Pfizer

Chills Narrative: Per SHIFT note 12/16/20: Patient received COVID vaccine Pfizer at approximately 1300. Patient reported chills and no further symptoms, vital signs are stable. Patient believes that it could be a part of his tendency to run cold. Extra blankets were provided to patient and room temperature has been increased to 70 degrees. Patient stated that he no longer felt chills after interventions were performed. Per 12/17/20 Inpt attending note, "No acute events overnight. Some chills last night but feels fine now."

2 degree temperture rise - slight headache - chills - increase in pulse - lethargic not concerned as I expect this is just a normal reaction

striking headache since receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), via an unspecified route of administration on the right upper arm on 07Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. Concomitant medication included unspecified allergy medication. It was reported that the patient got the COVID-19 Vaccine this morning (07Jan2021 at 12:45 PM). He said he waited 15 minutes after receiving the COVID-19 Vaccine, until 1:00 pm, and everything seemed to be okay and he had no major problems. On the same day of 07Jan2021, he said he was now having an annoying, striking headache. He described the pain like someone was stabbing him in the head, and then the headache pain goes away. He said the headache was not constant and only lasts 3-4 seconds. He said the headache has been hitting him every 10-15 minutes. He also mentioned that he takes allergy medication, so it was not unusual for him to have a headache. As treatment, the patient took a loratadine (CLARITIN 24 Hour), and naproxen sodium (ALEVE Liqui-Gel). He said the headache was not getting any worse. He said the headache started slow and was really painful, and then the headache pain lessens up. Outcome of the event was recovering.

Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.

AT APPROXIMATELY 10 AM THIS MORNING(01/202021) I EXPERIENCED A SHARP PAIN TO MY BRAIN WHICH LASTED ABOUT 8 SECONDS

fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks. Information on the lot/batch number has been requested.

Sunday Morning (2:00 AM) 01/24/2021 woke up with severe chills (body hot), breathing hard. Lasted about 45 minutes. took Advil and used the CPAC to calm my breathing down. Then slept until 9:00 am. But after I woke, I felt tired the rest of the day. I am doing fine now. I am not sure if this was a side effect of the covid vaccine or not. But I thought I let you know.

Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak. Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown. Information about lot/batch number has been requested.

Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 04Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation, naproxen sodium (ALEVE), via an unspecified route of administration on 04Jan2021 at an unspecified dose and frequency for an unspecified indication. Medical history included blood pressure abnormal, blood uric acid abnormal, hypersensitivity, blood cholesterol abnormal, all from an unknown date and unknown if ongoing. Concomitant medication included alopurinol (ALOPURINOL), 300mg take once daily by mouth for Uric acid, amlodipine besilate (AMLODIPINE BESILATE) 10mg; take once daily by mouth for blood pressure, atorvastatin calcium (ATORVASTATIN CALCIUM) 20mg; take one half daily by mouth for cholesterol, cetirizine (CETIRIZINE) 10mg take once daily as needed for allergy, omeprazole (OMEPRAZOLE) 20mg; take one twice daily by mouth for uric acid, losartan (LOSARTAN), 100mg; take once daily by mouth for Blood pressure. The patient called regarding the Pfizer COVID 19 vaccine. He received his first dose of the vaccine at the a Hospital. He added he had just taken Aleve before the vaccination. Then he was reading in his heart magazine and it said it could effect the efficacy of the shot if you take aspirin or ibuprofen. He was asking for more information about that and was it okay that he took Aleve. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 04Jan2021 at 15:00 PM in the left arm. He took the Aleve at 08:00 04Jan2021. He reports he had no pain the first day, no soreness in the arm or anything. The next day he had mild soreness in arm like the flu or pneumonia shot. On the third day he was a little fatigued. But by the fourth day he was able to take his usual walk of three or four miles without being winded and he was fine. He was planning for the second dose 25Jan2021 at 15:00. The outcome of the event pain in extremity was recovered on 06Jan2021 and the event fatigue was recovered on 07Jan2021.

