness like never before, fatigue (he was tired all the time and cannot get off the couch) and it was not going away on 23Apr2021. He had seen three doctors, tested negative to Covid-19 and his blood tests were normal. He had flu like symptoms for 13 days since 23Apr2021, and it never goes away. The symptoms seem to get better and then he exercises a lot and they come back. Patient has been nauseated, had extreme lethargy, sadness and depression, and body aches. The patient was on a plethora of medications now because of this. He wanted to know what does it say about his immune system? He was scared that he was dying, it feels like he's dying. He has worn two masks and not socialized at all and does not understand what has happened, he has done everything right. His inflammatory response was checked on 04May2021 which has not come back yet. The patient underwent lab tests and procedures which included blood test: normal on 06May2021, body height: 175 cm on 06May2021, platelet count: normal on 04May2021, red blood cell count: normal on 04May2021, sars-cov-2 test: negative on 04May2021, weight: 195-200 on 06May2021. He wanted to know when will these side effects go away and he will start getting better, and asked if he should get the second dose. Outcome of the events was not recovered.
54 2021-05-25 headache Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a s... Read more
Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered. Information on the lot/batch number has been requested.
54 2021-05-25 nasal congestion, sneezing, productive cough, respiratory tract congestion, fatigue Severe allergic reaction: nasal and throat congestion, mild fatigue, productive cough, sneezing Las... Read more
Severe allergic reaction: nasal and throat congestion, mild fatigue, productive cough, sneezing Lasted 10-12 days. No fever, no nausea
54 2021-05-25 fever, headache ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable h... Read more
ED Discharged 5/5/2021 - 5/6/2021 (3 hours) Last attending ? Treatment team Acute nonintractable headache, unspecified headache type Clinical impression Headache Chief complaint Triage Note: To ED c/o severe HA behind R ear since being dx w COVID 4/30. Denies cough, dyspnea, fevers. Reporting he has had 1 round of COVID vaccines. Has taken "alieve, tylenol, and advil" w/o relief. Last doses all "early this morning." pt awake and alert in triage. History of Present Illness Patient is a 54 y.o. yo male presenting to the ED with severe headache behind the right ear since 4/30. Patient was diagnosed with Covid at that time and has taken 1 round of the Covid vaccine. He has tried Aleve, Tylenol and Advil without relief. He states that his last dose were all early this morning. Denies any numbness or tingling, visual disturbances, ataxia, photophobia. He has no history of strokes, MI or blood clots. He states that prior to his Covid diagnosis he is otherwise healthy. ED Discharged 5/8/2021 (4 hours) Last attending ? Treatment team COVID-19 Clinical impression Fever Chief complaint Medical Decision Making 54-year-old male who presents today due to uncontrolled fever, diagnosed with Covid on April 30. Symptomatic for about 2 weeks now. On exam appears to be uncomfortable, is febrile and tachycardic, however remaining vitals are stable. Physical exam is also reassuring. Patient not complaining of any chest pain, shortness of breath, lightheadedness. Will provide patient with symptomatic relief including fluids and ibuprofen, if able to improve patient's symptomatology will have him discharged home. His labs also show some slight hyponatremia, he will likely improve from fluids as I believe this is secondary to his diarrhea that he has been having over the last few days. CK also slightly elevated, would likely benefit from fluids. After a single liter of fluids, patient symptoms improved, fever and tachycardia also improved, continues to endorse some generalized weakness, will give second liter of fluid and Tylenol at this time as he is due for this. After receiving a second liter, the patient states that his symptoms have greatly improved at this time, comfortable returning home. I advised the patient that she should take ibuprofen and Tylenol on 6-hour cycles very regularly, he can take it in a pattern where he takes Tylenol followed by ibuprofen 3 hours later followed by Tylenol again 3 hours later, as long as he keeps 6 hours in between doses, explained to him that he should not take this any sooner than this however he should be sure to take these regularly as these will help control his fever. Also encouraged him to hydrate appropriately as this will likely prevent him from feeling poorly. He is agreeable with this plan, I provided him with appropriate return precautions.
54 2021-05-25 sleepiness, fever, chills, fatigue ALMOST EXACTLY 24 HOURS LATER, FEVER 101, COLD CHILLS, TIRED, SLEEPY. SLEPT 2 HOURS WHEN I GOT HOM... Read more
ALMOST EXACTLY 24 HOURS LATER, FEVER 101, COLD CHILLS, TIRED, SLEEPY. SLEPT 2 HOURS WHEN I GOT HOME FROM WORK . GOT UP FROM NAP AND WENT TO BED. ALL NORMAL IN THE MORNING.
54 2021-05-26 chills, fatigue Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) ... Read more
Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) . A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318) via an unspecified route of administration in left arm on 01Feb2021 at 07:30 (at 54 years) at single dose for covid-19 immunisation. Medical history included kidney donor.No known allergy. There were no concomitant medications. On 01Feb2021 at 10:00 the patient was extreme tired and experienced chills and arm pain.No treatment given and patient recovered from the events in Feb2021.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201495 same patient, different drug/AE
54 2021-05-27 chills Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client w... Read more
Client received the 2nd COVID vaccine (Pfizer Lot # EW0185 and 06/19/2021) at 1906. At 1917 client was sitting in the observation area when he suddenly ran to one of the trash cans and started throwing up. PHN and EMT responded and assisted client into a chair and gave him an emesis bag. The client threw up one more time into the bag. Client stated that he ?suddenly felt nauseas, almost feels like a nervous reaction.? Client stated, ?I felt chills down my spine that traveled into my arms and my fingers tingled and my ears got hot. It felt like a hotflash.? Client was alert and oriented times four, and his skin was warm, and color was appropriate to race. Vital signs were taken at 1919 (blood pressure 110/78, heart rate 76, oxygen 96%). Client stated at 1921 ?I?m feeling better now,? and that the nausea had subsided. Vital signs were taken at 1924 (blood pressure 122/72, heart rate 73, oxygen 94%). Client was offered Benadryl by PHN and client refused. Client stated that he was feeling worried about receiving his second dose of the vaccine, ?we know someone who got their second dose a couple weeks ago and was paralyzed from it.? Client also stated that he was working outside in the sun all day. Vital signs taken at 1934 (blood pressure 122/80, heart rate 75, oxygen 96%). Client offered juice by PHN and he accepted and drank it. Client does not have any medical conditions, is not on any medications, and does not have any allergies. PHN advised client to follow up with his primary care provider, and education was provided to client on life threatening symptoms and to seek emergency services if he developed any. At 1947 client stated, ?I?m feeling fine,? and he left the facility unassisted with a steady gait.
54 2021-05-27 cough Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted for another diagnosis and found to have COVID-19 infection two days after vaccination. Vital signs on admission stable except blood pressure slightly elevated. Patient reported shortness of breath with exertion, dry cough, and mild dyspnea at rest. Received cough suppressants and supportive care. Patient discharged medically stable two days later.
54 2021-05-27 sluggishness, chills Severe chills, went to bed and slept well. Felt better in morning. Sluggish later in afternoon; to... Read more
Severe chills, went to bed and slept well. Felt better in morning. Sluggish later in afternoon; took very long nap and felt substantially better. Also, off and on for several days was soreness and skin sensitivity especially on right nipple area.
54 2021-05-28 malaise, nasopharyngitis Could he get the virus from the vaccine; a bad cold and yucky stuff coming out; sick; didn't feel we... Read more
Could he get the virus from the vaccine; a bad cold and yucky stuff coming out; sick; didn't feel well; This is a spontaneous report from a contactable consumer. A 54-years-old male patient received first dose bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number EM9809 and expiration date were not reported), via unspecified route on left arm on 25Feb2021 at 10:00 AM at single dose for covid-19 immunization. The patient's medical history was diagnosed myasthenia gravis (six to seven years). The patient's concomitant medications include Mycophenolate four 500 mg pills per day for Myasthenia gravis. On 28Feb2021, the patient had been sick with a bad cold with yucky stuff coming out. He didn't feel well most of the day on Sunday, 28Feb2021. The reporter wanted to know whether the patient could get the virus from the vaccine and should she have him tested. He doesn't have a fever. Information regarding sample of the product available to be returned, if requested was not provided and information regarding packaging sealed and intact was not provided. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks and no adverse events following prior vaccinations. The outcome of the events was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
54 2021-05-29 chills, headache, fever Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths ... Read more
Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths More Pain when lying down, cant turn on the side Eye Pain with Headaches
54 2021-05-30 headache, fatigue Started with tiredness, headache,bodyaches.
54 2021-06-01 headache headaches cerebral hematoma necessitating brain surgery
54 2021-06-02 fatigue, headache Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and b... Read more
Approximately 24 hours after second Pfizer vaccine dose, patient reported having severe vision and balance problems, headache and severe fatigue and memory loss. Vision symptoms included hallucinations, tunnel vision and blurred. Unable to stand up without staggering. Confusion. Difficulty verbalizing thoughts. Treated with ivermectin, D3, Z, quercitin, aspirin and other supplements on advice of doctor. Symptoms persisted in severe form for 48 hours, then began to improve. At 6/3/2021, blurred vision while reading, higher than normal heart rate during exercise, fatigue and intermittent memory loss. Being treated by doctor and kinesiologist for brain injury from vaccine
54 2021-06-02 headache, malaise, fever Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel... Read more
Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown. No follow-up attempts are needed. No further information is expected.
54 2021-06-02 headache Minor - headache, whole body muscular pain Acute - swollen lymph node, left armpit, big (~4") and v... Read more
Minor - headache, whole body muscular pain Acute - swollen lymph node, left armpit, big (~4") and very painful
54 2021-06-03 headache Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patie... Read more
Right arm sore; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 at 08:30 (at the age 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included simvastatin (ZOCOR) from an unknown date. On 17Mar2021, 22 hours post vaccination the patient experienced sore in right arm and had slight headache. The patient did not receive any treatment for the events. The clinical outcome of events sore in arm and headache were resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.
54 2021-06-05 sweating The patient developed severe arthralgias of multiple joints including bilateral knees, wrists, shoul... Read more
The patient developed severe arthralgias of multiple joints including bilateral knees, wrists, shoulders 2 days after the second dose of Covid 19 vaccine. The patient has had progressive pain of multiple joints, and migratory arthralgias for 2 weeks. He was evaluated 5/25/2021 initially and no source for his symptoms was found. Throughout the 2 weeks he has had no headaches, dizzyness, lateralizing neurological symptoms, but he did have profuse diaphoresis and mild myalgias. 3 weeks after the onset of symptoms patient has been diagnosed with Parvovirus infection reactivation due to the vaccine. He is responding to Prednisone 60 mg x 2 days, 40 mg x 3 days, 20 mg daily for 5 days and taper as tolerated. Patient also received Doxycycline for tick borne illness treatment until labs were negative. He received Percocet for pain management and Tramadol.
54 2021-06-07 fatigue, headache fatigue, dizziness, and headache for three days
54 2021-06-07 headache, cough, sleepiness Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a... Read more
Temperature ranging up to 102.6; body ache; headache; extreme weakness; cough; sleepiness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EN6198) via an unspecified route of administration in arm left on 05Mar2021 at 15:15 (at the age of 54-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot Number: EM9809) via an unspecified route of administration in arm left on 12Feb2021 (at the age of 54-year-old) at 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested covid post vaccination. On 06Mar2021, the patient experienced Temperature ranging up to 102.6, body ache, headache, extreme weakness, cough, sleepiness. Patient did not receive treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.6 on 06Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
54 2021-06-07 headache, fatigue SATURDAY HE BEGAN WITH TIREDNESS AND LOSS OF APPETITE.,PT BEGAN HAVING HICCUPS, HEADACHE, ABDOMINAL ... Read more
SATURDAY HE BEGAN WITH TIREDNESS AND LOSS OF APPETITE.,PT BEGAN HAVING HICCUPS, HEADACHE, ABDOMINAL DISTRESS, BLOOD IN HIS URINE, STOOL AND EMISIS.
54 2021-06-08 headache Itchy reaction and very minor bleeding at the same location after the first dose; Itchy reaction and... Read more
Itchy reaction and very minor bleeding at the same location after the first dose; Itchy reaction and very minor bleeding at the same location after the first dose; Constant minor headache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 06Apr2021 15:00 (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE for COVID-19 immunization at the public health clinic/veterans administration facility. Medical history included high blood pressure. Concomitant medication included fluocinolone acetonide (FLUOCINOLONE ACETONIDE) taken for an unspecified indication and therapy date. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. It was reported that the patient had itchy reaction and very minor bleeding at the same location after the first dose on 09Apr2021 and stopped after a day (10Apr2021). The patient also had constant minor headache on 09Apr2021 which disappeared after the second dose (on 04May2021). The patient did not receive any treatment for the events.
54 2021-06-09 chills, headache, fever Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved afte... Read more
Patient had mild symptoms after the second dose, classic fever, body aches, etc. which resolved after 1-2 days. Then 1 week later, he had more fevers and chills with worsening body aches, particularly right leg pain and worsening headaches and nausea. Rash developed on right lower extremity in an S1 dermatomal distribution, with severe neuropathic pain associated. PCR panel revealed Varicella Zoster Virus. Patient also presented with meningitis symptoms including headache, nuchal rigidity, and photophobia. PE positive for Kernig and Brudzinski signs.
54 2021-06-09 fatigue, fever, sinus congestion I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Genera... Read more
I began to feel the onset of the AE the next morning at around 3:00 AM after the vaccination. Generalize pain throughout my body, muscle aches, slight fever, muscular skeletal pain and general feeling of being extremely tired, and I feel like I have brain fog . Asthma and fibro maylagia are worse since I had the vaccination, sinuses I'm constantly congested. I feel more tired now than I did previously. I will never take this Pfizer vaccination again. My symptoms are not as bad as the week after the vaccination but I have not felt normal or as I did prior to the vaccination.
54 2021-06-09 lethargy, headache Headache; Nausea; Lethargy; This is a spontaneous report received from a non-contactable consumer (p... Read more
Headache; Nausea; Lethargy; This is a spontaneous report received from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via unspecified route of administration in left arm on 09Mar2021 02:00 PM (at the age of 54-year-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history was not reported. No COVID prior vaccination was reported. The patient's concomitant medications within 2 weeks included atorvastatin (LIPITOR) 40 mg, from unspecified date at 40 mg, daily. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 10Mar2021 10:00 AM the patient experienced headache, nausea, and lethargy. No treatment was received due to the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.
54 2021-06-10 malaise, fatigue General malaise; Fatigue; Dizziness; bodies aches and pains; occasional diarrhea; This is a spontane... Read more
General malaise; Fatigue; Dizziness; bodies aches and pains; occasional diarrhea; This is a spontaneous report from a contactable consumer (patient) and another consumer received from a Pfizer-sponsored program. A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 03Mar2021 07:15 (at the age of 54 years old), as first dose, single dose for COVID-19 immunization. Medical history included asthma and IPT. The patient had no known allergies. Concomitant medication included ongoing acetylsalicylic acid (ASPIRIN). On 04Mar2021, 05:00 AM, the patient experienced general malaise and fatigue at times increasing in waves mixed with dizziness over the past 10 days, to the point where rest was required. First 3 days, bodies aches and pains, occasional diarrhea. The patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient informed that he was scheduled to have his second dose on 02Apr2021. He mentioned he is currently taking low dose Aspirin 80 mg and wanted to know if he should stop taking it before the vaccine. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
54 2021-06-12 headache Arm swelling with pain extending up my neck and culminating with a headache. More than a month after... Read more
Arm swelling with pain extending up my neck and culminating with a headache. More than a month after 1st shot I still have neck pain.
54 2021-06-13 sweating, lethargy Heart palpatations started roughly 1 week after second dose, followed by shortness of breath and swe... Read more
Heart palpatations started roughly 1 week after second dose, followed by shortness of breath and sweating. Overall lethargic until 2 weeks after second dosage.
54 2021-06-14 body temperature increased Taken @ 7.30pm. By noon the next day, strong muscle aches over all body, a temperature of 102.00 (wi... Read more
Taken @ 7.30pm. By noon the next day, strong muscle aches over all body, a temperature of 102.00 (with Tylenol) and body weakness that lasted 24 hours, fatigue. Painful injection site that lasted several days.
54 2021-06-15 paranasal sinus discomfort, head discomfort Head/sinus pressure. Ears ringing loudly, tinnitus. Head fog, dizziness, mild confusion. At times, c... Read more
Head/sinus pressure. Ears ringing loudly, tinnitus. Head fog, dizziness, mild confusion. At times, can hear my eyes move. Can get dizzy just looking around the room now.
54 2021-06-16 throat irritation, throat pain severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and ... Read more
severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching; chest pain radiating into neck; chest pain radiating into neck/ left side of neck swelling and aching; both armpits swelling and itching extreme/ left side of neck swelling and aching; inside of right elbow were itching, swelling and medium pain; inside of right elbow were itching, swelling and medium pain/ severe pain in both shoulders which radiated down to hips; both wrists were itching and both hands were swelling with severe pain; wrist itching/ both heels were itching/ inside of right elbow were itching, swelling and medium pain/ both armpits swelling and itching extreme; hand swelling/ toes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Batch/Lot Number: ER8736) (at the age of 54-years-old) as 2nd dose, single for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medication included methylphenidate hydrochloride (RITALIN) 20mg ER. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in left arm on 29Mar2021 08:45 (Batch/Lot Number: EN6204) (at the age of 54-years-old) as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 09:00 (day after injection) on the same arm, the patient experienced wrist itching and hand swelling (left). On the next evening on 28Apr2021, both wrists were itching and both hands were swelling with severe pain, lasted 3 hours then they went away completely. The next day on 29Apr2021 at 03:00, both heels were itching, toes were swollen mildly with almost no pain. The next day on 30Apr2021, inside of right elbow was itching, swelling and medium pain. The next day on 01May2021, there was nothing. The next day on 02May2021, both armpits swelling and itching extreme with severe pain in both shoulders which radiated down to hips after 1 hour started to go to emergency room (ER) but it all vanished completely. Sometimes the patient got a day break but otherwise, since 27Apr2021 this had happened to some part of his body (most commonly in hands) up to Friday 28May2021. The patient was put on second round of steroids and now antihistamines and he hadn't had any symptoms for 2 days. The severe itching and pain also occurred at other locations such tongue, inside of cheeks, throat, and chest pain radiating into neck, left side of neck swelling and aching. The patient had never had similar symptoms before. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment medications to lessen swelling and pain. The outcome of events was unknown.
54 2021-06-18 fatigue extreme fatigue and nausea
54 2021-06-20 chills, fever, fatigue Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fev... Read more
Came to ED due to progressively worsening intermittent pleuritic chest pain, fatigue, subjective fevers and chills of x6 days duration. At ED patient found to have elevated troponins and non-specific ST and T wave changes on ECG. cardiology consulted who recommended continuing colchicine + ibuprofen therapy.
54 2021-06-21 fatigue Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, complete... Read more
Chest pain, shortness of breath, wheezing, fatigue. Sx severe for several days, then waned, completely recovered as of 6/22/2021
54 2021-06-22 fatigue Chest pains, exhaustion after minor physical activity, dizzyness
54 2021-06-23 headache 1. Severe headaches daily starting every night. Treatment for the headache is taking two 200 mg I... Read more
1. Severe headaches daily starting every night. Treatment for the headache is taking two 200 mg Ibuprofen. 2. Light headiness/dizzy spells. Treatment for it is rest. 3. Pain in left arm pit. No treatment other than the 200 mg Ibuprofen in item number one. 4. Blurred vision.
54 2021-06-24 fatigue, fever, chills chills; Low grade fever and next day fever of 101.5; feeling fatigue; This is a spontaneous report f... Read more
chills; Low grade fever and next day fever of 101.5; feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: 0172) via an unspecified route of administration in the left arm on 24Apr2021 at 1700, as a single dose for COVID-19 immunisation. It was reported that patient had no medical history. Concomitant medication included flonase nasal steroid (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 25Apr2021, the patient experienced fatigue. On 26Apr2021, the patient had low grade fever and on 28Apr2021, the patient had fever of 101.5 and chills. On 29Apr2021, the patient started to experience fatigue and fever again. The clinical outcome of the events fatigue, fever and chills were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-06-24 headache Headache; Significant increase in pain; This is a spontaneous report received from a contactable con... Read more
Headache; Significant increase in pain; This is a spontaneous report received from a contactable consumer, patient. A 54-years-old male patient received 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6955) to arm left on 17Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, spinal stenosis, spinal osteophytosis, chronic pain, hypertension and obesity. Relevant past drug use included Penicillin, Tetracycline and unspecified Sulpha drugs for an unknown indication from an unknown date and experienced drug allergy. Concomitant medications included Ibuprofen (MANUFACTURER UNKNOWN) and Acetaminophen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 17Mar2021 at 19:00, patient experienced significant increase in pain and headache. The patient stated that, he experienced a significant increase in pain in existing injuries and a headache within 7 hours of the dose and that's continued for 3 days. Pain levels were gradually decreasing at the time of the report. The patient reported that he did not receive any treatment for the events and did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. It was also reported that the patient was not diagnosed with COVID-19 prior to vaccination and since vaccination, patient was not tested for COVID-19. The clinical outcome of the events significant increase in pain and headache were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
54 2021-06-24 fever, chills, headache, fatigue fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) b... Read more
fever 101-100 (which resolved now) but having headache; Chills; fever 101-100 (which resolved now) but having headache; joint pain; fatigue; Shortness of breath; bruising at the injection site on right upper arm; swelling at injection site right upper arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL3249, expiration date unknown) 2nd dose, via an unspecified route of administration administered in right upper arm on 02Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, as single dose for COVID-19 immunization. Caller stated that he had his second shot of vaccine on 02Feb2021 in last week and after that he had having side effects from 03Feb2021 as he was having fever 101-100, chills, joint pain, bruising and swelling at injection site and shortness of breath. He stated that that his fever was 101 for the first two days and the third fourth days that it was 100.5. Caller wanted to know if this was normal, and should he go to ER and also mentioned that the fever was resolved now but he still has some joint pain and headache. He also mentioned that due to side effects he has missed four days of work. Therapeutic measures were taken with Tylenol and aspirin to treat the events. On feb2021, the patient underwent lab tests and procedures which included body temperature which result showed fever was 101 for the first two days and the third fourth days that it was 100.5. The outcome of the event Pyrexia was recovered on 05Feb2021 and patient was recovering from the events of chills, dyspnoea and vaccination site swelling and was not recovered from the events of headache joint pain, fatigue, arthralgia and vaccination site bruising. Follow-up attempts completed. No further information expected.
54 2021-06-24 fever High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, ca... Read more
High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
54 2021-06-25 fatigue Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've... Read more
Extreme fatigue, brain fog, constricted chest, chest pain for 4 days after my second dose. Now, I've been experiencing continued ongoing fatigue for 6 weeks. My legs grow heavy each day. I pass out from exhaustion early each night. I have trouble concentrating. I'm experiencing ankle and wrist pain with a feeling of low circulation as my feet and hands fall asleep if I sit too long. I'm also having vivid nightmares on an ongoing basis. Other than a back injury, I was healthy and normal before this vaccine. I have not been to a doctor. I have been resting, focused on eating well and taking 3000mg of Vit C a day.
54 2021-06-25 malaise Wife present with pt and she stated before he received his vaccine that he has been known to pass ou... Read more
Wife present with pt and she stated before he received his vaccine that he has been known to pass out during a vaccine or after getting a vaccine. Pt's wife came and got me from exam room around 2:50p (about 10 mins after receiving vaccine and while pt was sitting in waiting room) stating that he didn't feel well. Pt's face was pale and skin was cool and clammy but alert when I asked him if he'd like to return to an exam room to lay down. He stated that he wanted to stay in waiting room sitting with his wife. I gave pt 2 small bottles of water but he declined them at that time. I started to check his BP and he became unreponsive but eyes still open. This episode last approximately 20-30 seconds and then color return to pt's face and he became responsive and answer questions appropriately. I asked pt again if he wanted to come into an exam room and lay down but he decline again. I advised pt and wife to stay in waiting room and asked his wife to watch for any other symptoms and advised them to stay an additional 15-20 mins. Both verbalized agreement and understanding. Pt's wife said he was feeling better at 3:15pm and after drinking the water I gave him and they left. Pt was alert and ambulatory upon leaving, steady gait.
54 2021-06-27 malaise, headache, fever after the first dose, he came home and that night he had a headache, the nest day he still had a hea... Read more
after the first dose, he came home and that night he had a headache, the nest day he still had a headache and on this day he went to urgent care, after the second day he had a really bad headache was dizzy and had fever he could not get out of bed. he went to urgent care on the second day also. Urgent care suggested he visit his primary doctor. On the third day he visited his PCP, the PCP took xray and MRI and prescribed painkillers. The primary doctor stated it was ok to take the second dose and after taking the second does of the vaccine that was taken at the same location and the lot number is EW0183 he got really sick. He had the same symptoms after the second dose but they became more severe. Also has severe pain in left side down abdomen.
54 2021-06-27 respiratory tract congestion, throat pain The first thing that happened was I got a stomach virus that lasted for 24 hours. I did end up vomi... Read more
The first thing that happened was I got a stomach virus that lasted for 24 hours. I did end up vomiting 4 times, I had an upset stomach the whole time and had to stay in bed as a result. I could tell my voice was going. I ended up with laryngitis, I had no voice for 3 days. My throat was sore and then I began having upper respiratory pain. By Friday, I went to an urgent care. They gave me an antibiotic and said I should be significantly better in 72 hours. I went back on Monday because I was not a whole lot better. They did a COVID test that came back negative. By Wednesday of that week I was quite a bit better but I still had some congestion. By that weekend I was better. It lasted about a week and a half. The most important part to me is that I never get sick. I got two illnesses quite close to each other and the only varying factor was receiving the vaccine.
54 2021-06-29 productive cough, fatigue, runny nose Increase phlegm and mucus; Increased mucus; muscle aches; Sporadic fatigue; This is a spontaneous re... Read more
Increase phlegm and mucus; Increased mucus; muscle aches; Sporadic fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ELP266) via an unspecified route of administration on 13Mar2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma and hypertension. The patient was allergic to iodine and shell fish. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and emtricitabine (MANUFACTURER UNKNOWN) all for an unknown indication and from an unknown date. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Mar2021, the patient experienced increased phlegm, increased mucous, occasional muscle aches and sporadic fatigue. The patient did not receive any treatment for the events. The clinical outcome of the events increased phlegm, nasal mucous increased, occasional muscle aches and sporadic fatigue were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
54 2021-06-29 fever, chills Body aches; Fever (102F); Chills; This is a spontaneous report received from a non-contactable consu... Read more
Body aches; Fever (102F); Chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 54 -year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number. EN6198) via an unspecified route of administration in the left arm on 27Feb2021at 09:00 (at the age of 54-years old) as a single dose for COVID-19 immunisation. On 20Mar2021 at 20:00, body temperature was measured and found to be 102-degree Fahrenheit. On 20Mar2021 at 20:00, the patient experienced a fever of 102-degree Fahrenheit, chills and body ache. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome for the events fever, body ache and body aches were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
54 2021-06-29 fever, malaise, headache, fatigue Fever; Severe body aches; Headache; Diarrhea; Loss of appetite; Tired; Unwell; This is a spontaneous... Read more
Fever; Severe body aches; Headache; Diarrhea; Loss of appetite; Tired; Unwell; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 18Mar2021 at 11:00, the patient experienced initially tiredness and unwell feeling. fever up to 103, severe body aches, headache, diarrhoea and loss of appetite. Three days later severe symptoms started and still ongoing (unknown date) over 4 days later. The patient might seek medical attention if not the condition becomes better. The patient not received treatment for the adverse events. The clinical outcome of the events tiredness, unwell, fever, severe body aches, headache, diarrhoea and loss of appetite were not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
54 2021-06-29 sleepiness sleepiness; Minor ache at shot site; This is a spontaneous report received from a contactable consum... Read more
sleepiness; Minor ache at shot site; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 19Mar2021 at 14:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021 at 19:00, the patient experienced minor ache at shot site and mild sleepiness. No treatment was received by the patient for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain and sleepiness was resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information expected.
54 2021-06-30 fever, headache fever > 102 F 4 - 5 days, fever > 101 F 7-9 days; extreme body/muscle/joint ache; unable to walk 1 d... Read more
fever > 102 F 4 - 5 days, fever > 101 F 7-9 days; extreme body/muscle/joint ache; unable to walk 1 day; severe headache lasting 11-12 days; caused patients first shingles outbreak
54 2021-07-01 cough cough; I have problems with breathing after only 5 or 10 minutes of exercise which I did not have be... Read more
cough; I have problems with breathing after only 5 or 10 minutes of exercise which I did not have before I took the first shot; This is a spontaneous report from a contactable consumer. This 54-years-old male consumer (patient) reported that: A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 19:15 (at the age of 54 year) as single dose for covid-19 immunisation. Medical history included Allergy to penicillin from an unknown date and unknown if ongoing Maybe penicillin but I'm clear on this point. Patient other medical history reported as none and in good health. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient have problems with breathing after only 5 or 10 minutes of exercise on 14Mar2021 at 20:30 which did not have before he took the first shot, also have a small cough which started after the first shot on 14Mar2021 at 20:30 and it seems to have not gone away. Since vaccination patient not tested for covid-19. Patient visited to physician's office for the events. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.
54 2021-07-01 headache Headache; injection site pain.; This is a spontaneous report from a contactable consumer, the patien... Read more
Headache; injection site pain.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8728) via an unspecified route of administration in the right arm on 22Mar2021 at 10:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included unspecified cholesterol medicine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22Mar2021 at 13:00 (three hours after injection), the patient experienced injection site pain. It was reported that, the pain was uncomfortable but was not limiting use. The patient was able to sleep on the site at night. On 22Mar2021 at 20:15 (10 Hours after the injection), the patient had mild headache. Headache and arm pain were ameliorated by ibuprofen one dose before sleeping and another dose five hours later in the middle of the night. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events injection site pain and headache were resolved on unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
54 2021-07-08 fatigue Very tired and achy- took ibuprofen at night before bef
54 2021-07-10 fever, lethargy, cough Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spo... Read more
Lethargy; Body aches; Fever; Dry cough; Congestion in chest; loss of smell last night; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old adult male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, DM type 2. Concomitant medications included, fish oil (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN); used for unknown indication, from an unspecified date. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 24Mar2021 at 18:00, the patient experienced lethargy, body aches, fever, dry cough, congestion in chest and loss of smell last night. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lethargy, body aches, fever, dry cough, congestion in chest and loss of smell was not recovered at the time this report. No follow-up attempts possible. No further information expected.
54 2021-07-12 chills, fever For the first week, he had fever, body aches, and chills. After that, he had chest pain on both side... Read more
For the first week, he had fever, body aches, and chills. After that, he had chest pain on both sides. The pain was also between shoulder blades, stabbing in the chest in the middle of night. He had severe shortness of breath. His feet were cold and he could not sleep most of the nights. Today he said his breathing is okay, slowly getting back to normal.
54 2021-07-12 headache, dehydration Patient passed out at store several hours (2.5) after vaccine administration. He was transported via... Read more
Patient passed out at store several hours (2.5) after vaccine administration. He was transported via EMS to hospital and given fluids and told he was dehydrated. He still complains of headache 4 days later. He did not hit his head when he passed out.
54 2021-07-12 fever, chills, sweating Context: Patient is a 54-year-old male who presents with right-sided flank pain, low back pain and r... Read more
Context: Patient is a 54-year-old male who presents with right-sided flank pain, low back pain and right upper chest pain. Patient has had the discomfort in the right flank radiating up into the right chest for about 2 weeks. He states the pain in his chest is right upper chest, worse with breathing in and out. He also has right flank pain and right lower lateral chest pain worse with breathing in and out. Patient just developed dysuria with urinary frequency over the past 1 to 2 days. He has had subjective fever, chills and significant diaphoresis at night. He does have a history of multiple myeloma. This was treated with a stem cell transplant in February of this year. Patient and his wife report that recent laboratory data was concerning for possible recurrence and he had a bone marrow biopsy done about a month and 1/2-2 ago. He is to have a repeat bone marrow biopsy tomorrow Patient denies any midsternal chest pain. No shortness of breath. No cough or congestion. Patient denies a history of blood clots. Does have a history of heart disease, hypertension, hyperlipidemia. Patient is morbidly obese. Patient sees Dr. - oncology
54 2021-07-13 influenza like illness, fatigue, chills, fever, runny nose, headache BAD flu-like symptoms, severe headache, achiness, tired, runny nose, spiky fever/chills
54 2021-07-14 fever No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11.... Read more
No immediate adverse reaction, however, began developing nightly fevers/profuse sweating on June 11. This continued for two weeks with increasing symptoms of loss of appetite, nausea, abdominal pain, tingling sensation on scalp before going to ER. Visited urgent care on June 16 and bloodwork results indicated elevated white blood cell count and eosinophil count. There was a question as to whether patient had been subjected to a tick bite, so doxycycline was prescribed. After several days, patient returned to urgent care for follow-up bloodwork (June 20th). Results showed WBC and eosinophil count continued to escalate. He went to ER on June 25th and was admitted to the hospital for 5 days. During his visit at Hospital, he was seen by a team of specialists: cardiologist, pulmonologist, hematologist, infectious disease doctor. Multiple tests were run, as the doctors started broad to eliminate certain diagnoses - i.e., bone marrow biopsy, heart cath, CT scans, x-rays, thoracentesis, etc. Patient had fluid around his heart and lungs and was diagnosed with myocarditis. He had no previous heart issues nor family history of heart issues. Test results indicated no abnormal blockage or other issues, other than inflammation and his heart strength was at 27%. I am unable to access his account, as it was disabled after his death. An autopsy is being performed and results are pending; however, the question(s) at large: what was the condition of his heart at the time of his death and was this vaccine-related? Did his myocarditis get worse? Did his heart muscle weaken further and rupture? Please let me know if the autopsy results are needed and where to send them.
54 2021-07-17 headache headache/progresses to bad headache after a week; dizziness; This is a spontaneous report from a con... Read more
headache/progresses to bad headache after a week; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Mar2021 at 12:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. The concomitant medication included High blood medicine and ibuprofen (MANUFACTURER UNKNOWN).Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 08Mar2021 at 04:00, the patient experienced headache and then headache progresses to bad headache after a week. On an unknown date in Mar2021, (last week as reported) the patient had dizziness when he moves, the patient still had and reported that he was not able to report to work. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measure taken as a result of the event headache included ibuprofen (MANUFACTURER UNKNOWN) taken three times everyday. The clinical outcome of the event headache/progresses to bad headache after a week and dizziness was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-07-17 sweating, fever, malaise I am not feeling well; I am having the fever; there is a mess with my breathing; I am keep sweating ... Read more
I am not feeling well; I am having the fever; there is a mess with my breathing; I am keep sweating up under the fan. I keep sweating. I am breaking in sweat.; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: FA6780, Expiry date: unknown, at the age of 54-year-old), dose 1 via an unspecified route of administration on 29Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she was having some side effects. She was not feeling well. There is a mess with her breathing, little bit. She was having fever and kept sweating up under the fan. She was breaking in sweat all on 30Jun2021. Outcome of the events was unknown.
54 2021-07-18 malaise Symptoms of COVID which developed on 07/15/2021,
54 2021-07-19 fatigue Sleeplessness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 5... Read more
Sleeplessness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to walnuts. Concomitant medications included unspecified anaesthetic (MANUFACURER UNKNOWN) started on an unknown date for root canal procedure at dentist and ibuprofen (IBUPROFEN) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 04:00, the patient experienced sleeplessness. The patient had been unable to sleep for more than a few hours at a time. At first, the patient thought it was psychological (excitement/ anxiety) but this had persisted for weeks and it was unprecedented since the first shot. The patient also reported that he was usually exhausted by mid afternoon or early evening and often took a nap. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 30Mar2021 at 09:45 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events sleeplessness and exhausted was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
54 2021-07-20 headache, fever After taking the vaccine, I didn't have any symptoms. The next day, my arm got a little sore later o... Read more
After taking the vaccine, I didn't have any symptoms. The next day, my arm got a little sore later on in the day. That day at night, I started to feel a little headache. The next day after that, I started to get a little fever and a little headache. After that, everyday I was getting a headache and a fever for over a week. I went to the hospital and they said I had covid.
54 2021-07-21 fatigue extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a con... Read more
extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included slightly high Blood Pressure (BP), slightly high low-density lipoprotein (LDL) cholesterol and cigarette smoker. The patient was not allergic to any medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lisinopril dihydrate (LISINOPRIL) and zolpidem (MANUFACTURER UNKNOWN), all for an unspecified indications and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 07:00, day 6 after the vaccination, the patient felt extremely tired, had hoarse speech and developed a cold sore on lip. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events extremely tired, hoarse speech and cold sore on lip were recovered on 31Mar2021 (day 7.75 after the vaccination). No follow-up attempts are needed. No further information is expected.
54 2021-07-22 lethargy, influenza like illness Flu-like symptoms that persisted more than two weeks. Body aches. Nausea. Lethargy. Sadness. Hopeles... Read more
Flu-like symptoms that persisted more than two weeks. Body aches. Nausea. Lethargy. Sadness. Hopelessness.
54 2021-07-25 fatigue, lethargy, influenza like illness About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightnes... Read more
About 1 hour after the first vaccine shot, I started to have typical symptoms -- achy body, tightness of breath, basic flu like symptoms. About 3 hours after the vaccine I started having sharp pain (like 8 or 9 on a scale of 1-10) running down the insides of my legs. It felt like lightning was running through my body. I tried to sleep Friday as well as the weekend, and the pain was intense. I had to limit and stop all exercise, and to-date, I can only walk for limited times before I feel pain in my legs again. I have also long-term lethargy and tireness, and find I am sleeping 12-16 hours a day. Prior to Covid vaccine, I would only sleep 4-6 hours a night.
54 2021-07-26 malaise, body temperature increased, fatigue Malaise, fatigue, body aches, non-bloody diarrhea, dizziness, lightheadedness, disoriented, oral Tma... Read more
Malaise, fatigue, body aches, non-bloody diarrhea, dizziness, lightheadedness, disoriented, oral Tmax 100.4
54 2021-07-27 chills feeling hot; flushed with chills; strong stomach pain; Chills; This is a spontaneous report from a c... Read more
feeling hot; flushed with chills; strong stomach pain; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrochloride (MANUFACTURER UNKNOWN) 150 of unspecified units and omeprazole (MANUFACTURER UNKNOWN) 20 of unspecified units, both from an unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 12:00, the patient experienced feeling hot, flushed, stomach pain and chills. Its reported that the patient felt hot and flushed with chills and strong stomach pain lasting all day (it was day 12 of it at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the reported events and included treatment with tylenol (MANUFACTURER UNKNOWN) and pepto bismol (MANUFACTURER UNKNOWN). The clinical outcome of the events of feeling hot, flushed, stomach pain and chills were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
54 2021-07-27 cough, throat pain, fatigue dizziness; Phlegm dark in color; Extremely tired and fatigued; Little bit of a cough; felt like sore... Read more
dizziness; Phlegm dark in color; Extremely tired and fatigued; Little bit of a cough; felt like sore throat; He felt like he got the flu; This is a spontaneous report from a contactable consumer or other non hcp. A 54-year-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: ER8735)), dose 1 via an unspecified route of administration, administered in the right arm on 14May2021 11:00 in the morning, Friday (age at the time of vaccination 54-Year-old), as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient stated he was calling regarding the Covid 19 Pfizer vaccine and wanted to report his side effects. On an unspecified date May2021, the patient had felt like sore throat and he felt like he got the flu. On 17May2021, Monday, the patient had extremely tired and fatigued, little bit of a cough and has stayed the same. 18May2021, Tuesday, the patient had phlegm dark in color on Tuesday and Wednesday. On 19May2021, Wednesday, the patient had dizziness. It started Monday and has slowly progressed. It gets worse and worse every day. Was just a couple of moments where he would stand up and feel out of sync. It had not happened yet today. Just a couple of times when he coughed, he felt like he had a sore throat. Lives in the northwest and there are allergies all around them. He put it off at first as allergies, but this doesn't feel like allergies. Patient received the treatment as Ibuprofen. The patient did not go to emergency room and physician office. The pressure from everybody. He all-ready got COVID once before and thought he was pretty good. Everyone at work wants them to get it. Wants to go out and live life again. If he gets the vaccine, he can go places. The clinical outcome of the events extremely tired and fatigued, little bit of a cough, was not recovered, remaining all the events was unknown. Information Lot/Batch number is available; Further information has been requested.
54 2021-07-27 headache Ringing in ears; Slight headache; Moderate neck ache; General feeling of unease/anxiety; This is a s... Read more
Ringing in ears; Slight headache; Moderate neck ache; General feeling of unease/anxiety; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Mar2021 at 01:15(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the adverse event. The clinical outcome of the events ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
54 2021-07-27 malaise, fever pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. ... Read more
pt developed fever later the day after getting his covid vax so he took ibuprofen and went to bed. Next day he went back to work. Pt showed no symptoms until the month of June when he started complaining about pain in both arms. He was using a heating pad on his shoulders to help with the pain. He was taking Aleve for the pain but it was not helping so he no longer wanted to take it. He had a vomiting episode on the afternoon of June 16th stating he thought he has eaten a bad lemon. He wasn't feeling well the morning of June 18th, 2021 but continued working. He only wanted something light to eat since he didn't feel well and was headed to bed. When his wife went to go to bed she found him collapsed on the bedroom floor with face forward in the bed. She turned him around and found him unresponsive. She contacted 911 and he was taken to Medical Center ER. They were not able to revive him. County conducted an autopsy where they found a blood clot in left artery.
54 2021-07-27 fever, fatigue, sleepiness Tired; Slept most of the day; Strong muscle aches; Body aches; Restless all night; Low grade fever; ... Read more
Tired; Slept most of the day; Strong muscle aches; Body aches; Restless all night; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), allium sativum extract (KYOLIC GARLIC), ascorbic acid, tocopheryl acetate, ubidecarenone, zinc oxide, cupric oxide, betacarotene, selenium, manganese sulfate (COQ10), cyanocobalamin (VITAMIN B12) and colecalciferol (VITAMIN D3), all taken for unknown indications from unknown dates. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 18:00, the patient experienced body aches, was restless all night, slept little and had low grade fever overnight which continued to 12Apr2021. On 12Apr2021, the patient had slept most of the day, had strong muscle aches. On 13Apr2021, the patient felt tired. The clinical outcome of the events body aches, restless all night, slept little, low grade fever, slept most of the day, strong muscle aches and tired were resolved on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
54 2021-07-29 sweating, headache, fatigue Dizziness; Sweating; joint stiffness; fatigue; Severe Headache; Nausea; severe pain at vaccination s... Read more
Dizziness; Sweating; joint stiffness; fatigue; Severe Headache; Nausea; severe pain at vaccination sight; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), in the right arm on 11Apr2021 at 12:30(at the age of 54-year-old), as a dose for COVID-19 immunisation followed by second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) in the left arm on 01May2021 at 12:30 (at the age of 54-year-old), as a dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced dizziness, sweating, joint stiffness, fatigue, severe headache, nausea and severe pain at vaccination site. The clinical outcome of the events dizziness, sweating, joint stiffness, fatigue, severe headache, nausea and severe pain at vaccination sight was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
55 2021-01-05 headache Severe Headache; muscle pain (neck and left shoulder); muscle pain (neck and left shoulder); joint p... Read more
Severe Headache; muscle pain (neck and left shoulder); muscle pain (neck and left shoulder); joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration in the left arm on 30Dec2020 12:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes, hypothyroidism, hypercholesterolemia, and obesity. Concomitant medication included metformin hydrochloride (GLUCOPHAGE), metformin, semaglutide (OZEMPIC), fluoxetine hydrochloride (PROZAC), levothyroxine sodium (SYNTHROID). The patient previously took varenicline tartrate (CHANTIX) and experienced nightmare and allergies to varenicline tartrate. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 13:30, the patient experienced severe headache, muscle pain (neck and left shoulder), and joint pain. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020. The events were considered non-serious. The following information on the batch number has been requested.
55 2021-01-05 fever, fatigue, cough Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleepi... Read more
Woke up very fatigued 12/25 only minimal activity performed creating additional fatigue. Was sleeping 12 plus hours a day without feeling rested in the least. No problems with sleep. Also had heaviness of chest - felt like rib cage made of iron- this dissipated by the 28-29th. No excessive cough or fever, did have dyspnea with any exertion and this continues but seems to be lessening. Was not able to work due to fatigue. Yesterday remained tired but felt noticeably different-felt lighter-and today seems promising.
55 2021-01-06 chills chills and body aches
55 2021-01-06 headache, fever fever, headaches, muscle aches
55 2021-01-07 fever Joint pain; Pain at injection site; Fever of 100.4; This is a spontaneous report from a contactable ... Read more
Joint pain; Pain at injection site; Fever of 100.4; This is a spontaneous report from a contactable healthcare professional. A 55-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 17Dec2020 14:00 in right arm at single dose for COVID-19 immunization. Medical history included allergies to Ovaltine from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin calcium (LIPITOR). On 25Dec2020, the patient experienced pain at injection site x 2 days, fever of 100.4 and joint pain at day 7. The facility where the most recent COVID-19 vaccine was administered was in a military base. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event pain at injection site was recovered in Dec2020 and the outcome of the remaining events was recovered on unspecified date. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
55 2021-01-08 headache, fatigue Headache, Tachycardia, Fatigue, dizziness Narrative:
55 2021-01-08 headache, sweating Headache sweating, feeling hot Narrative:
55 2021-01-08 sweating Sweaty/Clammy, vomiting Narrative:
55 2021-01-09 fever, chills, headache Headache, Myalgia, Fever, lump under left arm axilla the size of a baseball or bigger, not red, not ... Read more
Headache, Myalgia, Fever, lump under left arm axilla the size of a baseball or bigger, not red, not hot, but very painful, also had chills yesterday, fever was at 102F Narrative: Has appt to see Occ Health provider today to evaluate the lump. Occupational health evaluated the mass, it appears to be fluid filled and may be larger than a baseball, it is substantial, the employee was sent to the ED for further evaluation to rule out infection or other possible diagnosis. Patient will need an ultrasound, CT scan, blood work, etc.
55 2021-01-10 malaise, fatigue general ill feeling, muscle aches, fatigue
55 2021-01-11 chills, fatigue Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on ant... Read more
Severe left knee pain and stiffness without trauma. No redness or swelling. Feeling of heat on anterior of both lower extremities. Associated with chills and moderate fatigue.
55 2021-01-11 fatigue, chills Extreme Chills, Muscle Aches, Tiredness, Joint pain throughout the body. Rest and Motrin used. Lengt... Read more
Extreme Chills, Muscle Aches, Tiredness, Joint pain throughout the body. Rest and Motrin used. Length: 48hrs
55 2021-01-11 influenza like illness Had flu/covid like symptoms for 7 days ...Just now feeling better on 1/12/21
55 2021-01-12 headache, chills The evening after pt received vaccine, he started with chills, body aches and minor headache that tu... Read more
The evening after pt received vaccine, he started with chills, body aches and minor headache that turned into explosive diarrhea and violent vomiting. There were a jaundice color to his skin. Pt was recommended to seek care with PCP, clinic or ER.
55 2021-01-12 headache, fatigue, sluggishness, chills Chills, achey joints, headache, backaches, swollen glands under right armpit, tired and sluggishness... Read more
Chills, achey joints, headache, backaches, swollen glands under right armpit, tired and sluggishness.
55 2021-01-12 headache Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: missed one day of work following second do... Read more
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: missed one day of work following second dose due to above symptoms
55 2021-01-12 malaise, headache, chills Total Body Malaise, chills, headache
55 2021-01-12 malaise, headache Total body malaise, headache, chills
55 2021-01-14 chills, fever mass in left brachial lymph nodes 11cmX8cmX5cm i also have fever chills and night sweats body aches
55 2021-01-15 fatigue fatigue arm pain, metallic taste, jaw pain, abdominal cramping, loose stool
55 2021-01-15 fever Fever on day 2 despite preemptive ibuprofen, max 100.8F, lasted 4 hours
55 2021-01-17 chills, fatigue 1st day after chills, minor. 2nd day fatigue all day, swelling of face noticed by wife in the evenin... Read more
1st day after chills, minor. 2nd day fatigue all day, swelling of face noticed by wife in the evening, moderate. Can not hear out of one ear. 3rd day, 4am get up to go to work. Still can't hear from one ear and my eyes are swollen almost shut face swollen. By 1100am it had gone down just a bit. Went see family doctor for assistance. He prescribed, Prednisone 20mg twice a day for three days. Benadryl 25mg every 6 hrs until swelling comes down. There may be some breathing difficulty but it is so far very minor unless exertion happens, then it's noticable.
55 2021-01-17 fatigue, chills severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contact... Read more
severe body aches; severe chills; night sweats; Fatigue; This is a spontaneous report from a contactable Physician (patient). A 55-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose bnt162b2 in Dec2020 three weeks ago at 12:00 noon in the left arm for covid-19 immunization and experienced mild pain at the injection site which lasted two days and then was gone. The patient experienced severe body aches, severe chills, night sweats, and fatigue on 07Jan2021. Event details: The patient reported that he received the first dose of the Pfizer COVID 19 vaccine three weeks ago at 12:00 noon in the left arm. He did not know the exact date. After the first dose there was mild pain at the injection site which lasted two days and then was gone. He received the second dose of the Pfizer COVID 19 vaccine on 06Jan2021 at 12:00 noon in the left arm. He noticed 12 hours later severe body aches, severe chills, and night sweats. He also felt fatigue. Everything had mostly resolved except for the night sweats and they were still pretty severe. All events were reported as serious by reporter per medically significant. The outcome of event night sweats was not resolved, outcome of other events was resolved on 10Jan2021. Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported severe body aches, severe chills, fatigue and night sweats, and the administration of the COVID 19 vaccine, bnt162b2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
55 2021-01-17 fever Slight fever. Severe left arm pain with arm pit swollen gland.
55 2021-01-17 throat irritation after 2 and a half hours of getting the vaccine, my throat got irritated. As I mention before I do ... Read more
after 2 and a half hours of getting the vaccine, my throat got irritated. As I mention before I do at times get sinuses nasal drip, but I didn't have it at the time of the vaccine.
55 2021-01-19 headache Headache and stoke
55 2021-01-21 fatigue Have had joint pain and fatigue since the vaccine 2nd dose. More so in the right elbow than other jo... Read more
Have had joint pain and fatigue since the vaccine 2nd dose. More so in the right elbow than other joints. Wrists, elbows, hip, ankle joints pain. Getting tired very quickly when trying to workout though I worked out 4-5 days a week up until the 2nd vaccine dose.
55 2021-01-21 headache, chills, fever, sleepiness Severe chills began at about 11 hours (11:30 pm) and lasted 4 hours(3 am). Following morning (6:00 a... Read more
Severe chills began at about 11 hours (11:30 pm) and lasted 4 hours(3 am). Following morning (6:00 am) severe headache, drowsiness, heartburn, low grade fever. Drowsiness, heartburn, fever lasted until around 11 pm. Headache is still present, but very minor.
55 2021-01-21 headache, fatigue Itching, a slight rash , headache and really tired
55 2021-01-21 malaise, fatigue had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ ... Read more
had vaccine 12/30. About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ legs. did not have breathing problem. pain and limited range motion lasted until 1/7/21. I called health clinic and they told me to call cdc number on vaccination card. That number sent me to reporting center, no help. Called family physician, they said they knew nothing about vaccine. Since i wasn?t having breathing problem i just dealt with pain and took Tylenlol couple times each day. Took second dose vaccine 1/20/21.
55 2021-01-22 fatigue, sweating 12 hours after injection: 12 hours after injection and then resolved the next day: drenching night s... Read more
12 hours after injection: 12 hours after injection and then resolved the next day: drenching night sweats severe joint pain especially in hips and knees - even ribs hurt passed out and disoriented significant contracture of bilateral upper extremities from elbow to hands when I could not open them for over an hour rt ear tinnitus numbness in hands and feet tiredness
55 2021-01-24 body temperature increased Patient developed a temperature of 102.9 orally at 5:30 pm. MD notified, APAP 650mg po administered... Read more
Patient developed a temperature of 102.9 orally at 5:30 pm. MD notified, APAP 650mg po administered. Temp at 9:00 pm 99.4. Patient also had poor appetite
55 2021-01-24 headache On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness... Read more
On January 21,2021 developed headache and on January 22,2021, left arm pain, warm to touch, redness and contralateral hand swelling (right )
55 2021-01-25 headache, chills Chills; Bone aches; Minor HA; Diarrhea; Violent vomiting; A jaundice color of skin; This is a sponta... Read more
Chills; Bone aches; Minor HA; Diarrhea; Violent vomiting; A jaundice color of skin; This is a spontaneous report from a non-contactable pharmacist. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), intramuscular on 12Jan2021 at a single dose for COVID-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. On 12Jan2021, the evening after the vaccine was administered, the patient experienced chills, bone aches, and minor HA that then worsened to explosive diarrhea and violent vomiting with a jaundice color of skin. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
55 2021-01-26 headache, chills After dose two - immediate feeling of fogginess then twelve hours later severe chills and headaches ... Read more
After dose two - immediate feeling of fogginess then twelve hours later severe chills and headaches Muscle and joint aches along with headache lasting 48 hours
55 2021-01-26 influenza like illness, sleepiness First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat dow... Read more
First episode 01-15-21, started 10am, i was at work, started feeling weak and brain fog so i sat down and another therapist came into the office and told her how i was feeling, they checked my BP 148/92, went to the ER. They took some blood work, CBC panel were negative, thyroid test, normal, anaiongap, normal, glucose reading, normal and an EKG normal. 2nd episode 01-21-2021 started 11;45am, that morning when i woke up i felt really strong feelings of sadness and despair. At 11;45a i was about to eat and i started to feel again brain fog, total body weakness, elevated BP, they took my BP again and it was 144/88 so i went to the ER again. I could not keep my eyes open. They did a EKG again with a CTA and a CT with perfusion both were normal. They gave me fluids, sodium fluids. Agian it was transient my BP slowly went down and went home. Third episode 01-25-2021 started about 9am, i was at home did not have access to a BP cup, symptoms were same but less intense, i could feel my heart pounding, brain fog and body aches and this lingered throughout the day. It felt like I had the flu. No elevated temperature on all three of my episodes.
55 2021-01-26 sleepiness, fatigue, malaise, influenza like illness It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very ... Read more
It started abruptly, i experienced brain frog and super weak, globally with al muscles and was very fatigues and malaise. I had access to a blood pressure cup the reading was 148/92, usually my BP is 100/60. Once they took my BP, then i went to the ER. As time went on, I got more sleepy and tired. The first ER visit they did lab work, CBC panel which was normal, thyroid test which was normal, EKG and aniongap which were negative. They gave me no medications to take and was probably there in the ER for about 6 hours. which was on 01-15-2021. The second time, it was around 11:45am on 01-21-2021. While sitting at the edge of my bed, I felt a total sadness and despair and feeling of being alone. I then went to work felt normal in the morning and as i went to type some notes after a minute i felt the same symptoms happening again, my BP 140/88 and went to the ER. I was really tired and could of fallen asleep, felt oriented but took me a while to process things. I also had trouble moving my entire body. They placed an IV, gave me fluids, did an EKG again which was normal. They did a CT scan, CTA to my chest and neck and CT perfusion, had to inject contrast, exams were both normal. The doctor came in and told me if I was okay to drive home and I drove home. On the third episode. 01-25-2021 it occurred around 9am, the symptoms came back but with less intense. I lied down and rested., could feel my heart racing just like the other two episodes. This symptom lasted for about two hours and kind of lingered all day but i could still function. i felt like I had the flu, moderate malaise with brain fog.
55 2021-01-27 dehydration, influenza like illness, sweating On 12/31,1/1 exp flu like symptoms. Then on 1/3 got dizzy,sweaty and sat down nurse nearby took my p... Read more
On 12/31,1/1 exp flu like symptoms. Then on 1/3 got dizzy,sweaty and sat down nurse nearby took my pulse 65. The ambulance was called went to a hospital there was no CT scan capability therefore transferred to another hospital.
55 2021-01-27 fatigue Fatigue lasting 24 hours
55 2021-01-28 chills, fatigue, fever, headache Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore ar... Read more
Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
55 2021-01-31 chills, dehydration, fatigue 1/30/21 Evening-2/1-21 Morning Body aches, chills, fatigue, nausea, dehydration
55 2021-02-01 cough, throat pain, fever Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of... Read more
Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021.
55 2021-02-02 fatigue, chills, sweating Very fatigued. Slept all day after vaccine. Broke out in drenching sweats and then chills.
55 2021-02-03 sinus congestion, nasal congestion angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezi... Read more
angio edema of lips and periorbital area; Nasal and sinus congestion; rash on chest and face; wheezing; This is a spontaneous report from a contactable physician. A 55-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 17Jan2021 at a single dose for COVID-19 immunization. Medical history included mixed hyperlipidemia. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on Jan2021 via intramuscular. On 17Jan2021, the patient experienced nasal and sinus congestion, rash on chest and face, angioedema of lips and periorbital area and wheezing. The outcome of the events was not recovered. The patient received an OTC antihistamine and monitored the condition. Information on the batch/lot number has been requested.; Sender's Comments: Based on a chronological association and known product safety profile, a causal relationship between event angioedema and BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
55 2021-02-06 headache Very mild headache, started 3 days after vaccine, comes and goes, but is still happening as of 2/7/2... Read more
Very mild headache, started 3 days after vaccine, comes and goes, but is still happening as of 2/7/21. No treatment done just took 2 Tylenol only twice.
55 2021-02-07 chills Chills; Joint pain; This is a spontaneous report from a contactable other health professional. A 55-... Read more
Chills; Joint pain; This is a spontaneous report from a contactable other health professional. A 55-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in left arm, in Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chills and joint pain both in Jan2021, 6 days after vaccination, with outcome of recovered after several hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-02-07 fever, throat irritation, sleepiness Next day had fever ,throat was scratchy, sleepy
55 2021-02-08 fever 99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to ... Read more
99.7 low grade fever, extreme body aches including aches and pains in feet which made it painful to walk, hand ached which made it hard to make a fist, all joints hurts especially hips and low back. Extremely low on energy causing me to have to sleep longer during the night and nap twice the next day.
55 2021-02-09 fever 2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper ext... Read more
2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through
55 2021-02-10 influenza like illness Flu like symptoms; Body aches; This is a spontaneous report from a contactable consumer (patient). A... Read more
Flu like symptoms; Body aches; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration (left arm) on 21Jan2021 at 00:15 at a single dose for COVID-19 immunization. Medical history included sleep apnea, and prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced flu like symptoms and body aches on 21Jan2021. Since the vaccination, the patient has not been tested for COVID-19. No treatment was administered for the events. The events resolved on an unspecified date in Jan2021.
55 2021-02-10 respiratory tract congestion, cough This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezi... Read more
This was my 2nd shot. (1st shot was 3 weeks prior). Four days after 2nd shot, I developed wheezing and congestion. On my 6th day, I had an asthma attack. I obtain an albuterol inhaler and used it occasionally for the next 3 days. Today, after 11 days, I still have a slight cough but feel like I'm getting my energy back.
55 2021-02-12 fatigue SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. ... Read more
SORE LEFT ARM ON 2ND DOSE, FATIGUE, ITCHY LEFT & RIGHT ARMS AND HANDS, ITCHING NECK AND UPPER BACK. TOOK BENADRYL AND RESOLVED
55 2021-02-15 fatigue, fever, chills, headache Vomiting, Headaches, Fever, Chills, Fatigue
55 2021-02-16 headache, sweating vitals: 15:27 patient complained of dizziness, slight head ache, sweaty, light headed. Dr was made a... Read more
vitals: 15:27 patient complained of dizziness, slight head ache, sweaty, light headed. Dr was made aware, checked BP. 162/114, HR 108, 02 99%. Advised patient lay down and 15:35 bp went down to 156/103, HR 79, 02 100%. at 15:40 while laying BP 144/87, HR 70, O2 100%. 15:45 laying BP 123/75, HR 77, O2 100%. 15:50 while sitting BP is 134/82, HR 82, O2 98%. at 16:00 BP is 129/84, HR78, O2 99%. Patient stated dizziness was gone. Dr charted: dizzy and lightheaded after 1st shot, bp elevated over baseline. Monitored and transfered to stretcher. BP improved and symptoms resolved with rest. No itching, rash, shortness of breath or chest pain. Patient was able to walk around asymptomatic prior release.
55 2021-02-17 chills sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, t... Read more
sore arm; terrible chills; night sweats; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 at 12:15 (at the age of 55 years-old) in the left arm as a single dose for COVID-19 immunisation. Medical history included Behcet's disease and penicillin allergy; from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included adalimumab (HUMIRA), testosterone (MANUFACTURER UNKNOWN), citalopram hydrobromide (CELEXA), dexlansoprazole (DEXILANT), and paracetamol (TYLENOL); all taken for unknown indications from unknown dates and unknown if ongoing. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient previously took sumatriptan (IMITREX) from an unknown date to an unknown date and experienced allergy. On 23Jan2021, the patient experienced sore arm, terrible chills, and night sweats. The patient did not receive any treatment for the events. The clinical outcomes sore arm, terrible chills, and night sweats was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-02-18 fatigue, chills, headache fatigue, muscle pain in left arm, muscle pain and stiffness in neck and upper back, headache, chills... Read more
fatigue, muscle pain in left arm, muscle pain and stiffness in neck and upper back, headache, chills, poor circulation in hands and feet (could not get warm), pain in lymph nodes (under arms, especially left, started 2/18)
55 2021-02-18 headache syncope, headache, slurred speech 2 days
55 2021-02-19 chills, fever, headache 16-17 Feb: low fever (99.8), chills, headaches, dizziness, gas; no meds taken 18 Feb: intermittent... Read more
16-17 Feb: low fever (99.8), chills, headaches, dizziness, gas; no meds taken 18 Feb: intermittent abdominal pain for first 3 hrs upon waking, hasn't re-occurred, no meds taken 19 Feb: rash on chest, triceps, ankles, dissipated by end of day, no meds taken 20 Feb: upon waking had hives in groin area, inside of right arm, wrists, around waist area, dissipated after ~6 hrs, no meds taken 20 Feb: upper lip swollen, so far for 3.5 hrs, 25 mg Benadryl taken at 3 hr mark (1 hr ago), no impact yet
55 2021-02-19 malaise high blood pressure: 188/110; patient felt flushed , unwell and experienced vertigo
55 2021-02-22 fever Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from... Read more
Per H&P and physician notes, patient was admitted to hospital on 2/7/21 with status epilepticus from home. He had received his second dose of COVID19 vaccine on 2/6/21 per Emergency Department note. Patient was febrile on admission (40.7 Celsius) and was intubated. Patient had issues with hypotension, neurologic impairment, and metabolic issues. Received pressors, IV fluids, Keppra, IV antibiotics to cover for possible CNS infection. Lumbar puncture performed. Abnormal EEG on 2/9/21. Recurrent seizure on 2/10/21. Pt extubated on 2/12/21. Blood cultures, urine culture, and CSF culture all no growth. Sputum culture mixed oral flora. As of 2/22/2021, patient tolerating tube feeds, shakes head yes and no responding to questions.
55 2021-02-24 body temperature increased My normal temperature is 97.3 degrees. Since my first vaccine, my temperature fluctuates daily betwe... Read more
My normal temperature is 97.3 degrees. Since my first vaccine, my temperature fluctuates daily between 97.3 and 99.3. I received my second vaccine on 02/08/2021. I haven't discussed this issue with my primary care as I have an appointment scheduled for 03/08/2021.
55 2021-02-24 headache, fatigue fatigue, sore joints, headache, swollen around eyes, blurred vision (2-22)
55 2021-02-28 chills, fever, headache, fatigue Injection site pain Extreme tiredness Headache Muscle, body aches Chills Fever Nausea No appetite... Read more
Injection site pain Extreme tiredness Headache Muscle, body aches Chills Fever Nausea No appetite Swollen lymph nodes Feels horrible
55 2021-02-28 chills, throat irritation, fatigue, cough, headache, runny nose Early morning on 2/27/2021 started experiencing some nausea, cough, runny nose, scratchy throat and ... Read more
Early morning on 2/27/2021 started experiencing some nausea, cough, runny nose, scratchy throat and mild headache. Persisted throughout the day on Saturday and overnight. On Sunday 2/28/2021 had bad headache, joint and muscle pain, cough, extreme fatigue, nausea and chills. Symptoms are persisting into today 03/01/2021.
55 2021-02-28 fatigue, chills Starting about 26 hours after injection I had body aches especially in joints on limbs, chills, and ... Read more
Starting about 26 hours after injection I had body aches especially in joints on limbs, chills, and fatigue. This lasted about 20 hours. I took ibuprofin and acetaminiphin alternating every 4-6 hours for the aches - this dulled the pain but did not eliminate it. Pain went from level 6 to level 4.
55 2021-02-28 headache Slight headaches for several days now. Otherwise feeling ok.
55 2021-03-02 headache PT GIVEN INCORRECT BRAND/DOSE OF COVID-19 VACCINE FOR SECOND DOSE. ORIGINAL DOSE (FIRST DOSE) GIVE... Read more
PT GIVEN INCORRECT BRAND/DOSE OF COVID-19 VACCINE FOR SECOND DOSE. ORIGINAL DOSE (FIRST DOSE) GIVEN WAS MODERNA, LOT 041L20A ON 02/02/2021 AT 1346. CAUSE OF INCIDENT UNDER INVESTIGATION. PT C/O MILD HEADACHE FOLLOWING INCORRECT DOSE WITH NO OTHER SYMPTOMS, EASILHY RESOLVED.
55 2021-03-03 sweating, headache, cough, chills, fatigue, head discomfort Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vac... Read more
Within two hours Swelling on the left arm - upper part and it was painful. The first dose of the vaccine, the pain started the second day and the injection site got swollen. But this second dose was within 2 hours of my vaccine even more and overwhelming fatigue. - aches, chills, muscle cramps, coughing, sweating - those lasted three days; headache - ever present and felt like head was in a vice; breathing was an issue - asthma was triggered on Sunday - I started prednisone - informal dr consultation with a friend - on Tuesday because of the asthma and by Friday I was feeling halfway better again and by the following Sunday about 75% better. 9 days later I was back at work. It took that week back at work though to get back out of the funk and by the following weekend I was close to 90%. Pain in the shoulder lasted about two weeks - it was quite tender for that long.
55 2021-03-04 fever PAIN IN THE BONES, JOINTS, SLEEP, FEVER, RASH ON THE SKIN (LIKE MEASLES), ITCHING ALL OVER BODY. DAY... Read more
PAIN IN THE BONES, JOINTS, SLEEP, FEVER, RASH ON THE SKIN (LIKE MEASLES), ITCHING ALL OVER BODY. DAY 3 AND 4 WAS STRONGER. AFTER TAKING BENADRYL IN PILL AND CALADRYL ON MY BODY, ITCHING WAS REDUCED. EVEN SOMETIMES I HAVE IT, BUT LESS INTENSE.
55 2021-03-07 fatigue Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened... Read more
Extreme fatigue, loopiness, slight vomiting in first two days but not since, shaking hands (happened on two days, was worse in the mornings but improved as day went on), cold sweats.
55 2021-03-08 chills, fatigue, fever Slight fever (+2F), chills, fatigue, muscle ache. From 2AM to time of filing.
55 2021-03-08 sweating Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness star... Read more
Dizziness starting 20 minutes after vaccination. Slightly fast heartrate, sweating, anxiousness starting within 1 hour of vaccination. All of the aforementioned symptoms went away by approximately 5.5 hours after vaccination. Left arm sore starting several hours after vaccination, increasing during the 24 hours after vaccine, then went away by roughly 48 hours after vaccination.
55 2021-03-08 influenza like illness, headache, fever Flu like symptoms - headache, low grade fever, body and muscle aches
55 2021-03-08 fever, chills, fatigue, headache Fever & chills overnight, difficulty sleeping. Continued fever & chills the next day with fatigue, m... Read more
Fever & chills overnight, difficulty sleeping. Continued fever & chills the next day with fatigue, mild headache and muscle aches, but all diminished as the day progressed. Better on 2nd day with only slight fatigue and muscle ache remaining.
55 2021-03-10 fatigue, headache, chills, fever Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last ... Read more
Soreness in shoulder yesterday. The next day had headache and tiredness and fever with chills. Last night had sweats the whole night. Felt fine this morning, all symptoms had gone. Feels pretty good today.
55 2021-03-13 chills Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: note: pt stated no allergies on form and when asked verbally by immunizer. at the 7 minute mark he began to exhibit weakness and started falling off his chair. seemed like he was going to pass out. his breathing seemed labored. we position pt on floor, rph admin epipen to left outer thigh. 911 called. ems responded. pt felt better after epipen. bp, hr normal. pt taken to er by ems
55 2021-03-13 fatigue injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, r... Read more
injection site pain, minor, 36 hours duration, resolved no treatment tiredness, 10 hours duration, resolved - sleep swollen lymph nodes, start within 30 minutes, duration 8 hours, resolved no treatment throat swelling, start within 1 hour, duration 6-8 hours, resolved no treatment dizziness and weakness, start within 2 hours, duration 6 hours, resolved - sleep
55 2021-03-14 headache light headache, nausea, light dizziness, these symptoms lasted for a day.
55 2021-03-16 fever, headache, chills, sweating During the night after the vaccine I experienced body ache, fever, chills, sweats, and headache. Thi... Read more
During the night after the vaccine I experienced body ache, fever, chills, sweats, and headache. This lasted for 1 1/2 days.
55 2021-03-17 nasal congestion, fatigue, sinus congestion, throat pain, fever, productive cough Sore throat. Extreme Fatigue, fever, nasal and head congestion, chest congestion (coughing up phlegm... Read more
Sore throat. Extreme Fatigue, fever, nasal and head congestion, chest congestion (coughing up phlegm)
55 2021-03-18 fever, fatigue fever much worse than when i actually had COVID, tiredness. loss of appetite. The day was as bad or... Read more
fever much worse than when i actually had COVID, tiredness. loss of appetite. The day was as bad or worse of any of the days i had Covid
55 2021-03-19 fatigue I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its... Read more
I started having severe diarrhea the day after the shot , i am weak and exhausted, ight headed , its been going on now 6 days
55 2021-03-19 fever, headache 30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It s... Read more
30 minutes after receiving vaccine, felt like electric shocks in the head (two to three times). It stopped in the evening but got constant low headaches afterwards. Around 5pm, felt like a change in taste (saltier taste) that was temporary. Has uncomfortable wrist pain like twisting a screwdriver too much. Started feeling itchy today after 9 am. Face was swollen after waking up today and has subsided greatly since. Had very low fever last night and now feels like no fever. Right now, feeling has a lot of saliva and then have to swallow and little uncomfortable in arms and knees, and weakness. Only took one Aleve pill last night. Around 4:30pm, felt a little blurry for 5 to 10 seconds.
55 2021-03-20 lethargy, headache, fatigue Headache, fatigue (ongoing) Lethargy, joint pain, muscular pain, dizziness (began 3/20/21 8:00 am th... Read more
Headache, fatigue (ongoing) Lethargy, joint pain, muscular pain, dizziness (began 3/20/21 8:00 am through bedtime 3/20)
55 2021-03-21 chills Body aches, chills lasting for 36 hours, joint pain injection site swelling, pain and itching. All l... Read more
Body aches, chills lasting for 36 hours, joint pain injection site swelling, pain and itching. All lasting for 36 hours
55 2021-03-22 fatigue, headache, productive cough, fever, respiratory tract congestion Coughing up phlegm, head congestion, fever, headache, fatigue I have been coughing up phlegm, had... Read more
Coughing up phlegm, head congestion, fever, headache, fatigue I have been coughing up phlegm, had head congestion, headache and been very fatigued for 12 days. Only my fever has gone away.
55 2021-03-22 sweating Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared dia... Read more
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
55 2021-03-22 runny nose Vaccinated with dose 1 of Pfizer COVID vaccine 1/6/21. On 1/12/2021 patient had loss of smell/taste ... Read more
Vaccinated with dose 1 of Pfizer COVID vaccine 1/6/21. On 1/12/2021 patient had loss of smell/taste and rhinorrhea. Test positive for COVID.
55 2021-03-23 headache After having slight headaches(normal side effects) with dull eye pain from 11pm thru overnight of Ma... Read more
After having slight headaches(normal side effects) with dull eye pain from 11pm thru overnight of March 23, at 10:30 I went out drving in car and my eyes were squinting. with heavy dark clouds(not bright) outside. I looked at my pupils and they were pinpoint to slightly bigger. My glasses are auto tint, but not so much behind car windows. When I got home I sat in a dim room(lights off, but sliding door blinds closed but some light coming in) for an hour eating lunch. I then checked my pupils and they were about a third the size of my iris. Mild headache, dull eye pain and squinting continued. I searched the internet and found no details about eye problems. I called, ask a nurse and was told they found no information about eye problems at CDC or internet related to vaccine, but perhaps it is headache causing eye problems. Seems like this should be listed somewher! Or do I need to see my opthalmologist? You should be complete in side effects that eye problems are possible. I had no problems prior to vaccine. Do with this what you will(likely ignore it as you are bidens cdc).
55 2021-03-24 chills, fatigue, fever Extreme fatigue, muscle and joint pain stiffness, chills, 102F fever.
55 2021-03-24 headache Mild Head ache, so far I have not taken anything for it but I may take some advil.
55 2021-03-24 headache Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremit... Read more
Diarrhea , weakness, sharp pain on back left flank, needles in pelvis and extremities, cold extremities, headache, disoriented
55 2021-03-24 sweating, headache Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the pati... Read more
Within 5-minutes of vaccination, the patient reported weakness and confusion. EMS evaluated the patient on-site. No signs of stroke. EKG demonstrated NSR, rate 77bpm, no ST elevation. FSBG was 290mg/dl. EMS transported the patient to Hospital Emergency Department. Enroute, the patient became increasingly confused, forgetting their birthday and location. Patient was hypertensive (178/104) and reported a "crushing headache". EMS crew became concerned for stroke. In ED, the patient remained hypertensive (178/93). ED Physician had high suspicion of TIA versus acute reaction to COVID-19 vaccine. Administerd 650mg acetaminophen and 1mg Lorazepam. Admitted patient to critical care unit where patient stated they had developed a sudden-onset diffuse banding-like headache with associated nausea, diaphoresis, blurry vision, and confusion. MRI was negative and patient was transferred from ICU to hospital. Hospital physician believed the symptoms were likely a vagal mediated response or reaction to his COVID vaccination. Patient was discharged on 3/20 with diagnoses of TIA, Acute encephalopathy, Insulin-dependent type 2 diabetes, Essential hypertension, CAD, Unspecified mood disorder, Dyslipidemia, Obesity, and Mild neuro cognitive disorder
55 2021-03-24 fever, chills Severe chills and fever days two and three (102.1 day three)
55 2021-03-24 fever, throat pain, sweating High fever , extreme sweeting , throat closed up but not completely. Still running low grade fever ... Read more
High fever , extreme sweeting , throat closed up but not completely. Still running low grade fever and have swelling and soreness still in throat. 4 days and counting. Two days of almost closed throat and soreness still continues.
55 2021-03-25 influenza like illness, fatigue fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day ... Read more
fatigue, flu-like symptoms, cramping in the legs and neck, severe back pain. Slept 18 hours a day for three days
55 2021-03-26 chills, headache, influenza like illness, fever Morning after receiving first dose I woke up with severe flu like symptoms. Bad headache, sore all o... Read more
Morning after receiving first dose I woke up with severe flu like symptoms. Bad headache, sore all over. Loss of appetite. Etc. Got worse as day went along. Was running slight fever. Was so sick I came home and went straight to bed. Today, the 27th, was feeling a little better for a bit then it came on again same as yesterday. Fever, chilling, loss of appetite, bad headache arm throbbing. Pain all over body. Still feeling pretty bad this evening.
55 2021-03-26 cough Little tingling in throat within 10 minutes of vaccine administration . Which subsided within 20 min... Read more
Little tingling in throat within 10 minutes of vaccine administration . Which subsided within 20 minutes. I took 20mg of reactine as prophylaxis before injection Cough and serious wheezing started night of Saturday Jan 16th ; had Covid tests done negative Ended up in urgent care Jan 29th , 2021
55 2021-03-27 fever, fatigue Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. ... Read more
Intense pain around base of tailbone. Mild fever, fatigue, hand/wrist pain, sensitivity to cold. Intense bloating.
55 2021-03-28 body temperature increased 1. After vaccination my temperature rose over 103 plus and I took 1000 mg of Tylenol over the counte... Read more
1. After vaccination my temperature rose over 103 plus and I took 1000 mg of Tylenol over the counter but it continued 2.After 12 hours whole body started etching specially hand wrist started swelling and too much not tolerable etching took medication Benadryl but till this morning March 29, 2021 ER could not stopped it so they gave steroid, I still have 30% of the same and doctor advise to continue Benadryl 50 mg everyday. This made my daily life Misérable
55 2021-03-28 chills, fever Beginning around 3 am, I began feeling chills and aches throughout my body. In getting up around 7:... Read more
Beginning around 3 am, I began feeling chills and aches throughout my body. In getting up around 7:30 am, I felt more intense aches, fever, and some dizziness. Nausea set in around 12 pm. After resting until about 5 pm, the symptoms began to subside though aches continued.
55 2021-03-28 chills Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches i... Read more
Experienced all symptoms that occured for my actual covid disease. These include dizziness, aches in joints and muscles, extreme chills, injection site soreness(4-5 days), headache, complete lack of appetite and overall weakness. All symptoms lasted for approximately 36 hours.
55 2021-03-28 headache, sweating started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with t... Read more
started to lose his vision; he couldn't see anything; Shot was painful; he started to get hot with the sweats; he started to get hot with the sweats; terrible headache; dizziness; nauseated; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 00:30 (lot number: ENG6199) (at age 55 years old) as single dose for covid-19 immunization administered in a pharmacy or drug store. The patient had no relevant medical history. No known allergies. The patient had no covid prior to vaccination and was not tested post vaccination. Concomitant medication included tramadol taken for numbing shot for tooth, start and stop date were not reported. No other vaccines received in four weeks. The patient experienced the following with his first dose of the Pfizer vaccine. Shot was painful and in about 15 to 20 minutes later everything felt fine. But by the time he and his wife drove out of town, he started to get HOT with the sweats, terrible headache, dizziness and started to lose his vision. He pulled over to let his wife drive and by the time he got out of the car he could barely navigate to the passenger side. They turned around and headed for the hospital, 8 min away, at this time he couldn't see anything, he was nauseated but knew the hospital was pretty close. During this whole time his heart rate never raced just kept and even beat. His breathing was also just fine. By the time they got into the parking lot his vision was slowly getting better, so they sat in the parking lot for 30 minutes with the air conditioner on as high as it could go. His wife read through the side effects, he was experiencing many on the list. They left without going in. Onset of the events was reported as 12Mar2021 12:45 AM. Treatment was not given for the events. The patient recovered from the event "shot was painful" on 12Mar2021; while recovered from the rest of the events on an unspecified date in Mar2021.
55 2021-03-28 headache, influenza like illness, fever, cough The flu-like symptoms I was expecting. Aches and pains, fever, headache, cough. Initial slight numbn... Read more
The flu-like symptoms I was expecting. Aches and pains, fever, headache, cough. Initial slight numbness in right arm, which just became soreness. Symptoms came on this morning, just going to wait them out. I'm told they will just go off like a light switch.
55 2021-03-28 headache 3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face sl... Read more
3 days after dose 3/23, felt pain in back of head behind right ear. 3/25, felt right side of face slightly numb. 3/27, visited ER , CT Scan taken. Diagnosed with Bell's Palsy.
55 2021-03-28 fever, cough Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, ... Read more
Symptoms started 3/19/21 and was diagnosed with COVID-19 on 3/21/21. Presented to ED with weakness, cough, confusion and fever on 3/27/21. He was started on supplemental oxygen, remdesivir, and dexamethasone and was admitted to hospital for 3 days.
55 2021-03-28 fever, headache Extreme soreness, fever and massive headache
55 2021-03-29 fever, headache Had vaccination on Friday morning. The following Monday morning I woke up feeling fine but by 9:00 ... Read more
Had vaccination on Friday morning. The following Monday morning I woke up feeling fine but by 9:00 AM started having stomach pain and back pain. As day progressed I developed diarrhea and a fever which reached 101.7 in the evening. By Tuesday morning the stomach and back pain were gone, but had a headache and 100.0 fever all day, and frequent diarrhea all day. By 8pm I am feeling much better and am able to bring the fever down with acetaminophen.
55 2021-03-29 runny nose, headache, cough Headache, ear pain, coughing, nose runny
55 2021-03-30 fatigue, sleepiness, fever, chills I had the chills 101° fever feelings of nausea , muscle weakness , extreme fatigue had to leave wor... Read more
I had the chills 101° fever feelings of nausea , muscle weakness , extreme fatigue had to leave work and slept for 15 hours straight I am currently taking today off to to fully recover
55 2021-03-31 lethargy, headache Overall soreness and lethargy. Headache. Very sore at injected site. Took some Tylenol. It helped a... Read more
Overall soreness and lethargy. Headache. Very sore at injected site. Took some Tylenol. It helped alleviate the symptoms.
55 2021-04-01 chills, fatigue, fever Chills/ Body ache / Low grade fever ~ 100.4 - fatigue - Lasted about 24 hours
55 2021-04-02 body temperature increased, fatigue Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly an... Read more
Extreme Fatigue; Achiness all over body, particularly back of arms; pain in joints, particularly ankle joints, soreness in arm (expected this) and 102.9 temp
55 2021-04-02 headache Body aches and headache. Taking Tylenol to help discomfort.
55 2021-04-02 influenza like illness, headache Headache, flu-like symptoms
55 2021-04-02 fever, headache The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21... Read more
The second day I only had a sore arm where I received the injection. Thereafter, and up until 4/2/21 PM when going to bed I had fluctuations of hot and cold sweats, difficulty sleeping, daily low grade fever, neck and shoulder pain, mild to medium headaches, and a much lower than usual energy levels.
55 2021-04-03 chills, fatigue No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as ty... Read more
No issues at/during injection, didn't even feel needle surprisingly. 1st 24 hrs, arm soreness as typical vax reaction 4 me. But that 2nd day after, G.I. issues began middle of nite. So fatigued & short-of-breath, barely made it to dialysis, where they put me on oxygen. All during treatment, BP fluctuated 90-170, temp 96-101, chills (shivering!), continued fatigue & weakness, even after leaving - they wanted to give me antibiotics & send me to e.r.!!! Staff did collect blood sample for culture (result in 24 hrs + neg). I refused antibiotics and e.r., convinced it was vax reaction, and I was right, all normal another day later. Anxious bout 2nd shot ??
55 2021-04-03 chills, fever, fatigue Injection at 11:40am on Friday. Fever/chills at 2:00am Saturday morning. Fever broke at 10:00am Satu... Read more
Injection at 11:40am on Friday. Fever/chills at 2:00am Saturday morning. Fever broke at 10:00am Saturday. Extreme exhaustion throughout Saturday 11 hours of sleep Saturday night-Sunday morning made it all better. Able to golf Sunday & resume normal activities.
55 2021-04-03 influenza like illness, chills Chills pain flu symptoms fine after 2 days rest
55 2021-04-04 chills, sweating chills and shakes followed by sweats.
55 2021-04-04 headache, fever, influenza like illness, chills 1/21 vaccination Twelve hours later, I woke up with flu like symptoms. I had fever, chills, joint pa... Read more
1/21 vaccination Twelve hours later, I woke up with flu like symptoms. I had fever, chills, joint pain, body aches and a HA. I also had cervical lymph node swelling (size of a golf ball) and axillary lymph nodes on the R side was severely swollen. I called my PCM and they put me on a call with a specialist. They told me to take Ibuprofen and 72 hours for lymph node swelling to go down, which they did.
55 2021-04-04 fever, headache Headache, low fever and diarrhea that lasted 36 hours
55 2021-04-04 fever, headache After 2 days, fever began at 100.4, ranged up to 102.8 for 5 days, headache, dizziness. Followed fe... Read more
After 2 days, fever began at 100.4, ranged up to 102.8 for 5 days, headache, dizziness. Followed fever protocol for secondary adrenal insufficiency, and increased hydrocortisone to 30mg
55 2021-04-05 lethargy, fatigue Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward,... Read more
Lots of pain at injection area. Severe chills lasting 3 hours, sharp pain in right hip. Afterward, real tired and a little lethargic.
55 2021-04-06 chills, fever Sudden onset of chills and body aches beginning at 1pm on 4/5/21; temperature taken at 2pm was 100.8... Read more
Sudden onset of chills and body aches beginning at 1pm on 4/5/21; temperature taken at 2pm was 100.8 and remained between 100 and 101 until 7pm. Chills and aches subsided greatly by 5pm. Had a COVID-19 test conducted at clinic around 5:30pm (results delivered the next day were Negative). Returned home and took 2 Tylenol - which brought my temperature down to 98.8. Took an additional 2 Tylenol before bed and woke up on Tuesday, 4/6 with no fever and no symptoms. Note - both the nurse and doctor that examined me at clinic indicated that I was not the first patient that they saw with these symptoms approximately one week after receiving the first vaccination .
55 2021-04-06 sweating at 1:55pm (approx 4 hours after the shot) all of a sudden my left arm at injection site hurt, my le... Read more
at 1:55pm (approx 4 hours after the shot) all of a sudden my left arm at injection site hurt, my left forearm hurt, left upper back under shoulder blade was painful. i had cold sweats, was dizzy and nauseous. took tylenol. by 4pm felt much better.
55 2021-04-06 throat pain Sore throat x2mins
55 2021-04-07 cough, fever Second shot Wed. Awoke Sunday to aches and pains, extremely dry and itchy eyes, runny nose, dry coug... Read more
Second shot Wed. Awoke Sunday to aches and pains, extremely dry and itchy eyes, runny nose, dry cough, slight fever. Finally today, Thurs., the symptoms are subsiding. Have used otc meds including cold and flu syrup, tablets, and allergy relief. Writing as I am finding comfort from FEXOFENADINE WHEN OTHERS DID LITTLE other than make me totally useless from extreme drowsiness; and because these symptoms are not the typical reported issues that come and go within a day or two of injection. Specifically, the store brand product is apparently highly effective and without the drowsiness issues.
55 2021-04-07 malaise I received the vaccine about two - three inches from the center of the muscle and in back of center ... Read more
I received the vaccine about two - three inches from the center of the muscle and in back of center - it was more in back of deltoid than the front of my deltoid. When I first got the shot, I had a burning sensation from the site of needle to back of neck to behind my ear area. It felt like a burning aching feeling. My ear felt like it was clogged up and aching. I told the medical site about it and the doctor on site said that more likely they hit a nerve. My blood pressure was very elevated. They had me stay to be observed for 45 minutes. I went back to work. I still felt it at night. The next day, I started feeling up my neck and my collarbone and my left side of my face and my head - my face felt tight and my lip felt numb on the left side and I had a slight confusion too. I went to Emergency room. They did CAT Scan and exam. After that, I noticed it was going all the way down my arm, all the left side of my body to toes. It felt like numbness - like neuropathy type feeling. It felt like constant pain. I went to the Urgent Care and they gave me Prednisone steroid (5 days of it) 5 mg to help with inflammation. I took that for the five days. I started noticing a little black bruising on my body. After that, I went to the Urgent Care again and they gave me Naproxen and and Dr gave me more Naproxen to take. He took bloodwork, too. I went to the ER and I was still feeling sick and hot. They said it was anxiety. I am still going through it - I feel it on the spot where I got the shot - and on my neck and on my head and on my left eye and down on my legs a lot - some days are worse than others but not as bad as when I had the first symptoms.
55 2021-04-07 malaise 4 hours after shot: Sore shoulder at site of injection 8-9 hours after shot: blurry eye vision, ma... Read more
4 hours after shot: Sore shoulder at site of injection 8-9 hours after shot: blurry eye vision, malaise (lasted about 1 hour, went away as sun went down??) Next Day: No issues.
55 2021-04-08 fatigue, fever nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his an... Read more
nausea, fever, elevated blood pressure, fatigue all currently resolved. This caused to worsen his anxiety which is still presenting effects
55 2021-04-08 pneumonia, malaise 55-year-old male with no diagnosed past medical history presents emergency department after cardiac ... Read more
55-year-old male with no diagnosed past medical history presents emergency department after cardiac arrest. Per patient's daughter, patient was feeling at baseline today. He got his COVID vaccine at 5 PM this evening. He was running some errands and called his daughter at 8:40 PM. He told his daughter he was not feeling well. She reports he sounded out of breath and sounded as if he was slurring his words. Daughter told him to pull over and she called 911. She met him on the side of the road and he was gasping for air. She arrived at the same time as EMS. Upon arrival of EMS patient was in ventricular fibrillation. He was defibrillated 3 times. He also had one episode of ventricular tachycardia. He was given 300 mg of amiodarone and 3 rounds of epinephrine with had return of spontaneous circulation. King airway was placed and patient was brought to the emergency department.
55 2021-04-08 fever, fatigue Body aches, fever (101.4F), trouble concentrating, fatigue, listlessness
55 2021-04-09 fatigue Fatigue, body aches x 12 hours Full body urticaria
55 2021-04-09 headache, fatigue Headache longer than 24 hours, minimally responsive to acetaminophen Mild nausea 12 hours Fatigue 18... Read more
Headache longer than 24 hours, minimally responsive to acetaminophen Mild nausea 12 hours Fatigue 18 hours Joint stiffness 18 hours
55 2021-04-09 fever, chills was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't ... Read more
was in the hospital trying to get his potassium up; extreme lower extremity weakness/my legs didn't want to work, I had to use a ladder to pull myself up out of the chair; checked his temperature and it was either 101 degree F or 100.1 degree F/running a fever now of 100.1 degrees Fahrenheit; he liked to froze to death in his house; his legs are so sore; chills; shaking; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6204), via an unspecified route of administration, administered in left arm on 23Mar2021 09:00 at single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (began years ago about 10 years ago, states he has no names or lot numbers of the blood pressure pill). The patient's concomitant medications were not reported. On 25Mar2021, the patient experienced chills and shaking. He stated he was probably running a fever but he don't know. On 26Mar2021, he woke up with extreme lower extremity weakness, stating his legs didn't want to work. He had to use a ladder to pull himself up out of the chair. He checked his temperature and it was either 101 degree F or 100.1 degree F. He was running a fever now of 100.1. Patient stated he had the 1st dose on 23Mar2021 and it was about three days ago and then yesterday (26Mar2021) he liked to froze to death in his house which was 80 degrees and he was covered up and had covers on him. He got ready for work today and when he got up his legs did not want to work and it would have been very easy to fall and when he came in, he fell in the door but his legs were so sore and he was running a fever now of 100.1 degrees Fahrenheit on 26Mar2021. Patient had the Pfizer COVID shot in his left arm and had no soreness or anything like that but stated he was in the hospital for three days trying to get his potassium up on an unspecified date and went through sixteen little bags of concentrated potassium and the first potassium bag was on a drip machine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
55 2021-04-09 runny nose, cough, respiratory tract congestion Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest... Read more
Terrible congestion, runny nose that did not stop from Sunday 4/4/21-Saturday 4/10/21 8:00 am, chest, lungs hurt, body aches earlier in week, had to stay in bed on and off all week, no energy, forced myself to eat, severe coughing by Wednesday 4/7/21 which has only stopped on 4/10/21. was most severe Thursday 4/8-Firday 4/9 Could not concentrate all week, even watching tv.
55 2021-04-10 fatigue, fever VOMITED 8 TIMES IN 12 HOUR PERIOD, BODY ACHES, NAUSEOUS, LOW GRADE FEVER, FATIGUE
55 2021-04-11 sweating I was at the Neuroscience center and in the auditorium shorty after. Where I started to sweat, blur... Read more
I was at the Neuroscience center and in the auditorium shorty after. Where I started to sweat, blurred vision, very difficult to breath and losing some motor skills. Luckily I got up in time and went to one of the nurses up front that got me to a waiting area to cool down, some water and to breathe without the mask. Probably stayed about 30 minutes as my vitals were pretty low before returning to normal. I will say it was pretty hot and a little crowded in there and the nurses all said it's been happening a bit with the heat in there. And it was about 11:40am so I only had crackers in the morning.
55 2021-04-11 fever, fatigue, headache Fatique, Fever, Headache, Muscle Pain 36 hrs
55 2021-04-12 cough, fever, fatigue Felt tired and worn out and had a fever of 99. Also coughing and congestion going down my throat. ... Read more
Felt tired and worn out and had a fever of 99. Also coughing and congestion going down my throat. all this started Sunday after noon and continue through the present time, although feeling more strength today
55 2021-04-12 headache On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. ... Read more
On 4/8/21 patient reported increased difficulty speaking, increased dizziness, and vision changes. Reports new headache rated 8/10 that started at 11am 4/8. Hx of stroke 2018 with residual right side symptoms. BP 162/104, HR 80, O2 sat 97% room air at 1740. Sent to a Medical Center ER and admitted with stroke symptoms and new onset diabetes.
55 2021-04-12 malaise My father felt sick the day after taking his 1st shot, called the nurse and was told to "give it a f... Read more
My father felt sick the day after taking his 1st shot, called the nurse and was told to "give it a few days. Drink electrolytes and water". He did that and did not get any better.
55 2021-04-13 fatigue, chills Extreme chills, nausea, terrible muscle ache, fatigue, diarrhea, intense abdominal pain, blurry visi... Read more
Extreme chills, nausea, terrible muscle ache, fatigue, diarrhea, intense abdominal pain, blurry vision on March 25th starting 7:30 pm - 8:00 pm for 6 days. Also, aggravated Crohn?s disease to severe condition which still continues.
55 2021-04-13 fatigue Dizzyness, tired.
55 2021-04-13 influenza like illness, fatigue, fever Flu like symptoms without throwing up. This included achy muscles, fatigue and a fever for at least... Read more
Flu like symptoms without throwing up. This included achy muscles, fatigue and a fever for at least 36 hrs.
55 2021-04-13 fever, sweating I had very severe vomiting followed by diarrhea and fever that lasted 2 complete days, now I am in ... Read more
I had very severe vomiting followed by diarrhea and fever that lasted 2 complete days, now I am in vaccination +6 days and now my wife is sick and I still have very bad nausea and near vomiting, I also still have sweating and fever but it is getting better, terrible light headedness when I stand and brain fog all day, still continues.
55 2021-04-14 fatigue Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing feve... Read more
Lower leg swelling from below knee to top of foot at ankle. Very angry red and swollen. Causing fever shakes and fatigue. Taking Amoxik Clav 875-125 tab. Nort. Began talking on Tuesday for 3 days with slight improvement.
55 2021-04-14 headache, fever, fatigue, chills fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY ... Read more
fatigue mild headache shortness of breath chills low grade fever diagnosed with ACUTE PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONATE had two hospital doctors two hematologist two pa-c specialist all suspect pfizer shot . taking eloquis for 90 days
55 2021-04-14 lethargy, fatigue 4 days after shot, immune system kicked, body aches, lethargic, tired, no appetite, abdominal musc... Read more
4 days after shot, immune system kicked, body aches, lethargic, tired, no appetite, abdominal muscle pain. Day 4-5 where bad, stayed in bed. Day 6 about 50% better Day 6 woke up with tinnitus in left ear- never had previous to shot. Tinnitus is continuous. Day 7 about 75% better Day 8 & 9 still not 100%
55 2021-04-14 fever, headache Fever, dizzy, loss of bladder control, killer head ache, weak.
55 2021-04-15 fatigue Fatigue for 3 days, allergy type reactions
55 2021-04-15 influenza like illness, fever, chills I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but ... Read more
I received the first Pfizer injection Tuesday, April 13th. I had signed up for the 12:15 slot, but when I arrived it was like a cattle call. I arrived in time for what I thought was a 12:15 appointment but ended up standing in line for an hour before actually getting the shot. I was fine the rest of that day aside from developing soreness in the muscles of my right arm. The following morning, Wednesday, April 14th, I was awakened to very noticeable soreness in both arms and the back of my neck. As the morning progressed, I developed flu-like symptoms, complete body aches, chills, fever, slight nausea, blurred vision, mild diarrhea.
55 2021-04-15 influenza like illness Flu like symptoms
55 2021-04-15 lethargy, headache Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process ... Read more
Following day a sore arm and lethargic. 3 days after developed a very foggy mind unable to process information, headache severe at times. Severe joint pain throughout body. Nauseous minimal but there. Anxiety very severe at times . 7 days post symptoms remain and elevated anxiety, tired, lethargic, unable to focus, panic attacks, debilitating at times. Woken up from deep sleep still 7 days post of incredibly severe arm pain in arm hat was injected.
55 2021-04-16 fatigue, headache, chills On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precurs... Read more
On April 16 had absence seizure. I have not had one in over 7 months and felt no warning or precursors. That night fatigue, chills (freezing) headache, nausea, foggy thinking, tense shoulder neck muscles, foot cramps. Day of 17th (ongoing) fatigue, tense shoulders/neck/ lack of hunger, foggy thinking, headache went away with Ibuprofen and Tylenol. Have ate yet so unsure of nausea.
55 2021-04-16 fatigue, throat pain, fever, cough From 4/11/2021 to 4/14/2021 experienced the following symptoms: sore throat, coughing, fatigue, and... Read more
From 4/11/2021 to 4/14/2021 experienced the following symptoms: sore throat, coughing, fatigue, and low fever.
55 2021-04-16 headache, sinus pain Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and che... Read more
Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and chest pain
55 2021-04-16 fever, headache Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying o... Read more
Instant onset Sharp headache, spiked fever, cramping, nausea, with all adverse events intensifying over a 30 minute period
55 2021-04-17 chills cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move... Read more
cerebral palsy in my left hand and it seems to be a better; left hand started hurting; couldn't move fingers; my whole hand swelled a little bit; hand had like a slight fever to it, it was warm; chills my whole hand like it's going down; little jerks in my hands; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 (at the age of 55years) as single dose for Covid-19 immunization. Medical history included Chronic obstructive pulmonary disease (COPD), heterotaxia (Situs inversus), ankylosing spondylitis, back problem, and cerebral palsy; all from an unknown date and unknown if ongoing. Concomitant medications included diazepam, methocarbamol, meloxicam, salbutamol (ALBUTEROL), and unspecified muscle relaxant; all taken for an unspecified indication, start and stop date were not reported. The patient reported side effects that has official after taking the COVID shot (confirmed as Pfizer COVID Vaccine). The patient stated "I've got cerebral palsy in my left hand and it seems to be a better connection in my left hand, I can now, it's easier for me to pick up small objects and I used to have problems doing that. It is like, I am messenger pain is eating my nerve endings. But here's what happened, 2 days after taking the shot around 26th, I took the shot on 24thMarch, 2021; I took Diazepam, Meloxicam and muscle relaxer (captured as unspecified medication) for back problem. I don't even know if it had anything to do with it, might be just been all the shot, but methocarbamol too. I took those 3 drugs, 2 hours after that, my whole hand, my whole left hand, just my left hand started hurting (further clarification unknown hence captured as suspect conservatively). In my left-hand kind of after feeling and I couldn't move my fingers as well. And afterwards it was in March, it started hurting, my whole hand swelled a little bit. It had like a slight fever to it, it was warm, and it swelled up just slightly not up here, nothing big. I still can't put in my ring, but it was slightly bigger than what it is today, and this hurt. It felt like, I've chills my whole hand like it's going down. So, I work it out, I stretched it, that helped the pain so I could work with them during my fingers stopped working it out. And then afterwards I found out I could, my hands were moving better, it works better. Before I've like little jerks in my hands, you know my hand wouldn't do what I wanted it to do. What I wanted to do more, I can press button, I can pick up smaller objects. It's not 100 percent better, it's not as good as my right hand which had no cerebral palsy in it but it's a lot better than it was. So, I just wanted to report that." The outcome of events was unknown.
55 2021-04-17 fever A touch of fever about 12 hrs after injection; the area of injection (left arm) got sore for about 3... Read more
A touch of fever about 12 hrs after injection; the area of injection (left arm) got sore for about 3 days and then it went away.; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 02:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, early diabetes. Patient was not allergic to anything. Concomitant medications included metformin hydrochloride, amlodipine besilate, Olmesartan, atorvastatin calcium. The patient had not received any other vaccines prior to the COVID vaccine. On 26Mar2021 18:00 patient experienced a touch of fever about 12 hrs. after injection. Also, after about 24 hrs. the area of injection (left arm) got sore for about 3 days and then it went away. No treatment received for reported adverse event. The outcome of the events was resolved. No follow-up attempts are needed. No further information is expected.
55 2021-04-17 runny nose Bell's Palsy - face drooped, couldn't keep eye open, left nostril ran only
55 2021-04-18 chills, sweating, fatigue A wave came over me that felt like I was going to die, or at least pass out. motor skills were impai... Read more
A wave came over me that felt like I was going to die, or at least pass out. motor skills were impaired, became drenched with sweat and then got the shivers. The worst part only lasted about 15 minutes but it scared the shit out of me. felt like crap the rest of the day, super fatigued. Slept well last night but still feel like I could sleep for another 10 hours. Not quite thinking clearly either.
55 2021-04-18 fatigue Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder... Read more
Pain in left jaw bone / joint area 4 days after vaccine shot; pain / soreness in left arm & shoulder area; overall feeling of tired
55 2021-04-18 malaise, chills Patient reported altered taste about 15 minutes after vaccination. Around 10:30-11pm the patient re... Read more
Patient reported altered taste about 15 minutes after vaccination. Around 10:30-11pm the patient reported body aches, chills and a general unwell feeling that lasted for 3 days.
55 2021-04-19 fatigue, fever Fatigue, sore arm, muscle aches, low grade fever overnight
55 2021-04-19 fatigue Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in han... Read more
Approximately 48 hours after shot I started feeling very warm flush and experiencing tingling in hands and feet. No fever, headache or joint pain. Also just not feeling like myself. Lack of concentration, agitated, general fatigue. Hand and feet tingling has been worse and night and causing interrupted sleep. This feeling has not gone away and I'm now past two weeks since shot and Wondering if I should get second dose.
55 2021-04-19 fatigue o I recently needed to travel to perform a walkdown of the nuclear power facility. o I opted to dri... Read more
o I recently needed to travel to perform a walkdown of the nuclear power facility. o I opted to drive, and had "layovers" i over 01-APR-2021 through 09-APR-2021 (yes, happy easter). o I kept public interaction to a minimum, but, having to eat, make a containment entry, and answer nature's call, some interactions were close quartered, and prolonged. o Upon my return I started a (10) day quarantine, as directed by CDC guidance . o I had muscle aches, and general fatigue, but attributed that to long daily drives in holiday traffic throughout the trip
55 2021-04-19 paranasal sinus discomfort 4-5 days after first dose, feeling sinus pressure, pressure in ears and constant high pitch ringing
55 2021-04-19 throat irritation Pt developed scratchy throat and tingling to his tongue approx 20 mins after vaccination. Monitored ... Read more
Pt developed scratchy throat and tingling to his tongue approx 20 mins after vaccination. Monitored in obs then transported to local ED via EMS. Stable vitals, BP 148/108, pulse ox 98% RA, P87; ED Update: don't see any notes in patient chart
55 2021-04-20 headache Patient was fine for several hours and was out shopping. Developed headache and dizziness. called ... Read more
Patient was fine for several hours and was out shopping. Developed headache and dizziness. called wife to pick him up. by time she got there he had developed vomiting. was taken to ER and subsequently admitted to hospital with rotary nystagmus in right eye and slightly less nystagmus in left eye, vertigo, vomiting.