He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pain and pain in his right arm, hand, and wrist area; He also has joint pain and pain in his right arm, hand, and wrist area; Diarrhea; He is also very fatigued and does not want to get out of bed and that he is so tired; off and on headaches; This is a spontaneous report from contactable consumers. A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 11:28 (also reported as about 1130) at a single dose on left arm for COVID-19 immunization. Medical history included pulmonary fibrosis from 2014 and ongoing, ongoing type 2 diabetes mellitus (Diagnosed probably in 1996-1997; under control). The patient previously had pneumonia shot in 2020 and flu shot in 2020 (few months ago in Oct2020/Nov2020) both for immunization. The patient's concomitant medications were not reported. The patient experienced diarrhea, very fatigued and does not want to get out of bed and that he is so tired, and off and on headaches, all on 07Jan2021. He also has joint pain and pain in his right arm, hand, and wrist area on 11Jan2021. He experienced coughing, somnolence, and had aches and pains on an unspecified date. Patient received the vaccine last Wednesday. He experienced diarrhea (on Thursday and Friday, went away then came back on Yesterday), had aches and pains, and severe fatigue (all I wanna do is sleep). Today he said that he wasn't having diarrhea that can be attributed to him not eating much yet, a few aches and pains, very tired, and a minor headache. He was asking how long do these symptoms usually last. Patient received it last Wednesday 06Jan2021 at about 1130. He said that he has been experiencing side effects, not severe, but on Thursday 07Jan2021 and Friday 08Jan2021, he had diarrhea. He said that on Saturday 09Jan2021 the diarrhea let up and Sunday 10Jan2021 was ok, but yesterday 11Jan2021 the diarrhea was bad. He said that he is also very fatigued ("severe fatigue (all I wanna do is sleep)") on 07Jan2021 and does not want to get out of bed and that he is so tired. He has had no fever, but has had off and on headaches. He said that he also has joint pain and pain in his right arm, hand, and wrist area. He said that it is hard to pick up a cup or glass because of the pain. He said that he got the injection in the left arm. He said that he is also experiencing coughing, but stated that he does have pulmonary fibrosis and it could be that. Diarrhea: patient said that his diarrhea is improved as of today 12Jan2021. Fatigued: he said that he noticed it on 07Jan2021, it subsided Saturday 09Jan2021 and Sunday 10Jan2021, but yesterday and today 12Jan2021 it is very prominent and he is very tired. Headaches: He said that the headaches are not severe, but they were there. He said that the headaches are not there today. Pain in the arm, hand, and wrist area: He said that he noticed the pain yesterday and stated that it is slightly worse. Coughing: He said that he coughs due to the pulmonary fibrosis too and sometimes it is a lot and sometimes it is a little bit. He said that he has to get his second dose on 27Jan2021 at 1500. He stated that his brother died of Covid last Thursday. The outcome of event diarrhea was recovering, of "he is also very fatigued and does not want to get out of bed and that he is so tired", "he also has joint pain and pain in his right arm, hand, and wrist area", and "coughing" was not recovered, of "off and on headaches" was recovered on 11Jan2021, of the events "all i wanna do is sleep" and "had aches and pains" was unknown. No relevant tests. No prior vaccinations within 4 weeks. No family medical history relevant to AE.

3-4 out of 10 headache immediately following the vaccine, persisted for over 2 weeks, pt came to ED with 10 out of 10 headache at 2.5 weeks. all head imagine was negative, including MRI. pt never gets headaches. presumed to be migraine

Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 76-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 vaccine) via unknown route of adminsitration on 15Jan2021 11:30AM on left upper arm at a single dose for covid-19 immunization(lives in senior center and because of his age). Medical history and concomitant medications were none. He is a little shaky, but not had any dizziness or anything. He wanted to make sure it's okay and not interfere with him getting the next dose. Is this normal. Has also had a few chills, but not feeling too bad. Is a little jittery, but is staring to feel better. He did not receive any other vaccines the same time or 4 weeks prior. Did get a flu shot last October (Oct2020) with no problems or reaction. States no history of problems with vaccines in past. Vaccination Facility Type was unknown. No Vaccine Administered at Military Facility. 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) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The events started from 15Jan2021 with outcome of not recovered. Information on the lot/batch number has been requested.

Assessment: Individual stated he was feeling lightheaded approximately four minutes after receiving his first dose of the Pfizer vaccine via IM injection in his upper arm. Individual was seated at the time and was about to move from the vaccination station to the check out desk. PT attempted to stand and said, ?Oh, I don?t feel so good?, after which vaccinator inquired with PT on what was wrong. After a brief assessment, notified personnel of the situation. Individual remained with the vaccinator, who obtained a set of vital signs and continued an assessment. Vitals: (as I recollect, I gave the post it to the check out staffers who monitored the individual prior to his departure) BP: 126/54, P: 78, RR: 18, pale and sweating across his brow area. Denied chest pain, difficulty breathing, nausea, tingling, headache, stated only symptom was lightheaded ness which was dissipating. Provided the individual with bottled water to sip on, which he did. Individual?s last oral intake was at ~0845 PTA at the clinic, a normal breakfast of eggs, toast and coffee. Individual stated he had several cups of coffee but had not had anything else to drink that morning. Individual receives dialysis three days per week. He had an appointment Wednesday, next appointment is Friday. Individual did not have anyone driving him to the clinic, stated he would be fine and did not have anyone to come pick him up. He stated he was feeling better already. After approximately 8 additional minutes, individual stated he thought he could get up and move to the check out station. Individual was able to stand an ambulate to the check out line. Upon arrival at check out, transferred the individual to the check out personnel and Exit workers to monitor the individual?s condition for the remainder of the 30 minutes.