55 2021-04-20 fever Development of fever blisters (cold sores). I've had cold sore/fever blister before. For the past... Read more
Development of fever blisters (cold sores). I've had cold sore/fever blister before. For the past 30 years I would typically get ONE cold sore roughly about every 3-4 years. Typically it was an indicator I was about to experience an illness. They were VERY rare and always noted as I will not kiss my children or wife when I would get one. It would always appear in the exact same location on the upper left part of my top lip. Very minor cold sore but a cold sore none the less. My reaction to the 2nd shot was pretty strong. I had a 102F fever starting at 10PM the evening after the second vaccination. Very strong muscle contractions and joint inflammation. The fever and soreness disappeared about 36 hours later and I was fine. Fast forward a week or two (from the second shot) and I developed an unusual coldsore on my lower lip. It appeared almost immediately. I began to apply Abrevia (10% Docosanol) right away. Honestly it was a very unusual cold sore. Much larger than any cold sore I had ever had. It even caused bumps on the interior part of my lower lip. This has never happened. In the past this cold sore would be it. Then I would be free of them for an extended period. As of April 21, 2021, I've had 2 additional cold sores. This is three cold sores in a period of less then 5 weeks. My diet, exercise and lifestyle have not really changed. This is VERY odd.
55 2021-04-21 cough, nasal congestion, headache He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he start... Read more
He got the vaccine, he had no issues at all. Then on Friday evening 4/16/21 around 6:00 PM he started having no appetite, he's having delusions/awareness of what's going on, headaches, light headedness. He still having soreness of the arm. He is having difficulty walking due to the dizziness. He is also having some coughing and congestion issues. He has a history of alcoholism and smoking. Has not taken anything for these symptoms, no insurance and trying to deal with it on his own to see if it would go away.
55 2021-04-22 chills, malaise, fever Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/... Read more
Patient Sick- Can?t get up, Fever, chills, Had Covid Shot yesterday. T 101.0-.5-6 P 72 R 32 BP 150/80 Sat 92 % ?no strength.? Hospitalized on 4/9/2021 with Sickle Cell Crisis
55 2021-04-22 headache, fatigue Injection site pain, tiredness, headache, muscle pain, injection site redness
55 2021-04-22 headache, sleepiness, fever, cough, chills Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed... Read more
Shoulder swelled and became sore. Eventually whole body became sore, weak, hot and sleepy. Developed fever/chills 99.5. Headache all day. Cough for about two hours. Symptoms faded overnight. No treatment.
55 2021-04-22 throat irritation Tinnitus Facial swelling Eye irritation Lip and mouth irritation Throat irritation Canchre sores... Read more
Tinnitus Facial swelling Eye irritation Lip and mouth irritation Throat irritation Canchre sores Tounge sore Ongoing - some improvement w Benadryl and nose steroid spray
55 2021-04-23 headache, fever, chills Received vaccine just after 12:30 PM on April 10th. Just prior to midnight on April 10th started ge... Read more
Received vaccine just after 12:30 PM on April 10th. Just prior to midnight on April 10th started getting some minor body aches. After midnight a low grade fever started along with chills. Was shivering quite a lot from about 1:00 AM to 4:30 AM on April 11th. Had a headache as well starting at midnight along with fever, chills, aches, and shivering. Body aches and low fever continued through April 11th and were gone by April 12th. Noticed lymph nodes swelling quite a bit under my left arm (arm that had the shot) through April 15th. Swelling went away and have not had any side effects since.
55 2021-04-23 fever fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old m... Read more
fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old male consumer reported that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: unknown), via an unspecified route of administration on an 10Feb2021 5.00 (Age at vaccination:55-year-old) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient did not have anything done on Thursday, but on Friday evening he got a fever and that was right after 2 days of getting the vaccine and he still has a fever. So, Friday night, Saturday night, Sunday night he had fever and on Monday morning he still has it. It goes down when taking Tylenol. Temperature went as high as 100.7.This morning he didn't have any fever, it was 97.9 and now it's at 98.9. He is also feeling cold. The patient wants to know if this is normal or is it because of the vaccine or did he actually get Covid after the shot. Could it be flu or anything, should he get Covid testing. On 10-Feb-2021, the patient was feeling cold and 12-Feb2021 the patient had fever. The patient was taking Tylenol for fever since 12Feb2021, and Tylenol therapy was still ongoing. The outcome of the events was reported as nor recovered. Information about lot/batch number has been requested.
55 2021-04-24 cough tested positive post vaccination. COVID + Rapid: 2/16; COVID+ PCR: 2/18; Symptoms: Loss of taste/sme... Read more
tested positive post vaccination. COVID + Rapid: 2/16; COVID+ PCR: 2/18; Symptoms: Loss of taste/smell and cough; Source: Spouse(works at Medical Center) who tested COVID + on 2/8
55 2021-04-24 fatigue, fever Low grade fever 99.3 - 100.3 from Friday noon through At least Sunday evening. I still have the fe... Read more
Low grade fever 99.3 - 100.3 from Friday noon through At least Sunday evening. I still have the fever. I also have a large red spot on my arm where I received the shot. It's sore to touch. Tired and fatigued since Friday.
55 2021-04-24 fatigue Mild injection site pain; muscle and joint pain; muscle and joint pain; fatigue; severe diarrhea; Th... Read more
Mild injection site pain; muscle and joint pain; muscle and joint pain; fatigue; severe diarrhea; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm Left on 26Feb2021 10:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, high blood Pressure ,neoplasm malignant and depression. Known allergies included shellfish. Concomitant medication included acarbose taken for an unspecified indication, glipizide taken for an unspecified indication, lisinopril taken for an unspecified indication, metformin taken for an unspecified indication, metoprolol taken for an unspecified indication. On 27Feb2021 12.00 am the patient experienced mild injection site pain, muscle and joint pain , muscle and joint pain, fatigue and severe diarrhea. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the adverse events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
55 2021-04-24 upper respiratory tract infection, throat irritation, fatigue sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mil... Read more
sleeping a lot; he was tested positive for covid; he was tested positive for covid; experiencing mild congestion in the head/congested in his head; sense of smell is pretty much gone; decided since his throat was scratchy; congestion in his ears; Exhaustion/ Fatigue; This is a spontaneous report from a contactable consumer (patient). A 55 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation, age at vaccination 55 years old. Medical history included Diabetic from 2013 (Diabetes is fairly under control. He has no super high readings. His diet is better); blood pressure (blood pressure abnormal) from 2013; ongoing overweight (obviously he is overweight) from an unknown date; and heart (disorder) from an unspecified date. Concomitant medications included metformin taken for an unspecified indication; lisinopril for blood pressure (abnormal); and lovastatin for heart (disorder), start and stop dates were not reported. Patient is taking an unspecified over the counter multivitamin. There were no other recent vaccinations or started any new medications. The patient is due for the second dose on 9April2021, but he tested positive for COVID-19 on 01Apr2021 with a PCR test described as oral saliva test. Patient was negative on a rapid test on an unspecified date. Patient wanted to know if he could reschedule the shot and when is it recommended. The patient had a coworker who tested positive, he decided since his throat was scratchy that maybe he had got it, then two more employees had gotten COVID-19 so he got a rapid test that was negative. On Mar2021, he stated he stayed home because he was experiencing mild congested in his head/congested in his head, which it still actually was, and he lost sense of smell completely. He was really tired, sleeping a lot, had congestion in his ears, and he can't smell anything. Patient had no fever, and his lungs were clear (unspecified date), so he commented it was deceiving since he feels fine like he can do whatever he wants, then he gets exhausted and sleeps. He stated he can't work for a whole week. He stated he is assuming his first dose of the shot is helping with it. Patient stated he is doing well, he has it (COVID-19), but he feels pretty good. Outcome of congested in his head was not recovered, while unknown for the other events.
55 2021-04-25 body temperature increased, chills 12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and b... Read more
12 hours after receiving the second Pfizer Covid 19 vaccination dose, I started getting chills and body shakes for about 24 hours. I had significant night sweats waking up completely soaked. I measured a fever at 101.7 in the morning of the next day after the dosing of 2 advils clearly had worn off. I continued to take 1 advil every 4 -6 hours when i noticed getting chills again until the afternoon on 4-25-2021 when I started to feel better. i had no other sideeffects with the exception of body aches which I contribute mostly to staying in bed for over 24 hours.
55 2021-04-25 fatigue, influenza like illness, fever Mild flu like symptoms. Low grade fever, muscle soreness, general fatigue. Lasted for about 12 hour... Read more
Mild flu like symptoms. Low grade fever, muscle soreness, general fatigue. Lasted for about 12 hours, woke up felling near 100%. No medications taken, just rest and slower schedule.
55 2021-04-26 headache Dizziness with possible vertigo and mild headache approx 10 mins after reaction. Denies SOB,CP, chan... Read more
Dizziness with possible vertigo and mild headache approx 10 mins after reaction. Denies SOB,CP, change in vision, itchiness. Symptoms began improving approx 30 mins after vaccine administration. negative orthostatics Reports baseline migraine at discharge d/c vitals BP: 141/89 HR: 83 RR:18 SPO2: 97%
55 2021-04-27 fever Pt called call center on 4/23/21. Pt got second dose Pfizer vaccine on 4/22/21 and first on 3/30/21... Read more
Pt called call center on 4/23/21. Pt got second dose Pfizer vaccine on 4/22/21 and first on 3/30/21. Pt complains of fever 99.5 F and states when he went for a walk outside 4 hours ago and as he was talking to his neighbor he felt dizzy, blacked out for a few seconds, had weakness in his legs and fell and bruised his knees. Advised pt this is an emergency symptom and need to go to emergency room immediately. Pt states he will think about it but verbalized understanding that this an emergency symptom and need immediate attention.
55 2021-04-28 fatigue, headache Swollen & painful Lymph nodes under left arm and above left Clavicle, headaches, fatigue and problem... Read more
Swollen & painful Lymph nodes under left arm and above left Clavicle, headaches, fatigue and problems concentrating.
55 2021-04-28 influenza like illness, malaise Upon second dose I have constant twitching at and around injection site of left upper arm, it is ver... Read more
Upon second dose I have constant twitching at and around injection site of left upper arm, it is very disturbing and persists to this moment. I noticed it about 24 hours after the shot. I also have the totally normal soreness at the injection site that persists to this moment. I did have flu like symptoms (body aches, limb weakness arms and legs, malaise) on 4/28/21 from 1pm till 9pm but has resolved. The First shot I do not remember which arm, I think it was the left but cannot be certain, but I had no side effects at that time. I also have a very occasional twitch in my right upper arm that persists to this moment which is similar to the twitch in my left arm but is much much less severe and very infrequent. Note I have specifically nickel allergy and a number of other minor allergies. I also used to have benign fastulations that were random though my body which resolved and has not been an issued since 2017.
55 2021-04-29 chills, fever, fatigue Fever, chills, sob, myalgias, diarrhea, fatigue
55 2021-04-29 cough Two days after 2nd COVID vaccine patient experienced loss of vision in right eye. He also reports ha... Read more
Two days after 2nd COVID vaccine patient experienced loss of vision in right eye. He also reports having a cough for a week after the shot. This adverse reaction was uncovered during an unrelated hospitalization while taking patient history. 22 days after the onset of vision loss, he reports that vision has slightly improved but remains hazy and distorted.
55 2021-04-30 fatigue Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report... Read more
Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Lot number: ER8735) on the right arm as single dose for COVID-19 immunization. Medical history included ADHD, hypothyroidism. No Allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number: EP7534) on the right arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not test for COVID-19. The patient did not have covid prior vaccination and did not have covid tested post vaccination. On 09Apr2021, patient experienced severe depression, anxiety, deep emotional distress, fatigue, insomnia. Events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The outcome of events was not recovered. This report was assessed by the reporting consumer as non-serious. No follow-up attempts are needed. No further information is expected.
55 2021-04-30 fatigue Tiredness the morning after 2nd vaccination; This is a spontaneous report received from a contactabl... Read more
Tiredness the morning after 2nd vaccination; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Feb2021 at 11:15 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, nasal polyps, chronic rhinitis and allergy to NSAID. Concomitant medication included 20mg olmesartan daily. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (Lot Number: EL3247) on 26Jan2021 at 11:15 AM, as single dose in left arm for COVID-19 immunisation. On 16Feb2021, morning after second vaccination, the patient experienced tiredness. There was no treatment received for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The outcome of the event was recovered.
55 2021-04-30 headache, chills, sweating, fever Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP... Read more
Sever distress, no food, water, sleep four days; Sever distress, no food, water, sleep four days; BP 180/120; fever; sweats; body pain; headache; 24 lbs lost 7 days; chills; smell/taste; smell/taste; still sick; This is a spontaneous report from a contactable consumer reporting for himself. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 08Apr2021 at 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. Medical history included chronic pain from an unknown date and unknown if ongoing, and liver issues from an unknown date and unknown if ongoing. Concomitant medication(s) included morphine taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; tamsulosin taken for an unspecified indication, start and stop date were not reported; and naproxen (NAPRO) taken for an unspecified indication, start and stop date were not reported. Past vaccination history included the first dose of BNT162B2 on 18Mar2021 as a single dose in the left arm for covid-19 immunization. The patient experienced sever distress, no food, water, sleep four days on 09Apr2021 at 20:00 with outcome of not recovered, blood pressure 180/120 on 09Apr2021 at 20:00 with outcome of not recovered, fever on 09Apr2021 at 20:00 with outcome of not recovered, sweats on 09Apr2021 at 20:00 with outcome of not recovered, body pain on 09Apr2021 at 20:00 with outcome of not recovered, headache on 09Apr2021 at 20:00 with outcome of not recovered, 24 lbs lost 7 days on 09Apr2021 at 20:00 with outcome of not recovered, chills on 09Apr2021 at 20:00 with outcome of not recovered, smell/taste on 09Apr2021 at 20:00 with outcome of not recovered, and still sick on 09Apr2021 at 20:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 180/120 on 09Apr2021, sars-cov-2 test nasal swab: negative on 11Apr2021. Therapeutic measures were taken as a result of sever distress, no food, water, sleep four days, blood pressure 180/120, fever, sweats, body pain, headache, 24 lbs lost 7 days, chills, smell/taste, and still sick and included migraine medications, pain control, fluids, and supportive care. It was reported that he was hospitalization in ER twice for supportive care and also reported that Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
55 2021-05-01 fever, chills Vaccine received 4-28, 9:20 AM, Started feeling chills and fever 10 hours later. Fever and chill... Read more
Vaccine received 4-28, 9:20 AM, Started feeling chills and fever 10 hours later. Fever and chills all day 4-29. stayed in bed. took ibuprofin and felt better the following day. On 5-1 at 10:30 PM I observed raised red rash on legs, very itchy. took 50 MG of benadryl. woke up early 5-2 with severe raised red rash all over body (90%) red and inflamed itchy
55 2021-05-02 throat pain Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw li... Read more
Right ear itchy after getting vaccine. Around 3 pm Right ear itchy, throat tight , sore under jaw like when you swallow clearing throat .No problem eating dinner.7 pm Trouble swallowing feels stuck when swallows food, esophagus tight. 10 pm took Benadryl . Panicky at 12 midnight. Benadryl helped still feels tight did not want to take second benadryl . Watched until 1:30 am felt tightness under chin but esophagus relaxed. Ringing in ears Saturday all day and still has it. Started Friday but has gotten worse. was told to inform patient to go to PCP.
55 2021-05-02 fever, chills, headache Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effec... Read more
Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/2. He had expected post-vaccine side effects including headaches, muscle aches, fever/chills, which lasted 2 days. On 4/19, he presented to the ED with 2 days of R sided pleuritic chest pain, dyspnea, and was diagnosed with PE based on CTA. He was started on treatment with apixaban and his symptoms of pleuritic pain and dyspnea have resolved.
55 2021-05-02 fever, headache Two days after my second shot, I started experiencing really bad joint pain, a headache, a fever an... Read more
Two days after my second shot, I started experiencing really bad joint pain, a headache, a fever and what felt like my veins were on fire. I received the shot on Wednesday and was fine on Thursday and Friday morning, but I had taken Tylenol and Airborne all day Wednesday Thursday and Friday morning in the hopes of reducing symptoms. The headache started on Friday afternoon. The other symptoms on Saturday morning and lasted on and off all weekend. It went a way for a bit, but then came back. The weather was very rainy, so I wrote it off as mild arthritis pain, but it persisted and kept getting worse. But, we had a rainy March and April. It is now May and the pain continues. Sometimes in my joints. Sometimes not. Across the back of my right hand is the worst and almost constant. On and off, I get the headaches, pains in my joints or muscles, or just across my thigh, or my calf. None of this happened before the shot, so I am thinking it may be elated.
55 2021-05-04 chills, headache, fever About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until ne... Read more
About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; About 12 h after vaccination, I got headache, chills, body aches and low fewer which lasted until next day; This is a spontaneous report from a contactable consumer (reported for himself). A 55-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at 07:45 as SINGLE DOSE (at the age of 55-years) in left arm for covid-19 immunization. Medical history included high cholesterol. The patient had no known allergies. Historical vaccine included: the patient received first dose of bnt162b2 via an unspecified route of administration on 26Jan2021 at 07:30 as SINGLE DOSE (at the age of 55-years) for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Concomitant medications included: atorvastatin (Lipitor), diphenhydramine hydrochloride (Benadryl), Ibuprofen and unspecified multivitamins. Prior to the vaccination the patient was not diagnosed with COVID-19. On 16Feb2021 at 20:00, about 12 hours after vaccination, the patient experienced headache, chills, body aches and low fewer which lasted until next day. It was reported that there was no treatment for events. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering.
55 2021-05-06 chills, malaise, fever, cough, headache Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with ... Read more
Coughing blood; Trouble Breathing; Lungs Damaged; Coughing; Headache; Fever; Body Shakes a Lot with Cold; Night Sweats, states it is like he took a shower; Diarrhea, states when he goes to the bathroom, it is water; Lost 14 Pounds; felt really bad; This is a spontaneous report from a contactable consumer reported for himself. A 55-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left at 55 years old on 06Apr2021 08:45 (Lot Number: ER8733; Expiration Date: 31Jul2021) at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure, diagnosed 20 years prior to the report. The patient's concomitant medications were none. There were no other vaccines Administered on Same Date of the Pfizer Suspect or within 4 weeks. The patient experienced coughing, headache, fever, body shakes a lot with cold, night sweats, states it is like he took a shower; diarrhea, stated when he went to the bathroom, it was water, coughing blood, trouble breathing, lungs damaged, lost 14 pounds, all on 06Apr2021. Patient stated he was calling because his doctor told him to call. Stated he got his first injection on 06Apr2021. Told to sit for 15 minutes, and he felt fine and went to work and felt really bad after 1 hour; 09:45-10:00. Since then he had been super sick and at the hospital 3 times, later confirmed ER, not hospitalized. Patient stated the doctor also told him his lungs are damaged and they were sending him to see a specialist. Patient was asking what was going on with his body, is this a normal reaction? Stated his doctor said to call because it had been too long, stated usually it lasted 2-3 days and with Tylenol, it was gone, then it should be clear, but it had been almost 16 days for him. Stated one hour after his injection, he started feeling really bad. Stated he was coughing up blood from coughing so much. Stated he was 154 pounds, but he has lost 14 pounds. Patient stated his first injection was on 06Apr2021. Stated his second vaccine is supposed to be on 28Apr2021 but he was not going because he was afraid to go back in case it got worse. Treatment received for the events included 3 Different Antibiotics; Tylenol and Drinking Hot Tea. Patient clarified that he has had 3 Emergency Room Visits (10Apr2021, 19Apr2021, and 20Apr2021), Physician Office on 21Apr2021, but he was never admitted to hospital. Patient stated one time they kept him in the ER for 20 hours. Patient stated once he went to Hospital and then yesterday and the other day, he went to Hospital because he was having trouble breathing. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.
55 2021-05-07 headache, malaise, fatigue, sweating Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could se... Read more
Extreme fatigue; Back of knees were cramping; Small bruise marks; Upper right arm inside he could see all of his veins; Head rush; Felt like he was going to spazz out; Sweating; Diarrhea; Headache and pressure at his temples; His ears were ringing; Left arm pain from injection site; Drop foot; Legs went to sleep; Arms were roided out or supercharged/Forearms did not feel like his blood was right; Difficulty/pain breathing in the upper chest; Difficulty/pain breathing in the upper chest; Pretty big at the base of his left index finger, red spot; Pain in the right thumb base/Pain in base of right foot; He felt like he was going to die 5 times; Thought he was having a stroke; Heart rate would go up or be faint; Lost four pounds during this, and gained one back; Stiff right arm/Left thigh was stiff; Thrashing event; Heart rate went up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, expiration date: 28Mar2021) via an unspecified route of administration on left arm 24Mar2021 10:00 at single dose for covid-19 immunization. Medical history included cytomegalovirus from on an unspecified date 2010 and Palpitations. The concomitant medications were not reported. The patient reported, he has gained back a pound and that he is starting on the road to recovery in the last week. Stiff right arm lasted the first and second week. It started the first day of when he got the shot. The next morning, he calls a thrashing event where he felt like his limbs would not work. They did work, but it felt like he needed to move them around. He was thrashing in bed and making the motion with his big joints, then getting into the small joints. It was his arms and legs. Over the course of like an hour, his heart rate went up to like 120. He does not qualify this as racing, but his heartrate is normally 60. This was several times over the course of the first week so it would have been around 04Apr2021 or 03Apr2021. Events occurred 9 days later, which is what he is considering this first week. His left arm was where he got the vaccine, but his right arm was stiff. He felt like he was going to die 5 times. He also had extreme fatigue. He never went to the emergency room. At this time, his glucose was high and his zinc was low. The doctor thinks the extreme fatigue was the antibodies reacted to the cytomegalovirus. He adds that the back of his knees was cramping in the first and second week. In the right arm, he had some small very small bruises. His forearms did not feel like his blood was right. He does not know how to describe it, but he has had metal slivers in his arm in the past and it felt like that, like an infection. He does not know how to describe it. He adds that in his upper right arm inside, he could see all of his veins, like a roadmap. He also had some other things, like his left side of his head rush, like it felt like blood was rushing from the top to left side of his brain. At dinner and meals he had several instances he could barely sit there, he felt like he was going to pass out or spazz out. His limbs felt like they were going to spazz out. In second week, he had several nights where he sweated a lot overnight. The second week into the third week, he did not have the thrashing stuff anymore but for pretty long his heart would go up a notch and/or the heart would be faint. He had diarrhea when he got up. It did not go up to 120, but maybe 80, Headache and pressure at his temples, ears ringing. Left arm pain from injection site. It started with a bang and really hurt. It was really sore and kind of spread into cramping. It was stiff and the source was the injection site. At work, he thought he was having a stroke. His left leg and thigh were stiff and spreading feeling. About 20 minutes after sitting, his legs did not work, and he collapsed. He had Drop foot when his legs got stiff. It took like a week to retrain his arm and leg, like he had a mini stroke. He did therapy for himself and retrained his arm to play guitar. He had a little bit of stiffness in his left arm that comes and goes, stiffness in his left thigh that comes and goes, and his ears are ringing a little bit and it comes and goes. He is not getting second vaccine. He took zinc per his doctor recommendation, but it did not go well. He felt like his arms were roided out or supercharged. He had difficulty/pain breathing in the upper chest, a pretty big at the base of his left index finger red spot like blood collection, and pain in the right thumb base. He had pain in the base of his right foot. Blood tests were in the second week. Glucose was high and he is hypoglycemic. Glucose 117 mg/dl (79-115 normal range), zinc 54 mcg/dl (60-120 normal range), CMV IGG AB >10 u/mL (positive is > or = 0.7 range). The outcome of the events was unknown.
55 2021-05-08 chills, fever, fatigue Fever 101.4, chills, exhaustion, body & head electrical jolts, tinnitus. Electrical jolts starting... Read more
Fever 101.4, chills, exhaustion, body & head electrical jolts, tinnitus. Electrical jolts starting to subside 5/9/21. Tinnitus continues still.
55 2021-05-10 fever chest pain and low fever. chest pain for 5 day (increase day to day). low fever for 1 day.
55 2021-05-12 headache, fatigue, sleepiness, fever Fever, body aches, weariness, sleepiness, headache. Treated with test and fluids.
55 2021-05-12 fever, fatigue, headache, sleepiness injection site soreness fever - 101, headache, tired, sleepy muscle pain, joint pain all over a peri... Read more
injection site soreness fever - 101, headache, tired, sleepy muscle pain, joint pain all over a period of 24-36 hours
55 2021-05-13 chills Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous r... Read more
Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI. On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
55 2021-05-13 fatigue, lethargy Mild, overall, but definitely result of the vaccination. Just providing as an FYI. Soreness at the s... Read more
Mild, overall, but definitely result of the vaccination. Just providing as an FYI. Soreness at the site of injection on my left arm starting several hours after and lasting through the next day. Took a Tylenol. Extreme lethargy/tiredness about five hours after the injection. Had to take a nap that afternoon and went to bed early. Felt normal the next day after a night's sleep.
55 2021-05-13 headache head aches; double vision; This is a spontaneous report from a non-contactable consumer (patient). A... Read more
head aches; double vision; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route on 01Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced head aches on 01Apr2021 and double vision on unspecified date in Apr2021. Patient stated that since he had the second shot Pfizer 01Apr2021, that same day he started having head aches and hasn't stopped since, last week Wednesday, he started having double vision that still exists, went to the eye doctor, bought new glasses. They want him to see a specialist next. Since he had the second shot this has been going on with him that is why he thought it was related to the vaccine. He asked is there anything else he should be doing. Response was a review of the prescribing information for Pfizer BIONTECH COVID 19 VACCINE did not find information regarding double vision. Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer BIONTECH COVID 19 VACCINE). Beyond what is described in the <Pfizer BIONTECH COVID 19 VACCINE prescribing Information, Pfizer does not provide any recommendations regarding the management or treatment of potential adverse events/reactions/symptoms that a patient /consumer may experience. Your doctor/healthcare provider is in the best position to advise you about the appropriate action to take as your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. There was no PQC present. The outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-05-13 lethargy, fatigue Mild overall, but more pronounced than the first vaccination in the series, and definitely the resul... Read more
Mild overall, but more pronounced than the first vaccination in the series, and definitely the result of the vaccination. Reporting just as an FYI. Soreness at the site of injection on my right arm starting several hours after, (Friday), and lasting through two days (Sunday). Took a Tylenol a day. Extreme lethargy/tiredness for several days, and somewhat "off", the first day being the worst. Wasn't really "myself" again until about Tuesday (fourth day). "Off" meaning tired and not 100% clear-thinking. Worst on Saturday and gradually better each day after.
55 2021-05-13 sinus pain, headache Left Side of Head and Face Hurt Teeth, Head, Ear, Sinus, Neck Pain
55 2021-05-14 cough 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after... Read more
2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; Received First dose on 03Apr2021, Second dose on 17Apr2021; Received First dose on 03Apr2021, Second dose on 17Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Apr2021 17:00 (at age of 55 years old) (Lot Number: EW0172) as single dose for covid-19 immunisation. The patient other medical history was none. No known allergies. The patient's concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 03Apr2021 17:00 (Lot Number: EW0150), also at age of 55 years old for covid-19 immunization. The patient reported that 2 hours after 2nd dose, he started to cough and wheeze and felt his throat was closing. He didn't want to go to the hospital and it felt better after his wife gave him diphenhydramine (BENADRYL). Adverse event start date was reported as on 24Apr2021 19:00 (CLARIFICATION PENDING). Events were reported as non-serious. AE treatment was reported as "no" (CLARIFICATION PENDING). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered in Apr2021.
55 2021-05-14 fatigue, sweating I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some ver... Read more
I felt absolutely fine after eating dinner, but was tired so got in bed around 9:30. I had some very vivid dream & woke up at 11:00, the sheet on the bed was wet with sweat, drool on pillow & every muscle in my body was cramped up. I think it was a convulsion/seizure, but was alone in the hotel room. Today, I feel perfectly normal -
55 2021-05-15 chills, fever, fatigue, cough pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sin... Read more
pain in arm, within 5 days-very tired and no apatite, fever/chills/cold sweats. within 30 days, sinus tachycardia, low Sp02, started having a cough. Sepsis secondary to severe right lung necrotizing pneumonia with empyema, hospitalized for 5 days. Discharged with a right chest tube with Pleur-evac. Will require at least 6 weeks of antibiotics.
55 2021-05-17 headache, fatigue, fever Low fever (100°F), headache, body aches, unusually tired, lack of concentration. This lasted for le... Read more
Low fever (100°F), headache, body aches, unusually tired, lack of concentration. This lasted for less than a day. I took ibuprofen, which helped.
55 2021-05-17 headache Headache followed by Tinnitus. Increased blood pressure at onset of each. Headache remains at lower ... Read more
Headache followed by Tinnitus. Increased blood pressure at onset of each. Headache remains at lower pain level. Tinnitus continues with no change, in both ears and has not improved.
55 2021-05-18 cough, fever tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous ... Read more
tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital. The patient also experienced fever, disorientated, and difficulty breathing. The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021. Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients
55 2021-05-18 respiratory tract congestion, chills, cough, headache, fever Long term painful arm, then a crazy fluctuating fever with headache and chills for 5 days 3 weeks af... Read more
Long term painful arm, then a crazy fluctuating fever with headache and chills for 5 days 3 weeks after shot, followed by congestion, coughing and then a growing red rash patch at sight of injection. Now 5 weeks later, hives all over my body including rash at injection site. Becoming itchier daily, not responding to antihistamines.
55 2021-05-19 chills, fever, headache severe fever, chills, burning headaches.
55 2021-05-19 cough ED to Hosp-Admission Current 5/8/2021 - present (12 days) Treatment team Sepsis due to severe acu... Read more
ED to Hosp-Admission Current 5/8/2021 - present (12 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Date: 5/8/2021 PCP: DC Hospitalist: MD Assessments Chief Complaint Patient presents with o Dizziness o Cough Principal Problem: Acute respiratory failure (CMS/HCC) Active Problems: COVID-19 Plan #Acute hypoxic respiratory failure requiring 50 L of oxygen support to maintain his oxygen saturations, patient came in with a saturations of 58% on room air. This is secondary to Covid pneumonia -Patient will be started on convalescent plasma, remdesivir and dexamethasone. -Reviewed entire plan of care with with him his interpreter at bedside and patient gave consent to receive convalescent plasma. -We will obtain acute inflammatory markers. -I will also obtain a CT scan of chest to rule out pulmonary embolism given severe hypoxia. -Anticipate hospitalization for 5 days given severe acute hypoxic respiratory failure requiring high flow oxygen. #Acute anion gap metabolic acidosis secondary to lactic acidosis secondary to Covid pneumonia resulting in severe hypoxic respiratory failure. -Check procalcitonin to see if patient is developing secondary bacterial infection. -If procalcitonin is elevated will start patient on antibiotics as well. -Use guaifenesin for mucolytic purposes. -Recheck lactic acid with the current management. #Mild hyponatremia: -Secondary to pulmonary infection with a Covid pneumonia. -No acute intervention needed, will continue to monitor. #GERD: -Continue PPI. Critical care time today is 38 minutes. Patient was educated regarding prone positioning and will prescribe a cough medication gave given intractable cough as well. # VTE Prophylaxis: heparin Full Code Diet: Active Orders No diet order for this patient
55 2021-05-21 chills, sweating Cellulitis; Chills; scaling; his leg started leaking; redness; sweating; had a crack in his skin; Th... Read more
Cellulitis; Chills; scaling; his leg started leaking; redness; sweating; had a crack in his skin; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular administered in arm left on 17Apr2021 (Lot Number: ER8737) at the age of 55-year-old as single dose for covid-19 immunisation. He was allergic to milk. He said it gave him sniffles and stuffs his nose but he drinks it anyways. The patient's concomitant medications were not reported. His 2nd shot of the Pfizer COVID Vaccine tomorrow and was asking if the vaccine would just be as effective if he delays the shot a week or 2 later because he was getting treatment for cellulitis on 26Apr2021 and he knew that the side effects of the vaccine and treatment are similar and he does not want to get "double whammed". He has heard that the vaccine would still be effective if delayed for up to 60 days and would like to confirm that. He confirmed that he had cellulitis and chills but said none of that was from the shot. He said that if he got the second shot he was worried about them double teaming his immune system. He said he had athletes foot and had a crack in his skin in Apr2021, and it got into him that way. He said the chills were from the cellulitis. The caller said that the events started shortly after his shot, oddly enough. He said he went to the hospital. He said he was at work. He said he went to the doctor on 29Apr2021 for the chills a week or two before that. He said on 26Apr2021 his leg started leaking. He said he was on antibiotics and it was going down but he still had redness and scaling that he wasn't able to get rid of. He said he got them at the same time, the leaking, the chills started that night. He said he noticed the cellulitis in the morning and he let it go for a couple of days. He went to the doctor on Thursday. He should have gone earlier. He said no more winter coat in the sun. He said his wife and his roommate were sweating and he had a sweater on; he had it bad. He said he didn't remember the days but he was tested for a blood clot which was negative and they checked out his heart. He did not provide the result of them checking out his heart. He says any doctor who knows about cellulitis knows to check these things. He also says they checked his blood pressure and other things: see formal field. He said after the emergency room they sent him home and told him to follow up with his primary care provider and a podiatrist, which he has done. He says he saw his primary care provider the following Monday 03MAY2021 and the podiatrist he didn't see until Wednesday 05MAY2021. He says he was supposed to see both of them within 2 days but he couldn't get in. Those events resulted emergency room and physician office. The patient was not hospitalized. He said his family had skin problems like eczema and such but he said it not relevant. The patient underwent lab tests and procedures on 29Apr2021 which included blood pressure: 110/63, temperature: 97.2, pulse: 84, oxygen saturation: 99%, respiration: 16. Outcome of event cellulitis, chills, his leg started leaking, redness was recovering; of sweating was recovered in 2021, of other events was unknown.
55 2021-05-21 headache just a light headache and it went away
55 2021-05-22 headache, chills, fever Received 2nd COVID vaccine on 5/20/21. Ten hours after vaccine, he developed fever, chills, severe m... Read more
Received 2nd COVID vaccine on 5/20/21. Ten hours after vaccine, he developed fever, chills, severe muscle pains, severe headache, & felt eyes were going to pop out of his head. He was bedridden. Symptoms lasted 36 hours, and he missed a day of work.
55 2021-05-22 headache Tinnitus non stop ringing in my ears and headaches
55 2021-05-23 cough, sweating, pneumonia, chills, fever I developed a pneumonia after receiving the 2nd dose. Symptoms included: fever, chills, sweats, cou... Read more
I developed a pneumonia after receiving the 2nd dose. Symptoms included: fever, chills, sweats, cough, rash, diarrhea shortness of breath.
55 2021-05-23 fatigue, headache I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint... Read more
I received the vaccine in the right arm and within about 20 seconds I felt like I was going to faint and had rapid heart rate (pulse of 155) measured by EMT. I needed to remove the mask as I was having difficulty with the rapid heart rate and feeling of fainting. I also felt pins and needles type feeling in my legs and my face felt slightly swelled. I felt tired and that tired feeling lasted for the entire day. I stayed at the vaccination site for approximately 30 minutes at the advice of the EMT and went home. Later I had a slight headache but heart rate became more normal.
55 2021-05-23 fatigue Rapid heartbeat, fatigue
55 2021-05-23 throat pain, malaise 4 days afterwards, I developed intense tinnitus in my right ear (the one affected by Meniere's) and ... Read more
4 days afterwards, I developed intense tinnitus in my right ear (the one affected by Meniere's) and fullness. The ringing, deafness & fullness continues until today. I have lost a lot of hearing acuity in both ears. I felt really ill (flu like) on 5/20/21. I had full body aches and severely sore throat. The PA prescribed Methylprednisolone 4 mg dosepak. I have been taking according to instructions. Today, I developed vertigo for the first time in 14 years.
55 2021-05-24 fatigue experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt re... Read more
experienced nausea; sore arm at the injection site; sore arm at the injection site; at night felt really tired; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 15Feb2021 (at the age of 55-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 26Jan2021 at the age of 55-year-old without any side effect. Concomitant medications were not reported. On 15feb2021 after second dose of vaccine the patient experienced sore arm at the injection site and at night felt really tired. On the morning of 16Feb2021 he experienced nausea lasting for a day. On 17Feb2021 the patient felt fine and the events resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-05-24 fever, cough Fever cough aching breathless
55 2021-05-25 fatigue, fever first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme ... Read more
first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme fatigue, I passed out and was unconscious for atleast 2-3 minutes 911 was called.
55 2021-05-25 fatigue anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a... Read more
anxiety attack; heart racing; intense feeling of heat in body; tired; shortness of breath; This is a spontaneous report from a contactable other HCP (patient). A 55-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 16:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy. There were no concomitant medications and the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient previously took levofloxacin and experienced allergy. The patient reported that approximately three minutes after taking the vaccine 24Apr2021 16:33 (also reported as 17:15), still waiting for the recommended 15 minutes to be released, he started to feel his heart racing and a very intense feeling of heat in body. After reporting to the nurse at the location, she listened to his heart asking him to take a deep breath several times. According to the nurse, he had an anxiety attack, as she did not show any signs of anaphylaxis. However, he felt very tired and the night with a little shortness of breath. He would like to know if he go for the second dose or look for another vaccine. the patient did not receive treatment for the events and the outcome of the events was resolved in 2021. Information on the lot/batch number has been requested.
55 2021-05-25 fatigue Fatigue; sleepless night; This is a spontaneous report from a contactable Non health care profession... Read more
Fatigue; sleepless night; This is a spontaneous report from a contactable Non health care professional consumer, the patient. A 55-Years-old adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207 and expiration date not provided) dose no:1 on right arm via an unspecified route on 13Mar2021 at 11:00(at the age of 55-years-old) as a single dose for COVID-19 vaccination (COVID-19 Immunisation). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included allergic to Morphine, Dilaudid and the past medical history included bipolar 1 disorder. Concomitant medications included Lithium carbonate, valproate, quetiapine and Pramipexole. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. After the vaccination, on 14Mar2021 at 02:00 AM patient experienced fatigue lasted for 2 days and sleepless night on the first night. The patient recovered from the events Fatigue and Insomnia at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-05-27 headache, lethargy My first vaccine was Feb 14, 2021, my second Mar 7, 2021. Following both I had <24 hours of headache... Read more
My first vaccine was Feb 14, 2021, my second Mar 7, 2021. Following both I had <24 hours of headache and lethargy before returning to normal. Symptoms were noted during hikes with cub scouts, so not particularly difficult terrain On March 27 I was very short of breath during an uphill hike and almost gasping at the top. I did no more uphill hiking until the next event May 1, at where I experienced shortness of breath and dizziness on an uphill hike. After resting a few minutes I continued for a brief period before it returned requiring me to back. May 7, short of breath and dizzy while doing yard work requiring ladder climbing May 10, short of breath and dizzy on a quick 1/2 mile walk May 10, visited GP and was admitted to hospital with abnormal ECG
55 2021-05-28 fatigue, fever, sweating, headache, chills muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barel... Read more
muscle soreness; flu; headache; chills; weakness; fatigue; difficulty thinking straight; could barely stand; could not eat; fever; lots of sweating; muscle fatigue; hard to breath; body aches all over; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 17:00 (Batch/Lot Number: EW0153) as 2nd dose, single for covid-19 immunisation. Medical history included asthma and samters syndrome. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and aspirin and experienced allergies. On 12May2021 12:30, the patient experienced muscle soreness which is much less and is gone at the time of the report, patient came down with the flu which began around 11:30 am to 12 pm, 20 hours after receiving the second shot. It began with headache, muscle aches, chills, weakness and fatigue. The patient also began having difficulty thinking straight. The patient is a truck driver and was on the road trying to finish up so he just could go home and call in sick. When the patient got out of the truck, he could barely stand as he was so weak. It was both fatigue but also his body had no energy to give. The patient had a hard time getting energy to finish and get ho//2021nt then got home and felt worse, like a full blown flu, could not eat, fever and lots of sweating yet lots of chills all over, weak, headache was worse, body aches all over, hard to breath from muscle fatigue, woke up soaked in sweat. The patient added that he has not felt this bad in years. The patient did not receive treatment for the events. Event muscle soreness was recovered on unspecified date; all other events was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-05-28 fatigue Approximately 1 week after receiving the shot my Crohn's disease came out of remission after almost ... Read more
Approximately 1 week after receiving the shot my Crohn's disease came out of remission after almost 15 years. Blood and mucus in stool, malformed stool, diarrhea, blood and mucus bowel movements, bowel movement urgency, physical fatigue.
55 2021-05-31 headache a few aches and pains; he had a headache; This is a spontaneous report from a contactable consumer (... Read more
a few aches and pains; he had a headache; This is a spontaneous report from a contactable consumer (parent). A 55-year-old male patient (son) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After received the 2nd dose, the patient experienced a few aches and pains and had a headache on an unspecified date. Patient's wife reported that can my husband get the COVID vaccine (probably by Moderna) if he's taking Xeljanz. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
55 2021-05-31 sweating Member in observation approx 10 mins after receiving vaccine became diaphoretic with complaints of n... Read more
Member in observation approx 10 mins after receiving vaccine became diaphoretic with complaints of nausea,. Member then began to vomit x 2.
55 2021-06-02 fatigue, chills, fever Light fever; Light chills; Fatigue; Body aches; This is a spontaneous report from a contactable cons... Read more
Light fever; Light chills; Fatigue; Body aches; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198; Expiration date was not reported) on the left arm on 25Feb2021 (08:00) as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Mar2021 (09:00), the patient had light fever, light chills, fatigue and body aches. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
55 2021-06-03 chills Markedly elevated blood pressure, anxiety, severe body aches, chills
55 2021-06-04 headache the first shot of the Covid-19 vaccine, he had a headache for one day/He has had lots of headaches s... Read more
the first shot of the Covid-19 vaccine, he had a headache for one day/He has had lots of headaches starting on 07May2021; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0164) via an unspecified route of administration in left arm on 15Apr2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0165) via an unspecified route of administration in left arm on 06May2021 13:30-14:00 (as reported) as 2nd dose, single dose for COVID-19 immunization. Patient was 55-years-old at the time of vaccination. Vaccination Facility Type was reported as Megasite. Vaccine was not administered at Military Facility. No prior vaccinations within 4 weeks. On 16Apr2021, patient experienced headache after first dose. Patient received the second dose of the Pfizer Covid 19 vaccine on 06May2021. He has had lots of headaches starting on 07May2021. He has had headaches off and on every day since then. Patient reported that he received the second dose of the Covid-19 vaccine on 06May2021 and has had a lot of headaches. Patient reported that with the first shot of the Covid-19 vaccine, he had a headache for one day. Patient reported that he got the second dose of the Covid-19 vaccine on Thursday (06May2021) and Friday (07May2021) he had a headache all day nonstop. Patient reported that for the past week and a half to 2 weeks, he has been having a headache every day, in and out all day. Patient inquired if it was normal to have a headache for 2 weeks following the Covid-19 vaccine and if he should go to the doctor. Patient reported that the headache has stayed the same since it began on 07May2021. Patient reported that the headache comes and goes and that he is taking Tylenol to ease the pain. The events did not result in emergency room or physician office visit. The outcome of the event was not recovered. Follow up attempts are needed. Further information has been requested.
55 2021-06-07 chills Chills, Sweats all night
55 2021-06-07 headache Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; u... Read more
Shingles to face/outbreak of Shingles; nerve pain to the right side of face and upper right teeth; upper right teeth are still numb and throb; right side of head hurt; right eye was swollen and almost fully closed; blister; terrible sunburn top of head and entire right side of face; trigeminal neuralgia; additional pain to front upper teeth from center to the right side of mouth; some pain on right side of face above mouth/ lot of pain all to the right side of face/terrible pain right side of face; pain to front upper right tooth/upper teeth ached/terrible pain upper right side of teeth/upper right teeth are still numb and throb; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received second dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Mar2021 (at the age of 55-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient received the first dose of bnt162b2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Feb2021 as first dose single dose for covid-19 immunisation. Concomitant medication included methylprednisolone (MEDROL [METHYLPREDNISOLONE]) taken for; amoxicillin (AMOXICILLIN) and secukinumab (COSENTYX) taken for psoriasis. On an unspecified date, the patient experienced shingles to face/outbreak of shingles. On 14Apr2021, the patient experienced pain to front upper right tooth. The patient saw dentist and the tooth looked fine. On 17Apr2021, the patient had additional pain to front upper teeth from center to the right side of mouth and some pain on right side of face above mouth. On 18Apr2021, the patient saw three different dentists, and none found any issues with teeth. On 19Apr2021, the patient had terrible sunburn on top of head and entire right side of face, upper teeth ached, having more pain to the right side of my face and the dentist thought he had trigeminal neuralgia. On 20Apr2021, in the evening the patient was in a lot of pain all to the right side of face and contemplated going to the hospital but did not go. On 21Apr2021, the patient woke up in terrible pain (right side of face and upper right side of teeth) and right side of head hurt, right eye was swollen and almost fully closed, and a blister was visible. The patient reported that, he saw a Rheumatologist who diagnosed Shingles and he started taking Valtrex and Gabapentin. The patient also saw an ophthalmologist who prescribed an antibiotic eye drop. The patient reported that, she was in bad shape, which is evident in a picture she took by 23Apr2021. The patient saw an ENT who had sent him back to the ophthalmologist and he consulted with Rheumatologist. The patient reported that, ENT gave him a Medrol Steroid for six days and Amoxicillin. The patient had been suffering greatly since this began. On 10May2021, the patient's swelling has receded, but still had significant nerve pain to the right side of face and upper right teeth and upper right teeth are still numb and throb. Therapeutic measures were taken as a result of herpes zoster, toothache, oral pain and eye swelling. Outcome of the events was unknown. Information on the lot/batch number has been requested.
55 2021-06-07 lethargy, fatigue He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confus... Read more
He had a stroke- sudden onset of weakness,- facial drooping, speech impairment, lethargy, and confusion obvious symptoms did resolve over 24 hour- he has some residual fatigue and questionable changes post stroke
55 2021-06-07 malaise, headache, chills, cough Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and ar... Read more
Headache; Chills; Feeling unwell; Tightness in chest; Wheezing; A lot of coughing; Lungs hurt and are kind of sore; It makes breathing difficult; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 19may2021 (at the age of 55-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 28apr2021. The patient medical history includes type 2 diabetes and patient is not a smoker. Concomitant medications were not reported. On 22may2021, 3 days after the second vaccination, the patient experienced headache, chills, feeling unwell, tightness in the chest, a lot of coughing, wheezing, lungs hurt and kind of sore and breathing difficulty. The coughing is usually dry with something coming up occasionally, but it's not much. It's been a lot of coughing and he was feeling rundown. He wants to know if this was normal after having the shot a week ago. The patient stated that his lungs begin to hurt after coughing a lot and it makes breathing difficult. He is a non-smoker, so it has nothing to do with smoking. He has tightness in the chest from coughing and his lungs are kind of sore. It just comes on and he feels fine for a while. But it just comes on and sticks with him for a while. Patient stated headache started on Saturday afternoon and it kept with him till Wednesday. After ibuprofen it stayed down but, occasionally it is off and on. It has gotten better. He had it for 3 days straight and it will come back and then it is gone away again. Patient also stated that chills happened once or twice and not sure on the day the chills stopped. Patient stated that he was at work and for a while and started feeling unwell on 22may2021 morning. And he starts with the coughing, it just comes and goes. His blood sugar has been okay. Patient received ibuprofen as treatment option for the events (headache). The seriousness of the events was unspecified. The outcome of the events headache was recovering and outcome of all other events was mentioned as unknown. No follow-up attempts possible. No further information expected.
55 2021-06-07 runny nose, headache, nasopharyngitis Head cold like symptoms including severe head congestion; headache; runny nose; This is a spontaneou... Read more
Head cold like symptoms including severe head congestion; headache; runny nose; This is a spontaneous report from a non-contactable consumer (patient himself). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN9581) 1st dose, via an unspecified route of administration, administered in right arm on 03Mar2021 10:00 (age at vaccination: 55 years) as single dose for covid-19 immunization at Health Clinic/Administration facility. The patient's medical history was not reported. Concomitant medications included loratadine (CLARITIN) for unknown indication and from unspecified date. There were no known allergies. On 04Mar2021 10:30, the patient experienced head cold like symptoms including severe head congestion, headache and runny nose. The patient did not receive any treatment for adverse events. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior to vaccination nor was tested for covid post vaccination. outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
55 2021-06-08 chills, headache, fatigue, fever The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such ... Read more
The day after the shot, the patient got the usual headaches, bodyaches, fatigue, arm soreness, such that it was difficult to raise his arm, nausea, dizziness and fatigue. That all resolved after two days. He then felt well for one week. Then, on May 29th, 9 days after vaccination, he got fever to 102, chills, fatigue, itchy vesicular whole body rash, headaches and bodyaches, such that, had he been working, he would have missed work for one week. He was seen, and put on Valacyclovir 1 gram tid * 1 week for probable recurrent varicella illness. Viral PCR was positive for VZV. He recovered over the course of 7 days.
55 2021-06-09 fatigue, malaise Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatig... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatigue, malaise, and anorexia. Patient was hypoxemic (oxygen saturation 90%) and tachycardic (pulse 108 beats per minute). Diagnosed with COVID-19 and acute hypoxemic respiratory failure, admitted to hospital, received remdesivir, steroids, anticoagulation, and oxygen. Patient improved and was discharged two days later medically stable.
55 2021-06-10 fatigue Shingles outbreak, Nerve damage, severe exhaustion
55 2021-06-11 sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
55 2021-06-14 fatigue, headache I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the b... Read more
I suffered a Subarchnoid brain hemorrhage. The was bleed in the subarachnoid space surrounding the brain. I went to emergency at hospital with worst headache of my life. After a brain hemorrhage was confirmed by CT-scan, I was rush to hospital were I was treated in the Cerebral critical unit. I suffered through the worst pain of my life for 10 days as the blood from the hemorrhage drained. It 2.5 months later and I am still dealing with the effects of the hemmorhage (headaches, exhaustion, light sensitivity, short term memory loss and speech issues,
55 2021-06-15 chills Slight arm pain day after injection. On 6/14/21 nausea with abdominal cramps thru the evening with ... Read more
Slight arm pain day after injection. On 6/14/21 nausea with abdominal cramps thru the evening with chills. On 6/15 and 6/16 severe diarrhea throughout the day. Treatment to this point has been maintaining fluids , water, sports drink and pedialyte. Immodiium taken on 6/16 at 5pm
55 2021-06-16 cough, runny nose, sinus congestion Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test posit... Read more
Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-06-16 head discomfort, influenza like illness, headache On May 21,2021 I Started To Come Down With Flu Like Symptoms Which Was Expected , Which Symptoms En... Read more
On May 21,2021 I Started To Come Down With Flu Like Symptoms Which Was Expected , Which Symptoms Ended Approximately On May 29,2021. On May 28,2021 I Felt A Sharp Pain In The Back Right Side Of My Head Which Also Made Me Feel A Slight Nausea. I Started To Have Headaches , Sharp Pain, Head Pressure In All Parts Of My Head . Head Pain Still Can Be Felt Today.
55 2021-06-16 headache Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth s... Read more
Brain fog; Nausea; weakness; Weird sensation on [his] tongue 5-10 mins; Weird taste in [his] mouth soon after that/funny taste in mouth; Shortness of breath/difficulty in breathing; Dizziness/Light headedness; Weakness in his upper chest and in both arms; Weakness in his upper chest and in both arms; Diarrhoea; Headache; felt like my throat is gonna close, I won't say I had any difficulty in swallowing, but it was not normal; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown), via an unspecified route of administration on 06Jun2021 at 11:30 hours as 1st dose, single dose (at the age of 55-years-old) for COVID-19 immunisation. Regarding lot number patient stated that it looks like EW, patient thought he was not sure if it was 6185 or 0185, not sure it looks like 0 but it looks like 6 too but patient think it was 0. The patient medical history included shortness of breath, sleep apnea and kidney disease (from an unknown date and unknown if ongoing). Patient sees a doctor for lot of conditions one was for shortness of breath and sleep apnea and sees a neurologist for Bph. The patient concomitant medications were not reported. Patient explained he was reluctant from getting vaccinated and nervous before the shot. On 06Jun2021, after patient took the shot, probably around 11:30 in the morning, patient was same, soon after 5 min maybe more, patient got a sensation on the left side of his tongue 5-10 mins, then kind of a weird taste came to his mouth, patient started to get a little dizzy, a little light headedness, weakness in his chest and both his arms, got shortness of breath but had been seeing a doctor for shortness of breath prior taking the Covid shot and had kind of reluctant of taking the shot but some other issues going on side, patient decided to take it, a couple of hours after the shot, patient had a headache, had the diarrhea. Patient described the weird taste like having a penny in his mouth. Patient explained he consulted a doctor on that Monday (07Jun2021), who said she encountered patients who also had the sensation on their tongues following vaccination, and that it was normal. Today (08Jun2021) patient had feeling just a little bit of nausea and patient kind a feel like a little brain fog, it was just his head doesn't feel right, the major concern was says some things risks factors and some of them had severe reactions, patient had a reaction difficulty in breathing, dizziness and feel little bit weakness, patient kind of a felt like his throat was going to close and he won't say he had any difficulty in swallowing, but it was not normal. Patient developed symptoms which spooked and scared him. Patient did not have his lab test but was constantly going to patient had just had right heart catheter right two weeks ago, you know last for him, patient was supposed to take another lab test to conduct at the end of the month for cholesterol, but patient saw neurologist for kidney disease. Events did not improve, patient just had this brain fog you know. Patient had to call a doctor after he got home, they did not prescribe him anything, patient mean he did bunch of appointment with doctor with the phone as soon as he got home from taken a Covid shot he was little worried. Patient stated he was concerned about getting the second dose of vaccine scheduled on 27Jun2021. Patient stated he will not be able to consult his doctor before the vaccination appointment and was not able to get further assistance from a pharmacist. Patient repeated he does not know what to do about the second dose. Patient was kind of reluctant taking the next shot, if he was going to feel the something like this again, he don't want to, as he already had uneasy you know just had and patient did not had difficulty in breathing all of time this comes and go, from the sentence he described it says on pamphlet that there was severe reaction to the shot and don't want to take the second shot and then end up in hospital because patient had more from it so his question was he was afraid to take the second shot. Patient don't had answer to that he means he would like to talk to somebody who can give him information kind of help me to relax little bit if it was normal and in in response it was responded that decision to receive the second dose for any other reason cannot be made by the company. Patient was referred to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection, as healthcare provider knows his health situation and had access to information that can better help inform this decision. The outcome of brain fog was not recovered and outcome for other events was unknown. Information about lot/batch number is requested.
55 2021-06-21 malaise Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a... Read more
Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a lot, sic, feeling better until the next day I experienced the same symptoms again, this went on for 5 days, The following Monday I wasn't feeling better so I called Doctor. I decided to go to urgent Care and they said I was Jaundiced, they wanted me to go to the hospital, I spent 4 days in hospital, they said I was having an auto immune response to something, did scan on liver and it looked fine, however liver biopsy did not look good, they won't tell me what I have to go in for more testing. My doctor consulted with a specialist and they concluded it may be an auto immune reaction and I was told my gallbladder is also inflamed, but it looks fine , my bilirubin numbers were off the chart. I am going to see a liver specialist at medical center at the end of July. My blood sugar has since raised into diabetic range due to steroids. I had no reaction to my first dose of covid vaccine.
55 2021-06-21 sleepiness COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; blocked ... Read more
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; blocked nose and ears; drowsy, sleepy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 16:00 (lot number: EP7534), at the age of 55-years-old, at 1st dose, single in the left arm, and second dose on 05Apr2021 16:45 (lot number: EP7533), at the age of 55-years-old, via an unspecified route of administration at 2nd dose, single in the left arm; both for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies and had no COVID prior to vaccination. Concomitant medications included linum usitatissimum seed oil (FLAX), multivitamin, and plant steroids. The patient had no other vaccines in four weeks. On 31May2021 22:00, the patient experienced body ache, cough, blocked nose and ears, drowsy, sleepy, feeling tired, and exhausted with talking and working. On 02Jun2021, the patient was tested for COVID via COVID-19 nasal swab test, and result came out positive on 04Jun2021. Despite having the two doses of the vaccine 8 weeks prior, the patient still tested positive. The patient was vaccinated in a pharmacy or drug store. Treatments such as home quarantine and care for COVID were given to the patient. Outcome of all the events was recovering.
55 2021-06-24 fatigue Lightheaded; Tiredness; Nausea; This is a spontaneous report from a contactable consumer, the patien... Read more
Lightheaded; Tiredness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route in left arm on 19Mar2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure, hypertension, afib (atrial fibrillation) and Depakote allergy. Past drug history included Depakote from an unspecified date. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), MOBIC, furosemide (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and NORVAS taken within two weeks of vaccination for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 15:30, the patient experienced tiredness, lightheaded and nausea. No treatment was received for the events. The clinical outcome of tiredness, lightheaded and nausea was recovering. Information about lot number cannot be obtained. No further information is expected.
55 2021-06-24 malaise Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable ... Read more
Yesterday he started to feel bad; Not feeling well; This is a spontaneous report from a contactable consumer(patient's sister).A 55-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on 14Jun2021(at the age of 55-years-old) as 2nd Dose, Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number was not reported ) via an unspecified route of administration on an unspecified date as 1st Dose, Single for COVID-19 immunization. After 2nd dose of vaccination, on 14Jun2021,the patient reported of not feeling well. On 17Jun2021,yesterday he started to feel bad. She would like to know what kind of side effects are to be expected from the vaccine. Seriousness by the reporter was No. The outcome for the events was Unknown. Information on lot/batch number has been requested.
55 2021-06-29 fatigue Extremely fatigued; mucus and sinus drainage increased by 500%; electrical shock in muscles and tend... Read more
Extremely fatigued; mucus and sinus drainage increased by 500%; electrical shock in muscles and tendons; breathing issues 02 sat is staying between 70 and 90; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 55-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: er8729 and Expiration date: unknown), via an unknown route of administration, in left arm on 22Apr2021 at 12:00 (at the age of 55-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included congestive heart failure, diabetes, bundle bunch blockage, coronary heart disease from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received long list of other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested positive for COVID-19. On 23Apr2021 at 10:00, the patient was extremely fatigued, mucus and sinus drainage increased by 500%, electrical shock in muscles and tendons, breathing issues 02 sat is staying between 70 and 90. The patient still have ongoing symptoms and issues from shot three months later. Doctor requested him not take second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for events included Steroids and increased treatment for congestive heart. Outcome of events reported as recovered with sequelae on an unknown date in 2021. Follow up needed, further information has been requested.
55 2021-06-29 headache Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a c... Read more
Difficult time trying to focus; Low energy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration to left arm on 17Mar2021 at 13:30 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 07:00, the patient experienced extreme headache, very low energy and he had a difficult time trying to focus currently (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of extreme headache, very low energy and difficult time trying to focus were not resolved at the time of this report. Information about lot/batch number cannot be obtained. No further information expected.
55 2021-06-29 fever, chills, fatigue, throat pain Had sore throat; Nausea; Chills; Tiredness; Muscle pain; 101.2 fever; This is a spontaneous report f... Read more
Had sore throat; Nausea; Chills; Tiredness; Muscle pain; 101.2 fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 12:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. On 19Mar2021 at 12:00, the patient experienced sore throat, chills, tiredness, muscle pain, nausea and fever. On 19Mar2021, the body temperature was reported as 101.2 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events sore throat, chills, tiredness, muscle pain, nausea and fever were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-07-01 runny nose, cough Little cough; Runny nose; Tested positive for covid; This is a spontaneous report from a contactable... Read more
Little cough; Runny nose; Tested positive for covid; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received his first COVID dose on 17Mar2021, afterwards the patient was not feeling well and on 29Mar2021, the tested positive for COVID-19. The patient reported that having mild symptoms, runny nose and a light cough. The patient reported that while the patient's isolation was completed. The patient was still had a little bit of a cough, but the patient was due for his second shot next day and asked if the patient should get it or wait. Call was not transferred to unit because the call was hanging up and Created Manual AE Form. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
55 2021-07-02 headache, throat irritation scratchy throat; ear ache; mild headache; Heart racing; dizziness; heart flip flopped and sped up, t... Read more
scratchy throat; ear ache; mild headache; Heart racing; dizziness; heart flip flopped and sped up, that lasted 10 minutes; gassy and reflux type chest pressure with feeling trouble breathing/Difficulty breathing; gassy and reflux type chest pressure with feeling trouble breathing; allergic reaction; This is a spontaneous report from a Pfizer sponsored program. via contactable consumer or other non hcp. A 55-year-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0158 and expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 26Apr2021 at 10:00 as dose 1 single, for covid-19 immunisation, (received the first dose of the Pfizer vaccine a week ago today, I had some reactions to the first shot, and am trying to determine whether or not to get the second shot). Patient medical history allergy to Penicillin diagnosed 2 years ago. He was advised as a child he was allergic to it, but the local medical provider wanted to actually prove if he was actually allergic and he was tested to verify. He was also allergic to the carrier that they give it to you in. Concomitant medication included cetirizine hydrochloride (ZIRTEC, Batch/Lot number and expiry date was not reported), 1 tablet daily for allergies (Started within the last year). There was no prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. There was no history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no family history. There was no relevant test. He did not take prior vaccination. The patient experienced within 5 minutes had dizziness on 26Apr2021 at 10:05, and my heart flip flopped and sped up, that lasted 10 minutes. I went home and later in the day I had mild headache on 26Apr2021 at 12:00 that came and went away after about 5 minutes, then on26Apr2021 at 12:05, ear ache lasted about the same amount of time and then on 26Apr2021 at 12:10 a scratchy throat and that went away, on Apr2021 gassy and reflux type chest pressure with feeling trouble breathing on 26Apr2021 that was later in the day and carried into the majority of the next day and Within 5 minutes of getting shot, he had the dizziness and heart racing. Difficult breathing was at 14:00. It was worse the following morning at 10:00. That is when he took Tums and Benadryl and by 14:00, they resolved. Headache was at 12:00 This would go away and then earache and then scratchy throat and then difficulty breathing. Ear Ache at 12:05, Scratchy throat at 12:10. There was no ER or physician's office required. Dizziness at 10:05, Heart racing at 10:05. The reporter states, He received the first dose of the Pfizer vaccine a week ago today, had some reactions to the first shot, and trying to determine whether or not to get the second shot. He had the shot at 10am, within 5 minutes had dizziness, and my heart flip flopped and sped up, that lasted 10 minutes. He went home and later in the day he had mild headache that came and went away after about 5 minutes, then he had an ear ache lasted about the same amount of time and then a scratchy throat and that went away, had gassy and reflux type chest pressure with feeling trouble breathing that was later in the day and carried into the majority of the next day. He saw in an article that a man who was hospitalized, they gave him Pepcid, and epinephrine, and Benadryl. So he took 3 tums, and two Benadryl and within a few hours symptoms decreased and felt fine. Looking at the vaccination facility where we got the vaccine, it states, there was a remote chance of severe allergic reaction. He wasn't hospitalized, etc. He did reach out, because he have tested for Penicillin reaction, he spoke to his allergy doctor, so they aren't very helpful. they said to front load with an antihistamine. They consider a severe allergic reaction if he were hospitalized and intubated. Reporter wanted to know if there was anything that has to go on the vaccination card, as to why he may not have received the 2nd dose, like if it was due to an allergic reaction. Within 5 minutes of getting shot, he had the dizziness and heart racing. It lasted 5-10 minutes. It felt like his heart flip flopped and it could have just been an increase in heart rate. The difficulty breathing happened after he came home and it was about 2 hours after the shot. Before that, he had a headache that only lasted a few minutes and it went away. Then an ear ache, which was 5 minutes after that. Then he had a scratchy throat and that went away, then the breathing portion of it kind of started that day and it continued and got worse until the next morning. It felt like he had gas and/or reflux type feeling and it was harder to take a deep breath. He saw online where someone had been treated for the same thing and was given Epinephrine, Pepcid and Benadryl. He does not know the person and read about this individual that was treated for it. He does not have any information to report for this person. Patient stated he took 3 Tums and 2 Benadryl and it resolved within a couple of hours the following morning from having taken the shot. He was allergic to penicillin diagnosed previously and was concerned about getting the shot but they said he would be fine. He had dizziness, and heart racing that lasted 10 minutes. He also was having difficulty breathing and had reflux for 8 hours for which he took a Benadryl. He would like to know if he can get second dose after experiencing side these effects. On the factsheet, it said this would be considered a severe reaction. He does not have a date, manufacturer, lot or expiration for the penicillin he was allergic to. He got tested in the last 2 years at University and tested that he was actually allergic. He later stated it was suggested in childhood that he was allergic, but never properly diagnosed until a couple of years ago. The outcome of event (dyspnoea, dizziness , ear pain, throat irritation, palpitations and Headache) was recovering and rest of events were unknown. Follow-up attempts completed. No further information expected.
55 2021-07-02 fever, fatigue, chills, headache Body aches; Low grade fever 99; chills; headache; fatigue; Inappropriate schedule of vaccine adminis... Read more
Body aches; Low grade fever 99; chills; headache; fatigue; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 06Mar2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 23Mar2021 at 13:00, the patient had inappropriate schedule of vaccine administration. On 24Mar2021 at 03:30, approximately 12 hours later after second injection, the patient experienced low grade fever 99, chills, body aches, headache and fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events low grade fever 99, chills, body aches, headache and fatigue. The clinical outcomes of the events low grade fever 99, chills, body aches, headache and fatigue were recovering at the time of the report while that of inappropriate schedule of vaccine administered was unknown. No follow-up attempts are needed. No further information is expected.
55 2021-07-07 paranasal sinus discomfort after the shots i've had complete sinus pressure in ears in which i've never had before. its been go... Read more
after the shots i've had complete sinus pressure in ears in which i've never had before. its been going on 4months of complete misery. my immune system is going crazy. I've had blood tests and all kinds of test and there's no problems accept severe allergies and ear drum with holes in both. i need help bad. this has never happen even close to what i'm experiencing now.
55 2021-07-08 body temperature increased, fatigue Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating w... Read more
Starting about 14 hours after vaccine administration, patient experienced difficulty concentrating with periods of hyperactivity, pain/soreness in bilateral hands with extreme pain at times with movement, soreness in bilateral feet, soreness across the back in the area of the kidneys, occasional mild dizziness, fatigue, mild nausea, hot flashes, a cold sore, poor sleep quality since vaccine, mild dyspnea on exertion, and increased temperature of about 0.5-1 degree F.
55 2021-07-08 head discomfort Woke up morning after receiving vaccine (about 20 hours after vaccination) with my head feeling den... Read more
Woke up morning after receiving vaccine (about 20 hours after vaccination) with my head feeling dense and heavy. Not a painful headache, but a strange fullness as if my head was solid. I took 2 Advil and went about my morning - yard work, cleaning, etc. The symptoms went away on their own approximately 4 hours later.
55 2021-07-08 fever On May 3rd I received my first jab. Days 2 and 3 my arm was pretty sore. Like a Charlie horse combi... Read more
On May 3rd I received my first jab. Days 2 and 3 my arm was pretty sore. Like a Charlie horse combined with a sore arm workout. Day 4 that soreness went away but I felt fatigued. It was like I was trying to move around under water. That lasted only one day. Day 5 my lymph node under my arm started to get sore. That lasted 3 days. Day 8 - Last night my outer arm started to feel funny. I looked down and had this good sized welt raised up. It was about 5? by 1?. On May 24th I received my second jab. About 4 hours after my jab my face became flush. The tips of my ears got hot. I went to bed and woke up with a fever between 100.4 to 100.9 in the morning. My body ached, my eyeballs hurt to move side to side. In the afternoon I had swelling in my scrotum sack and testicles ached. My fever topped out at 101.2 in the evening. The next day my fever went away and the swelling in my scrotum was gone. My testicles still occasionally ache during the day.
55 2021-07-11 headache I started to get severe headaches, burning sensation in my ears, nausea, disoriented. It went away f... Read more
I started to get severe headaches, burning sensation in my ears, nausea, disoriented. It went away for a couple weeks, and has started back.
55 2021-07-11 malaise, fatigue Patient is a 55 y.o. yo male presenting to the ED with fatigue, shortness of breath, difficulty brea... Read more
Patient is a 55 y.o. yo male presenting to the ED with fatigue, shortness of breath, difficulty breathing and poor appetite per patient's son-in-law. Patient received Covid vaccine on April 25, 2021 and about 3 days later, started to have symptoms that they thought were just postvaccination symptoms. Patient was having decreased appetite, fatigue and generally did not look well. The following week, patient was tested for work and resulted as positive for COVID-19 at that time. He then presented to the ED on May 8th, was admitted initially to the floor but had progressive decompensation of his hypoxemia and was transferred to the ICU on May 12th. He was intubated and subsequently cannulated for VV ECMO due to hypoxia. He remained on the circuit until 6/26/21 when he was successfully decannulated. He was still ventilator dependent and transferred to LTAC on 7/6. I was just asked by one of his care team members yesterday to submit this case to VAERS as he had no risk factors for such severe COVID disease other then his age of 55. He had normal BMI and no PMH. The concern from staff is that his vaccination may have not only failed to protect the patient, but could have boosted the virus's ability to infect cells; this concern is based on original vaccine and spike protein trials published back in 2005.
55 2021-07-11 fever, fatigue, cough Started to have many COVID symptoms, Fever, cough, fatigue, loss of appetite, difficulty breathing. ... Read more
Started to have many COVID symptoms, Fever, cough, fatigue, loss of appetite, difficulty breathing. The difficulty breathing has worsened over the past 2 weeks. The cough has been treated, but still have dry cough. Breathing is still labored with inhaler.
55 2021-07-11 fever, fatigue Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks lat... Read more
Arm soreness only for 36 hours. Occasional heart palpitations noticed approximately three weeks laters. Second dose 6/15/2021. Arm soreness and mild fever, aches, fatigue for 48 hours. Occasional palpitations continued. ER for treatment. Diagnosis: sinus arrhythmia with occasional premature ventricular complexes. Patient had normal ECG pre-vaccine (5/5/2021) based on annual wellness exam.
55 2021-07-12 fatigue pain at injection site; swelling at injection site; whole body swollen; my legs and arms were swolle... Read more
pain at injection site; swelling at injection site; whole body swollen; my legs and arms were swollen; ankles, elbows, wrists, shoulders had less mobility.; numbness at hands; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 10.15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV and COVID-19 on May2020. Concomitant medications included abacavir sulfate, lamivudine, dolutegravir sodium, (TRIUMEQ), naproxen (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN); all from unknown for unspecified indications. The patient previously took bioflavonoids on unknown date and experienced an food allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On the day of vaccination (24Mar2021), the patient experienced bit fatigued. Nothing bothersome. On 25Mar2021, the next morning, the patient woke up with a good deal of pain and swelling at the injection site. In addition, whole body was swollen, in particular the legs and arms were swollen, to the point that was much harder than usual to be ambulatory. The ankles, elbows, wrists, shoulders had less mobility and also had numbness at hands. Thankfully, by mid-afternoon of the 25th, felt much better and much of the swelling had subsided. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the fatigue, pain at injection site, swelling at injection site, swelling at whole body, legs and arms, decreased mobility of ankles, elbows, wrists, shoulders and numbness at hands were resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-14 fever, chills, headache diarrhea, anorexia, headache, fever/chills
55 2021-07-17 body temperature increased has got a high temperature of 107; This is a spontaneous report from a contactable consumer (Parent)... Read more
has got a high temperature of 107; This is a spontaneous report from a contactable consumer (Parent) or other non HCP A 55-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration (at the age of 55-year-old) on 01Jul2021 as dose 1 single for covid-19 immunization. The patient's medical history and concomitant medications was reported as no. On 02Jul2021 Reporter stated, his/her son received his Pfizer shot yesterday (01Jul2021) and that day he has got a high temperature of 107. The patient did not received any treatment for event. The patient underwent lab tests and procedures which included body temperature increased: 107 on 02Jul2021 (he has got a high temperature of 107). The outcome of event was unknown. Information on the lot/batch number has been requested
55 2021-07-17 chills, fever, fatigue Mild pain at injection site; fever of 99.9; chills (mild); Achy all over(moderate); Feeling worn dow... Read more
Mild pain at injection site; fever of 99.9; chills (mild); Achy all over(moderate); Feeling worn down; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 23Mar2021 at 13:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high triglycerides. No allergies to medications, food, or other products were reported. Concomitant medication included amlodipine(NORVASC), fenofibrate (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) all taken for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot no: unknown) via unspecified route of administration in left arm on 02Mar2021 at 13:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 10:00, the patient experienced vaccination site pain, fever, chills, general body pain and was worn out. The patient had mild pain at injection site, fever of 99.9, chills (mild), achy all over (moderate) and was feeling worn down. No treatment was received for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of all the events vaccination site pain, fever, chills, general body pain, worn out were resolved on an unknown date. No follow-up attempts are possible; information about lot number cannot be obtained.
55 2021-07-17 fatigue, chills, headache 23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical his... Read more
23Mar2021 at 09:15 (at the age of 55-year-old) as single dose for COVID 19 immunisation. Medical history and concomitant medication have not been provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318), via an unspecified route of administration in left arm on 02Mar2021 at 09:15 AM (at the age of 55-year-old) as single dose for COVID 19 immunisation. On 23Mar2021 at 09:15, the patient experienced (reported as only for second dose) chills with shivering, shaking and feeling cold for lasted four hours. Chills came back on next day and milder without shivering and shaking. Tiredness, headache continued the next day and also experienced mild pain at side of injection for first 24 hours. Treatment received for the adverse events was reported as no. The clinical outcome of the event chills with shivering, shaking, feeling cold, tiredness, headache and mild pain at side of injection was resolved on an unknown date in Mar2021. No follow up attempts are needed. No further information is expected.
55 2021-07-17 lethargy, headache, fever Fever (101); Extreme lethargy; Entire body ached; Headache (forehead)/Persistent sharp ache back of ... Read more
Fever (101); Extreme lethargy; Entire body ached; Headache (forehead)/Persistent sharp ache back of head; Persistent sharp ache back of neck; This is a spontaneous report received from a non-contactable consumer, the patient. A 55-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in his left arm on 24Mar2021 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroid and obese. Concomitant medications and medications within 2 weeks of vaccination included Multivitamin (MANUFACTURER UNKNOWN), Levothyroxine (MANUFACTURER UNKNOWN), Fish oil (MANUFACTURER UNKNOWN) and Magnesium (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in his left arm on 04Mar2021 at 13:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient did not have a history of allergies to medications, food or other products. The patient had not received other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient had not diagnosed with COVID-19 prior to vaccination. On 25Mar2021 at 09:00, the patient experienced fever (101), extreme lethargy, entire body ached, headache (forehead), persistent sharp ache back of head and neck, no loss of appetite, stayed in bed entire day on 25Mar and woke the following day and felt fine on 26Mar. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. On an unspecified date, the patient underwent body temperature recording and the result was fever 101. The clinical outcomes for the events fever (101), extreme lethargy, entire body ached, headache (forehead), persistent sharp ache back of head and neck was recovered on 26Mar2021. No follow-up attempts are needed. No further information is expected.
55 2021-07-17 fever, fatigue, headache This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient re... Read more
This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown), via an unspecified route of administration in the right arm on 27Mar2021 at 15:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included back pain, back hip pain and knees pain. The patient received unspecified medications within two weeks of vaccination. The patient previously received NAPROSYN and DILAUDID, both for an unspecified indications and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 at 01:00, the patient felt really tired, run down with fever, muscle aches and headaches which was coming and going and had an overall feeling that somethings not right. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event tiredness, fever, muscle aches and headaches were unknown at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
55 2021-07-19 body temperature increased, pneumonia 10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my ... Read more
10 after i got my vaccine , i got pneumonia had a temperature of 104 and had blood clots in both my arms and in my lungs. I went to the emergency room i was kept there for a week. they tested me for covid, ct scan and pvc panal. I had an infection in my lungs. took about a month to recover
55 2021-07-20 fever Gout in the left leg triggered.; injection site pain; mildtemperature rise; This is a spontaneous re... Read more
Gout in the left leg triggered.; injection site pain; mildtemperature rise; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7533) via unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included gout and colitis that had been in remission for the last 7 years. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (unspecified) (MANUFACTURER UNKNOWN) and diosmin, herperidin (DIOSMIN COMPLEX) for unknown indication from unknown date. On 01Apr2021 at 22:00, the patient had gout in the left leg which was triggered (gout aggravated) in the evening after the vaccination. He was prescribed with indomethacin and COLCRYS and had mild effects after 14 hours of first symptoms. On the same day, the patient had very little pain at injection site (vaccination site pain) and also experienced a mild temperature rise in the first 24 hours. Therapeutic measures were taken as a result of injection site pain, mild temperature rise and included treatment with indomethacin and COLCRYS. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event gout in the left leg triggered which was resolving, while the injection site pain and mild temperature rise was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
55 2021-07-22 chills, fever After the second dose, I had a high fever/chills/body aches/soreness at the site of injection for th... Read more
After the second dose, I had a high fever/chills/body aches/soreness at the site of injection for three days. After three days of the second dose, started feeling pain/pulling of chest muscles on the left side. After continued feeling of chest pain/muscle pulling for two days, I contact a doctor on the third day, who advised me to go to ER and have examined by a physician. I went to the ER where a lot of blood tests were done and an x-ray of the chest was taken. But the ER doctor ruled out any heart-related problem. This pain started gradually reducing and reappearing every few days along with the injection site becoming sore. I started reappearing every week, then every 10 days and now it appears every two weeks. After about two weeks had the first gout attack. The doctor did not advise taking any medicine(s) to reduce uric acid before - had annual physical in Jan. Now taking Febuxostat 40 mg once daily. Also, blood work showed giant/big platelets suggesting BSS (to be investigated by a specialist on August 9)
55 2021-07-22 cough, fever, fatigue, chills Patient tested positive for COVID 19 on 7/10/2021 in the Ed and was discharged home with instruction... Read more
Patient tested positive for COVID 19 on 7/10/2021 in the Ed and was discharged home with instructions to return if his respiratory status changed. He came back into the ED on 7/13 and was admitted to our PCU for fevers, chills, fatigue cough and worsening SOB. This patient live half of the time in NY where his PCP is located. He is still currently hospitalized and requiring heated high flow oxygen at 100% FIO2 at 70L. O2 saturations between 92-88. Patient was upgraded to ICU on 7/16 and vented. 7.23.21: Patient is still admitted at the time of this form submission.
55 2021-07-25 fatigue July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, s... Read more
July 27, 2021 12:45 PM. Started getting weak with exhaustion, Started getting shortness of breath, shortness of breath while exerting myself just walking across room or doing basic kitchen chores, pressure and heaviness in chest, shortness breathing trying to sleep even with a c-pap machine, and every night for the first two weeks major chest pains so much so had to hold two pillows against my chest trying to sleep, and was able to feel heart in my chest. After two weeks of this, my mother talked me into seeing my doctor 7/7/2021. Had an x-ray of my chest. 7/22/2021 had a stress test and the results were no blockages. Now waiting for a referral from my doctor to see a heart specialist and waiting for cat scan appointment. Note: I was walking 3 to 5 miles a week before this.
55 2021-07-25 malaise, fatigue Covid symptoms with 1st shot. Extreem fatigue and chest pain, shortness of breath with 2nd shot. A... Read more
Covid symptoms with 1st shot. Extreem fatigue and chest pain, shortness of breath with 2nd shot. After two trips to the Emergency room I was admitted to the hospital and diagnosed with Pericarditis and a Pericardial effusion. Traeted with steroids, Colchicine and high dose NSAIDS
55 2021-07-26 chills, fatigue, fever Started feeling fatigue, body aches, chills, and low grade fever. Symptoms have persisted on and of... Read more
Started feeling fatigue, body aches, chills, and low grade fever. Symptoms have persisted on and off during the days since onset.
55 2021-07-28 headache, fever fever; stomach pain/his stomach hurts; stomach burning; he experienced a bad headache/head hurt real... Read more
fever; stomach pain/his stomach hurts; stomach burning; he experienced a bad headache/head hurt really bad; This is a spontaneous report from a contactable consumer or other non hcp (Daughter) reporting for father (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date are unknown), via an unspecified route of administration on 15Jul2021 between 16:00-18:00 at the age of 55-years-old as dose 2, single for COVID-19 immunisation. Patient's medical history including any illness at time of vaccination and concurrent conditions included ongoing High Blood Pressure and ongoing Cholesterol from unspecified date. There were no concomitant medications. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for COVID-19 immunisation. Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. Family medical history relevant to AE(s) was none. Relevant tests were none. Patient age at time of vaccination was 55 years. On 15Jul2021, the patient experienced headache, head hurt really bad, stomach hurts and burns and on 18Jul2021, experienced fever. Caller was a caregiver calling on behalf of her 55-year-old father. The caller reports that he received his second dose of the Pfizer BIONTECH COVID-19 vaccine on 15Jul2021. Afterwards he experienced a bad headache and a fever, those symptoms have since resolved. He was now experiencing stomach pain, stomach burning and diarrhea. The case was reported as non-serious. The patient took received Tylenol as treatment for headaches and pyrexia. The outcome of event headache was recovered on 15Jul2021 and fever was recovered on 18Jul2021 while other events were not recovered. Information about lot/batch number has been requested.
55 2021-07-28 headache After my March 6, 2021 Pfizer vaccine (1st dose) I experienced a very severe headache behind my righ... Read more
After my March 6, 2021 Pfizer vaccine (1st dose) I experienced a very severe headache behind my right eye that continued for approximately 2 months along with loud high pitched ringing in both ears. I treated initially with an ENT who also diagnosed hearing loss in my right ear, prescribed steroids, and recommended that I not receive the 2nd dose of the vaccine. Three weeks post vaccine I began to experience double-vision and treated with both a neurologist and an ophthalmologist. I received two MRIs and a spinal tap which confirmed brain inflammation. Based on these findings ? with input from my initial ophthalmologist and a neuro-ophthalmologist - the diagnosis became cranial nerve inflammation/palsy. My symptoms have improved greatly and, thankfully, the double-vision resolved after three weeks and the headaches have diminished. I still suffer from tinnitus and plan to see my ENT to determine whether there are other treatments available and to monitor my hearing loss. Other than a brief course of steroids, I have not had any treatment for these symptoms.
55 2021-07-28 sweating, headache Sniffles, body aches and pains, nausea, diarrhea, light headed, profuse sweating, headache and inc... Read more
Sniffles, body aches and pains, nausea, diarrhea, light headed, profuse sweating, headache and increased BP for 7+ days
56 2021-01-02 fatigue, fever Fatigue, lightheadedness, Fever (99.9-100.1), nausea and weakness.
56 2021-01-03 headache HA, flushing, HTN
56 2021-01-03 headache flushing, HTN, HA
56 2021-01-03 fever, chills, headache fever 100.6, chills, headache
56 2021-01-05 headache Mild pain at the injection site the next day; Mild headache within 1-2 hours of injection; Mild head... Read more
Mild pain at the injection site the next day; Mild headache within 1-2 hours of injection; Mild headache within 1-2 hours of injection; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH 9899), via an unspecified route of administration in left arm on 18Dec2020 13:15 at single dose for COVID-19 immunization. Medical history included history of headaches and dyslipidemia. The patient has no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced mild headache within 1-2 hours of injection on 18Dec2020 and mild pain at the injection site the next day on 19Dec2020. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Dec2020 (reported as "resolved within 24-48 hours"). The reporter assessed the report as non-serious.
56 2021-01-06 chills At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At ar... Read more
At 01:30, 1/7/21, I developed Extreme chills, then body became hot but temperature was normal, At around 02:30, my whole body ached with a sharp pain just above my right wrist and a sharp pain at the ball of my right foot. It's 07:05 right now and still have body aches, pain in right foot and right wrist.
56 2021-01-06 fatigue, headache Starting on 1/4/21 he began having a severe headache, extreme fatigue, vertigo and lower back pain. ... Read more
Starting on 1/4/21 he began having a severe headache, extreme fatigue, vertigo and lower back pain. The symptoms lasted about 36 hours.
56 2021-01-06 headache Headache Narrative:
56 2021-01-06 throat pain, nasal congestion, chills, runny nose, fever, cough positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny... Read more
positive COVID test; positive COVID test; fever; chills; sore throat; cough; nasal congestion; runny nose; little diarrhea; tiny bit of shortness of breath; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; Caller received the COVID-19 vaccine on 17Dec2020 and is scheduled to take the second dose on 5Jan2021.; sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable physician (patient himself). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), via intramuscular route on 17Dec2020 at single dose (dose 1, left deltoid) for COVID-19 immunization. The patient medical history included non-smoker. Concomitant medications were reported as none. The patient was scheduled to take the second dose on 05Jan2021, also reported as 08Jan2021. The patient experienced sore arm for 24 hours afterwards on Dec2020. Patient experienced mild COVID symptoms such as fever, chills, sore throat, cough, nasal congestion, runny nose, little diarrhea, and tiny bit of shortness of breath on 24Dec2020, but stated he was better now. The patient was positive in the COVID test on 28Dec2020. He wanted to know if it was normal to get COVID after getting the vaccine and if he should get the booster shot if he gets better. He commented that testing positive for COVID was medically concerning. The patient did not require supplemental oxygen (including high flow ECMO) or receive a mechanical ventilation. Treatment included over the counter medication. No additional testing was done. The patient was not hospitalized. Outcome of the event sore arm was unknown; cough was not recovered; fever, chills, sore throat, nasal congestion, runny nose, little diarrhea, tiny bit of shortness of breath was recovering. No follow-up attempts are needed. Information about lot/batch number was already obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.
56 2021-01-07 chills, fatigue Severe chills, fatigue, shivering. Unable to do daily activities. Symptoms started 5 days after t... Read more
Severe chills, fatigue, shivering. Unable to do daily activities. Symptoms started 5 days after the COVID vaccine and have lasted for 7 days so far.
56 2021-01-07 chills, headache Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then... Read more
Headache sore arm, chills Narrative; 12/18 0100 AM woke up with a sore arm. Went back to sleep then woke up in the morning with ongoing sore arm, chills, and headache. He took 400 mg ibuprofen. All symptoms resolved by mid-afternoon on 12/18.
56 2021-01-07 chills, fever fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (... Read more
fever 103.5; Chills; achy; has no energy; This is a spontaneous report from a contactable consumer (patient's wife). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), intramuscular (right deltoid) on 30Dec2020 0900, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has been in bed since 30Dec2020. The patient was achy, has no energy, and has chills on 30Dec2020. Patient also has a fever with temperature of 103.5 on 31Dec2020. Reporter asked if this was normal. Event outcome for achy and chills was recovered on 31Dec2020, not recovered for has no energy and unknown for fever 103.5.
56 2021-01-07 dehydration, malaise patient begin to feel bad that night was admitted into hospital sometime in the next couple of days ... Read more
patient begin to feel bad that night was admitted into hospital sometime in the next couple of days for dehydration, patient discharged home and then readmitted to hospital for positive covid testing after feeling very ill.
56 2021-01-07 headache, sinusitis, sinus pain pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and up... Read more
pain in the right maxillary sinus, and upper right molars; pain in the right maxillary sinus, and upper right molars; right fronto-parietal scalp tenderness; numbness of right canines; possible sinus infection; headache; This is a spontaneous report from a contactable physician (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730) , intramuscular into the left arm on 17Dec2020,at 17:00 as first single dose for covid-19 immunization. Medical history included known allergy to dairy from an unknown date. There were no concomitant medications. The patient experienced pain in the right maxillary sinus, and upper right molars on 20Dec2020, at 06:00 with outcome of recovering; right fronto-parietal scalp tenderness on 20Dec2020, at 06:00 with outcome of recovering; numbness of right canines on 20Dec2020, at 06:00 with outcome of recovering; possible sinus infection on 20Dec2020, at 06:00 with outcome of recovering; headache on 20Dec2020, at 06:00 with outcome of recovering. Details were as follows: described as possible trigeminal neuralgia, awoke on 20Dec2020, and noted right eye appeared smaller than the left. Also noted, was pain in the right maxillary sinus, and upper right molars. The patient was afebrile. On 21Dec2020, noted onset of right fronto-parietal scalp tenderness along with numbness of right canines. Patient did not have any skin lesions. Therapeutic measures were taken as a result of the events; began azithromycin and sinus rinse for a possible sinus. Despite treatment, right scalp pain/tenderness, tooth pain numbness of canines persisted and peaked on 26Dec2020. Symptoms subsided but were still present. Acetylsalicylic acid (ASPIRIN) for headache infection was given with improvement. Symptoms appear to be in the right trigeminal dermatome. Patient had never had chicken pox and had been vaccinated. For varicella, the patient did not have a rash in the affected dermatome; valacyclovir (MANUFACTURER UNKNOWN), has been started. The events were reported as non-serious. The patient was recovering from the events.
56 2021-01-07 throat pain, throat redness Have a sore, reddened throat with significant uvula swelling. Diminished sense of taste.
56 2021-01-08 fatigue, influenza like illness, sleepiness Flu-like symptoms (muscle ache, multi-joint pain) but no fever or congestion; excessive fatigue and ... Read more
Flu-like symptoms (muscle ache, multi-joint pain) but no fever or congestion; excessive fatigue and sleepiness from about 16-48 hrs after receiving 2nd dose. Resolved after 48 hrs
56 2021-01-08 fatigue Sedation employee reported significant fatigue that required leaving work Narrative: Employee was un... Read more
Sedation employee reported significant fatigue that required leaving work Narrative: Employee was unable to remain at work second to significant fatigue that required him to go home and rest.
56 2021-01-08 headache Headache & Myalgia Narrative: Employee woke up this morning with a severe headache. He state that h... Read more
Headache & Myalgia Narrative: Employee woke up this morning with a severe headache. He state that he took one capsule of Tylenol and went back to bed sleeping for 5 hours. He states that he feels much better.
56 2021-01-08 headache Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache... Read more
Headache Left Arm soreness Narrative: Patient developed arm soreness at injection site and headache following vaccine administration. Resolved as of 1/2/21.
56 2021-01-08 fever, fatigue Myalgia, Fever, Fatigue Narrative:
56 2021-01-08 fever, fatigue Myalgia, Fever, Fatigue, reports that fever up to 101, drops to 100.8 with Tylenol Extra strength.
56 2021-01-09 chills, fever I had fever, chills, arm pain and swelling
56 2021-01-09 fever Fever of 102, waxed and waned over 12 hours with diffuse myalgias.
56 2021-01-10 chills, fever shaking chills fever
56 2021-01-10 headache, throat pain, fever Fever, headache and sore throat
56 2021-01-10 headache, respiratory tract congestion Congestion, Nausea, Headaches
56 2021-01-10 headache Headache, Diarrhea & NauseaVomiting Narrative:
56 2021-01-10 fever, fatigue Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outc... Read more
Arm soreness, severe muscle and joint pain, low grade fever, fatigue Treatment: Tylenol/ Motrin Outcome: symptoms better after 48 hours
56 2021-01-11 headache Ringing / buzzing in the ears and light headache beginning on 1/10.
56 2021-01-11 fever developed a fever day of vaccine
56 2021-01-12 fatigue, chills, headache Headache, Myalgia, Diarrhea, Chills, fatigue, loss of appetite Narrative:
56 2021-01-12 fatigue neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, mus... Read more
neuropathy; pain; nausea; fatigue; bone, muscle, stomach pain; bone, muscle, stomach pain; bone, muscle, stomach pain; flare; increase in joint pain from his baseline; This is a spontaneous report from a Pfizer sponsored program Accredo Xeljanz Program. A contactable nurse and contactable consumer (patient) reported that a 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), orally from 02Oct2020 at 11 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. On 19Dec2020, the patient experienced neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare. In Dec2020, the patient experienced increase in joint pain from his baseline. The physician was aware. The patient was placed on unspecified steroids for the events, neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare which minimized symptoms. While weaning off steroids, the severity of symptoms returned. The patient was instructed by the doctor to stop taking tofacitinib citrate which was stopped on 29Dec2020. The action taken in response to the events for BNT162B2 was not applicable and for tofacitinib citrate was permanently withdrawn on 29Dec2020. The patient reported slight improvement after stopping tofacitinib citrate. The outcome of neuropathy, pain, nausea, fatigue, bone, muscle, stomach pain and flare was recovering and of increase in joint pain from his baseline was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, the reported events are most likely due to patient underlying contributory factors and unlikely that it is related to the suspect product. However due to temporal association with the vaccine, a possible contributory role of vaccine cannot be ruled out. Case will be reevaluated based on additional information during the follow-up. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
56 2021-01-13 body temperature increased, headache first signs of a headache and body aches started on 12 Jan about 10:00 am and persisted into next da... Read more
first signs of a headache and body aches started on 12 Jan about 10:00 am and persisted into next day. At 0200 on 13 Jan suffered from headache, body aches, temperature of 99.8, chills. Evening of 13 Jan at about 2000 rash was discovered across front of torso from armpits to bellybutton on the front plane.
56 2021-01-13 chills, fever, malaise, headache H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 3... Read more
H/A chills, fever, malaise, then migraines. Then 1-2 migraine H/A every day. No H/A for the past 36 hours. Went to see pcp.
56 2021-01-13 headache, chills 12/16 vaccine 24 hours later, experienced diarrhea, chills, myalgia, HA, swollen/sore injections sit... Read more
12/16 vaccine 24 hours later, experienced diarrhea, chills, myalgia, HA, swollen/sore injections site. Felt 'out of it'. Bedridden for 24 hours. *noticed the 2nd dose was the same batch, same lot #; 1/6/2021 2nd vaccination; zero side effects
56 2021-01-14 head discomfort, chills, headache Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narr... Read more
Headache, Myalgia, heavy head pressure, chills and body aches; today dizziness and arm soreness Narrative:
56 2021-01-14 fever, chills, fatigue Chills followed by low grade fever; Chills followed by low grade fever; fatigue with body aches; fat... Read more
Chills followed by low grade fever; Chills followed by low grade fever; fatigue with body aches; fatigue with body aches; first dose on 22Dec2020/ second dose on 08Jan2021; This is a spontaneous report from a non-contactable consumer (patient) received via a Pfizer sales representative. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration; the first dose (lot EH9899) on 22Dec2020 01:00 AM at a single dose in the left arm and the second dose (lot EL0142) on 08Jan2021 13:00 (01:00 PM) at a single dose in the left arm; for COVID vaccine. Medical history and concomitant medications were not reported. The patient experienced chills followed by low grade fever and fatigue with body aches on 08Jan2021 19:00 (07:00 PM). Treatment was not received for chills followed by low grade fever and fatigue with body aches. Facility type vaccine was noted as hospital. It was unknown if other vaccines were received in four weeks. It was unknown if he had COVID prior to vaccination and if he had COVID tested post vaccination. The outcome of chills followed by low grade fever and fatigue with body aches was recovering. No follow-up attempts are possible. No further information is expected.
56 2021-01-15 headache Headache & Myalgia Narrative:
56 2021-01-17 headache After 4
56 2021-01-17 fever, headache, chills Chills, Fever 103.7, stomach cramps pain, Headache
56 2021-01-19 headache Body aches, headache
56 2021-01-20 headache, fatigue Onset of symptoms on 12 January, including weakness, fatigue, headache, muscle and joint stiffness.
56 2021-01-20 sleepiness, fatigue Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired,... Read more
Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced light arrhythmia on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm on 06Jan2021 with outcome of recovered; felt brain fatigue on 07Jan2021 with outcome of recovered , , felt very hungry before dinner on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast felt tired, so took a nap on 07Jan2021 with outcome of recovered , during the whole day i took three naps on 07Jan2021 with outcome of recovered. Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before. Next morning the patient woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years. The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
56 2021-01-21 headache, fatigue INJECTION SITE SORENESS/ LIGHT SENSITIVITY/ FATIGUE/ SLIGHT HEADACHE REST; NAPROXIN
56 2021-01-21 headache headache, localized pain/swelling/erythema at injection site with swelling into anterior lateral che... Read more
headache, localized pain/swelling/erythema at injection site with swelling into anterior lateral chest and under left axilla. Symptoms persisting past 3 days, slow to improve. treatment: Tylenol and Ibuprofen PRN
56 2021-01-23 headache Has continued to have mild headache since he received vaccine on 1/6/2021 and has been taking Tyleno... Read more
Has continued to have mild headache since he received vaccine on 1/6/2021 and has been taking Tylenol.
56 2021-01-24 fatigue Tiredness; Joint pain in right arm; This is a spontaneous report from a contactable consumer. A 56-y... Read more
Tiredness; Joint pain in right arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 12Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. Concomitant medication included guaifenesin (MUCINEX), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), fish oil (OMEGA 3 FISH OIL [FISH OIL]). The patient experienced Tiredness and joint pain in right arm on 12Jan2021 17:30 with outcome of recovering.
56 2021-01-24 fatigue My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe n... Read more
My autoimmune disorder went into overdrive and stayed there. I had joint pain and swelling, severe neuropathy, muscle pain, extreme fatigue and nausea that seems to never end. I still feel nauseated three hours after eating.
56 2021-01-24 fever, chills Chilling, fever and body aches
56 2021-01-24 fever, headache Complained of fever, headache with visual disturbance. Nausea and body aches 1 day after shot.
56 2021-01-25 malaise, chills I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the ex... Read more
I did not experience any adverse symptoms with the first dose of Pfizer-BioNTech vaccine with the exception of injection site pain after the first dose that began on day 2 through day 5 or for 3 days. The first Pfizer-BioNTech dose was received on December 30, 2020, LOT EK5730. I would rate the pain as a 5 out of 10 on VAS on 12/31/20. Please note that I completed the same pretreatment protocol 1.5 hours prior to dosing with Pfizer-BioNTech of Diphenhydramine 25 mg plus Pepcid 20 mg for both COVID-19 doses. I elected to complete a self-administered pretreatment protocol due to a shellfish allergy and literature reports of anaphylaxis with COVID-19 mRNA vaccines in food allergy recipients. I did not experience any adverse symptoms on Saturday afternoon after receiving the second dose of the Pfizer-BioNTech vaccine at 4:45pm on 1/23/21. On Sunday morning 1/24/21, I awoke feeling "cold." I dressed warmly, but the feeling progressed to chills by 3pm. Malaise ensued around 1pm. I also experienced injection site pain on the morning of 1/24/21 beginning at 7am. The pain lasted until 1/25/21. I would rate the pain as a 5 out of 10 on VAS ON 1/24/21. I began to feel uncomfortable with malaise and chills at 6:15pm on 1/24/21 and self-administered one dose of OTC Aleve, Naproxen sodium 220mg plus one dose of Benadryl 25 mg. I began to feel better by 9pm on 1/24/21. I awoke on 1/25/21 without any symptoms or discomfort with the exception of some injection site pain (2 out of 10 on VAS). I have been asymptomatic since 1/26/21.
56 2021-01-26 influenza like illness, fever, fatigue 4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no ... Read more
4-6 HRS post injection loose stool. 8-12 hrs fatigue, body aches. 12-22 hrs flu like body aches, no sleep, comfort at all. 36-48 hrs after, fever > 100 F. Slept 12 hrs straight, woke up soaking wet, 49 hrs after, Fine..... shoveiing snow
56 2021-01-28 chills nausea and vomiting, chills, body aches, chest discomfort
56 2021-01-30 sleepiness, fatigue After being administered with the. Vaccine fist it was a little after taste in my mouth. I felt lik... Read more
After being administered with the. Vaccine fist it was a little after taste in my mouth. I felt like I wasn?t toned off of marijuana. I then became goofy. Started laughing etc. Then in the drive home about 20 minutes later I started to be tired. I was in the phone with a friend and slipped into a deep slumber. The next day Saturday I woke groggy like from a hang over minus the headache. I had a sudden urge to eat , i bacon and egg sandwich with mayo then had a urgency to eat a bowl of cereal. (rice crispies. Then tried to work (remotely from home) but I could not concentrate or focus. Finally I just threw in the towel and went back to sleep. Woke up to send this report. Good night. I still recommend this inoculation to everyone!
56 2021-02-01 chills, headache Mild chills, sore shoulders (both sides),mild headache
56 2021-02-01 fatigue But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spon... Read more
But like a bit drunk; Felt a little tired; I'm very spaced out; feeling disconnected; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received his first dose bnt162b2 (BNT162B2 reported as Pfizer- Biontech COVID-19 Vaccine; lot number: EJ1686; expiration date: unknown), via an unspecified route of administration right arm on 19Jan2021 14:30 at a single dose for covid-19 immunization. Medical history included diabetes and high blood pressure, although both are mostly kept at bay with diet and exercise. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (AMPHET SALTS XR), trazodone, metformin and lisinopril. There was no other vaccine in the last four weeks. The patient received her vaccine in a school or health clinic. The patient reported that on about 30 minutes (19Jan2021 03:00 PM) later, he got home. He felt a little tired and maybe just out of it. It's now 2.5 hours later and he is very spaced out. He mentioned that she's feeling disconnected a bit but mostly just out of it. She was not dizzy but like a bit drunk. No treatment received for the adverse events. The patient did not have Covid tested post vaccination. The outcome of the events was not recovered.
56 2021-02-01 sweating FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 095... Read more
FOLLOWING THE Pfizer BioNTech COVID-19 Vaccine EUA, EVENTS: DIAPHORESIS AND SHAKINESS STARTED BY 0953 AM ON 02/02/2021 AND LASTED 15 MINUTES. HEART PALPITATION AND TACHICARDIA STARTED BY 0953 AM ON 02/02/21 AND ENDED AROUND 1025 AM INTERVENTIONS: RELAXATION OUTCOMES: DIAPHORESIS AND SHAKINESS ENDED BY 10:18 HEART PALPITATION AND TACHICARDIA ENDED AROUND 1025 AM PT NOTIFIED TO FOLLOW-UP WITH PCP IF NEW SYMPTOMS OR SYMPTOMS WORSEN
56 2021-02-02 chills, fatigue, headache, fever Headache, Diarrhea, Low grade fever, slight headache, fatigue, diarrhea, chills
56 2021-02-03 cough Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of... Read more
Uveitis (underlying condition occurring once every 2-3 years, I was NOT in a flare up at the time of the injection), and mouth ulcers (underlying condition occurring 2-3 times a year, I was NOT in a flare up at the time of the injection). For the Uveitis I went to my eye doctor and started a prednisolone regimen and am still on it. I received the 2nd does (lot EL9264) yesterday on 3 Feb at 09:00am. The mouth ulcers were treated with oral medication-Valtrex. 2nd dose does not seem to have aggravated the above noted reactions. Other symptoms common to the injection are occurring but seem more intense after the 2nd dose (aches, low energy, some minor coughing)
56 2021-02-03 fever nausea dizzy low grade fever vertigo
56 2021-02-07 fever, malaise 1/30/21 patient felt dizzy, had a fever and nausea with some confusion so stayed at work for awhile ... Read more
1/30/21 patient felt dizzy, had a fever and nausea with some confusion so stayed at work for awhile due to not feeling well enough to drive home. Became worse during the night and was sent to the hospital ER.