On the day after my vaccine, I had chills and felt mild malaise. No definite fever. Symptoms passed completely by awakening on 1/30/21.

Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns to bed at least two times per day, feel rested but upon rising to side of bed becomes weak again. Complaining of shortness of breath. Concerned about COVID infection; states had three negative tests with last test being in December. Was evaluated by Dr. with Family Medicine (his primary care provider was not available) and was prescribed Prednisone 20 mg QD x 5 days and Erythromycin 250 mg QD x 5 days; both have been completed. During office visit lungs were evaluated and reported as clear; physician mentioned a COVID test but none was obtained. Has continual cough with asthma, but feels symptoms have gotten worse since the COVID vaccine; "can't get his strength back". States the weakness, cough, shortness of breath, and joint pain have remained the same since first day noticed and has not seen any improvement since completing Prednisone and Erythromycin. Not on O2; states O2 sat is around 98 - 99%; uses a C Pap Machine. Wished to schedule a COVID test; appointment given for 2/3/2021. Denies dyspnea beyond usual SOB; instructed to seek emergency care if symptoms worsen; indicated understood and would do so if needed.

Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.

Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6 (highest) total feeling of unwell

Chills, fever, fatigue and headache came on 19 hours after receiving my 2nd shot. All symptoms were gone after another 17 hours.

diaphoresis, flushing, anxiety Narrative: Began feeling symptoms during monitoring period-mildly diaphoretic, dizzy, flushing upon standing. Was anxious about second vaccine. Received monitoring of vital signs for additional 15 min and water provided. Released to home.

sinus headache; Headache; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 76-year-old male patient (husband) received BNT162B2 (COVID-19 VACCINE, Batch/lot number: EL1283) on 19Jan2021 at about 10:30 AM on Arm Left for covid-19 immunization. Medical history was ongoing chronic sinusitis. Concomitant drug was warfarin. Reported that both her and her husband had a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. Reported her husband developed a headache during his sleep the night of receiving the COVID-19 Vaccine. She said her husband and her have chronic sinusitis. She said her husband's headache went away after he started moving around. She said because of having other conditions, her husband's headache was worse than with only his sinus issues. She clarified his whole head hurt. She said his headache was not a frontal headache like a person may get from their sinuses. Reported her husband thinks the COVID-19 Vaccine contributed to his headache, because his headache was a little different from what he normally experiences. She said his headache only lasted 1 day. She clarified her husband had a little sinus headache this morning. She said he blows his nose, and the headache goes away. She said his headache was short lived after getting the COVID-19 Vaccine. She said both her husband's and her headaches were mild. Outcome of the event headache was Recovered on 20Jan2021, for sinus headache was unknown. Reporter considered Related causality. No follow-up attempts possible. No further information expected.

little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. Outcome of the events was unknown. 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 reported events of fever, sluggish, weight decreased, night sweats and feeling unwell due to temporal relationship Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.

Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia

About 4-5 hours following injection, started to feel tired and achy. Went home to bed, slept for several hours. Woke up, went to sleep again. Woke in the middle of the night feeling urgent pressure to urinate. Rose to go to bathroom, became dizzy, fell and lost bladder control. Returned to bed with help from spouse. Measured fever of 100.2. Awoke in the morning feeling some better. By mid morning was sitting up in house. Fever and aches were dissipating. By evening felt normal except for fatigue.

profuse vomiting, no nausea/had a huge episode of vomiting; felt really tired/felt tired; sleeping; This is a spontaneous report from a contactable nurse. A 76-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3302, expiration date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11:00 at single dose on left arm for gain immunity against Covid-19. Medical history included stroke from 2017. There were no concomitant medications. Caller was reporting on her husband. He received the first dose of the Covid-19 vaccine yesterday (21Jan2021). He felt tired today (22Jan2021). 24 hours after he received the vaccine, he had a huge episode of vomiting. He was not nauseated and didn't even feel sick. He ate this morning as usual. All of a sudden he vomited. He still did not feel nauseated. He was tired on 22Jan2021 and was sleeping in Jan2021. Reporter had not measured his temperature but said he did not have a fever. He hadn't vomited in years. Outcome of the events was unknown. This case was reported as non-serious.