56 2021-02-09 malaise positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re... Read more
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient) reported for himself. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3248, exp date 30Apr2021, NDC number of COVID Vaccine: 59267-1000-2, on 07Jan2021 16:56 at 0,3ml single dose for COVID-19 immunization via unspecified route of administration at the left arm. The second dose of vaccine was scheduled on 28Jan2021. The patient medical history included Acid reflux. Concomitant medication included omeprazole for acid reflux, 20mg capsule once a day. Since Jan2021, the patient was violently sick one day, experienced diarrhea, puking and like a rock in his gut he could not get rid of. On 20Jan2021 he found out he had contracted COVID and tested positive for COVID. The outcome of the event was unknown. He has not had any additional COVID testing done since the one done on 20Jan2021.
56 2021-02-11 fatigue I have had severe body aches and joint pain for the last six or seven days when I get off work in th... Read more
I have had severe body aches and joint pain for the last six or seven days when I get off work in the afternoons I'm so tired I can barely get up the stairs I work as a nurse and I sit at a desk all day. Muscle pain in shoulders neck back and I am constantly tired.
56 2021-02-11 fever fever, throwing up, and labored breathing. If this worsens he is going to go to the hospital ER
56 2021-02-14 fatigue, chills had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head;... Read more
had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
56 2021-02-17 fever, chills fever,chills and arthralgias days #1-3 post vaccination then - Bilateral eye redness with c onjunct... Read more
fever,chills and arthralgias days #1-3 post vaccination then - Bilateral eye redness with c onjunctivitis both eyes onset days #4 post vaccination
56 2021-02-18 headache Patient complained of headache after receiving first dose; blood pressure monitored and was elevate... Read more
Patient complained of headache after receiving first dose; blood pressure monitored and was elevated. Patient was evaluated in the urgent care department and later discharged.
56 2021-02-18 fever, chills, fatigue, headache Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hour... Read more
Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hours Body aches, headache, chills, fever - one week after for about 48 hours
56 2021-02-19 chills, fever Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each ... Read more
Severe Chills, uncontrolled shaking, for 2 hours, moderate fever 102.4, moderate muscle aches. Each for 2 nights.
56 2021-02-19 headache Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptom... Read more
Pain throughout the body and some weakness Headaches Pain at injection site on left arm Had symptoms for two full days and treated with ibuprofen and or Tylenol
56 2021-02-19 fever Mild soreness at vaccination site, mild body aches, low grade fever (99.1) lasted 1 1/2 days. Did no... Read more
Mild soreness at vaccination site, mild body aches, low grade fever (99.1) lasted 1 1/2 days. Did not inform doctor.
56 2021-02-22 fatigue, chills, fever Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of a... Read more
Tiredness, shaky feeling, chills, mild lymph node swelling, low grade fever(<=99degreesF), loss of appetite. Treated w/ bed rest, water, and ibuprofen. Lasted three days after shot. Fourth day, no fever, no swollen glands, and appetite returning.
56 2021-02-22 headache Light headache, dizziness, low blood pressure (100/64 mmHg)
56 2021-02-23 influenza like illness, fatigue 24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from... Read more
24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration on left arm at the age of 56 years old on 02Feb2021 at 14:30 at a single dose for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Allergies to medications, food, or other products was none. Concomitant medications included atorvastatin calcium (LIPITOR), hydrochlorothiazide, irbesartan (AVALIDE), famotidine and amlodipine besilate (NORVASC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown) on left arm on 12Jan2021 at 07:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore shoulder, 24 hours of flu like body aches and extreme tiredness all on 02Feb2021 at 04:30 AM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has recovered from flu like body aches on 03Feb2021 while the patient recovered from the sore shoulder and extreme tiredness on an unspecified date in Feb2021. The information on the Batch/Lot number has been requested.
56 2021-02-24 malaise Around 0530 on 2/25/2021 reported heart started to race. Received second dose of vaccine on 2/24/20... Read more
Around 0530 on 2/25/2021 reported heart started to race. Received second dose of vaccine on 2/24/2021. Stated he did not feel good but the heart racing started the next morning. Came into medical for BP check. HR 159, ECG done, SVT at 153. Dr. able to convert to normal HR with vagal maneuver.
56 2021-02-25 nasal discomfort upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation a... Read more
upper lip edema; roof of mouth irritation and burning; gum irritation and burning; nose irritation and burning TRX: Benadryl 25mg X1 then Benadryl 50mg TID x 5 days Patient improved
56 2021-02-25 fever, throat pain Fever of 102.3, body aches, pressure on chest, sore throat
56 2021-03-02 influenza like illness I had some pretty bad flu like symptoms/Began to have flu like symptoms, pretty severe flu like symp... Read more
I had some pretty bad flu like symptoms/Began to have flu like symptoms, pretty severe flu like symptoms; pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration on 08Jan2021 (first dose, lot/batch number: EL1284, expiry date: Apr2021) at a single dose, then via an unspecified route of administration on 29Jan2021 (second dose, lot/batch number: EL1284 , expiry date: Apr2021) at a single dose for Covid-19 immunization. Medical history included was reported as none. There were no concomitant medications. Patient received his first vaccine on the 8th of this month and the second dose the 29th of this month. On both occasions for 3 days after the vaccine, he had some pretty bad flu like symptoms. He began to have flu like symptoms, pretty severe flu like symptoms and pain on 09Jan2021. He stated taking some Ibuprofen 400mg, every 8 hours as needed for pain. Outcome of the event flu like symptoms was not recovered while pain was unknown at the time of the report. No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.
56 2021-03-04 headache, fatigue, fever On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two d... Read more
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day. Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body. That lasted about 2 days in its greatest severity. On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion. This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs. A walk to the end of driveway.) has persisted since then. A cardiac w/u with Echo and treadmill stress ECHO were negative. I also have intermittent fatigue, headaches, and a mild "brain fog."
56 2021-03-06 fever, chills fever, body aches, shot site swelling, chills
56 2021-03-08 fatigue, headache Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine... Read more
Extreme nausea, headache, weakness, mentally unawares, dizziness, and at the gym on a cardio machine, couldn't get enough oxygen circulation in the lungs, swollen inner ear in both ears, swollen hands, just overall feeling of fatigue.
56 2021-03-10 cough, influenza like illness, fatigue Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No m... Read more
Starting 24 hours after vaccination, had mild influenza like illness-bodyaches, fatigue, cough. No measured fever or chills. Left sided tender but non painful axillary lymphadenopathy. Treated symptomatically with ibuprofen. Symptoms resolved within 36 hours. Left arm soreness resolved within approx 72 hours post vaccine; no injection site redness or swelling.
56 2021-03-10 fever, chills Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shor... Read more
Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shortness of breath and tightness in the chest the next day; tightness in the chest on Saturday. Patient had previously recovered from Covid in August 2020. First positive test for Covid was at the end of July 2020. Out of work, sick with Covid for over a month.
56 2021-03-11 chills Chills, joint pain, whole body aches, nausea, vomiting, diarrhea.
56 2021-03-13 headache, fatigue First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hou... Read more
First injection - only a sore right deltoid (injection site). Fairly intense but only lasted 24 hours and easily alleviated by Tylenol. Second injection - Ringing in my ears - noticeable starting about 9pm the day of the second injection (3/11/21) and it's still going strong. Intensity of ringing has remained constant to date unfortunately. Headache was minor and on & off starting the night of the injection date and appear to still encounter them but intensity has been low. Taken Tylenol to alleviate symptom with success. Soreness at injection site - less intense on second shot than first but it lasted about 48 hours. The Tylenol I took for the headache seemed to help with the arm pain. On the day after the injection, my right latissimus dorsi (same side as shot) became sore but only for about 24 hours. Tiredness - didn't feel the exhaustion until about 9pm on the day of the injection. Exhaustion/tiredness set in more than expected so very low activity the day after and went to bed several hours earlier than normal. Still feeling tired but emerging from that as i'm starting to feel more energy come back.
56 2021-03-13 headache, fever, chills On the 11th I was sore and assumed it was the work out and pulled a glut muscle. That evening I was ... Read more
On the 11th I was sore and assumed it was the work out and pulled a glut muscle. That evening I was hit with all symptoms and have been in bed the last three days Muscle aches, fever, chills, headache. Been taking Advil and hydrocodone Acetaminophen. Have had to stay in bed or the servers chills will cramp up my rib muscles
56 2021-03-14 fever, chills, fatigue fatigue fever chills..
56 2021-03-15 headache, fever, fatigue Fever, body aches/joint pain, nausea, fatigue, headache . Hot bath, ibuprofen, Tylenol, rest. Miss... Read more
Fever, body aches/joint pain, nausea, fatigue, headache . Hot bath, ibuprofen, Tylenol, rest. Missed 2 days of work.
56 2021-03-16 chills, fatigue Chills, nausea, vomiting, fatigue
56 2021-03-16 fever, chills Fever, chills, nausea, vomiting, diarrhea, body aches
56 2021-03-17 fever All my Covid symptoms returned and with the exception of the fever are still present.
56 2021-03-18 headache, fatigue Headache, fatigue
56 2021-03-18 headache headache, arm soreness
56 2021-03-18 fever Fever
56 2021-03-19 headache, chills, fever First Shot of the covid vaccine. Started with a slight headache, chills, and muscle ache approximate... Read more
First Shot of the covid vaccine. Started with a slight headache, chills, and muscle ache approximately 36hrs. after the shot. The symptoms progressively worsened throughout the day followed with an additional symptom of a slight fever (99.5°F) around 48 hrs. after the shot. A dose of Ibuprofen, plenty of fluids, and rest resulted in all of the symptoms running their course with 60 hr. after the shot.
56 2021-03-20 headache nausea / occipital headache. R arm soreness; DM; BG 200 per patient; TX - mask removal fresh a... Read more
nausea / occipital headache. R arm soreness; DM; BG 200 per patient; TX - mask removal fresh air- smoke out of car; educated; arm movement; Tylenol OTC if needed. Recheck- much better, H/A resolved - playing on phone; mild nausea presents.
56 2021-03-20 influenza like illness, fatigue General flu like symptoms.; Aching muscles; exhaustion; This is a spontaneous report from a contacta... Read more
General flu like symptoms.; Aching muscles; exhaustion; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 11Feb2021 12:15 PM at Left arm as single dose for covid-19 immunisation. Medical history included hypertension, hypertension (controlled). Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The concomitant medication included atorvastatin calcium (LIPITOR) at 10, amlodipine besilate (NORVASC) at 10, Lisinopril at 2.5. The patient historical vaccine included bnt162b2, lot number=EL3247), first dose on 21Jan2021 12:30 PM at Left arm SINGLE DOSE for covid-19 immunisation. The patient experienced general flu like symptoms, Aching muscles and exhaustion on 12Feb2021 05:30 AM. The patient did not received treatment for the events. The outcome of the events recovering.
56 2021-03-21 nasal congestion, cough Slightly lightheaded immediate afterwards. Fine with a few minutes. Sunday woke up stuffed up, wit... Read more
Slightly lightheaded immediate afterwards. Fine with a few minutes. Sunday woke up stuffed up, with cough and nausea. Felt better. Today, face is extremely red. Cough is present.
56 2021-03-22 fever, chills Fever, chills shortness of breath. He took tylenol on sunday and then was ok monday morning. monda... Read more
Fever, chills shortness of breath. He took tylenol on sunday and then was ok monday morning. monday afternoon breathing got worse. He went to the ER on tuesday morning
56 2021-03-22 fever Patient presented to physical therapy on 03/19/2021 for routine therapy follow-up visit. Patient re... Read more
Patient presented to physical therapy on 03/19/2021 for routine therapy follow-up visit. Patient reported prior to the start of the session he received his first COVID vaccine on 03/16/2021 and the proceeding 24-48 hours following had nausea, diarrhea, fever, and increased redness, swelling, and warmth of the right arm. Patient had a recent right shoulder surgery and received his injection in the surgical arm. Comparing his arm from Monday's visit to when he presented on Friday there was a significant change around his incision with increased redness, warmth, and firmness of his arm tissue. Call was placed immediately to patient's surgeon office and patient was seen later in the day by his surgeon for further follow-up. Therapy was put on hold for the day. Patient seen by surgeon 3/19/2021, arm warm to the touch so oral antibiotics started. Unsure if related to covid vaccine. Patient seen again 3/19/2021, still some warmth to mid humerus area and swelling that has been present since surgery. No active infection noted.
56 2021-03-23 cough, fever Pfizer-BioNTech COVID-19 Vaccine EUA On 3/11/21, ran fever 103 to 104.5, coughing, some fluid in lun... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On 3/11/21, ran fever 103 to 104.5, coughing, some fluid in lungs, around evening time started heart palpitations and tightness pain in chest. As of 3/24/21 still have heart palpitations when doing yard work or light exercise. Tightness pain in chest area has gone away.
56 2021-03-25 fatigue, headache It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea a... Read more
It began with a headache around 2 am, March 26, 2021. Around 8:30 am I began to experience nausea and fatigue. At 3:30 pm I vomited one time. Since 8:30 am I have slept about six hours. I also felt hot on and off during this time, but I have checked my temperature 3 times and it was normal all three times.
56 2021-03-26 fatigue Dizziness, fatigue. BP 84/58 (pulse 64), final BP 110/70. Orange juice, crackers, and water given. L... Read more
Dizziness, fatigue. BP 84/58 (pulse 64), final BP 110/70. Orange juice, crackers, and water given. Low BP observed for past few days.
56 2021-03-26 fever, headache, fatigue Swelling in arm nausea fever fatigue headache my fever is 101 202 I take Tylenol and appreciate the ... Read more
Swelling in arm nausea fever fatigue headache my fever is 101 202 I take Tylenol and appreciate the fever for 4 hours and then it comes back
56 2021-03-27 fatigue Aches, no energy, fatigue, spotty rash, itchy
56 2021-03-27 headache, fatigue, chills Body aches, tiredness, headache, chills
56 2021-03-28 headache Constant headache severe.
56 2021-03-29 fatigue, fever Full body red raised rash and hives developed. Rash not near injection site. The rash developed 10 d... Read more
Full body red raised rash and hives developed. Rash not near injection site. The rash developed 10 days after second dose/injection. Fatigue and low fever (99.5) accompanied the rash.
56 2021-03-29 fever, chills Sore arm at injection site Chills, joint pain, fever up to 102
56 2021-03-30 fatigue, headache The headache in the right eye was most troublesome; Nausea; Diarrhea; Achy; severe exhaustion; This ... Read more
The headache in the right eye was most troublesome; Nausea; Diarrhea; Achy; severe exhaustion; This is a spontaneous report received from a contactable consumer. This consumer reported for a 56-year-old male patient received first dose of BNT162B2 (Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Left Arm on 03Mar2021 11:00 am as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: no. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Not sure. The patient experienced the headache in the right eye was most troublesome (non-serious), nausea (non-serious), diarrhea (non-serious), achy (non-serious), severe exhaustion (non-serious); all on 03Mar2021 12:00 pm. Treatment was not received for the adverse event.Headache on right side, nausea, diarrhea, achy, severe exhaustion. The headache in the right eye was most troublesome. The outcome of all events was recovering.
56 2021-03-30 headache, fatigue fatigue, brain fog, mild headaches, serious TMJ - Jaw - left side only (same side as vaccine in left... Read more
fatigue, brain fog, mild headaches, serious TMJ - Jaw - left side only (same side as vaccine in left arm)
56 2021-03-30 headache headache but resolved
56 2021-03-30 fever Fever 104.2. Joint & muscle pain The next day after getting vaccine. Laster about 24 hrs. Fever wo... Read more
Fever 104.2. Joint & muscle pain The next day after getting vaccine. Laster about 24 hrs. Fever would go up and down.
56 2021-03-30 fever Adverse event reported was herpes zoster to left side with ocular involvement that occurred two days... Read more
Adverse event reported was herpes zoster to left side with ocular involvement that occurred two days after second dose of the COVID 19 vaccine. Treatment with Valtrex 1g TID with erythromycin ointment over skin lesions. Patient also had associated fever one day after vaccine around 100.0deg F. has since resolved with treatment.
56 2021-03-31 fatigue, fever, headache acute aches muscles and joints, moderate headache, fever of 100.7 for 3 hours each immunization. Ar... Read more
acute aches muscles and joints, moderate headache, fever of 100.7 for 3 hours each immunization. Arm sore for 3 days at injection site. Took 1000mg Tylenol after fever onset, was helpful but extreme fatigue for approx 24 hours kept me in bed. After approx 36 hours from injection, 90% of symptoms were gone. After 48 hours 95% of symptoms were gone. Final symptom was lingering pain lower back.
56 2021-03-31 headache, chills, fever Fever, headache, chills.
56 2021-03-31 fever, chills, fatigue Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hour... Read more
Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hours. Top of head numb and tingling . Severe Fatigue. Sore across the shoulders. Slight Blurred Vision. Fever of 100.5 Usually run around 97.1 on a normal day. Body ache to the point walk very slowly. Lose of appetite and only had about 10 oz of water during the adverse event time. With Tylenol and resting through the evening by 5:00 AM the next morning I was close to full recovery. Top of Head was still still slightly numb. 24 hours after the onset of the event I am back to normal.
56 2021-04-01 fatigue, chills, fever Chills, fever body aches shortness of breathe and fatigue
56 2021-04-01 fatigue, headache 3-hours post-injection: pain at injection site. 12-hours post injection: generalized fatigue, pain a... Read more
3-hours post-injection: pain at injection site. 12-hours post injection: generalized fatigue, pain and stiffness in hip and shoulder joints, reduced appetite. 24-hours post-injection: continued fatigue and joint pain, generalized body aches (including skin sensitivity and mouth pain) and headache. 36-hours post injection: continued tiredness and joint pain, slight weakness in legs, alternating episodes of feeling too hot/too cold (but no actual fever), no headache. 48-hours post injection: lessening of both the fatigue and joint discomfort, return of mild headache. No further temperature episodes, appetite returning. 72-hours post injection: lingering slight fatigue, slight pain at injection site, minor joint discomfort, mild headache. All side-effect symptoms are improving.
56 2021-04-01 fatigue, malaise Nausea, Diarrhea, Body Aches, Arm pain, Fatigue,Feel Unwell,Light Headed
56 2021-04-01 throat irritation Client called for assistance feeling a cold sensation down his throat. Firefighters first responded.... Read more
Client called for assistance feeling a cold sensation down his throat. Firefighters first responded. Client stated he was feeling good. Client was released to his home at 4:00pm.
56 2021-04-02 fatigue Felt fatigue one week after the injection and developed mild shingles around upper left arm (the inj... Read more
Felt fatigue one week after the injection and developed mild shingles around upper left arm (the injection area) with rash and blisters appearing in day 13 and day 15, respectively. Saw urgent care doctor in day 17 and confirmed they are shingles instead of coivd arm. Get antiviral medicine for treatment.
56 2021-04-02 headache About 14 hours after getting the shot, I was awoken to slight pain in my chest at what seemed to be ... Read more
About 14 hours after getting the shot, I was awoken to slight pain in my chest at what seemed to be rib #3. This would be the end of the rib at the center of my chest. I didn?t think much of it at that time. When I woke up around 0600, the pain was throughout the center of my chest. The more I exerted myself, the greater the pain. I also had a headache and neck pain. After 36 hours, I was fine. I didn?t go to the ER as I felt that the problem was muscular. My heart felt fine.
56 2021-04-02 sweating Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O... Read more
Flushing/sweating, dizziness, chest tightness. BP 162/110 (pulse 76). Final BP 153/104 (pulse 80). O2 sats 99%-100%. Apple juice and water given.
56 2021-04-03 headache At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed b... Read more
At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed by severe nausea and cold sweat. Couldn't open eyes or move head for fear of repeating episode. A few hours later, a repeat episode lasted a few minutes and triggered vomiting. Around 7am the next morning, a third episode violent enough to trigger vomiting again. The severe nausea and headache lasted around 12 hours, but the mild nausea and severe headache lasted 48 hours. At 5 days after vaccination, still feel lightly dizzy with a sense of confusion or fogginess.
56 2021-04-04 cough, fever, sinus disorder Fever, aches, cough, sinus issues
56 2021-04-04 fatigue, headache Body aches, headaches, tiredness, fatigue, injection site tenderness, lips/mouth swollen and very te... Read more
Body aches, headaches, tiredness, fatigue, injection site tenderness, lips/mouth swollen and very tender.
56 2021-04-04 fever Woke up with severe shortness of breath and a fever of 103.8 - got up to get something to drink and ... Read more
Woke up with severe shortness of breath and a fever of 103.8 - got up to get something to drink and then woke wife to take me to the hospital as difficulty breathing rapidly increased - wife was getting ready to take me to the hospital when I blacked out and landed on bedroom floor - wife called 911 - I was awake again a couple of minutes later and managed to get to a chair - before ambulance arrived started to feel better - ambulance staff took my vitals and questioned me in regard to overall health, my previous day's activities, and the timing of Covid vaccination - after 30 minutes all my vitals were normal except for fever which had decreased - went back to bed after the first responders left and woke up at 11:00 with no fever, soreness, or difficulty breathing - felt like I did before the shot
56 2021-04-04 sleepiness, headache, chills I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with ... Read more
I got home at 5 am from getting the shot, and laid down, I woke up at 9 am for a 10 am meeting with left arm soreness at the site of the injection. I then developed body chills, ackey sore muscles Back, chest, arms and a really nagging headache. I was very groggy. Saturday, I was a mess, I bundled up with an electric blanket to stay warm. I slept most of the day. The symptoms lasted until Sunday (Easter) around noon, when I started to feel normal again
56 2021-04-04 sleepiness I had no side effects from a 1st dosage of the Covid-19 vaccine except a little soreness at the inje... Read more
I had no side effects from a 1st dosage of the Covid-19 vaccine except a little soreness at the injection site. I had a 2nd dose of Pfizer Covid -19 vaccine at 11:30 a.m. on 3/31/21. Afterwards I went for a walk, came home, and fell asleep. I awoke at approximately 5:30 p.m., about six hours following the 2nd dose of vaccine, to an awful tone in both ears. This was most severe during the first 48 hours. This has continued as of this writing. At this point, I would self-diagnose this as some level of tinnitus. I have no previous history of tinnitus. This is awful -- need help!
56 2021-04-05 chills, fever minor injection site pain (started during the day of vaccination), chills, fever, faster than normal... Read more
minor injection site pain (started during the day of vaccination), chills, fever, faster than normal heartbeat (started that night, about 16 hours later, and lasted until morning)
56 2021-04-05 headache, fatigue, lethargy headache, anxiety, lethargy, shortness of breath with minor exertion. 2 days after vaccination; felt... Read more
headache, anxiety, lethargy, shortness of breath with minor exertion. 2 days after vaccination; felt better, but got tired after a couple hours of desk work. Slept 2 hours, did more desk work, got tired again. 3 days after vaccination; no symptoms.
56 2021-04-05 headache He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/2... Read more
He had the vaccine, and had some pain in his arm and a headache. He woke up Thursday morning 4/1/21 with severe back pain, spasm, and not able to more. He did not have this pain before the vaccine. He did alternate between Ibuprofen and Tylenol for the pain and it did not help.
56 2021-04-05 headache Touch ache, shot location very sore, severe headache for 2 days
56 2021-04-06 chills, sweating Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report... Read more
Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
56 2021-04-06 chills, fever, fatigue Nausea/vomiting, fevers, chills, fatigue
56 2021-04-06 headache, fever After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 10... Read more
After shot, started getting muscle spasms in entire body and muscle aches, bad headache, fever of 100.8 . Started the same night as the vaccine was given, worse the next day.
56 2021-04-06 sweating, chills Sudden onset diarrhea followed within a few minutes by body aches that became severe within 1 hour. ... Read more
Sudden onset diarrhea followed within a few minutes by body aches that became severe within 1 hour. Severe chills and sweating that lasted into the early morning hours. I awoke around 3 AM soaked with sweat and still with chills. I got up at around 8 AM and felt much better. Still having periodic diarrhea that is not explained by my diet.
56 2021-04-06 sweating, fever Sweating started approximately 10 hours after receiving the second dose. Took 2 Tylenol in the eveni... Read more
Sweating started approximately 10 hours after receiving the second dose. Took 2 Tylenol in the evening 6April21. The following day a fever up to 101.2 at noon on 7April2021. Took 2 Tylenol at 5 am 7April21 and 2 more Tylenol at noon 7April21.
56 2021-04-07 chills, fever Chills, fever, body aches
56 2021-04-07 cough Patient was incidentally found to have COVID infection while in hospital for other diagnosis. Patie... Read more
Patient was incidentally found to have COVID infection while in hospital for other diagnosis. Patient endorsed mild shortness of breath and cough but afebrile and did not require oxygen. Patient required no treatment for COVID and was discharged to home. Patient had previously received his first COVID vaccination.
56 2021-04-07 fatigue, headache Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pa... Read more
Autoimmune response involving all previous symptoms of PTLDS especially dizziness, multiple joint pain especially spine, shoulders and hands along with uncomfortable stomach pain and severe headache. Treatment -water, some pepto, and 2 ibuprofen. Started previous evening with fatigue and hands, woke up around two AM with tremors and cramping, all symotoms worsening to the mid afternoon. Unable to stand or walk with confidence or safely hold objects
56 2021-04-07 fatigue, nasal congestion Next day had intense burning on tounge, and on buccal mucosa-still present but not as bad -nasal co... Read more
Next day had intense burning on tounge, and on buccal mucosa-still present but not as bad -nasal conestion only with nuts and pineapple -fatigue x 2 days
56 2021-04-07 headache First Day my head was in a fog, struggled to concentrate. Day two and three I feel like I have a ha... Read more
First Day my head was in a fog, struggled to concentrate. Day two and three I feel like I have a hangover with headache. still struggling to concentrate.
56 2021-04-08 fatigue Patient stated 2 days after she received the vaccine she started c/o hives, very itchy all over the ... Read more
Patient stated 2 days after she received the vaccine she started c/o hives, very itchy all over the body, left eye swollen shut, no fever/body aches or chills, no n/v or sob, very fatigue and tired. As of 4/6/21 the patient is feeling better and the hives and itching are subsiding and getting better everyday. Patient went to ER on Thursday 3/25/21. ER MD gave an rx for Prednisone 20mg but stated to not use if she doesn't need it but to continue taking the Benadryl. Patient is also using the Benadryl cream and Hydrocortisone spray (both are helpful). MD ER called the CDC and he as informed by the CDC that the patient shouldn't receive the 2nd dose of Pfizer and it was recommended to get the JJ vaccine.
56 2021-04-08 pneumonia, cough, influenza like illness, chills, headache, sweating, fatigue double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; ... Read more
double pneumonia; body aches/I started aching; headache; tired/fatigue/exhausted; I got the chills; my skin felt like it was sunburned; cough; fog; no appetite; sweating; my arm hurt/sore arm; he had a previous flu like symptoms after the shingles vaccine.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727), via an unspecified route of administration in the left arm on 24Mar2021 at 10.30 (at the age of 56-years-old) as single dose for covid-19 immunisation. Medical history included hypertension diagnosed 20 years ago, blood cholesterol diagnosed about 7 years ago, Covid-19 in Dec2020 which hit him pretty hard, double pneumonia, he was wiped out, patient had a shingles vaccine a couple of years ago he had a fever and it felt like he had the flu, for about 48 hours he was wiped out. This happened with both doses of the shingles vaccine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) and vitamin C (ascorbic acid) (VITAMIN C [ASCORBIC ACID]). On 24Mar2021 (Wednesday), patient experienced double pneumonia, body aches/i started aching, my arm hurt, headache, tired/fatigue/exhausted, i got the chills, my skin felt like it was sunburned, cough, fog, no appetite, sweating, sore arm, he had a previous flu like symptoms after the shingles vaccine. It was reported that all the same symptoms the patient had with COVID, the caller had after the vaccine. The next morning was much worse and through that next day. Patient describes his side effects like a mini Covid 19 reaction. The symptoms were very similar to the symptoms he had 4 days into his Covid-19 diagnosis. It was reported that on Friday (26Mar2021) he felt normal and was able to workout on Saturday (27Mar2021) as usual. The patient believes his antibodies are strong following his virus and then the 1st Pfizer vaccine dose. The patient doesn't think he had a fever, but he didn't have that with covid along with no loss of taste and smell. The patient was very grateful for the vaccine. Patient had no other vaccinations within 4 weeks prior vaccination. The patient underwent lab tests which included blood cholesterol and blood pressure whose results are reported as high on an unknown date. The outcome of the event double pneumonia was unknown, and for all other events it was recovered.
56 2021-04-09 headache, fever, fatigue Moderate headache, pronounced fatigue, slight fever, medium body aches
56 2021-04-09 headache Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm i... Read more
Heavy Vomiting headache being very weak next day very weak no energy very weak slight headache arm is very very sore swollen for injection was injected
56 2021-04-09 fever, fatigue, headache, chills site pain,tiedness,joint pain, fever,headache,chills
56 2021-04-11 fatigue Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot ... Read more
Woke up with tinnitus in right ear on 2/27/21, almost exactly 2 weeks after second vaccination shot (Pfizer). Within days, fatigue and weakness set in with some sporadic joint and stomach pain. Symptoms persist today, six weeks later.
56 2021-04-11 fatigue Bruising around the are of shot administration, general fatigue with arm soreness and occasional min... Read more
Bruising around the are of shot administration, general fatigue with arm soreness and occasional minor throbbing.
56 2021-04-11 fatigue 40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other... Read more
40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other symptoms. I took a 4 hour nap and when I woke from the nap I felt perfectly fine and full of energy.
56 2021-04-11 fever, sweating, chills soreness at injection site, fever, chills, sweats for 12 hours. commencing 11 hours after injection
56 2021-04-12 fatigue, cough, chills, headache Not sure if this is related to shot. I have never had flu before. This October was the second year I... Read more
Not sure if this is related to shot. I have never had flu before. This October was the second year I received flu shot. I received the covid vaccine and continued my normal routine of distancing, mask, hand washing. 2 weeks after I began to feel extremely tired, headache, chills, muscle aches, cough and after 6 days went to walkin in and tested negative for covid and positive for flu type A. Dr said it was extremely rare as they had not seen any case of flu this season.
56 2021-04-12 headache, chills I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not... Read more
I started having a severe headache, chills and I thought I had fever I was feeling hot but I did not have fever, I had nausea , then after 3 hours of the above symptoms I vomited. From then I fully recover just I had light headache for a few hours.
56 2021-04-12 fever, chills Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after rec... Read more
Developed chills, body aches and low grade fever starting at 5pm on 3/30 (more than 24 hrs after receiving vaccine), fever topped out at 101.7 degrees, fever remained overnight, broke by 10am next day, chills remained for about another 24 hours. Likely unrelated, developed right knee, calf and foot pain and had numbness in 2 left foot inner toes, off and on for 3-4 days after fever broke. Took 2 Advil, pain completely disappeared by 2 days later. I have arthritis and have had 2 right/1 left knee surgeries, and the temperature rose right about the time the pain disappeared, but the cold has returned and no pain. Just odd, almost like a side effect of producing anti-bodies was excessive inflammation in parts of my body prone to inflammation. I get the flu vaccine every year, and I have flu-like symptoms (chills, aches, low-grade fever) for several days within 24 hrs every year.
56 2021-04-13 chills, fever On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He ca... Read more
On the evening of the injection, he had fever of greater than 104 degrees with shaking chills. He called the Health Dept. because he feels that the shot was given into the shoulder joint. He describes pain in the shoulder joint at a level of 2-3 on a 10 point scale. By yesterday, his fever was down to ~99degrees. Today, he is feeling better, but his arm is still tender and he increased tenderness when he raises his elbow.
56 2021-04-13 headache, fatigue Fatigue and Headache. Lasted for around 36 hours.
56 2021-04-13 headache The adverse event was a small stroke which occurred after/during a severe headache . There was numbi... Read more
The adverse event was a small stroke which occurred after/during a severe headache . There was numbing/tingling and muscle contractions in my left hand followed my face drooping and slurred speech. It was never said that the stroke was caused by the vaccine. It may have been a factor though.
56 2021-04-13 sweating, fever, chills, malaise Had vaccine at 1:30 p.m. Thursday, March 25. 11:00 p.m. Sunday, March 28: Chills, fever 100.5, sweat... Read more
Had vaccine at 1:30 p.m. Thursday, March 25. 11:00 p.m. Sunday, March 28: Chills, fever 100.5, sweating, body aches and general malaise. Lasted approx. 12 hours. Recurred 10:30 p.m. Thursday, April 1; again evening of Sunday, April 4; again around midnight Thursday, April 7. April 7 episode did not end as rapidly .... on Friday, April 8, fever intensified to high of 103.2 before I traveled to hospital emergency room where I was admitted and am still a patient as of this writing (9:00 a.m. Wednesday, April 14). No fevers since Sunday; probably will be released today. Several blood cultures completed; no infections. Doctors scratching their heads. Am scheduled for second Pfizer dose tomorrow, April 15, at 5:00 p.m. and am very nervous about it but doctors are recommending I take it.
56 2021-04-14 headache, fatigue Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue on... Read more
Fatigue, diarrhea, joint pain, muscle weakness, pain in both hands, headache, neck pain. Fatigue onset 4/10/21, symptoms worsened 4/13/21.
56 2021-04-14 headache Severe Headache 18 hours post injection. Headache lasted approximately 14 hours with little relief f... Read more
Severe Headache 18 hours post injection. Headache lasted approximately 14 hours with little relief from OTC Tylenol. Injection site became extremely painful 8-10 hours post. This lasted approximately 24 hours. I did not seek medical attention for either of these side effects, and both side effects were just about gone the morning of April 10.
56 2021-04-15 chills, fever Fever, chills, body aches, chest pain
56 2021-04-15 fatigue Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on ... Read more
Caller stated he had Pfizer first vaccine last Friday. Next day had arm pain and was tired. Then on Monday through Wednesday felt more fatigued with diarrhea. He stated feelin a bit better today.
56 2021-04-15 headache Mild headache and severe tinnitus in the right ear after waking the morning after the exam making it... Read more
Mild headache and severe tinnitus in the right ear after waking the morning after the exam making it difficult to concentrate on work or enjoy normal daily activities.
56 2021-04-15 sweating, chills, fever Patient is 56-year-old male who presents to the ED for complaint of febrile reaction and swollen axi... Read more
Patient is 56-year-old male who presents to the ED for complaint of febrile reaction and swollen axillary lymph nodes after covid-19 vaccine. Patient reports febrile episode overnight. Patient reports fever up to 104, chills, and diaphoresis. Patient reports nausea without vomiting. Patient reports axillary lymphadenopathy, however no chest pain, shortness of breath, sore throat, syncope, palpitations, or diarrhea. Patient has history of CLL, which is currently just being monitored without treatment. Patient otherwise feels well, is a nonsmoker, has no significant confounding illnesses.Patient was hospitalized for viral pneumonitis subsequent to covvid-19.
56 2021-04-15 sweating Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatme... Read more
Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatment- NO po water or juice given as patient is muslim and was fasting VS 203/138, HR 69, RR 12, Pulse Ox 99% EMS called for elevated BP and symptoms EMS arrived and repeated BP with manual cuff and BP was 137/86, accucheck normal and was released to go home Patient was obsed for one hour and DCed home
56 2021-04-15 fever Low grade fever 100.5 F
56 2021-04-16 chills, headache, fever, fatigue Headache, fatigue, low grade fever, chills, body aches.
56 2021-04-16 sweating, sluggishness Pt received initial Pfizer covid vaccine. About 8 minutes after the injection, his wife stated he w... Read more
Pt received initial Pfizer covid vaccine. About 8 minutes after the injection, his wife stated he was not feeling well. Upon assessment, pt was pale in color, a&Ox3, but sluggish to response. Pt was immediately placed from chair to floor and legs were placed in trendelenberg after initial bp was 90/60. Pt was weak but remained responsive. Pt was diaphoretic. Cold compress to forehead. No noted rash or hives, no difficulty speaking or respiratory distress. 0940- 90/60 0945 100/70 legs up on chair as he was supine on floor- pulse ox 93% 0955 110/70 97% sat; skin color returning to pink. 1000- 112/64 96% pulse 73 1010- 115/70 93% sat pulse 83 sitting up on floor 1012 bp 88/inaudible In chair 1012- bp 90/64 on floor 95% sat 78 pulse Pt remained A&O throughout assessment and to point of transfer to ER 911 ems arrived at 10:25 and began assessment. 10:35 EMS elevated pt to sitting position , and placed on cart and escorted pt to ER with security also. Pt stating he is feeling better, color pink/yellow tone.
56 2021-04-17 chills, headache, influenza like illness, fever Flu like symptoms-- night sweats abs chills, low grade fever, headache, muscle aches.
56 2021-04-17 dehydration This is a spontaneous report from a contactable consumer. This consumer reported that her 56 years-o... Read more
This is a spontaneous report from a contactable consumer. This consumer reported that her 56 years-old male son (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 24Mar2021. Relevant history and concomitant drugs were unknown. The reporter stated that her 56 year old son received his first dose of the Pfizer BioNTech COVID-19 vaccine a day earlier than she received hers (which was on 25Mar2021) and while waiting after getting his vaccination, her son became "very, very dizzy." He told the nurse working at the vaccination site that the dizziness was getting worse and "getting very bad." He was asked how his breathing was and he told the nurse it was okay, but an ambulance was called for him anyways and he was sent to the hospital. Her son reported feeling better when he laid down but still reported feeling dizzy. At the hospital, her son was told that all the test came back okay. When her son got up to use the restroom with the assistance of the doctor, the doctor told him that he was dehydrated and gave him IV fluids. Caller stated that her son reported feeling "a lot better" after the IV fluids but "couldn't hardly walk" and had to have someone else drive him. Her son reported feeling "alright" the next day. Caller stated that she was reading in the information pamphlet on the Pfizer vaccine that a severe reaction could include dizziness. Caller was worried about her son getting his second dose and think she should speak with his physician before receiving his next dose, and would like to know if this was okay. She was concerned because she states that she had heard that people have gotten sick from the second dose of the vaccine. Outcome of the events was resolving. Information about the Lot/batch number has been requested.
56 2021-04-17 fatigue, sleepiness About a week after the shot a noticeable fatigue set in. I need to sleep more and I am tired much mo... Read more
About a week after the shot a noticeable fatigue set in. I need to sleep more and I am tired much more often than usual. I actually fell asleep during a video conference with a colleague. These symptoms remain consistent to date ... a couple of weeks so far.
56 2021-04-17 fatigue 04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was He... Read more
04/01/2021 around 5:00 PM: 1. Sore Arm, Shortness of Breath, Chest Pains, Fatigue. | Thought was Heartburn, took tums and had a little relief 04/02 to 04/05/2021: Same Symptoms throughout those day, had No appetite, increased fatigue. and Tums No longer gave relief. 04/06/2021 6:00 AM: Went to emergency room and had to receive emergency heart surgery as I was diagnosed with blood clogged arteries and had been having a heart attack for the past several days
56 2021-04-17 headache, throat pain, fever Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck a... Read more
Inflamation and pain on left side of the body, beginning in the arm/shoulder and spreading to neck and left tonsil. Tonsil swelling was quite pronounced by 2am (nearly twelve hours after the injection) and blocked the airway when head was turned to the left, necessitating a makeshift pillow brace to keep head turned to the right overnight. Tonsil swelling began to diminish by about 6am and only slight enlargement remains thirty hours after injection. Additionally, a low-grade fever began at about 10 pm (~7 hours after injection) and reached a maximum of 100.5 degrees F approximately twenty-four hours after the injection. By twenty-eight hours, temperature was within normal limits (though still nearly a degree higher than typical for this patient). As of this writing, some thirty hours after the injection, headache, neck ache, and eye-ache persist, but none is severe. Symptoms appear to be continuing their improvement. I (the patient/recipient) hope the second installment of the vaccine is no worse than this one. The only truly alarming symptom was the swollen tonsil and some thought was given to seeking medical attention, but the pillow brace seemed to do the trick for keeping the airway open, so no assistance was sought. I have no doubt that these short-lived symptoms are much better than actual disease and I will not hesitate to follow up with the second vaccine installment?but I will monitor the tonsil situation very carefully.
56 2021-04-17 headache Tingling, nausea, headache day of vaccination. Brain fog for following 36 hours.
56 2021-04-17 sweating PT DIAPHORETIC, HYPOTENSIVE BP 90/40 HR 60-70 O2SATS 99% ROOMS AIR PT PLACED IN STRETCHER, VITALS A... Read more
PT DIAPHORETIC, HYPOTENSIVE BP 90/40 HR 60-70 O2SATS 99% ROOMS AIR PT PLACED IN STRETCHER, VITALS AND LOC CONTINUOSLY MONITORED-AT 2:33PM PT STATED "FELT BETTER, PT NO LONGER DIAPHORETIC, VITALS BP 114/60 HR 70, O2 SATS 99% RA
56 2021-04-18 chills, fatigue Next day tiredness and chills.
56 2021-04-19 fatigue For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the ... Read more
For the first three days, it was severe nausea, body & head aches, tiredness with flank pain on the left side toward the kidney area. Three days later, the severe nausea returned and caused weakness. The flank pain increased to my lower ribcage on the leftside and am still dealing with it. (4/20/2021)
56 2021-04-19 fatigue Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and l... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Severe Migrane Headache, Severe pain in left eye swelling and loss of vision, Nausea and Vomiting, Severe Fatigue
56 2021-04-19 fatigue A few days after my first dose I started feeling mild light headed when standing that would not go a... Read more
A few days after my first dose I started feeling mild light headed when standing that would not go away. I checked my standing blood pressures and notices that it was very low 83/56 with a heart rate of 110. This went on for several weeks with standing blood pressures in the 80-90's/50-60's . I was having difficulty with daily activities where I would get tired just going up and down steps. I was very concerned and made an appt with my Dr. He did not think it was related to the vaccine. I was treated with chemo and radiation in 1984 for Hodgkins disease (MOPP and ABVD) were the chemo agents. This treatment as left me with mild orthostatic hypotension which I have been dealing with for over 10yrs however I have
56 2021-04-20 headache, fever, influenza like illness Sever Flu like symptoms that included high fever, head aches and body pains lasting for 48 hours.
56 2021-04-21 chills Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole... Read more
Approximately 20 hours after receiving the vaccine, my hands and feet became very cold, and my whole body began to shake - have chills, and my teeth began chattering. Approximately 3 hours later, I began to feel warm; my eyelids were very warm whenever I blinked. Slowly but surely I began to feel better.
56 2021-04-21 cough, productive cough Patient is a 56 y.o. year old male with PMH of COPD, CAD, DM, HTN, HLD presenting to the ED for coug... Read more
Patient is a 56 y.o. year old male with PMH of COPD, CAD, DM, HTN, HLD presenting to the ED for cough and shortness of breath. Symptoms started one week prior to arrival. Patient states cough more frequently and productive of clear-yellow sputum. Dyspnea worse with exertion. Symptoms noticeable shortly after receiving first dose of pfizer COVID19 immunization today. Chest tightness though denies chest pain. No leg pain/swelling. Patient has been compliant with previously prescribed trilogy.
56 2021-04-21 throat pain VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being ... Read more
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/08/21pfizer,Lot#EL3248 2nd dose: 01/29/21Pfizer,Lot# EN5318 Diagnosed covid positive:04/12/21 Exposure:Travel Symptoms:Sore throat
56 2021-04-21 fever, chills Adverse events: Chills, fever, and swelling under left arm Outcome: all better after 24 hours
56 2021-04-22 fatigue, chills 4/22/21 at 5:00am: started feeling fatigue and chills 4/22/21 at 8:00pm: started noticing chest pain... Read more
4/22/21 at 5:00am: started feeling fatigue and chills 4/22/21 at 8:00pm: started noticing chest pains on left side 4/23/21 at 2:00am: continued chest pain, noticed a bulge on left armpit 4/23/21 at 7:50am: started noticing back pain
56 2021-04-22 headache, fever Mild headache, fever, diarrhea, loss of appetite
56 2021-04-22 headache, fever Headache, body aches, low grade fever and loss of energy
56 2021-04-22 headache 01/24/2021 - vertigo++ , bedrest all day 01/25/2021 -vertigo+, bedrest all day 02/01/2021- continued... Read more
01/24/2021 - vertigo++ , bedrest all day 01/25/2021 -vertigo+, bedrest all day 02/01/2021- continued dizziness, headaches. tinnitus, right earache Urgent Care visit, COVID rapid test - negative, dx - viral infection unspecified 02/02/2021 - Family physician visit. Prescribed Meclizine 02/15/2021 - continued dizziness, headaches, tinnitus, right earache. Urgent Care visit. DX - otitis media RX - Augmentin 2x per day for 10 days 02/18/2021 - continued dizziness, headaches, tinnitus, right earache. SARS-COV-2 RNA, QL, RT PCR test - NEGATIVE 03/01/2021 - continued dizziness, headaches, tinnitus, right earache. Family physician visit. RX - Allegra. MRI/MRA with/without contrast ordered 03/10/2021 - continued dizziness, headaches, tinnitus, right earache. MRI/MRA with/without contrast performed. 03/17/2021 - continued dizziness, headaches, tinnitus, right earache. Visit with ENT specialist. Hearing and balance tests normal. VNG test ordered. 04/06/2021 - continued dizziness, headaches, tinnitus, right earache. VNG test performed - Normal results 04/13/2021 - continued dizziness, headaches, tinnitus, right earache. Visit with family physician. ESR test ordered. 04/19/2021 - ESR test performed. Results normal
56 2021-04-22 fever, chills Body aches, fever 101.6, chills, minor shortness of breath
56 2021-04-22 fever, fatigue, headache, chills After receiving the second dose of COVID on April 10th, my husband experienced chills, muscle pain,... Read more
After receiving the second dose of COVID on April 10th, my husband experienced chills, muscle pain, fatigue and a low-grade fever. On the 4th day after vaccination, he started having a temporal headache that first was throbbing in the temple on left side of his head and tender to the touch. the headache was persistent for several days, and then, started coming and going until was gone. Overall, he had those headaches for about 10 days. I did report about this side effect to his PCP.
56 2021-04-23 chills, influenza like illness, headache SEVERE HEADACHES, ALONG WITH FLU SYSTOMS (dizzy, chills, vomiting, feeling very lightheaded). STILL ... Read more
SEVERE HEADACHES, ALONG WITH FLU SYSTOMS (dizzy, chills, vomiting, feeling very lightheaded). STILL HAVING SYMPTONS.
56 2021-04-23 headache Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient... Read more
Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient had visual disturbances within 1 hour of vaccination and lasted for an hour. then a migraine proceeded after the visual disturbances. the migraine last 3 hours, that is the first migraine he has ever had in his life. he managed the migraine with tylenol and ibuprofen. after 3 hours the migraine turned into a headache and last until late in the evening
56 2021-04-24 chills, fever Patient was find during 30-minute post dose observation but upon getting home he was experiencing di... Read more
Patient was find during 30-minute post dose observation but upon getting home he was experiencing difficulty breathing, lips were blue, chills, pains in lower back and fever. Patient called EMT and was taking to Hospital and treated then released same day.
56 2021-04-24 headache, fatigue, fever disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness... Read more
disoriented; Fever; Headache; swollen lymph node under left armpit for 4 days; body aches; tiredness; mild nausea; This is a spontaneous case is received from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, high cholesterol and acid reflux. It was unknown if the patient had known allergies. The patient's concomitant medications were not reported. On 24Feb2021 at 02:00, the patient experienced disoriented, fever, headache, swollen lymph node under left armpit for 4 days, body aches, tiredness and mild nausea. Therapeutic measures were taken as a result of fever. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
56 2021-04-24 headache, fever Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm... Read more
Chills starting at 5 pm day 1; severe chills and shaking for 10 minutes on preparing for bed at 8 pm, fever 98.9, which resolved upon lying down under warm blankets; fever 101.1 at 11 pm day 1, 102.0 at 5 am day 2, 100.7 at noon, 101.8 at 5 pm on day 2, with muscle ache and headache throughout day 2;100.5 at 2:30 am on day 3. Fever went down to 100.0 at 5 am and was normal thereafter, mild headache through daytime of day 3. No symptoms since.
56 2021-04-25 chills, fever, headache Headache, bad fever, chills, aches.
56 2021-04-25 sweating, malaise Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 min... Read more
Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 minutes of observation due to hx of anaphylaxis to penicillin. At approximately 5:55pm, RNs noticed that Pt had his head in his hands. When questioned, he stated he didn?t feel well. He was helped to the ground and his legs were elevated. His vitals were 190/90, P 88, Resp 34. The nurses helped him to a sitting position as he was feeling better and he answered some medical history questions. He shared that he was Type I Diabetic. He stated he checked his blood sugar last yesterday. He ate breakfast today and took insulin. No food since this morning. Patient had no symptoms of anaphylaxis and no chest pain or other complaints. Patient denied SOB or ?throat tightening?. No hives. Patient became diaphoretic and stated he was overheated. RNs helped to remove his shirt. Observation RN alerted Nurse practitioner of the ongoing incident. Nurse Practitioner went to seek sugar sources, suspecting the patient was severely hypoglycemic. Patient, still conscious and responsive and sitting up, took 10 oz. orange juice and frosting was massaged by APRN, in buccal area with patient consent. Patient initially seemed to be improving per APRN and RNs caring for patient. BP was 170/90 at next check. P 80. Regular respirations. Still no anaphylaxis symptoms (no hives, no angioedema, no throat tightening or wheezing). A few minutes later, Pt started shaking and said he was chilled. Patient was returned to supine position with legs elevated. He continued to shake and patient lips blue ? sweatshirt placed over him. RN noted that Pts? eyes rolled back in his head. RN went to alert the Clinical Team Manager/RN of the situation and stated that 911 should be called as patient not improving. Clinic Team Manager/RN concurred. While RNs stayed with patient and informed patient?s friend about what would occur, Clinic Site Manager called 911. BP 140/80 at next check. Patient continued to sweat and have chills. Rescue squad arrived ? blood sugar was 116. After emergency services assessment of patient, emergency services checked blood sugar again and it had dropped to 88 within those ~5 minutes. Patient was taken by Emergency Services at 6:36pm. RN noted that the patient remained with emergency services in parking lot for several minutes and then pt was transported to the hospital by the emergency services. His wallet, glasses and hat were given to his friend who had accompanied patient to the vaccination clinic. His friend stated that she would call patient?s wife to inform her that patient was taken to ED by emergency services.
56 2021-04-26 fever, fatigue, malaise, chills, cough, runny nose 4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy;... Read more
4-16 Friday 2nd COVID shot, feeling ok. A little tired; 4-17 Saturday tired, low grade fever, achy; 4-18 Sunday Rash on tops of both feet, tired achy, low grade fever, chills; 4-19 Monday Fatigue, slight rash on torso, feet better, low grade fever, chills; 4-20 Tuesday Rash entire torso front and back small red raised blisters, fever 100+, fatigue, easily winded and tired, runny nose, contacted Doctor, told to wait 7 days to call back if symptoms don?t improve; 4-21 Wednesday Severe Rash on torso, arms, legs, buttocks, no pain or itching; 4-22 Thursday Rash spreading to all parts of the body from head to soles of feet, difficulty breathing, fever hard to manage 101-102, mouth sores, eyes bloodshot, Went to urgent care, Negative Rapid Covid test, put on 50 mg Prednisone and 1 tab claritin; 4-23 Friday Rash more red, blisters gone no white on torso, some white areas on legs, arms, and other parts of the body. Breathing worse, coughing, chills, fever hard to manage 101-102, chills, no appetite, diarrhea, rash painful on sides of torso; 4-24 Saturday Went to ER for difficulty breathing, no unaffected skin on torso, general ill feeling, eyes still bloodshot, mouth sores, *Intravenous steroids, chest CT scan and xray showed inflamed lymph nodes, inflamed lung walls, no blood clots, bronchial walls thickening and faint peripheral ground glass opacities in the right lobe, mediastinal and right hilar lymphadenopathy as well as air-trapping in the right middle lobe and left upper lobe *strep test negative; 4-25 Sunday rash a little better after intravenous steroids, breathing worse, fever still 101-102 managing with tylenol and advil; 4-26 Monday Dermatology consult punch skin biopsy to rule out viral cause of rash, blood work done to rule out pneumonia, put on reducing course of prednisone 60/40/20/10/5 - Allergy consult no diagnosis; 4-27 Tuesday primary care doctor, added Symbocourt, rash peeling and flaking and painful, slowly receding, breathing still labored and difficult, no appetite, no energy, fatigued, eyes still bloodshot, mouth still sore and raw/canker sore like, ruled out any other cause diagnosed as vaccine reaction. Advised to contact in two weeks if breathing it still difficult.
56 2021-04-27 chills, fever full body hives and swelling, low grade fever and chills started morning after the 2nd shot was admi... Read more
full body hives and swelling, low grade fever and chills started morning after the 2nd shot was administered, today 5/28/2021 is much worse than yesterday
56 2021-04-27 headache, fever, influenza like illness, chills Flu like symptoms. Body aches, hot and cold with chills, bad headache, back hurts, slight fever
56 2021-04-27 malaise, fatigue, sluggishness Dizziness exactly 7 days after shot. I NEVER have dizziness. And suddenly, I am feeling dizzy at ... Read more
Dizziness exactly 7 days after shot. I NEVER have dizziness. And suddenly, I am feeling dizzy at time throughout the day. It's worse when getting up out of a chair or bed, but also feel it when just staying still. I can still function, but it is strange. Also: a day after the second shot (Day 2), I got "sick" for two days (Day 2 and 3)-- sluggish, exhausted, unable to focus. Spent two days in bed. But was fine by Day 4.. Then the dizziness started on Day 8.
56 2021-04-28 fatigue, throat pain, runny nose, respiratory tract congestion, fever, chills Fever or Chills Fatigue Muscle or body aches Sore throat Congestion or running nose
56 2021-04-28 headache, fever Fever, headache.
56 2021-04-29 nasal congestion, throat pain five minutes after 2nd dose shot ,nasal cavities became swollen and stopped up .slightly difficult b... Read more
five minutes after 2nd dose shot ,nasal cavities became swollen and stopped up .slightly difficult breathing occurred , 20 minutes after .used afrin nasal spray and nasal cavities returned to normal , breathing returned to normal . 2 hours later stiffness in the neck, and aches in knees and lower back ,treated with Tylenol ,12 hours later slight joint pain ,stiff neck, and sore throat ,treatment with Tylenol 2 500mg tablets .
56 2021-04-30 malaise, chills, fever did not feel well; severe chills; felt feverish; achy; This is a spontaneous report received from a ... Read more
did not feel well; severe chills; felt feverish; achy; This is a spontaneous report received from a contactable consumer. A 56-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration In the left arm on 12Apr2021 09:30 AM at single dose for COVID-19 Immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included caffeine/paracetamol (EXCEDERIN) and zolmitriptan (ZOMIG). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Mar2021 at 56 years old for COVID-19 Immunization. Approximately 14 hours after inject to about 19 hours after inject, the patient intermittently had severe chills, felt feverish, also was achy and did not feel well from 12Apr2021 11:30 PM. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Outcome of the events was recovered. This report was reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-05-01 fatigue, lethargy Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, S... Read more
Systemic: Confusion-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
56 2021-05-01 influenza like illness, fever, chills Fever, chills, body aches and flu like symptoms
56 2021-05-02 chills severe chills and shivering for about 2 hours. buried myself in blankets but could barely talk I wit... Read more
severe chills and shivering for about 2 hours. buried myself in blankets but could barely talk I with shivering so bad. woke up at 2:00 a.m. Sunday morning and was no longer shivering but I had muscle aches all over for another day
56 2021-05-04 head discomfort Approximately 5-6 days after the second vaccine I started developing Tinnitus with pressure in ears/... Read more
Approximately 5-6 days after the second vaccine I started developing Tinnitus with pressure in ears/head. As of today (5/5/2021), approx. 11 days, it has not improved and may be getting worse
56 2021-05-04 headache, fatigue, chills headache; throwing up; chills; Tiredness and being worn out; This is a spontaneous report from a con... Read more
headache; throwing up; chills; Tiredness and being worn out; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 11:30 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose on 27Mar2021. The patient just finished his 2-dose series of the PFIZER-BIONTECH COVID-19 VACCINE on 17Apr2021 and the first one on 27Mar2021. He wanted to confirm if the side effects that he is experiencing is normal. Side effects that he was experiencing were feeling of tiredness and being worn out from 17Apr2021, he also felt sick since 19Apr2021, by sick he meant he have been throwing up. Also he had chills for 19Apr2021 night and experienced headache. No emergency room or physician office visit. The outcome tiredness was recovered on 18Apr2021, throwing up was not recovered, chills recovered on 20Apr2021, outcome of headache was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.
56 2021-05-04 malaise Shingles and I have never had shingles before Also, very ill for a month
56 2021-05-04 runny nose, cough, respiratory tract congestion Cough Congestion or running nose
56 2021-05-05 lethargy general lethargy the day after or so, as was expected. However, several weeks later and now 4 weeks... Read more
general lethargy the day after or so, as was expected. However, several weeks later and now 4 weeks later, I have had consistent, daily lower digestive issues including irregular and incomplete bowel movements, and low level cramps throughout the day. I had NONE of this prior to getting the vaccine. I would consider it to be specific to me, but my wife had reported similar symptons when she received the Pfizer vaccine several months earlier (she's a nurse so was able to get the vaccine sooner) and they last 10 weeks and she went to the doctor. She was told by the doctor she is "not the first person" he's heard this complaint from.
56 2021-05-06 chills, fatigue Shoulder and neck pain, fatigue, chills, joint aches.
56 2021-05-06 chills, fever, fatigue Body and joint aches, fatigue, chills and fever.
56 2021-05-06 chills Chills and severe hives on the entire body lasting four days
56 2021-05-06 fever, cough, respiratory tract congestion, runny nose, headache FEVER, HEADACHE, CONGESTION/RUNNY NOSE,COUGH
56 2021-05-07 fatigue Have Dercum's Disease and noticed that my lipomas have more than doubled in size and my fatigue has ... Read more
Have Dercum's Disease and noticed that my lipomas have more than doubled in size and my fatigue has become way worse than it was. I did not think that the vaccine caused it until other people in my Dercums support group started asking if it was happening to others after they received the vaccine.
56 2021-05-07 headache Tinnitus, headache and slight dizziness. This is still occurring 3 weeks after the first vaccine.
56 2021-05-07 malaise, headache The first shot, I got it on 4/17/2021 around 3:30 pm and I felt only my arm for couple days. For the... Read more
The first shot, I got it on 4/17/2021 around 3:30 pm and I felt only my arm for couple days. For the second shot, I got it on 5/7/2021 around 10:10 am, I wakeup around 4:30 am feeling sick, all my body weak no energy, headache and diarrhea. It's know 2:00 pm and I still feeling sick.
56 2021-05-08 fever, chills, fatigue, headache Fever, chills, nausea, vomiting on seventh day, exhaustion, Headache, diarrhea, body aches and pains... Read more
Fever, chills, nausea, vomiting on seventh day, exhaustion, Headache, diarrhea, body aches and pains. All are still being g felt since my second shot. Stopped vomiting but experiencing all of the rest of the symptoms to date intermittently but regularly.
56 2021-05-09 fatigue, headache Headache beginning 16 hrs after the vaccine through 24 hrs after the vaccine. It eventually went awa... Read more
Headache beginning 16 hrs after the vaccine through 24 hrs after the vaccine. It eventually went away after a second treatment of ibuprofen. Some fatigue during this same period.
56 2021-05-10 fatigue, sleepiness This is a spontaneous report from a contactable consumer (patient) and another contactable consumer ... Read more
This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.
56 2021-05-10 headache Sporadic nystagmus within days after 1st shot. 12 hours after second dose, dizziness started. Had n... Read more
Sporadic nystagmus within days after 1st shot. 12 hours after second dose, dizziness started. Had nystagmus and vertigo episodes for a week, then full vertigo at 2am for 9 hours, , vomiting could not keep in solid or liquid. In ED for CT scans and medications. After that, dizziness and severe headache for 1 week. Treated one week of meclazine. Sent to DPT for nystagmus. . After ~ 4 weeks, dizziness, headache, and nystagmus still occur. Daily ibuprofen. occasional Dimenhydrinate. Can not work, on short term disability. Unknown if there will be permanent damage
56 2021-05-10 pneumonia, fatigue, sleepiness, cough, sweating, fever WEAKNESS AND COUGH COVID-19 pneumonia and urinary retention
56 2021-05-11 dehydration Pt. reported feeling dizzy 5 min. after getting vaccinated. BP done 94/40. Pt. stated, "I suffer f... Read more
Pt. reported feeling dizzy 5 min. after getting vaccinated. BP done 94/40. Pt. stated, "I suffer from anxiety and depression." "This afternoon I have an appointment with my psychiatrist." An IV was placed and NS was started. At 11:32am BP 126/80, HR 97, O2Sat 100%, R 19. Pt. also stated, "I have a history of alcoholism and last night I had a drink." "I think I'm dehydrated." At 11:37am BP was 113/78. Pt. agreed to be transported to the hospital. At 11:41am pt. was transported to the hospital.
56 2021-05-11 fatigue Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomni... Read more
Soreness in arm soon after shot. Fatigue, mental fogginess, body aches at joints and back, insomnia, night sweats. All began that evening and continued. I expected them to moderate but they continue. Also experiencing stomach queziness intermittently.
56 2021-05-11 influenza like illness Patient presented to the ED with acute onset right calf pain, in the absence of trauma or injury, 5 ... Read more
Patient presented to the ED with acute onset right calf pain, in the absence of trauma or injury, 5 days after receiving the 2nd dose of the Pfizer Covid vaccine. He reported flulike symptoms and being fairly sedentary in that time. He was found to have a lesser saphenous vein embolism that did not require anticoagulation.
56 2021-05-12 fatigue Extreme Fatigue for 6 days Unable to stop sleeping. First 24 hours of the event was sleep with only ... Read more
Extreme Fatigue for 6 days Unable to stop sleeping. First 24 hours of the event was sleep with only brief wakings (5 to 10 minutes). The following 5 days 16 to 20 hours of sleep each day.
56 2021-05-12 headache, fatigue, fever, chills Severe Chills and feverish - 12 hours after shot muscle aches tiredness headaches 24 hours after sh... Read more
Severe Chills and feverish - 12 hours after shot muscle aches tiredness headaches 24 hours after shot
56 2021-05-12 fever, headache sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contact... Read more
sore arm; headache; transitory fever for about one hour; This is a spontaneous report from a contactable pharmacist. A 56-years-old male patient received second dose of bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 27Jan2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. He received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection. patient reports that he received his seasonal allergies SC injection 24 hours before receiving the second BNT 162 b2 injection on 27Jan2021 in his right deltoid muscle. Patient also reports that he took 50mg of Benadryl prior to his BNT162b2 injection. A couple hours after receiving the BNT 162b2 vaccine he experienced a transitory fever that lasted 1-2 hours and resolved. The next morning,28Jan2021, patient stated that he had a headache that lasted for a day and a half which was unresolved by sleep or ibuprofen, 400 mg taken 3-4 times in the day and 1/2 time period. On Thursday 28Jan he noticed a lump in his Right arm pit which was visible and sore. The lump resolved by after 4-5 days and he has been symptom free. On 27Jan2021, the patient experienced transitory fever for about one hour and sore arm, headache on 28Jan2021.The outcome of the events was recovered. This is a supplement to the previous report submitted 28Jan. Patient emailed (Name) with additional information pertaining to the original report, information was added. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
56 2021-05-15 sweating Person experienced syncope after 1st Pfizer vaccine. Person was experiencing diaphoretic, nauseous ... Read more
Person experienced syncope after 1st Pfizer vaccine. Person was experiencing diaphoretic, nauseous and was pale. Shortly after receiving first Pfizer vaccine the person lost consciousness for about 2 minutes.
56 2021-05-18 malaise, nasal congestion, cough ED Discharged 3/14/2021 (1 hours) Hospital ED Treatment team Providers COVID-19 Clinical impressio... Read more
ED Discharged 3/14/2021 (1 hours) Hospital ED Treatment team Providers COVID-19 Clinical impression Covid-19 Emergency Medicine Expand AllCollapse All ED PROVIDER NOTE Date: 3/14/2021 This note was partially completed using voice recognition technology, and was scanned for gross errors; however some errors may still exist. Please contact the author with any questions or requests for clarification. Medical Decision Making 56 y.o. male patient who presents to the ED for COVID-19 screening. Patient reports PMH of sarcoidosis. Symptoms include nasal congestion, cough, and malaise. Vital signs as documented and stable. Exam reveals well appearing person in no acute distress. No accessory muscle use, speaking in full sentences. Slight rhonchi noted in left lung base. Heart sounds normal with normal rate and rhythm. Limbs warm and well perfused. No edema noted. Abdomen is soft and non tender. X-ray negative for acute process. Patient did test positive for COVID-19. Considered alternative causes such as ACS, PE, pneumothorax, pneumonia but unlikely given constellation of symptoms and exam findings. Assessment is likely viral syndrome caused by COVID-19. I have directed the patient to self monitor at home. Advised not to leave home and minimize contacts in home as much as possible for the next 10 days. Advised on symptomatic treatments for home. Patient was advised to follow-up with primary care physician and pulmonologist by telephone and to come back to the emergency department if symptoms worsen. Chief Complaint Chief Complaint Patient presents with ? Covid-19 Screening History of Present Illness Patient is a male who presents to the ED with for COVID-19 screening. Patient has been experiencing nasal congestion, cough, and malaise since earlier today. No specific aggravating or alleviating factors. No treatments tried at home. Reports sick contacts of father in law, son, and wife. Denies recent travel..
56 2021-05-18 fever, headache Painful swollen lymph nodes in armpit on same side as shot; Aches/pains; headache; low fever; This i... Read more
Painful swollen lymph nodes in armpit on same side as shot; Aches/pains; headache; low fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN5318) via an unspecified route of administration administered in Arm Left on 19Feb2021 at 11:15 (at the age of 56-years-old) as single dose for covid-19 immunisation. The patient's medical history includes CAD (coronary artery disease) and the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, #lot: EI3302) via an unspecified route of administration administered in Arm Left on 25Jan2021 at 03:00 PM for covid-19 immunisation. The patient underwent lab tests and procedures which included body temperature: 99.4 on 19Feb2021 low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. The patient's concomitant medications included simvastatin, omeprazole, cyanocobalamin, folic acid, pyridoxine hydrochloride (FOLBEE), fish oil and curcuma longa (TURMERIC [CURCUMA LONGA]). On 19Feb2021, the patient experienced aches, pains, headache, and low fever (maximum orally measured 99.4, on aspirin) for 30 hours. Onset at 10 hours. Painful swollen lymph nodes in armpit on same side as shot. Ongoing 3 days after vaccination. Pain mild. The outcome of the events was recovering. Therapeutic measures were taken as a result of low fever.
56 2021-05-22 sweating, headache 5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sw... Read more
5/21?severe headache and shaky feeling 5/22?vomiting, headache better but still bad, hot flashes, sweating, shaky feeling, tongue feels ?thick? 5/23?vomiting, shaky feeling, tongue feels ?thick? and this feeling is worse today
56 2021-05-23 fatigue, runny nose, fever, throat pain, headache, cough Symptoms of Cough, runny nose, Headache, fatigue, muscle aches, fever, sore throat - diagnosed as CO... Read more
Symptoms of Cough, runny nose, Headache, fatigue, muscle aches, fever, sore throat - diagnosed as COVID. Symptom onset 5/17/2021.
56 2021-05-23 headache Left Lymph Node swollen 2 days after the shot - this was resolved in about a week Started to develop... Read more
Left Lymph Node swollen 2 days after the shot - this was resolved in about a week Started to develop headaches 3 or 4 days after the shot and they are continuing as of today. Headaches are usually behind the eye and temple, some times in the back of the head in addition
56 2021-05-23 upper respiratory tract infection, sneezing, headache Encounter for screening laboratory testing for COVID-19 virus Upper respiratory tract infection, un... Read more
Encounter for screening laboratory testing for COVID-19 virus Upper respiratory tract infection, unspecified type Patient was seen today for headache and sneezing.
56 2021-05-24 fever Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactabl... Read more
Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male adult patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunization. No Known allergies. Facility type Vaccine was Workplace clinic. No other vaccine in four weeks. No covid prior vaccination, No covid tested post vaccination. Medical history included hypertension, diabetic. Concomitant medications in two weeks included metformin (METFORMIN); nebivolol hydrochloride (BYSTOLIC). On 28Jan2021, the patient experienced sore arm, fever of 100.2, blood sugar keeps dropping. No treatment provided for the events. The patient underwent lab tests and procedures which included blood sugar keeps dropping, body temperature was 100.2. The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
56 2021-05-25 fatigue, headache Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable ... Read more
Fatigue; Headache; Right arm pain; Muscle soreness; This is a spontaneous report from a contactable consumer or other health professional. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 at 14:30 (at the age of 56-years-old), as a second single dose for COVID-19 immunisation. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 22Feb2021 at 14:45 (at the age of 56-years-old), as a first single dose for COVID-19 immunisation. No relevant medical history and concomitant medications was reported. The patient did not have any known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced pain in right arm, headache, fatigue, and muscle soreness. There was No fever or other symptoms. The patient received Tylenol 500 mg for the adverse events. The clinical outcome of right arm pain, headache, fatigue, and muscle soreness was recovering. No follow-up attempts are possible. No further information is expected.
56 2021-05-25 lethargy, fatigue, headache, fever Fever (101); Body aches; Fatigue; Lethargy; Headache; Minor shortness of breathe; This is a spontane... Read more
Fever (101); Body aches; Fatigue; Lethargy; Headache; Minor shortness of breathe; This is a spontaneous report received from a contactable consumer (patient) via COVAES. This 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0161) via an unspecified route of administration in the left arm on 21Apr2021 at 12:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included back injury and arthritis, both from unknown dates and unknown if ongoing. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EP7533) on 31Mar2021 at 12:15 (at the age of 56-years-old) for COVID-19 immunisation. On 22Apr2021 at 06:00 the patient experienced fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of fever reported as 101, body aches, fatigue, lethargy, headache and minor shortness of breath were recovered in Apr2021. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
56 2021-05-25 respiratory tract congestion, runny nose, cough Note Does the patient have current symptoms of illness? Yes Date symptoms started: 5/16/21 1... Read more
Note Does the patient have current symptoms of illness? Yes Date symptoms started: 5/16/21 1. Does the patient have a fever (subjective or confirmed)? No 2. Does the patient have a new onset of cough? Yes 3. Does the patient have a new onset of shortness of breath? Yes, slightly with exertion. NAD. ? If Yes: Is the patient having difficultly breathing or in distress? No 4. Additional symptoms: Congestion, runny nose, nausea and vomiting. Bronchitis Suspected COVID-19 virus infection Chest pain, unspecified type Progress Notes Encounter Date: 5/25/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team:
56 2021-05-26 chills, headache, lethargy, malaise couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was... Read more
couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arms when he was hurting. He wrote down that it felt like somebody had hit him in the back with a bat in the lower back. One day it was that bad. His back pain was on Thursday 15Apr2021. The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. The sore like he was hit in the back pain was just the one day. He had diarrhea 12Apr2021, 13Apr2021, and 14Apr2021 then it left for probably a week. Then it came back last week one day. Instead of every day it was every 3 or 4 days. He has not had it in the last 4 days. He hopes it is done. He noticed any time he has salad or lettuce he feels bad in the morning so he stopped eating those. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. He felt irritable more when he started not feeling good. The last 5 days or so more towards the evening at 1800 or 1900 he starts not feeling good and gets irritated. His wife will ask him something and he gets really short and impatient. The irritable feeling started right away the Friday of the week he got the shot. He is still struggling some, it will come and go. Yesterday he was zonked. With having no energy it is a big thing. He has to do something instead of what he would be doing. He works all day and takes long orders and stuff. Now he does like one order when normally he did 10. One for him is a huge little sore so he will lay on his right side. His left arm still hurts like a pulling hurt from his neck to his arm. It has been every day from 13Apr2021. It is much better and he will move and it will relax a little bit. It was really weird. The whole time he held the phone with his left hand up until one second he moved his phone and it was the same pain. At night the left side where he had the injection pulls on his neck muscle coming from his arm. He was actually taking two Tylenol in the morning and two at night when he went to bed. With the pain he takes 2 during the day, 650mg each. He was just taking 500mg and then his wife said take these. It seems to have gotten a little better. He always took them 2 times a day and now he takes them 3 times a day. After the first dose he experienced difficulty breathing dizziness, weakness, a fast heartbeat, chills, nausea, headache, he passed out for 2 days and has been sick for 5 weeks. He started having some dizziness a couple of days later and reports, it's like I would stand up too quickly and get a head rush, that kind of dizzy feeling. He confirmed that his dizziness did not start until a couple of days after he received his first dose.
56 2021-05-26 malaise Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell si... Read more
Pericarditis: presented to the ED on 5.26.2021 with chest pain x2 days. Has generally felt unwell since his 2nd COVID vaccination on 5.13.2021.
56 2021-05-28 fatigue since 2nd shot I have been extremely tried and on 4/28/21 i had a stroke.
56 2021-05-30 headache Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed... Read more
Pain in my jaw and temple to start then my words started to slur then created a stroke and confirmed my the hospital. I have had a CT scan them MRI. I am in ICU. Who is going to pay for my bills since I have no insurance.
56 2021-05-31 chills, sweating Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no othe... Read more
Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no other issues. On 5/26/21, he note left lower extremity edema. This did not resolve with compression hose and went to hospital for a venous doppler revealing a nonocclusive DVT in the left lower extremity politeal and calf veins. He does not smoke, no change in activity, no recent travel by car or air. He is on lenalidomide and takes aspirin 81mg PO QD.
56 2021-06-02 chills, sweating Nausea, heavy vomiting back to back, severe stomach pain, sweating, chills, severely elevated bloo... Read more
Nausea, heavy vomiting back to back, severe stomach pain, sweating, chills, severely elevated blood pressure above 200. Sickness lasted from 3/18 -3/25. No solid food until 3/25.
56 2021-06-02 fatigue, malaise, throat pain, cough, headache Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numb... Read more
Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Numbness and pain in his arm where the shot was given and then continued to his left shoulder.; Back hurts; Severe fatigue; He feels dizzy; Does not feel well; Coughing; Sore throat; Wasn't eating/Not eating; Body aches; Feeling down; Weak; Eyes burning; Headache/a very bad headache; This is a spontaneous report from a Pfizer sponsored program, report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186), via an unspecified route of administration on 24May2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation.The patient medical history included COVID-19 in December 2020. The patient concomitant medications were not reported. On 25May2021, the patient experienced numbness and pain in his armed where the shot was given and then continued to his left shoulder and body aches, feeling down, weak, a very bad headache, eyes burning, backed hurt, severe fatigue and he felt dizzy and he had a coughed and fatigue, sore throat, not ate. Patient states that he did some construction worked yesterday before receiving the vaccine and next day he have had been experienced the same symptoms when he had covid-19 in december 2020. Patient states he knew that the vaccine has not had anything in it that would caused him to got covid-19 so he would liked to knew if his side effects were normal. Patient would also liked to knew what could've he took to eased his headache. Patient took Tylenol and it hadn't worked. He also put ice and cold watered on it. Patient states if his symptoms were not better by next day then he would contact a health care provider. Patient states when he had covid-19 in december he was a little sick but hadn't require hospitalization and his oxygen level was between 90-92. He was not experienced a fever or chest pain as he did when he had covid-19. He was positive for covid 19 in december and had coughing, sweating, sore throat, wasn't ate, body aches, feeling down, feeling weak, eyes burning, backed hurting, headache, chest pain, and sweating. After reading the side effects that had been reported patient states he was experienced everything he mentioned except a fever, rash, itching, hives and swelling of the faced. He was fine after the covid vaccine. Next day he have had all the symptoms that he listed that he had when he had covid 19 except for the chest pain and sweating. Patient states that he just wants to knew what he could've took and did. Patient took Tylenol. He have had Tramadol but he hadn't taken it. Patient states he has not wanted have been on the phone long because he has not felt well. He stated that he knew he hasn't had covid 19 again and stated that he may did a report later. The outcome of the events was unknown. PSCC Communication: Warm transfer to (withheld) at company attempted. INT-#. Caller disconnected right before the transfer. (withheld) from company, caller states that she will reach out to the caller.
56 2021-06-02 fatigue, fever, headache Patient stated he was encouraged by friend to call health dept now because his effects after the sho... Read more
Patient stated he was encouraged by friend to call health dept now because his effects after the shot didn't seem normal. He stated appx 50 minutes after shot #1 (4-1-2021), he had c/o of H/A that lasted 1 wk, brain fog for 1 wk, stomach cramps for 2 days & achy x1 wk, sore arm. He stated 90 minutes after 2nd shot (4-23-2021) he had c/o pounding H/A, arm fatigue, feverish off n on for 1 wk, all 4 extremities (hips to toes, shoulders to fingers) went numb for 2 hours & head fog for 2 days. No vaccines prior to covid vaccine. No issues with health history. Advised to call PCP with his complaints of side effects after the covid vaccine to decide about future booster doses, if they are offered in the coming months.
56 2021-06-05 fatigue, sweating Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-M... Read more
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: Patient fainted after 15-20 minutes of getting vaccination. He said he felt overheated and exhausted before passing out. Gave him ice pack and water and had him lie down for several minutes. His bloodpressure was low then rose after a few minutes. Patient declined to be checked out by EMTs and stated was fine to go home and lay down. Figured he was probably anxious about getting the shot
56 2021-06-05 malaise 5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure e... Read more
5 minutes after vaccine stomach and sides felt heat, upset stomach, lightheaded and blood pressure elevated way up. felt very sick, went thru 3 extended observations that lasted about 1 hour and things started to calmed down except light headed and anxious. Finally felt like I could drive home then while driving home my temple and side face started tingling and went numb, pain in the back of my right eye this lasted about 20 minutes and the numbness went away however I had a sensation for a week in my temple and forehead. Could not go to work the next day, felt bad on and off for 8 days. Triggered anxiety for several days, did not get second dose..
56 2021-06-05 fever, chills Chills, fever, nausea
56 2021-06-06 fatigue, headache About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache... Read more
About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache. About 18 days after the shot, I still had the same symptoms but also developed a red rash on my left upper bac, left arm, and left shin. The rash was painful and burned. When touched, I could feel the pain shoot through my nerves. I was seen by the PA referenced above, who treated it as shingles, but diagnosed it as a plant based reaction, as he could not be sure it was shingles. I was prescribed Mupirocin and valACYclovir HCI. I still had the fatigue and nausea for several days after starting the medication. Despite receiving my 2 shingles vaccinations in September and December of 2020, it appears the Pfizer vaccine may have triggered a mild case of shingles.
56 2021-06-07 cough, nasal congestion On May 28, 2021 had symptoms of stuffy nose and cough, On 6/1/2021 lost sense of taste and smell. O... Read more
On May 28, 2021 had symptoms of stuffy nose and cough, On 6/1/2021 lost sense of taste and smell. On 6/2/2021 had COVID test and was positive.
56 2021-06-07 headache feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mild... Read more
feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected. The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.
56 2021-06-08 fatigue, chills, fever Sudden worsening on day 4; fever; chills; muscle pain; wheezing; loss of appetite; diarrhea; fatigue... Read more
Sudden worsening on day 4; fever; chills; muscle pain; wheezing; loss of appetite; diarrhea; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 07Mar2021 at 00:30 (age at vaccination 56-year-old) at single dose for covid-19 immunisation. Patient's medical history was not reported. No known allergies were reported. Concomitant medications included clonazepam (KLONOPIN) at 0.5mg, trazodone and diphenhydramine hydrochloride (BENADRYL). Patient did not receive other vaccines in four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 10Mar2021 at 16:00, patient experienced Sudden worsening on day 4, fever, chills, muscle pain, wheezing, loss of appetite, fatigue, diarrhoea and nausea. No treatment was given for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained
56 2021-06-08 malaise Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; starte... Read more
Pericarditis; Pulmonary effusions; blood pressure was really low; heart rate was really high; started feeling ill/not feeling well; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer sponsored program. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 22Apr2021 as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus has had it about 10 years or so, blood sugars have been good, ongoing supraventricular tachycardia had this diagnoses for about 4 years and is medication control, and amputee from an accident many years ago from an unknown date. Concomitant medication included carvedilol (COREG) taken for supraventricular tachycardia from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 on 26Mar2021 (Lot number: EN6208) at 56 years old for COVID-19 immunization in the left upper bicep and experienced brain bleed. No history of Pfizer vaccine other than the first dose. No additional vaccine administered on the same date or 4 weeks prior. No family history. On 08May2021, it was reported that the patient started feeling ill and was not feeling well. On 12May2021, the patient walked into a clinic since he was not feeling well. They found his blood pressure was really low and heart rate was really high so he sent to the emergency room and they admitted him. When at the emergency room they did a CTA which is a CT angiography. The patient was diagnosed with the pericarditis. The patient was admitted on 12May2021 for the pericarditis and pulmonary effusions. The pericarditis is what they were concerned about though. The reporter explains before this he was fairly healthy. The patient was discharged on Friday 14May2021. He was doing pretty well for a couple days but now he is not feeling well again. He was good on 18May2021 but then was not felt well since the 20May2021. He went to doctor on 21May2021. The patient underwent lab tests and procedures on an unspecified date which included CT angiography: pericarditis, CBC: normal, Blood culture: negative, Flu test: negative, COVID-19 test: negative, RSV test: negative, Echocardiogram: normal. On 12May2021 blood pressure: really low and heart rate: really high. The events required physician's office and emergency room visit. The outcome of the events was unknown.
56 2021-06-09 fever Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea... Read more
Fever, shortness of breath, chest pain, bloody nose, heart AFIB, lack of sleep, Diarrhea, and nausea.
56 2021-06-11 fatigue Extreme Fatigue from 12 pm till 4 pm. I could have slept on the sidewalk or anywhere, but I pushed ... Read more
Extreme Fatigue from 12 pm till 4 pm. I could have slept on the sidewalk or anywhere, but I pushed through it. Then I was fine.
56 2021-06-13 throat pain, fatigue, headache, fever (Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fe... Read more
(Small Pericardial effusion). Acute pain in the chest, esophagus and throat, pain when breathing, fever, severe headache, diarrhea, fatigue. 12 hrs admitted and 3 days later admitted to hospital. Where a pericardiocentesis was performed.
56 2021-06-15 sweating Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contacta... Read more
Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contactable Other HCP. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) intramuscularly, administered in Arm Left on 02Feb2021 at 09:25 AM (at an age of 56-years, 7 months during vaccination) as single dose for COVID-19 immunisation. The patient's medical history included enlarged prostate, urinary frequency with no infection, hypertension. The patient previously took Doxycycline. The patient was allergic to medication, food, or other products including Doxycycline. The patient's concomitant medications included amlodipine, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]). The patient had not experienced adverse event following any previous vaccine. On 02Feb2021 at 09:53 AM, the patient experienced diaphoresis, shakiness, heart palpitation and tachycardia. Diaphoresis and shakiness ended by 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. On an unknown date, the patient underwent lab test and procedure which included: Blood glucose: 126 mg/dl. The patient was advised for relaxation. On the 02Feb2021, the outcome of the events was recovered for Diaphoresis and shakiness at 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. Follow-up attempts are completed. No further information is expected.
56 2021-06-15 respiratory tract congestion, productive cough, pneumonia Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms... Read more
Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms of a 'chest cold' and was having pain in left rib/lung/chest area. One morning walking at work and was noticing increased phlegm and chest congestion, spit up a wad of blood. Sharp left lung pain with taking a deep breath. Notes after episode, coughed up darker blood a few more times. Went to ER on 6/14/21 - imaging found with pulmonary embolism/blood clot in left lung. Discharged with Eliquis started pack 2 tab BID for 7 days, then 1 tab BID. New patient consult on 6/16/21 with myself, APRN - continuation of blood thinners initiated, referred for hematology consult, and echocardiogram ordered.
56 2021-06-16 chills had some blood on it, something dark; had a little bit of chills; soreness is very light; he has som... Read more
had some blood on it, something dark; had a little bit of chills; soreness is very light; he has some injection site pain; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 26May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 56-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 25May2021 (Batch/Lot number was not reported) as 2ND DOSE, for covid-19 immunization. The patient medical history was not reported. Concominent medications include ibuprofen for sneezes, Nasonex for pollen allergy, Tylenol. Patient previously took his first dose of bnt162b2 vaccine on 03-may2021 for immunization. Patient experienced Tiredness, arm soreness, Fever, chills, flu like symptoms, sneezing headache after first dose. The patient experienced had some blood on it, something dark, had a little bit of chills, soreness is very light and he has some injection site pain on an unspecified date.The patient stated that he had the second dose of the Pfizer covid 19 vaccine yesterday at 3 o'clock noting it has almost been 24 hours. The patient stated it was documented that side effects are more bad after the second dose stating that was not true for everyone. The patient stated he did not get a fever but had a little bit of chills last night. The patient stated his temperature stayed in 98.7 and 99 range. The patient asked was there a correlation between chills and fever. The patient stated the first dose on 03May2021 was no big deal, pretty ok, had tiredness but no fever. The stated that by day 3 the injection pain was gone. The patient stated that he had slight soreness after the first dose stating it was like the flu shot. The patient stated the pharmacist told him to take regular ibuprofen after the first dose if he had a fever noting he took two tablets after the first dose. The patient stated he has taken ibuprofen and tylenol pm and has taken tylenol pm for the last 2 to 3 years for sleeping. The patient stated he took a couple of days off work after the first dose. The patient stated the soreness is very light after the second dose stating the soreness was gone. The patient asked was that a good sign no fever or is that a bad thing when you do not have a fever. The patient wanted to know what percentage of participants showed low grade symptoms. The patient wanted to know which had the most significant amount, mild moderate or severe side effects. The patient stated he has some injection site pain noting no severe symptoms after the second dose. The patient asked if side effects have been shown to come back again. The patient asked does Pfizer have a plan for people that are uninsured and have to go to the emergency room. The patient also stated he would call back on Friday because maybe he would see more side effects. The patient stated that the second time when he took the tape off it had some blood on it, something dark. The patient underwent lab tests and procedures which included body temperature: 98.7 and 99 fahrenheit on an unspecified date 98.7 and 99 range. The outcome of events was unknown. Information about lot/batch number is requested.
56 2021-06-16 headache, fatigue he had some pink spots underneath the band-aid on the injection site; the area got very itchy and re... Read more
he had some pink spots underneath the band-aid on the injection site; the area got very itchy and real hot (felt like he have a fever on the arm); the area got very itchy and real hot (felt like he have a fever on the arm); weakness; tiredness; headache; some pressure on the administration site up to his ear; having some pink spot like a rash its like a little itchy but I haven't scratched; It was real real hot but its warm now; it was before it was inflamed, it was like real hot and it was pink but it's still pink but it's not as hot as it was before; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 01Jun2021 (Batch/Lot Number: EW0187) as Unknow, 0.3ml Single for COVID-19 immunization. The patient also received Lisinopril via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10mg once a day for hypertension. Medical history included Arthritis, Blood Pressure and Overweight. Concomitant medication included Celecoxib twice a day 200mg tablet for arthritis and Chlorthalidone 25 mg for High Blood Pressure. On an unspecified date, the patient received Pfizer Injection morning around 10:00 and now he was having under the injection site in the shoulder, he was having some pink spot like a rash it's like a little itchy but he hadn't scratched it he did put some camphor lotion and then wipe the excess of it all and now its itchy and now it's warm so, he put cold press on it with ice and it comes down a little bit and he took Acetaminophen. The patient did not know if he did something wrong but he did not want to damage the vaccine. The patient was bit of pressure and little bit of tired. He tried to water and anything if it's okay just stay there that's is and if it's okay it's just there. The patient did not feel anything else bad in the body or anything like that. it's a little worm now but it's gone down a little bit. It's not bad like it was before it was inflamed. In the afternoon (about 20-30 mins ago) the area got very itchy and real hot (felt like he has a fever on the arm). The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. The outcome of the events was unknown. Follow-up attempts are possible. Further information is expected.
56 2021-06-16 malaise, fatigue A lot of Muscle Pain; Tiredness; Feeling unwell; This is a spontaneous report from a contactable con... Read more
A lot of Muscle Pain; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via intramuscular route of administration, administered in arm left on 05Jun2021 (at the age of 56-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via intramuscular route of administration, administered in arm right on 30Apr2021 (at the age of 56-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient experienced a lot of muscle pain, tiredness, feeling unwell on 06Jun2021. Patient stated, I am just calling because the pains that they gave me when I got my shot that they report side effects. I got my second shot and I am having side effects. Patient stated, a lot of muscle pain, tiredness and just basically feeling unwell. Patient confirmed that he experienced the side effects after the second shot. The patient received Aspirin as a treatment medication for the events a lot of muscle pain, tiredness, feeling unwell. Outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
56 2021-06-18 chills Chills; his platelets were down; This is a spontaneous report from a contactable consumer or other n... Read more
Chills; his platelets were down; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, in Arm Right on an unspecified date in Mar2021 (at the age of 56 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cancer from Mar2020 to Oct2020, ongoing lymphoedema from an unspecified date in 2020, ongoing High blood pressure diagnosed 2-3 years ago, ongoing Allergies, white Coat syndrome. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 in right arm on an unspecified date in Mar2021 (at the age of 56 years old) as single dose for COVID-19 immunisation and experienced no reactions, Pneumonial vaccine and FLU Shot for an unknown indication and experienced no reaction on previous exposure to Vaccine. Caller reported that his dad passed away when he was 83 and after they found cancer on his bladder. Caller reported that no one in his family has immune problems, other than his daughter who has type I diabetes. Concomitant medications included Loratidine (CLARITINE) taken for hypersensitivity from 20May2021 and ongoing, potassium chloride taken for lymphoedema from an unspecified date in 2020, lisinopril for hypertension, Terbinafine for toenail fungus for the last month and a half. On an unspecified date in Mar2021, the patient experienced some chills on the second day following his second dose of the Covid-19 vaccine. Caller reported that he was not running a fever or anything, just felt chills and that was about it. Caller reported that then everything was fine, he just experienced chills for one day. The patient received both doses of the Pfizer BioNTech COVID-19 Vaccine in Mar2021. Last year he had cancer. He is now part of a study with (withheld). As part of the study, they have been doing blood work (three times now). His antibody test for COVID-19 came negative. Caller mentioned his platelets were at 118, he had no sign of cancer on scan at end of Oct2020 (he is in remission) and reported lymphedema in one leg. Caller stated that he is aware that Pfizer conducted a study with healthy individuals. Caller wants to know if Pfizer is conducting a study with patients who have received both doses of the Pfizer BioNTech COVID-19 vaccine and who have comorbidities such as transplant patients, or patients with cancer to see how the antibodies of the vaccine are affecting them because he would be interested to participate. Caller reported that his platelets and white blood cells are still low, and his physicians did biopsies to make sure there was no bone marrow cancer. Caller reported that his physician did notice that the bone marrow that makes platelets was really taking its time getting back. Caller reported that his last report showed 118 on platelets. Caller reported that his physician informed him that he developed lymphedema from the cancer medication that he was taking. Caller reported that his physician informed him that the cancer medication can kill cancer but can attack other parts of the body. Caller did not provide details for the medication he was taking for his cancer. Caller reported that they had checked his legs to make sure that he didn't have any blood clots. Caller stated that he needs to know if Pfizer is having something that determines if someone has antibodies for Covid-19. Caller stated that Pfizer put out that the Covid-19 vaccine is 80 something percent effective after having the vaccine. Caller reported that they were looking into people that have had immune diseases and immunity disorders. Caller reported that he is out of the cancer and doesn't have anything showing that his body has cancer, whether bloodwork or all that. Caller stated that he would really like to know if he has antibodies from the Covid-19 vaccine or if he doesn't. Caller reported that he is worried that there is no way of checking to see if he has antibodies from the Covid-19 vaccine. Caller inquired how he can find out if he has antibodies to Covid-19 besides a little kip that you put a few drops of blood on and put a solution on it. Caller reported that his weight was higher and that after he found out he had cancer, it started to go down. Caller reported that he has no other symptoms, he is not diabetic, and doesn't have any kind of immunity or other symptoms. Caller reported that the only thing stopping him from going back to work was going through cancer, his doctor didn't let him go back. Caller reported that he was at risk because his platelets were down, meaning that he could be susceptible to even the common cold. Caller reported that his physician let him go back to work a week after the first dose of the Covid-19 vaccine. Caller reported that his physician informed him that more than likely the caller had a little in one of his legs that didn't show up as there wasn't swelling or doing enough to cause it. Caller reported that he just wears compression socks now and there was no damage. Caller reported that the lymphedema started during his cancer. Caller reported that while he was getting chemo, his ankles were starting to get swollen and it was determined towards the end of his cancer that it was lymphedema. Caller reported that he heard someone saying something about the possibility that people may need to take boosters of the Covid-19 vaccine. Caller reported that he heard about delta versions of the Covid-19 virus. Caller reported that they say that if you had both doses of the Covid-19 vaccine, you're covered whereas if you only had one, you're not as covered. Caller reported that he has had several Covid-19 antibody tests performed since he received the first and second dose of the Covid-19 vaccine and they have all come back negative. Caller reported that the most recent result was from today, 15Jun2021. No additional Vaccines were administered on Same Date of the Pfizer Suspect. No adverse events following prior vaccinations. The reporter considered the events as non-serious. The patient underwent lab tests and procedures which included platelet count: 118 on an unspecified date (his platelets are still low), sars-cov-2 antibody test negative: negative on 15Jun2021, white blood cell count: low on an unspecified date (white blood cells are still low). The outcome of chills was recovered on an unspecified date in Mar2021 and platelet count decreased was unknown. Information about batch/Lot number has been requested.
56 2021-06-18 head discomfort, headache Approximately 1 hour after I received the shot I pressure and stiffness on the left half of my head ... Read more
Approximately 1 hour after I received the shot I pressure and stiffness on the left half of my head and face. I did not have muscle weakness any where or slurred speech. That sensation was not painful, but it was very noticeable like someone's hand was on your face. That was present for about two days at a significant level. Five weeks later it is still present but at a much milder degree. Also persistent over the entire 5 weeks since the shot is mild dizzyness off and on each day, along with increased headaches. Since i have chronic post concussion syndrome, it is normal for me to get headaches, but since the vaccination I have been getting headaches more frequently and I am a lot more sensitive to the usual triggers. I have a persistent mild pain in or around my left eye that never existed before.
56 2021-06-20 fever, headache Headaches, fever, rash, throwing up, heart rate uncontrollable until seen by medical specialists. It... Read more
Headaches, fever, rash, throwing up, heart rate uncontrollable until seen by medical specialists. It?s been 3 months, I haven?t felt better since the day I took the vaccine
56 2021-06-21 headache, chills Chills, left ventricle tightened, severe headache, heart palpitations.
56 2021-06-22 cough, headache, malaise, lethargy Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day l... Read more
Two days after the shot I was very ill with nausea, bad headache and was very lethargic. Four day later I went to an urgent care for treatment for nausea and the headache. Two days later I was in the emergency room in the Medical Center for treatment of the same symptoms. Eventually the headache got better so I could function but I was very lethargic and had a constant cough for the next 6-7 weeks.
56 2021-06-22 nasopharyngitis Woke up on May15th realizing he could not hear as well in the left ear, May 16th it got worse. Went ... Read more
Woke up on May15th realizing he could not hear as well in the left ear, May 16th it got worse. Went to work that Monday, May 17th and realized could not hear anything in left ear while wearing headphones so he called the doctor. Patient did state symptoms started with feeling like he had a cold. Also complains of dizziness and vomiting at time of reaction.
56 2021-06-22 pneumonia Inflamation - first of the left hand then the right hand, then inflamation of the lungs causing pneu... Read more
Inflamation - first of the left hand then the right hand, then inflamation of the lungs causing pneumonia, then inflamation in both shoulders and in the left knee and right elbow.
56 2021-06-24 malaise, chills, fever Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous repo... Read more
Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer or other non health professional. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0217, Pfizer NTEC), via an unspecified route of administration on 14Jun2021 as 2nd dose, single for covid-19 immunization (at the age of 56-years-old). He was not having medical conditions but every now and then he takes something like for his gas. The patient's concomitant medications were not reported. The patient did not receive any other prior vaccinations. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0187, Pfizer NTEC), via an unspecified route of administration on 17May2021 as 1st dose, single for covid-19 immunization The reporter stated this was the second dose, the first dose, he did not get sick. On 15Jun2021 10:00 patient was not feeling well, nausea, patient wife took his temperature he was running a fever and so he was having like chills and muscle pain and joint pain. The reporter seriousness for the events was unspecified. It was further stated that, he took some Tylenol at work that morning, two Tylenol, he only had two dosage, he got some Tylenol at work and he haven't had any since then. The pharmacy said that continue taking Tylenol and liquids and fluids. The clinical outcome for the events was unknown.
56 2021-06-24 throat pain, sinus pain, fatigue, headache Sore throat; Sinus pain; Body aches and pain; Stomach cramping; Diarrhoea; Extreme fatigue; Headache... Read more
Sore throat; Sinus pain; Body aches and pain; Stomach cramping; Diarrhoea; Extreme fatigue; Headache; Swollen lymph nodes in throat; Sinus drainage; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in left arm on 17Mar2021 at 10:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 19Mar2021 at 07:00, the patient experienced sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue. It was reported that the patient did not receive any treatment for the reported events. The clinical outcome of sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue were not resolved. No follow-up attempts are needed. No further information is expected.
56 2021-06-29 fatigue Dizzy; lightheaded; tired; This is a spontaneous report from a contactable consumer, the patient. A ... Read more
Dizzy; lightheaded; tired; This is a spontaneous report from a contactable consumer, the patient. A 56 -year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on the right arm on 20Mar2021 at 16:45 (at the age of vaccination was 56 years) as a single dose for COVID-19 immunisation. Medical history was reported as hypertension. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination (names and indications of which, are unknown). The patient had not tested for COVID-19. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient did not have allergies to medications, food, or other product. On 22Mar2021 at 12:00 patient experienced event dizzy, lightheadedness and tired. The clinical outcome of event dizzy, lightheadedness and tired were recovering at the time of reporting. The patient did not receive any treatment for the adverse events. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 headache, chills Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but... Read more
Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but no fever; headache; very sore body; I woke up feeling like I had pinkeye; No crust but a little redness; Eyes felt dry and tired by the end of the day.; Day 1 - No problem. Arm got sore.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201 and Expiration date not reported), (at the age of 56-Year-old) via an unspecified route of administration on 13Feb2021 at 14:30 on left arm as single dose for COVID-19 immunisation. The patient's medical history was not reported. He was allergic to dust, grass, english plantain and iodine dye. Concomitant medications were Losartan potassium 25 mg and Rosuvastatin calcium 10 mg. No other vaccine received in four weeks. On 15Feb2021 at 07:00, the patient experienced "Day 1 - No problem. Arm got sore". On 16Feb2021, he noticed eyes felt dry and tired by the end of the day and arm still very sore. On 17Feb2021, he woke up feeling like he had pinkeye and no crust but a little redness. It annoyed him all day. On 18Feb2021, he had lubricating eye drops so that helped. Stay developed on lower left lid. He used the drops in the morning. Otherwise, ok. On 20Feb2021, He informed that eyes still dry. Stomach cramping and spasming below naval. Diarrhea all day and vomiting bile x3 in morning. Chills but no fever. Headache and very sore body. Slept on and off all day. On 21Feb2021, he started with diarrhea x3 at 4am. Slept until 10:30. More diarrhea x3. Still fatigued but feeling better. Took Imodium to slow things down. Lost 4 pounds. He was thinking he would be 100% by Sunday. Not looking forward to second shot. The patient treated himself for adverse event. The patient tested COVID neither prior vaccination nor post vaccination. The outcome of the events was not recovered. Follow-up (13May2021): Follow-up attempts completed. No further information expected.
56 2021-06-29 headache, fever About 26 hours after vaccine shot, my skin felt like it was burning and turned very red, had to put ... Read more
About 26 hours after vaccine shot, my skin felt like it was burning and turned very red, had to put wet towels on skin to ease the pain, had slight fever (100.2) and a headache. Contacted Dr on call. Dr told me to go to urgent care or the ER and to take any allergy medication I happened to have. I took Claritin-D and waited for half hour. By then burning sensation was a lot better, but I started shaking and could not stop, even outside the house at a 100-degree heat. Went to the Urgent care clinic, I was given dexamethasone sodium phosphate and the doctor there told me to take benadryl every six hours as needed.
56 2021-06-29 headache Pain in arm; Headaches; This is a spontaneous report from a non-contactable consumer. A 56-year-old ... Read more
Pain in arm; Headaches; This is a spontaneous report from a non-contactable consumer. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm, on 12Mar2021 at 10:00 (at the age of 56 years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient received unspecified medications within 2 weeks of vaccination. On 12Mar2021 at 10:15 hours, the patient experienced pain in arm for about two days, headaches starting about 10 minutes after injection. still having multiple daily headaches eight days later. No therapeutic measures were taken as result of the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events pain in arm and headache were not recovered at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-06-29 headache Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a no... Read more
Extremely strong headache; Nausea; weakness; Some dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included CRESTOR and SYNTHROID, both for unknown indication from unknown dates. The patient did not had allergy to any medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021 at 16:30, the patient experienced an extremely strong headache for three days, nausea, weakness and some dizziness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, nausea, weakness and dizziness was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
56 2021-07-01 fever, fatigue, malaise On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infecti... Read more
On Sunday June 20th I was feeling sick, Fever, body aches, head ache, fatigue. I also had an infection in my gums around my teeth that was burning as if someone poured hot coffee in my mouth non-stop. especially the roof of my mouth and right behind my upper front teeth. After 4 days of trying to sweat it out the night sweats stopped. But my heart rate was at 161 beats per minute but I could not feel my heart beating at all. We went to an urgent care that immediately sent me by ambulance to the hospital. Right away they got my heart rate under control but they spent 4 more days trying fight the infection. Finally on June 29th I was well enough to go home.
56 2021-07-04 fatigue Per patient, "tired and thirsty" the next day; experienced "pain under left armpit that radiates to ... Read more
Per patient, "tired and thirsty" the next day; experienced "pain under left armpit that radiates to left breast and up to jaw when walking or going up steps" the following day and continues to persist at this time; patient is currently followed by a cardiologist for pre-existing health condition ("cardiac stents") >> seen by cardiologist and "nuclear cardiac stress test" was performed one week ago; "cardiac scans" also completed and results were no different than results from routine scans in March 2021; states cardiologist "cleared" him for work and has no intentions to follow up but patient states pain persists. Patient plans to seek second opinion and referral to different provider.
56 2021-07-07 headache Pt called call center at 5/10/2021 stated pt got 1st covid vaccine Pfizer 4/9/2021 at vaccination ... Read more
Pt called call center at 5/10/2021 stated pt got 1st covid vaccine Pfizer 4/9/2021 at vaccination site and pt got headache for 10 days, lower back and leg pain that pt couldn't walk normally. Pt said pt took tylenol and Advil by herself. Pt contacted pt's private MD and blood works done; normal. MD prescribed Aleve for symptoms however pt stopped taking Aleve since it gave stomach pain. Pt switched taking Advil by herself currently for lower back and buttock pain(3-4/10). Pt said pt contacted another MD to ask about covid vaccine pt to get 2nd vaccine regarding of symptoms(Headache, lower back, leg, buttock pain) and that MD recommended pt to get 2nd covid vaccine. Pt is educated covid vaccine side effects. Pt agreed and verbalized understanding.
56 2021-07-08 chills, malaise Severemuscle soreness radiating frominjection site; General malaise; Mild chills; Night sweats; Arm ... Read more
Severemuscle soreness radiating frominjection site; General malaise; Mild chills; Night sweats; Arm of limited use; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 18:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No concomitant medication was reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Mar2021 at 11:00, after 5.5 days of the injection, the patient had severe muscle soreness radiating from injection site, to the point where arm was of limited use, mild chills, generalised malaise and night sweats and no known fever. Temperature was taken in the evening and again in the morning. The patient did not have any other COVID or flu symptoms. Therapeutic measures were taken as a result of the events that included treatment with over the counter (OTC) cold and flu medications. The adverse events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events muscle soreness, arm of limited use, mild chills, generalised malaise and night sweats was resolving. No follow-up attempts are possible; Information about lot number cannot be obtained.
56 2021-07-08 fever, fatigue, headache flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fa... Read more
flu (fever, fatigue, headache, ache and pain); poor sleep; 100+ degree (F) fever; headache.; just fatigued; general aches; This is a spontaneous report from a non-contactable consumer. A 56-year-old adult male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: UNKNOWN), via an unspecified route of administration on 25Mar2021 (at the age of 56-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN 6205), via an unspecified route of administration on 04Mar2021 (at the age of 56-years-old) as single dose for COVID-19 immunisation. The patient was not tested with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced 100+ degree (F) fever, the night of receiving 2nd dose of the vaccine for several hours during the night, along with some general aches and pains and headache, generally, characterized the symptoms as mild flu symptoms. The fever was gone by morning, felt better, just fatigued, likely from poor sleep due to the flu symptoms. No treatment was taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of flu like symptoms, poor sleep, generalised body pain, headache and fatigue was resolved. No follow-up attempts are possible; information about lot number cannot be obtained.
56 2021-07-10 fever, headache Headache; Hives; Red spot all over; Low grade fever; Site was hurting; This is a spontaneous report ... Read more
Headache; Hives; Red spot all over; Low grade fever; Site was hurting; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown); via unspecified route of administration in the left arm on 26Mar2021 (at the age 56-year-old) at 09:30 as a single dose for COVID-19 immunisation. Medical history included tachycardia, diabetes type 2, asthma, allergy to mold and bee stings. The patient was allergic to pseudoephedrine and Aavelox. Concomitant medication included atenolol (MANUFACTURER UNKNOWN) and budesonide and formoterol fumarate (SYMBICORT) for unknown indication. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 12:30, the patient experienced headaches, hives, red spots all over, low grade fever and it was also reported that site was hurting. The treatment medication involved the usage of Benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of events headache, hives, red spots all over, low grade fever and site was hurting was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
56 2021-07-12 fatigue, malaise arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms... Read more
arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date. Follow up attempts are needed. Further information is expected. Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine. Follow-up attempts are completed. No further information is expected.
56 2021-07-12 fatigue I experienced extreme fatigue and exhaustion after receiving the vaccine. I had a visit with my doct... Read more
I experienced extreme fatigue and exhaustion after receiving the vaccine. I had a visit with my doctor and she said that my symptoms were side effects.
56 2021-07-15 fatigue Migraines, dizziness, Tinnitus, Vertigo. Fatigue, Difficulty concentrating, difficulty sleeping
56 2021-07-16 headache The very next morning had a severe stabbing headache, the headache subsided some the following day ... Read more
The very next morning had a severe stabbing headache, the headache subsided some the following day but was still bothersome. A couple days later developed a pain behind my right eye and the headache moved to the top middle of my head and was sore to touch. A few days later I woke up with severe double vision. I had pain in the right side of my neck and in my right temple area. My right eye also developed a redness on the lower right side. This all lasted for about 4 weeks. Everything seemed to go away at the same time.
56 2021-07-17 fatigue hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn;... Read more
hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn; had clot arteries based in blood clots; 1 artery was 99% blocked; cold sweats; afraid to eat because he was so bloated/acid reflux; could not hold food down; out of energy; fatigued, totally out of energy; minor chest pain which he thought was indigestion and heart burn; This is a spontaneous report form a contactable consumer (patient). A 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ) on 30Mar2021 for covid-19 immunisation at the age of 56-year-old. Lot number was EP7533. Medical history included diabetes in 2018. Concomitant medications were unknown. Patient received first dose of BNT162B2 on 09Mar2021 for covid-19 immunisation (Lot Number: EN6198 Anatomical Location: Left Arm). On unknown date, electrocardiogram showed shows heart attack. The patient experienced heart attack on 06Apr2021 (treated with surgery, and received 2 stents in his heart), hard time breathing on 11Apr2021, minor chest pain on 02Apr2021 which he thought was indigestion and heart burn on 06Apr2021, had clot arteries based in blood clots, 1 artery was 99% blocked, cold sweats, fatigued and totally out of energy on 06Apr2021, afraid to eat because he was so bloated/acid reflux, vomit on 06Apr2021. The patient was hospitalized for myocardial infarction, dyspnea and chest pain. The outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
56 2021-07-17 headache developed severe body aches and pain; severe headache; This is a spontaneous report from a non-conta... Read more
developed severe body aches and pain; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 56-years-old male patient received first dose of BNT162b2(PFIZER-BIOTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 22Mar2021 (at the age of 56-year-old) for COVID-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, within 12 hours of receiving the first vaccine, the patient developed severe body aches and pain and also a severe headache. These symptoms were still present 24 hours later. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was severe headache and severe body aches, and pain was not recovered on an unspecified date at the time of this report. Amendment: This follow-up report is being submitted to amend previously reported information: This is a spontaneous report from a contactable consumer, the patient" updated as "Non-contactable. For both events "developed severe body aches and pain" and "severe headache": Onset updated from "Mar2021" to "22Mar2021" per vaccination date 22Mar2021 and PRD 23Mar2021 and verbatim "These symptoms were still present 24 hours later". Adverse event Within 12 hours of receiving the first vaccine I developed severe body aches and pain. Also, a severe headache. These symptoms were still present 24 hours later. Event occurred in country. And events were not recovered on an unspecified date. The patient didn't receive any treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained
56 2021-07-17 fever, influenza like illness Whole entire body is aching; Flu-like symptoms; Fever; He feels really, really sick; This is a spont... Read more
Whole entire body is aching; Flu-like symptoms; Fever; He feels really, really sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (age at the time of vaccination was 56-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other products. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 30Jun2021 (in the middle of the night on the day of vaccination), the patient experienced whole entire body was aching, had flu-like symptoms and fever. The patient felt really, really sick. The patient asked that she need help and what should the patient take. The caller confirmed details provided by transfer agent. The caller stated that the patient had to skipped work two days now. The caller stated that the patient was not going to answer questions. The patient was not going to give all this information about the experience and not get help. The patient felt like this was unsafe. There are people that have been experiencing this. The needed help. Received communication reported that the caller informed that for medical treatment or advice the patient would have to reach out to his doctor or if the patient was having an emergency that the patient would need to call or go to the emergency room. Caller then abruptly disconnected the call. Full details unable to be obtained. The outcome of the events was unknown. Information about lot/batch number is requested.
56 2021-07-19 chills, malaise, headache Same symptoms as covid !! Cold chills; aching, pain; sick feeling; headache; This is a spontaneous r... Read more
Same symptoms as covid !! Cold chills; aching, pain; sick feeling; headache; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8727), via an unspecified route of administration in the left arm on 30Mar2021 at 19:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included prostate cancer, penicillin allergy and COVID-19 (which was diagnosed prior to the vaccination). Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 20:00 (one day after vaccination), the patient experienced the same symptoms as COVID which includes cold chills, pain, sick feeling and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, pain, feeling sick and headache was resolving at the time of the report. No follow-up attempts are possible. No further information is expected.
56 2021-07-20 headache Neck pain/ severe neck pain on right side of neck; He got vaccine in left shoulder, he had a little ... Read more
Neck pain/ severe neck pain on right side of neck; He got vaccine in left shoulder, he had a little soreness within the next day of his left shoulder; Numbness in hand/ severe numbness in right hand and fingers are tingly; Tingly fingers/ severe numbness in right hand and fingers are tingly; Had minor ear pain; Head pain/ severe head pains back of head; Minor leg pain; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0178; Expiration Date: Aug2021; NDC number: unknown) via an unspecified route of administration on 27May2021 (at the age of 56-years-old) in left shoulder as a single dose for covid-19 immunization. The patient's medical history, other products, other conditions, and concomitant medications were not reported. After receiving the vaccine on his left shoulder he experienced side effect on the right side of his body: severe head pain, severe neck pain, numbness in hand, tingly fingers. He stated he decided not to get the second dose due to this side effects that he was still experiencing. The patient experienced little soreness in his left shoulder on 28May2021, which was normal for any shot, but all the stuff was on his right side. On 31May2021 he experienced severe neck pain on right side of neck, it comes and goes, but definitely comes, it hasn't gone completely. He had severe head pains at back of head, it travels from back of head to the right, which he never had before, it started soon after neck pain but was there 6 weeks later. He also had severe numbness in right hand and fingers are tingly, which started after the other two, the other were generally at the same time, this started a couple weeks later. He also experienced minor ear pain and leg pain, all on right side, leg pain was within the last week, and was ongoing and improving, hasn't continued, and ear pain started about two weeks ago, and it was ongoing but hasn't continued. The events were assessed as non-serious. His second dose was supposed to be 17Jun2021. It's been 6 weeks he hasn't received the second dose as he had lot of side effects from the first vaccine was afraid to get the second one. He stated he has family and friends who received the vaccine but didn't experience side effects after the first dose, only after the second dose. He asked if someone gets the vaccine in left shoulder does the events happen on right side and why does it go to the other side. He stated a packet was delivered to him with a letter and a bottle. But he wanted to know the substance in the white packet. He was explained about the process of prepaid mailer. He stated that Pfizer believed he was a healthcare provider. Investigations was not provided. He was concerned about whether he had received the Pfizer one, because he looked at the bottle and he didn't see Pfizer on it. His vaccine card said Pfizer, but he wanted to verify the lot to see if it was the product. Product strength and count size dispensed was not provided. Additional lot numbers was not provided. A sample of the product available to be returned, if requested (Y/N) was not provided. Packaging sealed and intact was not provided. The outcome of the events neck pain and ear pain was not recovered, for headache and pain in extremity was recovering and for all other events was unknown. Follow-up attempts are needed. Further information is requested.
56 2021-07-21 cough Patient tested positive for Covid-19 on 7/21/21 after being fully vaccinated for Covid-19 He was exp... Read more
Patient tested positive for Covid-19 on 7/21/21 after being fully vaccinated for Covid-19 He was exposed to a family member who tested positive for Covid-19 on 7/17/21 on 7/18/21 patient developed cough.
56 2021-07-21 fever Developed what we believe was an encephalitis with confusion, memory loss, fever. MRI with abnormal... Read more
Developed what we believe was an encephalitis with confusion, memory loss, fever. MRI with abnormal enhancement of the mesial termporal lobes bilaterally. No other obvious etiology found. Slowly over several weeks improve.
56 2021-07-24 fever After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally j... Read more
After the first shot I felt like I had Covid again. Fever, body aches, rapid heart rate, generally just miserable.
56 2021-07-27 chills, headache, fever joint pain; muscle pain; chills; fever; headache; whole body aches; This is a spontaneous report fro... Read more
joint pain; muscle pain; chills; fever; headache; whole body aches; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0176; Expiration Date: 31Aug2021; NDC: Unknown), via an unspecified route of administration in arm left on 18May2021 at 17:00 (at the age of 56-years-old) as dose 2, single for COVID-19 immunisation. Medical history, family history, concomitant medications, additional vaccines administered on same date of the Pfizer Suspect; prior vaccinations (within 4 weeks) included none. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0164; Expiration Date: 31Aug2021), via unspecified route in left arm on 27Apr2021 at 17:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The patient was taking Pfizer COVID vaccine because of his age, did not want to get nothing and did not want to die this early yet. Patient reported vaccine administered at Military Facility and stated that it was all military. The patient experienced joint pain, muscle pain, chills, fever, headache, whole body aches on 19May2021. Therapeutic measures were taken due to events. Patient was asking if his symptoms will come back and forth over the next couple of days. Patient received his first dose of the Pfizer BioNTech COVID 19 Vaccine on 27Apr2021 and second dose on 18May2021. Yesterday, he started to develop joint pain, muscle pain, chills, fever, headache and whole body aches. He has been taking Ibuprofen and Aspirin and it's been helping. Whenever he got out of the shower, he was so cold, he had to put a blanket on. In response, provided disclaimer, spoke from EUA Prescribing Information, CONS-How Long Side Effects Last if received a second shot and referred to HCP if symptoms get worse. This report was not related to a study or programme. Patient got the COVID vaccine the day before this report, on 18May2021. He was reading the pamphlet and saw that he had a lot of the symptoms. He took an aspirin and felt better. He saw on the pamphlet that it said if you have any symptoms to call Pfizer and report them. Patient did not have Primary or Prescribing Healthcare Professional and stated that he had one, but his doctor passed way. Patient stated joint pain began in the morning on 19May2021. Clarified that all symptoms began on 19May2021. The joint pain started in his hand, then moved to his elbows. He took a shower and thought that maybe the hot water would loosen him up. He went to sleep and woke up and it was even worse. He took some aspirin. He's been taking Ibuprofen and his joint pain is getting better. Yesterday morning, he could not even open a two litter pop. Event onset time was unknown. All symptoms began about the same time. Began the morning of 19May2021. He woke up to cut the grass, and thought that man his hands are sore, and he could not really move them. Then he remembered thinking that his arms were killing him. The events did not require a visit to Emergency Room or Physician Office and patient was thinking about going to the hospital. Patient asked if this had 24 hours to it, or does it come back and forth. Also asked what to expect. Investigation assessment or relevant tests included none. Clinical outcome of the event joint pain was recovering, and outcome of other events was not recovered at the time of this report. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (21Jul2021) attempts have been completed and no further information is expected.
56 2021-07-27 headache, influenza like illness Flu like symptoms; headache; neck and body ache; radiating pain; swelling into my left shoulder arm ... Read more
Flu like symptoms; headache; neck and body ache; radiating pain; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; severe genital herpes outbreak; swelling into my left shoulder arm and hand with joint pain and swelling in left hand; This is a spontaneous report from a contactable other hcp (patient). A 56-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, in left arm on 11Feb2021 at 19:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included genital herpes from an unknown date and unknown if ongoing and hiv infection from an unknown date and unknown if ongoing. The patient was allergic to heparin. The concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. After the vaccination, the patient had been tested with covid-19. The patient reported that after first dose he experienced Flu like symptoms for 1-2 days including headache, neck and body ache, radiating pain and swelling into my left shoulder arm and hand with joint pain and swelling in left hand. Then for the next 2 and more weeks, severe genital herpes outbreak (no outbreaks in prior 2 years). The patient underwent lab tests and procedures which included Nasal swab: negative on 08Jan2021. Therapeutic measures were taken as a result of severe genital herpes outbreak that included Valtrex medication for herpes outbreak. The patient recovered from the events on an unknown date . No follow-up attempts are possible. No further information is expected.
56 2021-07-27 headache Sudden severe tinnitus in left ear. Sudden severe headaches in rear, left side, near the base of th... Read more
Sudden severe tinnitus in left ear. Sudden severe headaches in rear, left side, near the base of the skull.
57 2021-01-02 fatigue, headache Headaches two after injection and fatigue
57 2021-01-02 fatigue, malaise, headache Fatigue, Headache, Malaise
57 2021-01-04 throat irritation Scratchy throat, Lump in lip. Throat was swollen and could not swallow. Benadryl
57 2021-01-05 malaise, chills Had dizziness, strong spinning feeling in head, Chills while wrapped in blankets. Chills led into th... Read more
Had dizziness, strong spinning feeling in head, Chills while wrapped in blankets. Chills led into the evening of the 5th. Less prominent dizziness next day and chills had diminished mostly. Called in sick to work on the 6th due to dizziness.
57 2021-01-06 fatigue After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and cou... Read more
After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70 as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.
57 2021-01-06 headache, fever Headache, Myalgia, Arthralgia, Fever & NauseaVomiting
57 2021-01-07 headache, fatigue Headache, Rash, fatigue
57 2021-01-07 throat pain, fever Chills, low-grade fever, body aches, muscle and Joint and bone pain, sore throat
57 2021-01-07 fever, chills, fatigue, headache chills, vomiting, fever, headache, body ache, fatigue
57 2021-01-08 fatigue, headache Headache, Myalgia, Fatigue, stiffness in arm
57 2021-01-08 fatigue, influenza like illness flu like symptoms , significant fatigue
57 2021-01-08 headache, chills 3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first te... Read more
3 am chills, headache and dry throat, 9:30 am chills, headache and dry throat and I took my first temp 102. took two Tylenol and temp went down. 8Pm I was flush and my temp was 105.5, 5minutes later 106. PCP called and advised my wife to take me to the ER and took two more Tylenol. Arrived at ER Temp was down 100.2
57 2021-01-08 headache Developed significant headache following dose resulting in one day missed work; now feeling better
57 2021-01-08 lethargy, chills, headache, fever HEADACHE, SEVERE JOINT PAIN, RIGHT UPPER CHEST PAIN, LETHARGY, FEVER, CHILLS
57 2021-01-09 body temperature increased, runny nose, cough, chills Woke on the morning of 1/10/21 (about 30 hours after injection). Temp to 100.6F, mild chills, major... Read more
Woke on the morning of 1/10/21 (about 30 hours after injection). Temp to 100.6F, mild chills, major joints ache, dry cough, runny nose/eyes. Felt a bit better after Motrin400mg, but symptoms returned, although now worse the original presentation so far.
57 2021-01-09 chills, headache, fever Headache most frontal more pronounced overnight frontal sinus- 4-5 hours after second dose of vaccin... Read more
Headache most frontal more pronounced overnight frontal sinus- 4-5 hours after second dose of vaccine Fever, myalgia and chill 12 hours post vaccination - took Tylenol and Motrin around the clock Intermittent wheezing. It's January 10 pm and I am still having above mentioned symptoms but intensity is significantly less.
57 2021-01-10 chills Nausea, chills resolved after 24 hrs
57 2021-01-10 headache, fatigue, chills, sweating Depression, Headache, Myalgia & Arthralgia Narrative: chills, sweats, fatigue, lymph node swelling
57 2021-01-10 headache, fever, fatigue Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Employee reports 1/7 one hour... Read more
Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: Employee reports 1/7 one hour later his arm started hurting. Then throughout the day the pain got worse and he took Tylenol and ibuprofen. Onset of fatigue and body aches last night. 1/8 0300 woke up with nausea and started throwing up. This afternoon he still has headache, body aches and arm pain. He continues to experience vomiting. Temp to 99.1 He's drinking ginger tea and water and can keep that down. He's staying hydrated. 1/11 employee reports all symptoms have resolved. He felt better around 7:30-8:00 Saturday night.
57 2021-01-10 malaise, chills, fever fever upto 99.8 and chills, myalgia and malaise on day 3
57 2021-01-11 fatigue Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetamin... Read more
Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetaminophen 1000 mg from time of vaccination
57 2021-01-11 fatigue this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (n... Read more
this 57yo Male ret. He received his first Pfizer covid vaccine on Jan 7th to left arm at hospital (not where he works). He went home and reported was fine, but tired. Stated his fatigue and onset of shortness of breath began day 1 post vaccine kept him from working. As his symptoms worsened, on day 4 (1/11/2021) he obtained a pulse ox and O2 sats were in the "80's" with normal heart rate. He went to ER on 1/11 1507 with body aches, fatigue, chest discomfort and SOB where he was ultimately admitted with diagnosis of COVID-19 pneumonia. Is on O2 support via NC.
57 2021-01-11 headache, chills, fatigue Chills, Body aches, Head aches, fatigue began evening of 12/22 and lasted 24 hrs
57 2021-01-11 headache Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at ... Read more
Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at 10am
57 2021-01-11 headache HA, Body aches, symptoms manageable
57 2021-01-11 fever He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-1... Read more
He received the first dose of the Covid-19 Vaccine on 18Dec2020/ received the second dose of Covid-19 vaccine 04Jan2021; he experienced fever 102.5F; muscle and joint pain; muscle and joint pain; it hurts to raise his arms above his head; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient (Weight (kg): 79.38, height (cm): 170) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140, Expiry Date: Mar2021), intramuscularly in upper left arm on 04Jan2021 13:00 for covid-19 prophylaxis. The patient had no relevant medical history and concomitant medications. Prior vaccinations (within 4 weeks) was none, relevant tests was none. The patient previous received first dose of Covid-19 Vaccine on 18Dec2020 and had no side effects, received flu vaccine in Oct2020 for immunization. The patient experienced fever 102.5f, muscle and joint pain, it hurts to raise his arms above his head all on 05Jan2021 01:00. The event was not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included fever: 102.5 F on 05Jan2021. Vaccination Facility Type was hospital. Caller stated that he worked at a hospital, but he was not a doctor, nurse, or pharmacist. The caller said that he received the second dose of Covid-19 vaccine 04Jan2021 and 12 hours after receiving the vaccine he started running a fever of 102.5. He said that he got the second dose at 13:00 and started feeling the fever symptoms about 12 hours later at about 01:00 05Jan2021. His vaccination was done at the hospital. He said that with his first dose he had no side effects. He received the first dose of the Covid-19 Vaccine on 18Dec2020. He said that he had his flu vaccine in Oct2020. Caller also reported that he was having muscle and joint pain. He said that it hurts to raise his arms above his head. He let his employee health know about the symptoms he was experiencing. Caller wanted to know if his side effects are normal, especially the "mild - moderate". The outcome of events was not resolved.
57 2021-01-12 chills, headache, fatigue Arm soreness 8 inches around site of injection Fatigue Mild headache Chills for few hours last night
57 2021-01-12 fatigue arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patien... Read more
arm sore; tired; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 28Dec2020, the patient experienced arm sore and tired a couple of days. No treatment was received for the adverse events. Outcome of the events was recovered on an unspecified date. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.
57 2021-01-12 fatigue Around the Injection site is red and a little puffy as well as hot. Currently feeling very fatigued... Read more
Around the Injection site is red and a little puffy as well as hot. Currently feeling very fatigued and tired.
57 2021-01-12 headache A terrible headache made me awake in the morning. Toothache as if I have a gum problem. Drinking col... Read more
A terrible headache made me awake in the morning. Toothache as if I have a gum problem. Drinking cold water was a problem. All teeth are causing pain Tooth ache during chewing. Overall body ache
57 2021-01-13 chills, headache, fever Low grade fever 99.6 , Headache, body aches, chills, nausea for approx. 28 hrs
57 2021-01-15 fatigue, chills Myalgia fatigue, chills
57 2021-01-16 fatigue, influenza like illness, chills 3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms th... Read more
3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred. The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.
57 2021-01-16 fatigue, throat pain On Friday--four days after shot--I had fatigue and slight sore throat. This continued thru Tuesday w... Read more
On Friday--four days after shot--I had fatigue and slight sore throat. This continued thru Tuesday when at work I felt the fatigue get much worse. The next 3 days I stayed home from work (Wed to Fri). I started improving at home on Wednesday and by Friday I felt good (no symptoms).
57 2021-01-16 sweating, fatigue, headache, chills Dose 2 of Pfizer Covid vaccine on 1/12/2021 4:53 pm 1/13/2021 827 am Temp 99.3 , pulse 82/min sittin... Read more
Dose 2 of Pfizer Covid vaccine on 1/12/2021 4:53 pm 1/13/2021 827 am Temp 99.3 , pulse 82/min sitting. Feeling tired and very sleepy. Left work to go home 1/13/2021 350 pm temp 100.2 pulse 81 supine headache, tired, myalgias, run down 1/13/2021 554 pm 101.6 f 1/13/2021 815 pm 102.1. F chills after dinner. 1/13/2021 830 pm diaphoresis starts intermittently. Chills and sweating. 1/14/2021 temp at 8 am 99.7 F 1/14/21 11 pm 97.1 F, symptoms resolved. Missed two days of work
57 2021-01-18 fever, chills, headache This morning it started all these different side effects and it's progressively getting worse, so I ... Read more
This morning it started all these different side effects and it's progressively getting worse, so I left work; Body aches; Headache; Stomach issues; pain; Diarrhea; Chills; Fever I just checked it's 102.4; Little sore arm at night; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 around 2 O'clock for Covid-19 immunisation, administered ad hospital. Medical history included high cholesterol, hypertension, irregular heart beats, arrhythmia, acid reflux. Concomitant medication included amlodipine (AMLODIPINE) 10 mg once a day for hypertension, acetylsalicylic acid (BABY ASPIRIN) at 81 mg, once a day, carvedilol (CARVEDILOL) at 12.5 mg, two times a day hypertension, flecainide (FLECAINIDE) at 50 mg, twice a day for irregular heart beats, arrhythmia, olmesartan (OLMESARTAN) at 40 mg once a day for hypertension, omeprazole (OMEPRAZOLE) at 40 mg when needed for acid reflux, rosuvastatin (ROSUVASTATIN) at 20 mg, once a day for high cholesterol. The patient experienced little sore arm at night on 06Jan2021. Then, on 07Jan2021 morning he went in to work and it started all these different side effects and it's progressively getting worse, so he left work at abut 10 O' clock AM. He was getting body aches, headache, stomach issues, pain, diarrhea, chills, and fever I just checked it's 102.4 on 07Jan2021. The patient underwent lab tests physical examination with unknown results in Dec2020 3 weeks before this report (he had complete physical lab work with his doctor). Treatment included taking Tylenol and Advil. The outcome of all events was not recovered. Due date of second shot will be 23Jan2021.
57 2021-01-20 fatigue, fever fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days///... Read more
fever of 102, chills nausea, lack of appetite. fatigue .over 36 hours/ arm pain lasted for 4days/// fever of 100 at 4am then fever of 102.2 at 5am, took medicine but temperature was consistent. struggle to get out of bed, only for restroom- also I was covid positive on 12-8-20 . Was recovered for approximately 2 weeks before I received the vaccine. Was told I could and should receive the vaccine.
57 2021-01-21 fever, cough HPI from ED: 57-year-old male with history of reactive airway disease, T2DM, OSA presenting with sho... Read more
HPI from ED: 57-year-old male with history of reactive airway disease, T2DM, OSA presenting with shortness of breath. Patient states 2 days ago, he had to take his dog to the vet, and they accidentally ran away; he had to run "full tilt" to catch it, which caused him to become acutely short of breath. Since then, he has had worsening difficulty breathing with any type of exertion, progressing today to dyspnea at rest. He has been using albuterol several times per day (3-4 times today), as well as his BiPAP machine that he uses for OSA, during the day without relief. Denies chest pain, though he has chest tightness associated with difficulty breathing. History of similar difficulty breathing with exertion during the winter, but never this bad; has not been hospitalized or intubated for RAD. Got his second COVID vaccine 3 days ago, after which he had fevers, now resolved. Denies recent antibiotics; no history of COPD, slight cough today, not productive of sputum, no hemoptysis. Reports a month of right leg swelling; has a history of prior right knee surgeries; no posterior calf pain, no acute changes; no history of VTE, no history of cancer, no hemoptysis, no recent procedures/surgeries/immobilizations.
57 2021-01-22 sweating Dizziness, lightheadedness, sweating, SOB immediately after administration of vaccine
57 2021-01-23 chills Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated af... Read more
Chills lead to severe shaking / seizure-like activity for approximately 1 hour. Condition abated after taking 1000 mg apap, 200 mg Motrin and 10 mg prednisone. This occurred about 12 hours post vaccine. Reaction preceded by brain fog.
57 2021-01-24 fever, headache, cough, lethargy, chills Chills, fever, joint pain, headache, lethargic, slight coughing.
57 2021-01-24 fever felt feverish and a little achy; felt feverish and a little achy; This is a spontaneous report from ... Read more
felt feverish and a little achy; felt feverish and a little achy; This is a spontaneous report from a contactable consumer (patient's brother). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at left arm at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 at left arm for COVID-19 vaccination. The patient felt feverish and a little achy. No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovering. Information on the lot/ batch number has been requested.
57 2021-01-26 fatigue, cough Covid 19 symtoms (cough, difficult to breath, tiredness and weakness.
57 2021-01-26 fatigue Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and... Read more
Systemic: Exhaustion, Systemic: described by the EMT as a vasovegal reaction. patient passed out and had seizure like reactions. was unresposive and given epi pen. after EMT arrived, patient was monitored and allowed to leave; symptoms lasted 1 day
57 2021-01-26 headache, fatigue : All over body aches with head Aches, Fatigue.
57 2021-01-26 fever Elevated Blood Pressure 137/97 Fever temp 101 Body aches
57 2021-01-27 chills, fatigue, body temperature increased, headache started out as extreme chills with lower back soreness and headache, then went to a fever of 102 deg... Read more
started out as extreme chills with lower back soreness and headache, then went to a fever of 102 degrees with a severe headache severe fatigue for twenty four hours
57 2021-01-27 chills, sweating Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour. Also developed a large swelling/lump on the lower part underneath my right armpit. (soft to the touch but noticeable.)
57 2021-01-27 fatigue, fever, chills Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Num... Read more
Too large dose injected. Bolus was 1ml. Initial metallic taste and mouth 15 min after injection. Numbness, tingling, muscular weakness in the left arm radiating to fingers along C7 dermatome. Severe fevers, chills, mental confusion, muscular weakness, exquisite tenderness at injection site, severe fatigue. Had to leave work. Slept 12 hours. Lingering muscular pain and fatigue for 48 hours following injection.
57 2021-01-27 fatigue Starting 2 days after the injection he had severe fatigue that lasted for a number of days.
57 2021-01-27 sweating, chills Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but we... Read more
Had 2nd Pfizer COVID vaccine on 1/26/2021 at 12 pm. On 1/27/21 at 8 am had slight mild chills but went away after half hour. At 12 am on 1/27/21, I felt extremely dizzy, very low blood pressure (80/50), sweating, disoriented and lightheaded which lasted approximately an hour.
57 2021-01-27 influenza like illness ON 1/27/21, DEVELOPED COLD-LIKE SYMPTOMS, TESTED POSITIVE FOR COVID ON 1/27/21.
57 2021-01-31 chills, fatigue, headache Chills, slight headache, overall fatigue, injection site pain for approx 24 hours
57 2021-02-01 chills Staff was noted to have extreme chills after receiving vaccination. Unknown duration.
57 2021-02-01 fatigue, chills Woke up in the middle of the night of the 2nd day after 2nd covid vaccine with body aches, chills, f... Read more
Woke up in the middle of the night of the 2nd day after 2nd covid vaccine with body aches, chills, fatigue, slight nausea overall felt yucky....lasted for 3-4 hours.
57 2021-02-02 malaise, fever, lethargy fever started within 2 hours of shot. Next 2 days fevers and general lethargy. Day 3 started OK bu... Read more
fever started within 2 hours of shot. Next 2 days fevers and general lethargy. Day 3 started OK but by 8 PM ran a 102.3 F temp. Next day had issues breathing. On advice of Teledoc went to ER about 93 hours after shot. They did XRAYS and indicated it was a continued reaction to the vaccine. I am now 168 hours since injection and am running 100.7F temp and generally not feeling well
57 2021-02-03 fatigue felt fatigued; This is a spontaneous report from a non-contactable consumer (wife of the patient). A... Read more
felt fatigued; This is a spontaneous report from a non-contactable consumer (wife of the patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 09:30 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Medical history included allergy and anxiety. Past drug history included allergy to VICODIN. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 57-year-old. Concomitant medications included unspecified drugs for allergy and anxiety. The patient said to the consumer just at the time of report that he felt fatigued the morning after his second shot on 14Jan2021 at 06:00. The patient was not treated for the event. The patient recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
57 2021-02-04 chills, fever weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report fr... Read more
weakness; chills; nausea; temp was 101.3/fever; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration on left arm on 18Jan2021 19:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient received other vaccines within 4 weeks prior to the COVID vaccine including Whooping cough vaccine (Pertussis vaccine) on 11Dec2020 (dose number 1, left arm). On 19Jan2021 19:30, the patient had weakness, chills, nausea and his temperature (temp) was 101.3. He came home Wednesday from work at the 44th hour and had all symptoms "accept" (as reported) for swollen lymph nodes. Patient's fever broke 6 hours later at 22:00 (as reported) Wednesday night (on 20Jan2021, also reported as 50 hours after the injection), he slept all night comfortably, woke up with no issues and temp was 96.1 (21Jan2021). At the time of the report the patient felt fine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 20Jan2021 and other events recovered in Jan2021.
57 2021-02-04 cough, malaise, headache Shortly after vaccine receipt client complained of general not feeling well, progressing quickly to ... Read more
Shortly after vaccine receipt client complained of general not feeling well, progressing quickly to c/o nausea, headache, cough, chest tightness. B/P initially 174/88, P=64, subsequent B/P 188/110 and c/o "severe" headache. EMS called and client transported to emergency room
57 2021-02-04 headache sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's ... Read more
sore arm; headache; This is a spontaneous report from a contactable pharmacist reporting for self's father. A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown as not available/provided to reporter at the time of report completion), intramuscular at left arm on 20Jan2021 14:30 at single dose for COVID-19 immunization at a Nursing Home. The patient's medical history included hypertension and increased blood cholesterol. For concomitant medications, there was no other vaccine in four weeks. The father experienced sore arm and headache on 20Jan2021 after his first dose vaccination. He was scheduled for 2nd dose on 10Feb2021. Overall, the father was fine with the vaccine. Treatment was received for the events included Tylenol. The outcome of the events was recovered (in Jan2021). The father had no COVID-19 prior to the vaccination. The father had tested post vaccination, included COVID-19 virus test (Nasal Swab) on an unspecified date: Negative. Information on the lot/batch number has been requested.
57 2021-02-05 chills Chills, strong pain in left arm and left shoulder, light headed, foggy thinking.
57 2021-02-05 fatigue, chills signifcant fatigue for 48 hours followed two days later by 19 hours of chills
57 2021-02-07 chills, nasal congestion, headache Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; la... Read more
Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization. Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19. Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital. The outcome of events was recovering.
57 2021-02-07 fatigue, headache On 2/5/2021, he awoke with complaints of body aches/pains from head to toe that he rates as a 9 on a... Read more
On 2/5/2021, he awoke with complaints of body aches/pains from head to toe that he rates as a 9 on a scale of 0-10, 10 being the worst. He also had a headache that he rates as a 4 on a scale of 0-10. He did not want to eat, he slept due to fatigue during the day and night on 2/5, 2/6 NS 2/7. He developed diarrhea on the pm of 2/6 which lasted through the night of 2/7/2021. He pushed fluids and has remained hydrated. He was not aware of fever or chills. He did not go to work today 2/8/21 because he is still feeling fatigued, achey, and with a headache, but admits that he is feeling somewhat better.
57 2021-02-07 headache Very slight headache.
57 2021-02-08 chills Received the 1st dose at around 5pm on 1/21/21 - No immediate reaction. Slight soreness in right arm... Read more
Received the 1st dose at around 5pm on 1/21/21 - No immediate reaction. Slight soreness in right arm prior to going to bed that night. Next morning, 1/22/21, whole right shoulder became very tight and rigid. Took one Advil/Tylenol for symptomatic relief. Around 5 pm on 1/22/21, started getting body aches and chills, took an Advil/Tylenol for symptomatic relief. Took another set of Advil/Tylenol prior to going to bed at 11:30 pm on 1/22/21. All well the next day and thereafter.
57 2021-02-09 fever, fatigue I had some mild redness on my arms and on my hip areas. The most concerning was a blue spot on one o... Read more
I had some mild redness on my arms and on my hip areas. The most concerning was a blue spot on one of my hands...a small blue line. I felt a little feverish and tired as well. I got the vaccine on Sunday. Monday night I felt the side effects and Tuesday I was better and the blue spot on my hand and the red spots were gone as well.
57 2021-02-09 fever COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a sp... Read more
COVID-19 virus test positive; COVID-19 virus test positive; Blood pressure fluctuation; This is a spontaneous report from a contactable consumer reporting for himself and from another consumer. A 57-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in the right arm, on 05Jan2021 at 14:10, at single dose, for COVID-19 immunisation. Medical history included ongoing gout and ongoing blood pressure high. Concomitant medications included allopurinol (unknown manufacturer) from 2008 to an unknown date and from an unknown date to ongoing for gout, lisinopril (unknown manufacturer) from an unspecified date and ongoing for blood pressure high at 40 mg daily, an unspecified drug for blood pressure high from Dec2020 at 5 mg and an unspecified anti-inflammatory. The patient previously took allopurinol from 2008 for gout and experienced abdominal pain upper so the drug was stopped on unknown date but his uric acid levels get high and he had to go back on it again. The patient experienced COVID-19 virus test positive (medically significant) on 16Jan2021 with outcome of unknown and blood pressure fluctuation in Jan2021 with outcome of unknown. It was reported that the only symptom he had on 13Jan2021 at first was a crash in his blood pressure. It was in the 80's over 50's. After that he had a fever of 102.2 F on 13Jan2021 for which he took two Tylenol. On 13Jan2021 at 09:30 PM his temperature was back down to 98.8 F. He has not had anymore fever. He has not had any other symptoms since. His blood pressure fluctuated but they have made some changes with his medication. The patient underwent lab tests and procedures which included blood pressure: in the 80's over 50's on 13Jan2021, blood pressure: fluctuated in Jan2021, uric acid levels: high on unspecified date, body temperature: 102.2 F on 13Jan2021, body temperature: 98.8 F on 13Jan2021, COVID-19 virus test: positive on 16Jan2021. Therapeutic measures were taken as a result of the events.
57 2021-02-11 cough 2 days after my second injection, I developed an annoying cough. The cough is non productive, and i... Read more
2 days after my second injection, I developed an annoying cough. The cough is non productive, and is NOT accompanied by fever, nausea, vomiting, diarrhea, aches, chills or any other symptom. i would liken this particular cough to the same side effect cough as to what one would possibly get from taking Lisinopril. Just an annoying cough. Currently there has been no treatment other than a possible follow-up with my PCP should symptom remain the same or get worse. The outcome is yet to be determined.
57 2021-02-15 chills Patient presented to ED with palpitations after receiving the second dose of the Pfizer vaccine. Ove... Read more
Patient presented to ED with palpitations after receiving the second dose of the Pfizer vaccine. Overnight he reported chills and aches (unknown if febrile) with palpitations. Since then, patient felt some improvement but went to ED for further evaluation. Patient was observed overnight for persistent tachycardia with ID and cardiology evaluations. The following day, tachycardia improved and patient was discharged.
57 2021-02-17 cough cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable cons... Read more
cough; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Jan2021 (at the age of 57-years old) as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient was scheduled to get the second shot on 05Feb2021. Patient got COVID like symptoms, he had a cough and "all that stuff" starting about 3 days ago on unspecified date in 2021. He went to a pharmacy to get tested and waiting for results. He went to the hospital right after (pharmacy) and got admitted on 03Feb2021 and was still in hospital right now. His doctor suggested not to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 03Feb2021. Outcome of the cough was unknown. Information about lot/batch number has been requested.
57 2021-02-21 headache, chills, fatigue Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he fe... Read more
Day after vaccine arm was very very sore, with a hard lump on arm at injection site. He states he felt hot flashed and then cold flashes that continue to this day. States ' I feel like I have critters crawling up my skin starting at my legs and going through my body. Has headaches that start at the top of his head then pain radiates down the left side and then head feels very warm. At times he feels "like I am in a tunnel " and "everything slows down (mental/cognitive)" Continues s to this day to feel like there are "lumps within soft tissue areas on inner thigh, back and burning sensations. Chills on and off daily Exceptionally tired, no energy, feels drained. No changes in blood pressure
57 2021-02-21 fever, fatigue Mild fever onset at 4am on 2/21, mild fatigue throughout the day. Not debilitating.
57 2021-02-24 sweating Experienced mild vertigo for the first time one day after vaccination. Four days after vaccination w... Read more
Experienced mild vertigo for the first time one day after vaccination. Four days after vaccination was treated in the ER for severe vertigo including dizziness, vomiting and sweats. Resolved with 25mg Meclizine, but mild vertigo has returned twice, both times resolved with Meclizine.
57 2021-02-25 headache shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spon... Read more
shortness of breath; bad headaches; chest pain; rash on his neck and behind his ears; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number N5318), via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shortness of breath, bad headaches, chest pain and rash on his neck and behind his ears, all on an unspecified date in 2021. The events were all serious as they involved hospitalization from 02Feb2021 to 03Feb2021. Details were as follows: patient received the first dose of the vaccine on 27Jan2021; he had a lot of bad side effects and went to the hospital: shortness of breath, bad headaches, chest pain, rash on his neck and behind his ears. All this happened a few days after receiving the vaccine. He had an appointment with his cardiologist and he will have a cardiac catheter placed on 19Feb2021. The second dose of the vaccine was scheduled for 18Feb2021. The outcome of the events were unknown.
57 2021-02-25 fever, chills I developed severe back pain from an old injury. The back pain was far more painful this time and I ... Read more
I developed severe back pain from an old injury. The back pain was far more painful this time and I had a 25 minute long shivering attack (rigors?). I was admitted to Piedmont for observation (I had an intermittent fever) and tested for everything. All results; MRI, CT, Echocardiogram, showed normal for my age. The pain is better and improving but it?s still been significantly longer lasting than any previous time. My PCP suggested I post this info to the CDC website but I wanted to let you know in case you were compiling any info related to symptoms/side effects.
57 2021-02-28 headache This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency resp... Read more
This 57yo employee - reports he received his first Pfizer Covid vaccine on 1/13/2021 (Emergency response provider). Approximately 3 hours post vaccination he c/o prickly stabbing itchy pain to vaccine site with left arm pain x 24 hours. He stated day 1 post vaccination the roof of his mouth, lips felt swollen and sensitive with a random frontal dull headache that lasted for a few seconds but noted on/off for 3 min duration a few times a day. He also reported a few days of altered sense of smell, especially to automotive products that has resolved. He states this prickly-itch stabbing pain varies all over his body, in his mouth, eyes, torso, extremities, again lasting a few seco
57 2021-02-28 fever, chills 7 PM developed muscle pain and could barley pick up the right arm, chills and fever, blood pressure... Read more
7 PM developed muscle pain and could barley pick up the right arm, chills and fever, blood pressure was elevated, passed out
57 2021-02-28 fever Developed diarrhea, joint aches and fever leading to being unable to work for the next two days
57 2021-03-02 fever, fatigue Fever; Body aches; Fatigue; This is a spontaneous report from a contactable other healthcare profess... Read more
Fever; Body aches; Fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 3247, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:45 at a single dose in the right arm for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. The patient had no known allergies. Patient had no covid prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR); ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER); and fish oil. The patient had no other vaccine in four weeks. On 28Jan2021 22:30, patient had fever, body aches, and fatigue. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The patient recovered from the events fever, body aches, and fatigue in Jan2021.
57 2021-03-03 fatigue, fever, headache Had fever headache, dizziness, week and tired ness
57 2021-03-04 headache, chills Chills, headache and diarrhea
57 2021-03-04 lethargy, cough, fever, fatigue Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling t... Read more
Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling tired; Some coughing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on the left arm on 27Jan2021 17:15 at single dose for COVID-19 immunisation. Medical history included coronary heart disease, diabetes, high cholesterol, blood pressure, known allergies: tape and hay fever. The patient's concomitant medications were not reported. On 27Jan2021, fever started 2 hours after injection. Two days of fever, general lethargy and feeling tired. Third day started out good, but by 8PM, patient stated, "I was running a 102.3 F temp (30Jan2021). Next morning I as having difficulty breathing. So on advice of a Teledoc I went to an ER for chest XRAYS. They told me they believed it was continuing issues with the vaccinations. 168 hours after injection I am running a 100.3 F temp (03Feb2021), still feeling tired, having some coughing and breathing issues". The patient received no treatment. The outcome of the event was not recovered.
57 2021-03-07 chills Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my l... Read more
Numbness and tingling down my left arm to my middle and ring finger; Numbness and tingling down my left arm to my middle and ring finger; Occasional thoracic spasms; chills; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELD26U, expiry date: unknown), via an unspecified route of administration in the left arm, on 05Feb2021 09:00, at single dose, for COVID-19 immunization, at a physician's office. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3303, expiry date: unknown) received at 57 years of age, via an unspecified route of administration in the left arm, on 15Jan2021 10:45, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 06Feb2021 at 10:00, the patient experienced "numbness and tingling down my left arm to my middle and ring finger and occasional thoracic spasms and chills". It was unknown if treatment was provided. The outcome of the events was unknown. The reporter assessed the events as non-serious.
57 2021-03-07 fatigue, cough, headache, chills, fever, throat pain Had side effects on 3/4 of chills no fever, muscle aches, fatigue and vomited 3 times on way to work... Read more
Had side effects on 3/4 of chills no fever, muscle aches, fatigue and vomited 3 times on way to work at 6pm. Drank some water within 30 minutes only fatigue. Friday and Saturday felt fine. Sunday morning woke up at 930 with severe chills, fever, muscle aches, fatigue, headache, dry cough , sore throat and left gland sore. Today woke up with just the dry cough and sore left gland realizing that last 3 symptoms were separate event from rest.
57 2021-03-07 respiratory tract congestion mild congestion, tested for COVID and came up positive on 3/2/21
57 2021-03-08 fever Diarrhea with low grade fever. Treated with pepto-bismol and acetaminophen.
57 2021-03-09 fatigue I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued... Read more
I had my first shot of Pfizer vaccine last Friday morning (March 5). In the evening, I felt fatigued. So I went to sleep early. When I got up Saturday morning, I felt dizzy. The dizziness went away in a few minutes. In the next 36 hours, I had the angina feelings - tightness in the left chest and I felt heart be squeezed occasionally. When I stand up and walk, I felt better. Finally Sunday evening (March 7), I took a walk outside and felt symptom free. Maybe the walk helped, maybe the "thrombosis" had run its course before my walk. I have not had the severe angina symptoms since my PCI procedure in Feb 2018. I am sure the recent occurrence is related to the vaccine. Besides reporting the adverse event, I want to get advices whether I should receive the second shot. Thank you!
57 2021-03-09 headache, chills Chills, body ache, swelling at injection site. Prolonged side effects that included several visits ... Read more
Chills, body ache, swelling at injection site. Prolonged side effects that included several visits to Primary care physician's office: Chronic headache over left temple, forehead and left eye socket , pressure on left eye, blurred and double vision, continued soreness upper body, arm, neck and head., high blood pressure lasting now 11 days but as of today (Mar. 10, 2021) getting better but still existing. Seeing Ophthalmologist Thursday Mar. 11, 2021.
57 2021-03-09 headache After first dose pt had headaches and joint aches in his hands. After 2nd dose he had rash on bilate... Read more
After first dose pt had headaches and joint aches in his hands. After 2nd dose he had rash on bilateral hands. Has been 2 weeks and still has dry/cracking skin, itching.
57 2021-03-10 chills, cough After 8 days still have body ache and chills, weak and persistent dry cough
57 2021-03-11 chills Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. On Friday morning, at 6-7am, less than 24 hours from the time I received my vaccination, I was experiencing chills and could not get warm. I tried to go to work...well, I did go to work. When it became apparent that I was not going to get warm, I left work. When I got home, my wife made me breakfast between 8:30 & 9:00am. After i eat, I slept under a sheet and two blankets...fully dressed for 5 hours. When I came to, it was the first time all day that I felt some warmth.
57 2021-03-11 headache, chills, body temperature increased Woke up the next day with severe headache, chills and a temperature of 101.2 (8:30 am) 12:30 pm Tem... Read more
Woke up the next day with severe headache, chills and a temperature of 101.2 (8:30 am) 12:30 pm Temperature was at 101.3
57 2021-03-12 chills, fatigue From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off agai... Read more
From Dose on Thur 11:30am, became extremely fatigued around hour 4. Hour 12 - I had on and off again shivering chills for about 45 minutes. Hour 20 - I had sever body aches and overall weakness when I woke up the next day around 7-8am. The body aches continued for about 6-8 hours. The weakness continued for another few hours. No symptoms around hour 32 (7-8pm) on Friday.
57 2021-03-12 malaise, headache, fatigue, fever Headache, muscle pain, weakness, tiredness, feverish feelings, general malaise
57 2021-03-13 headache Three days after I received my first covid-19 vaccine, I started getting mild to moderate headaches ... Read more
Three days after I received my first covid-19 vaccine, I started getting mild to moderate headaches on a daily basis. It has been seven days, and I still get headaches on a daily basis. Mostly mild, but sometimes I take Tylenol.
57 2021-03-14 chills, fever, sweating, sleepiness, fatigue foul taste in mouth for about 1/2 hour following injection, extreme fatigue and sleeping approx 4 ho... Read more
foul taste in mouth for about 1/2 hour following injection, extreme fatigue and sleeping approx 4 hours after continuing for 24 hours, sweats, chills, fever, body aches
57 2021-03-14 headache, malaise PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-ye... Read more
PRESENTING PROBLEM: Syncope and collapse [R55] HOSPITAL COURSE: History of Present Illness: 57-year-old man known to me for bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral pleural effusions of unknown etiology and mild decrease in pulmonary mechanics, DVT on Eliquis who came to the Emergency Room 3/12/21 with a chief complaint of near syncope. Patient and woke up in the early morning hours of 3/12/21 to use the restroom. While urinating, he became very dizzy and nauseated and had a sense like he needed to lay down to rest. Other than nausea he did not have any other symptoms. He returned to his bed and fell upon his wife and had decreased level of consciousness but without total loss of consciousness (he was able to hear his wife talking to him but was unable to respond). This lasted about a minute and slowly he came back to his senses. After this he felt quite cold and did have some shaking but is not clear whether these were true rigors. He did not have any preceding fevers nor did he have any fevers in the emergency room. After about 5-10 minutes he was feeling back to his normal self but want to come into the hospital to get checked out. He has never had anything like this before.The patient has had chest pressure since his COVID vaccine which he had on Wednesday. This is been intermittent, mostly positional and better with laying on his side and leaning forward, worse with recumbency. It is not pleuritic in nature. No associated shortness of breath. No other fevers chills sweats. No sick contacts. Evaluation in the emergency room was done and a CT scan was done and no pulmonary embolus was found. No parenchymal abnormalities. The patient's pleural effusions remain, and her mildly worsened, personally reviewed. Baseline labs were unremarkable for anemia, kidney injury.EKG personally reviewed, normal sinus rhythm. High sensitivity troponin was done and negative. Family otherwise feels well, no sick contacts, eating well no nausea vomiting diarrhea blood in his stool. Pt admitted for observation. Continued to feel well VSS, ekg stable, ECHO without acute findings (see below), UA neg, cardiac monitoring uneventful, orthostatics negative, walking in halls and eating well. Appears to have had vaso vagal episode. Will be getting routine head imaging in the coming month with cancer history See below testing Care plan upon discharge > To call if any return of symptoms > To hold metformin until Monday due to recent dye load > Blood cultures Pending, low clinical suspicion > To change H2 blocker to PPI due to GERD on 3 month esophagram > Follow up in clinic when return from break > Dr discussing with pulmonary team most recent CT (see below) and treatment plan moving forward Brief exam: awake, alert, oriented, not in any distress. PERRL, EMOI, tongue midline. Upper and lower extremities at full strength 5/5 in the arms, hands, dorsi flex and flexion at the ankles, knees and legs. Sensation not tested. Brief history and medical decision making: s/p bilateral lung transplant for bronchoalveolar cell carcinoma complicated by bilateral loculated pleural effusion, DVT on eliquis presenting post syncopal event. Syncopal event without evidence of seizure like activity, fast recovery, and no sudden changes consistent with an acute cardiac event. Thus symptoms were likely due to vasovagal event possibly post COVID_19 related side effect (headache, achy muscles, not feeling well overall). He has no neurologic deficit, CTA thorax without PE, negative EKG, troponin and echocardiogram. He is not on antihypertensives and blood pressures have been normal. Given his initial diagnosis of BAC, there may be concern for metastatic disease, though symptoms have not persisted and he has no focal deficit. He also received contrast for his CTA today, thus will defer further imaging for now. Syncope: - defer 2nd dose of COVID-19 vaccine as its effectiveness in transplant patient is not established and patient potentially had an adverse event. - oral hydration encouraged - monitor for additional ongoing neurologic symptoms such as headaches, vision changes, neck stiffness, fevers, night sweats, weight loss, weakness or paraesthesias - patient advised to avoid driving until further evaluation - consider MRI brain with and without contrast if any symptoms persist or reoccur Complex loculated pleural effusion
57 2021-03-15 throat pain We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in ... Read more
We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in his throat. He felt like his throat was closing. His wife gave him 2 Benedryl while waiting for the paramedics to arrive. They arrived quickly, within 10 minutes. The medical team monitored him at home for about 30 minutes. During this time had high Blood Pressure. They offered to take him to the hospital but he declined. He wanted to monitor himself at home to see if it would resolve itself. He spent the rest of the night in a recliner to help him breath, with his wife by his side. He did not follow up with any medical professional. He did NOT get the 2nd vaccination and will NOT.
57 2021-03-16 sweating, chills 1) Each night I have had severe chills followed by hot sweats. 2) This morning (2 days after shot) I... Read more
1) Each night I have had severe chills followed by hot sweats. 2) This morning (2 days after shot) I had a very large and sensitive to touch bump in the armpit on the side where I had my shot. I beleive it was a lymph node. 3) Also this morning, I had a red rash across my chest and abdomin. I sometime get this when I'm getting well after being sick. My doctor called.
57 2021-03-17 fatigue, chills, headache Diarreah. Chills/hot. Fatigued. Headache. Joints hurt. Injection site hurts.
57 2021-03-17 fatigue Diarrhea fatigue Narrative: Other Relevant History:
57 2021-03-17 headache Headache, Myalgia, Arthralgia, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
57 2021-03-18 fatigue, chills, fever Fever, chills, exhausted
57 2021-03-18 fatigue, fever upset stomach, fever, tiredness
57 2021-03-21 fever Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary c... Read more
Fever - 101, chills and dizziness. Rotating Tylenol and Motrin every 6 hours. Was seen by primary care physician.
57 2021-03-22 chills Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both fee... Read more
Joint pain; lower back pain; bowel issues; stomach issues; chills; severe neuropathy attack/both feet were on fire when with proper medication, he has been under control for years; This is a spontaneous report from a contactable consumer. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 at a single dose for COVID-19 immunization. Medical history included gout, neuropathy, high cholesterol and heart disease with 4 heart 'stints' and known allergies to dairy. Concomitant medications included colchicine (COLCHICINE), gabapentin (GABAPENTIN), acetylsalicylic acid (ASPRIN). The patient had no other vaccine in four weeks. The patient previously took and had allergies with Cipro [ciprofloxacin] and Erythromycin. It was reported that 20 hours plus after the shot, on 06Mar2021 at 13:15, the patient experienced the most severe neuropathy attack of his life - both feet were on fire when with proper medication, he has been under control for years. The patient also reported joint pain, lower back pain, bowel and stomach issues and chills on 06Mar2021 at 21:15. The patient had no COVID prior to the vaccination and had not tested post vaccination. No treatment administered for the events. The events had not resolved. Information on the lot/batch number has been requested.
57 2021-03-22 chills Chills (24 hours), Medicine for Colitis failed resulting in diarrhea.
57 2021-03-22 fatigue Fatigue, injection site pain, use of prescription pain reliever or prevents daily activity Dizzines... Read more
Fatigue, injection site pain, use of prescription pain reliever or prevents daily activity Dizziness, lightheadedness Myalgia, diarrhea, vomiting Non-prescription medication use
57 2021-03-23 chills Uncontrollable Chills; This is a spontaneous report from a contactable consumer (patient). This 57-y... Read more
Uncontrollable Chills; This is a spontaneous report from a contactable consumer (patient). This 57-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 17Feb2021 at 13:00 (at the age of 57-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and obesity. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were too many to list, "17 of them." The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 on 27Jan2021 at 18:00 as a single dose in the left arm for COVID-19 immunization. On 21Feb2021 at 05:00, after dose 2 of BNT162B2, the patient experienced uncontrollable chills. The event was reported as non-serious. The patient did not receive any treatment for the event. The outcome of uncontrollable chills was not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
57 2021-03-23 fever, headache Headache, Arthralgia, Fever, Diarrhea & Nausea Vomiting
57 2021-03-24 headache, body temperature increased Headache, achiness, slightly elevated temperature
57 2021-03-24 headache Severe headache during the night. Solved with Tylenol.
57 2021-03-24 influenza like illness flu feel like symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-yea... Read more
flu feel like symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (unspecified trade name), via an unspecified route of administration on 11Feb2021 17:00 (Batch/Lot number was not reported) at 57-year-old as single dose for covid-19 immunization. Medical history included iodine allergy, "Iodine"(without other specified information), covid-19 prior vaccination, blood pressure abnormal and thyroid disorder. Concomitant medications included insulin for an unspecified indication, blood pressure meds, thyroid medicine. No other vaccine in four weeks. The patient had 24 hour flu feel like symptoms on the first vaccine on 12Feb2021 10:00 with outcome of recovered on 13Feb2021 10:00. The event was life threatening illness (immediate risk of death from the event). No treatment received. The patient did not tested for COVID post vaccination. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021316565 Same patient, same drug, different dose number/event
57 2021-03-24 fever Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 ch... Read more
Arm hurt really bad; Little bit of fever; Little bit of body aches; vitamin D deficiency; stage 4 chronic kidney disease; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 23Feb2021 10:30 (Batch/Lot Number: EL9267, expiry date not reported) as single dose for covid-19 immunisation. Medical history included ongoing diabetic, heart patient from 2005 and ongoing, cardiomyopathy from 2005 and ongoing, covid-19 from 14Jan2021 to an unknown date. The patient's concomitant medications were not reported. The reporter reported that her husband (patient) was diagnosed 2 days ago with a vitamin D deficiency and diagnosed at the end of last week with stage 4 chronic kidney disease. The patient just started on his Vitamin D pill until yesterday. He didn't know he was lacking Vitamin D until the doctor found out. She wants to know if her husband should go ahead and get the second vaccine tomorrow or should he wait a week and let the Vitamin D pill kick in. It was also reported that the patient's arm started hurting about 5 or 6 hours later after getting the shot on 23Feb2021. The next day, it felt really bad. The patient also had a little bit of fever and body aches on 23Feb2021. The patient had a bunch of labs done and is going back again on 25Mar2021 to have another extensive tests done. It was clarified that it was for the chronic kidney disease and this was also when he found out he had the vitamin D Deficiency. The patient is also getting an ultrasound done on his kidneys to see what is going on. Therapeutic measure were taken as a result of vitamin D deficiency which included treatment with vitamin D pill and for little bit of fever and body aches which included Tylenol PM. The patient did not recover from stage 4 chronic kidney disease and vitamin D deficiency, recovered from arm hurt really bad and little bit of body aches on 25Feb2021, a little bit of fever on 24Feb2021.
57 2021-03-25 sweating Patient reported nausea and lightheadedness and was vomiting in the bathroom 2-3 later. He ambulated... Read more
Patient reported nausea and lightheadedness and was vomiting in the bathroom 2-3 later. He ambulated standby assist to the bathroom, turned pallor, diaphoretic. Accompanied to the bathroom with an LVN and RN. Patient had 1 episode of emesis. Patient has a history of hypertension and takes meds for it.
57 2021-03-26 chills, fever Chills, fever
57 2021-03-26 fatigue, sweating, chills Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for... Read more
Nausea with slight chills and sweating the next morning. Fatigue and low energy with body aches for 12-16 hours after.
57 2021-03-26 fever, chills, fatigue, throat pain Nausea, chills, fever, headache, body fatigue sore throat and diarrhea. Conditions lasted 2 days ... Read more
Nausea, chills, fever, headache, body fatigue sore throat and diarrhea. Conditions lasted 2 days and resolved by day 3. I tested positive for covid in December but the vaccine side effects were much worse than Covid.
57 2021-03-27 fatigue Hives all over body, fatigue
57 2021-03-27 headache Tinnitus, especially in left ear. Throbbing neck and head behind ears.
57 2021-03-27 malaise, headache One week after the vaccine the arm was very red and looked infected. He went to the doctor and was g... Read more
One week after the vaccine the arm was very red and looked infected. He went to the doctor and was given Amoxicillin. But two days later he was feeling so ill he was in bed all day and had a horrible headache. He went back to the doctor 3-26. The doctor cut his arm open, drained it, flushed it and gave him an antibiotic shot in the rear end. He also prescribed Doxycycline and Linezolid because he believes its a MRSA infection. He did swab it but we don't have the results back yet. The wound is not as red today and my husband is feeling better. Should he get the second vaccine? the doctor said this was the second patient he saw that day with the same infection at the vaccine site. I received my vaccine the same time and had zero issues. The doctor thought maybe his arm was not sufficiently alcohol swabbed but I know he was swabbed as was I as we were in the same room. He has severe asthma so we wanted the protection from the Covid vaccine but want to know if it is safe to get the second vaccine? I have taken photos each day so I can share what his arm has looked like
57 2021-03-28 body temperature increased, lethargy Pain @ site and lethargy for 1st 6 days. Developed temp, body aches, extreme lethargy days 7-14 afte... Read more
Pain @ site and lethargy for 1st 6 days. Developed temp, body aches, extreme lethargy days 7-14 after vaccination
57 2021-03-28 chills, fatigue Muscle and joint pain. Chills. Overall tiredness.
57 2021-03-28 headache, fatigue, chills Initially minor soreness at injection site (no problem), the afternoon of the injection. That evenin... Read more
Initially minor soreness at injection site (no problem), the afternoon of the injection. That evening, I had slight headache, tiredness, and chills. Next morning, "pinching feeling" in left underarm. After continuing to feel this, I finally went and looked and found a "red spot" at the point of the greatest soreness and also noted swelling of the general area. This soreness has continued on through to today (3/29/2021).
57 2021-03-28 fever, influenza like illness Evening of the second vaccine, I started developing flu like symptoms. By 2 o?clock in the morning I... Read more
Evening of the second vaccine, I started developing flu like symptoms. By 2 o?clock in the morning I had a 103 fever and a rash all over my torso. Over the course of the next week, I developed fever blisters and swollen lymph nodes in my armpit on the side of the injection. I have some presently undiagnosed Nuro immune disease that may be transverse myelitis. The Covid vaccine exacerbated all of the symptoms of the Neuro immune condition.
57 2021-03-28 fever Fever, aches starting14 hours after vaccination, lasting until 30 hours after vaccination
57 2021-03-28 respiratory tract congestion, fever, cough Received dose 2 of COVID vaccine on 1/21/21. On 3/25/2021 the patient developed fever, nasal conges... Read more
Received dose 2 of COVID vaccine on 1/21/21. On 3/25/2021 the patient developed fever, nasal congestion, cough, and loss of taste/smell. Tested positive for COVID.
57 2021-03-29 throat pain Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed,... Read more
Persistent sore throat, right side, not inside esophagus, tender/sore when swallow and when pressed, lymph node area Tylenol little effect
57 2021-03-30 sweating Patient started breathing heavy and advised EMT that he was feeling dizzy. Patient was sweating hea... Read more
Patient started breathing heavy and advised EMT that he was feeling dizzy. Patient was sweating heavily and stated he had not eaten anything. EMT took vitals. Everything normal. Patient is fine.
57 2021-03-30 sweating Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and v... Read more
Patient felt dizzy and felt like passing out. V.S. taken Pulse 42, became clammy, diaphoretic, and very weak. Rapid Response called, patient to the Emergency Room.
57 2021-03-30 lethargy Patient reported extreme lethargy and body soreness the day after vaccination.
57 2021-03-30 nasopharyngitis, body temperature increased, throat pain On the evening of 3/21 I started to feel like I had a sore throat. Morning of 3/22 it felt like a f... Read more
On the evening of 3/21 I started to feel like I had a sore throat. Morning of 3/22 it felt like a full blow cold with soar throat, swollen glands. Symptoms became worse throughout the day. Reported sick at work on 3/23 because symptoms were worse. (measured temperature 98.9 to 99.9 throughout the say, normal temperature for me is 97.5) Had covid test that came back negative. Started taking cold relief medications. Conditions slowly improved over next few days but still don't feel 100% as of this report.
57 2021-03-30 fever feverish; Achy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient... Read more
feverish; Achy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose BNT162B2 (Pfizer Biotech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first shot BNT162B2 (Lot/Batch number: Unknown) on 28Dec2020 for Prevention of corona virus at 57-years and had arm sore and tired. On 11Jan2021, patient was Feverish and achy. No Admission to hospital due to the evet and no treatment received. The reported issue occur after use of a Pfizer product. Outcome of events was recovered on an unspecified date in 2021. Information about Batch/Lot number has been requested.
57 2021-03-31 chills, fatigue, headache, fever Fever (101), body aches, headache, chills, fatigue
57 2021-03-31 chills Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk ... Read more
Blood clot/very large blood clot from his thigh to his calf; Joint pain; chills; he can't even walk now; leg pain; This is a spontaneous report received from a contactable consumer (patient's wife). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration, on 25Feb2021 (at the age of 57-years-old), at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer stated she's asking on behalf of her husband. He received his first dose of Pfizer-BioNTech COVID-19 Vaccine on 25Feb2021 and had Joint pain and chills after that (on unspecified date in 2021) he was diagnosed with Blood clot (unspecified date in 2021); she stated he had no history of similar health issues and wanted to know if it could be directly linked to this vaccine. The wife further reported that it's dramatically changing his life, he can't even walk now. He had the Covid vaccine on 25Feb2021 and he has no history of blood clots. He developed a leg pain (on unspecified date in 2021) which was odd and they thought that maybe it was some arthritis or something like that. They went to the orthopedist and he was being treated for what the orthopedist thought was a bakers cyst. But then they discovered it was a very large blood clot from his thigh to his calf. They would like to know about this. They have been looking into what he had experienced, and it seems very unusual. It just seems too coincidental that this happened after the Covid vaccine. The emergency room doctor of course shut them down immediately and said that the Covid vaccine never would have done this. But the patient's doctor yesterday said that there are too many unknowns to say for sure that the Covid vaccine didn't cause this. She is not saying that they are against the Covid vaccine, but they are concerned. The patient is on blood thinners now and they just need to know if there is a possible correlation. She had heard on the world news that there is a connection after receiving the (company name) Covid vaccine and now they are shutting this vaccine down in (region name). She saw on the news last night they were asking if there is a correlation with the Pfizer and (company name) Covid vaccines and this. It is very concerning. They have been trying to do research and there is nothing that you can find. The only thing that they did see online was about the doctor that died of a blood disorder in (state name), he had thrombocytopenia. The patient is going to be sent to see a vein doctor. She stated that he has a lot of things ahead of him and he is too young to be dealing with all of this. They are going to be following up with the vein doctor and she would like to have this information when the vein doctor calls later today. The reported adverse events resulted to an emergency room and physician office visit (went to the orthopedist). The patient received corrective treatment as response to the reported events. Outcome of the events was unknown.
57 2021-03-31 fatigue light headed, chemical taste in mouth, fatigue. Evaluated by EMS-Cleared
57 2021-04-01 chills, headache headache, sore muscles, chills, night sweats for approx 24 hrs
57 2021-04-01 headache My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is expe... Read more
My Husband has a swollen lymph node on his left armpit the size of a golf ball or larger. He is experiencing cramping all over his body but especially his legs. He has a terrible headache, feels nautious and dizzy. Today has been the worst. This is day 3 after the Pfizer shot. The internet says it is normal for the lymph node in about 14% of patients. Your flyer handed out at injection day didn't mention all of this.
57 2021-04-01 fever, headache, chills vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm sor... Read more
vaccine was administered on Monday afternoon. arm soreness started Monday evening. symptoms: arm soreness, full body aches, chills, fever of 102, lymph nodes swollen the size of a racquetball, headache. all symptoms peaked in severity on Wednesday. improved on Thursday. resolved by Friday.
57 2021-04-01 fever High Fever, fast hart rate, shills and disturbed vision (vision got double)
57 2021-04-02 chills, fever, fatigue 12 hours after injection, body aches , fatigue 30 hours after injection, sore lymph node in right a... Read more
12 hours after injection, body aches , fatigue 30 hours after injection, sore lymph node in right armpit 36 hours after injection approx. 6 hours of chills and low fever 48 hours after injection lymph node is still sore 72 hours after injection lymph node is still sore
57 2021-04-02 fatigue Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling col... Read more
Ive had significant night sweats waking up with the bed and sheets soaked and subsequent feeling cold from the wet bed. I have not monitored completely but it seems I?ve had some degree of this sequelae in varying degree of sweating every night for the week since I was vaccinated. I don?t feel sick but feel slightly more tired than usual. I cycle on average 5-6 days a week riding 15 miles a day. On off days I walk for 3 miles. My health is generally good.
57 2021-04-02 fever, lethargy Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction i... Read more
Lethargy, erythema at site, fever to 104.2, loss of ability to stand or walk, confusion, reduction in speech ability. Symptoms started during the evening of 3/30/21 after vaccination. PCP was contacted on 3/31/21 and we were told the effects would only last 48 hours. Fever was reduced with Acetaminophen 1000 mg q6h x 2 doses, oral fluids, and icing the axillary. 911 was called on 4/1/21 when pt lost ability to stand and and was minimally vocal but alert. Pt was hospitalized and remains in that situation at this time.
57 2021-04-03 headache Soreness in arm at injection site.; General body aches and pains; intermittent headache; This is a s... Read more
Soreness in arm at injection site.; General body aches and pains; intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Left Arm on 24Mar2021 01:15 am as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension (controlled w/medication). Concomitant medication(s) (received within 2 weeks of vaccination) included enalapril maleate (10 mg/day). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. Allergies to medications, food, or other products: No. Historical vaccine included BNT162B2 on 04Mar2021 01:15 am (First Dose, Left arm, Lot No EL3247). The patient experienced soreness in arm at injection site, general body aches and pains, intermittent headache; all (non-serious) on 24Mar2021 23:45. Treatment was not received for the adverse event Outcome of all events was recovering. Follow up attempts are needed. Further information has been requested.
57 2021-04-04 fatigue, runny nose fatigue on saturday and sunday, indigestion and runny nose on sunday night, and monday morning with... Read more
fatigue on saturday and sunday, indigestion and runny nose on sunday night, and monday morning with vomiting
57 2021-04-04 fever Fever of 101+ to 103.9
57 2021-04-05 headache, fever Mild Fever - Bad Headache - Welts and rash on Chest, Shoulders, Stomach very ictchy
57 2021-04-06 chills, dehydration, fever Appx. 10 days after dose 1 of 2 of Pfizer COVID-19 Vaccine, patient began to feel fevers and chills,... Read more
Appx. 10 days after dose 1 of 2 of Pfizer COVID-19 Vaccine, patient began to feel fevers and chills, dehydration, and acute acid reflux. Pt went to urgent care facility for evaluation. Was tested for COVID-19 and Influenza and both were negative. Pt was given 2 liters normal saline. Next day, Pt went to ER with same complaint. Numerous laboratory tests were ordered, with numerous values being atypical, and a POSITIVE Epstein-Barr Virus (EBV) test. Pt had tested POSITIVE for EBV in 1989, but had had no recurrences since then, symptoms lasted 6 days.
57 2021-04-07 chills After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my... Read more
After receiving the vaccine and waiting the 15min, I left the vaccination site and headed home in my vehicle. After about 10 to 15 mins I encountered a metallic taste in my mouth and my mouth almost felt as though it was vibrating almost like a surging feeling. I then became flushed in the face and my tongue felt odd as if it was swelling. My throat became dry. I waiting five more minutes and decided to take the next exit off of I87 and drove directly to a urgent care center. Upon arrival I sat in my car for 20 more minutes to see if my symptoms would pass and they did. I did not need to enter into the urgent care facility. I have not had any other symptoms since this event.
57 2021-04-07 headache, fatigue Day 1 - Fatigue beginning about 6pm, then foggy feeling about 7pm, then mildly headachy about 8pm Da... Read more
Day 1 - Fatigue beginning about 6pm, then foggy feeling about 7pm, then mildly headachy about 8pm Day 2 - Fatigue, fog, and headachy continued through the day easing somewhat in evening Day 3 - pretty much back to square
57 2021-04-07 influenza like illness, chills, fever, headache Flu like symptoms with fever and chills off and on for 24 hrs. Aches and joint pain and stiffness. H... Read more
Flu like symptoms with fever and chills off and on for 24 hrs. Aches and joint pain and stiffness. Headache as well.
57 2021-04-07 malaise, fatigue Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage... Read more
Adverse events I?m all pissed off. cramps all over my body legs arms hands both sides of my rib cage neck I?m sick fatigued the runs just yesterday and Today
57 2021-04-07 fever Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, th... Read more
Rash, itching, hives. Started in groin area, then moved to triceps, then on both sides of trunk, then behind knees. Redness and flushing of face but no swelling/rash/hives/itching. As rash has subsided, low grade fever came on (100 degrees F).
57 2021-04-08 fatigue Aches, tired, diarrhea. Started a few days after shot and is still ongoing and seems to be getting w... Read more
Aches, tired, diarrhea. Started a few days after shot and is still ongoing and seems to be getting worse.
57 2021-04-09 chills dizziness, nausea and chills.
57 2021-04-09 fatigue Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after in... Read more
Sore Left Arm day/night of injection resolved next day Extreme Fatigue day of and next day after injection resolved third day
57 2021-04-09 headache Mild headache, at temples and mid-forehead (no analgesic needed or taken), a few hours in duration. ... Read more
Mild headache, at temples and mid-forehead (no analgesic needed or taken), a few hours in duration. Began approx 4 hours after administration; noticeable partial recovery within 4 (more) hours; complete recovery a few hours later (by the time I went to sleep). At all notable only because I so VERY rarely get random headaches and despite being specifically advised of the possibility by the vaccine administrator, I really didn't expect it given my general lack of susceptibility to them. For completeness' sake, I'll also mention the mild discomfort in my left deltoid muscle upon exertion but not at rest (not specifically at injection site), but with no visible or palpable inflammation, starting about 3 hours after administration. Slight increase in severity and slight spread in area of discomfort over the next 8 hours or so; further increase upon waking the next morning, but which dissipated quickly with use of the arm. (Complete recovery within 24 hours, with no "treatment" other than minimizing use of arm.)
57 2021-04-09 fever, chills Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasth... Read more
Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasthesia in right hand.
57 2021-04-10 headache, fatigue, runny nose Severe nasal discharge extreme fatigue extreme body aches and headache
57 2021-04-10 fever Low grade fever Significant body discomfort Weakness
57 2021-04-11 chills, fever Fever, body aches,cold chills
57 2021-04-11 headache DVT Left leg, headache, myalgias
57 2021-04-12 headache, fever fever up to 102 x 2 days; body aches; headache. Currently has headache and brain fog.
57 2021-04-12 influenza like illness, headache Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. ... Read more
Adverse event #1: Flu-like symptoms, severe headache, vision blurriness, lasting roughly 10 days. Adverse event #2: Deep Vein Thrombosis in the left Popliteal vein with moderate associated edema and pain. Required Emergency Room visit, diagnosis, and treatment with Eliquis. This event prevented normal daily work activities for 5 days, after which edema and pain has mostly subsided.
57 2021-04-13 fever, malaise 3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for com... Read more
3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for complaint of SOB, fever, body aches. Admitted for sepsis. 4/4 intubated. 4/12 extubated. 4/14 remains hospitalized. Workup negative for infectious cause. Oncologist consulted, does not appear cancer related. MD suspects reaction to vaccine.
57 2021-04-14 headache, fatigue Pain at injection site and upper left arm, headache, muscle/body aches, fatigue/tiredness. Pain ... Read more
Pain at injection site and upper left arm, headache, muscle/body aches, fatigue/tiredness. Pain still there, headache gone after 12 hours, muscle/body aches still there but less, fatigue/tiredness still there.
57 2021-04-14 headache Dizzy, fuzzy feeling starting within about 5 minutes, lasting approx 1 hour. Major headache focused ... Read more
Dizzy, fuzzy feeling starting within about 5 minutes, lasting approx 1 hour. Major headache focused behind the left eye. Starting about 2 hours later, lasting about 2 - 3 hours.
57 2021-04-14 nasal congestion, runny nose, fever, throat pain, headache, fatigue, cough, chills Vaccine administered Friday 4/9/21 morning. By afternoon and next morning, pt reports having many C... Read more
Vaccine administered Friday 4/9/21 morning. By afternoon and next morning, pt reports having many COVID 19 symptoms: cough, headache, congestion, fever, shortness of breath, nausea, diarrhea, fatigue, runny nose, loss of taste and loss smell, chills, body aches and sore throat. Pt tested for COVID 19 4/12/21; was negative.
57 2021-04-15 fatigue, headache, fever 2/3rds of patient?s torso covered in rash, rash under arms and center of lower back particularly. ... Read more
2/3rds of patient?s torso covered in rash, rash under arms and center of lower back particularly. Fever Headache, fatigue.
57 2021-04-15 fever, fatigue Patient reports feeling fine 4/7/2021. He did have a shot of whiskey on 4/8/2021 around 8pm. Reports... Read more
Patient reports feeling fine 4/7/2021. He did have a shot of whiskey on 4/8/2021 around 8pm. Reports fever, nausea and fatigue starting at 6pm on 4/8/2021. He then woke up every hour on the hour starting around 1200 midnight and reported having racing heart and having to use the restroom every hour (abnormal for him this frequent). The adverse event was tachycardia (160-180bpm) starting shortly before midnight and this was persistent until 4am. He has not had any tachycardia since. He did not seek medical attention and this has only happened to him once before (>20 years ago when he was dehydrated).
57 2021-04-16 fatigue, chills chills, fatigue for about a day felt fine next day
57 2021-04-16 fatigue, headache headache; nausea; fatigue; This is a spontaneous report from a contactable consumer. A 57-year-old m... Read more
headache; nausea; fatigue; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received the second dose BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date (at the age of 57-year-old as reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, nausea, and fatigue after receiving the second dose of the vaccine on unspecified date. The outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-04-16 headache, fever, chills, fatigue Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had sho... Read more
Fever, headache, body aches, joint aches, weakness, chills. abdomen pain, severe trembling. Had shot at 4:30pm, woke up the next morning at 6 am and symptoms were there. They got worse during the day. Had issues getting fever down. In the evening was able to break fever and was able to eat. Now second day since injection only have a headache and fatigue.
57 2021-04-16 fever, chills Woke up on 4/16 at 3:15a with chills and fever. After taking some Tylenol and drinking water and som... Read more
Woke up on 4/16 at 3:15a with chills and fever. After taking some Tylenol and drinking water and some green tea the symptoms resolved upon waking on 4/17. I was also able to eat a light breakfast and dinner on 4/16.
57 2021-04-17 body temperature increased I have severe Hives, swelling and itching across my entire body. My legs, arms, back, chest, belly, ... Read more
I have severe Hives, swelling and itching across my entire body. My legs, arms, back, chest, belly, butt, feet, face. I also have swelling of my face around the eyes and cheeks, swelling on my hands and wrists. I reached 103 degree temperature then it broke and became normal this was in association with the Hives.
57 2021-04-17 fatigue ACHES, CONSTANT FATIGUE, STIFFNESS\PAIN IN KNEES, RESTLESSNESS\SLEEP DISRUPTION, DEVELOPMENT OF BUMP... Read more
ACHES, CONSTANT FATIGUE, STIFFNESS\PAIN IN KNEES, RESTLESSNESS\SLEEP DISRUPTION, DEVELOPMENT OF BUMP IN THE LEFT SIDE OF FACE (HAD REDUCED SIGNIFICANTLY BUT NOT COMPLETELY HEALED)
57 2021-04-17 malaise, sweating I had the same symptoms that lead to my March 19, 2020 (13 months ago) ER admission to hospital, whe... Read more
I had the same symptoms that lead to my March 19, 2020 (13 months ago) ER admission to hospital, where I presented with left flank pain, diarrhea, cold sweat, nausea, dizziness, very high blood pressure, and feeling of malaise. Symptoms started within 7 days after the 2nd injection. Went to doctor on Apr. 16, 2021 with the same symptoms described above, except cold sweat. Had left flank pain that made walking difficult, diarrhea, nausea, dizziness, and BP 189/88. Normal BP is 140/88. Urinalysis showed blood in urine. Other results of blood test were not provided as of this date.
57 2021-04-17 fever Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability... Read more
Pt developed fever as high as 104.2; confusion, inability to form sentences; restlessness; inability to ambulate.; inability to form sentence; This is a spontaneous report from a contactable nurse. A 57-year-old male patient received the first dose of BNT162B2 (lot no. and expiry date were unknown), via an unspecified route of administration, administered in right arm on 30Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included Cancer Stage 4 - renal with mets. The patient's concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and sulfamethoxazole, trimethoprim (BACTRIM) in which he experienced allergies to both drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021, the patient developed fever as high as 104.2, confusion, inability to form sentences, restlessness, and inability to ambulate. He was hospitalized on unspecified date due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had nasal swab on 01Apr2021 with negative result. The outcome of the events was not recovered. Information on lot/batch number has been requested.; Sender's Comments: The information currently available is extremely limited and does not allow a meaningful case assessment. However, based solely on an implied temporal association, a causal relationship between events fever,confusion,aphasia,movementdisorder adverse events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
57 2021-04-18 chills, fatigue Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He... Read more
Immediately upon being vaccinated, the patient felt weak, tachycardic, and had chills and nausea. He was observed for 20 minutes, at which time his symptoms abated and he left the vaccination facility. However, his symptoms returned later in the day. He presented to our office 15 days after vaccination. At that point, he was suffering coldness in his extremities with peripheral cyanosis of hands, feet, and nose. He reported chest pain and had an abnormal EKG with ST depressions in several leads. He stated that over the past two weeks, his symptoms would come and go, lasting for hours at a time and constituting weakness, extreme fatigue, cold extremities, and body aches.
57 2021-04-18 fatigue, headache Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling ver... Read more
Started with a bad headache that wouldn't go away. Then heavy pressure over my eyes, and feeling very tired. Symptoms went away for a few days, then returned. Got tested for COVID-19, with a PCR lab test, and the results were positive.
57 2021-04-18 headache, sweating, fatigue pt received both a Johnson & Johnson as well as a Pfizer COVID 19 vaccines, 1 day apart. He started ... Read more
pt received both a Johnson & Johnson as well as a Pfizer COVID 19 vaccines, 1 day apart. He started to have headache, "hot sweat" and fatigue 4-5 days after the 2nd vaccine and still affecting patient.
57 2021-04-20 body temperature increased, fatigue, chills Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with ch... Read more
Slight discomfort in left arm injection site by 6PM and went to bed 9:30PM. Woke up 12:30AM with chills and did not sleep well for the remainder of night. Got up 5:30AM ate something and had some coffee. What was noticeable initially was fatigue, followed by chills. My temperature was 99.2 and 99.4. I never took any medication until going to bed. I reported in sick to work and went back to bed for 4 hours approximately. I felt bad all day even as I went to bed.(chills and very fatigued). I tried to keep very warm and took Tylenol PM to sleep. 100% recovery 1 day later
57 2021-04-20 chills, fever fever, aches, chills first 5 days. now runs a lowgrade fever at night, swollen feet and legs.
57 2021-04-20 fatigue, fever, chills, headache, malaise Fever, Tm 104 starting the day of vaccination (about 8 hours later). Body aches, chills, malaise, al... Read more
Fever, Tm 104 starting the day of vaccination (about 8 hours later). Body aches, chills, malaise, alterations of sense of taste, sense of smell. Extreme fatigue. Very mild headache. Fever lasted for 7 days in the 103 to 104 range. Current temperature is <100, but still has severe fatigue. Was seen in ER for 2 visits on 04/18/2021. Had labs drawn, was told these were normal. Has been taking Tylenol, added ibuprofen after 6 days, and drinking diluted Gatorade. Had video visit with me on 4/16, and then phone visits on 4/19 and 4/21.
57 2021-04-20 fever, chills Itching head to toe Chills fever Metal taste Vomiting Down two weeks after first shot and two week... Read more
Itching head to toe Chills fever Metal taste Vomiting Down two weeks after first shot and two weeks after second shot
57 2021-04-21 headache, chills Severe cold chills, headache, entire body is sore
57 2021-04-21 headache Sore arm into armpit and sharp headaches(off and on for a week)
57 2021-04-21 headache Stiff arm after shot for several days. Sharp headaches off and on for a week. Took ibuprofen for pai... Read more
Stiff arm after shot for several days. Sharp headaches off and on for a week. Took ibuprofen for pain.
57 2021-04-23 fatigue On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful u... Read more
On 4/8 felt flush and very tired. On 4/9 developed a large sore on my tongue that was very painful until 4/12. Continued to be tired until 4/15.
57 2021-04-23 headache, fatigue, sinus congestion Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, ... Read more
Uncontrolled hypertension, injection site pain, increased myalgia pain, headache, sinus congestion, nervous, tiredness, back pain, hip pain, increased heart rate, shortness of breath, shoulder pain, muscle soreness, sleeplessness. All ongoing.
57 2021-04-24 fatigue, headache headaches, severe, lasting > 1 day, body aches and fatigue
57 2021-04-24 headache This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 10:30 (at the age of 57-year-old), at single dose, for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from 2018 and ongoing, and had a shot, a steroid for COPD; high blood pressure from 2016 and ongoing, and patient took medication for it; 7 heart attacks; 8 stents in his heart; patient was a smoker (ongoing, had been smoking for a long time. He was a walking post card for don't smoke. He stated that he can only walk twenty feet before he was out of breath); and patient was allergic to penicillin and Lortab. Family history included patient had a family member die of cancer and lupus. Patient had two biopsies for skin cancer (unknown date) within 4 weeks prior vaccinations. Concomitant medications were not reported. On 07Apr2021, the patient experienced extremely high blood pressure, arm aching, body aches, night sweats, and headaches. The patient stated since receiving the vaccine, that his blood pressure was very high and his medications were not bring it down. He stated that one of his blood pressures was 197/121 and this morning it was 181/130, which was extremely high for him. He stated that he went through the aches and his arm was hurting. He even had sweats last night. Patient stated that his blood pressure still hadn't come down and he could feel headache from the pressure. He stated he already called the doctor, and the doctor told him that if it persisted to go to the emergency room. He stated that he took a couple of medications for his blood pressure and he declined giving medication information. He said that one started with an R and he took another one twice a day. He said that all the names of them, remembering them at his age was hard. He stated that he could read that small writing he had to get a magnifying glasses. Patient was scheduled for next vaccine on 04May2021. He stated that his blood pressure was not so unbearable but it was pretty high, he checked his blood pressure twice a day for everyday. He stated whatever he was lucky if he remembers if he had breakfast in the morning, until he remembered that he hadn't had breakfast. He stated that his arm started aching on 07Apr2021, it had improved but was still ongoing. He stated that it felt pretty good. Patient's blood pressure had been constant since today was the 8th it's only been a little over 24 hours now. On 07Apr2021 he had night sweats. He woke up pillow was soaking wet. He stated that his body aches still ongoing started about the same time. His headache started at the same time and was still going on. Patient stated he had a heart attack in 2016 and he hadn't had a normal blood pressure since. He hadn't been able to keep it all in check since the vaccine. His blood pressure medicine had been changed from 20 mgs to 40 mgs. He was under constant doctor care. The patient underwent lab tests and procedures, which included blood pressure was 197/121 (unknown date), 181/130 (08Apr2021), and 165/116 (08Apr2021). Patient's heart rate was 85 (unknown date). Patient stated his normal blood pressure was 135/85, his normal heart rate was 75. The outcome of the events "extremely high blood pressure", "body aches", "headaches" was not recovered; of event "arm aching" was recovering; of other events was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-04-24 headache Aches, dull headache, upset stomach
57 2021-04-25 fatigue, fever Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer ... Read more
Fatigue, fever of 101.2, sore arm, red rash at injection site, for 24 hours following second Pfizer dose ER8731. Five days after vaccination with ER8731, on 04/21/2021, was rushed to hospital at 3 pm with acute idiopathic pancreatitis attack.
57 2021-04-28 cough, fever, runny nose, fatigue, headache FEVER, COUGH, FATIGUE, HEADACHE, RUNNY NOSE
57 2021-04-28 sweating Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administra... Read more
Patient stated he was sensitive to the smell of alcohol and needed to turn away after the administration of the vaccine. He stated like he was feeling like he might pass out. He removed mask, stated he was getting warm, hat removed. He asked to be lowered to the floor. Never lost consciousness. Color pale. Skin diaphoretic. BP 137/84 pulse 80, SpO2 96%. Cold washcloth applied. Rapid response team called. Vital signs monitored. Patient assisted to chair for observation. 10:02 am patient recovered and left the facility in stable condition.
57 2021-04-28 fever, headache Fever, muscle pain all over the body, joint pains all over, especially kidney area, strong headache... Read more
Fever, muscle pain all over the body, joint pains all over, especially kidney area, strong headache, sleeping all day.
57 2021-04-29 body temperature increased, chills, fever Fever/chills, low temperature (up to 100.2F), feeling faint (fainting one time); symptoms lasted for... Read more
Fever/chills, low temperature (up to 100.2F), feeling faint (fainting one time); symptoms lasted for 3 days
57 2021-04-29 headache about an hour after shot started to get a headache on left side of head, from eye allthe way back to... Read more
about an hour after shot started to get a headache on left side of head, from eye allthe way back to neck. Never had a headache like this before. Still going on 9 days later
57 2021-04-30 fatigue Parts of the face, sides of cheek and neck had an itchy, rash; Eyelids puffy and swollen; Underneath... Read more
Parts of the face, sides of cheek and neck had an itchy, rash; Eyelids puffy and swollen; Underneath eye and part of cheek, swollen and puffy; Face got red, like a sunburn; Pain in arm; Tiredness and fatigue; This is a spontaneous report from a contactable male consumer. The 57-year-old male consumer (patient) received second dose (Batch/Lot Number: unknown) on 12Apr2021 at 3 pm and first dose (Batch/Lot Number: ER8727) on 22mar2021 via unspecified route of administration as a single dose for Covid-19 immunisation. The medical history was not reported. Patient reported he was on 9 medications. The patient experienced Pain in arm on 12Apr2021 in the evening and it was resolved on 13Apr2021, Tiredness and fatigue on 12Apr2021 at 3 PM, Face got red, like a sunburn on 13Apr2021 in the evening, Parts of the face, sides of cheek and neck had an itchy, rash on 13Apr2021 at 5 PM, Eyelids puffy and swollen on 13Apr2021, Underneath eye and part of cheek, swollen and puffy on 13Apr2021 at 5 PM. Patient did not specified seriousness. Patient did not have prior Vaccinations within 4 weeks. Patient did not have any relevant tests. Patient reported that there were side effects to the first shot, patient reclarified, his face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, earlobes red and swollen" all occurring 24 hours after he got the second dose of the vaccine. Patient stated then last night his face got red, stated it was like he had sunburn on his face and he had an itchy, rash, swollen under his eyes. Patient had a skin Cancer treatment a couple of months ago and he was told to stay out of the sun. Patient did not think about the vaccine being the cause of, his skin being red. Patient used this new facial cream and he thought he was having a reaction to that, but now he doesn't thing so, it could be from the vaccine. Patient stated redness hasn't gone away, and he is itching in certain areas of his face and neck. He had looked on the internet to see what anaphylaxis looks like, and the pictures do not look like what he is experiencing. Patient's rest of face is super red, like sunburn with a red, itchy rash. Patient took Benadryl and it Benadryl relieved the itching and swelling. Patient didn't think he was allergic to the main ingredient in the vaccine. Patient stated that he had an allergy to Tegretol. patient stated he had a reaction, a rash, and the medication was stopped immediately. Patient doctor put him on a strong antihistamine with good effect. Patient did not get any vaccine on the same day. Patient did not require visit to Emergency Room and Physician Office. Patient stated that his friend that got the Pfizer vaccine and her throat closed up on her at night and she was told not to get her second vaccine. Upon follow-up further information was received patient stated 45 days ago he had a preventative skin cancer procedure on his face and used Fluorouracil 5% topical cream applied daily on his face. patient said it made his face get "super red", which is what it was supposed to do. Patient stated that the medication contained Polysorbate 60. He is wondering if his reaction to the vaccine could be a "cross reactive. Patient further reported a delayed reaction to the second dose of the Pfizer Covid 19 vaccine. Patient stated he had no side effects after the first dose. However he reported the following: face getting super red, eyes swelling, upper cheeks swollen, under eyes swollen, face was very itchy, The outcome Pain in arm was recovered, tiredness and fatigue – recovering, face got red, like a sunburn was not recovered, parts of the face, sides of cheek and neck had an itchy, rash was not recovered, underneath eye and part of cheek, swollen and puffy was not recovered, eyelids puffy and swollen was not recovered. No follow-up attempts are possible. No further information is expected.
57 2021-04-30 headache, fatigue Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoul... Read more
Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
57 2021-05-02 cough, headache, fever, chills, throat pain Fever or Chills Cough Muscle or body aches Headache Sore throat
57 2021-05-02 cough cold-like symptoms, generalized body aches, diarrhea, nonproductive cough and some shortness of brea... Read more
cold-like symptoms, generalized body aches, diarrhea, nonproductive cough and some shortness of breath
57 2021-05-03 headache Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a f... Read more
Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks. Had a full evaluation at Medicine Center. Work up negative and symptoms resolved; atorvastin dose was doubled. He has had some short term memory loss and decrease in neurocognitive function. He had the second dose of the vaccine as scheduled, following which he had a severe unilateral headache but he did not seek care/evaluation.
57 2021-05-04 fatigue Broke out in hives/rash on the front of my neck. It was itchy and I treated it with Hydrocortizone.... Read more
Broke out in hives/rash on the front of my neck. It was itchy and I treated it with Hydrocortizone. This initially started on 05/03/2021 and as of today, 05/05/2021 the hives are still present. On the date of the 2nd vacination i felt totally exhausted and felt like I hit a wall withing 4 hours of receiving he 2nd vaccine. This reaction was more pronounced than after the 1st vaccine. This went on for 3 days. I am still experiencing being very tired. I also had a metalilc taste in my mouth on the first day after the 2nd vaccine that lasted for a week.
57 2021-05-04 fatigue LEFT EYE REDNESS, ITCHY EYE, SWELLING LEFT EYE, FATIGUE ALL BODY, NEXT DAY AFTER VACCINE AND ONE DAY... Read more
LEFT EYE REDNESS, ITCHY EYE, SWELLING LEFT EYE, FATIGUE ALL BODY, NEXT DAY AFTER VACCINE AND ONE DAY AFTER VACCINE THE RIGHT EYE START TO BE RED, ITCHY, SWELLING RIGHT EYE
57 2021-05-04 headache, fatigue, respiratory tract congestion, fever, runny nose FEVER, Fatigue, Muscle or body aches, Headaches and Congestion or runny nose
57 2021-05-04 nasal congestion, headache, cough, fatigue, runny nose COUGH, Fatigue, Muscle or body aches, Headaches, Congestion or runny nose, Nausea or vomiting and Di... Read more
COUGH, Fatigue, Muscle or body aches, Headaches, Congestion or runny nose, Nausea or vomiting and Diarrhea
57 2021-05-04 pneumonia, fever Fever of 99.9 on 5/3, 99.6 on 5/4, and 100 on 5/5. Patient started on IVF, Zosyn & Vancomycin ABT's ... Read more
Fever of 99.9 on 5/3, 99.6 on 5/4, and 100 on 5/5. Patient started on IVF, Zosyn & Vancomycin ABT's IC for Pnuemonia, Nebulizer treatment for COPD, VS every 4 hours x 48 hours.
57 2021-05-06 fatigue Day of Vax: At about 2pm....I had a severe reaction forcing me to lay down for several hours....bod... Read more
Day of Vax: At about 2pm....I had a severe reaction forcing me to lay down for several hours....body aches and pains, mental confusion, really weird feelings throughout my body. I had to take sick time from work. I felt better in the evening. Day 2(wed): woke up with moderate/extreme fatigue....body did not feel good...could not work took more sick time...spent most of day in bed. Day 3(thurs): Was going to try to get back to regular schedule.....worked in the morning...did my usual lunch time hike.....in the afternoon suffered from another bout of moderate/extreme fatigue...could not work..took more time off....in the evening had chest pain in my back between my shoulder blades. Day 4(fri): I am filling out this form...woke up with pain in between my shoulder blades....that seems to be feeling a little better now....I am trying to get back to my regular routine and have been working this morning. I believe that I will continue to get fatigued for a few more days....and I'm very sensitive between my shoulder blades.
57 2021-05-06 headache, fatigue, fever, chills injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, diarrhea, vomiting
57 2021-05-07 headache stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his... Read more
stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.
57 2021-05-07 fever, cough Cough Fever
57 2021-05-09 chills, headache, influenza like illness within an hour headache. For two days following the vaccine aches and pains accompanied by chills, ... Read more
within an hour headache. For two days following the vaccine aches and pains accompanied by chills, much like a flu. After that cleared, I noticed a pain in my upper chest on the left side. To this day it is still tender to the touch.
57 2021-05-09 headache, sneezing, runny nose, throat pain Runny nose, sneezing, mild headache, mild sore throat
57 2021-05-10 fatigue, sleepiness On the first one he was sleepy tired the next day; On the first one he was sleepy tired the next day... Read more
On the first one he was sleepy tired the next day; On the first one he was sleepy tired the next day; This is a spontaneous report from a contactable consumer, patient. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration, in the right arm on 24Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from Jan2021 to an unknown date (Verbatim: Blood pressure high). Concomitant medications included losartan for blood pressure measurement from an unspecified start date and ongoing; lorazepam for somnolence from an unspecified start date and ongoing. The patient received the first shot 24Mar2021 at 1115AM in the upper right arm muscle and was sleepy tired the next day. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
57 2021-05-10 fatigue Fatigue; Nausea; Vomiting; Diarrhea; Swollen glands; This is a spontaneous report from a contactable... Read more
Fatigue; Nausea; Vomiting; Diarrhea; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, in right arm on 22Apr2021 at 10:30 (at the age of 57-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced fatigue, nausea, vomiting, diarrhea and swollen glands on 23Apr2021 at 11:00. The events resulted in Emergency room visit and were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
57 2021-05-10 headache Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizzi... Read more
Extreme headaches in the back of my head, then radiating to the frontal lobe. Second stage was dizziness/ vertigo seemed like my brain was going to explode. Ringing in ears and then intense vivid dreams. It?s been two weeks since the second shot and I am still dealing with the dizzy spells. The headaches have gone . Also another symptom was I would get weak at times not for long but in spells. Still trying to over come this pressure and dizzy feeling other than that now I am getting better.
57 2021-05-10 nasopharyngitis, throat pain A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19... Read more
A male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Apr2021 13:50 (Lot Number: EW0169; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. There was no relevant medical history and concomitant medications. There was no Additional Vaccines Administered on Same Date of bnt162b2. The patient previously received the first dose of bnt162b2 on 29Mar2021 (Lot Number: EP6955; Expiration Date: 30Jun2021) for covid-19 immunisation. The reporter stated he thought he was having side effects. He thought he had a cold, sore throat so he took Nyquil and Tylenol PM. His side effects were nausea and threw up. his whole body was sore from arm to back. Time of Onset was Morning 05:45 on 20Apr2021. The patient also experienced up all night on 19Apr2021. The outcome of Nausea and Threw Up was resolved on 20Apr2021. The events did not require a visit to emergency room or physician office. The outcome of Whole Body is Sore from Arm to Back was not resolved. The outcome of Feels like he has a cold; Sore Throat was resolving. The outcome of up all night and Nausea and Threw Up was resolved on 20Apr2021. No follow-up attempts are needed. No further information is expected.
57 2021-05-11 malaise, fatigue Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home... Read more
Patient was feeling fatigue, unwell the night after getting the vaccine. The next day he stayed home, did not go to work as he was not feeling well. Two days after getting the vaccine, he had trouble breathing, an ambulance was called and he was pronounced deceased hours later. He had a heart attack.
57 2021-05-11 throat pain Within just a couple minutes, I felt tightness in my chest. A few minutes later I felt tightness in... Read more
Within just a couple minutes, I felt tightness in my chest. A few minutes later I felt tightness in my throat. This is the same affect I have when I breath in cooked, steaming mushrooms on pizza or other cooked foods. I informed a nurse nearby about it and she had another nurse come over and talk to me. They asked me if I wanted to go to the Emergency Room at the hospital and I declined, thinking it would subside, and because I was there with a woman whom I am one of her home care providers.. I did relaxation exercises and drank water to relax and it helped a little but after leaving, I went to a pharmacy and purchased Benadryl and took a 20ml dose. Within about 30 minutes I was feeling better and the next day my chest felt fine but my throat still bothered me; I assumed my throat muscles were still sore from the swelling.
57 2021-05-12 fever slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report... Read more
slurred speech; Right arm and right leg weakness; TIA; Fever; Weakness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8737), via an unspecified route of administration in right arm on 16Apr2021 16:00 as 2nd dose, single for COVID-19 immunization. Medical history included hypertension (Htn) and non-insulin dependent diabetes mellitus (Niddm). Concomitant medications included amlodipine and vitamins nos (MULTIVITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8730) in the left arm on 26Mar2021. The patient experienced slurred speech, right arm and right leg weakness, transient ischaemic attack (TIA), fever, and weakness, all on 18Apr2021 08:00. The events resulted to ER visit (Emergency room/department or urgent care) and patient was hospitalized for 2 days. Therapeutic measures were taken as a result of the events and reportedly included treatment with blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequel. Events seriousness was hospitalization and disability. Information on lot/batch number was available. Additional information has been requested.
57 2021-05-14 fatigue, influenza like illness immediate muscle contractions and spasms in the arm and neck upon injection. Flu like symptoms (ac... Read more
immediate muscle contractions and spasms in the arm and neck upon injection. Flu like symptoms (aches throughout the body and and fatigue started at about 8:00 pm. And have continued through the next day
57 2021-05-14 fever, headache, cough Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a ... Read more
Patient contacted the pharmacy stating that he received the vaccine from us and he informed us of a cough but with no fever or other symptoms. The same day the patient had headache, diarrhea, and fever, and eye pain. The cough also worsen and did not go away. He was then treated in the hospital with IV fluids and medication. He spent many days without food and was very weak.
57 2021-05-17 headache Have slight headaches 3-4 days after 2 bday shot . Had an episode of entire body numbing and feeling... Read more
Have slight headaches 3-4 days after 2 bday shot . Had an episode of entire body numbing and feeling disconnected from my body while driving. Came in suddenly and went away .
57 2021-05-17 fever, headache, fatigue 24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen te... Read more
24hrs post 2nd Dose Pfizer. Bradycardia, chest pain, fever, skin patches heat sensation, swollen testicals, lymph nodes swollen, entire body joint pain, severe headache, foggy, extremely tired. At 9:25am (24hrs after 2nd dose) I was able to muster enough energy to text. 15 minutes later my heart was beating so slow I was unable to move my hand to grab my phone. It was like I was paralyzed for a couple hours other than my heart beat hurt and below 30 bpm for a couple hours. In and out of being awake. After a couple hrs I was able to move and my heart was beating faster. My chest hurt significantly for 12 days. May 13th, (9days post) I went to Emergency Room in evening. Fear of blood clots with chest hurting and extreme fatigue. ER preformed an XRAY for heart size and lungs, Blood work for blood clots and markets for heart attach. All came in negative to a heart related event causing pain.