Mild nausea; Mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) via unspecified route of administration at left arm on 14Jan2021 at 08:00 AM at single dose for COVID-19 immunization. Medical history was not provided. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included simvastatin (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient experienced mild nausea and mild fatigue 6 hours after injection, at 02:00 PM on 14Jan2021. Duration for one week (6 days 10 hours). The events were reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive treatment for the adverse events. Outcome of the events was recovered on 21Jan2021.

Pronounced soreness near injection site; Mild flu-like symptoms; vivid dream; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration in left arm on 22Jan2021 21:30 at a single dose for COVID-19 immunization. Medical history included none. Concomitant medication included levothyroxine sodium (THYROXINE), vitamin D, tamsulosin. The patient experienced pronounced soreness near injection site, mild flu-like symptoms, and vivid dream on 23Jan2021 01:00. Pronounced soreness near injection site. Mild flu-like symptoms strong for two hours and then diminishing with time. Very, vivid dream, detail rich, color, flashing light. No treatment received for the events. The outcome of the events was recovered on an unspecified date. The events were assessed as non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. No other vaccines received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been been tested for COVID-19.

Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired

very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four days later very week and unable to do much activity

Patient received initial COVID vaccine on 2/11/2021 at Clinic. Direct observation for 15 minutes and no documentation noting an adverse reaction. On 2/14/2021 was diagnosed with Sepsis secondary to pneumonia, started on antibiotic therapy, cardiac arrested, and expired on 2/14/2021 while at Hospital.

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT. I DID NOT SEE A DOCTOR .

High Fever, shakes, chills, headache Feb 17 p.m. - Feb 18 plus all over ache. Tylenol time release. Felt good on Feb 19.

Severe shaking. Chills, headache,acute srvere sharp pain in both feet . Began after a short sleep period. Lasted for 3 hours. Then wesknesd and headache tiredness until bedtime the next eve. No isdued after 2nnd night sleep.

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.

fever commencing with heavy shuddering... temperature reaching 103 degrees... not receding for 48 hours... treated with Tylenol very 5 hours... ongoing headache

Pt received first dose of Pfizer COVID-19 at Vaccine Clinic 2/3/2021. Patient had previously tested positive for COVID at a community testing center on 10/2/2020, but is outside of the 90 day window where retesting is not recommendation. Pt began having headache and dizziness 2/21/2021, BP checked at home and was very elevated. Presented to ED and was diagnosed with hypertensive urgency, then admitted. Pt tested for COVID via PCR, positive.

Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and "losing stamina". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later.

Sore arm at the injection site; Exhaustion; Achy body; Low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL8982 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 26Jan2021 14:30 at single dose for Covid-19 immunization administered at Hospital. The patient's medical history Have a stent in my heart, mild heart attack 2+ years ago, and Covid-19. The patient's concomitant medication included acetylsalicylic acid (BABY ASPIRIN) at 83 mg, metoprolol, and evolocumab (REPATHA). On 26Jan2021 21:30, the patient experienced Sore arm at the injection site, exhaustion, achy body, low-grade fever. The patient did not received treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was recovering. 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

Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered

Fever, chills, diarrhea, nausea. I just let it run its course, no treatment, lasted approx 6 to 8 hous.