57 2021-05-18 headache, cough, chills ED to Hosp-Admission Discharged 3/28/2021 - 3/29/2021 (30 hours) Last attending ? Treatment team... Read more
ED to Hosp-Admission Discharged 3/28/2021 - 3/29/2021 (30 hours) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Unknown Type 2 diabetes mellitus without complication, without long-term current use of insulin (CMS/HCC) Yes Obstructive sleep apnea syndrome Yes Restrictive lung disease Yes Morbid obesity due to excess calories (CMS/HCC) Yes Prostate cancer (CMS/HCC) Yes Status post radiation therapy Not Applicable COVID-19 virus detected Yes Hospital Course COVID-19 Pneumonia Patient presented with headache, chills, diarrhea, dry cough and rash. Patient was maintaining saturation of 91-92% at rest and was desaturating down to 88-89% on slightest exertion. Patient was started on oral dexamethasone 6 mg daily and remdesivir therapy. Patient left AMA on Day 2 admission. Patient was provided 10 days of dexamethasone therapy. Atopic Rash Likely secondary to COVID-19 infection or allergic reaction. Rash responded well to Benadryl therapy initially. Patient reported reappearance of rash the next day. Patient was continued on Benadryl PRN. Chest Pain, Resolved Heart score of 3. EKG unremarkable for ischemic changes. Clinical suspicion for angina was low. Type 2 Diabetes Most recent HbA1c of 7.8 on 11/2020. Patient is on home glipizide therapy. Patient started on 8 units of Lantus nightly and low-dose sliding scale. Essential Hypertension Patient is on lisinopril 20 mg therapy at home. Home dose of lisinopril resumed Possible obesity hypoventilation syndrome Possible COPD Previous note by pulmonologist reflects that patient's disease might be restrictive instead of obstructive however as he had responded to inhalers, inhalers were continued. Patient's home Incruse Ellipta was resumed. DuoNebs as needed were given. Obstructive Sleep Apnea Patient uses CPAP at night. CPAP ordered to be used nightly during hospital stay Major depressive disorder Symptoms are well controlled on Prozac therapy. Home dose of Prozac resumed Hypercholesterolemia Home dose of atorvastatin 40 mg resumed Morbid Obesity
57 2021-05-21 fever, pneumonia This is a solicited report based on the information received by Pfizer (Mfr Report# UNT-2021-005860)... Read more
This is a solicited report based on the information received by Pfizer (Mfr Report# UNT-2021-005860). A contactable consumer (patient) reported a 57-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Feb2021 as age of 57 years old at 1ST DOSE, SINGLE for COVID-19 immunization. Co-suspect medications included: nifedipine via an unspecified route of administration from an unknown date at an unspecified dose, frequency and for hypertension; methylprednisolone (MEDROL, Tablet) orally from an unknown date at 16mg daily and for lupus; treprostinil diethanolamine (ORENITRAM, Extended release tablet) orally (PO) from 01Aug2019 at unknow dose and frequency; orally from unknown date at 3.875mg, every eight hours (q8h);(Lot: 2101647 and Expiration date:30Jan2022) at 0.25mg unknown frequency; (Lot: 2101648 and Expiration date: 31Jan2022) orally from unknown date at unknow dose and frequency; (Lot: 2101649 and Expiration date: 31Jan2022) orally from unknown date at 2.875mg, 3x/day; (Lot: 2101810 and Expiration date: 31Jan2023) orally from unknown date at 0.125 mg unknown frequency;(Lot: 2101646 and Expiration date: 31Jan2022) orally from unknown date at unknown dose and frequency; orally from unknown date and ongoing at 3mg 3x/day; all for primary pulmonary arterial hypertension. Relevant ongoing medical history included primary pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), calcium deficiency, systemic lupus erythematosus (SLE), obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP), hypercalcemia, chronically high peripheral artery disease (PAD), hypertension and multifactorial stable SOB (shortness of breath). Patient's family history included: COVID-19 (brother positive). Concomitant medications included ambrisentan (LETAIRIS), spironolactone (ALDACTONE), calcium citrate, ergocalciferol (CITRACAL + D), apixaban (ELIQUIS), epinephrine (EPIPEN), folic acid (FOLVITE), digoxin (LANOXIN), furosemide (LASIX), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), hydroxychloroquine sulfate (PLAQUENIL), and sildenafil citrate (REVATIO). This is a solicited report received on 31Mar2021 from a consumer via (pharmacy name). Patient began therapy with Orenitram (treprostinil diethanolamine), on 01 Aug 2019 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 0.25mg, 1mg, 2.5mg and 0.125mg and the current dose was reported as 3.875mg, via oral (PO) route, every eight hours (q8h). On 23Mar2021, the patient experienced event COVID-19 and pneumonia (COVID-19 pneumonia, hospitalization, medically significant).On 23Mar2021, 1 year 7 months 23 days after initiating PO Orenitram, the patient was hospitalized due to COVID-19 and pneumonia and discharged on 29 Mar 2021. The patient was on oxygen at the time of reporting. Action taken with PO Orenitram dose for the event of COVID-19 pneumonia was not reported. At the time of reporting, the outcome of the event of COVID-19 pneumonia was unknown.The reporter did not provide causality for the event of COVID-19 pneumonia. Follow-up information was received as solicited report on 15Apr2021 from a consumer via (pharmacy name). On 06Apr2021, the patient had pneumonia (pneumonia, medically significant and hospitalized). Additional lot number and expiration date were added to 2.5 mg concentration of PO Orenitram. On 06Apr2021, 1 year 8 months 6 days after initiating PO Orenitram, the patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient was also hospitalized in Mar2021 for COVID (previously reported COVID-19 pneumonia). Action taken with PO Orenitram dose for the event of pneumonia was not reported. At the time of reporting, the outcome of the event of pneumonia was unknown. The reporter did not provide causality for the event of pneumonia. Additional spontaneous information was received on 19Apr2021 from a consumer (social worker) via (pharmacy name). Event of pneumonia was omitted and subsumed under COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID (previously reported COVID-19 pneumonia). Follow-up information was received on 27Apr2021, from a nurse on behalf of the reporting physician via a query response. On 16Apr2021, the patient had acute hypoxemic respiratory failure (AHRF) from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH (acute respiratory failure, hospitalized, medically significant), pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus (pulmonary arterial hypertension, hospitalized and medically significant), AHRF secondary to Flu B and PAH with baseline PAH (influenza, hospitalized), volume overload (fluid overload, hospitalized). On an unreported date in 2021, the patient had fever, temperature 101.1 F (pyrexia). On an unreported date, the patient had worsening MR (mitral regurgitation) (mitral valve incompetence, medically significant), steroid induced diabetes (steroid diabetes, medically significant), lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs (oedema peripheral), weight slowly coming down, weight up 4 lbs (weight fluctuation), rash (rash), diarrhea (diarrhoea), and leg healing (limb discomfort). On 16Apr2021, 1 year 8 months 16 days after initiating PO Orenitram, the patient was hospitalised due to acute hypoxemic respiratory failure (AHRF) from COVID (previously reported COVID-19 pneumonia) and for AHRF secondary to influenza B exacerbating PAH, then transferred to the other hospital with volume overload and diuresis. The patient was presented with volume overload and needed oxygen requirement (none needed at home prior to both hospitalizations). The patient's breathing and oxygen were improved with diuresis. Patient's pulmonary hypertension was treated with steroids as though to be flare due to lupus. Patient was given intravenous (IV) solumedrol (25 mg in AM and 16 mg in PM) as per the discussion with rheumatology and pulmonary hypertension cardiology with improvement in oxygen status. On 24Apr2021, the patient relevant diagnostic and laboratory test included: complete blood count (CBC) WBC (white blood count) 4.79, RBC (Red blood cell count) 3.31, Hgb (hemoglobin) 8.4, Plt (Platelet count) 146. Comprehensive metabolic panel (CMP) Na (sodium) 141, K (potassium) 4.1, Blood urea nitrogen (BUN) 39, Creatinine 1.68, glucose 90. On 25Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.51, RBC 3.24, Hgb 8.2, Plt 159. Na 141, K 4.4, BUN 39, Creatinine 1.59, glucose 117. On 26Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.41, RBC 3.30, hgb 8.3, Plt 159. Na 141, K 4.4, BUN 37, creatinine 1.54, and glucose 90. The patient was discharged on 26Apr2021. Patient's physical exam at the time of discharge showed pulse 65 bpm, respiratory rate 18 per minute, blood pressure (BP) 138/78 mmHg, temperature 36.5 °C and weight was 90.9 kg. The patient was breathing comfortably in no distress on 2 Litre nasal cannula (NC). Minimal crackles appreciated in the morning posteriorly. The patient had 2+ pitting edema, to knees 1+ dependent edema at thighs and edema unchanged but overall leg size decreased. Continues to be pitting but improved on the day of discharge. Patient's discharge diagnosis pulmonary hypertension exacerbation. Patient's diuretics were increased from 40 mg daily to 60 mg daily and may needed more diuretics. Discharge medications included: Protonix (pantoprazole), Demadex (torsemide), Medrol (methylprednisolone), Citracal + d (calcium citrate, ergocalciferol), Lanoxin (digoxin), Epipen (epinephrine), Lexapro (escitalopram oxalate), Folvite (folic acid), Plaquenil (hydroxychloroquine sulfate). Patient's medications of Pepcid, Lasix, and Aldactone were stopped after discharge from the hospital. The patient was instructed to take pantoprazole 40 mg daily while on steroids and when steroids tapered, he had to discontinue it in future and would stop pantoprazole and resume taking home dose of famotidine. Patient was on nifedipine at home and physician thought to be the contributing factor to lower extremity edema so stopped taking the nifedipine in house. It was reported that steroid induced the diabetes. It was reported that the patient needs transesophageal echocardiogram (TEE) due to had worsening MR (mitral regurgitation) but not agreeable at that time. The patient tried ethacrynic acid 50 mg daily but felt it was not making a difference with his weight. The patient went back on the Bumex (bumetanide) on Friday. Patient's weight slowly coming down to see doing good later on Bumex, his rash subsiding and leg was healing. Patient's weight was stable at 155 lbs and had multifactorial stable shortness of breath (SOB). Patient's weight was above baseline and needed more diuretics. Patient had been in touch with his COVID positive brother who was symptomatic and refused to be covid testing quarantining at that time. On 24Feb2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 °F in 2021. The patient would take Tylenol (paracetamol) and monitor if fever persists to 48 hours he would go to the urgent care. Patient was started on Eliquis and felt much better and no longer to had temperatures and diarrhea. On an 21Apr2021, the patient had right heart catheterization which revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52. Patient had chronically high PAD's and could not take metolazone secondary to hypercalcemia and pending admission for colonoscopy with the physician. Patient reminded multiple times by physician for getting a COVID-19 swab. The patient also had increased 4 lb weight in Apr 2021 since discharge from the hospital. Action taken with PO Orenitram dose due to the event of COVID-19 pneumonia was updated to dose decreased and for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea and limb discomfort was not reported. Action taken with nifedipine, and Medrol dose for the events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia diarrhoea and limb discomfort was not reported. At the time of reporting, the outcome of the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation was unknown. The outcome of the events of rash and limb discomfort was recovering. The outcome of the events of pyrexia and diarrhoea was recovered on an unreported date in 2021. The reporter did not provide causality for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea, and limb discomfort. Case Comment/Senders Comment: The company has assessed the serious adverse events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, and steroid diabetes as not related to Orenitram. The event of COVID-19 pneumonia was related to the ongoing SARS-CoV-2 pandemic, and the event influenza was related to seasonal Influenza B. The event acute respiratory failure was likely related to acute influenza, but was also possibly impacted by pulmonary insult from COVID-19 pneumonia, and underlying lupus associated with PAH. The event pulmonary arterial hypertension was likely an exacerbation of the underlying PAH due to the concurrent infections. The event mitral valve incompetence and fluid overload were likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event steroid diabetes was likely related to co-suspect medication Medrol, which was used as treatment for the lupus, although co-suspect medication nifedipine was possibly contributory to the event in view of its safety profile and as such cannot be excluded. Pfizer is a marketing authorization holder of [Nifedipine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Nifedipine] has submitted the same report to the regulatory authorities. Information on the batch/Lot number has been requested.; Sender's Comments: Based on the temporal association and the known safety profile, a possible contributory role of BNT162B2 to the development of drug ineffective, COVID-19, pneumonia, rash, pyrexia and diarrhoea cannot be excluded. Acute hypoxemic respiratory failure was secondary to COVID-19, therefore was also considered as related to BNT162B2. The other events were considered as due to underlying or intercurrent conditions and unrelated to BNT162B2. Steroid diabetes was considered as related to methylprednisolone and other events were unrelated to methylprednisolone. Oedema peripheral and limb discomfort were considered as related to nifedipine and other events were unrelated to nifedipine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-05-21 fever AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to ... Read more
AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; COVID-19 and Pneumonia/COVID-19 pneumonia; COVID-19 and Pneumonia/COVID-19 pneumonia; Acute hypoxemic respiratory failure from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus; Volume overload; Worsening MR (mitral regurgitation); Steroid induced diabetes; Lower extremity edema, 2+ pitting edema, to knees. 1+ dependent edema at thighs; Weight slowly coming down, weight up 4 lbs; Rash; Diarrhea; leg healing (limb discomfort); Fever, temperature 101.1 F; This is a solicited report received from a non-contactable other health care professional via pharmacy. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 24Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation, nifedipine, oral from an unspecified date at unspecified dose for hypertension, methylprednisolone (MEDROL, tablet), oral from an unspecified date at 16 mg, daily (every evening), and oral from an unspecified date at 1.5 DF, daily for an unspecified indication, and treprostinil diolamin (ORENITRAM), oral from 01Aug2019 at unspecified dose, oral from an unspecified date (Lot Number: 2101647; Expiration Date: 30Jan2022) at 3.875 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101648; Expiration Date: 31Jan2022) at 3 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101649; Expiration Date: 31Jan2022) at 2.875 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101646; Expiration Date: 31Jan2022) at unspecified dose, and oral from an unspecified date (Lot Number: 2101810; Expiration Date: 31Jan2023) at unspecified dose for Primary Pulmonary arterial hypertension. The patient's medical history ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, ongoing Sleep apnoea syndrome (obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP)), ongoing Hypercalcaemia, ongoing Peripheral arterial occlusive disease, ongoing Dyspnoea, family history of COVID-19 (Brother positive), ongoing Continuous positive airway pressure, and ongoing Hypertension. The patient's concomitant medications included ambrisentan (LETAIRIS), sildenafil citrate (REVATIO), calcium citrate, ergocalciferol (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), digoxin (LANOXIN), epinephrine (EPIPEN), escitalopram oxalate (LEXAPRO), folic acid (FOLVITE [FOLIC ACID]), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); all ongoing, famotidine (PEPCID [FAMOTIDINE]) from an unspecified start date to Apr2021, furosemide (LASIX [FUROSEMIDE]) from an unspecified start date to Apr2021, spironolactone (ALDACTONE [SPIRONOLACTONE from an unspecified start date to Apr2021, and apixaban (ELIQUIS). On 23Mar2021, the patient experienced COVID-19 and pneumonia (COVID-19 pneumonia). The patient was hospitalized on 23Mar2021. The patient was on oxygen at the time of reporting. On 06Apr2021, the patient had pneumonia. The patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient clarified it as COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID-19 pneumonia. On 16Apr2021, the patient had acute hypoxemic respiratory failure (AHRF) from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH, Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus, AHRF secondary to Flu B and PAH with baseline PAH, volume overload. The patient was hospitalized due to the events on 16Apr2021 to 26Apr2021. The patient was presented with volume overload and needed oxygen requirement (none needed at home prior to both hospitalizations). The patient's breathing and oxygen were improved with diuresis. The patient was treated with steroids as though to be flare due to lupus. Patient was given intravenous (IV) solumedrol (25 mg in AM and 16 mg in PM) as per the discussion with rheumatology and pulmonary hypertension cardiology with improvement in oxygen status. On 24Apr2021, the patient relevant diagnostic and laboratory test included: WBC (white blood count) 4.79, RBC (Red blood cell count) 3.31, Hgb (hemoglobin) 8.4, Plt (Platelet count) 146. Comprehensive metabolic panel (CMP) Na (sodium) 141, K (potassium) 4.1, Blood urea nitrogen (BUN) 39, Creatinine 1.68, glucose 90. On 25Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.51, RBC 3.24, Hgb 8.2, Plt 159. Na 141, K 4.4, BUN 39, Creatinine 1.59, glucose 117. On 26Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.41, RBC 3.30, hgb 8.3, Plt 159. Na 141, K 4.4, BUN 37, creatinine 1.54, and glucose 90. The patient was discharged on 26Apr2021. Patient's physical exam at the time of discharge showed pulse 65 bpm, respiratory rate 18 per minute, blood pressure (BP) 138/78 mmHg, temperature 36.5 C and weight was 90.9 kg. The patient was breathing comfortably in no distress on 2 Litre nasal cannula (NC). Minimal crackles appreciated in the morning posteriorly. The patient had 2+ pitting edema, to knees 1+ dependent edema at thighs and edema unchanged but overall leg size decreased. Continues to be pitting but improved on the day of discharge. Patient's discharge diagnosis pulmonary hypertension exacerbation. Patient's diuretics were increased from 40 mg daily to 60 mg daily and may needed more diuretics. Discharge medications included: Protonix (pantoprazole), Demadex (torsemide), Medrol (methylprednisolone), Citracal + d (calcium citrate, ergocalciferol), Lanoxin (digoxin), EpiPen (epinephrine), Lexapro (escitalopram oxalate), Folvite (folic acid), Plaquenil (hydroxychloroquine sulfate). Patient's medications of Pepcid, Lasix, and Aldactone were stopped after discharge from the hospital. The patient was instructed to take pantoprazole 40 mg daily while on steroids and when steroids tapered, he had to discontinue it in future and would stop pantoprazole and resume taking home dose of famotidine. Patient was on nifedipine at home and physician thought to be the contributing factor to lower extremity edema so stopped taking the nifedipine in house. It was reported that steroid induced the diabetes. It was reported that the patient needs transesophageal echocardiogram (TEE) due to had worsening MR (mitral regurgitation) but not agreeable at that time. The patient tried ethacrynic acid 50 mg daily but felt it was not making a difference with his weight. The patient went back on the Bumex (bumetanide) on Friday. Patient's weight slowly coming down to see doing good later on Bumex, his rash subsiding and leg was healing. Patient's weight was stable at 155 lbs and had multifactorial stable shortness of breath (SOB). Patient's weight was above baseline and needed more diuretics. Patient had been in touch with his COVID positive brother who was symptomatic and refused to be covid testing quarantining at that time. In 2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 F. The patient would take Tylenol (paracetamol) and monitor if fever persists to 48 hours he would go to the urgent care. Patient was started on Eliquis and felt much better and no longer to had temperatures and diarrhea. On an 21Apr2021, the patient had right heart catheterization which revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, ci 3.52. Patient had chronically high PAD's and could not take metolazone secondary to hypercalcemia and pending admission for colonoscopy with the physician. Patient reminded multiple times by physician for getting a COVID swab. The patient also had increased 4 lb weight since discharge from the hospital. In 2021, the patient experienced had fever, temperature 101.1 F. On an unknown date, the patient experienced had worsening MR (mitral regurgitation), steroid induced diabetes, lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs, weight slowly coming down, weight up 4 lbs, rash, diarrhea, and leg healing (limb discomfort). In 2021, patient weight was up by 4 lbs since discharge from hospital. The action for nifedipine in response to the events was unknown. The action for methylprednisolone in response to the events was unknown. The action for treprostinil diolamin in response to the events was unknown. The outcome of the events COVID-19 pneumonia, drug ineffective, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation was unknown. The outcome of the events rash and limb discomfort was recovering. The outcome of the events pyrexia and diarrhoea was recovered on an unknown date in 2021. Case Comment/Senders Comment: The company has assessed the serious adverse events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, and steroid diabetes as not related to Orenitram. The event of COVID-19 pneumonia was related to the ongoing SARS-CoV-2 pandemic, and the event influenza was related to seasonal Influenza B. The event acute respiratory failure was likely related to acute influenza, but was also possibly impacted by pulmonary insult from COVID-19 pneumonia , and underlying lupus associated with PAH. The event pulmonary arterial hypertension was likely an exacerbation of the underlying PAH due to the concurrent infections. The event mitral valve incompetence and fluid overload were likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event steroid diabetes was likely related to co-suspect medication Medrol, which was used as treatment for the lupus, although co-suspect medication nifedipine was possibly contributory to the event in view of its safety profile and as such cannot be excluded. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, events of COVID-19 pneumonia, Drug ineffective, Fever, Diarrhea could be related to the suspected drug of BNT162B2. All the other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The reported events are considered unlikely related to the suspected drug of Nifedipine. The events of Diabetes steroid-induced is most likely related to co-suspect medication Medrol, which was used as treatment for the lupus. All the other events are considered unlikely related to the suspected drug of Medrol. Medical history of ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, and ongoing Dyspnoea may provide explanations for some of the events (such as Pulmonary arterial hypertension, Volume overload, Mitral regurgitation, and Oedema peripheral). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
57 2021-05-22 influenza like illness, fatigue Upper body aches: throughout arms, fingers, shoulders, chest, lower torso. Muscle weakness. Shortnes... Read more
Upper body aches: throughout arms, fingers, shoulders, chest, lower torso. Muscle weakness. Shortness of breath. Rapid exhaustion. Tiredness. I felt like I was coming down with the flu or a cold.
57 2021-05-24 cough, fatigue Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 w... Read more
Patient received a 2nd dose of Pfizer vaccine on 5/3/2021. Patient presents to the ED on 5/23/2021 with chief complaint of fatigue, chest pain, shortness of breath on exertion. Patient reports fatigue of 2 week duration associated with right-sided chest discomfort, dyspnea, and night sweats. He reports approximately 1 week ago onset of pleuritic R-sided, nonradiating chest pain, with provocative factor of cough and palliative factor of lying supine. He additionally reports dyspnea on exertion and at rest and night sweats of 1 wk duration. CT chest angio showed Large Pericardial effusion, moderate Left pleural effusion, mild right pleural effusion, ascites. On 5/24/2021, patient underwent pericardiocentesis with 800cc of reddish fluid drainage, and left thoracocentesis with transudative fluid. Cytology is pending.
57 2021-05-24 headache Dizziness, headache, and ear blockage/popping setting in 8 days after first Pfizer shot. Dizziness ... Read more
Dizziness, headache, and ear blockage/popping setting in 8 days after first Pfizer shot. Dizziness not incapacitating but noticeable and persistent. Consulted primary physician who diagnosed as ear canal pressure issue and prescribed Flonase. No relief after a week. Consulted ENT who diagnosed as BPPV and performed Epley Maneuver. Prescribed home Epley Maneuver treatment for a week. 5 days into those treatments and no relief (typically, 90% of patients suffering from BPPV will be cured by just one Epley Maneuver treatment).
57 2021-05-25 fatigue, headache Patient presented with SOB for 2 weeks post vaccination along with headache, fatigue/nausea. He was ... Read more
Patient presented with SOB for 2 weeks post vaccination along with headache, fatigue/nausea. He was found to have pericardial effusion and bilateral pleural effusions. He had pericardiocentesis with 975ml drained. He had bilateral thoracentesis with 820 ml drained from R lung and 800 ml drained from L lung.
57 2021-05-26 fatigue, headache, fever, malaise 101 fever, injection spot sore, headache, tired, feeling unwell
57 2021-05-26 sweating Pt became diaphoretic following1st dose of Pfizer vaccine. Medics placed pt on cardiac monitor. Ca... Read more
Pt became diaphoretic following1st dose of Pfizer vaccine. Medics placed pt on cardiac monitor. Cardiac rhythm was ST, then pt went into A-fib. VS: BP=184/100, HR= 128, RR= 22, 02 sat= 98% RA. Pt stated he had not taken his BP med today. 911 called and pt transported to hospital. VS at transport: BP= 165/122, HR= 130, RR= 22, 02 Sat= 99%. Cardiac rhythm: A-fibrillation Medics placed an 18G L AC prior to departure.
57 2021-05-27 dehydration, malaise passed out; blood pressure is low/blood pressure was 80 something over 50 something; white blood cou... Read more
passed out; blood pressure is low/blood pressure was 80 something over 50 something; white blood count is high; dehydrated; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received bnt162b2 (PFIZER COVID 19 VACCINE, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 22Apr2021 08:00 (57-years-old) as 1st dose, single for COVID-19 immunization (his cardiologist recommended him to get it and signed him up for it). Medical history included ongoing coronary stents (Has 18 coronary stents in total. The last three stents were put in 2018), burning of nerves in the back from Apr2021 (The burning of nerves was done through injection), underlying heart issue, neuropathy, diabetes, blood pressure, Cholesterol. Concomitant medications included metformin taken for diabetes from an unspecified start date and ongoing; pantoprazole from an unspecified start date and ongoing; lorazepam from an unspecified start date and ongoing; gabapentin like a nerve block for neuropathy and diabetes from an unspecified start date and ongoing; isosorbide taken for slow release nitro for heart from an unspecified start date and ongoing; carvedilol taken as beta blocker and helps blood pressure and stuff from an unspecified start date to 10May2021; rosuvastatin taken for cholesterol from an unspecified start date and ongoing; ticagrelor (BRILINTA) taken as blood thinner; losartan taken for blood pressure from an unspecified date and unspecified date; acetylsalicylic acid (ASPRIN, Bayer) from an unspecified start date and ongoing; magnesium from an unspecified start date and ongoing; furosemide taken as water pill from an unspecified date and unspecified date; metoprolol from 10May2021 to an unspecified stop date; amlodipine from an unspecified date and from May2021; chlorthalid tabniva taken as water pill (25mg at night at the time of the shot, couple of days ago he had to start cutting it in half, now he is only taking 12.5mg at night). The patient previously took Plavix (Brilinta replaced Plavix to keep his stents open. He was on Plavix over 6 years ago), Fentanyl, and Versed. The patient experienced passed out (hospitalization) on 04May2021, blood pressure is low/blood pressure was 80 something over 50 something (hospitalization) on 01May2021, not feeling well on Apr2021, white blood count is high on an unspecified date, dehydrated on an unspecified date. The patient was hospitalized for passed out and blood pressure is low/blood pressure was 80 something over 50 something from 04May2021 to 05May2021. The patient underwent lab tests and procedures which included blood count: 13 on 12May2021. The patient received Pfizer COVID vaccine and reported after 1st dose received on 22Apr2021 he is not feeling well, he has an underlying heart issue and a history of stents placed, white blood cells are high and has a low blood pressure. His Dr. asked him to call Pfizer to ask if this could have been reported as side effects from vaccination. He was asking if he should get the second dose. He had Pfizer shot and has got to get the second one on Saturday. He doesn't know if it is related or not. He has been going to the doctor. He has underlying conditions and takes heart medications and has stents. He has not been feeling good since getting the shot. He is not sure if it is affiliated. His white blood count is high and he has to go to the doctor. His doctor is advising him to hold off on getting the second one and told him to call and ask if anyone else has had side effects like that. He clarified shot as COVID19 Vaccine. He saw his cardiologist yesterday and they thought it was interesting that he started having problems. They wanted him to call the phone number and see if he can postpone the second one. He is not sure if it is related to the shot. His blood pressure has been really low (01May2021) since taking the shot. He takes a ton of medications and they are having to adjust his medications since. Not been feeling good is ongoing. It started 3 to 4 days after getting shot. White blood count is high information reported as he was in the hospital and they didn't say anything about his white count. They did his blood count yesterday and they said it was 13 and want him to see his primary care. He just found out about that yesterday. He is going to see his primary care today. He was in the hospital from 04May2021 to 05May2021 because he passed out because his blood pressure was 80 something over 50 something. Blood pressure is low has improved but they have adjusted his medications to help it improve. COVID19 Vaccination Card: it says first dose COVID19. It doesn't have how much was administered. There is a number 42221 on the vaccination card, but he is not sure what it is. At first caller had said he got the vaccine on 24Apr2021, but then clarified that he got the vaccine on 22Apr2021. The patient went to Emergency Room. His wife had to call the ambulance because his wife thought it was his heart. They took him to the ER. They were treating him for his heart and then realized it was his blood pressure was extremely low. Prior Vaccinations (within 4 weeks): No vaccine, but he did have burning of nerves in the back at Pain Clinic done in Apr2021. The burning of nerves was done through injection. He has had it done many times. They give him a local anesthetic when they do it and also Fentanyl and Versed. He has had Fentanyl and Versed many times, due to having stents. Family Medical History Relevant to AE: No. His sisters have gotten it and they are fine. His brother has gotten it and he is fine. Patient did not wish to do a report about his siblings experience with the vaccine. His brother has issues like caller and takes medications, but he hasn't had any side effects from the vaccine. The outcome of the event blood pressure is low/blood pressure was 80 something over 50 something was recovering, not feeling well was not recovered, while for other events was unknown.
57 2021-05-27 headache, chills body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shak... Read more
body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
57 2021-05-28 chills, headache body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report ... Read more
body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Apr2021 08:00 (Batch/Lot Number: EW0171) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, body aches, chills, goes from being cold and hot, headache and dizziness. Reporter clarifies that after the first dose of the covid vaccine, patient had all of the same symptoms but he did not pass out. Patient never felt 100 percent after receiving the first dose of the covid vaccine. All of the same symptoms after the first dose began the night patient received the first dose of the covid vaccine, 20 Apr 2021. The outcome of the event goes from being cold and hot was unknown while not recovered for the other events.
57 2021-05-28 cough, pneumonia Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath... Read more
Presented to ED with complaint of chest pain onset 0800 this morning. He endorse shortness of breath and a cough that has been ongoing for three weeks.Patient even at rest has significant tachypnea usually in the 40s and sometimes even into the 50s breaths per minute. Sepsis present on admission. COVID-19 infection was diagnosed on the eighth of this month, now is negative. Has been on a ceftriaxone and azithromycin. Could be due to multifocal pneumonia and PE. Changed to cefuroxime,7-day course. Leukocytosis could be due to steroids, recommend to repeat CBC in about a week. Multifocal pneumonia: With underlying COVID-19 diagnosed on the eighth, now is negative. Completed azithromycin for 3 days and was on a ceftriaxone, changed to p.o. cefuroxime on antibiotic for suspicion for secondary bacterial infection, will complete the course. Acute bilateral pulmonary emboli: on Xarelto. Echo reviewed. Mild hemoptysis: Could be due to pulmonary emboli, infarcts, remains on anticoagulation. No recurrence. Left lower extremity DVT/SVT: Anticoagulation as above. Transaminitis: Denies use of alcohol, he has some nonspecific complaint on the right sided abdomen but negative Murphy and ultrasound shows normal gallbladder, normal liver, stable.
57 2021-05-28 headache Headaches neck pain followed by emergency room visit, schingles and meningitis. 8 days in hospital ... Read more
Headaches neck pain followed by emergency room visit, schingles and meningitis. 8 days in hospital on iv aciclovir followed by 2 weeks more at home. then 3 weeks of oral aciclovir. off work since April 28Th.
57 2021-05-30 fever, chills, throat pain, headache, fatigue, cough Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), f... Read more
Skin hurting/sensitivity (Day 1 forward), severe chills (day 2 forward), headache (day 1 forward), fatigue (day 1 forward), mild cough on/off, eye pain (? day 4 forward), achey (day 1 forward), chest rash (? day 3 forward), fever (? day 5 forward 101.9 day 5), back pain (? day 5 forward), labored breathing (? day 5 forward), diarrhea (? day 5 forward), sore throat (? day 5 forward) vomit (day 7). Symptoms of chills and miserable feeling increased day 4 on. Tylenol, Albuterol on day 6, Day 8 hospitalized, antibiotics and oxygen, Sepsis and shock, less than one day in hospital - passed on 3/2/21 am.
57 2021-05-31 fever, headache, chills At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). ... Read more
At 4:00 p.m. after shot, had nausea, fever, chills and headache. This lasted until 8:00 p.m (4hrs). Symptoms went away but started again at 1:15 a.m and lasted until 4:15 a.m. After waking up at 8:00 a.m. noticed pronounced ringing in my right ear. Later that day noticed that the top of my toes (at the base of my toes) had a burning sensation, my lower back hurt and a general overall unwell feeling. The ringing in my right ear has been nonstop since it started. The other symptoms have come and gone intermittently but are still present.
57 2021-06-01 dehydration dehydrated; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable co... Read more
dehydrated; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), fist dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 04Mar2021 (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation. Medical history included cholesterol from an unknown date and unknown if ongoing. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported. The patient reported that he had lingering effects from all week long mostly fatigue and dizziness and so just to rule it out, he had a covid test on 11Mar2021 and it came back; he found out today, 13Mar2021 that it came back positive. He further reported that he was a little bit of tired before the vaccine but didn't really had the dizziness and fatigue. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test for sugar: unknown results, urine test: unknown results (was dehydrated); all on 12Mar2021, sars-cov-2 test: positive on 11Mar2021. The patient was recovering from COVID-19 while the outcome of dehydrated was unknown.
57 2021-06-02 headache I've been experiencing itching through the night and slight headaches
57 2021-06-04 headache Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; achi... Read more
Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report. No follow up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No. Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
57 2021-06-06 chills Chills and nausea for 18 hours. Resolved on its own.
57 2021-06-07 malaise Pt c/o not feeling well in 30 min waiting area. Pt taken to Observation area via w/c. Small emesis... Read more
Pt c/o not feeling well in 30 min waiting area. Pt taken to Observation area via w/c. Small emesis. Pt laid on cot with feet up for 20 minutes & stated he was feeling better. 4:25 pm BP 136/92 P 96 Pt left with daughter walking w/o assistance.
57 2021-06-08 cough chronic dry cough.
57 2021-06-08 sweating 57 y/o with past medical history of HTN who presents with dizziness and diaphoresis post vaccination... Read more
57 y/o with past medical history of HTN who presents with dizziness and diaphoresis post vaccination. Patient states that this is the first dose in the two-dose series. Patient states that vaccination was received to the right arm. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. Patient evaluated by the NP and Paramedics. Patient placed in Trendelenburg position. Patient initial vitals all within normal limits (118/81 BP, 86 HR, 96% O2 RA and 12 Resp). Within 5 mins of Trendelenburg position patient states feeling better. Patient states that the reaction is probably due to fearing needles. Patient placed in sitting up position and water provided. Patient vitals remained within normal limits. Patient discharged in stable condition.
57 2021-06-10 respiratory tract congestion Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccin... Read more
Patient called health system call center on 5/10/21. Per pt, he had received dose 2 of pfizer vaccine on 4/20/21. Pt said about 5/6/21, he started to feel pain in arm, back and chest. Pt said, he feels congestion, lost appetite, have difficulty when swallowing, itchy and numbness in hands and fingers sometimes. Per pt, heTakes 2tablets of 500mg tylenol twice daily since pain began 5/6/21 . URgent care visit made for patient for 5/10/21
57 2021-06-11 throat pain, chills, fever, malaise, headache, fatigue Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due ... Read more
Her husband passed away; Sepsis; Shock due to bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage; misery and feeling horrible; Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number: EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation. Medical history included high cholesterol from 2017 to an unknown date, seasonal allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017 to an unknown date. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number: EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the patient previously received ZYRTEC (10mg almost daily) for seasonal allergy, ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went to the hospital emergency room (ER). It was reported that an autopsy was performed on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage. The manner of death was natural and the lung presentation is highly suggestive of diffuse alveolar damage due to COVID-19 although the patient had several negative tests for COVID. The patient tested negative for influenza AB, negative for valley fever, negative for Legionnaire's disease and was in the hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021 and was feeling miserable and asking for blood tests and urine tests, stated at that time his platelets were low at 122, glucose was high at 105, sodium was low at 134, calcium was low at 8.3, urine was negative and the patient did not get these labs til Monday when he was on the way to the emergency room and it was all different when he got to the hospital. The test for strep was negative, the oxygen was low at 86 percent when he got to the hospital on Monday and they just had to keep increasing his oxygen, stated a culture, no further details provided about the culture. A CTA done on the chest on Monday which was bad and stated the patient was symptomatic and they did not treat him for COVID but had a clinical suspicion for COVID. Adenovirus was not detected, metapneumonia virus was not detected, respiratory syncytial virus was not detected, parainfluenza was not detected, his platelets kept dropping and he had two tests for valley fever which is Cocci IGG and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222, bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at 18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD was 45.5, and platelets were low at 61. The patient came into the emergency room those labs were when he was failing completely and on 01Mar2021 was when he arrived in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at 18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3, glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The patient was negative for strep pneumonia antigen and negative for Legionnaires Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in misery and feeling horrible and they sent him home with albuterol and possible antibiotic to start that Monday and he had severe chills, headache, shortness of breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he tested negative for influenza AB and he never got to the antibiotic because they said to wait til Monday and by that time this was an emergency. The patient outcome of sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage was fatal and unknown for the other events. The patient died on 02Mar2021. An autopsy was performed that revealed the cause of death was sepsis and complications from sepsis and shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death: Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary acute disease syndrome; Diffuse alveolar damage
57 2021-06-13 cough 1st dose Pfizer 12/26/2020 Lot# EL0140, 2nd dose 01/20/2021 Lot# EL3247 Sever coughing, pericarditis... Read more
1st dose Pfizer 12/26/2020 Lot# EL0140, 2nd dose 01/20/2021 Lot# EL3247 Sever coughing, pericarditis, high blood pressure medication on now 50mg Metoprolol twice daily
57 2021-06-13 lethargy Ringing in ears, dizziness, lethargy and constant tingling in lower legs and feet.
57 2021-06-13 runny nose, sneezing Started with Running nose and sneezing approximately 2 weeks after my 2nd COVID Vaccine. LEVOCETIRIZ... Read more
Started with Running nose and sneezing approximately 2 weeks after my 2nd COVID Vaccine. LEVOCETIRIZINE, 1 per day for 35 days and then Montelukast, 1 per day for 25 days. This did not fully stop the allergy of running nose and sneezing. Visited ALLERGY Specialist, Dr. on 14 May 21 and ALLERGY test was conducted to note I was positive to tree allergy and Non-Allergic. Rhinitis. Doctor prescribed FLONASE, twice a day spray for each nostril. Got under control in 15 days. Now using Flonase once a day and feel running nose and sneezing is in control.
57 2021-06-15 cough, fever Positive Covid test; high fever; Cough; This is a spontaneous report from a contactable consumer or ... Read more
Positive Covid test; high fever; Cough; This is a spontaneous report from a contactable consumer or other non health care professional(Patient himself). A 57-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Right on 02Mar2021 18:00 (at the age of 57-year-old) as 1st dose, single dose for covid-19 immunisation at hospital. Medical history included bronchitis in the past and was slightly overweight, cough, but was told that it was probably from reflux. There were no concomitant medications. Patient was not on other Products. Patient did not take any other vaccinations within four weeks prior to the covid-19 immunisation. No AE experienced following prior vaccinations. No Family Medical History Relevant to AE. Patient's Medical History including any illness at time of vaccination was none. No History of all previous immunization with the Pfizer vaccine considered as suspect. On 02Mar2021, the patient experienced high fever, cough. He received his 1st dose on Tuesday, and since then he has had a high fever started in the evening he got the vaccine and cough. Patient said that it goes away when he takes Advil or Tylenol, then it comes back. He took cough medicine for a day or so, and now his cough just comes and goes. He would say that his cough has improved. The day before he got the vaccine, he had his annual visit with his cardiologist, and he had a cough that day, but was told that it was probably from reflux. He did not have a fever on Monday, or on Tuesday before getting the vaccine. He called his doctor and told him what was going on and his doctor recommended that to get tested for Covid. He went to an urgent care and got tested today at 2pm and patient had tested positive for covid test. Reported AE does not required visit to Emergency room. Therapeutic measures were taken as a result of events included Z-pack, Vitamin D, Vitamin C, Zinc, and Quercetin. The patient underwent lab tests and procedures which included body temperature: 99.1-101.6 degrees fahrenheit on an unknown date and COVID-19 rapid POC test results positive on 05Mar2021. Patient asked whether he get the 2nd dose in 3 weeks or does he need to start all over again and Stated that his 2nd dose was scheduled for 23Mar2021. Investigation Assessment was reported. There was a Product Complaint. The outcome of the event fever was not recovered, cough was recovering, covid-19 was unknown. Follow-up (08Mar2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that, new information included the other reporter details were updated. Description of Product Complaint: Patient Calling about the Covid 19 vaccine. He received his 1st dose on Tuesday, and since then he has had a high fever and cough. States that he went in today and had the rapid test for Covid and it was positive. Stated that the day before he got the vaccine, he had his annual visit with his cardiologist, and he had a cough that day, but was told that it was probably from reflux. He did not have a fever on Monday, or on Tuesday before getting the vaccine and he called his doctor and told him what was going on and his doctor recommended that he get tested for Covid. He went to an urgent care and got tested today at 2pm. The rapid test was positive. They also did the PCR test, which he won't get results of for about 48 hours.
57 2021-06-15 fatigue Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later... Read more
Starting on the day of the vaccine 1st dose- I felt a little dizzy in the waiting area. A day later, I felt tired and fatigued. About 6 days post vaccine, I woke up with flushing and both ears started to ring, more signficantly in the left ear. I took my blood pressure and it was elevated at 160/90. I went to the doctor the next day and had an MRI (came back normal). I was prescribed blood medication (amlodipine). I went to an audiologist and was found to have hearing loss. I went back to my PCP and my BP was still elevated and was prescribed atenolol in addition to amlodipine. Currently, I am still having flushing, fatigue, and tinnitus.
57 2021-06-16 chills, headache Severe headache, vomiting, body aches with chills all began the evening of June 15th - the day of th... Read more
Severe headache, vomiting, body aches with chills all began the evening of June 15th - the day of the vaccine. At home rest, Tylenol
57 2021-06-16 headache, fever He woke up in the middle of the night and felt like he got punched in the left arm. It really hurt; ... Read more
He woke up in the middle of the night and felt like he got punched in the left arm. It really hurt; Fever; headache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6209, expiration date: unknown), intramuscularly in the left arm on 22Apr2021, as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patients concomitant medication included calcium carbonate, colecalciferol (VITAMIN D 2000) for unspecified indications (start and stop date were not reported). Historical vaccination included patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported) via in tramuscularly in the Arm left on 01Apr2021, as a single dose for COVID-19 immunization. After vaccination the patient experienced pain in extremities. On 22Apr2021, the patient stated that he woke up in the middle of the night and felt like he got punched in the left arm. It really hurt. On an unspecified date in Apr2021, that patient experienced fever and headache and he stayed home that Friday. By that evening, he felt better. The next morning, he was 100% better. He felt so great, he went for a really long bike ride. All the events were non-serious. The outcome of the event pain in extremity was recovering. The outcome of the events fever and headache was recovered on an unspecified date in the Apr2021. No follow-up attempts are possible; Information about lot/batch number has been requested.
57 2021-06-16 headache Woke the next morning with severe headache (9/10) and stiff neck.
57 2021-06-19 influenza like illness, fever I did not experience any side effects from my first Pfizer dose. Approximately 12 hours after the v... Read more
I did not experience any side effects from my first Pfizer dose. Approximately 12 hours after the vaccine (second dose), I developed mild flu-like symptoms and I ran a low grade (99.7F) fever. During the time I had a fever, I developed a low-level, high pitch ringing in both my ears. By the next morning, the flu-like symptoms and fever were gone, but the tinnitus remained. After two months, I still have ringing in both years. Though I still consider the volume low level, it has gotten more noticeable over time.
57 2021-06-20 fever My tongue became sensitive to cinnamon oil. I had a low grade fever.
57 2021-06-21 influenza like illness, dehydration Patient reported ER visit 2 days following 2nd dose of covid 19 pfizer vacccine. He stated that he ... Read more
Patient reported ER visit 2 days following 2nd dose of covid 19 pfizer vacccine. He stated that he had severe flu-like illnesses & became severely dehydrated. He was given 4 bags of IV fluids in ER.
57 2021-06-22 fatigue This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 at 57-year-old, via an unspecified route of administration in arm left on 31Mar2021 at single dose, and the second dose at 57-year-old via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation, and testosterone, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020, and left arm bothered him. There were no concomitant medications. Patient reported his tongue and taste buds were "screwed up" and it had been painful to eat which had resulted in weight loss of 50 pounds in the last 5 months and this had gotten worse since being vaccinated. He was fatigued and his whole body hurt and sports injuries from past were very painful. He had previous Covid infection in Dec2020. He had seen many doctors and had an appointment with neurologist coming up. He didn't have much hope. He felt like he had 75% Covid all the time and his body felt like he had been hit by a truck. Not really that bad but like his taste buds were screwed up and it kind of progressed since he received the vaccine. Ever since the patient got the vaccine, the arm that he got the vaccine in it killed him, every joint in his body hurt, and he had seen lots of doctors about this and no one could figure it out. The patient was 250 pounds before this started. Patient was having something wrong with his tongue and taste buds, it was hard to explain. It was painful to eat, the patient had been to an ENT and they were sending the patient to neurology to figure it out. The tongue thing went away they thought it was thrush, then talked to another ENT and thought it was something neurological. The patient's whole body hurt. The patient was unsure when all of this started but he stated that it had worsened over the last couple of months. The patient's mouth was in pain. The patient was fatigued. The patient's left arm bothered him before the vaccine but it had progressively gotten worse over time. All of the symptoms that the patient had from COVID got progressively worse after the vaccine. The patient's arms were really lose and it felt like the arms wanted to come out of the socket. The pain could be a 9/10 and nothing touched it. The day after the first shot, the patient got testosterone shots, they found and erratic heartbeat which freaked out the patient. They did and EKG and said it was okay but couldn't determine what it was. Patient was tested and it showed hypothyroid and they did an intake test. The doctors thought it was thyroiditis but that got better but then it snowballed into what it was. Investigations: The patient was tested for cancer, rheumatoid arthritis and all sorts of different things which were all negative. The patient was a healthy guy otherwise, besides these symptoms. Action taken in response to the events for testosterone was unknown. Outcome of events his tongue and taste buds were "screwed up", the arm that he got the vaccine in it kills him/left arm bothered him before the vaccine but it had progressively gotten worse over time, every joint in his body hurt, and erratic heartbeat was not resolved, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-06-22 headache 1st day after the shot - I had a strong reaction to the 2nd dose of the Pfizer vaccine - usual sympt... Read more
1st day after the shot - I had a strong reaction to the 2nd dose of the Pfizer vaccine - usual symptoms, muscle aches, headache. 2nd day after the shot - mild achiness, getting better. 3rd day after the shot - significant chest pains in the left chest. Went to hospital. Blood test showed elevated levels of troponin. I was admitted, stayed overnight, and the next day underwent an angiogram (no blockages), a sonogram (no markers for pulmonary embolism). My last test was a cardiac MRI which definitively showed that I had MYOCARDITIS. Symptoms subsided and I was discharged from the hospital that same day on April 2nd. I've since resumed my normal workout regimen with no lasting symptoms, only a large hospital bill.
57 2021-06-24 sweating 58 y/o male presented for his second pfizer dose. Reports no medical history but stated that he had ... Read more
58 y/o male presented for his second pfizer dose. Reports no medical history but stated that he had some abdominal pain earlier and had his last meal of half egg sandwich around 12pm. He reports that he was told 1 year ago by his PCP that he had borderline diabetes. Reports that he usually passes out when he gets blood drawn. Pt reported that he felt dizzy about 5 minutes after injection at about 1:46pm that he felt lightheaded and was about to pass out when the observation staff transferred the patient to the bed stretcher. On examination, patient was alert & oriented X 3, and sweaty. Initial vital signs at 1:46pm were BP 117/67, HR 71, Temp 97, O2 sat 100%, fingerstick was 138. Repeat Vitals at 2:09pm were BP 108/83, HR 64, Temp 96.9, O2 sat 97%. Pt was escorted off the premises in stable condition at 2:09pm
57 2021-06-24 fever, body temperature increased low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to ar... Read more
low grade fever ( 100 degrees F) developed; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees.; Flushing and redness in face; Flushing and redness in face; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunization at hospital. Medical history included pollen allergies and no known allergies with medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included omeprazole 20 mg, atorvastatin 10 mg and tadalafil 5 (units not provided) (received within 2 weeks of vaccination). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:45 as a single dose for COVID-19 immunization. On 08Apr2021 at 13:15, the patient experienced rash/itching/hives, starting in groin area, moving to arms, then both sides of trunk, then behind knees and had flushing and redness in face but no swelling/itching. As rash was subsided, low grade fever (100 degrees Fahrenheit) developed. Patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event rash was recovered on an unspecified date in 2021 and the rest of the events was recovering. Information on Lot/Batch number was available.
57 2021-06-25 fever, chills, influenza like illness, headache, fatigue Severe flu like reactions for 2.5 days. Fever, extreme fatigue, body muscle aches, chills, headache,... Read more
Severe flu like reactions for 2.5 days. Fever, extreme fatigue, body muscle aches, chills, headache, loss of appetite, slight nausea.
57 2021-06-25 fever, fatigue First shot: 102 fever for first 3 days after vaccination. Then chest pain day 4-6. Shortness of b... Read more
First shot: 102 fever for first 3 days after vaccination. Then chest pain day 4-6. Shortness of breath, fatigue for 7 days. Resting heart rate elevated from 60 to 90 for 13 days. 2nd Shot: Same response & duration. Not as severe. Fever was 100. My heart rate monitor measured high Heart Rate Variation during both shots. 2-1/2 months after first shot, resting heart rate & heart variation returned to almost normal.
57 2021-06-28 influenza like illness, sinus congestion Flu like symptoms 24hrs after 2nd shot. I was happy because I felt the Vacine was working and my b... Read more
Flu like symptoms 24hrs after 2nd shot. I was happy because I felt the Vacine was working and my body was building antibodies I have had three Covid 19 tests the last week from Embry Womens Health care Phx Arizona on 6/21 and 6/23 both positive and another test yesterday still waiting results. I have Clogged sinus cavities like a cold or I am swimming are the only symptoms. I am reporting this as I think I have a breathru variant possibly Delta
57 2021-06-29 chills, headache, fever, sweating, fatigue Sweat; Body ache; Vomiting; Diarrhea; Chills; Fever; Headache; Tiredness; This is a spontaneous repo... Read more
Sweat; Body ache; Vomiting; Diarrhea; Chills; Fever; Headache; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 1115 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, high cholesterol and deaf. Concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 1400, the patient experienced vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache. The patient did not receive any treatment for the reported events. The clinical outcome of the events vomiting, diarrhea, chills, fever, sweat, headache, tiredness and body ache was resolving at the time of this report. No follow-up attempts possible. No further information is expected.
57 2021-06-29 chills, influenza like illness, fatigue extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This... Read more
extreme exhaustion; flu like symptoms set in; chills; body aches; uncomfortable; a little achy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on 05Feb2021 at 04:45 pm on the left arm as a single dose for COVID-19 immunisation. The patient's medical history included depression. The patient's concomitant medications were not reported. Patient did not take any other medications with in four weeks of vaccination. Patient's other medications within two weeks included Effexor. The patient was not tested for COVID prior vaccination. Patient's COVID past vaccination was none. The patient stated that within the 1st 24 hrs of vaccination on 06Feb2021 at 08:00 am, the patient felt uncomfortable& a little achy. On the second day after vaccination, the patient had flu like symptoms, chills, body aches in joints and lower back. On the third day, the patient experienced chills, body aches and extreme exhaustion. The patient was treated with OTC medication for the events. The outcome of the events was resolving. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
57 2021-06-30 chills, fatigue Chills; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A... Read more
Chills; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 57 years) at 14:00, as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and COVID-19. The patient was allergic to strawberries. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills and tiredness on 22Mar2021. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills and tiredness was resolving at the time of this report. No follow-up attempts needed. No further information expected.
57 2021-07-01 fatigue, sweating Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous rep... Read more
Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering. No follow-up attempts are needed. No further information is expected.
57 2021-07-01 sweating, fever Background: Exposed to Granddaughter who began experiencing fever, nausea and vomiting the evening o... Read more
Background: Exposed to Granddaughter who began experiencing fever, nausea and vomiting the evening of 3/19. Ten of twelve of the children in her preschool class (and many of their parents also) experienced the same symptoms beginning that evening or the following day. Granddaughters mother (my daughter) and father (son-n-law) also began experiencing the same symptoms on 3/21 and 3/22, respectively. I was also exposed to them on those dates. Their symptoms all resolved within two-three days. My adverse experiences: I was vaccinated at noon on 3/23. Shortly after midnight, 3/24, I began experiencing the same symptoms (see background) as my family members. The symptoms persisted throughout the days of 3/24 and 3/25. On 3/25 I visited my internist, Dr., who prescribed ciprofloxacin and ondansetron. He also ordered a COVID-19 test, for which I was negative. Shortly after midnight, 3/26 I awoke diaphoretic, noting my nausea had resolved. Also at that time, I began experiencing joint pain and a dull ache in my chest. By around 4 am the joint pain had subsided, but the chest pain had increased, to the point that I went to the Hospital ER. Although my ECG was inconclusive, troponin levels drawn were indicative for a possible NSTEMI. A cardiac catheterization was performed showing no coronary artery disease and normal cardiac function. After an echocardiogram was performed and further troponin levels decreased over the day, I was diagnosed with MYOCARDITIS, and told it was likely a result of a suspected virus that was presumed to be the cause of my previous GI illness. I was released from the hospital on 3/27. I have experienced no further symptoms since my hospitalization.
57 2021-07-02 sweating Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 10-15 mins after vaccine, pt stated he was feeling dizzy. RPh went to take pt's BP, but pt fainted. called 911. pt woke up after 5 mins, no trouble breathing, but sweating. BP was 167/93 & pulse 78. First responders came and took BP and blood sugar. pt fainted again for 5-10 mins, stopped beathing few mins and decided to transport him to nearest ER. RPh called next day 6/29 & 7/1 but no response and left message.
57 2021-07-04 runny nose, fatigue, sneezing, nasal congestion Stuffy and runny nose, sneezing, watery eyes, tired. Since July 3 to July 5.
57 2021-07-05 fever, malaise The next day I felt malaise, body aches, low grade fever. I felt like I had covid again. Couple days... Read more
The next day I felt malaise, body aches, low grade fever. I felt like I had covid again. Couple days later my ears started filling up had severe tinnitus and I started having drops outs and dizzy spells. I had a total of 5 dropouts. Severe hearing loss in left ear and have not gotten it back after the shot.
57 2021-07-06 fatigue Lost energy, head spins, tird all the time. Failed stress test, quad pupils surgury. Lost 3 months i... Read more
Lost energy, head spins, tird all the time. Failed stress test, quad pupils surgury. Lost 3 months income (17500) 225,000 dollar surgury, Is this long term effect. Sent email a couple time in the last 3 weeks
57 2021-07-06 headache I had a headache, that lasted for about a day. No meds taken for the headache, just slept.
57 2021-07-06 sinus headache Dry skin; swollen feet, hands and face; hives; peeling skin; itchiness; pressure on chest; sinus hea... Read more
Dry skin; swollen feet, hands and face; hives; peeling skin; itchiness; pressure on chest; sinus headaches; and bleeding skin
57 2021-07-07 headache Ongoing headache
57 2021-07-10 headache, sweating Tinnitus constant ringing in the ears. Ongoing went to DR unable to determine actual cause. Vertig... Read more
Tinnitus constant ringing in the ears. Ongoing went to DR unable to determine actual cause. Vertigo dizzy sweaty went to hospital no significant findings to cause incident. Daily headaches
57 2021-07-11 malaise, fever Chief Complaint covid since last friday, getting more SOB, was 88% RA History of Present Illness ... Read more
Chief Complaint covid since last friday, getting more SOB, was 88% RA History of Present Illness Patient is a 58-year-old male with a history of ADHD, Depression, sleep apnea on CPAP, hypertension, hypercholesterolemia, and type 2 diabetes presenting for concerns of shortness of breath after being diagnosed with Covid. Patient first started having symptoms 10 days ago with fevers, diarrhea, and malaise. He tested positive for Covid 8 days ago, despite being vaccinated with the Pfizer vaccine in February. He states that he has been getting progressively more short of breath, to the point where he is having to take breaks while going upstairs to his bedroom. He called EMS to the scene, who state that when they arrived that he was saturating 88% on room air, so he was placed on a nonrebreather. Patient states that his fevers have stopped and the biggest issue that he is having is his shortness of breath. He does endorse some intermittent swelling in his lower extremities, which he takes furosemide for. Furthermore, patient started crying thrice during the interview, seemed depressed but had no thoughts of hurting himself. He denies any history of heart failure or heart attacks. He also denies any chest pain. Chest Xray was done in the ED and it showed severe diffuse bilateral lung consolidation, consistent with Covid 19 pneumonia.
57 2021-07-12 chills rashes on his hand; swelling of his eyelid; Itching; redness of his eyelid; "covid toe" blisters; ch... Read more
rashes on his hand; swelling of his eyelid; Itching; redness of his eyelid; "covid toe" blisters; chill; This is a spontaneous report from a Pfizer sponsored program by two contactable consumers (one of them was patient's wife and the other was patient self). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm on 31Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 57-year-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen; acetylsalicylic acid, ascorbic acid (ASPIRIN). The patient previously received BNT162B2 (at an unknown age) for COVID-19 immunisation as dose 1 and no reaction reported. The patient did not take any vaccination 4 weeks prior to COVID 19 Vaccine. Vaccination Facility Type was a set up clinic. The patient received his second dose of BNT162B2 on 31Mar2021 and had been experiencing AEs. The patient's wife was wondering what they should do about the AEs. The patient had been having rashes on his hand and swelling of his eyelid. The patient has been diagnosed with the "covid toe" blisters on his toe that keep coming back and getting reinfected, and rashes on his hand that keep coming back and redness of his eyelid for which they had used hydrocortisone. Right after his second dose of BNT162B2, he experienced chill, struggled for a day and that the blisters on his foot and rashes on his hands and then his eyelids appeared 3 or 4 days later. The consumer wanted to know how long will these AEs last. Treatment included the patient went up to Podiatrist, they had the patient on some antibiotics for some days or so and then he used hydrocortisone for the itching and he had also taken the Benadryl time to time. Anatomical location of administration was in the arm. Outcome of the events was unknown. Information on Lot/Batch information has been requested.
57 2021-07-14 headache Extreme headaches that started on 7/14/2021. Pain begins in neck and moves upwards in top of head.
57 2021-07-14 fever, fatigue, respiratory tract congestion, headache Positive COVID diagnosis 6/24/2021. Headache, congestion, fever, tiredness
57 2021-07-15 fatigue Developed numbness in left foot. Numbness is constant and similar to foot falling asleep. Experienc... Read more
Developed numbness in left foot. Numbness is constant and similar to foot falling asleep. Experiencing extreme fatigue.
57 2021-07-17 cough shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - ... Read more
shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving. Information about lot/batch number has been requested.
57 2021-07-17 headache, fatigue, chills, malaise, fever Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection side swe... Read more
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection side swelling, feeling unwell, hot flashes.
57 2021-07-19 throat pain, sinus disorder, cough, fever Pt received both doses of the Pfizer COVID-19 vaccine on 12/28/2020 and 1/16/2021. On 7/19/2021, he... Read more
Pt received both doses of the Pfizer COVID-19 vaccine on 12/28/2020 and 1/16/2021. On 7/19/2021, he called in to his PCP's office to report loss of taste and small, low grade fever, coughing, sore through, and "feeling like he has a sinus infection". He was tested via PCR for COVID-19, which resulted positive. Pt thus far has not needed further medical attention.
57 2021-07-19 fever, chills Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body ache... Read more
Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 29Mar2021 at 20:30, four days after getting first vaccine shot, the patient had sudden and severe reaction of side effects. At 8:30 PM, the patient was fine and then within minutes, the patient was having serious chills (the patient had a 101-degree fever), shaking, yawning constantly (very weird) and having creeping body aches. The patient struggled to bed and thankfully, the worst of it had receded within a couple of hours and patient had recovered in about 36 hours. While the patient cannot be 100 percent sure this was vaccine related. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the events of general body pain, yawning, shaking, fever and chills. The clinical outcomes of the events general body pain, yawning, shaking, fever and chills were resolved in 31Mar2021 at 08:30. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
57 2021-07-20 respiratory tract congestion, cough Tingling hands, Lungs diminishing, rash, congestion, throat swollen, cough, flushed appearance, dila... Read more
Tingling hands, Lungs diminishing, rash, congestion, throat swollen, cough, flushed appearance, dilated pupils, burning sensation at the site
57 2021-07-20 runny nose, respiratory tract congestion, fatigue, throat pain, nasal congestion sore throat, nasal congestion and runny, chest congestion, tired and body aches
57 2021-07-21 headache After receiving the vaccine, I had the initial symptoms like a headache and arm soreness. Wednesday ... Read more
After receiving the vaccine, I had the initial symptoms like a headache and arm soreness. Wednesday night at 9 o'clock, the bottom of my left foot was asleep and had a tingling feeling, like lack of circulation. The next day Thursdays, it was now on my right foot just not as bad. By Friday morning, I couldn't walk. My left foot was much worse than the right foot. I had to wobble around because I couldn't walk properly. By Friday afternoon, I went to an urgent care and the doctor said it could be a blood clot so she told me to go to the ER to check to see if I had a blood clot. I decided not to go to the ER and get that checked. On Monday I made an appointment with Dr. because it didn't get any better. I seen him and he said it is possible that this is a side effect of the vaccine. There was no test he could run on me so he informed me to sit back and keep an eye on it. I have a follow up appointment with him on July 26th because the left foot at the bottom is still asleep and tingly. I still have a tingly feeling in my right foot as well, but I am able to walk now. About 2 weeks ago, I started to get a tingly feeling in the palm of my left hand. My feet has not got any better or worse. They are just tingling. I only had this happened to me after taking the 2nd dose because I have never had this issues before.
57 2021-07-22 body temperature increased, chills body aches; chills; Temperature 99.5; upset stomach; This is a spontaneous report from a contactable... Read more
body aches; chills; Temperature 99.5; upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 08:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medications included amlodipine besilate; atorvastatin calcium (CADUET) and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 at 19:00, the patient experienced body aches, chills, temperature 99.5 (units unspecified) and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events body aches, chills, temperature 99.5 (units unspecified) and upset stomach were recovered with lasting effects on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.
57 2021-07-22 fatigue Extremely sore Arm, fatigue, migraine and cloudy mind starting 12 hours after injection
57 2021-07-25 fatigue Tinnitus, skin rash and excessive tiredness
57 2021-07-27 fatigue, headache, chills, fever, cough This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 57 years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 31Mar2021 12:00 (at the age of 57 years)(Batch/Lot Number: ER8732) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date. There were no concomitant medications. The patient previously took allegra and experienced allergies. Patient historical vaccine included Shingrix (he got Shringrix closer to 2 months ago). It was reported that, caller would like to know why he got sicker from the covid vaccine than from the natural infection itself which he had 27Nov2020. DSU: E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Report# #. Caller states 'how do I have more symptoms than when I actually caught the virus?' after receiving the 1st dose of the covid vaccine. It was not anaphylaxis or an allergic reaction as his shortness of breath happened 1-2 days after receiving the dose and today was the 5th day and he was starting to feel better. Caller used the term (Withheld) information referring to information he has received so far. Unclear from who exactly. Additional Context: States he was calling about the Pfizer covid vaccine and was calling to report severe side effects he experienced last week and for some questions he had. States he had COVID four months ago on 27Nov2020 for about 2 weeks it took to shake it and he was no worse for wear but had 103 degree Fahrenheit temperature, lost 13 pounds, had a cough that drug on and he figured he was building immunities. States he does not know how long the immunity would last from having covid so he got the Pfizer COVID Vaccine and took the 1st dose on 31Mar2021; states the vaccine made him sicker with more symptoms and he was worse with the vaccine than he was with the actual disease covid. HCP information: Caller declined to provide HCP information and states he feels that is not necessary. Reporter details: Caller declined to provide email address. States by the evening on 31Mar2021, he had a headache, a very sore arm and never had a vaccine or shot that hurt as much as the Pfizer COVID Vaccine did; no further details provided. States what he experienced was listed as potential side effects and by that evening, he was feeling shivers, had a temperature, it made him really tired, pounding headache and elevated pulse; states his fever got up to 102.2 degrees Fahrenheit and he has probably hotter than that when he checked his temperature. Caller states these symptoms lasted through about 2 days; states the fever resolved with Tylenol and has not taken it this morning and kind of had leftovers and was trying to shake it; states he had 3-4 days of Tylenol and last night it seems to take the fever out. States the elevated pulse was up by 30 and he clarified to state his pulse usually runs normally by his wrist 55-75 resting heart beat and his pulse was 87 for about three days and the Pfizer vaccine jacked him up. States he had muscle joints, aches and pains and chills and doesn't know if the vaccine caused the fever or how severe but he had to get in bed and the 2nd day he did not get up. States the injection site was swelling and had pain and he had swollen lymph nodes. States if he had not felt better on Saturday morning he would have gone to the urgent care or to his HCP but he started to feel a little better. States the Pfizer vaccine caused a cough and shortness of breath for about 2 of the three days after he got the vaccine. States the elevated pulse struck him as strange and he did not experience this with the covid he had last fall and he did have the cough last fall with covid after Thanksgiving but was not short of breath and was able to keep exercising at that time and going through that hit him harder with the vaccine. Caller states he slept in his chair which cleared his lungs and it really surprised him that this occurred. States he takes vitamins and an allergy pill Allegra and takes Tamsulosin in the morning for his prostate deal and has taken all of these for years and started the Allegra probably last month since it was spring and he has allergies. States he got the 1st dose of Shingrix weeks earlier than the Pfizer vaccine but does not know the date; states he got Shringrix closer to 2 months ago when he had his annual physical and follow up and checked before scheduling the Shingrix and was told as long as it was two weeks apart from the Pfizer vaccine he was good and thought it might be around 6 weeks that he had the Shingrix and the HCP is his primary doctor and it was Dr. (Withheld). States he tried to do the online filing with the CDC website from the sheet they gave him but the website did not work and when the channels and numbers don't work it wastes everyone's time. States he got the Pfizer vaccine and the Shingrix vaccine in different arms on purpose. States his questions are if he can't get the disease from the Pfizer vaccine, why did he get additional symptoms that were more severe than when he had the disease covid; what is the level of effects with one dose of the Pfizer Vaccine and he would not have taken it if he knew how severe he would react and is not planning on getting the 2nd dose; if this is normal and was it expected and Pfizer is keeping quiet to coax everyone to get the vaccine right now he is not taking the 2nd dose, so what is good for the 1st and he feels like he had a booster with his 1st dose and feels like he had 2 doses since he actually had covid prior to the vaccine; people his age are older and have more severe side effects with the 2nd dose he has read and maybe this is the 2nd dose so why would he get the 2nd dose. Caller states he will take his chances on getting the disease. States he thinks it had been more than a month since he had the Shringrix vaccine and states he has no lot number, expiry date or NDC to provide. The patient underwent lab tests and procedures which included on an unspecified date, shake: 103 fahrenheit, shake 102.2 fahrenheit, heart rate: up by 30, heart rate: 87. Therapeutic measures were taken as a r Therapeutic measures were taken as a result of event fever got up to 102.2 degrees Fahrenheit. The outcome of the events fever got up to 102.2 degrees Fahrenheit was recovered on 02Apr2021, shortness of breath was recovering, for other events outcome was unknown. No follow-up attempts are possible. No further information is expected.
57 2021-07-27 fatigue I'm a long-time platelet donor. Since receiving my celiac disease diagnosis 6 years ago, my iron num... Read more
I'm a long-time platelet donor. Since receiving my celiac disease diagnosis 6 years ago, my iron numbers have stayed up, as I am able to absorb nutrients better. However, since the vaccinations, my hemoglobin levels have dropped. Before the vaccinations, my hemoglobin levels were always in the 14-15 range, but since receiving the vaccinations, the levels have dropped to the 12-13 range. As a result, I have been deferred several times from making donations. Also, because of the lower iron levels, I have been tired more often.
57 2021-07-27 fatigue brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bri... Read more
brain fog; Tiredness; Spike in blood pressure/High very high Blood pressure, needed treatment to bring down 210 over 109.; immediately ringing in ears; Facial stiffness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm (reported as left shoulder) on 29Mar2021 09:30 (Batch/Lot Number: ER8730) (at the age of 57-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient had no relevant medical history and no known allergies. There were no concomitant medications. On 30Mar2021, the patient experienced spike in blood pressure, immediately ringing in ears, and facial stiffness. On 31Mar2021, the patient experienced brain fog and tiredness. It was further reported that after tracking O2, blood pressure, heart rate and exercise for one and half years with all being under normal, the patient almost immediately had ringing in ear, facial stiffness, high very high blood pressure, needed treatment to bring down 210 over 109 (blood pressure medicine). The events spike in blood pressure, had ringing in ear, and facial stiffness were considered as serious important medical event. The events spike in blood pressure, brain fog and tiredness resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: normal in 2020, blood pressure measurement: needed treatment to bring down 210 over 109 in 2021, heart rate: normal in 2020, oxygen saturation: normal in 2020, and physical examination: good (released for sports) on 30Sep2020. Therapeutic measures were taken as a result of all events. The patient received the second dose of bnt162b2 administered in left shoulder on 19Apr2021 09:30 (Batch/Lot number: EW0153). The patient was recovering from spike in blood pressure, immediately ringing in ears, and facial stiffness while outcome of brain fog and tiredness was not yet recovered. Follow-up attempts are completed. No further information is expected.
57 2021-07-27 fever, fatigue Received the 1st dose of the Moderna vaccine on 17Apr2021 and for his 2nd dose of vaccine, he was ad... Read more
Received the 1st dose of the Moderna vaccine on 17Apr2021 and for his 2nd dose of vaccine, he was administered the Pfizer Vaccine yesterday 20May2021; Vertigo; Had throwing up; Was very tired; Has severe pain in the left arm; Fever; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0177) via an administered in left arm via unknown route of administration on 19May2021 at 11:15 am as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 048BZ1A) via an unknown route of administration on 17Apr2021 at 12:45 to 17Apr2021 12:45, at dose 1, single for an unknown indication. Medical history included ongoing diabetes mellitus diagnosed 4 years ago. The patient's concomitant medications were not reported. The patient received first dose of the moderna vaccine on 17apr2021 and for his second dose of vaccine, he was administered the pfizer vaccine yesterday 20may2021. On 20May2021, the patient having like vertigo, had throwing up and has severe pain in the left arm where he took the doses of the vaccines and fever. The patient reported the events began just now and he was very tired and slept and when he woke up he was standing up a little bit and throwing up and had severe pain in his left arm where he took the doses of the Moderna and Pfizer vaccines. It was reported that the events are ongoing but better after he threw up. The outcome of all the events was reported as unknown. Information on lot/batch number was available. Additional information has been requested.
57 2021-07-29 chills having arthritis in his hands, bones and joints; chills; After second dose it was worse/The second s... Read more
having arthritis in his hands, bones and joints; chills; After second dose it was worse/The second shot make this arthritis pain unbearable/The chills got worse he still has them even in 80 degrees; After second dose it was worse/The second shot make this arthritis pain unbearable/The chills got worse he still has them even in 80 degrees; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 24Mar2021 at around 3:30 or 4:00 (at the age of 57-year-old) as dose 1, single; again received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0162) via an unspecified route of administration, administered in left arm on 12Apr2021 at 4:30 as dose 2, single, both doses for COVID-19 immunization. Medical history included severely allergic to bee stings from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. There was no History of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. On 27Mar2021, 3-days after first dose, the patient began having arthritis in his hands, bones, and joints along with chills; after second dose it was worse/the second shot make this arthritis pain unbearable//the chills got worse he still has them even in 80 degrees on an unspecified date in 2021. Adverse events resulted in physician office visit on an unspecified date. The second shot make this arthritis pain unbearable. Patient couldn't hold a coffee cup after the second. Patient had to use both hands. After the second shot, a day later, the arthritis nailed him big time. Patient could have lived with the pain after the first shot. The chills set in at the same time. Patient reports HCP who told him it may be immune response and for him to call Pfizer. The doctor prescribed methotrexate and prednisone. If he were to stop it the swelling comes back in his joints again. No further details about the prednisone or methotrexate were provided. If he doesn't take the prednisone or methotrexate, he wouldn't be able to use his hands at all. The chills are worse but constant. Patient stated that it has been 3 months now since getting vaccine. The events were serious (medically significant). Patient wants to know if arthritis is associated with vaccine and how long will side effects last. Patient had no relevant tests but, there was a set up for blood work for immune response but has not had blood drawn yet. The patient received methotrexate and prednisone as treatment medication for the events. The outcome of the events arthritis, chills was not recovered; arthritis aggravated, chills worsened was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on plausible dose-event relationship and increased severity the causal role of BNT162B2 cannot be excluded for the reported events. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
58 2020-12-31 cough, respiratory tract congestion, nasal congestion Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, n... Read more
Tested positive Covid-19 infection, Cough, bronchospasm, weakness, muscle pain, chest congestion, nasal congestion, Loss of appetite since vaccine given,
58 2021-01-01 fatigue, sweating I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that mornin... Read more
I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that morning symptoms of warmness at home no fever , I checked. No issues with vaccine given approximately 0715, until 1005 am after a very busy morning with nothing but coffee to drink. As I sat down to assist in order entry in our chemo clinic I suddenly became aware of a very rapid heart rate. I realized that I was having a vaso-vagal response and started perspiring lightly and realizing I was having drop in blood pressure. I composed myself removed my mask and breathed slowly and drank cold water while sitting. After a few minutes I was able to slow my heart rate and felt secure enough to leave the pharmacy. I slowly walked and controlled my breathing and continued to drink water. I was able to return to work and continued until the end of the day. I felt somewhat fatigued until bedtime that evening. Slept reasonably well that night and had no other symptoms to my memory the following day.
58 2021-01-01 fatigue Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in ... Read more
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection. Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!! This is absolutely miserable. I think I'd rather have COVID
58 2021-01-02 fatigue Non-Pruritic Rash on Trunk and Back, Fatigue.
58 2021-01-03 chills, fatigue, fever chills; fever; bodyaches; fatigue; The initial case was missing the following minimum criteria: no a... Read more
chills; fever; bodyaches; fatigue; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 24Dec2020, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other HCP. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ej1685), via intramuscular in left arm on 22Dec2020 14:45 at first single dose, via intramuscular in left arm on 22Dec2020 15:00 at second single dose (pending to clarify), for COVID-19 immunisation. Medical history included COVID-19, high blood pressure (BP) and high cholesterol and myocarditis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. 24 hours after receiving the first vaccine (23Dec2020 16:00), the patient experienced chills fever body aches and fatigue. The events were non-serious. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered in Dec2020.
58 2021-01-03 throat irritation 30 minutes after receiving the vaccine the patient developed hives, scratchy eyes, and a scratchy th... Read more
30 minutes after receiving the vaccine the patient developed hives, scratchy eyes, and a scratchy throat. He reported to the ED and was given Benadryl, methylprednisolone, and famotidine. His symptoms resolved and he was shortly thereafter discharged.
58 2021-01-04 chills, sinus disorder sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm ... Read more
sinus issues; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; right arm sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 58-year-old male patient received the first dose of BNT162B2 (lot number: EH9899; Expire Date: 31Mar2021), via an unspecified route of administration, in arm, right upper, on 16Dec2020 11:10 AM at single dose for COVID-19 immunization. The vaccination facility type was hospital. The vaccine was not administered at military facility. Patient's medical history (including any illness at time of vaccination) was none. The patient got ill from all pain medications- from prescription strength pain killers to OTC products such as tylenol, ibuprofen and aspirin. All of them make him sick- experienced hot flashes and nausea. No additional vaccines administered on same date of the Pfizer suspect vaccine. Prior vaccinations (within 4 weeks) was none. The concomitant medication included 2 different blood pressure pills, mentioning Lisinopril, but stated he did not think his blood pressure pills were relevant to what he was experiencing with the COVID-19 Vaccine. A MRI tech (clarified by caller as MRI technologist) at a hospital who received the COVID-19 Vaccine on 16Dec2020 (caller clarified he received the vaccine at 11:10 AM on 16Dec2020). Caller stated on 17Dec2020 he had signs of aches and pains allover, a sore arm (clarified as his right arm), no fever. He also experienced sinus issues and a loss of sense of smell. Clarified his right arm was sore for only a day, his sinus issues started on 20Dec2020, and his loss of the sense of smell gradually started on 22Dec2020. He stated on 23Dec2020 he had a COVID-19 test performed and the test result was positive for the COVID-19 virus. Caller asked since he had the first COVID-19 Vaccine dose, and has now tested positive for the COVID-19 virus, should he get the second COVID-19 Vaccine dose scheduled for 06Jan2021. Patient's Height: 5' 8'' as provided by caller, who stated he has shrunk 1''. No further details provided. Patient's Weight: 169 lbs. as provided by caller, who stated his weight was as of today. Reported he worked an overnight shift, clarifying he was injected with the COVID-19 Vaccine after his overnight shift was finished on the morning of 16Dec2020. He stated he came back to work later in the day on 16Dec2020 to work another overnight shift from 9:00 PM to 7:30AM. He said after he finished is overnight shift on the morning of 17Dec2020, he went home to bed, and woke up around 12:00 PM on 17Dec2020. He said when he woke up, he started to feel aches and pains allover, and after that noticed he was getting chills periodically. Clarified he experienced the aches and pains allover for a couple of days, and then the aches and pains went away. He said he then started to get the feeling a sinus infection was coming on, but he never got a sinus infection. He said the aches, pains, and chills came back. Reported his co-worker received the COVID-19 Vaccine on Saturday, 19Dec2020, clarifying his co-worker did well with the COVID-19 Vaccine. He clarified his employer was concerned that he may have exposed his co-worker to COVID-19 when the two worked together on the overnight shift of 22Dec2020. He said both he and his coworker kept their PPE on the whole time they worked except when the two ate dinner. He said the two of them sat at a round table about 6 feet apart, and took off their masks to eat. He said his partner agreed that the two of them were right at 6 feet apart when the sat at the table to eat dinner, so their employer deemed his coworker as low risk. Reported on 22Dec2020 he had to go back to work, so he was asked for his temperature at the time, which was 98.8 degrees. He did have a flu shot previously. He was instructed as long as he doesn't have a fever over 100 degrees, he can work. The caller said he went to work on 22Dec2020, and read an email from his employer's wellness office. He said the wellness office email spoke about the COVID-19 Vaccine side effects, and instructed employees to contact the wellness office with any COVID-19 Vaccine side effects experienced. He said he left a voicemail with his employer's wellness office explaining exactly what his COVID-19 Vaccine side effects were. He said he instructed his employer's wellness office call him in the afternoon because he was going to go home, go to bed, and wake up at noon on 23Dec2020. He stated he spoke with his employer's wellness office at around 11:30 AM on 23Dec2020, and the wellness office asked for him to go to the hospital, and have a COVID19 test. Caller stated his employer performed a COVID-19 nasal swab test, and on 24Dec2020, he was told he was COVID-19 positive. He said his employer backed up his quarantine start date to 17Dec2020 (the first day he experienced symptoms), and had him follow a 10-day quarantine until 27Dec2020. He stated today, 28Dec2020, was the first day he has been off quarantine. Reported he was not saying he got COVID-19 from receiving the COVID-19 Vaccine, but should he have the second COVID-19 Vaccine injection. Clarified his symptoms were intermittent, and started coming back around 20Dec2020. Reported he was not experiencing any scratchiness in his throat, and his eyes were not watering. He said he has had no cough, no sneezing, and no trouble breathing. He said in general, it felt like something was coming on, saying it was building up, but not getting out. Clarified he had gone back to work on 23Dec2020 to have his COVID-19 nasal swab test performed, and was told by his employer on 24Dec2020 that the COVID-19 nasal swab test was positive. No AE required a visit to emergency room or physician office. The outcome of the event right arm sore was recovered on 18Dec2020 and the other events was unknown.
58 2021-01-05 chills Aches, Dizzy, Chills, high pulse rate, cant sleep
58 2021-01-05 chills diarrhea, chills, sinus drainage
58 2021-01-05 fever Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with h... Read more
Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.
58 2021-01-06 headache, chills, fever Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiet... Read more
Fever, chills, headache, body on day after vaccination. The persistent ventricular ectopy and anxiety days 2-4 after vaccination.
58 2021-01-06 headache, fatigue 01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dos... Read more
01/06/2021 2nd dose: Sore arm, metallic taste in mouth mild nausea tired feeling 12/17/2020 1st dose Pfizer vaccine :Sore arm, metallic taste in mouth mild nausea tired feeling and headache .
58 2021-01-07 chills, fever fever, chills,
58 2021-01-07 cough CoughWheeze, NauseaVomiting, restlessness/no sleep
58 2021-01-07 headache, chills Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizzi... Read more
Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; Dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site.; This is a spontaneous report from a contactable nurse. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, in left arm, on 30Dec2020 at 07:30 (at the age of 58 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a hospital. There was no medical history. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), celecoxib (CELEXA [CELECOXIB]), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccines in the 4 weeks prior to this vaccination and other medications (concomitant medications) were taken in the past 2 weeks. Prior to the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 0745, the patient experienced dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the events of dizziness, neck pain on injection side, nausea, headache, chills, arm pain at injection site, was recovered on an unspecified date. After receiving the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
58 2021-01-07 throat pain, headache, chills, lethargy Injection site pain, lethargic, headache, chills, muscle/joint pain, sore throat; increased severity... Read more
Injection site pain, lethargic, headache, chills, muscle/joint pain, sore throat; increased severity of chronic tinnitus
58 2021-01-07 pneumonia, productive cough, headache Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose. CXR in ED fo... Read more
Intermittently productive cough, dyspnea, body aches, HA, neck pain 3 days after dose. CXR in ED found LLL pneumonia and enlarged heart; given ABX and isolation.
58 2021-01-07 fever, fatigue fever 100-101, fatigue
58 2021-01-07 throat irritation, fever, chills, cough Fever chills and low grade fever at bedtime, slight throat irritation with dry cough Narrative: Low ... Read more
Fever chills and low grade fever at bedtime, slight throat irritation with dry cough Narrative: Low grade fever, body aches, chills, body aches are the worse.
58 2021-01-08 headache Headache, Myalgia, Arm pain at injection site and worsening of symptoms Narrative: Progressive head... Read more
Headache, Myalgia, Arm pain at injection site and worsening of symptoms Narrative: Progressive headache symptoms and arm pain
58 2021-01-08 headache Headache, Myalgia & Arthralgia Narrative: Developed headache shortly after vaccination, dose 1. Ove... Read more
Headache, Myalgia & Arthralgia Narrative: Developed headache shortly after vaccination, dose 1. Over time also experienced muscle and joint aches. Missed one day of work. Used ibuprofen. Feeling better now.
58 2021-01-08 fever, headache, sweating Headache, Fever, Diarrhea, NauseaVomiting, Sweating Narrative:
58 2021-01-10 chills, fatigue Myalgia, Arthralgia, NauseaVomiting, chills, fatigue Narrative:
58 2021-01-10 headache Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was... Read more
Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was becoming flushed. Nurse checked NP with reading of 212/104. Patient complained of headache and was taken to emergency department where BP was 240/112.
58 2021-01-10 sweating Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating... Read more
Taste of the vaccine in my mouth as soon as administered followed by full body flushing and sweating and hypersensitivity to sound and touch sense of depersonalization, anxiety Next morning, severe muscle and joint pain
58 2021-01-11 chills, fatigue, headache Headache, Body Aches, Chills, Fatigue
58 2021-01-11 chills, fatigue, malaise, fever Fever 3pm malaise an tiredness; chills at 3am on 1/12/2021 Narrative:
58 2021-01-11 chills severe chills & systemic symptoms that lasted 48 hours w/ the 2nd dose of this vaccine. tolerated 1s... Read more
severe chills & systemic symptoms that lasted 48 hours w/ the 2nd dose of this vaccine. tolerated 1st dose with mild arm soreness only.
58 2021-01-11 fatigue Sedation fatigue, tiredness Narrative:
58 2021-01-11 lethargy, fever diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a sponta... Read more
diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a spontaneous report from a contactable nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1686, from 04Jan2021 10:45 to 04Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included heart disorder and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included prasugrel hydrochloride (EFFIENT), metoprolol, ASA, lisinopril and atorvastatin. The patient experienced diarrhea, vomiting, body aches, fever, nausea, lethargy and shortness of breath (SOB) on 04Jan2021. The patient did not receive any treatment for the adverse events. The outcome of the evet was not recovered.
58 2021-01-12 chills, headache, fatigue Chills, headache, body aches, nausea, diarrhea, fatigue
58 2021-01-12 fatigue, malaise, headache Hwadache, body malaise, fatigue.
58 2021-01-12 fatigue fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in h... Read more
fatigue; threw up a little; patient received the second dose of BNT162B2 on 06Jan2021; soreness in his right arm/soreness in his legs/legs were hurting; did not sleep good; sick to his stomach; This is a spontaneous report from a contactable consumer (patient himself). A 58-year-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via intramuscular on 06Jan2021 15:00 in right arm at 0.3 mL (30mcg), single for preventative. There were no medical history and concomitant medications. Patient had the first dose of BNT162B2 vaccine on 19Dec2020 for covid-19 immunization. No investigation assessment was received. Patient had the second Pfizer COVID19 vaccine shot yesterday around 15:00 on 06Jan2021. He was asking if it was normal to be sore, patient had a little fatigue on 07Jan2021 and be sick to his stomach in Jan2021. The soreness in his right arm started last night (06Jan2021). He experienced soreness in his legs. He did not sleep good and his legs were hurting last night through the night. As of now his legs do not seem as bad. Patient went to work this morning and then he left work to go back home. He ate a cake and milk before he left for work. He threw up a little on 07Jan2021. It did not take much for him to gag, he even gags when brushing his teeth. Right now and within the last hour, he had not felt sick to his stomach. Outcome of soreness in his right arm/soreness in his legs/legs were hurting was not recovered, of fatigue was recovering, of sick to his stomach was recovered on 07Jan2021, of other events was unknown.
58 2021-01-12 fatigue Severe arm pain Fatigue No energy
58 2021-01-12 throat pain Anaphylaxis tongue swelling and throat soreness Narrative: developed throat pains and tongue swelli... Read more
Anaphylaxis tongue swelling and throat soreness Narrative: developed throat pains and tongue swelling 1/6/21 whereas mRNA vaccine Covid 19 Pfizer was given at Hospital. Advised not to taken 2nd dose until etiology of tongue swelling and throat pains identified. His 1/6/2021 covid 19 test (biofire- which include Covid 19 infection and all possible viral etiology was negative.
58 2021-01-12 fever myalgia Subjective fever
58 2021-01-13 fatigue, fever He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effe... Read more
He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
58 2021-01-13 throat pain, fatigue, influenza like illness Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains... Read more
Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness. ER visit for chest pains, labs and testing done, heart attack ruled out. Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed. Patient reports feeling better.
58 2021-01-14 chills, fever The day after the second dose of the vaccine this person woke up with fever, chills, muscle aches, f... Read more
The day after the second dose of the vaccine this person woke up with fever, chills, muscle aches, frequent urination, and facial swelling especially around eyes.
58 2021-01-14 fatigue, chills Got chills when tired; Got chills when tired; This is a spontaneous report from a contactable consum... Read more
Got chills when tired; Got chills when tired; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date: Mar2021) on 22Dec2020 (11:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital (not at a facility). The patient had no relevant medical history and concomitant medications. On 04Jan2021, the patient got chills when tired; further described as very minor chills in the evening or on and off in the day. The outcome of the events, chills when tired, was recovering. The patient was planning to receive the second dose on 12Jan2021.
58 2021-01-14 fever, chills, headache A couple days after the vaccination I had headache, myalgia, fever, chills and lost my sense of sme... Read more
A couple days after the vaccination I had headache, myalgia, fever, chills and lost my sense of smell. And on 12/26 I tested positive for COVID-19 after the vaccination.
58 2021-01-16 fever, lethargy, chills Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; sympt... Read more
Severe body aches, chills, fever, shaking, lethargy all staring about 12 hours after 2nd dose; symptoms lasted about 18 hours. Mild arm soreness occurred with both doses.
58 2021-01-19 fatigue Aphthous ulcer of mouth, swelling of hands and eyelids, fatigue, nausea Treatment: Triamcinolone ace... Read more
Aphthous ulcer of mouth, swelling of hands and eyelids, fatigue, nausea Treatment: Triamcinolone acetonide 0.1% dental paste, ondansetron HCL 4mg, prednisone 20 mg
58 2021-01-19 headache initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilater... Read more
initial symptoms 1 hour post vaccine: joint pain left arm (shoulder/elbow/wrist), joint pain bilateral ankles and joint pain to right foot specifically 2nd and 3rd MTP, back pain and headache. Left arm pain, back pain and headache resolved within 48 hours. Patient has continued with moderate pain into right foot (2-3rd MTP joints), now with forefoot edema and erythema and continued bilateral ankle pain.
58 2021-01-19 headache Moderate to severe joint pain. Headache. 2 ibuprofen and water. Slept for 2-3 hours . Pain gone wi... Read more
Moderate to severe joint pain. Headache. 2 ibuprofen and water. Slept for 2-3 hours . Pain gone within 8 hours
58 2021-01-20 body temperature increased Employee received COVID vaccine #2 at 0830. By 2200, employee had temp of 102.6 and bodyaches. Con... Read more
Employee received COVID vaccine #2 at 0830. By 2200, employee had temp of 102.6 and bodyaches. Continues to have temp 24 hours later.
58 2021-01-20 chills, sweating Came down with cold chills and sweats. And feeling run down
58 2021-01-21 body temperature increased Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizzines... Read more
Tempeture of 101, Spike in blood pressure, Spike in sugar of 310, Pains in Joints weakness, Dizziness
58 2021-01-21 fever, fatigue Per employee this morning started running a low grade fever of 99 and felt out of the ordinary fatig... Read more
Per employee this morning started running a low grade fever of 99 and felt out of the ordinary fatigue.
58 2021-01-22 sweating, headache, fatigue, chills, fever 15 hours after vaccination, severe body aches, chills, fever up to 101.9 (baseline 96), sweats, fati... Read more
15 hours after vaccination, severe body aches, chills, fever up to 101.9 (baseline 96), sweats, fatigue, these symptoms for 46 hours. Then nausea, headache, light headed on day 4. I had Covid pneumonia June 2020.
58 2021-01-24 body temperature increased 100F fever from 2pm - 6pm. 98F at bedtime. Normal temperature in the morn upon awaking at 6:30am.
58 2021-01-24 fatigue Body aches, fatigue, weakness
58 2021-01-25 nasopharyngitis, cough, bronchitis, throat pain About 72 hours after the shot, I got a sore throat, then a cough. Severe congestion followed. No fev... Read more
About 72 hours after the shot, I got a sore throat, then a cough. Severe congestion followed. No fever, but cold-like symptoms increased. Very bad cough. Went to urgent care twice; two COVID tests were negative. Continued worsening illness. Diagnosis on 25 Jan was Bronchitis and small lung cell collapse. Prescribed antibiotics, cough medicine, steroid shot, steroid aerosol.
58 2021-01-25 sleepiness lightheadedness; drowsiness; This is a spontaneous report from a non-contactable healthcare professi... Read more
lightheadedness; drowsiness; This is a spontaneous report from a non-contactable healthcare professional (patient). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9231, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:45 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient experienced lightheadedness and drowsiness on Jan2021 15:00. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
58 2021-01-27 chills, fever, malaise Feeling sick; fever; chills; Body aches; back pain; This is a spontaneous report from a contactable ... Read more
Feeling sick; fever; chills; Body aches; back pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK9231), intramuscular (left arm), on 12Jan2021 15:00 at single dose, for covid-19 immunization. Medical history included had Covid prior vaccination, high blood pressure, high cholesterol, and myocarditis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), intramuscular (site: left arm), on 22Dec2020 15:00 for covid-19 immunization at 58-years-old. The patient experienced feeling sick, fever, chills, body aches and back pain - all on 13Jan2021 06:00AM. No treatment was received for these adverse events. The patient had no other vaccine in four weeks, and had not been Covid-tested post vaccination. The outcome of the events was unknown.
58 2021-01-27 fatigue fatigue lasting 48 hours
58 2021-01-28 fatigue, headache, fever I developed a 108.3 degree fever 16 hours after injection. Also swollen lymph glands in left armpit,... Read more
I developed a 108.3 degree fever 16 hours after injection. Also swollen lymph glands in left armpit, inflammation on left side of body, headache, extreme fatigue
58 2021-01-29 sweating Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out... Read more
Severe pain in injection arm, profuse sweating on second day. A lot of vomiting causing me pass out out and be taken to the hospital via ambulance.
58 2021-01-31 fatigue, fever, chills 24 hours after second dose. No interruption of current medications. Patient had a syncopal episode a... Read more
24 hours after second dose. No interruption of current medications. Patient had a syncopal episode after experiencing fatigue, fevers, and chills.
58 2021-01-31 sweating, fever, headache, chills High grade fevers up to 104.0; shivers/rigors; unable to eat or drink 24-36 hours due to rigors; hea... Read more
High grade fevers up to 104.0; shivers/rigors; unable to eat or drink 24-36 hours due to rigors; headache; eye aches/ eye movements painful; extensive drenching sweats x 3 days; head shakiness; dizziness; Body aches; This is a spontaneous report from a contactable Physician (patient). A 58-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL1283), intramuscular on left arm on 07Jan2021 12:15 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 07:00 via intramuscular on left arm. No other vaccine in four weeks. On 07Jan2021 at 22:00, the patient had high grade fevers up to 104.0, shivers, rigors, headache, eye aches and eye movements painful, extensive drenching sweats for 3 days then slowed down, head shakiness and dizziness, unable to eat or drink 24-36 hours due to rigors. The patient reported that he experienced body aches, confined to bed 48 hours, then gradually and fully recovered by the end of day 4. No nausea or vomiting, and no cough. The patient took Acetaminophen 500mg x 1 oral (PO) as treatment to the events. No COVID prior vaccination. The patient was COVID tested post vaccination with 'POC test' (covid test type post vaccination=Nasal Swab) on 11Jan2021 which showed negative result. The outcome of the event body ache was recovered on 11Jan2021 and other events was recovered on unspecified date in Jan2021.
58 2021-01-31 malaise, influenza like illness, chills General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; C... Read more
General malaise; Back pain; flu like symptoms; couldn't go back to sleep; generalized muscle pain; Chills; Injection site pain; arm soreness; he did have injection site pain again and arm soreness after the second injection; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1203), via an unspecified route of administration in left arm on 14Jan2021 09:00 at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history included hypertension, high cholesterol, heart rate irregular. Ongoing concomitant medications included metoprolol for heart rate control, telmisartan (TELMISARTAN) oral at once daily for Hypertension, rosuvastatin calcium (CRESTOR) oral at 40mg once daily for high cholesterol. The patient received first dose bnt162b2 (Lot Number: EJ1685) at the age of 58-year-old for COVID-19 immunization and experienced injection site pain and arm was pretty sore. Reports he received the first dose of the Pfizer COVID 19 vaccine three week prior to the second dose. First states that was about 14Dec2020, but then clarified from his vaccine card, he received the first dose of the vaccine 23Dec2020 at 09:00AM in the left arm. He noticed injection site pain that lasted about two days and his arm was pretty sore. Both of these effects all completely resolved before the second dose. He received the second dose of the vaccine 14Jan2021 at 09:00 in the left arm. That night on 15Jan2021 at about 03:00AM in the morning he woke up with chills and general muscle pain, which he described as flu like symptoms. Adds he took his temperature but it was normal on 15Jan2021. He couldn't go back to sleep on 15Jan2021 so he took some Motrin. The next morning 15Jan2021 at 07:00 AM when he woke up, he felt okay but then in the late afternoon he started to feel the pain in his back and chills. He took Motrin and his pain and chills were gone after four or five hours. Adds it seemed like it took awhile for the Motrin to have an effect that time. Then the third day 16Jan2021, he had the same back pain and chills. He took Motrin and the pain and chills went away after 2 hours. The fourth day he only felt mild muscle pain in his back and just a little chills. He took Motrin again and it went away pretty quickly. Clarified he took Motrin at 16:00 and his pain had gone away by 16:30. He was fine by 19:00PM that evening. Adds he felt general muscle pain starting the first night he woke up and continuing with the back pain but each day all his symptoms got milder. The generalized muscle pain was minimal yesterday. He was still sore but not as bad. All of his symptoms are gone now; so far today he has not had any symptoms of the effects he reported. Adds he did have injection site pain again and arm soreness (Jan2021) after the second injection but it resolved completely by the next day (15Jan2021) after the second dose and was not as bad. Adds he felt a generalized malaise from the time he woke up on 15Jan2021 at 03:00AM after the second dose that has completely resolved when all his other symptoms resolved yesterday (17Jan2021). No any AEs require a visit to physician or ER. Therapeutic measures were taken as a result of the events. The outcome of events Injection site pain and arm soreness was recovered on 15Jan2021. The outcome of other events was recovered on 17Jan2021. Relatedness of drug to reaction(s)/event(s) was reported related.
58 2021-02-01 head discomfort, fatigue mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very ... Read more
mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the 58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative. Information on the lot/batch number has been requested.
58 2021-02-01 headache On Saturday, 1/23, 72 hours after the vaccine; I experienced a severe headache with nausea around 1... Read more
On Saturday, 1/23, 72 hours after the vaccine; I experienced a severe headache with nausea around 1;30 PM. The pain persisted for several hours. I vomited around 4:30pm and began to feel better. I remained queasy until Monday, 1/25.
58 2021-02-01 headache I developed a headache and very mild difficulty concentrating about 16.5 hours after the injection.
58 2021-02-02 body temperature increased Wheezing, Decrease in O2 saturation, Increase in RR, SOB, Temp of 99.3.Hospitalized.
58 2021-02-02 fatigue, chills Chills and fatigue began at 11:45 pm (Feb ) and ended 5:00 am (Feb 2). Mile soreness at the injectio... Read more
Chills and fatigue began at 11:45 pm (Feb ) and ended 5:00 am (Feb 2). Mile soreness at the injection site for approximately 24 hours.
58 2021-02-02 headache Dizziness, Headache, Myalgia, NauseaVomiting, Red eyes Narrative:
58 2021-02-03 fatigue, malaise Day 1-4 was pronounced fatigue, day 5-9 was intense GI distress and stabbing stomach pain, following... Read more
Day 1-4 was pronounced fatigue, day 5-9 was intense GI distress and stabbing stomach pain, following these significant events and continuing are fatigue and general malaise. Most problematic has been the re-emergence of a long dormant auto-immune disorder (12+ yrs), bullous pemphigus. This disorder, when active, causes blistering and sloughing skin in soft tissue areas. It can be very painful and uncomfortable. It usually emerges when I have a significant event that causes my immune system to plummet. I fully believe this vaccine precipitated this occurrence.
58 2021-02-03 fatigue Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not... Read more
Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not a new issue for him and frequently happens when fatigued) 1/20 sharp intermittent pain in right inner hear pinna which stopped 1 week ago 1 week ago noted some slight right facial droop which has persisted 2nd vaccine given 1/26 (prior to him seeking care for symptoms) He was seen in my office on 1/29 where he was treated for Bells Palsy.
58 2021-02-03 headache Blurred vision in right eye, spots as if I had looked into a bright light, double vision in a small ... Read more
Blurred vision in right eye, spots as if I had looked into a bright light, double vision in a small spot of my eye, then headache began to occur above right eye and progressed to the base of my neck on the back right side of the skull. After about 45 minutes the blurred vision began to subside but the headache remains.
58 2021-02-03 sweating After about 15 minutes s/p injection, patient verbalized feeling his heart racing. Vital signs at 14... Read more
After about 15 minutes s/p injection, patient verbalized feeling his heart racing. Vital signs at 14:32 BP 143/83, spo2 98% on room air, HR 102. No acute distress noted. Patient stated he felt his heart racing after his first dose but it resolved without intervention. We waited about 15 minutes more for continued observation. Patient ambulated to restroom and collapsed, diaphoretic and verbalized his heart was racing. Rapid response called and patient assisted to the ED via wheelchair.
58 2021-02-03 fever 102.7 fever 2 days. Flu symptoms severe.
58 2021-02-03 fever A fluid sack developed under the left arm in the arm pit and up into a portion of the bicep . Arm pi... Read more
A fluid sack developed under the left arm in the arm pit and up into a portion of the bicep . Arm pit is tender. Slight fever and rash on left arm under the injection site.
58 2021-02-04 chills, fever, headache, fatigue nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); c... Read more
nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
58 2021-02-04 cough, fatigue Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began ... Read more
Sore arm; mild fatigue for 24 hours; mild shortness of breath upon exertion (persists); cough began within 1 hour of 2nd vaccination; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3248), via intramuscular route in the right arm on 19Jan2021 16:30 as a single dose for COVID-19 immunization. Historical vaccine data included the first dose of BNT162B2 on 29Dec2020 at 16:30 (at the age of 58-years) via intramuscular route in the right arm. Medical history included rheumatoid arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included tofacitinib citrate (XELJANZ XR), methotrexate, atorvastatin (LIPITOR), lansoprazole (PREVACID), and celecoxib (CELEBREX). The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 19Jan2017 at 17:30, the patient experienced sore arm, cough began within 1 hour of 2nd vaccination and persisted 2 days later, mild shortness of breath upon exertion which persisted, and mild fatigue for 24 hours. The patient did not receive any treatment for the events. The patient was not tested for COVID-19 post vaccination. The clinical outcome of the events sore arm, fatigue, shortness of breath, and cough was reported recovering. No follow-up attempts are possible. No further information is expected.
58 2021-02-04 fatigue, body temperature increased I've had both the first and second shot, with the second shot initial side effects occurring 10 minu... Read more
I've had both the first and second shot, with the second shot initial side effects occurring 10 minutes sooner and lasting about 6 hours longer. 2nd wave effect occurred 3-4 days after shot; it's only been 2 days since the 2nd shot, so that effect hasn't hit yet. Note that I had similar reactions to the flu vaccine's for 17 straight years , with the exception of the brain fog. Flu shot reactions stopped when I started taking Amway Double X multivitamins and tripling up on Vitamin A, C, Zinc and echinacea 3 days before through after the vaccine. Shot 1 - initial side effects: 40 minutes after shot within a mile of returning to work from hospital, I suddenly got lightheaded and very tired with brain fog creeping in. Since that was closer than home, I continued on to work hoping it would soon pass. Brain fog, dizziness and fatigue all continued to worsen, and I was taken home. Effects lasted 9 hours. 3-4 days later the symptoms all came back and lasted 2-3 days, with the addition of temperatures in mid to high 96 range. My normal temperature is a degree low at 97.8.
58 2021-02-04 headache, chills Chills; Muscle pain remote from injection site; Headache; Painful lymphadenopathy (left axilla); Adm... Read more
Chills; Muscle pain remote from injection site; Headache; Painful lymphadenopathy (left axilla); Administration date=19Jan2021, dose number=2/ Administration date=21Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on 19Jan2021 at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. Patient has no known allergies. Concomitant medication included atorvastatin and lisinopril. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 21Dec2020 at a single dose on left arm for COVID-19 immunization. The patient experienced chills, muscle pain remote from injection site, headache, and painful lymphadenopathy (left axilla) on 20Jan2021. No treatment received for events. The outcome of the events was recovering. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
58 2021-02-04 headache, fever, sweating, chills extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120... Read more
extreme chills; awful headache; body aches; severe sweating; low oxygen; 102 degree temperature; 120 pulse rate(abnormal for me); my arm felt like it was broken (9/10), but no other problems. Twelve hours later, the pain was still 9/10".; shoulder still sore; This is a spontaneous report from a contactable 58-year-old female consumer reporting for herself A 58 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) on 16Jan2021 at 23:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. The patient did not have medical history. Concomitant medications were not reported. The patient reported at inoculation, the injection was high on right arm, and his arm felt like it was broken (9/10), but no other problems. On 17Jan2021 twelve hours later, the pain was still 9/10 so the patient put two heating pads on the site of injection. On the same day (17Jan2021) shortly thereafter, patient also experienced extreme chills, low oxygen (94), 102 degree temperature, 120 pulse rate (abnormal for him), awful headache, body aches, then severe sweating. This peaked 8 hours later and it was gone within 24 hours. No Treatment was given for the events. At the time of rh reporting the patient informed his shoulder was much better, but still sore. Patient also informed he was positive for SARS-Cov-2 from 07Dec2020 to 28Dec2020.He had mild symptoms. The patient recovered with sequel from the events on an unspecified date.
58 2021-02-09 fever Developed diverticulitis 7 days after vaccination. Low grade fever, diagnosed by CT-scan, treated as... Read more
Developed diverticulitis 7 days after vaccination. Low grade fever, diagnosed by CT-scan, treated as outpatient with oral antibiotics. I am not alleging a cause: effect realtionship between the vaccine & development of diverticulitis. I had a previous sigmoid colectomy in 2018 for diverticulitis. This was the only flair since surgery in 2018.
58 2021-02-10 headache, fatigue Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms ... Read more
Pain in arm spreading to torso. Shooting pains in torso and upper legs. Fatigue, headache. Symptoms started 12 hours after vaccination, and persisted until 36 hours.
58 2021-02-12 fatigue pain and rash at injection site, bodyaches, chest pain, fatigue, joint pain.
58 2021-02-13 headache, fatigue Significant stomach pain and distress, pronounced fatigue, headache. Most concerning was the emergen... Read more
Significant stomach pain and distress, pronounced fatigue, headache. Most concerning was the emergence of a long dormant auto-immune disorder (Bullous Pemphigus) that I have. None of these problems were present prior to the vaccination. I missed several days of work at the onset and have sought medical treatment three times.
58 2021-02-16 chills, fever, fatigue Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/hea... Read more
Immediately experienced chills; elevated pulse/heart rate and low oxygen; elevated fever; pulse/heart rate went to 120; fever went to 102.5; and oxygen at 94. After 4 hours, metrics returned to within normal range. Weak and tired the rest of evening and into the next day.
58 2021-02-17 fatigue Fatigue
58 2021-02-17 malaise, fatigue, headache activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was in... Read more
activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus; day 5-8 was intense GI distress with stabbing stomach pain; day 5-8 was intense GI distress with stabbing stomach pain; general malaise; Day 1-4 was significant fatigue and headache; Day 1-4 was significant fatigue and headache; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 14Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included high cholesterol, blood pressure abnormal, degenerative arthritis and allergies to penicillin and NSAIDS. Concomitant medications included gabapentin, lisinopril, levothyroxine and atorvastatin. On days 1-4, the patient experienced significant fatigue and headache on 15Jan2021. On days 5-8, there was intense GI distress with stabbing stomach pain, following these events has been continued with fatigue and general malaise. Most problematic was activation of a long dormant (over 12 years) auto-immune disorder, bullous pemphigus, which attacks soft tissue areas on the body with blisters and sloughing skin. This is a very uncomfortable experience to go through. The patient's healthcare provider is aware and treating him for such. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of day 1-4 was significant fatigue and headache, day 5-8 was intense gi distress with stabbing stomach pain and general malaise. The outcome of the events was not recovered.
58 2021-02-18 influenza like illness Flu like symptoms starting about 12 hours after vaccination that last for 2 days. Since then he has... Read more
Flu like symptoms starting about 12 hours after vaccination that last for 2 days. Since then he has noted an vague "lightheaded" sensation that is slowly improving. He has also noticed some heart palpitations.
58 2021-02-20 sweating Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken t... Read more
Onset of sweating, lightheadedness, dizziness, shakiness, about 5 minutes after vaccination. Taken to medical area, BP 180/100s, HR 90, Temp normal. Exam normal except for hand tremors. Minimal liquid and no food intake in last 24 hours. POC glucose 96 a minute or two after eating crackers. Given more food and water. Initial symptoms improved but continued hand tremors and persistent hypertension to high 170s/high90s for over 1 hour, HR 70s. One BP 160s/90s HR 60 but then back to BP systolic 170s. Transferred patient to local emergency room for further evaluation. Patient reported that he was discharged from ED after several hours that evening.
58 2021-02-25 fatigue pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain... Read more
pain and rash at injection site; pain and rash at injection site; body aches; joint pain; chest pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old male nurse received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Feb2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 58-year-old. Lot number was el1283. Medical history included allergy to penicillin, diabetes, Hypertension, Covid-19 (covid long haulers). Concomitant medications were unknown. On 12Feb2021, the patient experienced pain and rash at injection site, body aches, joint pain, chest pain, fatigue. The patient was not treated for the events. The patient did not recover from the events. Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
58 2021-02-25 fever Woke up this morning with a slight fever and body aches.
58 2021-02-27 chills, fatigue, headache Chills, muscle aches, headache, fatigue
58 2021-02-27 fever, headache Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache ... Read more
Next day had sore left arm 2 days after injection had mild nausea, mild fever and moderate headache 3 days woke with all symptoms gone except one new symptom - very red conjunctivitis - left eye red cornea
58 2021-02-27 fever, sweating Pfizer-BioNTech COVID-19 Vaccine EUA. Muscle pain, joint pain, lymph node pain, fever, profuse sweat... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA. Muscle pain, joint pain, lymph node pain, fever, profuse sweating. Duration: 40 hrs.
58 2021-03-01 headache Patient completed second COVID vaccine and stated had a headache and some neck stiffness, but overal... Read more
Patient completed second COVID vaccine and stated had a headache and some neck stiffness, but overall is doing really well.
58 2021-03-01 headache Nausea, diarrhea, body aches, headache, disorientation. Severe to moderate for 48 hours, light or in... Read more
Nausea, diarrhea, body aches, headache, disorientation. Severe to moderate for 48 hours, light or intermittent for another 12 hours. Tylenol, liquids, and bed rest.
58 2021-03-01 lethargy, headache Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting ... Read more
Tongue and right side of face went numb within minutes of receiving in right arm. Continued getting worse. After getting home, I waited 2 hours and took Benadryl and went to bed. Morning still numb but better. Feels like I can?t taste on that side. Also have a headache and just overall feeling lethargic.
58 2021-03-01 malaise Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clin... Read more
Pt reported he got the second COVID vaccine at 8:33 am at the Center at an event run by Health Clinic. At 10 am he began to feel unwell describing "disorientation" which upon further explanation seems he is describing difficulty with his proprioception, ie not able to tell where his body is in space, and disequilibrium, ie having to stop and hold on to something while walking. This lasted most of the day and subsided by evening. He has continued to have ongoing shorter episodes 3-4 times per day lasting 5-10 minutes. In addition he has noted increasing weakness in his right thigh, particularly when going from sitting to standing and the through swing while walking. He describes these as "paralytic attacks" that occur once or twice per day and last hours. Both symptoms are similar to those he had post CVA in 2019 and greatly improved with PT and home exercises. In addition he has noted fecal urgency and fecal incontinence in the last couple of weeks, he is unsure if this is directly related to the vaccine.
58 2021-03-01 fever Pt began feeling short of breath and feverish the night after receiving vaccine, which worsened to r... Read more
Pt began feeling short of breath and feverish the night after receiving vaccine, which worsened to right-sided chest pain w/ inspiration that radiated to his back. Pt returned to work 03/01/2021 then checked into urgent care the following day d/t worsening symptoms. Patient Plan written by PAC: "At this time the nature of your pain is not clear. Your cardiac enzymes are within normal limits except for myoglobin which often goes up with skeletal muscle pain. Your BNP test which can come up with congestive heart failure is elevated slightly from your normal. We will want to recheck this in a week or so. Differential diagnoses could be skeletal muscle pain/injury, herpes zoster or shingles. (This can sometimes have sharp nerve type pain that will develop into a rash within the first 7 days.) Your rapid COVID test was negative. We are sending a PCR test out just to confirm. While awaiting test results please isolate at home. We will call you soon as results are back. Refer to Mendocino County's packet/isolation order. Your potassium level is low at 3.2. It should be 3.6. We gave you some potassium to take in the clinic. I am going to give you some to take for an additional few days. When you follow-up next week plan to have your labs redrawn." Plan Orders: SARS-CoV-2 RNA (COVID-19), QUALITATIVE NAAT to be performed. URIC ACID to be performed. The patient had the following medication order(s) completed today: Potassium Chloride 40meq PO; Toradol 15mg IVP.
58 2021-03-02 headache, fever, chills 103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a s... Read more
103 degree fever; chills; body aches; headache; feeling hot through the night; Got sick; This is a spontaneous report from a contactable consumer (the patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided, expiry date May2021), via an unspecified route of administration in the left arm on 30Jan2021 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization; and apixaban (ELIQUIS, lot number ABA8272S, NDC 0003089421, expiry date Oct2021) film-coated tablet, via an unspecified route of administration from an unspecified date to 31Jan2021 at 5 mg, twice daily for cerebrovascular accident prophylaxis. Medical history included: he had tested positive asymptomatically for COVID due to contact contamination on 02Jan2021 or 03Jan2021, blood pressure, and A-fib (atrial fibrillation). Concomitant medication included ongoing metoprolol for blood pressure. There were no vaccines administered on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that he got sick after getting the vaccine (on 30Jan2021) and had an important question. He got a fever (31Jan2021) and all that stuff that lasted like a day and a half after getting the vaccine, just like a million other people. But he missed the part about asking a doctor about taking his blood thinner, which he took as normal up through the day that he got the vaccine and the next morning, then he stopped it. The patient clarified that he got the vaccine on Saturday (30Jan2021), stopped the blood thinner on Sunday (31Jan2021), the sickness subsided around Monday (as reported), but he still hasn't gone back on the blood thinner. He wanted to know when it was safe for him to start taking the blood thinner again, and he needed to know what to do for the second vaccine. The clinical course was as follows: He got the first dose of the vaccine on 30Jan2021 at 10:00 and at 22:00 he started feeling hot through the night. On Sunday, 31Jan2021, he had 103 degree fever, chills, body aches, and a headache. He clarified that he recovered completely by Wednesday, 03Feb2021. He had been on Eliquis for years for A-Fib. He stopped taking it once he got sick after getting the vaccine and went back and read the material and noticed what it said about the blood thinner. He did not go to the emergency room or physician's office. The action taken in response to the events for apixaban was temporarily withdrawn. The outcome of the events was recovered on 03Feb2021. Follow-up (05Feb2021): This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013684), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: #) on 05Feb2021 and was forwarded to BMS on 09Feb2021. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE in 58-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. ABA8272S) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine injection for COVID-19 immunisation. Concurrent medical conditions included Blood pressure abnormal. On an unknown date, the patient started Eliquis (batch no. ABA8272S) (unknown route), 5 milligram twice a day. On 30Jan2021, the patient started Covid-19 Vaccine (unknown route) Unknown dose by injection in left arm. On 31Jan2021, an unknown time after starting Eliquis, the patient experienced PYREXIA (103 degree fever), CHILLS, PAIN (bodyaches) and HEADACHE. Eliquis (Unknown) was interrupted due to event. On 03Feb2021, PYREXIA, CHILLS, PAIN and HEADACHE resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31Jan2021, Body temperature: 103 degree. For Eliquis (Unknown), the reporter did not provide any causality assessments. Information about lot/batch number has been requested.
58 2021-03-02 fever, fatigue Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridd... Read more
Achy after day 1. Big fibromyalgia flare days 2-8, unable to pursue normal activity but not bed-ridden. Very tired, lots of naps. On day 9, nausea began. Day 12, fever (100 degrees), nausea, vomiting, diarrhea
58 2021-03-04 fatigue, headache, fever Fever, body aches, headache, nausea, upset stomach, overall body fatigue.. Most adverse effects las... Read more
Fever, body aches, headache, nausea, upset stomach, overall body fatigue.. Most adverse effects lasted about 10 hours and all gradually wore off on their own within 24 hours onset.
58 2021-03-07 body temperature increased, headache, fatigue, chills 2/16/21 0800 - Headache, enlarged lymph node under left arm 1300 - body ache, chills 1700 - temp = 1... Read more
2/16/21 0800 - Headache, enlarged lymph node under left arm 1300 - body ache, chills 1700 - temp = 102.4, took Acetaminophen 1000 mg, temp decreased to 98.4 by 1900 Felt ok but tired at 2000
58 2021-03-07 cough, fever, chills 2 days after the vaccination he had chills, fever, cough.
58 2021-03-09 headache Shaking, Confusion, Head Ache
58 2021-03-10 fatigue High level of fatigue. Fatigue and extreme tiredness seems to have triggered PVCs.
58 2021-03-11 headache First started feeling upset stomach and severe headache, then a couple hours later, the body aches a... Read more
First started feeling upset stomach and severe headache, then a couple hours later, the body aches and joint pain set in. He said his lower body felt like he'd been in a car accident. He couldn't keep anything down to take pain medicine all day long so was miserable all day until about 4pm when he was able to drink some water and take some Vicodin, which did not help. He was up and down all night long with the headache and body aches, and I gave him Excedrin about 6am and that finally started alleviating the headache. He took it again at 11am and was able to eat then, and is gradually been feeling better throughout the day. He was finally able to take his regular meds so now the body aches have subsided (48 hours after injection/36 hours after onset of symptoms).
58 2021-03-11 headache headache on day 1 that resolved. Tinnitus on day 3 that has not yet resolved
58 2021-03-14 sweating He received the vaccine at 1055. At 1108 am the patient became light headed, dizzy, and diaphoretic... Read more
He received the vaccine at 1055. At 1108 am the patient became light headed, dizzy, and diaphoretic. The patient experienced LOC for a few seconds. He did not fall during the episode. After a few minutes he was able to stand and walk to the observation area with assistance. Vitals were taken at 1110 BP was 104/57, HR 53, sat 97%. The patient's hands were clammy and he was pale at the time. He denied SOB, chest pain, or difficulty breathing. At 1122 am vitals were 134/73, HR 59, and sat 97%. He reported he felt better at that time. He called his wife to take him home so he would not have to drive. His wife arrived at 1210. The patient left in a stable condition, vitals normal, and walking without assistance.
58 2021-03-14 fever Fever , Body aches, Stomach pain - 3 Days
58 2021-03-17 dehydration, fatigue Felt nauseous 3/12-3/15, feeling exhausted March 16 and 17, this morning several bouts of diarrhea ... Read more
Felt nauseous 3/12-3/15, feeling exhausted March 16 and 17, this morning several bouts of diarrhea ( and last night as well) and I am dehydrated
58 2021-03-18 chills The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle... Read more
The first sign was numbness in my chin and cheeks which would come and go. The next sign was muscle pain followed by severe joint pain followed by nausea,and a loss of appetite.The next sign was chills and weakness.This went on for a day and a half and went away .During this time I took extra strength tylenol
58 2021-03-18 sweating Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
58 2021-03-18 fever, chills Light headed, dizzy, chills, fever. Fever broke quickly other symptoms persist.
58 2021-03-20 chills, fever Shivers, fever vomit
58 2021-03-20 cough, fatigue Body aches. Fatigue. Nausea. Headache. Earache. Couging. For 1 week
58 2021-03-20 fatigue, chills, headache, sweating, fever Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 sol... Read more
Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 solid, then fever began to drop day 4, but headache persisted along with sweats and violent chill. No real appetite. Also experienced body ache, but not as bad as other symptoms. No, or little bowel movement during this time. On day five (today) urine output is dark, but went 18 hours without Tylenol. Piot to that i need 2 extra strength Tylenol every 5 hours for 4 days straight. No nausea or vomiting associated with any of this. I have extreme fatigue due the extreme headache pain keeping me awake. Headache on the left and right side of the head, not front or behine the eyes, more over the ears. Today I just feel wiped out by it all, but much improved. I have never had any reaction to any vaccines previously, including allergy, flu, shingles and pneumonia.
58 2021-03-20 headache, chills Severe abdominal pain, vomiting, diahrea, chills, headache, body aches, pain in wrist, these lasted ... Read more
Severe abdominal pain, vomiting, diahrea, chills, headache, body aches, pain in wrist, these lasted about 2 days.
58 2021-03-20 headache Severe headache within 2 hours of the shot, followed by significant Tinnitus (constant high pitch ri... Read more
Severe headache within 2 hours of the shot, followed by significant Tinnitus (constant high pitch ringing) in both ears. The Tinnitus was noticeable the next morning and at 2 weeks post vaccine continues to be a problem. Tinnitus is a new condition and I have never had the problem previously.
58 2021-03-20 fever, cough 1. Supra-ventricular tachycardia arrhythmia with cough. 3/06/21 11pm and lasted 15 days. Still somew... Read more
1. Supra-ventricular tachycardia arrhythmia with cough. 3/06/21 11pm and lasted 15 days. Still somewhat present but much less the last 2 days. 2. 102.1 fever and severe myalgia and mod-severe nausea. 03/06/21 6pm to 03/09/21 6pm about 72 hours.
58 2021-03-20 fever, headache Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, laste... Read more
Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, lasted the rest of that day, night, and the next day. Still feeling weak and feverish at present time.
58 2021-03-21 throat irritation, throat clearing, headache Clearing throat, scratchy throat, headache.
58 2021-03-22 sweating pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt ... Read more
pt passed out about 2 minutes after receiving vaccine. Pt was seated when he lost consciousness, pt was initially disoriented but was fully conscious and lucid within seconds. Pt stated that he did not hit head when falling from chair, blood pressure was normal at two separate readings minutes after the incident, pt was sweaty with loss of color but was more embarrassed than anything, wife and son returned from shopping, pt felt much better and left with his wife approximately 30 minutes after receiving the vaccine. A follow-up call 4 hours after the event was made. Pt stated he was at work and felt fine.
58 2021-03-23 headache, fever, influenza like illness On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by... Read more
On 3-11-21 at 0930, I developed low grade headache up neck over top left side of head in morning, by 1300 hours I felt very crappy similar to how it feels days after a fever breaks when having the influenza. At bedtime 3-11-21, I had a fever 100.1. At 0100, fever rose to 101.1. At 0500 fever rose to 102.6. During day on 3-12-21, I felt like I had the flu, fever broke mid-morning. on 3-13-21, I felt OK. On 3-15 and 16, I felt like I generally like I had a flue bug. I felt better days later and then around March 21-24th I've had a pretty continuous headache and neck ache which I have not had before the vaccine. Lack of energy and feeling crappy. Scheduled for second vaccine April 2nd.
58 2021-03-23 sweating Pt reported having chest pain and labored breathing 10mins after the vaccine. PT was nauseous and al... Read more
Pt reported having chest pain and labored breathing 10mins after the vaccine. PT was nauseous and also felt faint. PT was also very sweaty. EMS to scene. Pt BP was 189/99. Pt was advised he needs to go to the ER. Pt refused transport and signed documents by ems. No Epi pen was given. Pt had a coworker take him to ED where he had an ACS workup. No findings. Discharged from ED
58 2021-03-24 chills, fever, sweating Approximately 12 hours after the vaccine i started to get very bad chills and body aches and also fe... Read more
Approximately 12 hours after the vaccine i started to get very bad chills and body aches and also fever that reached 102. Every bone in the body felt like it was cracking. This lasted about 24 hours. I was also sweating a lot. The sweating at night lasted 3 days. I have the dry mouth and tongue with a thick layer of saliva and the mouth is swollen. I also have very dry eyes and nose/throat. These also are the after side effects of covid which i had in mid jan that i was getting better from. After taking the vaccine the symptoms of swollen mouth and thick saliva including dry eyes flared up again. Today is day number 6 after the vaccine and its a little better but not much.
58 2021-03-24 fatigue, chills, sweating I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my firs... Read more
I have had Post Acute Covid-19 syndrome since Nov 4, 2020. The first night after receiving my first vaccine I got the chills about 16 hours after my shot went away after a few hours. Woke of the next day with my post acute syndrome symptoms much worse than I had prior to shot, my fatigue in my legs were to the point I could hardly walk, my brain fog and tremors were much worse, that lasted about 1 day then the next two nights I woke up in the middle of night with severe sweating. I was then felling like I had before the shot. Then about 4 days after receiving the vaccine the post acute syndrome symptoms again were much worse than before. This last for about 2 weeks then gradual worked back the my original feeling of fatigue, brain fog and tremors that I had prior to vaccine
58 2021-03-25 headache pt states that he about an hour after taking the vax he had slight pain at the injection site and he... Read more
pt states that he about an hour after taking the vax he had slight pain at the injection site and headache. He started getting dizzy and lightheaded. Pt took 1000mg Tylenol for his head ache.
58 2021-03-26 sweating Pfizer COVID-19 Vaccine EUA Was shaky and lightheaded sent to medical obs and provider kept for 30 ... Read more
Pfizer COVID-19 Vaccine EUA Was shaky and lightheaded sent to medical obs and provider kept for 30 mins. Felt better after juice and crackers. Patient presents today for medical monitoring of complaint of being dizzy, sweating s/p COVID - 19 vaccine # 1. Past medical history is significant for intermittent vertigo and asthma. Patient reports previous history of vasovagal episodes with blood draws. Patient was monitored for a total of 30 minutes. Patients vital signs remained stable. Patient reported improvement in symptoms prior to being discharged.
58 2021-03-27 fatigue Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, sev... Read more
Dizziness, shortness of breath, cold sweats, fatigue, unsteady on feet, feeling of heart racing, severe vomiting, total exhaustion. These symptoms were severe, much worse than when I had the virus in December. I thought I was having a stroke and was minutes away from dialing 911.
58 2021-03-27 headache Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely de... Read more
Ongoing headaches, severe at times along with nausea and dizziness. Some days it is completely debilitating. These started about a week after second shot. They have continued with some days being less present. I also have been learning to cope with symptoms.
58 2021-03-27 fever, chills, fatigue Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and w... Read more
Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and was transported by EMS to ER and admitted. He was tested 3 times for COVID 19 and found to be negative. CT scan was concerning for viral pneumonia and suspected COVID. He was treated and released to home on 3/4/21. Followed by pulmonologist. Received second Pfizer COVID19 vaccine on 3/21/21. On 3/23/21 developed fatigue, weakness, shakiness, nausea and vomiting. had significant decline over the week. Has acute event on 3/27/21 and was pronounced dead at home.
58 2021-03-27 fever, cough Dizziness, chest pain, cough, subjective fever, body aches
58 2021-03-28 chills, fatigue Very tired, chills, muscle aches
58 2021-03-28 chills, fever Chills, fever, aches, soreness at injection site
58 2021-03-28 headache Cold sweat, dizziness, tachycardia, headache, persists after 24 hours but not as much
58 2021-03-29 sweating Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180... Read more
Swelling at injection site immediately after injection. Slight light-headedness Vital Signs: BP 180/96 HR 86 O2sat 98% Skin Signs: Warm and dry, Clammy, other: swelling at injection site Circulation: Cap refill <2sec Respiratory: Breath and sound clear bilaterally Initial Treatment: Observed swelling marked out original size checked for enlargement or skrinking. 1:48 PM: BP 160/96 HR 86 O2sat 98% Skin Signs: Cool and dry, clammy, diaphoretic, other: plush 2:08 PM: BP 156/104 HR 93 O2sat 96% Skin Signs: Warm and dry (neck/head), cool and dry (arms) 2:30 PM: BP 142/100 HR 90 O2sat 96% Up and walking, no dizziness of pink warm dry, alert x3 continues to have decreasing swelling in left deltoid, tender to touch, decreasing redness at site, attempted to call wife x2 and friend x1 Disposition: Other: Pt will wait for friend who will follow pt in his car to where he will meet up w/ wife. Pt advised to notify PCP of rxn to vaccine and to notify future vaccinators of this fact.
58 2021-03-30 headache pt. c/o light headache, dizziness, body weakness after pfizer vaccination. BP 159/98 ; p-82- Sat 97... Read more
pt. c/o light headache, dizziness, body weakness after pfizer vaccination. BP 159/98 ; p-82- Sat 97%
58 2021-03-30 fever, chills, malaise 3/25/21,Thursday at around 4:00 PM was when I received my 1st dose of the Pfizer/BioNTech COVID vacc... Read more
3/25/21,Thursday at around 4:00 PM was when I received my 1st dose of the Pfizer/BioNTech COVID vaccine 3/26/21, Friday at around 6:00 PM, I developed a fever of 100.4 for which I took Tylenol. The fever resolved only to come back after 4 or 6 hrs. It was accompanied by chills, general feeling of being unwell and poor appetite. These symptoms continued until 3/27/21 (Saturday), 3/28/21 (Sunday), 3/29/21 (Monday), 3/30/21 (Tuesday). 3/30/21, Tuesday, I sent a mesage to my PCP, informing her of the above. I lso went to Urgent Care and reported the same. There I was swabbed (nasopharyngeal) for COVID testing which turned out positive. As of this reporting, symptoms of fever and chills, are still present.
58 2021-03-31 chills, headache, fever Fever. Chills. Headache. Severe Joint Pain. Started about 2am on Sunday 14 hours after injectio... Read more
Fever. Chills. Headache. Severe Joint Pain. Started about 2am on Sunday 14 hours after injection Subsided in the morning and returned after lunch on Sunday. Finally subsided Monday afternoon.
58 2021-03-31 headache, sleepiness, lethargy Felt well/fine after shot. Second day, felt lethargic with headache, skin ache, and general apathy. ... Read more
Felt well/fine after shot. Second day, felt lethargic with headache, skin ache, and general apathy. Relatively minor symptoms, but enough to complain about. Took two naps during day. Hope to feel better tomorrow.
58 2021-03-31 fever, chills, influenza like illness Slight fever, significant body aches, chills, and nausea. Like a bad flu. Went to bed at 7pm. Fel... Read more
Slight fever, significant body aches, chills, and nausea. Like a bad flu. Went to bed at 7pm. Felt better the next morning. ~12 hours
58 2021-04-01 fatigue Sore injection site, shoulder, neck and back muscles and general body aches. Fatique.
58 2021-04-01 headache Red I eyes. An herpes close to mouth and head ache
58 2021-04-01 headache Pain in the back of the head on the lower left side which still comes and goes
58 2021-04-01 throat irritation Itchiness in the throat, using rescue inhaler. Initially, then own breathing treatment. 10:41am C... Read more
Itchiness in the throat, using rescue inhaler. Initially, then own breathing treatment. 10:41am Client left site. Verbalized that he feels much better.
58 2021-04-02 chills, sweating Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Mild
58 2021-04-02 sweating, chills the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck ... Read more
the right side of my neck begin to start hurting if I turn my head forward or sideways/general neck pain/also tender across the entire neck area; warm to touch; stabbing pain; muscular twisting; constant feeling of flushing; shaking/severe shaking at night; chilling; profuse sweating; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 17:00 (at the age of 58-years-old) as single dose for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccine in four weeks. The patient was not covid tested post vaccination. Medical history included neck and back injuries, and covid prior vaccination: Yes. The patient had no known allergies. Concomitant medication included gabapentin (NEURONTIN). On 19Mar2021 at 17:45 (approximately within one hour of the injection), the right side of the patient's neck begin to start hurting if he turned his head forward or sideways. It was warm to touch and also tender across the entire neck area. This only turned into a more severe that was excruciating one turning head in any direction. As well as lying down the patient had to sleep sitting up in a recliner. With absolutely no relief all the pain the stabbing pain and muscular twisting and general neck pain additionally there was a constant feeling of flushing but at the same time shaking and chilling with severe shaking at night and profuse sweating. Treatment included ibuprofen (MOTRIN), paracetamol (TYLENOL) to tizanidine. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The outcome of the events neck pain, pain and muscle twitching was not recovered while for the remaining events was recovering. Information on the lot/batch number has been requested.
58 2021-04-03 chills, headache Injection 3/31/21 3:00pm - 4/1/21, diarrhea all day, 10:00am - 1:30pm. slight headache. 4:00pm - 10:... Read more
Injection 3/31/21 3:00pm - 4/1/21, diarrhea all day, 10:00am - 1:30pm. slight headache. 4:00pm - 10:00pm, chills & body aches. After 10:00pm, back to normal!
58 2021-04-03 fatigue Nausea and fatigue 4 days so far. Getting better. Wish I wouldn?t have taken the second shot. No pro... Read more
Nausea and fatigue 4 days so far. Getting better. Wish I wouldn?t have taken the second shot. No problems with the first shot.
58 2021-04-03 headache, fatigue Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 h... Read more
Joint aches and pains, headache, fatigue, coldness in my hands and feet. Symptoms lasted about 20 hours, with a bit of residual fatigue and odd feelings for about 1 more day.
58 2021-04-04 fatigue I had surgery for spinal stenosis on 07/09/2020, including a decompression and fusion at L4/L5. I r... Read more
I had surgery for spinal stenosis on 07/09/2020, including a decompression and fusion at L4/L5. I reported the following symptoms, which I attribute to the COVID-19 vaccination, to my spine surgeon. I had my second dose of the Pfizer COVID-19 vaccine on Monday, March 29th at 5:45 PM. Lower back pain in the general area of my surgery (07/09/2020) woke me up from sleep around 4:30 AM Tuesday (03/30/2021) morning. Being woken up from sleep had never happened previously - not before surgery, following surgery, ever. I recall the pain being a dull throbbing ache, nothing sharp. I recall being generally pain free Tuesday during the day and went for a mile and half walk Tuesday evening and hit about 20 40-yard (or less pitch shots) Tuesday evening. I woke up Wednesday at my usual 6:45 AM. Although I don't recall being in pain getting out of bed, I do remember being in excruciating pain the remainder of the day. It hurt to walk (landing either foot) and the only position that I had any relief was sitting at work. The pain was frequent, sharp, and up to a 6 on a scale of 1 to 10. I felt exhausted and feel asleep at 7:30 PM Wednesday night. I was in significantly less pain Thursday, although it was still uncomfortable rising from a seated position and bending at the waist (to assume a putting position in the office) caused pain to the extent that I chose not to fully bend. Thursday night was generally OK but there was one point, while seated on a couch, where I felt a sharp stabbing pain in the general area of my surgery. I tried to change positions to alleviate the pain, but it persisted for 30 seconds before finally subsiding. The pain felt like I was being stabbed and it was a 8 or 9 on a 1 to 10 scale. Friday was a repeat of Thursday. Generally, I have very little pain except when I stand from a seated position (1 or 2 on a 10 point scale) or bend slightly at the waist (3 or 4). The pain is dull but the pain from bending does prevent me from bending comfortably. All of this pain is new this week since Monday. This past weekend I worked in the yard, including some heavy lifting and digging. Is there any chance this is a side effect of the vaccine? Should I schedule an office visit to evaluate the pain? NOTE: I was generally symptom free by Saturday, 04/03/2021 and totally symptom free by 04/05/2021.
58 2021-04-04 sweating Immediately following injection pt felt dizzy and became diaphoretic. Pt monitored in emergency tent... Read more
Immediately following injection pt felt dizzy and became diaphoretic. Pt monitored in emergency tent and found to have bradycardia and hypotension. With continued observation pt continued to be dizzy, diaphoretic, hypotensive and bradycardic. EMS called and found glucose to be within normal range.
58 2021-04-04 fever fever the 1st day
58 2021-04-05 headache Headache x 2 and on going. Rash on forehead.
58 2021-04-06 chills, fever Fever, chills, body aches lasting 24 hours
58 2021-04-06 fatigue, cough Fatigue, minor chest tightness, minor chest congestion, nighttime cough.
58 2021-04-06 fatigue Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, howe... Read more
Within 15 minutes, felt extremely tired. This was the same response when taking the 1st shot, however, it didn?t seem as bad. After waiting 30 minutes, began driving home, but within 10 minutes, began to feel like heart was racing, and whole body was kind of numb feeling. I did check heart with my watch which only showed 89bpm. After another 10 minutes, I arrived home, and I was shaking uncontrollably and my hands and feet were cold. Temp was only 97.4. After another 20 minutes, the symptoms all went away.
58 2021-04-06 headache, fever, fatigue Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes ... Read more
Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes blurred,sleepness
58 2021-04-07 body temperature increased, fatigue, headache Temperature over 100 degrees, headache, body aches, tiredness.
58 2021-04-07 chills, fever I have fever and chills since April 1st until today (April 8th, 2021)
58 2021-04-07 fatigue, fever Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain ... Read more
Bad gout flare-up, worst symptoms and longest lasting flare-up to date. Three days of intense pain in left knee, ankle, and foot 4/1-3. Whole leg was swollen and currently (4/8) ankle and foot are still swollen and achy. Low-mid grade fever from 4/1 to 4/6. Still experiencing fatigue. Consulted primary care physician, 4/8, and may do a video visit next week if symptoms persist.
58 2021-04-07 fatigue Extreme fatigue/tiredness for about 24 hours.
58 2021-04-07 fever, chills, headache Fever & chills Lack of energy Headache
58 2021-04-09 body temperature increased, fatigue, chills 11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, ... Read more
11 hours after shot (Sat 3/27/21 2:00am): Chills, high temp & hallucinations, then hot, neck, back, arms & legs muscles tightened, freezing for a few hours. 8:00a: wiped out. 1:00pm (Sat): chills, hot, body aches, upset stomach, slept on/off until 4 or 5pm when I started shivering, vomiting, some hallucinating. Armpit glands felt twisted and pulled. I felt worse & asked my wife to call 911. Paramedics came, took vitals, blood, offered to take me to hospital (didn?t go). They stayed an hour until I felt stable. Sun 3/28/21am, exhausted, slightly better but my mind was spacey, body achy & armpits hurt. 12:00pm: noticed short term memory loss, ate a few crackers, drank water, napped on/ off, went to bed around 900pm. Mon, 3/29/21, still achy and mentally fuzzy. Side effects diminished over a few days.
58 2021-04-09 headache On the morning after the second vaccine, I awoke with a bad headache. I was expecting something like... Read more
On the morning after the second vaccine, I awoke with a bad headache. I was expecting something like this so I didn't worry about it. Within a couple of hours, however, the headache began to include migraine-like visual disturbances primarily in the left eye field of vision. The pain got worse. I took Tylenol as I was advised not to take ibuprofen. The headaches and visual disturbances continued intermittently for a couple of weeks. (The headaches are still here at a low level. The visual disturbances/flashes disappeared after 12 days.) While I was having the migraine-like symptoms, after about two or three days, I developed additional visual problems in my left eye. There was like a gray nebula of strands in my visual field. I went to the ophthalmologist on 4/6/21, 10 days after the shot. She diagnosed Posterior Vitreous Detachment (PVD). While she knew of no mechanism for the vaccine to cause this, I am reporting this as the headaches, visual disturbances/flashes, and the PVD developed immediately after the second Pfizer shot, headache rolling into flashes rolling into PVD nebula. The doc said this may or may not go away after a while. We shall see.
58 2021-04-09 malaise I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointmen... Read more
I hadn't been feeling well. Called my Doctor the day after receiving the shot and made an appointment for the first available time (Friday April 2). On Thursday morning I was having vision problems, high blood pressure, weakness on left side. I was rushed to the hospital administered tPA and was diagnosed with a stroke.
58 2021-04-10 headache, chills Vaccine received at 11:00 AM on 04/09. No issues on Friday. Saturday evening starting at 6:00 PM, sl... Read more
Vaccine received at 11:00 AM on 04/09. No issues on Friday. Saturday evening starting at 6:00 PM, slight headache and chills. Took 2 Tylenol. Woke up at 1:00 AM and took 2 more Tylenol. Got up at 7:00 AM on Sunday, and noticed a red rash on arms, torso and legs. No associated pain. Called hospital and was referred to my family physician unless I was having breathing issues. No breathing issues. I will be contacting the doctor on Monday for instructions.
58 2021-04-11 headache, fever, chills This started Fri. with body aches. on sun cont. with body aches , headache, fever of 101.9, vomite... Read more
This started Fri. with body aches. on sun cont. with body aches , headache, fever of 101.9, vomited, chills. After 24 hours the fever broke and started to feel better. still have headache and body aches.
58 2021-04-11 malaise, fatigue, influenza like illness Pt reports beginning to feel ill on 4/5/21 with flu-like symptoms (body aches, muscle pain, fatigue,... Read more
Pt reports beginning to feel ill on 4/5/21 with flu-like symptoms (body aches, muscle pain, fatigue, and chest pain when deep breathing). Saw PCP on 4/6/21 and was sent to hospital for chest X-ray. Pt states that X-ray was normal but PCP treated for pneumonia with antibiotics based on symptoms.
58 2021-04-11 fever, headache, chills Fever, chills, muscle aches, headache
58 2021-04-11 fever fever of 100-101 which has persisted for 1 week
58 2021-04-12 cough Constant cough since the 2nd vaccine
58 2021-04-12 fatigue, fever Overall, it went really well during the first day (4/10/2021), as I took a 15 mile bike ride a few h... Read more
Overall, it went really well during the first day (4/10/2021), as I took a 15 mile bike ride a few hours after my shot. On the 2nd day, I experienced fatigue, neck/muscle pain, and my wife encouraged me to take my temperature and I found I had a slight fever of 100.2F. On the 3rd day (4/12), I felt only slightly fatigued with some neck pain but no fever at all. Today (4/13), I have only neck/muscle stiffness (no soreness/pain) and no fatigue. I still have soreness at the injection site, but consider it mild. I don't have my 2nd dose scheduled yet, but anticipate it to be around May 6th.
58 2021-04-12 fatigue Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving ... Read more
Day 2 Extreme fatigue and foggy head. I had to leave work as I was extremely tired and just driving home was as if I was under the influence. Day 3 - Extreme fatigue and sever body aches Day 4 - Slightly better, but still not able to resume normal activities Day 5 - Tried to resume normal activities (bike ride), but I have to stop due to extreme fatigue and severe muscle cramping. Day 6 - Actually felt normal Day 7 - Back to 100%...
58 2021-04-13 headache Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while runni... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Intense pain behind left eye then left side of head while running/exercising. Went to emergency room within an hour had CT scan verifying acute subatachnoid hemorrhage. MRI, Angiogram and Ultrasounds of the head and neck were also performed.
58 2021-04-13 sweating Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling d... Read more
Vomiting, dizziness, flushing/sweating. BP 134/82; HR 85, SpO2 98%, Temp 97.3. Pt reported feeling dizzy while in observation. Pt was brought in to observation area. Pt felt dizzy, and nauseous began vomiting. Provider was called to assess pt; Pt reported feeling slightly better but still felt dizzy.
58 2021-04-14 fatigue, fever, throat pain, influenza like illness, cough, headache 10 days after vaccination (Apr 10) flu-like symptoms appeared. Low grade fever, muscle aches, cough,... Read more
10 days after vaccination (Apr 10) flu-like symptoms appeared. Low grade fever, muscle aches, cough, sore throat, upset stomach, severe headache and exhaustion.
58 2021-04-14 fever, chills, fatigue Patient experienced fever and chills x 36 hours. In addition, patient reported disabling fatigue fo... Read more
Patient experienced fever and chills x 36 hours. In addition, patient reported disabling fatigue for the same period. "Symptoms were way worse than COVID-19 itself when I had it." Patient self-administered supportive treatment (e.g. "analgesics and supportive treatment").
58 2021-04-15 chills Extreme chills, shortness of breath, vomiting
58 2021-04-15 fatigue, headache Headaches, body aches, exhausted feeling, diarrhea upset stomach, insomnia
58 2021-04-15 fever, headache, fatigue, chills Chills, fever, slight headache, tiredness
58 2021-04-16 fatigue Exhaustion / Fatigue - significant exhaustion at about 5:30 PM. It came as a wave while standing up... Read more
Exhaustion / Fatigue - significant exhaustion at about 5:30 PM. It came as a wave while standing up talking to someone. I fell back against wall. I went home and fell asleep at about 8:30pm for 13 hours. Felt tired the entire next day and went home and fell asleep at about 8:30 pm and slept for 14 hours. Felt tired most of the day. Felt exhausted and went to bed at 9:30 on Saturday night (the 3rd night) and slept for about 12 hours. This is very unlike me because I normally stay up and watch a movie with my wife on a Saturday night. This pattern of feeling exhausted by 6:00pm continues and we are now at about 3 weeks after the vaccine. It?s improving a bit but it?s still outside the normal pattern for me. I?m still feeling quite tired early in the evening and going to be much earlier than Normal. Additionally, I feel like I?m not myself. At times, my brain feels a bit foggy in that I?m not as aware or clear in my thinking as I normally would be.
58 2021-04-16 headache Had bad headache one week after taking Pfizer covid vaccine. 3 days later went to ER due to severe h... Read more
Had bad headache one week after taking Pfizer covid vaccine. 3 days later went to ER due to severe headache and high blood pressure. was diagnosed with Shingles in ER.
58 2021-04-16 headache Headache, body aches and sore arm on injection site.
58 2021-04-17 chills, fatigue, fever, cough, malaise fever; chills; muscle aches; nausea; fatigue; cough; very sick; This is a spontaneous report from a ... Read more
fever; chills; muscle aches; nausea; fatigue; cough; very sick; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Mar2021 04:00 as single dose for covid-19 immunisation. Within 30 minutes of receiving the vaccine, on 19Mar2021 16:30, patient got very sick: fever, chills, muscle aches, nausea, fatigue, cough. The fever broke early the next morning but the other symptoms remained for 2 more days. At that point, he continued having fatigue, cough, nausea and chills for a further 5-6 days. At that point, and continuing now, he still have low level nausea, fatigue and a cough. It's very slowly getting better but it has take 2 weeks to not feel completely sick. The patient underwent lab tests and procedures which included viral test (Nasal Swab, Aegis PCR): negative on 01Mar2021. No treatment. Outcome was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-04-17 fatigue, sluggishness exhausted achey sluggish for 10 days plus
58 2021-04-17 headache I got the shot and came home ever thing was fine then arm started hurting no big deal then thr heada... Read more
I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
58 2021-04-18 malaise, chills skin pain, shivers, feeling sick for about 6 hours
58 2021-04-19 chills, headache, fever, body temperature increased Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck... Read more
Day after first vaccine (Tuesday March 30) was administered, developed severe headache, chills, neck pain, and slight abdominal cramp. By Friday April 2, severe abdominal cramp, headaches, nausea, slight high temperature. Persisted throughout the whole weekend. Called in sick Tuesday April 6 for abdominal cramp, temperature, confusion - admitted to ER.
58 2021-04-19 fever, fatigue Vaccine 4/5/21. Fever and fatigue 4/6/21. Better 2 days later. Started feeling ill Wednesday 4/14... Read more
Vaccine 4/5/21. Fever and fatigue 4/6/21. Better 2 days later. Started feeling ill Wednesday 4/14/21. Went to the Doctors 4/16. They treated as sinus infection. Sunday 4/18 started rash - Clinic gave shingles medication. Went to Optomologist and Medical MD on Monday 4/19/21. Shingles on face left side, eye, eyelid, head, swelling. Cornea 3 lesions. Scrip for eye medication also. First shot on 3/13 no reaction, only a little tired the next day, fully functional.
58 2021-04-20 headache Severe random headaches throughout my day every single day.
58 2021-04-20 headache c/o headache after receiving vaccine. 138/74, O2Sat 97%. 9:15am Pt. stated that he is feeling bette... Read more
c/o headache after receiving vaccine. 138/74, O2Sat 97%. 9:15am Pt. stated that he is feeling better. EMS recommended that if patient still feels symptoms to contact 911 or primary care physician.
58 2021-04-21 headache Follow 1st injection of Pfizer, he woke the following morning with a headache which has persisted si... Read more
Follow 1st injection of Pfizer, he woke the following morning with a headache which has persisted since - almost 7 weeks. He has treated it with Aleve daily, with some improvement but the headache never goes away. He had a phone visit with his physician today. Medication has been prescribed, which he will pick at the pharmacy today. His physician plans to see him in office if the medication does not stop the headache.
58 2021-04-22 body temperature increased Started developing morbiliform exanthem that spread to the whole body, sparing palms and soles of fe... Read more
Started developing morbiliform exanthem that spread to the whole body, sparing palms and soles of feet 4 days after Vaccination, Worsened into day 8 in spite of Prednisone 20mg Daily 2 doses. Also developed Temp up to 102 day 7-8.
58 2021-04-22 chills, fatigue, headache, fever 1. Aches/Pains muscular/joints 2. Slight fever with chills 3. Extreme Fatigue 4. Headache 5. Acu... Read more
1. Aches/Pains muscular/joints 2. Slight fever with chills 3. Extreme Fatigue 4. Headache 5. Acute Tinnitus with hyperacusis
58 2021-04-22 fatigue 4/14/21 Patient is a 58 y.o. male who presented for confusion, fatigue and dizziness since the past ... Read more
4/14/21 Patient is a 58 y.o. male who presented for confusion, fatigue and dizziness since the past couple of days. Patient was getting lost on the train and forgetting his work duties. 4/14/21Neurologic exam: MS - awake, alert, oriented to name, -age, hospital, -time, speech fluent and without dysarthria, naming & repetition intact, follows commands, attention and concentration are impaired, clock drawing is impaired and shows L sided neglect, line bisection test is impaired, remote and recent memory and fund of knowledge are impaired CN - PERRL, EOMI and without nystagmus, visual fields are intact to confrontation but there is extinction on the L to double simultaneous stimulation, facial sensation is intact to PP V1V2V3, no facial droop, hearing is intact to finger rub B, palate is not well visualized due to his palate/tongue anatomy, head turn is 5/5 B, tongue protrudes symmetrically. Fundoscopy is deferred due to the COVID-19 pandemic and need for PPE which precludes exam. Motor - Normal bulk/tone, 5/5 B UE and LE, curling of the L fingers on pronator drift testing Sens - Pinprick is intact B UE and LE. There is extinction to double simultaneous stimulation on the L DTR's - 1/4 B bi/tri/BR and patellar/ankles. No clonus. No Hoffman's. Babinski is down B. Coord - finger-to-nose is without dysmetria B, there is dysmetria of the L leg on heel-to-shin
58 2021-04-22 headache Severe pain on right side head and neck, felt like pinched nerve. Could not rotate head at all wit... Read more
Severe pain on right side head and neck, felt like pinched nerve. Could not rotate head at all without pain, lots of fun at 1:30 in the morning. Approximately 12 hours after shot. I might have been better off catching Covid, than have to go thru this.
58 2021-04-22 sweating He got the vaccine, had no reaction at all. After 4 days he noticed it was messing with his blood s... Read more
He got the vaccine, had no reaction at all. After 4 days he noticed it was messing with his blood sugar. He had a lot of sweats, itching, high levels up to 396 and lows to 48 within the last 2 days. Today so far he seems to be okay other than blood sugar of 340. He did call his doctor who told him to take an extra pill and then to reread it at noon and call him back.
58 2021-04-23 chills, headache Nausea, headache and extreme chills. Did not occur until over 12 hours after getting the vaccine. M... Read more
Nausea, headache and extreme chills. Did not occur until over 12 hours after getting the vaccine. Mostly recovered, still a headache and mild nausea
58 2021-04-23 chills, fever Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; n... Read more
Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
58 2021-04-23 headache The injection site was high on the deltoid; nearly to the apex of the shoulder. Within a few hours, ... Read more
The injection site was high on the deltoid; nearly to the apex of the shoulder. Within a few hours, I begin to experience some discomfort and a limited range of motion. By the next morning, the right side of my neck was stiff. This may have been a result of me unable to sleep comfortably on my right side. I have also been having some slight headaches. Headaches are very rare for me, and these particular episodes do not tend to subside with over-the-counter relief. The oddest thing is my inability to focus visually. I wear corrective eye wear, but mostly for close work and reading. This Saturday, 4/24/2021, I had difficulty reading the subtitles on the television, with or without my glasses.
58 2021-04-23 headache Initial symptom was swollen lymph nodes in left armpit--where I got the shot. I am informed enough t... Read more
Initial symptom was swollen lymph nodes in left armpit--where I got the shot. I am informed enough to know this means I had active antibodies that recognized the virus and attacked it. This lasted approximately 4 days. After day 2, this began where I am today; occasional vertigo/loss of balance with persistent high blood pressure/headaches consistent with when I contracted Covid 11/2020. I have been to my primary doctor twice. The possibility of this being a vaccine reaction has never come up. It is as if I have the headache/blood pressure portion of Covid infection all over again. There is no outcome yet. Having read other people's comments, it is a waste of time and money to get diagnostic tests, and physicians are guessing. No thank you, I learned of these symptoms and this website from the many internet forums (one is listed above) where people are discussing their vaccine reactions. I never wanted this vaccine, but there is considerable pressure to get vaccinated, even when you contracted the virus. I feel vaccine passports are going to be forced on people. I regret the decision to do this. My second shot is scheduled for 4/30, but I am cancelling it, I am certain this is Covid vaccine related. I am a very healthy and physically fit 58 year old that eats well. Don't drink, don't smoke, mainly vegetarian diet.
58 2021-04-23 fever Fever about 12hours after vaccination.
58 2021-04-24 cough, fatigue tested positive for COVID-19; tested positive for COVID-19; cough; fatigue; This is a spontaneous re... Read more
tested positive for COVID-19; tested positive for COVID-19; cough; fatigue; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6204), via an unspecified route of administration, administered in left arm on 17Mar2021 at 12:30 (at the age of 58 years old) at a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, high cholesterol, all were ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ongoing metformin HCL at 1000 mg for diabetes, ongoing fenofibrate at 135 mg, once a day and ongoing amlodipine besilate, atorvastatin calcium once a day (5-40 mg once daily). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the caller tested positive for COVID-19. He was and continues to be symptomatic. He stated that he still had a cough and fatigue on an unspecified date in 2021. He also stated that his 10 day required isolation period would be completed and he would like to know if he should proceed with receiving his second dose of the Pfizer COVID-19 vaccine on 07Apr2021 as scheduled. Patient was scheduled to receive his second dose on 07Apr2021. The patient underwent Covid-19 test performed on 30Mar2021 positive results were yielded on 31Mar2021. The patient was treated for the cough with cough pills. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-04-24 cough, influenza like illness, nasal congestion, sinusitis, headache Intense flu-like symptoms starting two days after vaccine. Lasting for four days. No fever at any ti... Read more
Intense flu-like symptoms starting two days after vaccine. Lasting for four days. No fever at any time during the four days. Symptoms included joint and muscle pains, severe sinusitis, headaches, nausea, cough and chest congestion. Substantial improvement later on 4th day. On day 4 of symptoms went to walk-in clinic. Received direction to take covid test and chest x-ray. They were not able to provide either service. Later that day went to urgent care took both the rapid covid test with a negative result and PCR covid test. Awaiting results within 48 hours. Examined by doctor told that lungs were clear and flu was negative.
58 2021-04-24 fatigue, sluggishness Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood press... Read more
Full blown seizure; Fatigue; Confusion; Breathing was off; breath was heavier; patient's blood pressure was very low; Real sluggish/get slow; Speech started to get slow; This is spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734) via an unspecified route of administration in left arm on 04Apr2021 12:00 at age of 58-year-old at single dose for COVID-19 immunization. It also stated the patient was one of the most vulnerable against virus so he took the Covid-19 Vaccine. Medical history included ongoing cardiac failure congestive diagnosed probably 10 years ago, ongoing diabetes mellitus diagnosed probably 20 years ago, ongoing dialysis for 3.5 years. Concomitant medication included ongoing unspecified blood thinner. Caller reported that the patient didn't take any blood pressure medications and that she knew the patient took a blood thinner. Caller unable to provide further detail for the patient's medications as she doesn't have the patient's list of medications with her. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534) injected in left arm in Mar2021 at age of 58-year-old for COVID-19 immunization and experienced fatigue after the first dose of the Covid-19 vaccine. Caller reported that it was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient has been more fatigued since he received the first dose of the Covid-19 vaccine. The patient was a compromised fellow with a host of pre-existing conditions as far as heart disease, diabetes, and dialysis. Caller was calling in regard to the Pfizer Covid-19 vaccine. Caller reported that she was calling to report a bad reaction that her husband, the patient, received on Sunday, 04Apr2021, following his second dose of the Covid-19 vaccine. Approximately 3 hours after receiving the Covid-19 vaccine, the patient had a full blown seizure at 15:00 on Sunday, 04Apr2021. Caller reported that she had to call emergency responders following the patient's seizure. The patient was doing better but the experience with his seizure was quite traumatic. Caller stated that if it was going to happen, it was going to happen to us. About 3 hours after receiving his Covid-19 vaccine on 04Apr2021, the patient became real sluggish and his speech started getting slow before the seizure occurred. Caller reported that the patient made a gradual descent downwards. Caller reported that she swears the patient has not been the same as far as fatigue goes since the patient received his first dose of the Covid-19 vaccine 3 weeks prior. Caller reported that she thought the fatigue was maybe from dialysis. The patient started to get slow just before the seizure, about 2.5 hours after he received the second dose of the Covid-19 vaccine. The patient was laying down following the second dose of the Covid-19 vaccine. Caller reported that the patient's breathing was off. The patient's breath was heavier. Caller reported that after she noticed the patient's breathing was off, she asked the patient if he was ok. Caller reported that this is when she noticed that the patient's speech was really slow and that he was experiencing confusion. The patient has had no more seizure activity. The patient was still being monitored in the hospital. Caller reported that the patient didn't remember any of it. It's hard to say if the patient's sluggishness and fatigue were ongoing. Caller reported that she couldn't go see the patient while he was in the hospital but that the patient's voice sounds much stronger. For Confusion and Speech: Caller reported that the patient seems to be back/ returned to normal. Caller reported that she knew that the patient's cardiologist went to see the patient. The patient's cardiologist said that there was nothing that happened to the patient's heart, that what the patient experienced was not a heart issue, and that the event had no effect on the patient's heart. The medical staff stated that the seizure the patient experienced was related to a blood pressure drop. Caller reported that the patient's blood pressure was very low on 04Apr2021. The patient required a visit to Emergency Room for event seizure, no visit of physician office. Admitted on Sunday, 04Apr2021 for seizure, and still hospitalized. For investigations: Caller reported that the medical staff at the hospital definitely did lab work but she was not sure if any imaging was performed. Caller reported that she has no results available for tests that were performed. The outcome of events confusion and "speech started to get slow" was recovered in Apr2021, the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021380129 same patient, different product(dose)/event
58 2021-04-24 fatigue fatigue; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old ma... Read more
fatigue; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in Mar2021 (Lot Number: EP7534) on left arm at single dose for COVID-19 immunization. Ongoing medical history included patient was diagnosed with congestive heart failure probably 10 years ago, was diagnosed with diabetes probably 20 years ago, had been undergoing dialysis for 3.5 years. Concomitant mediation included a blood thinner. The patient experienced fatigue after the first dose of the Covid-19 vaccine in 2021. It was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient had been more fatigued since he received the first dose of the Covid-19 vaccine. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-04-24 headache, malaise, fatigue, cough Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/d... Read more
Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/diagnosed with COVID-19 virus; Headache; Cough; feeling ill; Fatigue; feeling bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX Support. A58-year-old male patient received first dose BNT162B2 (Solution for injection, Pfizer-Biontech Covid-19 Vaccine, lot number: EN6208, expiry date: 30Jun2021) via an unspecified route of administration in left arm on 20Mar2021 at 10:05 AM at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine on 25Mar2021. He wants to know if he should get the second dose of the vaccine. He states he got the first shot and then he got the COVID virus. He says he doesn't know if he got the virus before or after shot. He states he contracted the virus 4 or 5 days after getting the shot. He started feeling bad on an unspecified date in Mar2021. He has gone through the 14 days of quarantine and is suppose to get his second shot. He wants to know was it smart to get second shot on top of getting COVID? He states he was 6 foot or 72 inches. States he got the first shot 3 weeks ago, on Saturday 20Mar2021. He states that he started feel ill on the 25Mar2021 and went and got a COVID test. His results came back positive on Thursday 26Mar2021. On 25Mar2021, he states that he has a cough and a headache, and a few other symptoms as far as fatigue and things like that. He does not have a fever. He states that he has gone through the 14 day quarantine and was planning on going back to work tomorrow. He states that he was due to take the second shot this Saturday and he doesn't want to get sick all over again. He doesn't want to feel like this after being gone for two weeks. His headache, cough, and feeling ill started on 25Mar2021. He states that his symptoms are improving everyday seems like it is a little better. He left his vaccine card in his truck because he figured he would need it when he went back, and it was better than putting it in his wallet and loosing it. He got the vaccine because he didn't want to get the virus and then he got it anyway. He was tested for COVID on 25Mar2021 and got a positive result on 26Mar2021. Reported, as he had 1st shot 20Mar2021, but was diagnosed with COVID-19 virus. He was concerned about getting the 2nd shot scheduled on 10Apr2021. He was not yet getting better, and the caller still has the symptoms. (Name) calling also about his wife, named (Name) was in quarantine and also experiences an adverse reaction after the 2nd shot. Outcome of events was recovering. No follow up attempts are possible. No further information is expected.
58 2021-04-24 sweating, dehydration, chills, fever Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for ... Read more
Felt like all my nerve endings were being electrified while on Fire; I could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R; High Clotting Factor; dehydration; chest pains/Had pains in my heart also; Heart was not beating correctly; body cramps all over; High temperature along with sudden chills; High temperature along with sudden chills; frequent sweats; Extreme pain; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 06Apr2021 at 07:00 PM, at single dose for COVID-19 immunisation. The patient had medical history of fibromyalgi, anxiety and allergy to all anti-depressants. The concomitant medication included clonidine once a day for anxiety. It reported that, on 07Apr2021 at 8:00 AM, patient experienced extreme pain felt like all nerve endings were being electrified while on fire such extreme pain ever since the vaccine. After 10 days he could not take it anymore. Patient could not keep down food for 10 days. Then, could not keep down liquids for 3 days then went to the E/R. Had a high clotting factor along with dehydration and chest pains. Heart was not beating correctly, and they were worried his blood would clot, heart attack, aneurism and death. He had pains in heart also, body cramps all over. High temperature along with sudden chills and frequent sweat. Contact the ICU ward at for all the details on the problem vaccine caused. The all adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient hospitalized for the 2 days and treated with the morphine for pain, 5 bags of Saline and blood Thinner. Vaccination facility: Pharmacy or Drug Store. Patient did not take any other vaccine in four weeks. There was no COVID prior vaccination and COVID tested post vaccination (Nasal Swab, result negative) on 16Apr2021. Information about lot/batch number has been requested.
58 2021-04-24 malaise, chills, fatigue, headache, fever tiredness; headache; muscle pain; chills; joint pain; fever; not feeling well; injection site pain; ... Read more
tiredness; headache; muscle pain; chills; joint pain; fever; not feeling well; injection site pain; This is a spontaneous report from a contactable consumer. A 58-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 31Mar2021 as single dose for Covid-19 immunization. Patients medical history and concomitant medications were not reported. It was reported that patient's sister went in for a chest x-ray and COVID-19 test & the x-ray was clear but she tested positive for COVID-19. Patient had a question, should I wait to go tested or should I just proceed with my second dose. Response received as Spoke from attached document, explained ACIP recommendation, and referred to HCP for further guidance. Patient experienced 8 of the possible side effects as tiredness, headache, muscle pain, chills, joint pain, fever, not feeling well, and injection site pain. Outcome of the event was unknown No follow-up attempts are needed. No further information is expected.
58 2021-04-24 throat irritation the allergist prescribed Fexofenadine HCl 180 mg and Famotidine 40 mg/allergic reaction; Had some ir... Read more
the allergist prescribed Fexofenadine HCl 180 mg and Famotidine 40 mg/allergic reaction; Had some irritation in throat; Burning sensation in esophagus; Hands swollen; Hives; Hives/patient did have pretty much the exact same reaction 30 years ago in 1991 when he had the measles vaccine and was told not to take further measles vaccines after that; Itching; red, itchy rash; Body rash; Body rash/patient did have pretty much the exact same reaction 30 years ago in 1991 when he had the measles vaccine and was told not to take further measles vaccines after that; This is a spontaneous report from a contactable consumer. A 58-years-old male patient (boyfriend) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 08:30 (at 58-years-old) as single dose for COVID-19 immunization (So he wouldn't get Covid). The patient medical history was not reported. There were no concomitant medications. Caller reported that the patient did have pretty much the exact same reaction 30 years ago in 1991 when he had the measles vaccine and was told not to take further measles vaccines after that, patient had rash and hives. It was reported that after, the patient received the shot on 26Mar2021. 9 days later on 04Apr2021, he began he got a rash on his skin all over his body. He got rash, hives and itching. He also had irritation in his throat on 08Apr2021. So, he went to the doctor and the emergency room and he is taking medication and he has been taken the medication for approximately 4-5 days now. Medication worked during the day but by the next morning the rash and itching start all over that. Body rash: Caller reported that the body rash started in the patient's torso and under the patient's arms. Caller reported that the rash spread up the patient's neck. Caller reported that the patient had a red, itchy rash (04Apr2021) and there were some hives involved. Caller reported that the patient went to his doctor on 05Apr2021 in terrible, miserable shape. Caller reported that the patient's physician prescribed prednisone. Caller reported that the patient took the prednisone later in the day on 05Apr2021. Caller reported that the patient went to work on 06Apr2021 and felt a little bit better but during the night of Tuesday, 06Apr2021, the rash began to spread again and the patient began to get the hives. Caller reported that the patient went to work on 07Apr2021, after taking a dose of prednisone. Caller reported that the patient called her around 8:00 PM on the evening of 07Apr2021 and stated it's starting all over again and it's spreading. Caller stated that the patient reported that he had hives on his neck, his shoulders, his body, his private parts, and his butt. Hands swollen (07Apr2021): Caller reported that the patient's right hand was swelling and had swollen to at least 1 or 2 sizes bigger than normal. Caller reported that the patient's left hand was swelling some. Caller reported that the patient had difficulty squeezing both hands into fists due to the swelling. Caller reported that the patient went to the emergency room during the night of 07Apr2021. Caller reported that the emergency room provider prescribed a stronger dose of prednisone and administered prednisone to the patient in the emergency room. Caller reported that the patient did not go to work on 15Apr2021. Caller reported that the patient took a dose of the new, stronger prednisone and the prednisone seemed to settle the rash down a little bit. Caller reported that around 3:00 AM 07Apr2021 into Friday, 08Apr2021, the rash started all over again. Caller reported that the patient already had an appointment scheduled with his physician for 08Apr2021. Caller reported that the patient's physician referred him to an allergist and the allergist prescribed Fexofenadine HCl 180 mg and Famotidine 40 mg. Caller reported that so far, the fexofenadine and famotidine seem to be working. It was also reported that patient had Burning sensation in esophagus on 08Apr2021. Caller reported that the concern of her and the patient is that the patient is scheduled to get the second dose of the Covid-19 vaccine this Friday, 16Apr2021. Caller reported that the patient's allergist is recommending that he wait another 2 weeks to get the second dose of the Covid-19 vaccine. Caller reported that she and the patient are going to go to the appointment on 16Apr2021 and request for the appointment to be rescheduled for 2 weeks later. Caller reported that she is very concerned if the patient should be getting a second dose of the Covid-19 vaccine or not. Caller reported that the patient's allergist informed the patient that the patient could get Covid-19 and die from that, but that the patient won't die from the allergic reaction he is experiencing. Caller reported that she questions the allergist's opinion because of the misery that the patient has been in. Caller stated that she just needs some answers. Caller reported that the patient's allergist had stated that there was one other person that he was aware of that had a reaction 10 days after receiving the Covid-19 vaccine. Caller stated that it was odd that the rash had started 10 days in, and reported that the patient ruled out food and ruled out any changes as the patient hadn't changed soap or laundry detergent recently. Details were not provided for the other patient the allergist reported had a delayed reaction 10 days after receiving a Covid-19 vaccine. Caller reported that the patient's allergist thinks the Covid-19 vaccine caused the patient's reaction. Caller reported that she and the patient are scared about whether he should get the second dose of the Covid-19 vaccine and are unsure of what she and the patient should do at this point. Caller stated that she knows that people don't like to give advice, but that they say if you have immediate adverse reaction you shouldn't get the second dose of the Covid-19 vaccine. Caller stated that the patient's reaction wasn't immediate, and asked if it the rash should still be considered an adverse reaction and the patient should not go get second the second dose, or should the patient go with what his doctor said as it is recommended that you should listen to physician. Body rash: Caller reported that the patient's rash has dissipated for the most part. Caller reported that the patient still has some redness in parts, but the itching has subsided at least as of this morning, 12Apr2021, when she spoke to the patient around 6:00 AM. Hands swollen: Caller reported that the swelling the the patient's hands went down in the emergency room on Wednesday, 07Apr2021, night and began to dissipate on Thursday, 08Apr2021, with 50 mg of prednisone. Caller reported that she believes the patient's hands have returned to normal at this point, reporting that the patient is at work and as a mechanic, the patient has to work with hands. Caller reported that the patient's primary care physician did take blood work, but the patient's allergist said that the results of the bloodwork would probably not be relevant based on fact that the patient was on medication at the point that the labs were drawn. Caller reported that she believed the initial prescription for prednisone was 10 mg tablets. Caller reported that the patient had to take 4 tablets the first day, 3 tablets the second day, 2 tablets the third day, and 1 tablet after that. Caller reported that she and the patient are concerned about the patient getting the second dose of the Covid-19 vaccine. Caller reported that she and the patient are trying to anticipate what would happen after the patient received the second dose. Caller stated that she would like to know if someone would recommend or say it's ok for the patient to get the second dose of the Covid-19 vaccine, and if the patient has a reaction, that it won't be as life threatening as getting Covid-19. Prednisone did not help rash, hives, or itching (10 mg tablets, dispensed in pharmacy bottle). Outcome of the events red, itchy rash; body rash; body rash/patient did have pretty much the exact same reaction 30 years ago in 1991 when he had the measles vaccine and was told not to take further measles vaccines after that; and hands swollen was recovering. Events had some irritation in throat and burning sensation in esophagus was recovered on 09Apr2021; while other events was unknown. Information on the lot/batch number has been requested.
58 2021-04-25 fever High Fever (102 F) and shakes followed by swelling Lymph nodes in the back of the neck - under chin... Read more
High Fever (102 F) and shakes followed by swelling Lymph nodes in the back of the neck - under chin - temple and scalp.. Rash breakout similar to a skin burn -- swelling in cheeks - swollen ears and eyes -- forehead and entire face cover .. - still growing .
58 2021-04-27 fever, throat pain initially had fever, sore throat and body aches after 3 days felt a swelling in his neck and more dr... Read more
initially had fever, sore throat and body aches after 3 days felt a swelling in his neck and more drainage in his throat with swallowing but no shortness of breath
58 2021-04-28 fatigue tiredness and fatigue started 8 hrs after shot, ringing in ears started 8 hrs after shot, body aches... Read more
tiredness and fatigue started 8 hrs after shot, ringing in ears started 8 hrs after shot, body aches started 16 hrs after shot, tiredness and fatigue resolved 32 hours after shot, ringing in ears has continued some days are worse than others
58 2021-04-29 sweating Nausea, sweating, pale. Given water and crackers. BPs 142/78 (pulse 75), 144/76 (pulse 74), O2 sat 1... Read more
Nausea, sweating, pale. Given water and crackers. BPs 142/78 (pulse 75), 144/76 (pulse 74), O2 sat 100%.
58 2021-04-29 sneezing, fatigue, cough Cough, sneezing, fatigue
58 2021-04-30 cough chest pain/a little worse; It feel sore every time I move from one side to another/Sore/Hurts when h... Read more
chest pain/a little worse; It feel sore every time I move from one side to another/Sore/Hurts when he coughs; It hurts when I cough; Short of breath; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solu-tion for injection, lot number: Solution for injection, lot number: EW0164, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 19Apr2021 18:00 (at the age of 58-year-old) as single dose for COVID-19 immunisation (for Covid-19). The patient had no medical history. There was no family history. The patient did not take concomitant medications. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date as the Pfizer vaccine. Patient did not receive prior vaccinations (within 4 weeks). Patient experienced chest pain/a little worse on 19Apr2021, It feel sore every time I move from one side to another/Sore/Hurts when he coughs, It hurts when I cough, short of breath on an unspecified date in Apr2021. Patient stated he have received the first Pfizer shot and experienced chest pain. It feel sore every time he move from one side to another. It hurts when he cough." It was informed to patient that chest pain has not been reported with the vaccine. However, muscle and joint pain has been associated with the vaccine. Please seek medical advice if your symptoms persists or get worst. Chest pain is a symptoms that should not be ignored. Chest pain started late last night and its still sore, it hurts, the same, it was a little worse this morning, but he's laying down not moving around, so it still feels the same, verified as persisting. He did not treat the symptoms in any way. States he said he is going to take some Advil. Any adverse event did not require a visit to emergency room or physician's office. There were no relevant tests. The outcome of event for chest pain/a little worse was not recovered and for other event it was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-04-30 headache Nauseous; Stayed in bed as head was hurting; He felt really sick; This is a spontaneous report from ... Read more
Nauseous; Stayed in bed as head was hurting; He felt really sick; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 15Mar2021 (Lot Number: EN6206), as single dose, for COVID-19 immunisation. Medical history included hypertension, blood cholesterol and spinal fusion surgery. Concomitant medications included losartan (unknown manufacturer), rosuvastatin (unknown manufacturer) and oxycodone (unknown manufacturer) for spinal fusion surgery (taking from last decade, as needed). The patient experienced nauseous (nausea) (non-serious) in Mar2021 with outcome of recovering, stayed in bed as head was hurting (headache) (non-serious) in Mar2021 with outcome of recovering, he felt really sick (illness) (non-serious) in Mar2021 with outcome of recovering. No follow-up attempts are needed. No further information is expected.
58 2021-04-30 malaise felt 'ill'; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report... Read more
felt 'ill'; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Nurse. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 01Jan2021 at 08:30 (Batch/Lot Number: EL3248) as a single dose (at the age of 58-years-old) and dose 2 intramuscular, administered in left arm on 02Feb2021 at 12:15 (Batch/Lot Number: EL3248) as a single dose, (at the age of 58-years-old), for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination. The patient experienced vaccination failure on an unknown date in Mar2021. On 16Mar2021 the patient reported he felt ill and tested positive for COVID on 22Mar2021(as reported). The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The patient underwent lab test which included on 21Mar2021 COVID-19 test (PCR nasal swab test) was positive. The outcome of events vaccination failure, COVID-19 (tested positive for COVID-19), and felt ill was recovered on an unknown date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
58 2021-04-30 fever Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Exp... Read more
Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.
58 2021-05-01 fever Patient received his first dose of COVID vaccine on 4/16/21, and he developed nausea, occasional che... Read more
Patient received his first dose of COVID vaccine on 4/16/21, and he developed nausea, occasional chest pains, dyspnea, and fever ~ 4/21/21. Patient tested positive for COVID on 4/23/21 and his symptoms progressively worsened until he presented to the ED on 5/1/21. Patient was admitted to the hospital for COVID treatment, but was discharged on 5/2/21 since his symptoms rapidly improved.
58 2021-05-02 fatigue Mild fatigue and body aches began about 10 hours after the vaccination and lasted about 36 hours. T... Read more
Mild fatigue and body aches began about 10 hours after the vaccination and lasted about 36 hours. Tinnitus began 5 days after the vaccination, and persists.
58 2021-05-02 fatigue 1st day much arm pain at shot site . 2nd day severe indegestion, stomach cramp, nausea , very painf... Read more
1st day much arm pain at shot site . 2nd day severe indegestion, stomach cramp, nausea , very painful to touch stomach , 3rd day fatigue, slept all day
58 2021-05-02 sweating, cough, chills, fatigue chills sweats, cough, fatigue and body aches. Over the counter cough and cold medicine.- mucinex, t... Read more
chills sweats, cough, fatigue and body aches. Over the counter cough and cold medicine.- mucinex, try flonase for congestion Tea with honey Throat lozenges Gargle with salt water several times a day Motrin or Tylenol as needed for pain or fever Lots of fluids and rest Return for any worsening symptoms
58 2021-05-02 malaise On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up.... Read more
On 4/14/2021 pts sugar dropped to 40. EMT was called. They gave him some meds to bring it back up. He was still not feeling well that night he took some more sugar meds and went to bed. Next morning he was foaming at the mouth and unresponsive. EMT was called again. On 4/15/2021 Pt was taken to the ER. He was intubated and transferred to another ER. He has a trach, has a feeding tube and has swelling of the brain.
58 2021-05-02 malaise Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient has history... Read more
Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Patient has history of PAT (tachycardia) and heart palpitations and is history of Verapamil per patient. He was not feeling well after the shot and we observed him and had the minute clinic nurses come to take his blood pressure and heart rate. He was feeling heart palpitations after the shot. After the nurse took the blood pressure he felt better and his palpitations slowed down so we had him sit again. He had palpitations again nurse call 911 paramedics took pt to hospital
58 2021-05-03 chills, fever, fatigue Chills; fever; body aches; painful lump in armpit; chest fullness/discomfort; hard to take a deep br... Read more
Chills; fever; body aches; painful lump in armpit; chest fullness/discomfort; hard to take a deep breath; fatigue.
58 2021-05-03 cough, headache, fever Fever, cough, headaches Netti pot Loratadine 10 mg daily OTC Sudafed Tylenol Plenty of res... Read more
Fever, cough, headaches Netti pot Loratadine 10 mg daily OTC Sudafed Tylenol Plenty of rest / fluids
58 2021-05-03 cough respiratory illness Cough - benzonatate (TESSALON PERLES) 100 mg capsule; Take 2 capsules (200 ... Read more
respiratory illness Cough - benzonatate (TESSALON PERLES) 100 mg capsule; Take 2 capsules (200 mg total) by mouth 3 (three) times a day as needed for cough for up to 7 days Increase fluids. Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed. OTC Tylenol or ibuprofen for fever, discomfort. Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night. If symptoms persist without improvement over the next 2-3 days despite above treatment, follow-up with PCP for further evaluation.
58 2021-05-03 cough Arm pain and cough.
58 2021-05-04 chills Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (p... Read more
Cold Sweats; Chills; getting frustrated; This is a spontaneous report from a contactable consumer (patient). male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Apr2021 (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 (Lot: ER2616) on 24Mar2021 for covid-19 immunisation. The patient got the second shot and he had cold sweats in the middle of the day (15Apr2021) and chills on and off, patient was getting frustrated with all of these questions. None treatment was received. The outcome of cold sweats, chills was not recovered, getting frustrated was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-04 fatigue fatigue next day after vaccine, second day fatigue gone but muscle pain all over and severe neck mu... Read more
fatigue next day after vaccine, second day fatigue gone but muscle pain all over and severe neck muscle spasm.
58 2021-05-04 fatigue mild fatigue; didn't feel as motivated; The initial case was missing the following minimum criteria:... Read more
mild fatigue; didn't feel as motivated; The initial case was missing the following minimum criteria: unspecified adverse effect. Upon receipt of follow-up information on 20Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer (patient). This case refers to dose 2 experience. A 58-year-old male patient received the second dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: ER8734, Expiry Date: 31Jul2021) via intramuscular in right arm on 05Apr2021 at single dose for COVID-19 immunization. The patient's medical history included autoimmune condition. The patient's concomitant medications included ongoing azathioprine (IMURAN) 150mg by mouth daily and prednisone 7mg orally daily, both for autoimmune condition. The patient previously received the first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EP6955, Expiry Date: 30Jun2021) via unspecified route of administration in left arm on 15Mar2021 at single dose for COVID-19 immunization and experienced felt like someone punched him in the arm about 12 hours after. The patient stated when he went to get his second dose he noticed there was still a black and blue mark on his left arm from where he had the first shot and this was 21 days later, so he decided to get the second shot in his right arm. He did not end up with a black and blue mark for an extended period of time with the second dose. The patient stated the second shot didn't really feel any real symptoms at all, maybe some mild fatigue he noticed when he was working out the day after. The patient stated he didn't feel as motivated and it lasted only a day. The patient experienced mild fatigue; didn't feel as motivated from 06Apr2021 to 07Apr2021. On 19Apr2021, the doctor ordered a SARS-COV-2 IgG antibody test and it came back negative with SARS COV2 IgG index of 0.02. The patient stated he wanted to know was that the appropriate test that was run, asked if he had an immune response. The patient stated that he didn't want to run around with a false sense of security. The outcome of the events was resolved. No Follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : Same patient, different dose and event.
58 2021-05-04 fever, chills fever for hours,then chills for hours and fever for hours. Day three after 2nd shot lesion on the r... Read more
fever for hours,then chills for hours and fever for hours. Day three after 2nd shot lesion on the roof of my mouth and eye infection in left eye. Antibiotic 500 mg for 10 days.They helped some. Then Amoxilillin 500 mg . After 8th day mouth cleared up. Left eye , I hot packed.
58 2021-05-05 headache, fever, chills, fatigue Fever (101), chills, muscle aches, headache, strong fatigue. I had Covid-19 in Oct, 2020.
58 2021-05-07 fatigue Extreme Fatigue , Blurry Vison, Inability to Focus/Concentrate - Brain Fog
58 2021-05-07 fatigue Extreme Fatigue, Inability to Focus, Concentrate , Brain Fog
58 2021-05-07 headache I don't know it is stroke or something; heart burn something; its like I am having a heart attack; f... Read more
I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.
58 2021-05-07 pneumonia This 58 year old male received the Covid shot on 3/27/21 and went to the ED on 4/3 /21 with th... Read more
This 58 year old male received the Covid shot on 3/27/21 and went to the ED on 4/3 /21 with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019
58 2021-05-09 cough, headache, chills, throat pain sore throat, headache, body aches, cough, loss of appetite, chills, OTC tylenol, cold and flu monoc... Read more
sore throat, headache, body aches, cough, loss of appetite, chills, OTC tylenol, cold and flu monoclonal antibody infusion
58 2021-05-09 headache I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches ... Read more
I continue to struggle with these re-awakened symptoms from my Covid infection 11/2020 * Headaches * Spiking blood pressure * Brain fog/light headedness * I often smell a campfire, i.e. wood burning smell
58 2021-05-10 cough, body temperature increased 104 temp extreme body aches cough lasted30 hrs
58 2021-05-10 headache, sweating, chills, fever Super, heavy fever, intense; Chills, later described with heavy sweating and shaking; Arm sore, desc... Read more
Super, heavy fever, intense; Chills, later described with heavy sweating and shaking; Arm sore, described as left arm at injection site; Chills, later described with heavy sweating and shaking; Chills, later described with heavy sweating and shaking; Low grade fever; Terrible headache; Bumpy rash on opposite arm, near elbow; This is a spontaneous report from a Pfizer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:00 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYLENOL), ibuprofen (IBUPROFEN). On 14Apr2021, 5 hours after vaccination patient experienced arm sore, described as left arm at injection site; chills, later described with heavy sweating and shaking (hyperhidrosis), chills, later described with heavy sweating and shaking (chills), low grade fever, terrible headache, bumpy rash on opposite arm, near elbow (rash), chills, later described with heavy sweating and shaking (tremor), On 25Apr2021 16:00, super, heavy fever, intense. Both has had doses of covid vaccine. Patient Said 12 hours after 2nd dose had unusual side effect and went away 36 hours after vaccine. Suddenly side effect is back. The patient was taking Pfizer Covid 19 vaccine protection, doing his duty. Caller stated that then reclarifies, he did not have a primary care provider right now. Caller stated that he would also volunteer to donate blood if it is needed in the future for evaluation. Caller states after the second vaccine, on the same day, 14Apr2021, his arm was sore, he had chills with heavy sweats every 3 hours, a low grade fever, terrible headache and a bumpy rash on the opposite arm near his elbow, that was 3 inches by 3 inches. Caller stated he took Tylenol, which helped, and the symptoms went away. Caller stated that yesterday, the bumpy rash came back, but it was worse. Caller stated he thought it was unusual for his symptoms to come back a week later. Caller stated he does not have a healthcare provider presently. Caller restated that his fever, chills, headache and rash, all appeared on 14Apr2021 and then went away on the 16th and then came back on 25Apr2021. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. Caller added at the end of the report that he is fair skinned, and has freckles, and felt that was important to add. Caller mentioned again that if Pfizer would like a sample of his blood in the future, he is willing to provide it. Or if Pfizer does want to contact him, he is willing to answer questions. Caller spoken quickly at times and provided a lot of details, multiple reclarifications made to capture the information. The outcome of events (vaccination site pain), chills, low grade fever, rash) were recovered and events (hyperhidrosis, terrible headache, super, heavy fever, intense, tremor) were not recovered. No any unaddressed medical questions were referred or forwarded to Medical Information. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-05-10 fever Muscle/ body aches (back, leg and arm pains) and joint pain (wrists), even feet difficulty bending a... Read more
Muscle/ body aches (back, leg and arm pains) and joint pain (wrists), even feet difficulty bending and pain back and hips sitting low-grade fever Brain fog; trouble focusing/ concentrating.
58 2021-05-13 headache, productive cough, throat pain, chills "Pfizer-BioNTech COVID-19 Vaccine EUA" -- pt admitted for covid-19 after 1 dose of covid-19 vaccine ... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" -- pt admitted for covid-19 after 1 dose of covid-19 vaccine Pt received covid-19 vaccine on 3/18/2021. Admitted to hosp on 4/2/2021 with c/o SOBx6dyas, with intermittent chest tightness+pleuritic chest pain+ productive cought with yellow sputum + chills, loss of taste and smell, myalgia, sore throat, headache. Spouse was tested positive one week PTA. Hypoxia on RA at home with 88% readings. Received Remdesivir x5days and Dexamethasone; 4/2/2021 89% O2sat on RA, put on 2-3L NC and O2 sat improved to 95-98% 4/3/2021 on 3L NC, O2 sat 97-98% 4/4/2021 on 2L NC, O2 sat 94-95% 4/5-4/6 on 2L NC, O2 sat 97-99% 4/7/2021 O2 sat 96-99% on RA
58 2021-05-14 cough, sleepiness, sinus pain, headache, nasal congestion Severe cough and congestion and hacking up green stuff like infection; Severe cough and congestion a... Read more
Severe cough and congestion and hacking up green stuff like infection; Severe cough and congestion and hacking up green stuff like infection; Pain in mouth; wheezing; Pain in face from that; in the roof of his mouth near his teeth and it was extremely painful; Excessive sleepiness; Pain in sinus cavity; Headache; Thrush; Cannot hardly breathe; Mouth blister; Laryngitis; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Apr2021 (Batch/Lot Number: EW0151; Expiration Date: 01Jul2021) as 1st dose single for COVID-19 immunization, prophylaxis. Medical history included diabetes mellitus and blood pressure measurement ongoing. The patient's concomitant medications were not reported. Today is the first day he has a voice since the injection on 23Apr2021. He later stated he received injection on 22Apr2021. Today he is able to speak. The patient experienced laryngitis on 23Apr2021, excessive sleepiness (sleeping until around 3pm every day for the last 3 days) and pain in sinus cavity on 03May2021, cannot hardly breathe on 24Apr2021, mouth blister on 23Apr2021, thrush on 26Apr2021, headache on 27Apr2021, severe cough and congestion and hacking up green stuff like infection (cough and nasal congestion). He is getting a little better and is on antibiotics and Mucinex and everything trying to get a control of it. It has been so bad he cannot breathe. He is still wheezing. Now it is like bronchitis and he is still coughing today. In the beginning, it was like pneumonia. It was so bad. Pain in mouth, pain in face from that and in the roof of his mouth near his teeth and it was extremely painful on an unspecified date. He did not realize they were there until he brushed teeth and popped them and had massive amounts of blood in his mouth. He did not experience anything like that before and that really scared him. They gave Nystatin to heal up his mouth. Blisters are fading and blood blisters have stopped bleeding. He still has pain in mouth and face from that. He was also given Albuterol to help him breathe. The antibiotic is a great big pink tablet. It is 800 some mg of Amoxicillin. All of these are in a pharmacy vial and he does not have a lot or expiration for any. He was also prescribed Bromphen cough syrup. It is in a pharmacy vial with no lot or expiration. All are in pharmacy vials except the Mucinex and it is over the counter. He started taking it after the vaccine to control the cough. No further details provided. He was going to see an infectious disease doctor. They were going to do a vaccine challenge test to find out if he needs IVIG. He will see if it is something inside of him that the vaccine triggered that he needs to fix and won't know until he sees the doctors. The doctor's are hoping the infectious disease doctor will be able to give him answer about second dose as well. Received call from consumer regarding the Pfizer COVID vaccine. He received it at pharmacy and nothing happened the day of. He wanted to report what happened after that. He also would like to know if he should attempt to get second dose. PSCC Communicated to the patient as due to extended hold time caller opted to be transferred to hold his place in the queue and Provided caller with websites and contact information. Treatment was received and Therapeutic measures were taken. The outcome of the events pain in mouth, wheezing, pain in face and gingival pain were unknown whereas the other events were recovering. Follow up attempts needed. Further information is expected.
58 2021-05-14 influenza like illness, fatigue I had the same reaction after the second shot that I had with the first it started with slight numb... Read more
I had the same reaction after the second shot that I had with the first it started with slight numbing in my face and then 2 days of severe flu like symptoms including aches from head to toe and freezing and not being able to get warm I was very tired and stayed in bed for a day and a half and then it went away with no further problems
58 2021-05-14 fever 25 hours after getting the 2nd vaccine. I had a fever of 101.9 then I took 4 ibuprofen 200mg and ten... Read more
25 hours after getting the 2nd vaccine. I had a fever of 101.9 then I took 4 ibuprofen 200mg and ten minutes later my temperature dropped to 97.3
58 2021-05-15 head discomfort, sleepiness Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. ... Read more
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by date 05/17/21 at 1515) at 1438. The patient reported feeling dizzy to EMT, who immediately moved him to the anti-gravity chair. RN assisted in positioning him in a Fowler's position and ice packs were placed on his back and behind his neck. Patient's face mask was removed and his vital signs were taken at 1459, the patient was wearing a thick jacket, so the palpable radial pulse on the left forearm was 145, HR 83, RR 16, oxygen saturation was 97%., and pupils were equal. The patient denied any shortness of breath, difficulty breathing, difficulty swallowing, chest pain, or loss of consciousness. The patient was alert and oriented to person, place, time, and situation. The patient was speaking in full sentences and immediately responsive to questions. The patient was given a bottle of water and reported last eating around 1300. The patients color slowly reappeared when he was placed in Fowler's position. Reported being allergic to penicillin and taking Seroquil, 400mg, daily and Hydroxyzine, 25 mg for anxiety. Denied any chronic medical disorders other than general anxiety. Vitals were retaken at 1459, BP: palpable radial pulse, 140, RR 16, HR 79, and oxygen saturation at 98%. The patient stated that he felt flushed in his face, and the patient was immediately offered Benadryl but he stated, " Let's wait a few minutes, I don't like taking anything if I don't have to."The patient denied any shortness of breath, difficulty breathing or swallowing, lip tingling, or facial swelling. The patient decided to take the oral Benadryl at 1503 and was given Benadryl, 50mg oral suspension, PO. At 1505 we attempted to position him to a sitting upright position in the gravity chair and he stated, " I feel lightheaded, can we place me back how I was?" EMT and RN repositioned the patient in the anti-gravity chair to a Fowler's position and assisted the patient with removing two layers of shirts, as he was wearing multiple layers. Vitals were retaken at 1506: 120 palpable radial pulse, RR 16, HR 78, and oxygen saturation at 97%. The patient was alert and oriented to person, place, time, and situation. The patient was able to follow commands, had strength equal bilaterally in the upper extremities, and had a symmetrical smile. Vitals were retaken at 1515, BP: 120/82 (R arm), HR 81, RR 16, oxygen saturation at 97%. The patient was given juice and repositioned to a semi-Fowler's position. Denied dizziness or lightheadedness. The patient stated, " I'm usually pretty sensitive to medication, now I just feel like I could go to sleep." Denied experiencing shortness of breathing, difficulty swallowing, or difficulty breathing. Vitals were retaken at 1528, BP 120/85, HR 66, RR 16, oxygen saturation at 98%. The patient was able to follow commands, and stated, " I feel a pressure in my head." RN was going to call 911 to have EMS transport the patient to a hospital, but the patient denied EMS services and did not want 911 to be called when it was offered at 1528. The patient was repositioned to a Fowler's position. Patient reported no longer feeling flushed on the left side of his face at 1535. At 1540, vitals were retaken, BP 120/85 ( R arm, sitting upright), HR 79, RR 16, and oxygen saturation at 97%. The patient's color returned and he denied feeling lightheaded or dizzy. RN instructed the patient about emergency precautions and to follow up with his primary care provider. RN educated the patient about not operating machinery as the patient was given Benadryl and this may cause him to be drowsy. The patient contacted a friend to pick him up from the site. RN gave the patient reporting information. Vitals were retaken at 1550, BP: 120/82, HR 76, RR 16, and oxygen saturation at 98%. The patient's mouth was moving with regular movements and the patient was rapidly responding to questions. Patient called friend to coordinate his ride home. RN educated him about ER precautions again. The patient was alert and oriented to person, place, time, and situation, and his facial color had returned to baseline. EMT was instructed to stay with the patient until patient's friend arrived on site. At 1610 EMT reported to RN that patient reported feeling flushed and lightheaded again. EMT immediately placed him in a Fowler's position and RN called 911, EMS. The patient stated, " It's hard for me to recall things, like my head is really foggy." Patient's speech was slower than baseline, no facial swelling was observed and patient denied any difficulty breathing, shortness of breath, chest pain, or loss of consciousness. Patient was alert and oriented to person, place, time, and situation. Fire Department assumed care at 1615, RN gave report to the responders. The responders completed an EKG on site and completed a set of vitals. Patient denied transportation by EMS to hospitaland signed AMA paperwork given to him by the responders. Patient's friend arrived on site at 1618. RN educated patient's friend about transporting patient to hospital, as patient stated, " I'm going to have my friend take me to the hospital." RN quickly educated patient's friend that if while transporting patient to hospital, he began to experience shortness of breath, loss of consciousness, or difficulty breathing, to immediately pull over and call 911. Patient's friend verbalized understanding and patient was pushed in a wheelchair to the friend's vehicle, as he was very lightheaded. EMT, EMT, and RN assisted patient into the vehicle. Patient and friend stated that they were going to pick up a few items from patient's car and then go to the hospital immediately. Patient left the site at 1621.
58 2021-05-15 headache Hypertension. Severe swelling of hands feet. Nausea diarrhea headache cognitive impairment
58 2021-05-16 headache Dizziness and headache started about 1-2 hours after shot. Felt like I was going to fall when I stoo... Read more
Dizziness and headache started about 1-2 hours after shot. Felt like I was going to fall when I stood up. Last about 12 hours. Very sore arm at the injection site.
58 2021-05-17 headache, chills, fever, fatigue Headache, Muscle Pain, Chills, Fever, Nausea, Diarrhea, Tiredness
58 2021-05-17 lethargy, influenza like illness He got his vaccine, he had flu-like symptoms for about 2 1/2 days, and then he was fine until yeste... Read more
He got his vaccine, he had flu-like symptoms for about 2 1/2 days, and then he was fine until yesterday. He woke up with extreme hearing loss and extreme ringing in his ears as if he was under water with some problems in hearing. It feels like today that he has cotton in his ears. He did try some antihistamines which did not help. He seems to be more tired since he's gotten the vaccine, lethargic and not completely with it.
58 2021-05-17 sleepiness foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unre... Read more
foaming from the mouth/foaming at the mouth; blood sugar dropping; He would not wake up and was unresponsive; seizures; swelling on brain; Pneumonia aspirating; so cold he could not work or anything; This is a spontaneous report from a contactable consumer reporting on behalf of her fiance. A 58-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunization at the age of 58 years old. Medical history included sugar /diabetic, blood pressure. None vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family Medical History Relevant to AEs was none. Concomitant medication(s) included metformin hcl for Diabetes, he has been on for a long time; pregabalin for his back and leg because he had 2 pinched nerves or something and he has to get it repaired with injections. He has not gotten injections because of what he has been going through right now. It is 25 mg and he has been on this for a little while; lisinopril for cholesterol and is a blood pressure and heart pill; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) for his vitamin D was low; diclofenac sodium (DICLOFENAC NA) for inflammation, he has been on this for as long as she knows; potassium chloride (POTASSIUM [POTASSIUM CHLORIDE]) for his potassium is low, She has been giving this to him. Whenever he gets blood work, sometimes they say his potassium is low so she gives it to him everyday; amlodipine besylate for blood pressure and heart; sertraline hcl for a mood pill, he has been on a long time; Metoprolol succinate for blood pressure and heart, He has been on for a long time. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 28Dec2020 (Batch/Lot Number: EJ1682) as SINGLE DOSE for covid-19 immunisation. The patient experienced foaming from the mouth/foaming at the mouth, blood sugar dropping, he would not wake up and was unresponsive, seizures, swelling on brain, pneumonia aspirating, so cold he could not work or anything in Apr2021. Reported as: He had the Pfizer shot, but he is currently hospitalized, he had an experience of foaming from the mouth, 3 months after the vaccine. He is on a trach/ requires trach and feeding tube. He is also on dialysis to clean the toxins in his blood. Caller stateed she is calling on behalf of her fiance. He can not talk to anyone at the moment. The reason she is calling is because he had his vaccine 08Jan2021. Caller states but the thing is that nobody knows what symptoms anybody is going to have. It has been what, 3 months, but his sugar dropped to 40 one day, and 30 one day. He was foaming at the mouth and had seizures. Aspirated, pneumonia: caller states that her fiance aspirated and had pneumonia in his right lung and has been in the hospital ever since. Foaming at the mouth: He is on a trach and feeding tube, dialysis in his neck, and caller is trying to figure out what is going on. Caller adds that he was foaming at the mouth. Blood sugar dropping, so cold he could not work or anything: caller states this happened Tuesday 2 weeks ago. She has been working and going there to see him. This is the first time she has trying to think and get answers herself. Caller adds that she tested his blood sugar and must have touched it with her own finger because it said 197. The paramedic said no it was 40. Caller states the paramedic gave her fiance IV stuff that shot it up and brought it up to 290, which was good. They wanted him to eat peanut butter and jelly and he said no and fought with them. The sugar was still not going up, and sugar was out of sorts. He took a few bites and it was okay. He asked for soup because he was so cold he could not work or anything. Caller becomes tearful and adds that her fiance's mom passed 6 months ago and they were talking. He got 20 units of lantus, normally he takes 50. They went to bed and caller adds she guesses because her nerves were shot or something she called off of work that night. She got up to go to the bathroom and let the dogs out and went to check on him. She did not have the light on and when she turned the light on she saw her fiance foaming at the mouth. He would not wake up and was unresponsive. Paramedics came and gave him a shot and IV to put sugar back in. They asked which hospital she would like him to go to and they said they could not take him to that hospital so they took him to another place. Seizures: They then put a breathing tube into him. The doctor said she was sorry but she knocked the man's tooth out. Then, they had to switch him to the mother hospital because they had to put probes on his head to monitor his seizures because he had seizures. He had swelling on the brain, pneumonia, and was aspirating. Caller adds she is not sure if she touched the strip with her finger and that was the false reason, and his blood sugar was only 40. caller confirmed that the blood sugar increased to 290 following the paramedics giving her fiance sugar. Caller adds she does not know how to work that stupid thing. He never showed her how to do it. If he had showed her, she would know what to do. She said it said 197 but the paramedics told her it was 40. She has to learn how to do this. Patient requires trach, feeding tube, and dialysis: Caller was asked to clarify dates and she states that this was Wednesday, the next day. He has not foamed from the mouth since then, and they are not sure if he is doing seizures or not. They asked and the hospital said they are not sure because they do not have probes on him. Now, he is on a trach and feeding tube. They are also giving him some type of dialysis through his neck to get rid of toxins in the blood and filtering it back to him. Caller clarifies date of hospitalization as 15Apr2021 she would think, but she does not even know. Caller thinks it has been two or three weeks. First, he went to the place she mentioned and then he was transferred to the other and that is where he has been since. Indication: he worked up on 4 a lot which he is the maintenance where he works. They wanted him to get the Pfizer because not too many people wanted to go up there. He figured he would take it and with his blood pressure and sugar it would help. He was up there fixing things and stuff like that, or at least that is what she was told by someone else. Caller verifies that the low blood sugars, foaming at the mouth, and being unresponsive were what hospitalized the patient. She does not know dates, she thinks it was around 15Apr2021, and he is still in the hospital. Investigations: caller states that she knows he went back, she does not know when, and that since it is May now, he must have gone back a few months ago for lab work. It was in the morning, he went before work, and they did all kinds of stuff and to see where his A1C was. Caller adds that it was 11. Whatever else they are checking him for now she is not sure. Reporter details: caller states that she is a health care professional right no. She adds she is in housekeeping and in the health field and that she hears a lot of things, just because she does not say them. caller does not clarify statement regarding hearing a lot of things. Her head is going all sorts of ways. Caller adds she is batting her head against the wall. She is trying to put her head around everything happening. This is the only thing different. Everybody's body is different. No AEs required a visit to Physician office. but leading to Emergency Room, She states that it is the MIC Unit, and then clarifies as MICU. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-05-18 cough, runny nose Runny nose Cough Contact with and (suspected) exposure to covid-19
58 2021-05-18 headache Really bad headache; "moody aches"; "moody aches"; This is a spontaneous report from a contactable c... Read more
Really bad headache; "moody aches"; "moody aches"; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0170) via an unspecified route of administration on 17Apr2021 at 14:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. the patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included amlodipine from an unknown date for an unknown indication. On 17Apr2021 the patient experienced a really bad headache and "moody aches" the first 24 hours after injection. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of headache and "moody aches" were recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
58 2021-05-21 cough, fatigue Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient sta... Read more
Patient exhibits cough, severe HTN, fatigue, and development of Bell's palsy. Treatment: Patient started Ivermectin
58 2021-05-22 sweating, lethargy, chills, fatigue 2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my bod... Read more
2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my body ached. 2021.05.20 12 midnight - 2021.05.21 8:00AM - slept very poorly with several interruptions, lots of sweating, mattress and bedding damp by the morning. I did not feel hot like when I have a fever. 2021.05.21 - 8:00AM - 9:00PM - Felt weak and lethargic. Muscle pain all over body continued. I needed to nap for two hours during the day. My heart rate was elevated about 15 percent above normal. After the nap I still felt tired. Food helped a little, but I went to be early, at 9PM. 2021.05.21 - 9:00PM - 2021.05. 22 - 8:00AM - Slept poorly with several interruptions, chills, and night sweats. Again awoke with damp mattress and bedding. For the first 10 minutes after rising I felt a little better, but then the muscle pain intensified and the lethargy too. I spent several hours of the day lying down in bed. Ate normally, which improved my overall feeling and energy level. Also consumed electrolytes and water. In the evening I started to feel not fully recovered, but a lot better than 24 hours prior. I went to bed at 11PM. 2021.05.22 - 11PM - 2021.05.23 - 10AM - I had some chills on preparing my bed, but overall slept better. Some sweating still. 2021.05.23 10AM - present 8PM - Felt much better. 95 percent of normal.
58 2021-05-24 cough, respiratory tract congestion ED Discharged 4/21/2021 (5 hours) Treatment team COVID-19 Clinical impression Covid+ Chief complai... Read more
ED Discharged 4/21/2021 (5 hours) Treatment team COVID-19 Clinical impression Covid+ Chief complaint ED Provider Notes PA (Physician Assistant) ? ? Emergency Medicine Cosigned by: DO at 4/21/2021 10:52 PM Expand AllCollapse All ED PROVIDER NOTE History provided by: Patient Language interpreter used: No CHIEF COMPLAINT: Chief Complaint Patient presents with ? Covid+ Encounter Details Date Type Department Care Team Description 04/23/2021 Office Visit Covid - 19 Testing Site Contact w and exposure to oth viral communicable diseases (Primary Dx); 2019 novel coronavirus detected ED Discharged 4/28/2021 (3 hours) Treatment team COVID-19 Clinical impression Medication Infusion Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All Chief Complaint Patient presents with ? Medication Infusion HPI Patient presents here for monoclonal antibody infusion for Covid. He was diagnosed with Covid 1 week ago. He has having cough, congestion, myalgias, nausea and abdominal pain. Minimal shortness of breath. Severity of symptoms right now is mild to moderate. He has a history of coronary artery disease, diabetes and hypertension. Orders Only Open 5/5/2021 Diarrhea due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection Dx Orders Placed COVID-19 PCR Medication Changes None Medication List Visit Diagnoses Diarrhea due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
58 2021-05-24 headache, fever High Fever - 102.0 to 103.5 Extreme body aches Shortness of Breath Headaches - Extreme Rash
58 2021-05-25 headache, malaise Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and rep... Read more
Patient received the vaccine on 3-31-21. Then at 4:00 am on 4-1-2021, he became lightheaded and reports passing out. He had several weeks of general malaise and mild headache. He does not recall head trauma and had no bruising, "goose egg", etc. He felt generally unwell with a mild headache since then. Then on May 16th, 2021, while traveling with his wife, his left hand and arm and left side of tongue became numb and week. He was mildly confused. His wife took him to the ER and he was transferred to hospital for neurosurgery admission. Hospital records note that they presume the subdural bleed was triggered from the fall the morning of May 5th.
58 2021-05-25 headache stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds ... Read more
stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes; This is a spontaneous report from a contactable consumer(patient). The 58-year-old male patient received BNT162B2, via an unspecified route of administration on 21Apr2021 15:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included none. She had no known allergies. There was no covid tested post vaccination, no covid prior vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes, ended up in emergency room and physician office on 22Apr2021 02:30, which also led to hospitalization for 1 day with outcome of recovering. Treatment received included pain medication infusion. Information on the lot/batch number has been requested.
58 2021-05-25 fever, influenza like illness entire body ached; running a fever but did not check his temperature; it was kind of like a sick day... Read more
entire body ached; running a fever but did not check his temperature; it was kind of like a sick day where he got nothing productive done; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 58-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 (Batch/Lot Number: EP7533, Expiration date: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. On 03Apr2021, when he woke up, the patient experienced, entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy and fever. Especially the first time because he didn't take any medication with the first dose side effects and was probably running a fever but did not check his temperature but was definitely running a fever the next day. The outcome of the events entire body ached, it was kind of like a sick day where he got nothing productive done. He experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was recovered on 04Apr2021 and fever was recovered on 05Apr2021.
58 2021-05-25 fever, lethargy Lethargy; low grade fever; This is a spontaneous report from a non-contactable consumer, the patient... Read more
Lethargy; low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 15March2021 at 14:15 hours (at the age of 58-years-old) for COVID-19 immunisation. Medical history included high cholesterol. Patient was administered first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: UNKNOWN), via an unspecified route of administration in his left arm on 22Feb2021 at 14:15 hours. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 10:00 AM, the patient experienced lethargy and low-grade fever, Therapeutic measures were not taken for events experienced. The clinical outcome of the events of lethargy and low grade fever was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
58 2021-05-26 headache Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of th... Read more
Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of the COVID-19 vaccine on Monday 5/17. The hearing loss was accompanied by continuous buzzing sound, static noise, sensation of ear fullness, local discomfort, headache. It progressed over the first week. On saturday 5/22, I performed an online hearing test that confirmed the hearing loss (see section 19 for results). I went to urgent care to get the ear checked and cleaned, with no noticeable improvement in symptoms. On Sunday 5/23 I was started on 30 mg predinsone po. On Monday 5/24, I went to specialist care, she increased dose to 60 mg of prednisone and order additional tests.