Quite tired; He has a slight headache; he felt achy/Body aches and pains; Injection site pain; Had a fever 99.7F, 99.9 fever, later 101F; discomfort/slight injection site discomfort; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number EL9263, expiry date not reported), intramuscular on 26Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included years ago he did have an issue with a lung disease when he went to (country name); he did have COVID 19 in Mar2020 and he recovered from that; high blood pressure; psoriatic arthritis diagnosed 30 years ago; and non-smoker. Family medical history included that they are all smokers in his family, and he is not. His sister died of pancreatic cancer and his mother died of oat cell lung cancer. Concomitant medications included valsartan (DIOVAN 160 mg) for high blood pressure at 160 mg, daily started 3.5 years ago to an unknown date; and patient was taking some health store vitamins. The patient previously took infliximab (REMICADE) on unspecified dates 5 years ago as Arthritis medication administered IV and apparently it lowered his immune system and he wound up in the hospital with a lung infection. He recovered completely. He does not have a lot or expiration. It was administered in the doctor's office and he does not go to that doctor anymore. It was reported that patient had no prior vaccinations (within 4 weeks). He had second dose of Shingles vaccine and it was close to 4 weeks ago. Shingrix administered on upper left arm received it at an in-store clinic, and patient had slight injection site discomfort. No other vaccines administered on same date of the Pfizer suspect. Patient received the first dose of the Covid 19 vaccine on 26Jan2021 at noon, with just a bit of discomfort. He seemed to be fine except slight injection site discomfort, also reported as injection site discomfort on left upper arm, on 26Jan2021. Later that night (also reported as last night 26Jan2021 23:00) he felt achy, he had bad body aches and pain and still has it this morning. Injection site pain worsened last night and now it has improved. He woke up in the middle of the night, and had a fever 99.7 F, 99.9 fever and later it went as high as 101 F (26Jan2021). He took Advil and Tylenol. The body aches improved after he took 2 Tylenol when he took his temperature. He took temperature about 1.5 hour ago. He went into bed and waited and took it again about 1/2 hour ago and it went up to 101. He then took Tylenol and took his temperature again. This morning (27Jan2021) his temperature was now back/down to 99.3 F. He was still feeling aches but not as bad as before. He might still have a slight temperature now, but it has improved. He believed vaccination was given in the muscle because it was in the upper part of his arm where the skin is thinner. He had a slight headache and was quite tired (27Jan2021). Patient asked if there's anything he should do or be concerned about. He was scheduled for the second dose on 16Feb2021 and he heard that the second dose was stronger than the first one, that after the second dose there may be more side effect, and he wanted to know if this is true and wanted to know if he can get the second dose. Therapeutic measures were taken as a result of the events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain. Patient had no ER or physician's office required. The events discomfort/slight injection site discomfort, he felt achy/body aches and pains, fever, and injection site pain were recovering. The outcome of the event tired and headache was unknown.

Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.

Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation

Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.

Shortness of Breath; Asthma; Cough; he is experiencing asthma, shortness of breath and a cough/he has had these symptoms previously but it was cleared up and then he had the shot and it hit him again last night; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on the left arm, on 28Jan2021 08:10, at single dose, for COVID-19 immunization, at the hospital. Medical history included cholesterol, blood pressure, coronary artery bypass in 2008, asthma, shortness of breath and cough which the patient already had before receiving the vaccine. Ongoing concomitant medications included rosuvastatin calcium (CRESTOR) for cholesterol and losartan for blood pressure. The patient did not receive any prior vaccinations within four weeks. On 01Feb2021, the patient experienced asthma, shortness of breath and cough. The patient stated that he already had these symptoms before receiving the vaccine and clarified he has had these symptoms previously, but it was cleared up and then he had the shot and it hit him again. He added that last night, on 01Feb2021, he had to sit in a chair all night due to the coughing. He did take some albuterol in his nebulizer and he was better on 02Feb2021. He was asking if he can take prednisone between doses of the Pfizer COVID 19 vaccine. His second dose was scheduled on 19Feb2021. The events did not require visit to a physician or emergency room. The outcome of the events was recovering.

Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting for 3-4 days.

Patient with history of TIA one week prior presented to the ED for recent onset of fever and epigastric abdominal pain. Pt found to have calculus of bile duct with acute cholecystitis and obstruction. In Ed pt had fever as high as 104 and pulse as high as 129. The gallbladder was found to be distended with wall thickening and large gallstone in the lumen. Patient transferred to tertiary care facility.

I felt great after my vaccine until midnight that same day. My legs from the knees down including my feet were painfully cold as if they were on dry ice. I didn't get much sleep that night, but the next morning at 2:00 a.m. the pain was gone. I was just extremely fatigued which was a symptom I expected. I don't know what to think of the first symptom but wanted you to know. Thank you.

Patient presented to the Emergency Department with fever and confusion. After receiving his second dose of Pfizer Covid vaccine, someone stopped in to check on him and he was confused. He had only had a donut since he got the vaccine 24 hrs ago. He was struggling to do his normal activities of daily living. Oxygen readings were in the 80s at home, heart rate was over 100, and temperature was over 100. The patient was complaining of diffuse body aches. He did not have a headache, chest pain, shortness of breath, abdominal pain, vomiting, or diarrhea. Past medical history is remarkable for chronic pulmonary disease due to asbestos exposure, Covid infection the last November. While in the ED, he was treated with a liter of normal saline, a liter of lactated ringers, 1000 mg of acetaminophen, and 600 mg of ibuprofen. His heart rate decreased and fever was gone after receiving fluids, acetaminophen, and ibuprofen. The patient was then discharged home.

Fever 100.8 Chills Injection site pain 2days Body ache 3 days Fatigue 4 days All went away on their own

Exacerbation of previously controlled hypertension with blood pressure spiking to 200/100; Had skeletal chest pain; doing well until Covid vaccine; This is a spontaneous report from contactable physicians (one of which was the patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1283), via an unspecified route of administration at the right arm on 22Jan2021 08:30 at single dose for COVID-19 immunization. Vaccination was done in a TN. Medical history included CABG Post op RT CABG (coronary artery bypass; doing well until Covid vaccine) from 11May2020 and hypertension. Concomitant medication included metoprolol succinate (TOPROL), ubidecarenone (COQ10), losartan and Hybrid. There was no other vaccine receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took atorvastatin (LIPITOR) and experienced allergies: Lipitor. The patient experienced exacerbation of previously controlled hypertension with blood pressure spiking to 200/100 on 26Jan2021, went to local ER, BP 180/100 there on 26Jan2021. He had skeletal chest pain which began 25Jan2021 22:00. He stated post op right cabg from 11may2020, doing well until covid vaccine on 22Jan2021. Treatment IV Hydralazine received. The events were considered non-serious by the reporter. On 26Feb2021, it was reported that the patient provided information to another physician regarding the reported adverse events with the use of BNT162B2. The physician did not consider the Pfizer product had a causal effect to the adverse events. Lab data also included Covid test (rapid nasal swab) on 26Jan2021 was negative. The outcome of the events was not recovered. Follow-up (26Feb2021): New information received from a contactable physician in response to HCP letter sent includes: reporter details (added a physician as a reporter), causality assessment and clinical course details. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT62B2 to the events hypertension aggravated, skeletal pain and unwell cannot be excluded. The fluctuation of underlying hypertension may be major cofounder. 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.

2nd vaccine fever and severe chills started 6 hours later. over the next 11 days he would show the same fever and chills. @ extra strength tylenol would help. He also developed a slight cough and general malaise. His blood sugar level which he takes 2x a day was much higher than normal even eating the same foods as usual. Concerned where he has so many health issues, Called his doctor for him to be seen and they said he needs a covid test. He will have had vaccine 2 weeks ago this upcoming Wednesday. 1st vaccine he had no symptoms until 5 days later and then fever and chills also. Called his doctor today 3/15/21

Fatigue; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EL8982), via an unspecified route of administration in left deltoid, on 28Jan2021 at 11:45 AM, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included losartan (unknown manufacturer) from 2009 and ongoing, alopurinol (unknown manufacturer) from 1980 and ongoing, omeprazole (unknown manufacturer) from 2012 and ongoing, amlodipine besilate (unknown manufacturer) from 2010 and ongoing, cetirizine hydrochloride (CETIRIZINE) from 1998 and ongoing, atorvastatin calcium (unknown manufacturer) from 2019 and ongoing. The patient previously took the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# EJ1686) on 04Jan2021 at 03:00 PM, for COVID-19 immunisation and experienced mild soreness/arm sore/soreness in the arm and fatigue. Previously the patient received 1 pill of naproxen sodium (ALEVE) on 04Jan2021 to anticipate fever and pain. The patient experienced fatigue (non-serious) on 28Jan2021 with outcome of recovered in 2021. No therapeutic measures were taken as a result of the event.

High fever every night with temperature ranging from 100.7 to 2.90. This remained consistent until 3/12/2021 at which time I had no fever. I did have a fever on 3/13/2021. No fever from 3/13/2021 until present 3/15/2021.

Chills and overall ache for the whole day after 2nd vaccination. The following day all was pretty normal. Took Tyle ol a d Advil during g that day.

I received the second Pfizer shot on March 1st. My initial reaction consisted of a couple of days of flu-like systems that abruptly went away. Then a week ago I came down with what appeared to be an intestinal bug. My subjective sense is that my immune system got confused and is now mounting random immune reactions - chills and fever, severe back pain, diarrhea, etc.

Received 2nd vaccine on 3/5/21 & developed symptoms on 3/6/21. Symptoms lasted 2 days. Symptoms included confusion, Fever > 100, Oxygen Saturation upper 80's, & body aches.