58 2021-05-26 sweating Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation ar... Read more
Patient received their 2nd Pfizer COVID vaccine and about 5 minutes afterwards in the observation area the patient became lightheaded and collapsed hitting his head against the wall, EMS was called. While collapsing the patient bit his tongue, scraped his knee, and developed a visible bump on his head. Patient was unconscious while collapsed lasting approximately 45 seconds to 1 minute. When he regained consciousness he was confused and unaware where he was or what happened. Vitals were taken throughout being unconscious every 5 minutes until EMS arrived which was about 5-10 minutes after the patient collapsed. After regaining consciousness patient was cold, diaphoretic, nauseas, and emesis x 2. Report was given to EMS and transported to Hospital.
58 2021-05-26 sweating Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against w... Read more
Approx 5 min after receiving the 2nd Pfizer COVID vaccine the patient fainted hitting head against wall, scraping knee from falling and biting his lip. Pt was unconscious for approx 45 secs to 1 min. Vitals remained within normal limits during entire encounter except for increase in respiration rate of about 26-28. After regaining consciousness the pt was confused, nauseas, vomiting, diaphoretic and clammy to the touch. EMS arrived un scene approx 5-10 minutes after pt hitting his head and was transported to Hospital
58 2021-05-30 headache Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th di... Read more
Serious diarrhea, vertigo, headaches, nausea, shaky, weak Dicyclomine 20 mg 3x daily May 20-28th did not help, still have diarrehea, vertigo, etc metroNidazole 500mg 2x daily - still have loose bowels, vertigo, etc
58 2021-05-31 chills Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; ... Read more
Saying he could not breath; anxious; reported being cold; complained of Chest pain; began to shake; This is a spontaneous report from a contactable other hcp reported that a 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3302 and expiration date: unknown), via intramuscularly in Arm Left on 29Jan2021 at 09:45 (at the age of 58 years old) as a single dose for COVID-19 immunisation. Medical history included allergies to Sulfa drugs from an unknown date and unknown if ongoing, Cardiac stents from 2004 to an unknown date. Concomitant medications included Lipitor, Aspirin, Plavix, Nitroglycerine for an unspecified indication from an unspecified date. No other illness reported at the time of vaccination and up to one month prior. The patient was in observation for 30 minutes. At approximately 25 minutes post vaccination at 10:15am, Patient signaled that he wanted to leave and was instructed to stay 5 minutes. Patient anxious and began to shake, saying he could not breathe. Vitals were 147/88, HR 86, O2 98% on RA. Pt was reclined on floor and reported being cold and was striking his head on the blanket; head stabilized. Patient was alert and oriented X3 but complained of Chest pain. EMS called, arrived at 10:25, vitals: 144/92, HR83 O2 99% on 2L. Pt stable & transported by EMS at 10:35am. The patient underwent lab tests and procedures which included heart rate: 86, 83, investigation: 147/88, 144/92, oxygen saturation: O2 98% on RA , oxygen saturation: 99 % on 29Jan2021. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
58 2021-05-31 fatigue Nausea; Dizziness; vertigo like symptoms; Not able to stand; vomiting; Fatigue; This is a spontaneou... Read more
Nausea; Dizziness; vertigo like symptoms; Not able to stand; vomiting; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 13:15 (at the age of 58-year-old), at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); zolpidem tartrate (AMBIEN); Amlodipine; Benazepril. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme nausea, vomiting, extreme fatigue, dizziness, unable to stand without help, vertigo like symptoms, on 15Mar2021 at 18:00. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. It was unknown if any treatment received for events. The clinical outcomes of reported events were not recovered. The report was reported as non-serious. No follow-up attempts are needed. No further information is expected.
58 2021-05-31 headache Patient reports shortness of breath, headache and dizziness 15 minutes after received COVID-19 vacci... Read more
Patient reports shortness of breath, headache and dizziness 15 minutes after received COVID-19 vaccination. Patient stayed in observation area for 1 hour. Patient reports "brain fog" for 4 days after vaccine and 1 week after vaccine experienced tinnitus.
58 2021-06-01 headache, fever, fatigue An on and off headache; Had fever on and off; Tiredness; This is a spontaneous report from a contact... Read more
An on and off headache; Had fever on and off; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 06Apr2021 (reported as last Tuesday) (at the age of 58-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021, patient experienced fever on and off, tiredness and an on and off headache. Patient wanted to know for how long this expected to last and would like to enquire if the vaccine can cause a positive test result for covid. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-06-01 sweating Vasovagal, diaphoretic.
58 2021-06-01 fever, fatigue, chills, headache, influenza like illness, malaise headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the sit... Read more
headache; chills; joint pain; 100.4 fever; injection site swelling; little bit of redness on the site/injection site redness; injection site redness, pain, and swelling; nauseated; pain in the arm/arm started hurting/his arm and all the way up to his jaw was hurting; It felt like he had the flu and he had body aches.; It felt like he had the flu and he had body aches; He felt like what he was experiencing was COVID symptoms.; tiredness; general feeling of unwell; This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A 58-year-old male patient (Reporter's husband) received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177), via an unspecified route of administration, administered in left arm on 14May2021 in the evening (at the age of 58-years-old) as single dose for covid-19 immunization in pharmacy. Medical history included covid-19 in 2020. Family history included COVID (They all had COVID last year). Concomitant medications included acetylsalicylic acid (ASPIRIN), oral at 81 mg, daily started a couple of months ago and ongoing rosuvastatin at 40 mg, daily, has been taking it for a couple of months; paracetamol (TYLENOL, Strength: 650mg, Lot: SEA002, Expiry: Mar2021) at 650 mg. No additional Vaccines were administered on same Date of the Pfizer Suspect. It was unknown if he had prior Vaccinations (within 4 weeks). When he goes to the doctor he goes by himself. It was reported that reporter's husband had the first dose of the Pfizer Friday and enquired some people say on the second dose the symptoms are worse, if it was true. He had tiredness and had general feeling of unwell on 14May2021; on 15May2021 he had headache, chills, joint pain, 100.4 fever, little bit of injection site redness, pain, and swelling/ injection site swelling, was nauseated. It felt like he had the flu and he had body aches. He went to sleep early on Friday night. She asked if he wanted Tylenol he said no. He mentioned in the middle of the night his arm started hurting. Then in the morning his arm and all the way up to his jaw was hurting. For the past two days their son has been sick and caller hasn't been able to talk to her husband much. He comes home from work and goes to bed. It is unknown if symptoms are ongoing. It was the 8 hour muscle ache and pain. He took Tylenol twice on Saturday. On Sunday, he was feeling better. He felt like what he was experiencing was COVID symptoms. Reporter asked if he could wait a couple of days for getting the second so he can be off work. The second vaccine was scheduled for 04Jun2021. That is a Tuesday and he prefers a Thursday so he could have Friday and Saturday off. A visit to emergency room or physician office was not required. Seriousness for the events was reported as unspecified. The outcome of the events was unknown. Information on the lot/batch number has been requested.
58 2021-06-03 headache Nausea, Headache, Dizziness
58 2021-06-03 headache Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme head... Read more
Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme headaches lasting for 9 days, then recurring on Apr 27 for another 7 days Intolerance to heat or temperatures above 72F lasting 30 days Positional dizziness lasting 30 days
58 2021-06-04 chills, fever, malaise, headache Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear D... Read more
Large Amount of Histamine; he still did not feel well/ felt terrible this morning; Earache and Ear Drainage; Dizziness; Chills; Fever; Soreness; Spitting up Blood; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the second of two reports for dose 2. This 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 05May2021 11:30 (Lot Number: EW0179) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization and experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated all of the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The patient had no other vaccine within 4 weeks. The patient received the second dose on 05May2021. The patient experienced earache and ear drainage from 08May2021 to 11May2021; dizziness from May2021 to 18May2021; chills and fever from May2021 to 18May2021; soreness from May2021 to 18May2021; spitting up blood from May2021 to 18May2021; problems breathing from May2021 to 18May2021; shaking worse than usual from May2021 to 18May2021; headache from May2021; nausea from May2021; chest pains from May2021. The patient stated he had the same side effects with both the first and second doses, but with the second shot they were worse and longer. The patient stated he still did not feel well. The patient stated the side effects from the second vaccine started either the 06May2021 or 07May2021 and recovered 18May2021, except the headache, nausea, and chest pain were persisting. The patient stated he felt terrible this morning (21May2021) and he realized this could be from something else. The patient also experienced large amount of histamine; more than usual after the second dose. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of event large amount of histamine; more than usual was resolving. The outcome of event headache, nausea, chest pains, did not feel well/ felt terrible was not resolved. The outcome of other events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582540 same drug/ patient, different dose number/ event
58 2021-06-04 headache, chills, fever Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; He... Read more
Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
58 2021-06-06 headache Headaches, nausea, shingles
58 2021-06-06 fever, cough fevers, cough, elevated trop 1.45, low voltage EKG, possible myocarditis 10 days post vaccination wi... Read more
fevers, cough, elevated trop 1.45, low voltage EKG, possible myocarditis 10 days post vaccination with the 2nd dose. Also tested positive for COVID 19 with CT of 35 (had COVID in April) - unclear if this is reinfection vs vaccine effect
58 2021-06-07 headache This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162... Read more
This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Time the Vaccination Was Given: about 3-4pm. Patient's medical history included herpes zoster since 10 years ago and takes immunosuppression medication. The patient reports he takes medications and he doesn't want to list all of them. The patient experienced shingles (when he got in the shower), pain on 18Apr2021, felt pain on his shoulders (after 2 weeks), headache (which he states is pretty common) and reddish spots on an unknown date. He takes an immunosuppression medication and it may have triggered the shingles. He mentioned the word immunosuppressed. When attempting to clarify if he was immunosuppressed he said, his immune system is weak. The patient shingles is very close to the injection point, almost the same spot as where he received the injection. Consumer wants to know if he can proceed with receiving the 2nd dose even if he has not fully recovered from his shingles yet and asks if he can receive the second dose beyond the 21 days. He reports he did not get diagnosed by a doctor but he feels strongly that shingles is what it is based on the symptoms. Clinical course of events includes; e reports 3-4 days later maybe about the 22nd or 23rd the pain started to go away and now he has no pain, reddish spots were gradually getting smaller. When asked if he had any treatment caller reports he did have a video appointment with a provider and they wanted him to take antiviral medicine and he did not take the medicine. He stated if it was on his whole back or something dramatic like that but it improved and he has no pain now, so he decided not to take medicine. He can tolerate it and it did not cause him too much of a problem. He did note that he works 12 hours a day and he is pretty healthy and has no other effect. Upon follow-up; it was reported that; the patient who was administered the first dose of Pfizer Covid-19 Vaccination and 14 days after that dose developed shingles. There is no evidence of whether the shingles is or is not related to the Pfizer COVID-19 Vaccination he is not sure if it is related. He is due to have the second dose of Pfizer COVID-19 Vaccination but he is not 100% cured of shingles, he can still see spots there. He called to ask should he wait a little time to get the second Pfizer COVID-19 Vaccination relative to shingles.The outcome of the event shingles was recovering, pain was recovered on an unknown date in Apr2021 and felt pain on his shoulders was unknown, reddish spots was not recovered. Patient: Sex: Patient referred to as male during this report but sex not verified with caller who was unwilling to complete report. No Follow-up attempts are needed. No further information is expected.
58 2021-06-07 headache Headaches
58 2021-06-08 lethargy, headache, fever recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly s... Read more
recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin; a slight headache; a month after the 2nd shot I ran a fever that lasted 3 weeks. the first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; A week after the 2nd shot I felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 26Mar2021 13:00 as 2nd dose, single for COVID-19 immunisation. Medical history included autoimmune disease suspected. Concomitant medications included losartan; hydrochlorothiazide; atorvastatin and tadalafil (TADAL). The patient previously received first dose of BNT162B2 on 06Mar2021 for COVID-19 immunization (first dose, administration time: 11:00 PM, anatomical location: arm left). A week after the 2nd shot (Apr2021), patient felt lethargic and without ability to focus - eyes also were achy. This lasted for a few weeks but no fever. Event resulted to a Doctor or other healthcare professional office/clinic visit; no treatment received. A month after the 2nd shot (26Apr2021 01:00 AM) patient ran a fever that lasted 3 weeks. The first week the fever would reach 103.5 and second week 101 and 3rd week between 99.5 and 100.5. Eyes still hurt and fever was controlled by aspirin during day. It was not a normal fever and he did have a slight headache. Recently diagnosed with suspected autoimmune disease Sarcoidosis but no coughing involved - mainly skin. He felt fine now. Note extensive blood tests and sonograms/xrays turned up nothing that would cause such a prolonged fever. "I've never run a fever for more than 4 or 5 days. I also hardly ever get sick". Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Covid test post vaccination: Nasal Swab negative and blood test negative both on 26Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event sarcoidosis was unknown, while recovered on an unspecified date for the other events. Information on the lot/batch number has been requested.
58 2021-06-08 sinus headache I HAD HEADACHE FOR TWO WEEKS LIKE A SINUS HEADACHE, I HAD A WELP ON MY FOREHEAD, NOSE, AND A SORE IR... Read more
I HAD HEADACHE FOR TWO WEEKS LIKE A SINUS HEADACHE, I HAD A WELP ON MY FOREHEAD, NOSE, AND A SORE IRRITATED AND BLOODSHOT EYE (LEFT). STILL RED AS OF TODAY.
58 2021-06-09 headache, sweating, nasal congestion lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night swea... Read more
lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown. No follow-up attempts are possible. No further information is expected.
58 2021-06-10 fatigue I was more fatigued, more than normal. Just completely exhausted. I did not get any treatment. I wen... Read more
I was more fatigued, more than normal. Just completely exhausted. I did not get any treatment. I went to my doctor.
58 2021-06-10 pneumonia J18.9 - Left upper lobe pneumonia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality an... Read more
J18.9 - Left upper lobe pneumonia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia
58 2021-06-10 sleepiness drowsiness and he couldn't stay awake; This is a spontaneous report from a contactable consumer (Pat... Read more
drowsiness and he couldn't stay awake; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 26Apr2021 as 1st dose, single dose for covid-19 immunisation. Medical history included narcolepsy [use of Adderall (amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate), and use of generic Adderall for "at least 15 years" (relative to 21May2021)]. Concomitant medications included vitamin d nos (VITAMIN D NOS); omeprazole (OMEPRAZOLE; for 10 to 20 years); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for narcolepsy and daily vitamins. On 03May2021, Patient had slept for 4 days since starting it, also described as drowsiness and he couldn't stay awake. He thought there might be a tiny chance the drowsiness could be from the COVID vaccine, but he thought if the drowsiness was from the vaccine it would not last as long as it had. The drowsiness and being unable to stay awake were ongoing, as he had "slept for almost 3 weeks". On 17May2021, patient received his second dose of the COVID vaccine. The outcome of events was not recovered. Information about batch/Lot number has been requested.
58 2021-06-15 fever I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report f... Read more
I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report from a contactable consumer (reported for himself). A 58-years-old male patient received second dose of BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 23Feb2021 at 08:15 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 01Feb2021 at 08:10 (at the age of 58-years-old) as single dose for COVID-19 immunisation. On 24Feb2021, at 05:00, the patient experienced she woke up in the morning feeling muscle aches, weakness and temperature 99.5. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 24Feb2021. No treatment was given for the events. The outcome of the events was resolving. Information about Lot/batch number has been requested.
58 2021-06-16 sweating, body temperature increased, headache After 2nd. shot on Tuesday: early on Thursday morning woke up 102+ degree temp, extreme nausea, swe... Read more
After 2nd. shot on Tuesday: early on Thursday morning woke up 102+ degree temp, extreme nausea, sweating, severe headache, joint stiffness and head felt like I was in a fog. Severe systems lasted for four days. Today (6/17/21) still having headaches, head fog, and severe joint stiffness in hands elbows and ankles. Taking Tylenol and Advil for relief.
58 2021-06-18 influenza like illness, fever Flu like body aches; Flu like body aches; low fever; This is a spontaneous report from a contactable... Read more
Flu like body aches; Flu like body aches; low fever; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:45 (Lot Number: EN6207), at vaccination age of 58 years, as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks. Medical history included High BP treatment and Known allergies: Penicillin and Sulfa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); sertraline hydrochloride (ZOLOFT); lamotrigine; ezetimibe, simvastatin (VYTORIN); amlodipine besilate, olmesartan medoxomil (AZOR), all taken for an unspecified indication, start and stop date were not reported. On 19Mar2021 04:00 the patient experienced flu like body aches and low fever. The patient did not receive treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The events were non-serious with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Mar2021 (Nasal Swab). No covid prior vaccination. No follow-up attempts are possible. No further information is expected.
58 2021-06-18 throat pain, cough, malaise, headache Caller states its hurting now like his whole head is swollen; He states he has COPD and seemed like ... Read more
Caller states its hurting now like his whole head is swollen; He states he has COPD and seemed like it made it worst; he gets hot flashes; he was exposed at work to the coronavirus; he is not eating; he feel like his voice is going; throat feels like he swallowed a hot pepper, like there is fire inside of it.; cough is always there due to smoking but it has gotten worse; can't hardly smoke a cigarette right now; headache; cough; diarrhea; sore throat; shortness of breath; he felt fine until he took it and he has not felt good since; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number END162; Expiration date was not reported), via an unspecified route of administration, administered in arm left on 09Jun2021 (at the age of 58-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (He states he has COPD and seemed like it made it worst, patient stated he had COPD and seemed like it made it worst), tobacco user (he smokes and can't hardly smoke a cigarette right now). The patient concomitant medications were not reported. Prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine included flu shot or pneumonia shot. Patient stated it was one of those shots that is supposed to last for 7 years (NO LOT, NDC or EXP date unknown) and did not know what he did with the paper and stated he got it about 2-3 weeks ago. No adverse events noted following the prior vaccinations. No family medical history relevant to the events. No additional vaccines administered on same date of the Pfizer Suspect. On 09Jun2021, the patient experienced sore throat, shortness of breath. On an 10Jun2021, the patient experienced diarrhea. On 11Jun2021, the patient experienced cough. On 12Jun2021, the patient experienced headache. Caller states its hurting now like his whole head is swollen on an unspecified date, he states he has COPD and seemed like it made it worst on an unspecified date, he gets hot flashes on an unspecified date, he was exposed at work to the coronavirus on an unspecified date, he is not eating on an unspecified date, he feel like his voice is going on an unspecified date, throat feels like he swallowed a hot pepper, like there is fire inside of it on an unspecified date, cough is always there due to smoking but it has gotten worse on an unspecified date, can't hardly smoke a cigarette right now on an unspecified date, he felt fine until he took it and he has not felt good since on 09Jun2021. Caller reported the outcome of the events. Patient stated the reason for taking Pfizer covid vaccine as it was offered at work and said insurance would be cheaper so took it and plus to be safe. Patient was told to call and report his symptoms and wanted to know if his symptoms been reported before. Patient stated he does not have a doctor. Caller stated he was on this way to work when the diarrhea hit, then it was ok for two days and then the diarrhea hit again on Friday, Saturday and Sunday. He stated this morning he was having diarrhea as well. It seems to be getting better today, although he was not eating. He stated the diarrhea mainly hit him when he coughed and then he has a mess to clean up, especially with a deep cough. With headache, caller stated its hurting now like his whole head is swollen and outcome stayed the same. Caller stated his sore throat was way worse in some ways and way not in others, feel like his voice was going. He states he had COPD and seemed like it made it worst. He also mentioned, he smokes and can't hardly smoke a cigarette right now and maybe that is a good thing he guesses it was keeping him from smoking because it makes him cough. Caller stated his throat feels like he swallowed a hot pepper, like there is fire inside of it. Caller stated his shortness of breath stayed about the same, his cough is always there due to smoking, but it has gotten worse. He stated that on Friday even he took one puff of his cigarette and coughed his head off. He thought that might be why he had a headache. It hurts when he coughs. He states it has him worried and he just wants to be truthful and honest about all these symptoms. He was just curious of what was going on. He was tested for coronavirus, said tested negative, but wants to know what was going on. About Cough, caller stated it has gotten no different, staying about the same. Caller stated was not understanding why he is having all these side effects and stuff. Caller gave the number from the vaccine card as END162 and stated he can hardly read the writing. Caller stated if he would have known this, he wouldn't have taken it and he felt fine until he took it and he has not felt good since. Caller stated he has not had taken any other vaccines that he can remember, unless he did as a kid. He stated he was pretty healthy. The last 6-7 days though he hasn't felt like himself because he has been going to bathroom, headaches, coughing, and sometimes he gets hot flashes, and having the sore throat for over a week now or right around week, 09Jun2021 to now, over the last 6 days and with the headache the last 3-4 days. Commented he feels like a whiny butt. Patient did not require to visit physician office due to the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Other relevant tests or investigations assessment included none. The clinical outcome of the sore throat, headache, shortness of breath, diarrhea, cough, headache, caller states its hurting now like his whole head is swollen were not recovered and for the other events unknown.
58 2021-06-18 fever After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itchi... Read more
After taking the 1st vaccine in March 2021, His skin peeled over his entire body, with minimal itching. He was only given skin cream and tried different lotions. In april, he took the 2nd vaccine he had the normal side effects for a little over a week, and then he started getting weaker, eventually he was rushed to the hosptial on May 7. He had spiked fevers and sugar levels from him being so ill. He is now paralyzed from the waist down and still in the hospital fighting it.
58 2021-06-20 sweating Ten minutes after administration patient became sweaty, nausea, light headed. I had patient elevate ... Read more
Ten minutes after administration patient became sweaty, nausea, light headed. I had patient elevate his legs. i got cold compresses for his face and some water to drink. He then said he felt like he had to vomit, which he did into our wastebasket. He sat back and his eyes rolled back. I felt he was going to pass out. I had a pharmacy technician call 911 and stayed with the patient until EMS arrived. Patient was checked out and released to go home. I spoke to patient today and he said he was fine after a few hours.
58 2021-06-21 throat pain, cough, nasal congestion PATIENT FULLY VACCINATED FOR COVID, RECEIVED SECOND SHOT IN MARCH, INFECTED WITH COVID IN JUNE. COU... Read more
PATIENT FULLY VACCINATED FOR COVID, RECEIVED SECOND SHOT IN MARCH, INFECTED WITH COVID IN JUNE. COUGH, SORE THROAT, AND NASAL CONGESTION STARTED 6/17/21. POSITIVE HOUSEHOLD CONTACT WITH COVID. PATIENT HAD POSITIVE COVID TEST ON 6/21/21.
58 2021-06-22 fatigue 27 years ago I had Epstein Barr ( Mono). One week after my second dose I have a resumption of sympto... Read more
27 years ago I had Epstein Barr ( Mono). One week after my second dose I have a resumption of symptoms including night sweats, fatigue and sore joints. These symptoms are still present
58 2021-06-22 headache, sluggishness About 17 hours after the shot, preparing to go to my office I suddenly became dizzy in a way similar... Read more
About 17 hours after the shot, preparing to go to my office I suddenly became dizzy in a way similar to an episode of vertigo I had 15 years prior. I notice I had a headache that got worse in minutes. I sucked down 3 and 1/2 two hundred mg Aleve pills and hit the sack. Four hours later I drank 14 oz of water and took another 2 Aleve since the headache was still strongly with me. My body had a general soreness and an ache. I went back to bed thinking I might need to call my MD. About 3 hrs later, I took more water, ate nothing, took 2 more Aleve, and my wife made a call to schedule an appointment with Dr. I was awakened by my wife for dinner. I had an appetite but was foggy and sluggish. I took two more Aleve skipped any alcohol - and went to bed for the evening. The following morning - Jan 18th, 2021 - I awoke with no headache, no soreness, no vertigo.
58 2021-06-24 chills Swelling of cheeks, tongue and chin; Swelling of cheeks, tongue and chin; Redness or arms and face; ... Read more
Swelling of cheeks, tongue and chin; Swelling of cheeks, tongue and chin; Redness or arms and face; chills; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right (At vaccination age 58-year-old) on 12Mar2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included Heart disease, known allergies: Sulfa meds from an unknown date. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient took other medication in last two weeks. The patient experienced swelling of cheeks, tongue and chin, redness or arms and face, chills, and shortness of breath 12Mar2021 08:15 AM. Therapeutic measures were taken as a result of events which include BENEDRYL and rest. The outcome for all events were recovering. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
58 2021-06-24 fatigue, nasal congestion, cough DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician sp... Read more
DOSE 1 12/20/2021, began to feel sick. 12/24/2021 I had a high fever, called the CDC, a physician spoke with me, then on Christmas day I called into work sick, I went to ER, and I tested positive for COVID. DOSE 2 01/07/2021, I had shortness of breath, high heart rate, fatigue, brain fog, body aches, some coughing, some nasal congestion. Testing on Feb 1st, 2021 visited ER.
58 2021-06-26 sleepiness Pain in left arm, sleepy, sore muscles.
58 2021-06-27 headache I started having a headache on 04/03/2021 that wouldn't go away. I checked my blood pressure on 04/... Read more
I started having a headache on 04/03/2021 that wouldn't go away. I checked my blood pressure on 04/06/2021 and it was elevated at 190/100. It stayed elevated for the next few days. I went to a care center on 04/09/2021 and started on Amlodipine 5mg until I could see my primary Dr. a couple days later. He added Losartan 25mg which I am still taking both. I have never had an elevated blood pressure.
58 2021-06-29 fever, fatigue, headache Fever; Extreme fatigue; Headache; This is a spontaneous report from a contactable consumer, the pati... Read more
Fever; Extreme fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EZ6207) via an unspecified route of administration, on 19Mar2021, at 15:30, (at the age of 58 years) via unspecified route of administration, on left arm, as a single dose for COVID-19 immunisation. Medical history included high blood pressure and milk allergy. Concomitant medications were unspecified. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration, on 26Feb2021, at 15:30, on left arm, as a single dose for COVID-19 immunisation. On 20Mar2021, at 12:00, the patient experienced fever, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of event fever, fatigue and headache was recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
58 2021-06-29 fever, headache, chills, malaise, fatigue tiredness; headache; muscle pain; chills; fever; nausea; swollen nodes; feeling totally unwell; This... Read more
tiredness; headache; muscle pain; chills; fever; nausea; swollen nodes; feeling totally unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in the left arm on 13Mar2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 14Mar2021 at 00:00, the patient experienced tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell for at least 9 days so far. No treatment was received for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, headache, muscle pain, chills, fever, nausea, swollen nodes and feeling totally unwell was recovering at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
58 2021-06-29 fever, headache Body aches; Fever; Diarrhea; Joint pain; Headache; Sore arm; This is a spontaneous report from a con... Read more
Body aches; Fever; Diarrhea; Joint pain; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: ER8727), via an unspecified route of administration in the left arm on 20Mar2021, at 10:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes, high blood pressure and high cholesterol. The patient had no allergies to food or medications. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and fluvoxamine (MANUFACTURER UNKNOWN), all from an unknown date and for unknown indication. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Mar2021 at 13:00, the patient experienced fever, body aches, diarrhea, joint pain, headache and sore arm. No therapeutic measures were taken as a result of events. The clinical outcome of events fever, body aches, diarrhea, joint pain, headache and sore arm were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.
58 2021-07-01 headache Head ache for about a week and felt bad Ringing ears- started after first shot and got worse after ... Read more
Head ache for about a week and felt bad Ringing ears- started after first shot and got worse after the second shot
58 2021-07-07 cough After receiving my second shot, I developed a cough, which has not gone away since the shot. I deve... Read more
After receiving my second shot, I developed a cough, which has not gone away since the shot. I developed the cough the next day. It is a dry hacking cough.
58 2021-07-08 chills Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year... Read more
Body aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204) via an unspecified route of administration in the right arm on 23Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included PAC's and Meiners. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6203), via an unspecified route of administration in the right arm on 02Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 09:30, the patient experienced body aches and chills. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events body aches and chills. The clinical outcomes of the events body aches and chills were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
58 2021-07-08 fatigue Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper bo... Read more
Fatigue, Chest pangs (not significant enough to call them pains), sensitive spleen / liver, upper body aches, swollen feet, inner thigh pain. Fatigue started day after 2nd shot and has continued. Additional systems started ~ 2 weeks post second shot and continued. Intensity of additional symptoms have reduced over the past 3 weeks.
58 2021-07-08 headache, cough Salivary Gland disfunction, and Oral Inflammation in lower mouth and Lymph Glands. Headache. Blood ... Read more
Salivary Gland disfunction, and Oral Inflammation in lower mouth and Lymph Glands. Headache. Blood bruise weeping down left arm. Headache resolved after two days and was treatable with Ibuprofin. Salivary disfunction alternated between steady flowing salivation causing coughing at night, to Zero Salivation causing dry burning and oral pain. It was possible to force salivation once awake. This continued for four days and then stopped. Throat Lymph swelling and mouth pain continued for two weeks, and reoccurred after 4 weeks. Lymph Swelling resolved after July 4th, but a lump remained on the left side of the throat but seems to decreasing.
58 2021-07-08 headache, fatigue severe pain in entire arm, Severe fatigue, GI discomfort, Headache, This lasted 3 full weeks
58 2021-07-08 fever Fever, Body aches, indigestion, nausea
58 2021-07-10 headache, chills, fatigue headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to ge... Read more
headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-07-11 fatigue Pt. states received Phizer vaccine 06/02/2021 experiencing fatigue, nauseous. 06/10/2021 adverse ev... Read more
Pt. states received Phizer vaccine 06/02/2021 experiencing fatigue, nauseous. 06/10/2021 adverse event of vomiting, aspiration, heart attack, cardiac arrest, coma 4 days, ICU reporting slight brain damage. Discharged 06/18/2021 to Rehabilitation Facility discharged 07/07/2021.
58 2021-07-11 fever FEVER ,DIZZINESS, BILATERAL DEAFNESS, TINITUS TREATMENT - PREDNISONE, EAR DROPS, IBUPROFEN STRICT... Read more
FEVER ,DIZZINESS, BILATERAL DEAFNESS, TINITUS TREATMENT - PREDNISONE, EAR DROPS, IBUPROFEN STRICT BED REST.
58 2021-07-15 chills, head discomfort Strong Hissing in both ears (still present), high blood pressure (147/92 pulse 98). Pressure in my ... Read more
Strong Hissing in both ears (still present), high blood pressure (147/92 pulse 98). Pressure in my head and 'feeling my heart pounding'. Normally I do not have high blood pressure, nor pulse nor headaches. Mild chills that went away Hissing still present but at lower levels. Blood pressure is back to normal. Taking Metroprolol in addition to the hives medication mentioned in the beginning. It is helpful. Also took Iboprufen and Tylenol the first two days after vaccination. Have been given Singulair for anti-inflammatory action re. my ears that show congestion. Will follow up in a week and if it does not help might switch to cortizone. Will follow up with a dr. appointment at the end of the month. Blood test next week Feeling better slowly and hopefully surely.
58 2021-07-17 headache, fatigue, fever, chills 101 Fever; Chills; Body ache; Headache; Fatigue; This is a spontaneous report from a contactable con... Read more
101 Fever; Chills; Body ache; Headache; Fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 25Jun2021 as unknown, single for covid-19 immunisation. Medical history was none. Concomitant medications included Doxycycline and Metoprolol. On an unknown date, the patient experienced some serious side effect of 101 fever, chills, body ache, headache and fatigue. The patient underwent lab tests and procedures which included body temperature of 101. The outcome of all the events was reported as unknown.
58 2021-07-17 headache very bad neck cramps; gave headache; blurry vision now; This is a spontaneous report from a contacta... Read more
very bad neck cramps; gave headache; blurry vision now; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: box-18) via an unspecified route of administration in the arm left on 29Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and fluticasone propionate(FLONASE) on unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was reported as unknown if the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 01:00 PM the patient experienced very bad neck cramps, had headache and blurry vision. It was unknown if the patient took any treatment for the reported adverse events. The event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events was unknown at the time of report. No follow-up attempts are needed. No further information is expected.
58 2021-07-17 fever, headache Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This i... Read more
Headache; Vision problems; Fever; Night sweats; Bodyaches; Confusion is turning yellow again; This is a spontaneous report from a contactable consumer, the patient. A 58-years old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose on left arm via unspecified route on 22Mar2021 at 03:00 PM (at the age of 58-years old) for COVID-19 immunisation. The patient medical history included major cirrhosis of the liver needs a liver transplant. The patient was allergic to morphine cipro and motto patch.Concomitant medications was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, at 20:00 the patient experienced major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again. The patient did not receive treatment for the reported events. The clinical outcome of major headache vision problems as well both on left side of head, fever night sweats body aches confusion was turning yellow again was not recovered. No follow-up attempts needed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: Verbatim of Relevant Med History updated as same as source document, note added, "Concomitant medications were not reported" updated as "Concomitant medications was reported as none", "on left arm", "The patient did not receive treatment for the reported events " added in narrative and Reference No. added.
58 2021-07-21 headache Headache I never get headaches and my head began to ache the next day- it subsided and is gone now b... Read more
Headache I never get headaches and my head began to ache the next day- it subsided and is gone now but I had a fairly good headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination included olmesartan (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00 the patient experienced headache. The patient never gets headaches and his head began to ache the next day- it subsided and was gone at the time of report but the patient had a fairly good headache. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache was recovered on an unknown day in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
58 2021-07-21 fever, headache, fatigue, chills achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at inje... Read more
achey eyeballs; tiredness; low grade headache; chills; bone pain; muscle pain; mild swelling at injection site; mild occasional nausea; welts; light headedness; joint point; Possible fever; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration on 01Jul2021 13:15 (age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. COVID-19 vaccine was administered at workplace clinic. On 02Jul2021 06:00 the patient experienced achey eyeballs, tiredness, low grade headache, chills, bone pain, muscle pain, mild swelling at injection site, mild occasional nausea, welts, light headedness, joint point, possible fever, persisting 5 days as of report submission. The patient had not received any treatment for events. The outcome of events was recovering.
58 2021-07-22 chills, headache, fatigue, cough, fever, nasal congestion Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache;... Read more
Contracted COVID 19; Contracted COVID 19; Extremely tired and fatigued; Cough; Congestion; Headache; Fever; Chills; Body aches; Diarrhea; Loss of taste; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0158) via intramuscular route of administration in Arm Left on 09Apr2021 17:00 as DOSE 2, SINGLE, patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via intramuscular route of administration in Arm Left on 19Mar2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination the patient received other medications within 2 weeks of vaccination was Lipitor. Medical history included lymphoma from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported patient was not diagnosed with COVID-19 prior to vaccination patient was tested to COVID-19 to post vaccination. On 07Jul2021 the patient experienced contracted covid 19, contracted covid 19, extremely tired and fatigued, cough, congestion, headache, fever, chills, body aches, diarrhoea, loss of taste patient had physician office visit for the events. The patient received treatment for rest all events was unknown and for vaccination failure, covid-19 did not received any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Jul2021. The outcome of the events vaccination failure, covid-19, fatigue, cough, nasal congestion, headache, pyrexia, chills, pain, diarrhoea, ageusia was recovering.
58 2021-07-25 pneumonia death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9... Read more
death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9 - Acute kidney failure, unspecified
58 2021-07-26 headache Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Seve... Read more
Systemic: Bell's Palsy-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: wife came to the pharmacy and explained that after the shot the patient had one side weakness went to er and the er stated that the covid shot was the cause of bells palsy severe headaches, and visual changes. she states that it isnt resolving and they are going for more doctors visits
58 2021-07-27 fatigue stated that his eye his eye is closed/drooped all the way down; tired; This is a spontaneous report ... Read more
stated that his eye his eye is closed/drooped all the way down; tired; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 22May2021 11:00 (Age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history included hit with an airbag and his eye was shut (five years ago he was hit with an airbag and and his eye was shut. Stated that he went to the doctor and could not open it all of the way. Stated that for the last two years that he could open it and could see). The patient's concomitant medications were not reported. On 23May2021, the patient experienced stated that his eye is closed/drooped all the way down and on 22May2021, tired. It was reported that caller stated her husband received the Pfizer COVID vaccine on Saturday and since then his right eye has been completely closed. Consumer states since it is closed again like it was back then should he go to the emergency room. The reporter stated the patient was tired. Reporter stated once he got the shot he came home and he mentioned he was tired from the shot. Patient was received treatment for right eye has been completely closed. The event considered related to a medicinal product. The patient underwent lab tests and procedures which included body height: 171 on cm, weight: 61.23 kg. The clinical outcome of event stated that his eye his eye is closed/drooped all the way down was not recovered; while event tired was recovered on 24May2021. Information of the lot/batch number has been requested.
58 2021-07-28 headache, fatigue feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it... Read more
feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; felt a lump on his collar bone next to his carotid artery, can move it around and it is tender; Dizzy spells; feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches; Tiredness; eyes were burning; head ached and was foggy and he was not feeling like himself; head ached and was foggy and he was not feeling like himself; This is a spontaneous report from a contactable consumer (Patient)or other non Health care professional. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported ), dose 2 via an unspecified route of administration on 26Mar2021 as dose 2, single (Age at vaccination: 58 years) for covid-19 immunisation. Medical history included, diabetes mellitus from Mar2020 and ongoing, hiatus hernia from 1992 and ongoing, Acid Reflux from 1992 and ongoing. Patient did not had prior vaccinations within 4 weeks. Concomitant medications included METFORMIN taken for an unspecified indication, he States that he did not have the bottles with him and that he has been taking it for a year; OMEPRAZOLE taken for Acid Reflux, he States that he did not have the bottles with him and that he has been taking it for 15 years, TAMSULOSIN taken for prostate infection States that he did not have the bottles with him and that he has been taking it for 3-4 years. Patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT: EN6202) on 05Mar2021 as dose 1, single for covid-19 immunisation states that he was sick for three days from the first vaccine, and still feels ill, everything smelled like cigarette smoke and every he ate tasted nasty like stale cigarettes, really sick to his stomach, he couldn't go to the bathroom, his stomach was all bloated and he lost his appetite, every joint in his body ached, eyes were getting a burning sensation like someone was taking a blow torch to both eyes. Patient received second dose on Friday. He reports that "a little knot showed up on his collarbone like a cyst. He was not sure what it was. It was tender to the touch. It's by his carotid artery to his head Caller states that he has experienced two weekends from H due to the vaccine. The patient experienced tiredness, his eyes were burning, headache and was foggy and he was not feeling like himself on Saturday 27Mar2021 Morning when he woke up. He was, feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches on, felt a lump on his collar bone next to his carotid artery, can move it around and it is tender, dizzy spells on 28Mar2021. He states the first day, he had about the same things a gnarly headache, his eyes were burning and then his stomach hit yesterday. He states that the shoulder that he got the shot in on his right side, that morning he felt a lump on his collar bone next to his carotid artery. States that he can move it around and it is tender. he never had it before and it appeared after the second shot. He states it was like a cyst appeared, he can move it around over his collar bone. He states that it is weird because it happened where he broke his collar bone 10 years ago. Clarifies that he is calling to report his reactions and he has questions about the lump on his collar bone. His doctor doesn't know about it [the lump] because it appeared over the weekend. He tried to call last night but he was on the phone for 2 hours and he fell asleep and when he woke up he hung up because he figured no one calls that late on a weekend. States he was debating getting it as bad as a reaction he had to first one, but he went ahead against his instincts, he thought he needed to finish what her started and went in and got the shot and it didn't bother him right away. He states that Saturday morning when he woke up, he didn't get a lot of rest and he woke up early, he was tired, his eyes were burning, his head ached and was foggy and he was not feeling like himself. States as the day progressed as he was basically getting things done he had to stop and take a nap and he was sleepy and went to bed early. He states that he woke up yesterday feeling achy especially in his neck and shoulders and where he broke his shoulder it really aches and so he started rubbing it and felt a little knot and it moves around and it is really tender. He states that he was also having dizzy spells and he was having it right now. States that it was all ongoing but it was hard to say if it has improved, worsened or persisted until he gets moving around because that was when he really notices it. He states right now he doesn't feel that bad except his joints were achy. States that he woke up with not such bad headache. He took Excedrin for headache. He states that it helps some but not completely. Patient did not visit emergency room or physician office. The outcome of the events Tiredness, eyes were burning, head ached and was foggy and he was not feeling like himself, feeling achy and joints ache especially in his neck and shoulders and where he broke his shoulder it really aches was not yet recovered. The outcome of felt a lump on his collar bone next to his carotid artery, can move it around and it is tender, Dizzy spells was unknown. No follow-up attempts are needed. No further information is expected.
58 2021-07-28 headache Pt stated pt got 1st covid vaccine Pfizer 5/1/2021 and pt got arm pain, neck pain and headache with ... Read more
Pt stated pt got 1st covid vaccine Pfizer 5/1/2021 and pt got arm pain, neck pain and headache with nausea until 2nd covid vaccine scheduling. Noted no show of 2nd covid vaccine schedule on file. Pt said that pt still have neck pain when pt moves his neck side to side and headache with nausea at least a month. Noted pt has no emergency s/sx. Pt is educated covid vaccine side effects. Informed pt to call 911 or go to ED if pt experienced emergency s/sx. Pt scheduled 9:40am 7/21/2021 urgent care provider for consultation
58 2021-07-29 headache stiff neck, cannot move head side to side; Pain at base of skull at neck; Felt like head would explo... Read more
stiff neck, cannot move head side to side; Pain at base of skull at neck; Felt like head would explode; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on the left arm on 27Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's and ulcerative colitis since age 11. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 06:00, the patient experienced stiff neck, could not move head side to side, pain at base of skull at neck, could not lay down, felt like head would explode. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of stiff neck, pain at base of skull at neck, felt like head would explode were not recovered. No follow-up attempts are needed. No further information is expected.
59 2021-01-03 lethargy, body temperature increased, sleepiness, fatigue temp of 102.4. that was about 11 hrs after the vaccine was administered. Took Tylenol and temp came ... Read more
temp of 102.4. that was about 11 hrs after the vaccine was administered. Took Tylenol and temp came down to normal and have not had a temp since. Nausea without any vomiting and poor appetite on and off 4 days. Very Tired and lethargy at times. Difficult time waking up would fall asleep at the drop of an hat. Extremely tired and sleepy. This lasted about 7 days.
59 2021-01-04 fever Low grade fever , joint and muscular pain
59 2021-01-05 body temperature increased, headache "I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain ... Read more
"I've got 1st vaccination shot at 11 am 12/21/2020. Got moderate (3 to 5 on 10-steps scale) pain in left upper arm/shoulder around 9 pm, limited mobility. Took 2 extra-strength Tylenols. Between 2 and 3 am woke up because of severe headache (7 to 8), couldn't normally sleep because of that. Temperature 99.6 F. Another 2 Tylenols about 4 am. Not effective. Drinking a lot of water. Decided to stay home. Contacted my supervisors by text and e-mail, left a voice message for EH. 8 am - another 2 Tylenols. Tried to sleep - slept till 1 pm. Headache improved (3-5), 99.3 F. Water and tea, minimal activity. Received instructions from EH - to stay at home if any symptoms will take place, to get COVID test upon returning to the hospital. Condition was improving during the day. Low pain and discomfort in the evening (2-3). Sleeping normally during the night. No symptoms in the morning. No reason to delay returning to work. Took COVID test at 9 am. Negative. No symptoms since then"
59 2021-01-05 fatigue, chills Mild chills and fatigue. Took a couple of Advil. Same repeated the next day evening
59 2021-01-05 fatigue, headache, fever, malaise Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart b... Read more
Arm soreness; Feeling of fever for 48 hrs (but no fever); Malaise; Fatigue; Headache; Severe heart burn for 48 hrs; One episode of watery diarrhea; One episode of vomiting; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in left arm, on 23Dec2020 09:30 at single dose for COVID-19 immunization. Medical history included being overweight, prediabetes, hyperlipidaemia and Known allergies: Statins. Concomitant medication included fish oil, ergocalciferol (VITAMIN D), ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (ARED-2 VITAMINS) and finasteride. The patient experienced arm soreness, malaise, fatigue and headache, severe heart burn for 48 hrs, one episode of watery diarrhea, one episode of vomiting and feeling of fever for 48 hrs (but no fever) all on 23Dec2020 at 10:00. Treatment included unspecified antacids and proton pump inhibitors (PPI). The patient did not have COVID prior to vaccination. The patient was tested for COVID on 25Dec2020 post vaccination (nasal swab for rapid test and antibody test on 25Dec2020 which resulted to negative). The outcome of the event Feeling of fever for 48 hrs (but no fever) was recovered on 25Dec2020 at 10:00 and the patient recovered from the remaining events on an unspecified date in Dec2020. Information on the lot/batch number has been requested.
59 2021-01-05 fatigue, headache Feeling tired; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient... Read more
Feeling tired; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231) via an unspecified route of administration on the right upper arm on 30Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril (LISINOPRIL) for high blood pressure. The patient experienced feeling tired, nauseous and a little headache on 30Dec2020 08:15. Outcome of events was not recovered.
59 2021-01-06 fatigue Fatigue, Dizziness, Sore Arm at the administration site onset-morning after adminstration
59 2021-01-06 headache, fatigue Sore arm, tingling in hand and fingers. severe nausea and head ache. fatigue
59 2021-01-07 fatigue Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on li... Read more
Dizziness, Constipation, Extreme Fatigue, pain in arm form shot Narrative: Significant impact on life as he missed work due to this
59 2021-01-07 malaise Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving ... Read more
Got the vaccine in left arm on 12/31, sat for 15 minutes for observation. After leaving and driving home, started feeling worse pain in left arm and numbness around the left ear and left cheek. Went back, they examined and observed for another hour, then released. It went away and returned; has been intermittent since. Left V2/3 distribution
59 2021-01-08 fatigue, headache, fever Headache, Diarrhea, Low grade fever, body aches, fatigue Narrative: Developed a low grade fever, fa... Read more
Headache, Diarrhea, Low grade fever, body aches, fatigue Narrative: Developed a low grade fever, fatigue, body aches, headache, lightheadedness, and diarrhea following vaccine administration. Resolved by 12/30/20.
59 2021-01-09 fever, chills, fatigue All That you describe. What are the risk of the PFIZER Vaccine. injection site pain tiredness, Se... Read more
All That you describe. What are the risk of the PFIZER Vaccine. injection site pain tiredness, Severe headache, muscle pain, severe chills, slight fever, injection site swelling, nausea, pain in crest area and lung pain. When taking deep breaths the lung issue would diminish.
59 2021-01-10 fatigue, body temperature increased Temperature 101.7 and fatigue
59 2021-01-10 headache Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird... Read more
Vaccine recipient developed headache, dizziness, fogginess, feeling flushed, cold sweats and a weird tingling sensation hours after receiving the vaccine. He also noted developing mental confusion. He did not have to go to the ED and went home for the rest of the day. For 1.5 days, he was home resting. On a follow-up call on 1/11/2021, vaccine recipient reported feeling better. Pfizer-BioNTech COVID- 19 Vaccine EUA.
59 2021-01-11 chills, fever developed fever, chills, muscle aches approximately 12 hours post vaccine
59 2021-01-11 chills, fever fever; chills; extreme muscle aches; constant nausea; Right deltoid was swollen and hot; Right delto... Read more
fever; chills; extreme muscle aches; constant nausea; Right deltoid was swollen and hot; Right deltoid was swollen and hot; This is a spontaneous report from a contactable healthcare professional (patient). A 59-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), via an unspecified route of administration on the right deltoid on 04Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included high blood pressure (BP), gout, and shingles. The patient also had allergies with minocycline. Concomitant medications included allopurinol (ALLOPURINOL), amlodipine (AMLODIPINE), and valaciclovir hydrochloride (VALTREX). The patient previously received the first dose of bnt162b2 (lot/batch number: EH9899) for COVID-19 immunization on 18Dec2020 10:00 AM on the left arm and no reaction. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. The patient received 2nd dose of vaccine 04Jan2021. When the patient woke up on 05Jan2021 05:00, she had fever, chills, extreme muscle aches and constant nausea which continued until the morning hours of 06Jan2021. It was also reported that the patient's right deltoid was swollen and hot noted on 05Jan2021. Outcome of the events of right deltoid was swollen and hot were unknown while the patient recovered from the remaining events on 06Jan2021.
59 2021-01-11 fever, malaise Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday ... Read more
Received vaccine on Saturday 1/9/21, had usual symptoms low grade fever, general malaise. On Sunday begin to experience left arm neuropathy at the media aspect of elbow, no sensation in affected area. Lateral aspect is fine, can move fingers and complete activities of daily living.
59 2021-01-12 fatigue, chills Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneou... Read more
Chills; nausea; dizziness; fatigue; Epi-gastric pain; racing heart; depression; This is a spontaneous report from a contactable healthcare profession (HCP) (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), COVID-prior-vaccination: Yes. No allergies to medications, food, or other products. Concomitant medication included ibuprofen in two weeks. On 24Dec2020, the patient experienced chills, nausea, dizziness, fatigue, epi-gastric pain, racing heart, and depression. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for adverse event. The outcome of events was recovered on 24Dec2020. This is a non-serious report. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not test for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
59 2021-01-12 headache, fatigue, fever "Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after va... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA". Symptoms: Tiredness throughout day at approx 2 hrs after vaccination. Felt feverish around midnight, headache, some nausea, pain on arm where vaccination was applied, overall upper discomfort, joint pain (shoulders) and kind of disoriented. Took Tylenol Extra Strength, 500mg, to ease the discomfort.
59 2021-01-13 chills, fatigue, body temperature increased 01/07/2021 7pm staff was shivering, chill, 100.2, body ache, joint pain, upset stomach. Following da... Read more
01/07/2021 7pm staff was shivering, chill, 100.2, body ache, joint pain, upset stomach. Following day fatigue, did not eat. Saturday, Sunday, still having upset stomach. Feel like having cold sore in mouth but could not see the cold sore. Spoke with PCP. PCP said could be something else.
59 2021-01-13 chills 2-3 hour episode of shaking chills
59 2021-01-13 fever altered mental status, hypoxic, fever 39.3, agitated
59 2021-01-14 chills, headache chills; muscle ache/muscle pain about 10 hours after injection; headache; Dose Number: 2, Date of st... Read more
chills; muscle ache/muscle pain about 10 hours after injection; headache; Dose Number: 2, Date of start of drug: 08Jan2021; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration in left arm, on 08Jan2021 12:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included polymyalgia rheumatica. The patient has no known allergies. Concomitant medication included methotrexate and folic acid. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0140), via an unspecified route of administration in left arm, on 22Dec2020 at 11:00, for COVID-19 immunization. The patient experienced chills, muscle ache, headache, and muscle pain about 10 hours after injection on 08Jan2021 at 22:00. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, muscle ache/muscle pain about 10 hours after injection and headache was recovering.
59 2021-01-14 fatigue, chills Myalgias, fatigue, chills for 48 hours, left axillary lymphadenopathy unresolved at 72 hours
59 2021-01-14 headache, fever, chills Dose received at 10:00 am. 1/14/2021 Initially some pain at injection site, Around 7 pm there were... Read more
Dose received at 10:00 am. 1/14/2021 Initially some pain at injection site, Around 7 pm there were chills and fever (eventually spiking around 102.7 degrees), There was a severe headache along with severe joint pain that made it difficult to even walk. These symptoms persisted until about 11:00 am the following day (1/15/2021) A low grade fever has continued throughout the day.
59 2021-01-14 fever, cough, fatigue, malaise After my second vaccine, I have developed a dry cough/I have had the cough for 24 hours so far; at t... Read more
After my second vaccine, I have developed a dry cough/I have had the cough for 24 hours so far; at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular at single dose in the right arm, first dose (lot: EK5730) on 17Dec2020 11:30 am, second dose (lot EL0142) on 07Jan2021 18:00, both for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. After his second vaccine, on 08Jan2021, he has developed a dry cough at the same time he experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally). He has no known exposure to Covid 19 in the last few weeks. He has had the cough for 24 hours so far. The patient did not receive any treatment. Outcome of events was recovering.
59 2021-01-15 fever, headache, fatigue (Fever 102.3, Head ache, Nausea, Fatigue., DIB, First shot for 3.5 days) (Nausea, Fatigue, Head ach... Read more
(Fever 102.3, Head ache, Nausea, Fatigue., DIB, First shot for 3.5 days) (Nausea, Fatigue, Head ache from 2nd shot lasting7 days)
59 2021-01-16 malaise Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs a... Read more
Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs after vaccine and got worse over next 1-1/2 days then plateaued. Body aches and chest pain lessened 3rd day but rheumatoid arthritis flared up in hands and feet especially on 4th day
59 2021-01-17 malaise, fatigue Fatigue, malaise, aches and pain. Mainly at injection site. Just took sick leave for the day.
59 2021-01-17 malaise, headache, fatigue Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pa... Read more
Had my 2nd COVID vaccination shot at 2 pm on Monday, January 11, 2021. Next morning - moderate pain in upper left arm/shoulder (place of injection). Working full shift. Around 4 pm on Tuesday (after almost 3hrs OR case) - feeling very tired. Completed the working shift at 6 pm. Minor to moderate headache started to develop later in the evening. Two pills of Tylenol at 9 pm, another two around 2 am - while headache was getting worse. @6:30 am Wednesday - informed managers that I'll have to stay off work because of bad headache (7 to 8 from 10), called EH as well. During the day - mostly staying in the bed. Tylenol, water, tea with lemon, apples for hydration. Headache -- up and down (between 4 and 8), occasional fatigue and nausea (after staying upright more than 10-15 minutes), left upper arm pain, moderate pain in joints (knees, hips, low back). No fever. Troubled night-time sleeping because of headache. 7 am - informed managers and EH about my condition, Got approval for another day off - with request to have a C-Test after that. Similar feeling and treatment. Slow improvement during the day. Around 5 pm - feeling good enough to start moving more actively, headache and shoulder pain on low level, though getting tired quickly still. Much better sleeping. No symptoms in the morning. Had a COVID test before returning to work.
59 2021-01-17 fever high grade fever 34 hrs post vaccine up to 104 for next 3 days , followed by diarrhea -on day 3 re... Read more
high grade fever 34 hrs post vaccine up to 104 for next 3 days , followed by diarrhea -on day 3 requiring ivf ( 3 liters)due to hypotension( I did not take this day my antihypertensives ) On day 4 low grade fever followed by resolution and loose stools continued through day 6.
59 2021-01-20 chills, fever Fever, chills, muscle aches
59 2021-01-20 fatigue, chills, headache Chills, myalgia,fatigue, headache. Taking Tylenol.
59 2021-01-20 fatigue, headache, fever, chills sore arm at the injection site; chills; subjective fever; fatigue; headache; This is a spontaneous r... Read more
sore arm at the injection site; chills; subjective fever; fatigue; headache; This is a spontaneous report from a contactable physician (reporting for himself). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular in left arm on 12Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included migraine, rosacea and overweight (not obese) from an unknown date and unknown if ongoing. Concomitant medication included doxycycline, magnesium, sulfamethoxazole, trimethoprim (BACTRIM) and Vitamin D. The patient was 59 years old when vaccinated with first dose of BNT162B2 (lot number: EL0140), intramuscular in left arm on 22Dec2020 11:00 at single for COVID-19 immunization and experienced a sore arm at the injection site. The facility where the most recent COVID-19 vaccine was administered was in the nursing home/senior living facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. For the first 24 hours, the patient simply had a sore arm at the injection site on 13Jan2021 09:00, similar to what he had with the first vaccination. Then for the next 12 hours had chills, subjective fever, fatigue, and headache on 13Jan2021 that did not respond simply to ibuprofen. The outcome of the events was recovered on unspecified date. The patient took ibuprofen, triptan as treatment for the events. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and were not a congenital anomaly/birth defect.
59 2021-01-20 headache, chills, fatigue next day was very tired with a slight headache; next day was very tired with a slight headache; 12 h... Read more
next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered. Information on the Batch/Lot number has been requested.
59 2021-01-20 sweating hot and sweaty lasting two minutes after rash
59 2021-01-20 runny nose injection site pain (mild), runny nose (mild), headache (mild), generalized muscle aches (mild)
59 2021-01-25 headache EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AN... Read more
EVENINING OF 1ST DOSE - LEFT ARM AND SHOULDER WAS EXTREMELY SORE. MIDNIGHT - NECK STARTED HURTING AND FELT A FLASH HEADACHE. SOON AFTER, BACK STARTING HURTING, (LOWER RIGHT & LEFT FLANKS OF BACK), NECK AND LEGS FELT WEAK. 9AM NEXT DAY, HEADACHE RETURNED.
59 2021-01-25 influenza like illness, chills DURING THE DAY. BODY ACHES. DURING THE NIGHT- DEVELOPED FLU LIKE SYMPTOMS FROM 8PM TO 3AM (BODY ACHE... Read more
DURING THE DAY. BODY ACHES. DURING THE NIGHT- DEVELOPED FLU LIKE SYMPTOMS FROM 8PM TO 3AM (BODY ACHES, CHILLS, JOINT PAIN, BUT NO FEVER) TOOK ADVIL WITH NO RESULTS.
59 2021-01-27 fatigue Upper Stomach pain; Pain at injection site; Fatigue; This is a spontaneous report from a contactable... Read more
Upper Stomach pain; Pain at injection site; Fatigue; This is a spontaneous report from a contactable pharmacist. A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3248, expiry date not reported), intramuscular on 15Jan2021 13:30 at a single dose in the left arm for COVID-19 immunization. Medical history included diabetes, HBP (high blood pressure), and cholesterol. The patient had no allergies. The patient had no covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 16Jan2021, the patient experienced upper stomach pain, pain at injection site, and fatigue. Therapeutic measures were taken as a result of the events reported which included esomeprazole 40mg and rantidine 150mg. The patient was not tested for covid post vaccination. The outcome of events upper stomach pain, pain at injection site, and fatigue was recovering.
59 2021-01-28 cough, chills, fever Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so... Read more
Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Lymph nodes under arm, on injection site swollen so bad that I could barely lift my arm up it was so painful; Swollen lymph nodes; Coughing; Fever; Body aches; I still have body aches; Chills; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal and COVID-19 from Jun2020 and was hospitalized, and double pneumonia. Concomitant medications included trandolapril for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol, and tadalafil (CIALIS). The patient stated, "I experienced fever, body ache and chills in the evening, which I took some Tylenol (treatment) for and then this morning when I woke up my lymph nodes under my arm on the injection site were swollen so bad that's I could barely lift my arm up it was so painful and I have body aches and the cough I have been coughing quite this morning too, which some slightly concerned what the looks swollen lymph nodes." Clinical outcome of event body aches was not recovered, while for the rest of the events was unknown. Information on the lot/batch number has been requested.
59 2021-01-28 sleepiness Dizziness, numb hands, heavy tongue, and somnolence
59 2021-01-29 sinus headache, sinus congestion, fatigue Excessive ringing in the ears, intermittent Sinus headache and congestion,, dizziness, bouts of comp... Read more
Excessive ringing in the ears, intermittent Sinus headache and congestion,, dizziness, bouts of complete exhaustion. and a slight cognitive issue.
59 2021-01-31 cough, fever Cough; rash on both arms; rash was inflamed; it was red and burning; it was red and burning; 20 litt... Read more
Cough; rash on both arms; rash was inflamed; it was red and burning; it was red and burning; 20 little red dots on each arm from his elbow to his hands; they were like welts; they were inflamed and the skin around the welts was swollen.; Fever; This is a spontaneous report from contactable consumers. A 59-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at left arm on 13Jan2021 3pm at single dose for COVID-19 immunization. Medical history included blood pressure high diagnosed about 5 years ago and being in the hospital seeing patients every day, sometimes they were Covid patients. Concomitant drugs included losartan ongoing for blood pressure high. Patient had his 2nd vaccine on Wednesday 13Jan2021. On 14Jan2021 Thursday he had a fever, and on 15Jan2021 Friday he developed a cough and a rash on both arms that continued through the weekend. He stated that the rash was inflamed on 15Jan2021 Friday and Saturday; it was red and burning; he had about 20 little red dots on each arm from his elbow to his hands, but on 15Jan2021 Friday and Saturday they were like welts; they were inflamed and the skin around the welts was swollen, then on Sunday it started to subside, and today it's almost gone but still a little bit red. Outcome of event fever was recovered on 16Jan2021, cough was recovered on 18Jan2021, and the rest of events was recovering. Information about Lot/batch number has been requested.
59 2021-02-01 fatigue, headache, fever Starting on day 10 after receiving the first vaccine dose, I developed headaches, body aches, low gr... Read more
Starting on day 10 after receiving the first vaccine dose, I developed headaches, body aches, low grade temperature (100.1 max), and fatigue. Temperatures returned to normal 2/1/2021. However, other symptoms are continuing as of 2/2/2021. I called my physician, who ordered a COVID/Flu test. Only COVID was available at the testing center, which was performed today and resulted negative.
59 2021-02-03 fatigue, chills, fever Chills, low grade fever, body aches, tiredness. Approximately 36 hours
59 2021-02-03 headache muscle ache at the injection site; total body ache and soreness; headache; This is a spontaneous rep... Read more
muscle ache at the injection site; total body ache and soreness; headache; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL1283) via an unspecified route of administration in the left arm on 19Jan2021 at 08:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history included a pacemaker, chronic obstructive pulmonary disease (COPD), asthma, and high blood pressure (HBP). Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not have any allergies. Concomitant medications included aspirin; lisinopril; fluticasone furoate, umeclidinium bromide, vilanterol (TRELEGY); and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 19Jan2021 at 11:00 the patient experienced muscle ache at the injection site, total body ache and soreness, and headache. The patient did not receive treatment for the events. The outcomes of injection site, total body ache and soreness, and headache were not recovered. It was also reported that since the vaccination the patient was not tested for COVID-19. No follow-up attempts are needed. No further information is expected.
59 2021-02-04 sweating Patient became diaphoretic with shirt drenched. Vital signs within normal limits. Declined to go t... Read more
Patient became diaphoretic with shirt drenched. Vital signs within normal limits. Declined to go to ED. Remained for 15 min. Diaphoresis resolved.
59 2021-02-04 fever, chills Soreness at the injection site; chills; low grade fever; This is a spontaneous report from a contact... Read more
Soreness at the injection site; chills; low grade fever; This is a spontaneous report from a contactable other healthcare professional reporting for himself A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 20Jan2021 at 11:45 (at the age of 59 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included gastroesophageal reflux disease, and heart disease, both from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included Evolocumab (REPATHA) and omeprazole (OMEPRAZOLE DR). The patient did not receive any other vaccines within four weeks prior to the vaccination, On 21Jan2021 at 01:00AM, the patient experienced soreness at the injection site, chills, and low grade fever. The patient did not receive treatment for the events. The clinical outcome of soreness at the injection site, chills, and low grade fever was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
59 2021-02-06 headache, chills Significant intractable body and joint aches from 14-36 hours post vaccine. Chills from 29 hours-32 ... Read more
Significant intractable body and joint aches from 14-36 hours post vaccine. Chills from 29 hours-32 hours post vaccine. Mild but intractable headache from 24-42 hours post vaccination.
59 2021-02-08 cough right arm sore with difficulty lifting the arm without pain, stomach spasms, throat feels like closi... Read more
right arm sore with difficulty lifting the arm without pain, stomach spasms, throat feels like closing off, coughing Narrative: Patient received vaccine on 01/26/2021. Was assessed per the protocol and showed no signs of being unwell and was healthy looking. Vaccine was administered IM to RT arm. Patient then was monitored for 15 mins by staff over seeing monitor in clinic that day. After 15 mins time, patient was released. Pt call the call center the next day 01/27/2021 with a complaint of stomach spasms, sore arm that is difficult to lift with out pain being present, feeling like his throat is going to close off and starts to cough.
59 2021-02-08 headache 2:45pm less than ten minutes post vaccination c/o severe headache. BP elevated above normal greate... Read more
2:45pm less than ten minutes post vaccination c/o severe headache. BP elevated above normal greater than 180/ denies dizziness. Hx of DM currently on holter monitor. Hx of MS 2:50pm BP 179/81HR 69 SPO2 99% 2:55pm BP 180/81 HR 66 SPO2 99% 3:08pm BP 171/76 HR 64 SPO2 99% 3:25pm BP 185/79 HR 62 SPO2 100% 3:30pm EE verbalized feeling much better able to ambulate per self went home.
59 2021-02-08 fever Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospita... Read more
Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospitalized for 8 days. The physician diagnosed me with bacterial pneumonia. After being discharged from hospital had another CT scan found 3 in undefinable mass on right lung and nodules left lung. I have a appt scheduled to follow up with a Pulmonary specialist on 3/9.
59 2021-02-09 malaise Threw up 3 days after getting the COVID 19 vaccine; Feeling unwell; Having pain in his private area;... Read more
Threw up 3 days after getting the COVID 19 vaccine; Feeling unwell; Having pain in his private area; This is a spontaneous report from a contactable consumer (patient's caregiver). This 59-year-old male patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 22Jan2021 at a single dose on the left arm for COVID-19 immunisation. The patient was disabled. No additional medical history was provided. No relevant concomitant medications were provided. On 25Jan2021 (3 days after getting the COVID-19 vaccine), the patient threwup, once. After vaccine, the patient was feeling unwell and he was having pain in his private area. The outcome of the events was unknown. Information about lot/batch number has been requested.
59 2021-02-09 fever, chills Nausea, body aches, low grade fever and chills.
59 2021-02-09 fever, malaise, influenza like illness, headache vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle jo... Read more
vomited; felt sick; very loose stool; fever; felt like beat with baseball bat; body aches; muscle joints hurt; flu like symptoms; head pounding; this may have been a bad batch or something; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3302 , via an unspecified route of administration on 22Jan2021 10:00 (at the age of 59-years-old) as a SINGLE DOSE in the left arm for COVID-19 vaccination. Medical history included potentially had Covid prior to receiving the vaccine from an unknown date and unknown if ongoing, he had antibodies prior to the vaccine from an unknown date and unknown if ongoing. The consumer reported he must have had Covid in the Spring because he got sick, took a Sudafed and had Afrin nose spray and was fine after that. The patient previously took pseudoephedrine hydrochloride (SUDAFED) for he got sick, oxymetazoline hydrochloride (AFRIN) nasal decongestant for he got sick. They were giving shots out to the military. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Jan2021, the patient experienced flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool. The consumer reported that this may have been a bad batch or something in Jan2021. The consumer reported that the body aches started at 8AM and resolved at 6PM. The consumer reported that he recovered from all other events late afternoon on Saturday. The consumer reported he vomited from noon-1PM. The consumer reportedhad body aches at 08:00, muscle joints hurt at 08:00, felt like he was beat with a baseball bat 08:00, felt sick at 10:00, vomited 12:00, loose stool 09:00 and fever 08:00 .The events did not require a visit to the emergency room or physician office. No treatment was received for the events. Outcome of the events flu like symptoms, body aches, head pounding, muscle joints hurt, felt sick, fever, felt like beat with baseball bat, vomited, very loose stool was recovered on 23Jan2021. Outcome of the event this may have been a bad batch or something was unknown.
59 2021-02-11 headache Sore shoulder muscle, nausea, headache.
59 2021-02-11 fever, chills, headache Sudden onset fever, chills and terrible headache. Lasting at least 2 days
59 2021-02-13 headache Severe, persistent headache following the second dose of the vaccine, beginning approximately 22 hou... Read more
Severe, persistent headache following the second dose of the vaccine, beginning approximately 22 hours after the administration of the vaccine and continuing, so far, for three days.
59 2021-02-17 chills 12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed sev... Read more
12 hours after vaccine started having chills-could't get warm. 15 hours after vaccine developed severe vomiting for about 7 hours.
59 2021-02-17 lethargy, headache Headache, Myalgia, lethargy Narrative:
59 2021-02-18 chills, fatigue Dizziness, mental fog, insomnia, severe fatigue, chills, bodyaches, delayed onset (3rd night) muscle... Read more
Dizziness, mental fog, insomnia, severe fatigue, chills, bodyaches, delayed onset (3rd night) muscle/joint pain, delayed onset (day 5) rash at injection site and swollen mass (supraclavicular lymph nodes, larger on left side).
59 2021-02-18 throat irritation ~20 minutes after vaccine patient began to have wheezing and "scratchy throat". He reported it to pa... Read more
~20 minutes after vaccine patient began to have wheezing and "scratchy throat". He reported it to paramedic on scene who obtained vital signs (all normal) and got Physician Assistant. Patient non taxic appearing and had self administered 2 puffs from albuterol inhaler prior to PA evaluation. Pt states that his breathing is much improved, "almost back" to baseline. Patient still states that his throat feels scratchy. Patient given option of going to ER or getting single dose of benadryl here and monitoring at home. He chose to have benadryl ( PO here). His wife is driving and will notify 911 if not improving or getting worse over the next 2-4 hours.
59 2021-02-21 chills, fever chills and felt feverish; chills and felt feverish; This is a spontaneous report from a non-contacta... Read more
chills and felt feverish; chills and felt feverish; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264) via an unspecified route of administration in left arm on 28Jan2021 at 08:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and diabetes. Patient has no allergies to medications, food, or other products. Concomitant medications included amlodipine besilate, atorvastatin calcium (CADUET) and escitalopram oxalate (LEXAPRO), both received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 29Jan2021 at 14:00, the day after the shot, which was the 1st shot, reporter's husband had chills and felt feverish. He took 2 ADVIL then he felt fine. No treatment and no seriousness criteria was reported. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.
59 2021-02-24 cough I began to cough within 30 minutes of receiving the shot. Then turned into severe wheezing and diffi... Read more
I began to cough within 30 minutes of receiving the shot. Then turned into severe wheezing and difficulty breathing. I used inhaler twice on the way home and used two doses of albuterol nebulizer immediately as soon as I arrived home. The next day I was coughing wheezing throughout the day. On my drive home from work it got worse and I drove to URGENT CARE . I received steroids and breathing treatment and chest X-ray. I have a medical appointment with my primary care doctor 02/26/21 at 11:00 am.
59 2021-02-26 fever, chills Dose 2. Fever Chills mild aches in knees
59 2021-02-28 fatigue injection site pain, tiredness, injection site swelling.
59 2021-03-01 fatigue Within hours, mild injection site soreness. The next day, mild muscle soreness and fatigue lasting a... Read more
Within hours, mild injection site soreness. The next day, mild muscle soreness and fatigue lasting about 48 hours.
59 2021-03-03 fever Fever of 102°F. Not serious. Should go away in 24 hours.
59 2021-03-06 fatigue, body temperature increased fatigue, temp of 100.1 degrees F, redness on legs and a little on chest (looks like a rash but not i... Read more
fatigue, temp of 100.1 degrees F, redness on legs and a little on chest (looks like a rash but not itchy)
59 2021-03-07 headache, fatigue Extreme faitigue/exhaustion, moderate but lingering headache, lasting approximately 36-48 hours
59 2021-03-08 fever, chills, fatigue, headache Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, s... Read more
Maybe Important: I had COVID-19 Oct 2020 for 4 weeks, bad case, still have deep breathing issues, shortness of breath and get tired much quicker than I used to (I'm an avid Tennis player, several times a week). Shot Info: from 3/5 10am to 3/6, no issues, I didn't even feel the shot, no soreness or other symptoms. woke up at 2am (first noticed): Very sore arm, Sore from head to toes, headache, sever chills/shaking, very tired, severe shortness of breath, joints (knees, hips, wrist) constant (not overly severe) pain. Severe symptoms lasted for 24 hours before starting to taper off, felt pretty good by Sunday 3/7 12pm/Noon. My chills were so bad, just getting up to go to the restroom 15 ft away, didn't know if I could make it back to the bed. Headaches was the last thing to go.
59 2021-03-09 headache Headache, nausea, muscle pain
59 2021-03-10 body temperature increased patient woke up filling faint and dizzy. temperature went to 102 and his blood glucose level was 160... Read more
patient woke up filling faint and dizzy. temperature went to 102 and his blood glucose level was 160.
59 2021-03-10 fatigue Joint pain, fatigue, felt weird. Felt spacey. Light headed.
59 2021-03-10 fever, headache HIGH FEVER AND HEADACHE . TOTAL DURATION APPROXIMATELY ONE HOUR. FULLY RESOLVED WITHOUT ADDITIONAL T... Read more
HIGH FEVER AND HEADACHE . TOTAL DURATION APPROXIMATELY ONE HOUR. FULLY RESOLVED WITHOUT ADDITIONAL TREATMENT.
59 2021-03-11 fatigue, chills, sweating General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell bac... Read more
General Fatigue during the day went to sleep and had terrible shivers to violent shaking. Fell back asleep and then awoke to being being drench. Cotton pajamas were thoroughly wet as was bedding. It would have taking a pint or two of water to have made this wetness. [and no it was no urine! ;) ] had to get new pajamas and throw a towel on the bed to have dry bedding.
59 2021-03-12 fever, headache, fatigue Headache, body aches, fever, nausea that evening/night. All symptoms mild to moderate. Next three... Read more
Headache, body aches, fever, nausea that evening/night. All symptoms mild to moderate. Next three days, fatigue and diarrhea
59 2021-03-12 sluggishness, fatigue Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Ar... Read more
Immediate after the shot i had a weird taste and slight feeling of nausea which soon went away. Around 6 pm on the day of the injection I noticed that my taste buds were more sensitive. Following that I became very sluggish. So I went to bed shortly afterwards. The following morning I was still sluggish and there was a feeling of openness in my upper chest area. The feeling of tiredness an no energy started and continued until Wednesday the 3rd of March. That morning I awaken feeling better. I still have a feeling of openness in my upper chest area. But overall I feel great.
59 2021-03-13 chills, headache Headache, muscle aches, chills all the day following the injection and some the day after that
59 2021-03-13 fatigue fatigue for 3 days, no treatment, rest, resolved.
59 2021-03-14 chills, headache Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer... Read more
Headache; Chills; Body aches; Sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received BNT162B2 (Lot Number: EL3248), via an unspecified route of administration in left arm, on 02Feb2021 at 07:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 at 11:00 PM (23:00), the patient experienced headache, chills, body aches, and sore arm. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Feb2021. No follow-up attempts are possible. No further information is expected.
59 2021-03-15 fatigue, fever, chills About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not b... Read more
About 32 hours after given the shot, chills, fever and nausea began. This quickly escalated to not being able to breath. Face and neck were turning purple. My dad was about to call 911 when he finally was able to calm down and catch his breath. His lungs and chest burned afterwards and he was completely spent for days after.
59 2021-03-17 fever Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairm... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairment over the past year who was brought to hospital after 4 days of food/medication refusal, withdrawal from care and more recently disorientation and tremor. Pt was recently transitioned from haldol decanoate to clozapine. Last dose haldol decanoate was on 2/16/21. First dose clozapine 12.5 mg was on 2/24/21. Increased to 12.5 BID the following day. Increased to 25 mg BID on March 2, without reported side effects or other issues. Pt got his first dose of Pfizer COVID vaccine on March 4, and that night was less engaged with staff, felt feverish. Did not spike a temp per bedside accompaniment who was with him that day. The following day, he barely ate any food and did not get out of bed all day. This continued for the entirety of the weekend - bed bound, turning to look at staff when called but did not engage/respond verbally. He was incontinent of urine over the weekend. Treated for Neuroleptic malignant syndrome 2/2 clozapine Uncertain if vaccine contributed to event, but recent case report published relating clozapine toxicity and Pfizer COVID vaccine, so submitting to VAERS for evaluation
59 2021-03-18 fatigue, headache my blood sugar spiked. had just had blood work done prior to first dose no sign of diabetes 2 days a... Read more
my blood sugar spiked. had just had blood work done prior to first dose no sign of diabetes 2 days after 2nd shot started feel fatigue headache and urine increase went to doctor today i have type 2 diabetes.
59 2021-03-18 fatigue, fever, headache, chills Headache, Myalgia, Arthralgia, Fever, Injection site pain, Chills, Fatigue
59 2021-03-18 fatigue Exhaustion - onging Swollen lymph node left arm pit - ongoing Lower back ache - ongoing Hair loss - ... Read more
Exhaustion - onging Swollen lymph node left arm pit - ongoing Lower back ache - ongoing Hair loss - ongoing
59 2021-03-18 influenza like illness The Flue-like symptoms and body aching lasted for 24 hours.
59 2021-03-19 chills, body temperature increased, nasal congestion At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M... Read more
At 7:00 pm I started experiencing sinus drainage & stuffiness. When I went to bed at around 8:30 P.M. I Noticed some difficulty getting enough air into my lungs ( 11/2020 Ablation for A fib, compromised phrenic nerve Not usually SOB unless high physical demand ) At 9: 30 P.M started moderate shacking/Chills until around 3 A.M. with little sleep. Then some sleep until 5:00 A.M. woke up with 102.4 temp and felt lousy with joint pain in various joints that do not typically hurt. Did not go to work spent most of the day in bed until 4:00 P.M. Feeling somewhat better now
59 2021-03-19 chills Muscle soreness, chills, joint pain for first 24-36 hours. Joint pain continued for 60 hours. Resi... Read more
Muscle soreness, chills, joint pain for first 24-36 hours. Joint pain continued for 60 hours. Residual joint pain in formerly broken toe has continued for 3 days, though has gradually lessened.
59 2021-03-20 headache, chills, fatigue Head ace, chills, joint pain, nausea, overwhelming fatigue. Shortness of breath.
59 2021-03-22 fatigue The Patient presents with cricket sound and high pitch Tinnitus in both ears that began 4 days ago. ... Read more
The Patient presents with cricket sound and high pitch Tinnitus in both ears that began 4 days ago. Additional information:2nd dose of pfizer covid vaccine friday at noon. 3 hours later pt got ringing in ears. Noted B/L high pitched chirping in ears about 3 hours after receiving 2nd Pfizer vaccine 5 days ago, no hearing loss, no dizziness or HA feels fatigued and has L arm soreness that has improved
59 2021-03-22 throat pain, fever, fatigue Swollen Lymph nodes in neck and under chin, sore throat, slight fever, tiredness
59 2021-03-23 fever Became nauseous in the night and ran a fever the next morning
59 2021-03-24 fatigue, body temperature increased Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly pa... Read more
Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly passed out one evening when I got up out of bed. Nearly didn't make it back to bed. Body aches. Used cold compresses and took extra strength Tylnol and Aspirin. Lots of water and Ensure. Dressed in layers to stay warm. My wife and I are sick at the same time from vaccine injection. Missed 2 days of work. Also had skjn hypersensitivity in my upper back. Had fatuque, but not as bad as my wife.
59 2021-03-24 headache Headache headache x2 days Narrative: Other Relevant History:
59 2021-03-24 sweating Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sus... Read more
Pt with witnessed ground level fall from chair due to syncopal event after receiving vaccine. Pt sustained blunt trauma to his head that included a contusion over his right forehead and laceration to posterior right ear. Pt was AOx2, not oriented to time, confused and repeating himself. Pt was also diaphoretic and hypotensive after the event. Due to altered mental status pt was transported by EMS to a local hospital for further evaluation.
59 2021-03-24 fever Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and l... Read more
Severe fever lasting still on day 5 most days over 100 brought down only with ibuprofen, dizzy and lightheaded that prevents me from working and driving. I've missed 2 days of work so far. Soreness continues in my arm as well. I've also had nausea at times and appetite that varies.
59 2021-03-25 fatigue, headache At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pa... Read more
At 11pm that evening headache (worst ever in my life), joint pain in hands, hips, knees, muscular pain in thighs and lower back, lasting about 6 hours. Diminished gradually over the next 4 hours. Fatigue ongoing.
59 2021-03-25 fatigue Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, t... Read more
Dizzy, vertigo, difficulty breathing immediately after shot. Dizziness subsided after a few hours, typical arm pain at the injection site a few days after. Fatigue and difficulty breathing increased over the next few days. On the third day after injection, experienced cognitive difficulty using words, vertigo. Went to emergency for possible stroke symptoms. Cognitive testing, Brain CT scan w/contrast, MRI, Echocardiogram, 24 hour in patient observation. All negative. Still experiencing shortness of breath and anxiety a week after injection.
59 2021-03-25 head discomfort Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels press... Read more
Feet and legs Tingly like falling asleep. Pins needles also occasionally all over. Head feels pressure like sinus but not sinus. Hands feel slight vibration like small amount of electricity going through my body. No symptoms felt while laying in bed. Start in the morning when moving around.
59 2021-03-25 sweating Pt at chair, received vaccination and proceeded to pass out, Placed in wheel chair and elevated feet... Read more
Pt at chair, received vaccination and proceeded to pass out, Placed in wheel chair and elevated feet. ammonia spirits under nose. groggy but able to answer questions. very pale and sweaty. knew where he was and his name. Strong pulse noted. Pt moved to stretcher to Observation room @11:45 BP 105/58, Pulse 58, RR 24 Pulse Ox 100. 11:31 BP 111/66, Pulse 58, RR 28 Pulse Ox 100. Vital signs remain stable for next 15 minutes. started to take sips of apple juice and water. Head of bed raised bits at a time. Felt dizzy at drastic head of bed elevations. 11:55 BP 110/65 Pulse 51, RR 20, Pulse Ox 100. Pulse dipping to high 40s but pt states that this is his normal. Wife at bedside. reports feeling nausea and did eventually vomit. feels better after emesis. 1230 BP 126/74 pulse 53 RR 20 PO 99. eventually sitting and standing up. 12:50 BP 134/79 pulse 64 RR 20 po 96. felt good. walked with pt and wife out to exit. Discharged to home with wife.
59 2021-03-26 fever, chills 100plustemp,chills,joint pain,backache,2days
59 2021-03-26 fever, fatigue Fever 100 degrees fahrenheit, joint aches, fatigue. 8 hours after onset took 2 ADVIL ibuprofen. Symp... Read more
Fever 100 degrees fahrenheit, joint aches, fatigue. 8 hours after onset took 2 ADVIL ibuprofen. Symptoms subsided for 8 hours then took 2 more Advil. Symptoms subsided and 3 hours later felt symptoms disappeared.
59 2021-03-26 sluggishness, fatigue Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. ... Read more
Left arm very sore about 8 hours later and the next day. Discomfort stopped around 12 noon 2nd day. Also, 2nd day, sluggish and exhausted beyond normal after my work day (PT 1:30 to 5:30 pm.)
59 2021-03-27 fatigue, fever 101 degree fever, aching joints, aching muscles, constipation, fatigue. Starting at 3:00 am, approx... Read more
101 degree fever, aching joints, aching muscles, constipation, fatigue. Starting at 3:00 am, approximately 12 hours after vaccination. Diarrhea occurred all day the following day and into the next, though fever subsided, fatigue remains.
59 2021-03-27 sweating, fatigue, chills Sweats, chills, fatigue and nausea
59 2021-03-27 throat pain, headache On the Monday and Tuesday (March 22 and 24) after I got the second vaccine, I had some minor wheezin... Read more
On the Monday and Tuesday (March 22 and 24) after I got the second vaccine, I had some minor wheezing. On Wednesday I got a very bad sore throat on the right side. I had intense headaches. The pain moved unilaterally to the right side of my head, ear, and neck. It was very painful. I went to see medical center on Thursday. I tested negative for Covid 19 and Strep. This pain persisted until today, March 28 (4 days)
59 2021-03-28 chills, fever 15 hours after injection started with vomiting, diarrhea, fever, and chills. Symptoms lasted 32 hour... Read more
15 hours after injection started with vomiting, diarrhea, fever, and chills. Symptoms lasted 32 hours.
59 2021-03-28 lethargy, chills About 14 hours after injection, I awoke with extreme lethargy, tired muscles over entire body, and m... Read more
About 14 hours after injection, I awoke with extreme lethargy, tired muscles over entire body, and moderate chills. Within about 24 hours after that, symptoms had mostly subsided. We took my temperature but I did NOT have a fever.
59 2021-03-29 headache, chills, sweating Shivers, sweats, headache
59 2021-03-29 sleepiness, fatigue 24 hours after vaccine, extreme fatigue, sleepiness. Lasted 24 hours then cleared up. Slept most of ... Read more
24 hours after vaccine, extreme fatigue, sleepiness. Lasted 24 hours then cleared up. Slept most of the day on Monday
59 2021-03-30 fever, fatigue I tested positive for covid back in August, and experience the same symptoms , fever 100.8 joint ach... Read more
I tested positive for covid back in August, and experience the same symptoms , fever 100.8 joint aches, fatigue and brain fog
59 2021-03-31 chills Full body aches and chills
59 2021-03-31 headache, fatigue He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; p... Read more
He will keep him up until 3 in the morning and he stays awake; headache; it is really frustrating; pain in his joints and his bones and it was getting worse; pain in his joints and his bones and it was getting worse; pain all over; Any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; body is so weak/ doesn't have any energy to move; tired; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; a little bit of small itching, not much, just a little bit that made him feel not comfortable with it; ribs moving quicker; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2, via an unspecified route of administration (left arm) on 06Mar2021 at a single dose for COVID-19 immunisation. Medical history included pain, high cholesterol, and testosterone low, joint pain, bone pain, muscle pain, any place in his body had pain, and doesn't have good memory, all ongoing. Concomitant medications included ongoing hydrocodone for pain, ongoing atorvastatin for high cholesterol, ongoing clomiphene citrate for testosterone medication because it was low because of his age, ongoing colecalciferol (Vitamin D), ongoing ascorbic acid (Vitamin C), ongoing oxycodone for pain, and unspecified eye medication. He had many different medications that he was taking. Historical vaccines included chicken pox vaccine for immunization and shingles vaccine in Jan2020 for immunization and experienced pain all over. The patient stated that he was a torture survivor and he has been taking pain medication because of him being tortured previously. He was taking medications for the pain, clarified to be hydrocodone and oxycodone. These medications kept his body stable. He was able to sleep and relax. One day after he received his Pfizer COVID vaccine (07Mar2021), he started feeling the pain in his joints and his bones and it was getting worse but the pain used to be stable with the way he was using his medicines. But now his body was not stable. Any place in his body, his muscles, joints, and bones have had pain previously because of the damage of torture but now it all came up after the COVID vaccine. Every piece of his body hurt even if he takes his medications. He still had the pain and his body was so weak for about 4 to 5 hours. He used to be able to do his business all day but now after about 3 to 4 hours on his feet he got so tired and he needed to sit. He didn't know why this happened. He has talked to others that have received COVID vaccines and none have had this kind of reaction like him. He has asked them about it. It was very frustrating to him on an unspecified date. Every month he sees a physician. He would like for Pfizer to contact him with further questions, he can't understand the pain. This was really killing him especially when the pain goes to his bones. He will keep him up until 3 in the morning and he stays awake on an unspecified date. He then took medicine and he had to wait for 30 minutes for it to start working and then he will be able to sleep. But other than that, the pain jumped. He has had the chicken pox and the shingles vaccines and none did like that. The pain was not going away in his muscles or joints. And now he was getting a headache on an unspecified date, it was really frustrating. He didn't have good memory from the torture. This morning, when he woke up, he had the pain in his joints and his bones. He didn't like to use too much medication. He liked to use it only as he needs it. Pain medications are strong. But this COVID vaccine somehow made him need to use more medication and then that caused him to have a headache. His pain should get better with his medications but today, he had pain all over him and he didn't have any energy to move. He didn't know how to explain it. The COVID vaccine had really kind of made him weak. Sometimes he drinks a lot of cranberry juice to try and take the vaccine out of his system and it was frustrating because he hasn't ever been like this. When he had pain like this it reminded him of his torturing and what had happened to him. When the pain came on strong was when it reminded him of that. The medications he was taking were supposed to kill the pain. That was the reason he got so pissed and was trying to ask what was going on. This COVID vaccine is not safe he believed because it has been almost 10 days and it was not helping him. He was still not good. After he got his COVID vaccine on 06Mar2021, he had a little bit of small itching, not much, just a little bit that made him feel not comfortable with it. That was why they kept him for 20 minutes after his vaccine. When he got back home, he was okay, it was nothing serious. But then the day after his COVID vaccine on 07Mar2021, his joints, his muscles and his bones had pain. On 06Mar2021 the itching lasted about 20 minutes. He felt like he was chewing his lip, he was a little uncomfortable and he felt his ribs moving quicker. Nothing happened but he could feel it. He tried to chew his lips a couple of times, but not that much. But after that, he had pain all over on the day after his COVID vaccine, 07Mar2021. By the time this vaccine started getting into his body, it was really hurting and getting worse. He had the shingles vaccine and for 1 1/2 to 2 days, he had pain all over and then 2 days after it was all gone, he was back to normal life. The pain was gone. With this COVID vaccine he thought that maybe it was going to be the same but it was not the same and it was hurting. The shingles vaccine was last year in 2020, 3 months before people knew about the coronavirus that was when he got the vaccine for shingles, so maybe Jan2020 was when he had the shingles vaccine. He had no medical conditions or heart and chest problems. No other vaccine he has taken has ever had this type of side effect to him. He took his shingles vaccine in his right arm and the COVID vaccine was in his left. With both he had the same start of having the bad pain. This COVID vaccine goes deeply to the body. The vaccines job is to wake the body. The vaccine's job is to wake up the body for the virus. The body has to make some kind of soldiers to stand up on the virus and this COVID vaccine had actually made his body weak. After the vaccine is supposed to wake the body, little by little the side effects are supposed to go away. His body was not learning this vaccine. It kept fighting to learn whatever was in this COVID vaccine, his body can't learn it and fight it. That was the reason his body got weak and the pain has not gone away. His body is still in alert and that's why the pain was still there. His body was still fighting. Somehow it didn't match the inside of the body. Maybe for some people that this will happen to, they will be okay but for some they will not be okay. It is not because some people have nothing wrong with them. The patient recovered from itching and discomfort on 06Mar2021; not recovered from any place in his body, his muscles, joints, and bones have had pain previously/ pain in his joints and his bones and it was getting worse/ pain all over on the day after his COVID vaccine; while outcome of other events was unknown. Information about lot/batch number has been requested.
59 2021-03-31 sweating Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:1... Read more
Occurrence Date: 03/19/2021. Patient c/o feeling hot, and sweaty during the observation around 10:15 after receiving his Covid-19 vaccine. V/S taken, and first reading: BP: 179/103, HR: 100, and Spo2: 96% . Hydration provided. Patient was asked about medications. Patient stated that he had taken his meds @ 06:00. Patient did not remember his baseline. Patient was taken to the ED.
59 2021-04-01 chills, fever, headache, fatigue Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body a... Read more
Day of shot, 9 hrs later chills, 18 hrs later fever of 103 Day 2, fever 102, chills, fatigue, body aches Day 3, fever 101.3, chills, fatigue, body aches, rash at injection site, arm pits, feet, headache, unable to sleep, stomach ache Day 4 , no fever, very weak, headache, same rash, can not concentrate, stomach ache
59 2021-04-01 headache Headache, nausea, dizziness, sore arm from 2nd shot
59 2021-04-01 sweating At 11:39am, patient & wife mention that patient has history of passing out. Then suddenly, patient s... Read more
At 11:39am, patient & wife mention that patient has history of passing out. Then suddenly, patient started to feel lightheaded & dizziness. Patient loss of conciousness and was lay down to the floor assisted. Patient was diaphoretic, loss of conciousness for about 1 to 2 mins, VS#1 130/90, 68 & 98%. Patient regain conciousness, alert & oriented. At 11:46am, VS#2 132/100, 96% & 71 sitting down. Transfer to wheelchair & monitored for 30mins, 11:54 VS#3 130/70, 97% & 66. At 1209, VS#4 140/90, 97% & 67 on standing position, denies dizziness, lightheadedness, SOB & with steady gait. Patient able to go home with wife. No s/sx of distress.
59 2021-04-01 fever, fatigue, influenza like illness Fever, fatigue, feeling like onset of flu.
59 2021-04-01 fever Fever of 101.9F from March 29, 2021 @ 1:00 AM through March 30, 2021 12 Noon.
59 2021-04-02 headache, fever, chills Fever, chills, total body aches, headache
59 2021-04-02 headache 24 hrs post vaccination I had severe pain in the back of my skull. Burning, shooting pains, felt bum... Read more
24 hrs post vaccination I had severe pain in the back of my skull. Burning, shooting pains, felt bumps on back of head and Left side of head. Went to Dr. on 3/30 and was diagnoised with shingles. I had chicken pox as a child, and was not vaccinated for shingles.
59 2021-04-02 sweating PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBT... Read more
PATIENT HAD SYNCOPAL EPISODE, UNAROUSABLE TO STERNAL RUB, PALE, CLAMMY, DIAPHORETIC. VITAL SIGNS OBTAINED. 911 WAS CALLED FOR TRANSPORT.
59 2021-04-03 fatigue Muscle and joint ache, fatigue when I woke up day after receiving second dose. Muscle & joint aches ... Read more
Muscle and joint ache, fatigue when I woke up day after receiving second dose. Muscle & joint aches reduced after morning run / workout, though symptoms persisted at a lower level throughout that day. Felt fine by second day after vaccination.
59 2021-04-03 headache, sluggishness, fatigue Headache, body aches, tired/sluggish.
59 2021-04-03 fever Muscle soreness throughout the body, fever, chills. The symptoms were gone by 4/3/21
59 2021-04-04 fatigue, headache Extreme fatigue / tiredness. Could not get up and stay up for 24 hours. Bad headache in lower back o... Read more
Extreme fatigue / tiredness. Could not get up and stay up for 24 hours. Bad headache in lower back of head and neck.
59 2021-04-04 fatigue Severe vertigo; nausea and vomiting; eye pressure; fatigue. Began 4/2 and on-going. No resolution o... Read more
Severe vertigo; nausea and vomiting; eye pressure; fatigue. Began 4/2 and on-going. No resolution of symptoms. Slightly ameliorated by taking Meclizine
59 2021-04-04 fatigue Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 7... Read more
Extreme fatigue / tiredness, couldn't get up and stay up for 16 hours. Developed hive like rash on 75% of facial skin that was painful / burning sensation for 24 hours and itchy after that. Still have the rash 60 hours after onset of rash, but it has subsided to approximately 50% of facial skin.
59 2021-04-04 lethargy voices, paranoia, anxious, difficulty thinking and processing thoughts, light sensitivity, very leth... Read more
voices, paranoia, anxious, difficulty thinking and processing thoughts, light sensitivity, very lethargic
59 2021-04-05 chills 1. Had a severe gout flare up in left knee same night as I received shot. Sought treatment 2 days la... Read more
1. Had a severe gout flare up in left knee same night as I received shot. Sought treatment 2 days later. Received a steroid injection (10mg of Decadron) at urgent care faciilty. Received Rx for 50mg Indomethacin capsules. Overnight, the combination of the 2 drugs greatly lowered the pain and helped the swelling go down a little. 2. Second night after shot, I had a brief attack of severe chills, which woke me up, They went away after adding a blanket and dressing warmer.
59 2021-04-05 fatigue Extreme fatigue, severe body stiffness, pain with movement by over 45 days. MRI with tendinitis in... Read more
Extreme fatigue, severe body stiffness, pain with movement by over 45 days. MRI with tendinitis in all tendons within the area examined. Muscle pains , tendon swelling and pain. This started to subside after 45 days post-vaccination of the second vaccination.
59 2021-04-05 nasal congestion Loss of taste and smell, nasal congestion on 3/27/2021
59 2021-04-05 fever, throat pain, throat redness Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patien... Read more
Fever, Dizziness, Weakness, confusion for 3 day. racing heart and sore throat. Ladder brought patient to Doctor office for treatment. Antibiotics treatment for sore throat to no effect. 2nd dose started and to date same effect. Patient is in pain.
59 2021-04-06 chills, fatigue, headache Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain),... Read more
Side effects began the morning after ? severe headache and body ache (back and abdomen muscle pain), followed in the afternoon by severe fatigue (I slept two hours in the late afternoon before dinner), then by evening mild nausea and chills. I ended up going to bed at 9pm and slept nearly 10-1/2 hours after, for a total of 12-1/2 hours.
59 2021-04-06 fatigue Very tired and weak
59 2021-04-06 headache, malaise 1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. Patient was as... Read more
1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. Patient was assess 30 minutes later, denies allergic reaction. A follow up call an hour later, to inform the patient of 1 vial undiluted vaccine given to the patient, pt c/o of body malaise, Patient was told to go to the Hospital, patient don't want to go. Another follow up call 2x in the afternoon and patient starts having headache, patient said will go to Hospital if condition worsen. Another follow up call 4/7/21 AM and PM, patient went to work , feel better, no more headache and body malaise or allergic reaction to the Covid vaccine but sour to the injected site.
59 2021-04-07 chills diarrhea, chills but no fever, achy
59 2021-04-07 headache, fever Fever 103.6, Aches and pain throughout entire body Severe headache Nausea Fever at highest 20 hour... Read more
Fever 103.6, Aches and pain throughout entire body Severe headache Nausea Fever at highest 20 hours after vaccine Fever levelled off to 100-101 and persisted for 2 days.
59 2021-04-07 influenza like illness, fatigue, fever, malaise, headache He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on... Read more
He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine. Later on he took his temperature and it was 99 range. It then went up to 101.4 that evening, but he felt very hot. He felt very hot, face was red. Somebody brought him over a thermometer and checked it again and it was 101.7, felt terrible and he took Tylenol. The next day he felt achy like he had the flu, a headache, body aches and weakness, nauseous as well. Then the next morning it was 102.3. It fluctuated throughout the day. Then later it went to 102.7 at 9:00 PM. Then about 2 hours later before he went to bed it came down to 101. Then he woke up on Sunday morning 3/28/21 his temperature was normal, he was exhausted from the fever. He felt run down for a few days after that, knocked out and the nausea came back on 4/3/21. No reaction at the injection site, just standard arm soreness, rash below the area of injection that lasted for about a week and went away. He is still more tired than usual this week, but doesn't know if that's related to the vaccine or not. The right arm 8 days later he got a rash at the injection site and a little bump that felt swollen. That also ended up going away after a day or so.
59 2021-04-07 malaise Feelings of sickness and elevated blood pressure as well as dizziness.
59 2021-04-08 chills Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode las... Read more
Uncontrollable shivering, chills for more than an hour followed by being hot. The whole episode last 2-3 hours.
59 2021-04-08 fatigue Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam... Read more
Began feeling a little warm and flushed and tired. I felt off overall. On the 8th around 12pm. I cam e home from work around 4:30 and laid down til 5:30 and I woke up feeling a little better but around 6:15 I felt the same as earlier that day and then it got worse. My ears were ringing loudly and I had shortness of breath, I had difficulty breathing, and my chest was tight and I had pain in the center of my chest and I was nauseous and hungry but really couldn't eat anything. I checked my BP at home and it was 189/127 and then 192/122. I was well hydrated but I drank 2 16 ounce glasses of water and sat down to try and relax. An hour later the ringing stopped and I was feeling much better. I took my BP again and it was up to 202/126. I decided to go to the ER at this time. around 11pm it was 143/89. Ringing and flushed still present with some stomach issues (4/9)
59 2021-04-08 headache, chills Date and time adverse event started: Approx. 2-3 days from date 2nd dose rcvd (3/29/2021) approx. ti... Read more
Date and time adverse event started: Approx. 2-3 days from date 2nd dose rcvd (3/29/2021) approx. time unknown. Patient reported that with the first dose he had a mild headache which went away. Reported that from the second dose rcvd (3/29/2021), same day had left shoulder soreness and stiffness which went away two days later without any treatment. Reported that the headache felt worse from rcvding the 2nd dose, which occurred 2-3 days later. Pt is still experiencing the headache which has not gotten better, there's pain and stiffness in the back of his neck and skill area (lots of discomfort in the neck and skull area from trying to rotate his head). Also reported that he can't sleep, and the chills are still coming off and on (chills also started approx. 3 days from 2nd dose rcvd). Patient reported since his headache started 2-3 days from rcvding 2nd dose, he has been taking Tylenol 650mg tablet (dosing approx. 2-3x per since headache started) which helps alleviate the headache for approx. 30-45 minutes and then the headache would return. He had tried to reach out to his PCP but his PCP has moved. Patient advised will go to urgent care today to get check out. ***NOTE*** Counseled patient to stay hydrated (recommend water or fluid with electrolytes, and avoid caffeine to prevent dehydration) and can continue to take Tylenol as needed just a long as he does not exceed 4,000mg per day. Counseled patient to avoid consuming alcohol while taking alcohol to prevent drug interaction with Tylenol. Recommend patient to seek medical care since his headache his not gotten better and he has been taking Tylenol for almost a week now. Patient called back 4/6/2021 at 9:09am: Patient reported that he felt much better today headache, pain or stiffness in the back of his neck or skull areas, and slept fine last night. Patient stated he did not get a chance to go to urgent care. He stated he took Tylenol last night. Recommend patient to continue to stay hydrated, and if his headache comes back to contact his PCP for further follow up.
59 2021-04-08 headache, sweating, malaise Came to Vaccine clinic feeling unwell with headache and lightheadness. After the vaccine, he was c/... Read more
Came to Vaccine clinic feeling unwell with headache and lightheadness. After the vaccine, he was c/o feeling unwell with 9/10 HA, lightheadedness, dizziness. He noted that his HA/symptoms had been present for 2-3 days prior and he had been taking ASA without relief. He was HD stable but diaphoretic. Clinic staff administered glucose gel without effect after he stated that he was diabetic and had only eaten a banana all day. Because he continued to report feeling unwell and was ill appearing, EMS was called and the patient was taken to local ER. At local ER he was told his blood pressures were high, and he was given something via IV (unsure what). He reported then that he did not take his blood pressure medication on the date of the vaccine administration because the timing conflicted with the COVID vaccine. He was discharged from ED after four hours and PCP follow up arranged within the week.
59 2021-04-09 chills, headache, influenza like illness, fever Substantial flu like symptoms. Fever. Chills. Body aches. Minor headache. Stayed in bed all day, 04/... Read more
Substantial flu like symptoms. Fever. Chills. Body aches. Minor headache. Stayed in bed all day, 04/09/2021. Felt better and resumed normal life activities the next day, 04/10/2021.
59 2021-04-09 chills, fever Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from ... Read more
Reported cause(s) of patient death: Heart failure; chills; fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 59-years-old, via an unspecified route of administration in left arm on 17Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included congestive heart failure, diabetes, and high blood pressure. He has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included olmesartan medoxomil, furosemide, repaglinide, metformin, amlodipine, atorvastatin, carvedilol, hydrochlorothiazide, and metoprolol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced chills, fever, and heart failure on 18Mar2021. The events resulted in emergency room/department or urgent care, doctor or other healthcare professional office/clinic visit, and hospitalization for 8 days from Mar2021 to Mar2021. He eventually passed away on 31Mar2021. Treatment received for the events was reported as unknown. The patient underwent lab test and procedure which included nasal swab for COVID which was negative on 20Mar2021. The outcome of the events chills and fever were unknown. The patient died on 31Mar2021. The cause of death was heart failure. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart failure
59 2021-04-09 headache, fever Fever of 101.5, headache, vomiting , body aches
59 2021-04-10 chills Woke up at approximately 02;30 the night of the vaccination with chills and I suddenly had a problem... Read more
Woke up at approximately 02;30 the night of the vaccination with chills and I suddenly had a problem breathing, I could take regular size breaths but it seemed like there was no oxygen in the breaths, which made it like hardly breathing at all. This lasted approximately 10 minutes as I was getting ready to wake my wife up and possibly call 911, thinking I would soon pass out, it began to subside and then ended.
59 2021-04-10 headache, fatigue Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday... Read more
Symptoms of mild headache, body ache, fatigue, cold sweat, and nausea and diarrhea began on Saturday afternoon.