Received vaccine on March 18th. Was very tired that day. March 19th slept most of day, had muscle aches. Saturday, March 20th had fever, muscle aches, headache, fatigue. March 21 had all the above but short of breath. March 22, in the hospital with fluid in the lungs, very high blood pressure, short of breath, on oxygen.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

Total body pain followed by extreme chills then feverish then uncontrollable tremors accompanied by unable to keep my balance(had to hold on to desk )then massive amounts of nasal mucous all in about a 9 0 minute time period then just headache and fatigue - felt fine 90 mins after headache and fatigue

Same evening of vaccine injection 3/24 - chills and severe headache and extreme fatigue. Overnight - nausea, vomiting and fever 102.6. Next morning 3/25, woke up and tried to get out of bed. Legs were so weak they gave out and I fell out of bed on the floor. I had no strength to get back up to get on the bed. My wife could not lift me, so she called 911 for a "lift assist". Paramedics were told I received the 2nd dose of the Covid vaccine the day before, so they picked me up off of the floor and put me back in bed. They took my vitals - blood pressure was 116/73 and temperature was still 102.6. Paramedics offered to take me to the hospital but I refused. Paramedics told my wife that if my breathing became labored, she should get me to the ER or call 911 again. I was not able to get out of bed the whole day on Thursday 3/25, because I was so weak I could not stand up, and I also had body aches and had to use a urinal because I could not walk to the bathroom. My wife gave me Tylenol and the fever finally broke late evening of Thursday 3/25 and I started to feel a little bit better. I had not eaten all day, but my wife made sure I stayed hydrated with water. On Friday morning 3/26 I was able to sit up on the side of the bed, and I was able to walk with the assistance of a cane to the bathroom. Extreme fatigue affected me all day Friday, but I did feel better. Fever did not come back after it broke. Saturday 3/27 - still experiencing extreme fatigue, but feel better overall.

2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper extremities, aphasia). 2/24 RML pneumonia. Found to have MSSA bacteremia and bacteriuria. Transition from vanco/pip-tazo to cefazolin Mental status improved and he was sent on cefazolin which he was to complete on 3/26/21. Was not sent out on seizure prophylaxis. 3/23 second dose Moderna. Had recurrent seizure on 3/27. Evidence of post central stroke. Expressive and receptive aphasia.

severe fatigue; severe sleepiness and sleeping like 20 hours a day; Cough; headache; lack of appetite; This is a spontaneous report from a contactable consumer reported for a male patient (Reporter's husband). A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Solution for injection, lot number: EN5318, Expiration date; unknown), intramuscular injection in right upper arm on 28Jan2021 05:00, at single dose for COVID-19 immunization. The patient's last weight was 242lbs, but on 07Jan2021 he weighed 257lbs. Reporter said that was considerable weight loss. The patient medical history included ongoing Diabetes, high blood pressure, High cholesterol, Sleep apnea, unspecified Small B Cell Marginal Zone Lymphoma. Concomitant medication included monthly B12 shots ongoing, unspecified route of Administration for underlying conditions such as lymphoma type cancer (Small b cell marginal zone Lymphoma). Patient taken medication for diabetes, high blood pressure, and high cholesterol no further details provided. On 28Jan2021, the patient experienced severe sleepiness, sleeping like 20 hours a day, Cough, Headache, lack of appetite and severe fatigue. The patient was taking treatment Nyquil taken for cough. The outcome of events were not recovered.

feeling unwell; muscle weakness; excessive tiredness; loss of appetite; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 76-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 administered in left arm at a pharmacy or drug store on 09Mar2021 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 it was unknown if COVID was tested post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]), atorvastatin, and donepezil. On 10Mar2020 at 08:00 AM, the patient experienced feeling unwell, muscle weakness, excessive tiredness, loss of appetite, fever, and chills. The reporter considered the events as serious due to hospitalization. The events resulted in emergency room/department or urgent care. It was unknown if treatment was given for the events. The patient had not yet recovered from all events.

onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. chills and fever continued through next day. feeling better on 04/02/2021. still weak. was hospitalized in October 2021 for five days due to COVID.