59 2021-04-10 malaise Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car... Read more
Patient had the vaccine at 4:03 pm and his 15 minutes was done and the patient left to go to his car. Patient stated that when he got to his car he felt flush and a little light headed. He decided to make his way back up to the front door because he was not feeling himself. When he got to observation we checked his vitals and his blood pressure was 191/104 and his checks were very red. I repeated the blood pressure again at 4:40 pm and it was 167/92, checked at 4:46 pm BP was 155/103, BP at 4:51 was 175/101, BP at 4:59 was 196/107 and then checked it again but this time on the left arm and the BP was 195/108. Patient was transported By EMS to the hospital for further evaluation.
59 2021-04-11 head discomfort After my first shot, my brain has felt fuzzy or foggy and heavy. I have also felt some depression an... Read more
After my first shot, my brain has felt fuzzy or foggy and heavy. I have also felt some depression and weird thoughts (lot #ER 2613). My ears also felt heavy. After my 2nd shot yesterday, I awoke this morning with ringing in my ears and it has not gone away and my brain fog is still there as well.
59 2021-04-11 headache, fatigue, fever Body ache, fever, headache, nausea, tiredness.
59 2021-04-12 headache, chills Late afternoon of vaccine date: Dull headache intensified with chills Evening of vaccine date: Hea... Read more
Late afternoon of vaccine date: Dull headache intensified with chills Evening of vaccine date: Headaches, substantial body aches, chills and and nausea Morning following vaccine date: Dull headache with body aches and nausea Afternoon following vaccine date: Subsiding headache and body aches, nausea 2 mornings after vaccine date: No symptoms
59 2021-04-13 fatigue, sweating Post vaccine patient became diaphoretic- felt dizzy. HR 170. Water given afterwards patient began to... Read more
Post vaccine patient became diaphoretic- felt dizzy. HR 170. Water given afterwards patient began to feel fatigued and have shortness of breath. EMS on site assessed and felt patient needed to be seen at local ED. Patient transported via ambulance.
59 2021-04-14 fatigue, headache Headache & tired
59 2021-04-14 lethargy, fever Joint and muscle aches, low-grade fever, lethargy, loss of appetite, weakness.
59 2021-04-14 fever, chills Chills,it and back pain,fever,
59 2021-04-15 malaise, sweating Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccina... Read more
Pt has hx of vasovagal reaction when getting any sort of immunization/injection. Pt found in Vaccination boot number 1 with healthcare provider. PT had just received his Pfizer immunization. PT stated he wasn't feeling well and needed a moment. Pt then became diaphoretic, pale, cool skins. Paramedic asked patient if we could take him to cot for observation. PT agreed and stood up turned and sat in wheel chair. PT taken to cot and as we arrived pt became unconscious. Pt was unresponsive to verbal and painful stimuli. Pt remained unconscious for approximately 20 seconds. Once patient regained consciousness he was immediately Alert and Oriented x4, skins were pale, moist, cool. pt was carried to cot during his unconscious episode. pt layed down for a while, vitals were assessed at 1556: BP-128/88, HR 64, RR 22, SPO2- 94%. Pt immediately feeling much better and taken to observation for an additional 30 minutes. Pt advised to let us know if he was feeling faint again.
59 2021-04-16 headache, chills Severe headache. Body ache, chills, Temperature up to 101.6
59 2021-04-17 chills, fatigue Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body ac... Read more
Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body aches, chills, shivering, hot and cold flashes. At this time the symptoms have persisted for 30 hours, although the shivering subsided after sleeping through the night. The heavy fatigue and body aches continue however.
59 2021-04-17 chills, fever, fatigue Chills, upset stomach, tiredness and fever 101.1 to 102° starting at 2:30 am April 15 until 12:30 ... Read more
Chills, upset stomach, tiredness and fever 101.1 to 102° starting at 2:30 am April 15 until 12:30 am April 16th.
59 2021-04-17 headache, lethargy, chills, sweating Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, c... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 4/14/21 12:45 pm - vaccination - no issues 11:00 pm - Chills, chattering teeth, nausea 4/15/21 1:00 am - loose bowels, minor headache 8:30 am - Vertigo, unable to stand, collapse on floor, major nausea, dizziness - go straight to bed 8:30 am - 8:30 pm - Sleep off/on entire period, arm pain, drink water, take tylenol, chills, nausea, lethargy 8:30 pm - Midnight - profuse sweating soaking clothes, major headaches, nausea - continue to sleep 4/16/21 Midnight - 6:00 am - Restless sleep, loose bowels at times All day - Awake, tired, occasional nausea. limited appetite 4/17/21 Limited appetite - occasional nausea
59 2021-04-17 malaise Blood vessel bursts in whites of eye; Feeling of pressure on eye; General ill feeling; eye discomfor... Read more
Blood vessel bursts in whites of eye; Feeling of pressure on eye; General ill feeling; eye discomfort; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in right arm, on 24Mar2021 (at the age of 59 years old) at 13:15, as a single dose, for COVID-19 immunisation. Medical history included Colon re-section surgery in 2020 due to diverticulitis. The patient did not have allergies to mediations, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162b2. On 24Mar2021 (at 4:00pm), the patient experienced blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events, blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling, was recovering. Follow-up attempts are completed. No further information is expected.
59 2021-04-18 fever 1- Pfizer vaccine on 4-14-21 @10am monitored family clinic. 2-Thursday 4-15-21 Acute febrile events ... Read more
1- Pfizer vaccine on 4-14-21 @10am monitored family clinic. 2-Thursday 4-15-21 Acute febrile events at 1pm temp 40 degree C. Altered mental status, went to ER. work up included CSF-NL, D/C's on 4-18-21
59 2021-04-19 headache, chills Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blur... Read more
Patient received vaccination at 10:15am, waited 15 minutes, then went to work. Patient reported blurry vision, cold chills, dizziness and stomach cramping beginning 12:30pm. Patient sat down and began experiencing a new onset headache. Patient tried to get up once, sat down, then tried to get up again and reportedly blacked out. Patient was aroused by coworkers at which time was taken to his residence. Patient did not seek treatment. Roughly 24 hours after the event the patient reported still feeling weak and light headed. Patient was urged to seek medical treatment.
59 2021-04-19 fever Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pa... Read more
Fever (102.6 x 48hrs), Mialgia, Nausua, Diahrrea, severe weakness, dizziness, confusion. Abominal pain & cramps. Left upper arm pain. Symptom course lasted total 5 days and completely resolved by Sunday evening(4/18/21)
59 2021-04-20 body temperature increased, fatigue patient developed ~1 week of temperatures to 100 and fatigue, covid tested negative, saw in the offi... Read more
patient developed ~1 week of temperatures to 100 and fatigue, covid tested negative, saw in the office with labs notable for WBC 250. now in the hospital, likely CML but wonder if vaccine set off cytokine cascade that led to his symptoms
59 2021-04-20 fatigue, headache Pfizer-BioNTech COVID-19 Vaccine EUA: 2nd dose Took 5 weeks after 1st dose. Feel very tired, but t... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: 2nd dose Took 5 weeks after 1st dose. Feel very tired, but trouble sleeping; achy, especially headache
59 2021-04-20 headache, fatigue I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dos... Read more
I had minimal reaction to the 1st dose, slightly sore arm at injection site for 3 or 4 days. 2nd dose, I was feeling off by 3:30pm, mild headache and extremely tired. By 5 I was exhausted, and paranoid about a work situation, paranoia is not part of my normal state of being. By 6pm my left upper arm was very painful from shoulder to elbow. Took aspirin and went to bed at 7pm. Woke at 8am Friday with mild headache an very tired, by 10am was back in bed, slept 4 hours, Repeated the Friday pattern for 2 more days. Monday the extreme tiredness and arm pain abated. Tuesday, the paranoia abated. Now just Brain Fogged.
59 2021-04-20 fever Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fev... Read more
Pain on arm and fever stating later in the same day of taking the shot. It last over a day and fever reducer was taken.
59 2021-04-21 chills, fever Both vaccines I received gave me a high fever 103.7 bad bodyaches chills injection site extremely so... Read more
Both vaccines I received gave me a high fever 103.7 bad bodyaches chills injection site extremely sore couldn?t move my arm both shots.Two or three days or times to feel a little better
59 2021-04-21 fatigue 3/28/21 Patient presented to the ED with peakness, poor po intake and diarrhea. In ED, RA pulse ox w... Read more
3/28/21 Patient presented to the ED with peakness, poor po intake and diarrhea. In ED, RA pulse ox wa 88%. Pt was placed on O2 and admitted for COVID pneumonia. He was outside window for Remdesivir. Was started on IV Decadron. He gradually worsened ind required higher O2 concentration. He was proned. Imaging showed worsening infiltrates. ID was consulted and recommended adding Tocilizumab.-administered 4/1. He had significant improvement and was discharged to home on oxygen 2L per NC on 4/2.
59 2021-04-21 sweating Flushing/sweating, shortness of breath. BP 150/83 (pulse 89), 99% O2 sat.
59 2021-04-21 fever, chills Fever, Chills, Generalized body-aches. Frequent burning micturation with hematuria. Treated with an... Read more
Fever, Chills, Generalized body-aches. Frequent burning micturation with hematuria. Treated with antipyretics (max. strength Tylenol), IV antibiotic, and a regime of antibiotic (ciprofloxacin) treatment for 2 weeks. Fever and body-aches have subsided. Some residual discomfort in urinating, but other symptoms have subsided.
59 2021-04-22 headache, fever Headache, confusion, fever, body aches
59 2021-04-23 chills, throat pain pain at injection site started within 24 hours; Chills; sore throat; This is a spontaneous report fr... Read more
pain at injection site started within 24 hours; Chills; sore throat; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided), first dose via an unspecified route of administration, in Arm Left, on 17Feb2021, 01:45 PM as a single dose for COVID-19 immunisation at Workplace clinic. Patient medical history included like elevated cholesterol, blood Pressure, Generalized Anxiety Disorder (GAD). No allergies reported. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced pain at injection site(within 24 hours), Chills(within 24 hours), Sore throat(within 24 hours) on 18Feb2021, 08:00 AM. The events are subsided within the next 24 hours. No treatment received for the events. Outcome of the events were recovered on an unspecified Feb2021. Information about lot/ batch number has been requested.
59 2021-04-24 cough Shortness of breath; wheezing cough; This is a spontaneous report from a contactable consumer (patie... Read more
Shortness of breath; wheezing cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 11:30 as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included etanercept (ENBREL). After the 3rd day (31Mar2021 06:00 PM), patient developed increasing shortness of breath accompanied with a wheezing cough. The treatment was not received. No covid prior vaccination nor covid test post vaccination. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcomes of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-04-24 fatigue extreme tiredness
59 2021-04-24 headache Headache and dizziness followed by red, irritated left eye
59 2021-04-24 pneumonia Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontane... Read more
Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontaneous report received from a contactable consumer. A 59-year-old male patient received, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown and expiry date was not provided), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient reported that he contracted with covid on 25Mar2021 and had double pneumonia. On 25Mar2021, the patient underwent lab test and found positive with Covid-19. The patient wanted to know if he can take the second dose. Information on the lot/batch number has been requested.
59 2021-04-24 fever, headache, fatigue, malaise Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could on... Read more
Became very ill..Extreme fatigue..Nausea, fever bodyaches leg cramps..Threw up from nausea..Could only lay down..Extreme headache and huge reaction from injection site..Blood sugars would not come down..Remained stubbornly high..Sleep...Wake up..have extreme leg cramps and body aches..Made way to bathroom brvause of nausea..Nearly threw up..Ended up just lying on the floor and going to sleep again...Got up ..Went into bedroom. Sip of diet soda..Back to sleep...Finally got up at 3pm...Signs of being able to come through..Was very close to going to Urgent Care but physically would have been too challenging to go...Had food at 10pm ...Slept through 5am...Soreness in arm has become much less..Signs of survival...Seriously have second thoughts about ever having another vaccine in future unless they improve the process...
59 2021-04-24 runny nose, influenza like illness Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the... Read more
Left arm, shoulder, and upper body severe pain. I couldn't lift my left arm. It felt as if I had the flu. Body aches, disorientation, difficulty breathing, severe body weakness, nose running. I used 8hr Tylenol for the pain. I was restless and couldn't sleep Friday and Saturday night. On Sunday, the symptoms began to subside, but the general weakness and disorientation remained.
59 2021-04-25 headache, fatigue 1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutte... Read more
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
59 2021-04-25 headache, fever Headache, Fever, Soreness in body and joints.
59 2021-04-25 fever, headache, malaise, nasal congestion Started not feeling well on Wednesday, April 21st. Have gotten worse and have had a fever (100) for... Read more
Started not feeling well on Wednesday, April 21st. Have gotten worse and have had a fever (100) for the last 2 days. Body aches, head ache, congestion, burning eyes.
59 2021-04-26 influenza like illness Aches and pains; this morning I went and I had a rapid COVID test and it says it tested positive; th... Read more
Aches and pains; this morning I went and I had a rapid COVID test and it says it tested positive; this morning I went and I had a rapid COVID test and it says it tested positive; still felt like had some flu; This is a spontaneous report from a contactable consumer or other non-HCP. A 59-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. Concomitant medications included Aimovig sureclick 70 mg once every 30 days for migraine. Historical vaccine included BNT162B2 (Batch no. EN6208, expiry date Jun2021) on 24Mar2021 for Covid-19 Immunization. Patient stated that he received both doses of Pfizer vaccine shot and about week before of the second shot he started having a aches and pains like a mild flu on 01Apr2021 and so this last, so on Sunday he got the second dose and then still felt like had some flu, aches, and pains. The events were considered non serious. Patient received Tylenol, Every 4 hour twice a day as a treatment of the events. In morning on 13Apr2021, he went and had a rapid COVID test (RT PCR test) which tested positive which was considered serious as medically significant event. Patient had not yet recovered from the events aches and pains like a mild flu and outcome of event, this morning patient went and had a rapid COVID test and it says it tested positive was reported as unknown.
59 2021-04-26 malaise This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfiz... Read more
This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfizer sponsored program. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP534) via an unspecified route of administration, administered in Arm Left, at the age of 59-year-old, on 22Mar2021 08:30, as SINGLE DOSE for covid-19 immunization. Medical history included three strokes, hypertension, diabetes mellitus. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect and had no prior vaccinations within the last 4 weeks. Concomitant medications included metformin taken for diabetes mellitus (has been taking for many years) and losartan taken for hypertension since 2018 (has been taking for about 3 years). On 09Apr2021, the patient was feeling bad and went to the hospital. There he was told that he has had three strokes in the past. The patient was told that one of the strokes was about a month ago (Mar2021). He went to the hospital three days ago. He was not admitted and was sent home. He went back again and was sent home. He was started on Plavix two days ago for stroke. The events required emergency room visit. The patient right now is working and travelling and he supposed to have the 2nd dose of the vaccine on 12Apr2021. He wants to know if he can take it late or what possible that he can do. Outcome of was feeling bad was unknown while the event stroke recovered in 2021 with sequelae.
59 2021-04-26 throat redness Throat tightening (like the beginning of feeling like throat is closing from an allergic reaction); ... Read more
Throat tightening (like the beginning of feeling like throat is closing from an allergic reaction); redness to the left and right of the Uvula.
59 2021-04-28 fatigue Fatigue, Nausea, Dizziness, Body Aches. I couldn't hardly move without being very nauseated, this la... Read more
Fatigue, Nausea, Dizziness, Body Aches. I couldn't hardly move without being very nauseated, this lasted until 4/27. I'm still suffering from dizziness and some fatigue. I took Phenergan and Zofran 8mg to try and combat the nausea.
59 2021-04-28 productive cough, cough He is not sleeping because he is constantly chocking and coughing every second.; having excess mucou... Read more
He is not sleeping because he is constantly chocking and coughing every second.; having excess mucous/ He has fits where he is trying to cough up mucous/ having a mucous coughing spell/He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EM6208), via an unspecified route of administration, administered in Arm Right on 15Mar2021 11:00 (received at 59-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history and concomitant medications were not reported. The patient just got his second Pfizer shot Monday 12Apr2021 10:45 am (lot number: EW0162) administered in Arm Right, and he got his first one on 15Mar2021. He wants to report what he thinks is a side effect. He does not know if it is related or not, but at the end of Mar2021/ beginning of Apr2021, he started having excess mucous. He has fits where he is trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care on 11Apr2021 but decided to go to the ER (emergency room) instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. The chests x-ray was clear with no pneumonia. They are saying it is allergies, but he has never had a reaction like this with mucous. He has been wearing his mask too. He knows the allergy season is supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. They were contributing it to allergies, but he has never had them this way before. He wants to report because he is thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. His GP has him on Sudafed now, Flonase, Allegra, and Benadryl. He has fits at night nothing seems to change. He is not sleeping because he is constantly choking and coughing every second. Last night, 13Apr2021, he finally fell asleep at 3 am and woke up at 9am. They do not want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-29 runny nose, sweating, chills, fever Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweati... Read more
Sore left arm, armpit. Numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing. A runny nose, nausea, fever spiked to 103.7 from a normal of ~97.3 at about the 23 hour mark. As of right now 04/30/21 14:21, 3 days later, still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb.
59 2021-04-30 chills, influenza like illness Chills; aches; fluish; with a knot at the injection site; he felt burning in his injection arm; meta... Read more
Chills; aches; fluish; with a knot at the injection site; he felt burning in his injection arm; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 13Apr2021 as single dose in arm for covid-19 immunization at the age of 59-year-old. The patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunisation at the age of 59-year-old and experienced a little sore on injection arm in Mar2021 and a metallic taste in his mouth on 23Mar2021 with outcome of unknown. The patient medical history and concomitant medications were not reported. The patient felt burning in his injection arm about 10 minutes after injection on 13Apr2021. The patient woke up 14Apr2021 with a knot at the injection site and has been experiencing chills, aches, and feeling overall flu-ish. The patient also reported a metallic taste in his mouth when he got the vaccine on 13Apr2021. The outcome of events was unknown. No treatment information was reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-04-30 chills, influenza like illness Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all ... Read more
Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all day; Chills; Feels like I have the flu; metallicy taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 at 14:00 (Lot number: EW0150, Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy that diagnosed probably 8 years ago. Family history included mother and father are diabetic. There was no concomitant medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 at 15:30 (Lot number: ER2613; Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization, that experienced a sore arm. There were no additional administered vaccines, no prior vaccinations within 4 weeks. Patient experienced a really metallicy taste in his mouth about 10 to 15 minutes after he received the Covid-19 vaccine. On 14Apr2021, the patient reported that he had a knot on his arm at the injection site. He had experiencing an achy feeling joints following the Covid-19 vaccine. His arm was really sore this morning, 14Apr2021, he can't lift his arm up past shoulder height without it hurting, and that when he went to rub his arm to massage the soreness out, he felt the knot in his arm. Patient also hasn't had an appetite all day long, he would think about eating something and it didn't sound good. Patient reported it was very unusual for him not to have an appetite, that he normally loves to eat. On 14Apr2021, patient was experiencing the chills off and on, he also felt like he had the flu. When queried for product details, patient reported that he was going to put his cheat glasses on, that the writing on his vaccine card was like micro writing. No events required a visit to emergency room or physician office. The outcome of events "Knot in arm at injection site", "Achy feeling joints", "Feels like I have the flu" was not recovered, while the other events was unknown. No follow-up attempts are needed. No further information is expected.
59 2021-04-30 cough has fits at night nothing seems to change/ constantly chocking and coughing; has fits at night nothi... Read more
has fits at night nothing seems to change/ constantly chocking and coughing; has fits at night nothing seems to change/ constantly chocking and coughing; excess mucous was reported as worsened; he is not sleeping because he is constantly chocking and coughing every second; Feeling funny; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 12Apr2021 at 10:45 (batch/lot number: EW0162) as a single dose for COVID-19 immunization. The patient has no medical history and no concomitant medications. Historical vaccine included BNT162B2 first dose on 15Mar2021 at 11 am (lot number: EM6208) for COVID-19 immunisation and experienced excess mucous (started at the end of Mar2021 or beginning of Apr2021), has fits where he was trying to cough up mucous and allergies. The patient reported that he just got his second Pfizer shot Monday 12Apr2021, and he got his first one 15Mar2021. He wanted to report what he thinks was a side effect. He doesn't know if it was related or not, but at the end of Mar2021 or beginning of Apr2021, he started having excess mucous. He has fits where he was trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care Sunday 11Apr2021, but decided to go to the ER instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. They were contributing it to allergies, but he has never had them this way before. He wanted to report because he was thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. Her GP has him on Sudafed now, Flonase, Allegra, and Benadryl. They were saying it was allergies, but he has never had a reaction like this with mucous. He has been wearing his mask too. He knows the allergy season was supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. On an unspecified date, excess mucous was reported as worsened. He has fits at night nothing seems to change. He was not sleeping because he was constantly chocking and coughing every second. Last night, he finally fell asleep at 3 am and woke up at 9 am. They don't want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. The patient also experienced "feeling funny" on an unspecified date. The patient underwent lab tests and procedures which included chest X-ray: negative for pneumonia on 11Apr2021; the chests X-ray was clear with no pneumonia. Vaccine was not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. The adverse events excess mucous, cough and not sleeping required a visit to the physician's office. No prior vaccinations (within 4 weeks). The outcome was not recovered for the events "has fits at night nothing seems to change/ constantly chocking and coughing", "excess mucous was reported as worsened" and "he was not sleeping because he was constantly chocking and coughing every second"; and unknown for the event "feeling funny". No follow-up attempts are needed. No further information is expected.
59 2021-04-30 headache, fatigue moderate body aches; fatigue; headache; This is a spontaneous report from a contactable consumer. A ... Read more
moderate body aches; fatigue; headache; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in arm left on 12Apr2021 at 10:30 as a single dose for COVID-19 immunization. Medical history included high blood pressure management. Concomitant medications included atenolol taken for an unspecified indication. Historical vaccine included first dose BNT162B2 on 22Mar2021 at 04:00PM. On 12Apr2021 at 18:00 patient experienced moderate body aches, fatigue and headache. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
59 2021-05-01 influenza like illness Immediately following injection, he developed extreme back pain. He was sent to hospital emergency... Read more
Immediately following injection, he developed extreme back pain. He was sent to hospital emergency room, where his back was iced, for several hours, for the pain. Following that, he was sick in bed, with pain and flu like symptoms, for several days.
59 2021-05-03 fatigue, headache 8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days ever... Read more
8:30 am the day after the vaccine my lower right lip and lower right face swelled. For 14 days every day I had a headache and cramps. Daily fatigue. One day it felt like a giant hand was squeezing me around the chest and back. Random periods of nausea. One day I had overwhelming fatigue, it took every ounce of my strength to lift myself. It felt like something was laying on me pushing me down. Another day my upper right lip and upper right face swelled. Arm hurt at vaccine site. All this went on over a period of 2 weeks. To this day my upper right lip randomly swells.
59 2021-05-03 sweating For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body i... Read more
For around 5-minute duration: - Stomach knot - Sudden strong sweating in the upper part of my body including my forehead, felt very hot - Dizziness Never experienced such symptoms before in my life
59 2021-05-04 cough ringing in the ears flushed face cough dizziness waken at night in a cold sweat
59 2021-05-04 fatigue, malaise Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot... Read more
Extreme fatigue; brain fog; Passed out; Told possible seizure; Felt ill shortly after receiving shot; Threw up; This is a spontaneous report from a contactable consumer (the patient) and then from a contactable consumer (the patient's wife). A 59-year-old male patient received the first dose of BNT162B2 (lot number not provided), via an unspecified route of administration in the left arm on 31Mar2021 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included: fish oil (OMEGA 3 FISH OIL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient felt ill shortly after receiving the shot. Told to sit down. Passed out. Awoke on the floor. Told possible seizure. Sat up. Threw up. Told to lie back down. Ambulance came and took him to the hospital. He spent 90 minutes in the Emergency Room. He was unable to work for a couple of days. He had extreme fatigue and brain fog. He was not back to relatively normal for at least 10 days. Treatment received was reported as yes: ran tests including 3 EKGs, on an unspecified date. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
59 2021-05-04 nasal discomfort This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.
59 2021-05-04 pneumonia Pneumonia, Kidney failure, Sepsis Vent for 2.5 days Steroids, heavy dose of antibiotics - 7 days
59 2021-05-04 fever, chills Shortness of breath Fever Chills Tessalon
59 2021-05-05 headache, fever, cough Cough ? Fever ? Shortness of Breath ? Generalized Body Aches ? Headache Pneumonia due to COVID-19 v... Read more
Cough ? Fever ? Shortness of Breath ? Generalized Body Aches ? Headache Pneumonia due to COVID-19 virus monoclonal antibody infusion IV remdesivir and dexamethasone and also received 1 unit of convalescent plasma.
59 2021-05-05 fever, fatigue Patient had the typical fever/fatigue/body ache/fever But then developed a severe case of ophthalmi... Read more
Patient had the typical fever/fatigue/body ache/fever But then developed a severe case of ophthalmic zoster about 5 days later
59 2021-05-05 fever Fever spiked to 100° briefly, Night Sweats every night for a week, Achy joints worse day 5/2 but st... Read more
Fever spiked to 100° briefly, Night Sweats every night for a week, Achy joints worse day 5/2 but still ongoing, better each day.
59 2021-05-06 cough, fatigue cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increas... Read more
cardiac amyloidosis; Dilated cardiomyopathy (I42.0); left ventricular hypertrophy (LVH); has increased on fatigue; cannot take breath well occasionally on exertion; abdominal swelling; weight gain/ weight had increased from 217 lbs to 227 lbs; dry cough since Covid shot; This is a spontaneous report received from a contactable physician. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 for Covid-19 immunization on an unspecified date. He reported that on 27Mar2021 he got the 2nd COVID Pfizer shot and has increased on fatigue now and cannot take breath well occasionally on exertion, also reported some abdominal swelling, none in legs. He reported weight gain but can la flat and no issues on resting conditions. He also reported dry cough since COVID shot but did not have any of such issues after the 1st dose. No fever, no dizziness or passing out. Diagnosis: Dilated cardiomyopathy (I42.0) -Left ventricular ejection fraction (LVEF) 25-30. Left ventricular hypertrophy (LVH) was diagnosed with cardiac amyloidosis. His weight had increased from 217 lbs to 227 lbs - reported shob but no edema, they discussed increasing furosemide (LASIX) to 40/d from 20 daily for a week and reassess. Also suspect COVID vaccine related immune phenomenon. Treatment received for the events (Dilated cardiomyopathy, Left ventricular hypertrophy, cardiac amyloidosis and weight gain). Events (has increased on fatigue, cannot take breath well occasionally on exertion, abdominal swelling, weight gain and dry cough since COVID shot) onset date was on unspecified date in 2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported cardiac amyloidosis, Dilated cardiomyopathy, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. More information on the patient's medical history, underlying medical conditions would be helpful for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
59 2021-05-06 sweating, malaise Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, n... Read more
Note 01/18/2021 Wife called patient has been ill all weekend. He is pale, passing out, Arhythmia, no fever, no cough, no SOB (but hasn't been doing much either). Was going to have pt seen this am, but spoke with healthcare and wants Pt to go to ER for emergent testing. Called wife back and she was notified. CHEST PAIN, PALPITATIONS, NAUSEA, SOB
59 2021-05-06 fever 4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confir... Read more
4/28/2021-Lower left leg hurting; 4/29/2021-can't put weight on leg; ER visit with doppler to confirm blot clot in calf; ER gave Norco 5-325 mg for pain; fever of 101; 4/30/2021-still can't put weight on leg and fever of 101.8; 5/1/2021-woke up with no pain; clot still there; 5/3/2021-saw primary doctor for ER follow-up on clot; primary doctor confirmed there is a small clot in deep vein and could take up to 6 months for it to dissolve on its own.
59 2021-05-08 headache Headache comes and go through out the day and evening right until sleep. I am not taking any medicat... Read more
Headache comes and go through out the day and evening right until sleep. I am not taking any medication because the headache is bearable
59 2021-05-08 malaise, fever, headache, chills severe upper arm pain for 4 days, fever of 101 for 1 day, feeling unwell for 2 days, headache for 4 ... Read more
severe upper arm pain for 4 days, fever of 101 for 1 day, feeling unwell for 2 days, headache for 4 days, chills and shaking sometimes for 1 day.
59 2021-05-09 sweating, chills, body temperature increased, headache After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm ar... Read more
After about 10 hours, pain at injection site. By 12 hours, pain is considerable, cannot move arm around without wincing. Went to bed and woke up about 3 hours later (e.g. 15 hours after injection). Suffering from full body aches, headache (even my teeth and eyes hurt), chills, uncontrolled shaking, followed by uncontrolled sweating, muscle spasms, nausea, severe pain at injection site, swollen and painful lymph node in left armpit. Little to no sleep that night. In a fog all day Sunday, low grade fever just below 100. Went to bed early (around 8:30pm) with similar but reduced symptoms. Pain at injection site has subsided by now. Shakes and chills are far less but still there. Still sweating, really bad body aches, headache, swollen and tender lymph node under left arm. Challenge sleeping but did a little better. Today, Monday, still in a serious fog. No energy. Other symptoms appear to be subsiding
59 2021-05-10 fatigue, nasopharyngitis Fatigue, severe head cold, weak muscles NO fever,No chills No cough
59 2021-05-11 headache, cough, fatigue, chills Chills, Generalized Body Aches, Cough, Headache, Fatigue.
59 2021-05-11 sweating, headache, chills headache, uncrollable shivering and cold, sweats and weakness
59 2021-05-12 headache, throat pain, runny nose body aches, runny nose, headache and sore throat
59 2021-05-12 headache Painful Rash followed by Shingles diagnosis. 7 days headache, body aches, mostly bedridden.
59 2021-05-13 chills About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting read... Read more
About 13 hours after the shot, at about 12:45 am of 5.5.21,, I had severe shaking while getting ready for bed. This happened while standing up. The shaking was so bad that I could not use my phone to search the side effects. The shaking started to subside after I laid down. Other symptoms after this event: unable to fall asleep for about 4 hours; feeling warm at times, with some minor chills; thirsty during this 4 hour period.
59 2021-05-13 malaise, headache Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizz... Read more
Headache, feeling sick, weakness, swelling at injection site, pain at injection site, diarrhea, dizziness.
59 2021-05-13 throat pain, lethargy February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs... Read more
February 7, 2021 to March 20, 2021: Same evening burning sensation in forehead, muscle aches in legs. Following three weeks: sore throat, 3 weeks laryngitis, shortness of breath, chest and upper respiratory pain, overall lethargy, late February and March: 3 weeks abdominal pains and continuous diarrhea .
59 2021-05-14 fatigue Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain... Read more
Rheumatoid arthritis flare up; Pain in joint involving hand; Injection site papule; Bruising; Sprain; Dizziness; Loss of balance; Sickness; Vision decreased / Bilateral abnormal vision; Blurring of eyes; fatigue; bumps from the injector pen; Pain in extremity / ARM PAIN; This is a solicited report from non-Pfizer sponsored program received from a contactable physician based upon information received by Pfizer from company (21K-163-3820459-00). A 59-year-old adult make received the first dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not provided) as a single dose on 12Mar2021 (at 59-years-old) for COVID-19 immunisation. The patient also started to receive subcutaneous adalimumab (HUMIRA, unspecified formulation) 40mg at an unspecified frequency from an unspecified date for arthritis. Relevant medical history included rheumatoid arthritis, inflammation, high blood pressure, red face, red skin, used cane for walking because he could not walk (before adalimumab), and a loss of hearing in the left ear (one month prior to starting adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included sulfasalazine for inflammation; lisinopril for high blood pressure; and another [unspecified] medication for inflammation. The patient previously received treatment for inflammation with steroids which were not good enough. On an unspecified date in Mar2021, after receiving the vaccine, the patient developed arm pain, it made him tired, he had dizziness, fatigue almost every time, and a loss of balance. The patient had bumps from the injector pen/ Injection site papule, Pain in joint involving hand, bruising, sprain, and sickness. On an unspecified date in Apr2021 the patent experienced bilateral abnormal vision/vision decreased and blurring of eyes. On 09Apr2021, patient received second dose BNT162b2 (solution for injection; Lot EL3302 expiry information not provided) as a single dose. The action taken with adalimumab was unknown. The outcome of the event Sickness was recovered on an unspecified date. The outcome of the events bilateral abnormal vision/vision decreased, blurring of eyes, and fatigue, was not recovered. The outcome of the events pain in extremity / arm pain, bruising, sprain, dizziness, loss of balance, was recovering. The outcome of the events Pain in joint involving hand, Injection site papule, and bumps from the injector pen was unknown. The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of subject product, BNT162B2 vaccine cannot be excluded for the reported events of Injection site papule, Pain in joint involving hand, bruising, dizziness, loss of balance, fatigue and sickness, based on temporal relationship. Based on the information provided by the reporter, it appears unlikely that the subject product contributed to the RA flare and other reported events, which likely represent intercurrent medical conditions. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
59 2021-05-14 headache Severe headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old m... Read more
Severe headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in right arm on 02Feb2021 at 10:30 AM (at the age of 59-year-old) as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks. There was none known allergies. Patient did not have covid prior vaccination. The patient's medical history included type II diabetes mellitus. The patient's concomitant medication (other vaccine in two weeks) included metformin, lisinopril, jardiance, atorvastatin. On 15Feb2021 at 10:15 AM, the patient experienced severe headache. The patient did not receive any treatment for the event. The patient had not tested for covid post vaccination The outcome of the event was recovered on an unspecified date in 2021. Follow-up attempts completed. No further information expected
59 2021-05-14 fever, chills, headache Headache, body aches, low grade temperature, chills and swelling in left arm pit. Body aches, low g... Read more
Headache, body aches, low grade temperature, chills and swelling in left arm pit. Body aches, low grade temperature and chills lasted for 48 hours. Headache lasted for 96 hours. Swelling in left arm pit lasted 8 days.
59 2021-05-14 runny nose, chills, sweating, fever fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left ... Read more
fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left arm, armpit; Numbness/ache in forearm, slight numbness in hand; bad chills; lot of sweating starting that evening and continuing; runny nose; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (Lot Number: EW0170) as 2nd dose, single for COVID-19 immunisation. Medical history included chronic lymphocitic leukemia, Known allergies to environmental. Concomitant medications included atorvastatin; azelastine; fluticasone propionate (FLONASE ALLERGY RELIEF); metformin, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: EW0150) for Covid-19 immunisation on 06Apr2021 in left arm at the age of 59-year-old. The patient experienced sore left arm, armpit, numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing, a runny nose, nausea, fever spiked to 103.7 from a normal of about 97.3 at about the 23 hour mark, since 27Apr2021 21:00. As of right now 30Apr21 14:21, 3 days later, the patient was still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received. Adverse events resulted in Emergency room/department or urgent care. The outcome of events was recovering.
59 2021-05-16 fever, chills Fever 101.7 for a whole day, chills and nausea
59 2021-05-17 fever, fatigue minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; ... Read more
minor injection muscle site tightness & pain; minor injection muscle site tightness & pain; fevers; muscle aches; shortness of breath; lung pain; severe swelling; pain in my neck&shoulders; pain in my neck&shoulders; fatigue; On April 6th, I tested positive for Covid; The patient received the Pfizer unspecified vaccine on the same date (28Mar2021).; This is a spontaneous report from a contactable consumer (patient). This is the 1st of 2 reports, for the 1st dose. A 59 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 13:00 (Lot Number: ER8737) at age of 59 years old as single dose for covid-19 immunisation. The patient received the Pfizer unspecified vaccine (lot number=ER8735, dose number 2, vaccine location=Left Arm) on the same date (28Mar2021). Medical history included restless legs syndrome, poison ivy (severe allergy to poison ivy). Concomitant medication(s) within 2 weeks of vaccination included clonazepam 0.5mg. Reported Event: "I had my first shot in my left arm on March 28th. I only had minor injection muscle site tightness & pain that resonated down my left arm for 2-4 days. On April 6th, I tested positive for Covid (Nasal Swab) and experienced fevers, muscle aches shortness of breath, lung pain, severe swelling & pain in my neck & shoulders which persisted until April 16th. I had a second COVID PCR test on April 16th (Nasal Swab). which was also positive. I also have experienced severe fatigue since the onset of Covid on April 6th with only mild relief coming over the last few days beginning on May 1st." Adverse events result in Emergency room/department or urgent care, patient recovered with lasting effects, and no treatment received for events. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for events was Recovered/Resolved with Sequel(except for Product use for unapproved combination). Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021497277 same patient, same drug, different AE, different dose of vaccine.
59 2021-05-17 respiratory tract congestion, cough, runny nose New loss of taste or smell, and Congestion, or runny nose, cough.
59 2021-05-18 fatigue, headache 1ST Day , severe body aches , tired . 2ND day severe headache , disoriented , could not think clearl... Read more
1ST Day , severe body aches , tired . 2ND day severe headache , disoriented , could not think clearly and very tired. This headache condition has persisted for the last 7 days. At times it is mild and at other times severe . It makes you on edge ,causes loss of focus and disoriented. I rarely ever get a headache , maybe a handful in my lifetime. As of today 5/19/21 @8:40 AM my headache is painful even after taking 2 Tylenol hours ago. i am still dizzy and disoriented and moody. The headache is focused on my front left side , it feels as if someone is sqeezing my head tightly. Today I may go to clinic . Not sure what they will do except say to stay in bed.
59 2021-05-18 fatigue Patient developed renal infarct May 4, 2021. No previous history of thromboembolic disease. He sub... Read more
Patient developed renal infarct May 4, 2021. No previous history of thromboembolic disease. He subsequently developed severe upper chest pain and fatigue with an elevated high-sensitivity troponin I greater than 1000. He had cardiac catheterization on May 17,2021 which revealed nonobstructive coronary artery disease. His inflammatory markers are elevated (CRP, sed rate). He is scheduled for cardiac MRI to look for inflammatory disease of the heart. The patient himself is wondering if these events could be triggered by the COVID-19 vaccine he received.
59 2021-05-18 sweating, chills Chills; Sweats; Muscle pain; Joint pain; Slight less taste sensations; This is a spontaneous report ... Read more
Chills; Sweats; Muscle pain; Joint pain; Slight less taste sensations; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date: unknown) dose 1 via an unspecified route of administration on 20Jan2021 (at the age of A 59-years-old), as single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 27Jan2021, the patient had experienced some chills, sweats, muscle pain, joint pain, and slight less taste sensations. The patient asked it would that still be from the first dose of the vaccine. Patient mentioned that he will call his doctor first then report online. No treatment was reported. The outcome of events was unknown. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
59 2021-05-18 fever Fever, body aches
59 2021-05-19 headache, fatigue 1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following da... Read more
1. (Day of injection) minor headache, pain at injection site; confusion/wooziness 2. (Following day) 30 minutes severe shaking of right hand followed by 30 minutes minor shaking; headache; fatigue, sense of a sharp instrument like an ice pick being pressed hard into the inner surface of my ankles and my lower thighs - but only felt this in one location at a time as it there was a ghost poking me in those locations intermittently with just one ice pick; wooziness; pain at injection site 3. (2 days after injection) morning still had wooziness but subsided by evening.
59 2021-05-19 headache Tetanus RIGHT ear, mild ongoing herd ache
59 2021-05-20 fatigue Patient noted when he removed the bandage after the vaccination, there was a significant amount of c... Read more
Patient noted when he removed the bandage after the vaccination, there was a significant amount of clear fluid tinged with blood between his skin and the bandage. He stated the bandage bubbled due to the volume. He stated the vaccination itself was pretty painful, unlike his other shots. He did not experience the post vaccination side effects of a sore/swollen arm or systemic effects like fatigue, headache, fever or chills. He noted he DID experience arm soreness and fatigue with the first dose. This lack of side effects and the volume of fluid he witnessed when removing the bandage, the patient does not feel he received a full dose. He did not report this to the administering pharmacy for 6 weeks.
59 2021-05-21 headache, chills, fever Passed out; Vertigo; Nausea; felt like he was going to pass out; Lost 12 pounds since getting the se... Read more
Passed out; Vertigo; Nausea; felt like he was going to pass out; Lost 12 pounds since getting the second shot; 103 fever; Severe chills/Shivering uncontrollably; Every inch of body ached; Headache; Low back pain; could barely walk; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in left arm on 09Apr2021 at 17:00 (at 59-year-old) at single dose for COVID-19 immunization. Patient medical history was reported as none. He had a family history of ulcers but he has never had any ulcers but that could maybe be related to the blood in stool. The patient's concomitant medications were not reported. No additional administered vaccines. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in right arm on 20Mar2021 at 18:00 (at 59-year-old) at single dose for COVID-19 Immunization, and experienced soreness in the arms. On 10Apr2021 03:00 (reported as 10 hours after receiving the second dose of the vaccine), the patient had a 103 fever, severe chills, every inch of his body ached, headache, shivering uncontrollably and most of this was just for 2 or 3 days. Patient stated then in Apr2021 (reported as a week ago) he had severe low back pain where he could barely walk. Patient stated then last weekend in Apr2021 he had noticed blood in his stool, this started either on last Thursday (29Apr2021) or Friday (30Apr2021). Patient stated and on Tuesday (04May2021) he started getting vertigo, nausea, and passed out. Caller asked was that common side effects or was this an unrelated virus. For event headache, patient stated for 1 day it was a severe headache and then it was a bad headache for 2 or 3 days but he was still experiencing a headache currently. Patient stated the worst part of the headache he has recovered from but he still had a headache and it has gotten much better. For event low back pain, patient stated the back pain got really severe for a week then it got better then came back and right now it was minor but the severe pain was only for about a week. Patient stated that nausea comes and goes. That was another symptom he has lost 12 pounds since getting the second shot. He still felt like he was going to pass out but only passed out that one time. He still had symptoms that he could pass out at any minute. Patient clarified that he went to the emergency room the day after the second dose of the vaccine when his first set of symptoms started. He had also taken ondansetron hydrochloride (ZOFRAN), dimenhydrinate (DRAMAMINE), and paracetamol (TYLENOL). Patient did not visit physician office but he let the physician know. No relevant tests. The outcome of the event severe chills/shivering uncontrollably was recovered on 11Apr2021, events 103 fever and every inch of body ached were recovered on 12Apr2021, event passed out was recovered on 04May2021; outcome of events headache, low back pain, could barely walk, nausea was recovering; outcome of events blood in stool, vertigo, lost 12 pounds since getting the second shot, felt like he was going to pass out was not recovered.
59 2021-05-21 headache Patient presented with headache rated at 8/10 on pain scale. Pain improved with acetaminophen. Labs,... Read more
Patient presented with headache rated at 8/10 on pain scale. Pain improved with acetaminophen. Labs, CT unremarkable (chronic changes noted on CT. Patient discharged with instructions to notify his PMD of the reaction, but to plan to continue to receive the second dose of the vaccine as scheduled.
59 2021-05-23 cough, fever Vaccine 3/15, 4/8. Admit 5/1. Admit for hypoxia d/t COVID PNA. H/O RA w/interstitial lung disease. I... Read more
Vaccine 3/15, 4/8. Admit 5/1. Admit for hypoxia d/t COVID PNA. H/O RA w/interstitial lung disease. In ER temp 100.1, SpO2 94%. WBC WNL, later elevated. CXR shows interstitial lung disease. Treated w/steroid, dose of convalescent plasma, supportive care, oxygen. Brief History: Patient who presented with the above complaints. Patient with a history of longstanding rheumatoid arthritis who presents to the ER with above-stated symptoms. Patient reports history of chronic dry cough which she attributes to having lung disease related to rheumatoid arthritis. Patient has received both doses of Pfizer COVID-19 vaccine, 2nd dose on April 8th. About 2 weeks ago he started having low-grade fevers with worsening of cough and shortness of breath. Patient was tested at an urgent care center and tested negative for COVID-19. Denies any known sick contacts. No recent travel history. Symptoms worsened about a week ago with persistent fevers, increasing cough and shortness of breath. Patient went to see his rheumatologist and diagnosed with interstitial lung disease this week and referred to see pulmonology. He was monitoring his oxygen saturations at home which have been dropping down to 88-89% on room air that made him come to the ER. Patient tested positive for COVID-19 in the emergency room. CT angiogram of the chest showed no evidence of any pulmonary emboli but evidence of interstitial lung disease bilaterally. He is currently being admitted for hypoxia secondary to COVID-19 pneumonia. Patient denies any chest pain Hospital Course: Patient was admitted. Kept on steroids and oxygen. Seen by Infectious Disease. Got a dose of convalescent plasma This morning he is on room air. Past the walk study. Feeling lot better. Seems to be stable for discharge on oral steroids to finish up the course.
59 2021-05-24 headache Numbness on left hand Headache Overall body aches Nausea
59 2021-05-25 fever low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was va... Read more
low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was vaccinated; difficulty sleeping; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) as a single dose via unspecified route of second dose on 15Mar2021 at 11:30 AM for COVID-19 immunization. The concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) for unknown indications. The Medical history included Ibuprofen allergy. Past medication included BNT162b2 had taken as a single dose via unspecified route of 1st dose on 22Feb2021 at 11:30 AM (lot number: EL3247). Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, 11 hours after dosing patient woke up with low grade fever (99+), pain in joints, muscles and swollen lymph node under the arm that was vaccinated. He had difficulty sleeping the rest of the night and still 22 hours after dosing) had sore muscles. The therapeutic measures taken were not reported. The clinical outcome of all the events were reported as recovering/resolving at the time of report. No follow-up attempts are possible. No further information is expected.
59 2021-05-26 headache The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremit... Read more
The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremity pain, erectile dysfunction and urinary retention. 24 hours prior to presentation he had been experiencing new neck pain/headache. He had no chronic history of these symptoms apart from arthritic pain in both knees and hips.
59 2021-05-28 chills, headache Headache; Brain fog; Stomach cramps; Diarrhea; Chills; This is a spontaneous report from a contactab... Read more
Headache; Brain fog; Stomach cramps; Diarrhea; Chills; This is a spontaneous report from a contactable consumer. This consumer reported for 59-year-old male patient (age at vaccination: 59 Years) received a dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient had headache, brain fog, stomach cramps, diarrhea, and chills which was started 24 hours after vaccination on 27Feb2021. The patient did not receive any treatment for the adverse events. The reporter responded to the query that the reporter became aware of the occurrence on 01Mar2021. The reporter was not the patient in this case and the patient was not a Pfizer colleague. Outcome of the events was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-05-28 fatigue Injection pain, chest pain, tachycardia, fatigue,. nausea and vomitting
59 2021-05-28 fatigue s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past ... Read more
s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.
59 2021-05-28 headache Severe headache
59 2021-05-28 headache Pounding headache; This is a spontaneous reporter from a non-contactable consumer. A 59-year-old mal... Read more
Pounding headache; This is a spontaneous reporter from a non-contactable consumer. A 59-year-old male patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via unspecified route of administration on 04Mar2021 at 10:00(at the age of 59-years-old) as a single dose for COVID-19immunisation. The patient medical history was not reported. The patient had no history of allergies. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 04Mar2021 the patient experienced pounding headache. The patient did not received any treatment. The outcome of the event is not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-05-31 fatigue 3/26/21 Chest pain 1 day after vaccine then shortness of breath with exertion and fatigue. Symptoms... Read more
3/26/21 Chest pain 1 day after vaccine then shortness of breath with exertion and fatigue. Symptoms worsened when at work 3/29/21 so went to ER. Saw PCP 3/30/21 and tests ordered. No change in symptoms. Saw Cardiologist next week 4/6/21 and admitted to hospital for heart catheterization 4/7/21. Cath was negative so was discharged from hospital. Symptoms continued so saw Cardiologist NP 4/28/21 and tests ordered EGD done 5/10/21 and was negative Echocardiogram and AAA sonogram done 5/13/21 and were negative as well Was released to go back to work 5/18/21 Continue to have rare chest pain with exertion that is not as severe now. Shortness of breath and fatigue daily with moderate exertion now
59 2021-06-01 chills, headache, fever Fever; Chills; Muscle aches; Headache; got really sick; This is a spontaneous report from a contacta... Read more
Fever; Chills; Muscle aches; Headache; got really sick; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0173, Expiration date: unknown), via an unspecified route of administration, administered in right arm on 30Apr2021 between 1300 and 1500 hours as 1st dose, single (at the age of 59-years-old) for covid-19 immunisation and stated that he did not had an appointment to receive the first dose of the BNT162B2. Medical history included ongoing high blood pressure diagnosed 5-6 years ago, ongoing high cholesterol, diagnosed 5-6 years ago, spine surgery 3 years ago from an unknown date and unknown if ongoing, knee replacement about a year before spine surgery, whole body hurts all the time (because his collar bone was broken and he was an old man) from an unknown date and unknown if ongoing, both hands operated on from an unknown date and unknown if ongoing, collar bone was broken from an unknown date and unknown if ongoing, little overweight (because he smokes and drinks a lot of beer) from an unknown date and unknown if ongoing, smokes from an unknown date and unknown if ongoing. Patient reported that his weight fluctuates. Concomitant medication(s) included losartan at a dose of 100 mg, once daily taken for high blood pressure from an unspecified start date and ongoing (taking probably 5 years now); simvastatin at a dose of 20 mg, once daily taken for high cholesterol from an unspecified start date and ongoing (taking for 5-6 years); fexofenadine at a dose of 180 mg, once daily taken for allergies from blood pressure medication/blood pressure medication makes him itch from an unspecified start date and ongoing (taking for about 5 years); ergocalciferol at a dose of 1.25 mg, weekly taken for unspecified indication from an unspecified start date and ongoing (taking for about 5 years); oxycodone (taking after his spine surgery) for unspecified indication from an unspecified start date and ongoing (taking on and off for 5 years). Patient had no prior vaccinations (within 4 weeks). On 01May2021 (beginning), patient experienced a fever, chills, and muscle aches. Patient took some Theraflu for fever, chills, and muscle aches and the next day, 02May2021, felt fine. Patient reported that he got the Covid-19 vaccine because he does not want to get sick. Patient never had the flu in his life, and this was probably the first time that he ever had a fever. On unspecified date of May-2021, patient began with headache, about 3 days later after receiving the Covid-19 vaccine and stated that headache was the last side effect he experienced and was the worst side effect and stated headache lasted about a day. On unspecified date of 2021, patient got really sick off the first dose of the Covid-19 vaccine. Patient had no emergency room and physician office visit. Patient was scheduled to get the next one on Thursday, 20May2021. Patient reported that he had to go out of town for a family emergency and inquired if it matters if he reschedules the second dose of the Covid-19 vaccine or does it have to be on that date, 20May2021. Patient stated that his doctor and everyone else was telling him that he should get the Covid-19 vaccine. The outcome of the got really sick was unknown, headache was recovered on unspecified date of May-2021 and recovered for rest of the events on 02May2021. Information on Lot/Batch number was available. Additional information has been requested
59 2021-06-01 fatigue, headache Headache; Fatigue; This is a spontaneous report from a contactable physician. A 59-years-old male pa... Read more
Headache; Fatigue; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021(at the age of 59 years old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient does not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Unknown) via unspecified route of administration in left arm, administered on 05Mar2021 at 12:00 for covid-19 immunisation. On 27Mar2021 at 13:00, the patient experienced headache and fatigue. No treatment was received for the adverse events. The reporter classified the events as non-serious. The outcome of the events was resolving. Follow-up (11May2021) was processed as non-significant: No new information was reported. Follow-up attempts completed. No further information expected.
59 2021-06-01 fatigue, fever This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 25Feb2021 13:30 (at the age of 59-years-old) as first dose, single dose for COVID-19 immunization. Medical history included severe case of COVID-19 in which the patient spent 21 days on a ventilator from 2020 (spring) to an unknown date; hypertension from an unknown date and chronic health conditions (resulted from severe case of COVID-19) from 2020, both unknown if ongoing; and rash which was experienced with the disease (severe COVID-19) from 2020 to an unknown date. Concomitant medications included galcanezumab gnlm (EMGALITY), amlodipine, tamsulosin hydrochloride (FLOMAX), metoprolol and nystatin (STATIN); all were taken for an unspecified indication, start and stop dates were not reported. No other vaccine was given to the patient in four weeks. The patient was not tested for COVID post vaccination. The patient has no known allergies. On 25Feb2021 18:00, the patient experienced fever of up to 102.2 degrees for four days, a recurrence of a rash that the patient experienced with the disease, joint pain, fatigue, and issues with his dexterity reminiscent of when he had the virus (prior to being hospitalized). Therapeutic measure, paracetamol (TYLENOL), was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 102.2 degrees (fever) on 25Feb2021 and COVID-19 test: Positive on 2020. The outcome of the events was recovering. The patient wanted to known if he should take the second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-06-02 body temperature increased Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started ... Read more
Received vaccine on 3/26/21 by 3/27/21 in the afternoon, arm became real sore. On 3/28/21 started running a 102 temp with body aches, by 3/29/21 whole arm was sore and that night moved into the chest area. In the middle of the night pain was unbearable and took him to hospital where we were told he was having a heart attack. Transferred him by ambulance to Regional hospital.
59 2021-06-02 fatigue, headache, respiratory tract congestion, cough Developed muscle aches, fatigue, cough, congestion, and mild headache on 5/26/2021. Tested positive ... Read more
Developed muscle aches, fatigue, cough, congestion, and mild headache on 5/26/2021. Tested positive for COVID on 5/28/2021, with SARS CoV2 RNA NP swab. Advised to go to the ED, with regard to history of Asthma with respiratory manifestation of COVID. Went to the ED, and administered Decadron IV, vitals monitored, EKG and CXR performed, and labs drawn. Labs showed mild anemia, a low WBC, and Lymphcytopenia. Normal EKG and CXR. Given Prednisone orally for 5 days, Zithromax Z-Pack, and Ivermectin 5 day oral course. Returned to the ED on 5/31/2021 for administration of IV monoclonal antibody infusion and repeat Labs/Vital sign evaluation. Remain on 10 quarantine up to today, with ongoing mild SOB and cough unremitting.
59 2021-06-02 headache, fatigue fatigue; upset stomach; Still experiencing headache; This is a spontaneous report from a contactable... Read more
fatigue; upset stomach; Still experiencing headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 08Mar2021 at 08:00 as 2nd dose single for covid-19 immunization. The patient previously received first dose of BNT162B2 on 15Feb2021 via unspecified route, administered in right arm on 15Feb2021 as 1st dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included Losartan for blood pressure and Multivitamin Active. On 09Mar2021, after the second dose of Covid-19 vaccine, the patient experienced headaches for a week. He heard of 24-36 hours, but this is dragging. On 11Mar2021, the patient experienced upset stomach and fatigue The outcome of the events Still experiencing headache and upset stomach were not recovered and fatigue was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
59 2021-06-03 chills, fatigue, fever Soreness/Body aches; Feverish; Chills; Fatigue; This is a spontaneous report from a contactable cons... Read more
Soreness/Body aches; Feverish; Chills; Fatigue; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 59-year-old male patient received BNT162B2 (COVID 19, Pfizer BioNTech, Solution for injection) via an unspecified route of administration, administered to his left arm on 05Mar2021 01:30 PM (at the age of 59-year-old) as single dose for Covid-19 immunisation. The patient's medical history included blood pressure. Other medications in two weeks: blood pressure, anti-acid. No known allergies. No Covid was tested prior or post vaccination. The patient previously took BNT162B2 (Pfizer BioNTech) to his left arm on 13Feb2021 as single dose for Covid-19 immunization (other vaccine in four weeks). On 05Mar2021 03:30 PM, the patient experienced soreness, feverish, chills, body aches and fatigue. The patient did not receive any treatment in response to the events. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-06-03 fatigue, headache onset of fatigue, headache, within hours of vaccine, difficulty with concentration, cognition, memor... Read more
onset of fatigue, headache, within hours of vaccine, difficulty with concentration, cognition, memory, headaches 1 month after vaccination
59 2021-06-06 fever facial swelling, muscle aches, shortness of breath, fever
59 2021-06-07 fatigue, malaise Malaise; Tiredness; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-year-... Read more
Malaise; Tiredness; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 25Jan2021 (at the age of 59-years-old) as a single dose for Covid-19 immunization in hospital. The medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2, Covid-19 immunization and experienced injection site pain, tiredness, headache, chills and nausea. On an unspecified date, the patient experienced malaise and tiredness. The patient relevant tests were none. The treatment was included Acetaminophen 1gm (oral) on 04Jan2021 prior and after the vaccination. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
59 2021-06-08 cough Patient had breakthrough COVID-19 infection requiring hospitalization, presenting with 4 day history... Read more
Patient had breakthrough COVID-19 infection requiring hospitalization, presenting with 4 day history of cough and diarrhea.
59 2021-06-08 fatigue Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in... Read more
Starting on the day of the vaccine (2nd dose)- I felt "a warm, chemical and electrical sensation" in my chest a few hours after the vaccine. The next morning, I was unable to have a bowel movement, when usually I am very regular. I was not able to have a bowel movement for a couple of days. I felt very constipated and would try to force myself to have a bowel movement. I ate more fiber and fiber pills and drink more water, which was uneffective. I was finally able to have a bowel movement but it took a lot of force and would push the point of exhaustion and almost passing out. On 2/19/2021, I decided to seek medical care for my constipation, stomach cramps, fatigue, difficulty concentrating and shortness of breath. The doctor diagnosed me with Covid long hauler (I had a previous covid infection in 11/2020). I was prescribe probotics (for constipation) and rest for 2 months. I am still feeling fatigue and having heart palpitations. They order ECG(normal) and blood work (normal).
59 2021-06-09 fatigue Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has no... Read more
Left ulnar neuropathy. Tingling in fingers and fatigue in arm. Soreness at injection site. Has not subsided.
59 2021-06-09 fatigue Beginning two days after the vaccination, dizziness, joint pain, difficulty falling asleep, difficul... Read more
Beginning two days after the vaccination, dizziness, joint pain, difficulty falling asleep, difficulty concentrating, difficulty with balance. Symptoms became less severe slowly over 2 months. Currently, 6/10/21, symptoms are dizziness, difficulty concentrating, fatigue, stuffiness in left ear, and some difficulty falling asleep. Below, you ask about disability. I don?t know yet.
59 2021-06-09 headache blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontan... Read more
blood pressure was elevated; a migraine like headache; persistent severe headache; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Apr2021 (Lot number and Expiry date was not reported) as 2nd dose, single dose for COVID-19 immunisation. Medical history included ongoing body mass index increased. The patient's concomitant medications were not reported. The patient received first dose of vaccine on an unspecified date for COVID-19 immunisation. History included he does not really take anything. He has had some injuries lately but that is not a medical condition. On 20Apr2021 the patient experienced a migraine like headache, on an unspecified date the patient experienced blood pressure was elevated. He has had a persistent severe headache which sometimes feels like a migraine since receiving the vaccine. She was concerned because his MD has never heard of a headache lasting this long (approximately 3 weeks) after the vaccine. She wants to know if this has been reported before. The migraine like headache from what caller's husband said was it started in the evening. He had the vaccine in the morning, but caller was a little fuzzy on that because they did not go together. By evening, he had a dull headache that got worse. He has headache ever since. He went to the doctors a week ago and they checked his blood pressure and did all kinds of things. They did say they thought there was a chance it was the vaccine even thought they had not heard of it lasting that long. This week, yesterday, they took him to the ER to get an evaluation and it just will not stop. The family doctor did full blood workup and everything was in normal ranges. They took his sugar and protein that tells you hydration. His blood pressure was elevated. When he went to the ER, caller things they repeated the screenings. They did carbon monoxide testing, CAT Scan, and Chest x-ray. Everything came out good or, well, it was negative. They want him to see a neurologist. They hooked him up to an IV and they tried to relieve the pain with a headache cocktail and it did not take the edge off of it. So, they are a little baffled by that. Caller does not know specific dates, times, or results. Caller states she does not know what the medications were, maybe it was Toradol was one thing she heard, and they also gave him Benadryl with it. They said it was something they give to people with migraines and it takes it out and helps them sleep. He usually does not take anything but she got him to try allergy medicine, a couple days of Excedrin, and a couple of days of other things. None of them seem to work. He told the ER and they said if it does not work, do not take it. Also, he took Aleve a couple of days. Caller does not have any of this information as she is at work, and she states she did buy all of them. He tried name brand Aleve, Allegra for about 3 days, generic Excedrin which she thinks was Ibuprofen, and Tylenol. Caller confirms her husband was not admitted to the hospital, they sent him home with a referral to follow up with neuro and not the family doctor, and to come back if it gets worse. Today he was supposed to call them. Caller's husband was at the ER yesterday, 09May2021. A CAT Scan showed no mass or anything. They gave him several different things to relieve the headache and nothing worked. The outcome of the events was unknown. Information on the lot/batch number has been requested.
59 2021-06-10 headache, pneumonia E87.1 - Hypo-osmolality and hyponatremia J18.9 - Pneumonia of both lungs due to infectious organism,... Read more
E87.1 - Hypo-osmolality and hyponatremia J18.9 - Pneumonia of both lungs due to infectious organism, unspecified part of lung WEAKNESS - GENERALIZED HEADACHE multiple hospital admissions
59 2021-06-10 headache got very sick; I thought I was having an anaphylactic reaction, i have a nut allergy, but my face ne... Read more
got very sick; I thought I was having an anaphylactic reaction, i have a nut allergy, but my face never got swollen; woke up with bad headache; terrible asthma attack; This is a spontaneous report from a contactable consumer or other non hcp (Patient) reported himself that. A 59-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Batch/Lot Number: EN6204, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 at 17:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patent medical history included asthma he hasn't had a bad asthma attack like this since he was 5yrs old and Nut allergy. Patient Concomitant medication included Trospium Chloride. After the First 1st dose on Friday (12Mar2021) and 5-6hours later at around 11:30pm he had a terrible asthma attack, he had difficulty breathing, it started out with a cough then wheezing that kept getting worse, he did not have an inhaler that was not at least 10yrs old. He was lying down, so he sat up and that helped him. he didn't' want have the ambulance come over or take him to the hospital because it's too expensive and he don't have insurance. He thought he was having an anaphylactic reaction, like the caption drive ship in the storm. So, he sat up for 2 hours because I could not lie down could not breathe when he lies down. So, he sat up and pulled for breath and he had a terrible asthma attack, terrible wheeze, and coughing. If he would have started to get blotchy and swollen, then he probably would have call back the ambulance. He called the information for the number, hospital, they gave me the neurology department in the hospital for whatever reason he does not know. Then he called the police station and then googled phone number for the hospital that does not work anymore, and he could not call the hospital then he called the police station they tell him not to keep following. That is quite alright he had that Covid shot if he dies overnight then you can document what he told but he did not die overnight because he is feeling better, but the question is has not had an asthma attack like that since he was like 5 years old. The outcome is Unknown for all the events Response: Unable to determine how someone will react to 1st or 2nd dose. Referred to HCP on recommendations for 2nd dose.
59 2021-06-14 fatigue Carditis, vertigo, dizziness, shortness of breath, extreme fatigue, restless leg syndrome
59 2021-06-15 fatigue, chills bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressu... Read more
bad chills; shaking; Fatigue for 2 days; higher than normal sleeping heart rate; higher blood pressure; workouts much more difficult.; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male consumer reported that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 03Feb2021 at 14:00 (at the age of 59-years-old) at single dose for COVID-19 immunization. No other medications in two weeks. Medical history included high blood pressure. After receiving the second shot, bad chills and shaking that night. Fatigue for 2 days. For the next month, higher than normal sleeping heart rate, higher blood pressure, workouts much more difficult. No treatment received. Outcome was Recovering. No Covid prior vaccination and no Covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-06-15 lethargy Vaccinated at 3:10 pm. Went for a walk at about 5pm for 40 minutes. Resting heart rate that day was ... Read more
Vaccinated at 3:10 pm. Went for a walk at about 5pm for 40 minutes. Resting heart rate that day was 55. O2 was 98%. For the walk my average heart rate was 98. AM BP reading was 87/55. The longer I walked the more I felt a mental fogginess. By the end I could not even remember prayers I have known my entire life. Yes, I was praying or trying to. I honestly wondered if I was having a stroke. I got home and rested and it seemed to go away. I walk every day and for the next 7 days I had the same effect, but to a lesser degree each day. I got the first dose on March 18, 2021. Lot number 2613. Same location. Just felt lethargic and run down for 3-5 days.
59 2021-06-16 fever, chills, fatigue Mild fever (99.7); chills; fatigue; This is a spontaneous report from a contactable consumer (patien... Read more
Mild fever (99.7); chills; fatigue; This is a spontaneous report from a contactable consumer (patient) A 59-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 11:00 (Batch/Lot Number: unknown) as single dose (at the age of 59) for covid-19 immunisation. Medical history was none. Concomitant medications included atorvastatin calcium (LIPITOR) taken for an unspecified indication, omeprazole (PROTONIX) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced mild fever (99.7) on 17Mar2021 01:30, chills on 17Mar2021 01:30, fatigue on 17Mar2021 01:30. No treatment received for the adverse events. The patient recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
59 2021-06-17 fatigue, sleepiness, fever lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things ... Read more
lost so much weight; there it inflamed the places where you have bumps; dry skin; had fungus things push under the nail; fever, says 98.6 is about a half point to a point high; passed out; dead for a while; Itching; Stomach a little bit bad/Sick to his stomach; Really, really tired; Brain is scrambled a little bit/Brain things get a little not right/Brain things get a little not right/Fogged up a little bit more lately/ Feeling kind of crummy/ Feeling a little bit bad; Dry mouth; Judgement is off; Falling a bunch of times; Slept and slept and slept; This is a spontaneous report from a contactable consumer reported for himself. This 59-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Deltoid on 13May2021 (Lot Number: EW0167; Expiration Date: Aug2021) at single dose for COVID-19 immunisation. Medical history included ongoing cardiac failure, ongoing hypoxia (Hypoxia, brain injury), Kidney problems , ongoing myoclonus (he has several different things, says stuff comes from the brain injury, and from medicines they gave him), hepatitis C (he had treatment for Hepatitis C when it first came out, says it's cleared up and has never had bad liver function. States he was diagnosed 15 years ago), ongoing attention deficit hyperactivity disorder (ADHD, combined type), ongoing ventricular fibrillation, ongoing gastrooesophageal reflux disease (GERD, he has had GERD all his adult life), ongoing back pain (chronic back pain, he has had chronic back pain since he was about 15). Handicapped/ disabled, depression, heartburn and acid reflux, cardiomyopathy, pain, urine flow decreased. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN (E.C.)) taken for cardiac failure, he has been taking this medication for years; ongoing atorvastatin (LIPITOR [ATORVASTATIN]) as heart medicine, he has been taking this medication for years; ongoing clonazepam (CLONAZEPAM) taken for brain injury; ongoing escitalopram oxalate (LEXAPRO) taken for depression, he has been taking this for 25 years; ongoing esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for heartburn and acid reflux; ongoing furosemide (FUROSEMIDE) taken for heart failure and fluid, he has been taking this somewhere between 5-10 yrs; ongoing isosorbide mononitrate (ISOSORBIDE MONONITRATE), he doesn't know what he takes these for, something for added heart; ongoing levothyroxine sodium (SYNTHROID) taken for thyroid disorder; ongoing losartan (LOSARTAN) taken for cardiomyopathy; nystatin (NYSTATIN), he doesn't know why he takes this, says it's probably for his heart; ongoing primidone (PRIMIDONE); ongoing promethazine (PROMETHAZINE); ongoing spironolactone (SPIRONOLACTONE); ongoing trazodone (TRAZODONE) taken for sleep disorder, he uses it as a tranquilizer, uses it for pain, they say he's a drug seeker and won't give pain medicine.; ongoing morniflumate (FLOMAX [MORNIFLUMATE]) taken for urine flow decreased. The patient experienced passed out on May2021 with outcome of unknown , dead for a while on May2021 with outcome of unknown, itching on May2021 with outcome of recovered in 2021, stomach a little bit bad/sick to his stomach on May2021 with outcome of recovered on May2021, really tired on May2021 with outcome of unknown, brain is scrambled a little bit/brain things get a little not right/brain things get a little not right/fogged up a little bit more lately/ feeling kind of crummy/ feeling a little bit bad on May2021 with outcome of recovering , dry mouth on May2021 with outcome of recovered in 2021, judgement is off on May2021 with outcome of recovered in 2021, falling a bunch of times on May2021 with outcome of recovering , slept and slept on May2021 with outcome of unknown, lost so much weight on unspecified date with outcome of unknown, there it inflamed the places where you have bumps and dry skin on unspecified date with outcome of unknown, had fungus things push under the nail on unspecified date with outcome of unknown, fever on unspecified date with outcome of unknown. The clinical course was reported as follows: This past week he has been feeling kind of crummy, says he's disabled, and can lose track. He says his brain is scrambled a little bit since he got hit, says he passed out, was dead for a while, states that affects him quite a bit, and he says he loses track. He says when he tells about that, he didn't know he got the first shot and it had a little place that hopes it didn't mess up. He states he put on small wounds, corcetin. States when they did the shot, says usually they'll make you hold, ask you to hold the cotton ball in place, says they get a Band-Aid on tight and push down, says they put compression so it doesn't leak. He states this was loose when he got home, it was leaking like a little bubble, a little fluid. When he washed it, he washed it off. Right close to it, there were two other places. He states when they gave him some steroid cream, he put that on there it inflamed the places where you have bumps and dry skin and a cut and looks like a little cut. Says when he put cream, it got inflamed and angry. He stated he was watching Dr, and when she calls it a cyst or something is infected, she calls it angry. He says there was a bunch where they put the Band-Aid, and he put just a dab of corcetin, believe that's what he had when he put, took it off the first time, and it had two bigger places that were a scab. He says once he put 2 by 3 Band-Aids and left it on for a couple of days, says he did this several times since last year or two, says to try to clear some of this stuff up, don't scratch, says he did get an itch in that location when he got the shot. He didn't scratch, said he wanted to pull Band-Aid off and scratch but didn't do it. He says it cleared up but he's been feeling a little funny, just maybe a little sick to his stomach, dry mouth, stuff like that. He says he didn't think it's a problem, says he had that problem like after 3, 4, or 5 weeks and all of a sudden he has a little episode where he gets to feeling funny, says his judgement is off and the brain things get a little not right. He stated he then fell a lot, says he's been falling a bunch of times in the last week, he'll feel better and it won't bother him. He says it's a cycle he's gone through since he lost oxygen. He doesn't think it's anything, it's confusing, says it has so many symptoms, and when he read this it has so many symptoms. Confirmed patient was referring to COVID vaccine. He states he hasn't had eczema then most of it, sometimes he'll scratch, it will build up like a scab and he'll scrape it off, put some of the ointment on there. but a band aid on top, leave it down for a couple of days, after a shower, a couple of showers, it comes off. He says it clears it up, says if it doesn't, just wash, wash it hard, it scrubs the scab off. He states the worst thing he had was his toenails, he had to work on them, had fungus things push under the nail, under the side, and he cut it. He used cortisone 10 on it, says they always quit making something that works well, states you know how you get a yellow toenail. He says he's been putting Neosporin on it. Clarified corcetin is Cortizone 10, it is pretty strong stuff. He says he puts it on these places on his arm using Neosporin. Attempted to clarify that itching began after use of Cortizone 10, states nothing like that, says it did itch a few days after still a little bit, there were three little places under that Band-Aid where they put the shot. He ended up putting Neosporin right when he took that band aid off it was itching, says he washed it good, then put Neosporin on it, says it's cleared back up to its normal roughness. For event itching, he states at first it was almost a scab, but it was not quite a scab, it was wet like a little bubble. After the scab, when he got ready to take, it was itchy after the band aid was on there a couple of days, he took a shower, washed it, and put more ointment on it. Each time he took the Band-Aid off, he washed it, washed his arm, and put the Band-Aid back on. He did the same again and it's gone away. He states he is feeling a little bit bad, his stomach is a little bit bad. He hadn't checked it lately, when he gets a fever, says 98.6 is about a half point to a point high. He was really, really tired, says he slept and slept and slept. Says this is similar to the cycle that he goes through with his brain injury, says it's the same cycle he goes through. He also stated he lost so much weight laying in bed.
59 2021-06-18 fatigue Symptoms: Chest pain radiating to neck starting on June 4, 2021 with fatigue and slight shortness of... Read more
Symptoms: Chest pain radiating to neck starting on June 4, 2021 with fatigue and slight shortness of breath Seen at Urgent Care and sent to Hospital and found to have PERICARDITIS and PERICARDIAL EFFUSION. Given medications and hospitalized for 24 hours.
59 2021-06-22 fatigue Five days after receiving his second dose of the Pfizer Vaccine, my husband began to occasionally e... Read more
Five days after receiving his second dose of the Pfizer Vaccine, my husband began to occasionally experience mild jabs of pain in his heart. At the time, he thought little of it. Two days later, Pt developed an irritating skin rash in the lower region of his left shoulder blade. A day later, the rash had spread to include the left side of his torso, beneath his left arm. Now, 7 days since the onset of symptoms, Pt jabs of heart pain are sharper and more frequent and the rash has intensified in its appearance and irritation. Additionally, my usually super-active, mountain-bike-riding husband has become quite fatigued. In other words, Pt has what appears to be a classic case of SHINGLES. And, since Pt overall health has been excellent throughout his 59 years of life, we wondered if the vaccine might be responsible for having triggered his shingles outbreak. We thought it important to report this possible correlation, just in case.
59 2021-06-22 headache On third day after injection I had an achy head and ringing in my ears for two full days. On fifth... Read more
On third day after injection I had an achy head and ringing in my ears for two full days. On fifth day I felt normal myself. No after affects since. Have full hearing capabilities.
59 2021-06-24 chills, fever, pneumonia, cough High Fever; chills; cough; vomiting; Pneumonia; This is a spontaneous report from a contactable cons... Read more
High Fever; chills; cough; vomiting; Pneumonia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23May2021 18:00 (at the age of 59 years old), dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the has not patient been tested for COVID-19. On 26May2021 15:00, the patient experienced high fever and chills, cough and vomiting. He reported to his doctor. Chest x-ray on 09Jun2021 showed Pneumonia. Pneumonia was reported to have lasted more than 30 days and not getting better. A CT scan was done on 09Jun2021 and waiting for report (unknown results). The adverse events resulted in doctor or healthcare professional office/clinic visit. The adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.
59 2021-06-24 headache sick; throwing up; Diarrhea; Headache; feet and legs swollen, left worse than right; he couldn't wal... Read more
sick; throwing up; Diarrhea; Headache; feet and legs swollen, left worse than right; he couldn't walk; fell; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 24Mar2021 in between 10:00 to 11:00 as 1st dose, single(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported patient had no prior vaccinations. The patient has been sick with vaccination, and experienced throwing up, had diarrhea, a headache, and did not realize that when he started walking around that it was doing the damage it was doing until he figured out he couldn't walk, states one of the days, exact date not provided, he got out of bed one day and fell to the floor, states then he realized what happened, states it has been going on for a good while, states his feet and legs swollen, started about 4 weeks ago, exact start dates of all events unknown. States he can hardly walk due to the swelling. States they gave him a medication for the diarrhea, exact name unknown. Patient was not hospitalized and no hospital stay. No Investigation Assessment. Therapeutic measures were taken as a result of diarrhea. Patient was recovering from throwing up, been sick and outcome was unknown for feet and legs swollen, left worse than right, unable to walk, fell, and not recovered from rest of the events. Follow-up attempts are possible. Further information is expected.
59 2021-06-24 throat redness Tightening in throat (like the beginning of throat closing due to allergy); Redness inside throat.; ... Read more
Tightening in throat (like the beginning of throat closing due to allergy); Redness inside throat.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm as a single dose on 22Apr2021 at 09:15 (at the age of 59-year-old) for COVID-19 immunisation. The medical history included seasonal allergies, allergic to horses, cats and hay. The patient previously took cherries, peaches, nectarines, plums, kiwi, melon, cantaloupe, raw nuts and raw carrots (as reported). Concomitant medication included famotidine(PEPCID) for an unknown indication ,fexofenadine(ALLEGRA)for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient has not tested positive for COVID-19 since vaccination. The patient experienced tightening in throat (like the beginning of throat closing due to allergy) and redness inside throat on 23Apr2021 at 01:00. The patient took antihistamine ALLEGRA as treatment for reported events. The clinical outcome of the events tightening in throat and redness inside throat were recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
59 2021-06-25 fever, headache Symptoms immediately started on Sunday, June 20, 2021. These effects are exactly like Walking Pneum... Read more
Symptoms immediately started on Sunday, June 20, 2021. These effects are exactly like Walking Pneumonia: fever, headache, muscle & bone aches, no appetite (have not eaten a full meal since that Sunday), no bowel movement, 18 hours of sleep per day, with constant run on nightmares that make me feel as if I am going insane. I have no mental health issues whatsoever. I will not drive since my brain is clouded. This is affecting my school time since I cannot focus because of this vaccine. I will not lose earning my degree over experiment.
59 2021-06-25 fever Pt received dose #2 of Pfizer-BioNTech COVID-19 vaccine on 6/26/2021. Pt had a witnessed seizure at ... Read more
Pt received dose #2 of Pfizer-BioNTech COVID-19 vaccine on 6/26/2021. Pt had a witnessed seizure at home shortly therafter. No history of seizures in the past. Pt admitted to the hospital and later noted to be febrile to 102.5 degrees F. Currently undergoing work-up for infection.
59 2021-06-26 headache Tinnitus increased greatly after 2nd shot, within the same day. Tinnitus is still very bad 2 months... Read more
Tinnitus increased greatly after 2nd shot, within the same day. Tinnitus is still very bad 2 months after shot. Slight headaches started within a week of 2nd shot, would happen a couple time a week. After two months they have mostly gone away. Moderate Short term memory loss started after 2nd shot. This has greatly improved after 2 months.
59 2021-06-27 headache Stroke like symptoms, severe headaches, elevate blood pressure, tingling and numbness around mouth, ... Read more
Stroke like symptoms, severe headaches, elevate blood pressure, tingling and numbness around mouth, right side of body was sore and numb, right side of neck was sore
59 2021-06-27 runny nose Sore and tightness in left side of neck, running nose, running eyes, tingling in side of mouth, havi... Read more
Sore and tightness in left side of neck, running nose, running eyes, tingling in side of mouth, having trouble walking, unbalanced
59 2021-06-28 fatigue Bodily fatigue lasting until 6/28/2021. I had to make myself get out of bed each morning because I f... Read more
Bodily fatigue lasting until 6/28/2021. I had to make myself get out of bed each morning because I felt exhausted, even after 9 or more hours of sleep. I normally function best with 7.5-8 hours of sleep.
59 2021-06-29 chills, fever, fatigue body aches; fatigue; Fever up to 101; cold chills; This is a spontaneous report from a contactable c... Read more
body aches; fatigue; Fever up to 101; cold chills; This is a spontaneous report from a contactable consumer (reported for himself). A 59-year-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EM9810), dose 2 via an unspecified route of administration, administered in arm left on 03Feb2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation at Hospital. Medical history included enlarged prostate elevated psa ongoing since 1990, hypertension ongoing since 2001, diabetes mellitus ongoing since 2019, blood cholesterol increased ongoing since 2019, prostatomegaly ongoing since 2019, cardiovascular disorder, arthropathy, immune system disorder, cardiac disorder and product communication issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. Concomitant medications included rosuvastatin tablets, metformin tablets, hydrochlorothiazide tablet, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) capsule ongoing since an unknown date for health, amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) capsule, curcuma longa (TURMERIC) ongoing since an unknown date for cardiovascular disorder, arthropathy, immune system disorder, fish oil (FISH OIL) ongoing since an unknown date for cardiac disorder and serenoa repens (SAW PALMETO) ongoing since an unknown date for prostatomegaly. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 at 13:30 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation at Hospital. On 04Feb2021 at 14:00, the patient experienced fever up to 101, cold chills, fatigue and at 14:30 body aches. No treatment was given for the events. The patient underwent lab tests and procedures which included covid-19: negative on 20Nov2020 and body temperature: up to 101 on 04Feb2021. The outcome of the event body aches was resolving, and remaining events were resolved on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.
59 2021-06-30 chills, headache AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine;... Read more
AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering. Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Committees, and Investigators, as appropriate.
59 2021-06-30 headache Feet and legs swollen, left worse than right; Started walking around that it was doing the damage it... Read more
Feet and legs swollen, left worse than right; Started walking around that it was doing the damage it was doing until he figured out he couldn't walk; Sick; Throwing up; Diarrhea/Diarrhea was reported as worsened; Headache; Got out of bed one day and fell to the floor; Blood clots in both legs; This is a spontaneous report from a contactable consumer (the patient). A 59-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0153), via an unspecified route of administration, administered in right arm on 14Apr2021 (at the age of 59-years-old) at hospital as a single dose for COVID-19 immunisation. The patient's medical history and his family history were reported as none. There were no concomitant medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in right arm on 24Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation and experienced sick, headache, throwing up, diarrhea, fell, feet and legs swollen, left worse than right and he couldn't walk. No other vaccinations. On an unspecified date in Jun 2021, the patient experienced blood clots in both legs and on unspecified date the patient experienced sick, throwing up, diarrhea/diarrhea was reported as worsened, headache, started walking around that it was doing the damage it was doing until he figured out, he couldn't walk, got out of bed one day and fell to the floor and feet and legs swollen, left worse than right. The consumer stated that "he has been sick with both shots. Stated after the last shot he got blood clots in both legs and just got back from the doctor, stated the doctor said that the blood clots were caused by the vaccine. Consumer stated he went to see the doctor yesterday, 15Jun2021 at 09:00. Caller stated that after the first and second dose he has been throwing up, had diarrhea, a headache, and did not realize that when he started walking around that it was doing the damage it was doing until he figured out he couldn't walk, states one of the days, exact date not provided, he got out of bed one day and fell to the floor, stated then he realized what happened, stated it has been going on for a good while, stated his feet and legs swollen, started about 4 weeks ago, exact start dates of all events unknown. Stated he can hardly walk due to the swelling. Stated they gave him a medication for the diarrhea, exact name unknown. Stated they are treating the blood clots with Eliquis, two pills in the morning and two in the evening." Event Blood clots in both legs was required physician office visit. Therapeutic measures were taken as a result of blood clots in both legs, diarrhea/diarrhea was reported as worsened. The outcome of events blood clots in both legs, diarrhea/diarrhea was reported as worsened, headache, started walking around that it was doing the damage it was doing until he figured out, he couldn't walk and feet and legs swollen, left worse than right was not recovered whereas the outcome of sick and got out of bed one day and fell to the floor was unknown, throwing up was recovering.
59 2021-06-30 sinus headache, fatigue, nasopharyngitis, runny nose, sleepiness Woke up the next day and I felt like I had a really bad cold. I had a runny nose and a sinus headach... Read more
Woke up the next day and I felt like I had a really bad cold. I had a runny nose and a sinus headache. I didn't have a fever or chills. I went to the doctor for a routine appointment and was diagnosed carcinoma of the head and neck. I have a lot of fatigue and a lot of problems to stay awake.
59 2021-07-01 malaise I got sick for 3 days and I still have tightness in the chest and difficulty breathing with exertion
59 2021-07-02 fatigue, headache METALLIC TASTE IN MOUTH; Itching of ears and face; INJECTION SITE PAIN; TIREDNESS; HEADACHE; This is... Read more
METALLIC TASTE IN MOUTH; Itching of ears and face; INJECTION SITE PAIN; TIREDNESS; HEADACHE; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 24Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and chronic pain. The patient had no allergies to medications, food or other products. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 12:30, the patient experienced metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events metallic taste in mouth, itching of ears and face, injection site pain, tiredness and headache were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-02 fever, chills, fatigue, headache tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; rin... Read more
tiredness; headache; muscle pain; chills; un-controlled shaking; fever; nausea; loss of balance; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered on Arm Left on 24Mar2021 08:15 as dose 1, single for COVID-19 immunization at hospital. Medical history included prostate cancer. The patient had no known allergies to medications, food, or other products. Concomitant medications included Escitalopram at 10 mg; Pantoprazole 40 mg; Metoprolol Tartrate; all are received within four weeks of vaccination. The patient did not receive any other vaccines within four weeks. On 24Mar2021 19:30, the patient experienced tiredness, headache, muscle pain, chills, un-controlled shaking, fever (102 degrees), nausea, loss of balance and ringing in the ears. The patient did not have Covid prior vaccination and was not tested for Covid post vaccination. No treatment was received for the events. The outcome of events was recovered in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-07-06 chills, headache, fatigue Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not bei... Read more
Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not being able to relax and extreme fatigue started on 3rd day after vaccine and lasted about 2-3 weeks.
59 2021-07-08 fatigue Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and d... Read more
Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain). I did not have any cold fever or flu-like symptoms. But, within the next day or two, more concerning symptoms appeared: I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter. I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once. I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep. I have felt the restlessness and fatigue off and on night and day, interfering with focus and work. This has gone on for over two months now since the first vaccine dose. My overall health and how I felt were excellent the day prior to the vaccine. There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself. I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine. The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning. I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe. This was persistent for awhile and now seems to be more off and on, becoming less often. I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems. There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
59 2021-07-08 fever, chills My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/s... Read more
My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/shortness of breath; Chills; I wasn't feeling right, my breath was not right; temperature was 101; This is a spontaneous report from a contactable Consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 as single dose for covid-19 immunization. The medical history included acid reflux. The concomitant medication included Pantoprazole taken for acid reflux (40 mg, Once every other day for acid reflux) and Patient had been taking it from past 3 years. In Mar2021, the patient experienced that his arm was sore and it was still sore, patient wasn't feeling right, his breath was not right, shortness of breath, don't feel good, went to the bathroom a lot and chills. Patient further explained his arm was just a little sore other stuff went away. It was also reported, that was all until last Monday, after Monday I still have sore arm, my arm is still sore but I don't have shortness of breath anymore. patient is supposed to go back on the 2nd of Apr for his shot. Patient reported that he took some Tylenol and NyQuil for the chills and all. The patient underwent lab test of blood test and diabetes check-up and temperature was 101, SWAB test and it was positive 22Feb2021. The outcome of the event arm was sore was not recovered, wasn't feeling right, breath was not right, chills was recovered. No follow-up attempt are needed. No further information expected.
59 2021-07-09 fatigue The day after my second immunization, I began feeling extremely fatigued. The extreme fatigue conti... Read more
The day after my second immunization, I began feeling extremely fatigued. The extreme fatigue continued until June 14, 2021, when I went to my doctor. The VA doctor indicated that it could be related to a heart issue. Testing confirmed an abnormal ECG with atrial fibrillation with rapid ventricular response. I was given a prescription for blood pressure medication and sent a heart monitor to wear for two weeks. I have never had any issue prior to the second immunization with my heart. I had an EKG last year as part of a routine examination and my heart was deemed at that time to be absolutely normal. I am still having issues with extreme fatigue that has not improved with time.
59 2021-07-10 fatigue Since the first shot I've been experiencing some fatigue and oversleeping .; Since the first shot I'... Read more
Since the first shot I've been experiencing some fatigue and oversleeping .; Since the first shot I've been experiencing some fatigue and oversleeping .; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730) dose 2 via an unspecified route of administration in Arm Left on 09Apr2021 14:00 (at the age of 59 years old) as single for COVID-19 immunisation at pharmacy or drug Store. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient received other medications within 2 weeks of vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151) via an unspecified route of administration in Arm Right on an unspecified date as single for COVID-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced as, since the first shot i've been experiencing some fatigue and oversleeping. I normally sleep 4-6 hours but now after the shot I sleep a lot more 14-18 hours daily intermittently I thought I might sleep it off but it's taking longer than normal on 12Apr2021. Since the vaccination, the patient did not tested for COVID-19. No treatment was given. Outcome of the events were not recovered. Information on Lot/Batch number was available. Additional information has been requested.
59 2021-07-10 headache Sore neck; Tingling around my mouth, the right side of my mouth; Tingling around the right side of m... Read more
Sore neck; Tingling around my mouth, the right side of my mouth; Tingling around the right side of my face; Numbness; my right arm is sore; My whole right side is sore; Headache; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0177), via an unspecified route on 29May2021 (at the age of 59-years) as dose 1, single in the right arm for covid-19 immunization.The patient medical history included fibromyalgia, blood pressure, cholesterol. The patient concomitant medications included atorvastatin calcium (ATORVASTATIN [ATORVASTATIN CALCIUM]) 40 mg for Cholesterol, one tablet every day at bed time, lisinopril (LISINOPRIL) 10 mg, one tablet every day for blood pressure and acetylsalicylic acid (ASPIRIN) for unspecified indication from an unknown date and unknown if ongoing. When needed. I occasionally take low dose Aspirin but that's it.The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021, the patient experienced tingling around the right side of his face, numbness, right arm was sore, whole right side was sore, headache, on 30Jun2021 the patient had sore neck, tingling around my mouth, the right side of my mouth. Patient stated that he had both COVID shots and his primary physician feels that he might have had side effects due to that COVID shot. He had been taking some Aspirin, since he had the side effects he had been taking another medicines. He stated the diagnosis date of Fibromyalgia had been since many years ago. Patient took Gabapentin 100 mg (Intent: treatment) for tingling in the right side of my face just got a week ago. Consumer stated he had the side effect with the COVID shot. The patient had both COVID shots and my primary physician feels that I might have had side effects due to that COVID shot. When probed for the side effects, consumer stated, Tingling around the right side of my face, numbness, my right arm is sore and my whole right side is sore and also a headache and sore neck, tingling around my mouth, the right side of my mouth. Consumer stated, There was no expiration# date but I took the first one 29May2021 and the second one 24Jun2021. Consumer stated, Well I have been taking some Aspirin but that's it but also I have been (incomplete sentence), since I have the side effects I have been taking another medicines, would you like them? When again probed for the diagnosis date of Fibromyalgia, consumer stated, "Oh! It's been many years ago. Consumer stated, "The first one is Atorvastatin 40 mg for Cholesterol, one tablet every day at bed time. The next one Lisinopril 10 mg, one tablet every day for blood pressure.(Further clarification was unknown, hence not captured in tab). When probed if consumer had Cholesterol and blood pressure as well, consumer stated, "That was given to me after the first side effect, after the side effect on 14th (Further clarification was unknown if consumer was experiencing Cholesterol and blood pressure after the vaccination, hence not in captured in tab) and then I am taking one as well called Gabapentin 100 mg (Intent: treatment) and that was given to me a week ago.Indication of Gabapentin: Consumer stated, For my tingling in the right side of my face.When probed if consumer started taking these medications (Atorvastatin, Lisinopril, Gabapentin) after the vaccine, consumer stated, The first two were (incomplete sentence) yeah (Further clarification was unknown). Gabapentin I just got a weak ago.The patient underwent lab tests and procedures which included computerised tomogram: negative on 27Jun2021, magnetic resonance imaging: negative on 23Jun2021, x-ray: unknown on 27Jun2021.Therapeutic measures were taken as a result of tingling around the right side of my face (paraesthesia). The patient received Gabapentin 100 mg (Intent: treatment) and that was given tothe patient a week ago.The outcome of the events was unknown.
59 2021-07-10 upper respiratory tract infection Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient repor... Read more
Upper respiratory infection; This is a spontaneous report from a contactable consumer (patient reported for himself). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 59-year-old), as single for covid-19 immunisation. Relevant medical history included: Stroke, COPD (Chronic obstructive pulmonary disease) and Cholesterol. Concomitant medications included: blood thinners and Cholesterol medicine and use a nebulizer because she had COPD. She stated that she was on blood thinners and "cholesterol because" (not clarified further). She had a couple of strokes for last 10 years, almost 10 or 12 years ago. The patient experienced upper respiratory infection on an unspecified date. On an unspecified date (on Monday) his doctor prescribed a Z-Pak and Prednisone (treatment) for an upper respiratory infection and he was scheduled for his second dose to on an unspecified date (this Friday). On an unspecified date about a month ago, the patient had blood work done in which everything came back fine. The patient stated nothing unusual for her, as she had COPD (medical history) and this time of year with the pollens and that it was not her first upper respiratory infection, and nothing was unusual. The patient wanted to know that if it would be okay to still go-ahead and get her second vaccination while on doing these antibiotics and steroids for upper respiratory infection. The outcome of the event was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
59 2021-07-11 fatigue Left side arm and leg weakness, fatigue, weight loss,
59 2021-07-11 headache New onset of headaches.
59 2021-07-11 fever, chills, headache severe headache, fever overnight 100F, chills, shivering, overall muscle aches, lasted about 24hrs, ... Read more
severe headache, fever overnight 100F, chills, shivering, overall muscle aches, lasted about 24hrs, first 12hrs worst, very challenging to perform any sustained activity during course of symptoms.
59 2021-07-13 headache Pt developed tingling in toes and fingers that have progressed to numbness and climbed up extremitie... Read more
Pt developed tingling in toes and fingers that have progressed to numbness and climbed up extremities to now include above the wrist down, and patient is now unable to ambulate. Progression has been over three days. Providers have diagnosed Guillain-Barre. Patient received Pfizer Covid vaccine on 5/6/21 and 5/27/21. Additionally, patient has underwent lumbar laminectomy in June 2021. Pt also complained of trouble swallowing and headache on admission. Pt received first dose of IVIG last night, is due to receive second dose tonight. Pt was transferred to ICU level of care over night. He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time. If he remains stable he will stay here.
59 2021-07-17 headache, fever fever; headache feels like a migraine; light-headed/dizzy; pain continues and left arm; nausea at ti... Read more
fever; headache feels like a migraine; light-headed/dizzy; pain continues and left arm; nausea at times; lack of desire to eat at times; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included ascorbic acid (VITAMIN C) and Prednisone (MANUFACTURER UNKNOWN) and Silver (COLLOIDAL SILVER) for unknown indication from unknown date. The patient was allergic to codeine. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021 at 15:00 patient experienced fever, Day 5 still fever most days over 100, headache feels like a migraine, light-headed and dizzy, pain continued and left arm, lack of desire to eat at times. It was reported he missed work for 2 days and unable to drive due to headache and light-headedness. Treatment was taken for the reported events and included ibuprofen for fever and meclizine for dizzy. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events fever, headache, dizzy, pain in arm, nausea and appetite lost was not recovered. No follow-up attempts possible. No further information expected.
59 2021-07-17 malaise, chills, fatigue, headache, fever Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain;... Read more
Restless legs; Headache; Fatigue; Injection site pain; Muscle pain; Chills; Fever 100.6; Joint pain; Malaise; This is a spontaneous report from a contactable healthcare professional, the patient. A 59-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. No medical history was reported. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any known allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 22:15, the patient experienced headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs. The patient received treatment for event fever 100.6 with acetaminophen(TYLENOL). It was reported that the events had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcomes of events headache, fatigue, injection site pain, muscle pain, chills, fever 100.6, joint pain, malaise and restless legs were resolving at the time of the report. No follow-up attempts possible. No further information expected.
59 2021-07-17 fever, chills, fatigue medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latano... Read more
medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN), esomeprazole (MANUFACTURER UNKNOWN), all for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient received vaccine about 8 weeks after being exposed to COVID and about 4 weeks after recovery, on 22Mar2021 at 14:00, the patient experienced sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite for 2 days - began about 18 hours after injection, the events were worst about 24-30 hours after, later the events continued to be moderate for about 48 hours, finally recovered after 72 hours. The patient did not receive treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm, fatigue, aches, chills, fever, mild nausea and loss of appetite was recovered on 25Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.
59 2021-07-19 headache debilitating headache day after shot, headache has not completely gone away since shot. Pain level v... Read more
debilitating headache day after shot, headache has not completely gone away since shot. Pain level varies day to day between 3-5 on a good day and 8-10 on bad days. Good and bad days are about equal. There is no way I would ever take a third dose.
59 2021-07-20 headache Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxie... Read more
Vision loss; Severe Vertigo; Headaches; insomnia; High blood pressure; Tinnitis; Sleep issues; Anxiety; Absolutely feel horrible/Had not feel himself in 90 days; Possible diagnosis of post vaccine psychosis.; Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received bnt162b2 (BNT162B2) at the age of 59-years-old, dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 15:30 (Batch/Lot Number: ew0162) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination included Trilogy, Flownase Sensimist. Historical Vaccine included BNT162B2 for COVID-19 immunization on 18Mar2021 at the age of 59-year-old (dose 1, product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=16:30, vaccine location=Left arm). The patient experienced vision loss, severe vertigo, headaches, insomnia, high blood pressure, tinnitis, sleep issues, anxiety, absolutely feel horrible, possible diagnosis of post vaccine psychosis on 11Apr2021 07:30, migraine in 2021, with outcome of not recovered. Detail information was as following reported Event: Severe Vertigo, headaches, insomnia, high blood pressure, vision loss, Tinnitis. Vertigo just about 3 days after 2 nd vaccine. Had not feel himself in 90 days. Still experiencing headaches, sleep issues, anxiety. Absolutely feel horrible. Blood pressure up significantly over historical levels. Being treated for high blood pressure, sleep, anxiety, headaches. Currently seeing a neurologist. Possible diagnosis of post vaccine psychosis. The report was reported as non-serious. The events resulted in Doctor or other healthcare professional office clinic visit Emergency room department or urgent care. Treatment received included Vertigo treatment, Migraine treatment, Ongoing. Since the vaccination, the patient has not been tested for COVID-19.
59 2021-07-21 malaise, fatigue, headache Injection site pain; Muscle ache; Tiredness; Injection site swelling and redness; Injection site swe... Read more
Injection site pain; Muscle ache; Tiredness; Injection site swelling and redness; Injection site swelling and redness; Headache; Nausea; Sick feeling; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0150) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and COVID-19 on an unknown date. Concomitant medications were reported as no. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 18:00, the patient experienced injection site pain, muscle ache, tiredness, injection site swelling and redness, headache, nausea and sick feeling. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events injection site pain, muscle ache, tiredness, injection site swelling and redness, headache, nausea and sick feeling were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
59 2021-07-22 fatigue fatigue; still having lower intestine cramping; Votimed 3 times starting; diarrhea; This is a sponta... Read more
fatigue; still having lower intestine cramping; Votimed 3 times starting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the arm left on 25Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal), and diverticulitis. The patient did not receive any other medications within 2 weeks of vaccination. The patient was allergic to penicillin. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6202) via an unspecified route of administration in the arm left on 4Mar2021 at 11:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, at 17:00 the patient experienced vomited 3 times. From 25March2021 at 17:00 to 26March2021 at 18:00, patient experienced diarrhea and again diarrhea started from 28March2021 at 18:00 to 29March2021. On 26March, the patient experienced fatigue, lower intestine cramping and still have it and forwarded on. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events diarrhea, vomited, fatigue and lower intestine cramping were not resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
59 2021-07-22 fever, fatigue severe asthma attack; throwing up; head rush/dizziness; fever; fatigue/slept all the rest of the day... Read more
severe asthma attack; throwing up; head rush/dizziness; fever; fatigue/slept all the rest of the day; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 30Mar2021 at 12:00 (at 59 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included asthma, hypersensitivity, and high blood pressure; all from unspecified date. The patient had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and antihistamines, both from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that approximately 48 hours after vaccine dose, the patient experienced a severe asthma attack including throwing up and having to use albuterol sulfate nebulizer. Note: Day of vaccine the patient had severe cytokine-antivirus response symptoms with head rush, dizziness, fever, fatigue, slept all the rest of the day. The date of adverse events was on 31Mar2021 at 12:00. Outcome of the events was recovered on unspecified date in 2021. Information on batch/lot number has been requested.
59 2021-07-23 sinus congestion, throat pain, headache, cough Seen in clinic on 07/22/2021 for upper respiratory infection symptoms x1 week. Symptoms started 07/... Read more
Seen in clinic on 07/22/2021 for upper respiratory infection symptoms x1 week. Symptoms started 07/15 and consisted of sore throat, sinus congestion, sinus drainage, headache, dry cough. Symptoms initially mild, and worsened throughout the week with sinus symptoms more prominent. Patient presented to believing he had a sinus infection. Rapid test was positive and patient notified. He was frustrated as he thought he was protected by vaccine status. We collected a second sample for confirmatory Coronavirus PCR testing and sent this out later in the day. Patient was notified of the positive confirmatory test on 07/24. No current information on his recovery.
59 2021-07-27 fatigue, fever Mild fever; fatigue; This is a spontaneous report from a contactable consumer. A 59-year-old male pa... Read more
Mild fever; fatigue; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 18:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 15:00 the patient experienced mild fever and fatigue after second dose. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mild fever and fatigue was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-07-28 fatigue Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb... Read more
Extreme fatigue, constipation, lower muscle pain down legs, severe pain in knees, difficult to climb stairs. Out of work for 5-6 weeks. Went to primary care doctor and a cardiologist. Still experiencing severe fatigue
59 2021-07-29 fatigue, cough Body pain; Joint ache; Loss of appetite; Nagging cough; Fatigue; This is a spontaneous report from a... Read more
Body pain; Joint ache; Loss of appetite; Nagging cough; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 22Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of 0.3 ml of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 01Apr2021 at 08:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 20:45, 12 hours after vaccination the patient experienced severe body pain, nagging cough, loss of appetite, fatigue and joint pain. It was reported that the joint ache and loss of appetite went away 48 hours after injection, but nagging cough and fatigue continue until an unknown date in May2021. The clinical outcome of the events loss of appetite and joint pain were resolved on 24Apr2021. The clinical outcome of the events nagging cough and fatigue were resolved on an unknown date in May2021 while the event body pain was resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
59 2021-07-29 headache Providers have diagnosed Guillain-Barre; Pt developed tingling in toes and finger; progressed to num... Read more
Providers have diagnosed Guillain-Barre; Pt developed tingling in toes and finger; progressed to numbness and climbed up extremities to now include above the wrist down; patient is now unable to ambulate.; trouble swallowing; headache; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EW0170), via intramuscular route of administration, administered on 06May2021 (at the age of 59-years-old) as SINGLE dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via unspecified route of administration, administered on 27May2021(at the age of 59-years-old) for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included Amlodipine (Amlodipine) taken for an unspecified indication, start and stop date were not reported; Atorvastatin (Atorvastatin) taken for an unspecified indication, start and stop date were not reported; Benazepril (Benazepril) taken for an unspecified indication, start and stop date were not reported; Duloxetine (Duloxetine) taken for an unspecified indication, start and stop date were not reported; Omeprazole (Omeprazole) taken for an unspecified indication, start and stop date were not reported. the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19.The patient experienced providers have diagnosed guillain-barre on 12Jul2021, pt developed tingling in toes and finger that have progressed to numbness and climbed up extremities to now include above the wrist down and patient is now unable to ambulate on 12Jul2021, Progression has been over three days. Patient also complained of trouble swallowing and headache on 12Jul2021, patient has underwent lumbar laminectomy on Jun2021. Therapeutic measures were taken with first dose of IVIG last night is due to receive second dose tonight as a result of providers have diagnosed guillain-barre, pt developed tingling in toes, progressed to numbness, patient is now unable to ambulate, trouble swallowing, headache, patient has underwent lumbar laminectomy. Pt was transferred to ICU level of care over night. He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time. If he remains stable he will stay here. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Guillain-Barre syndrome, Paraesthesia, Hypoaesthesia, Gait inability, Dysphagia and headache cannot be totally excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
59 2021-07-29 headache Body aches; Lymph node swelling under left arm; headache; This is a spontaneous report from a contac... Read more
Body aches; Lymph node swelling under left arm; headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the arm left on 03May2021 at 10:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included losartan (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 02:00, one day after vaccination, the patient experienced body aches, lymph node swelling under left arm and headache. The clinical outcome of the events body aches, lymph node swelling under left arm and headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.