Blood pressure spike 10 minutes after shot. 6 hours later had intense burning of nerve bundles down arms and legs for 2 hours. After that had 1 hour of uncontolled severe shaking and shivering . Next day felt fine. Afew days started noticing LOW FREQUENCY INTERMITTANT TINNITUS THAT IS A HUM, BUT ONLY IF I AM AROUND HIGH VOLTAGE POWER TRANSMISSION LINES AND POWER TRANSFORMERS . HEAR IT IN MY HOME WHICH IS 1000 FEET FROM HIGH VOLTAGE LINES 24/7 SINCE DAY 2-4 OF DOSE #1. Can hear it in other enclosed areas, but doesn't seem to happen AS MUCH outdoors, although if I am within 1000 feet of high voltage lines I will hear it UNLESS there are many trees to block the EMF's or HUM between me and the source. SOUNDS CRAZY, BUT IS TRUE FOR PAST 3 MONTHS 24/7 AND HAS RUINED MY LIFE BECAUSE I CANNOT SLEEP AND SLEEPING PILLS DON'T WORK. HAS DISRUPTED MY SLEEP CENTER SOMEHOW. ALL OF THIS IS SINCE FIRST COIVD19 SHOT ! HAVE HAD #2 SHOT AND WILL NEVER GET ANOTHER !

On December 30th my father tested positive for COVID. He was reported asymptomatic by the care facility staff. He was given vaccine on Jan 14th and began feeling ill that evening. The morning of the Jan 15th the nursing facility had my father admitted to emergency and then to ICU. He stayed in the hospital for 10-14 days and then was released on hospice at the senior care facility. He passed away on Jan 31st. I'm not sure if the sudden change in my father's health was due or made worse due to the COVID vaccine as the hospital was treating several symptoms, but the timing seems suspicious. I have also not been able to get an explanation for why he was given a vaccine if he tested positive. I do not know which vaccine was given, but needed to select one to submit the form.

At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning he had fever, oxygen was low, not speaking not walking.

Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration in right arm on 23Jan2021 at 10:30 as a single dose for COVID-19 immunisation. The patient's medical history included diabetic type 2, stent from an unspecified date in Dec2019, sulfa allergies. Concomitant medications included metformin (Strength: 500 mg) at four times a day, buspirone (Strength: 10 mg) at thrice a day, sitagliptin phosphate (JANUVIA, Strength: 50 mg), hyoscyamine sulfate (OSCIMIN, Strength: 0.125 mg), lisinopril (Strength: 5 mg) at once a day (bedtime) for BP (blood pressure), silodosin (Strength: 8 mg) at once a day (bedtime), simvastatin (ZOCOR, Strength: 40 mg) at once a day (bedtime), fish oil (Strength: 1000 mg) at twice a day, zinc (Formulation: Tablet) at once a day (in the morning), vitamin D3, cyanocobalamin (B12 20 MIL, Strength: 1000 mg) at once a day, allium sativum bulb (GARLIC EXTRACT) at 1 DF (Dosage Form), once a day (1 pill, once a day), ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 NOS, vitamin d NOS, vitamin e NOS, vitamin k NOS, xantofyl, zinc (MEN 50+) at once a day, ubidecarenone (COQ-10, Strength: 200 mg) at once a day, exenatide (BYDUREON PEN, Formulation: Injection) at weekly (once a week on Monday) for diabetes, doxepin (Strength: 10 mg) at twice a day (bedtime). Family history was none. The patient did not receive prior vaccinations (within 4 weeks). The patient experienced pain in arm on 23Jan2021, fatigue on 24Jan2021. The patient did not require the initiation of new medication / other treatment / procedure for the events. Relevant tests was none. The outcome of the event fatigue was not recovered and recovered on an unspecified date in 2021 for the other event.

4/3 = SATURDAY - 12:30 AM , USED 2 ACETAMINOPHEN PM ( This what i use nightly ) 6:30 AM , CHILLS (FEVER) LASTED COUPLE OF HOURS TIRED NO ENERGY , NO FOOD UNTILL DINNER TIME , WAS TOLD I LOOKED PALE , ** THAT SATURDAY AFTERNOON I WAS SMELLING AN ODOR LIKE GARBAGE, WIFE SAID SHE DIDN'T SMELL ANYTHING, LASTED FOR A FEW HOURS.??? 4/4 = SUNDAY - STILL LOW ENERGY. EVERY MORNING FOR PAST 20 YEARS I RINSE EYES WITH SALINE SOLUTION. I SKIPPED SATURDAY, TRIED SUNDAY & MY EYES STARTED BURNING, TRIED A DIFFERENT BOTTLE STILL BURNING, HAD TO STOP. 4/5 = MONDAY - FEELING BETTER & EYES RINSED WITH NO PROBLEM .???

Could not sleep night the shot; Had chills; No appetite; could not have a bowel movement; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 14:00 (Batch/Lot Number: EWG200) at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]); atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN) colecalciferol (VITAMIN D). No known allergies. The patient not had other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient could not sleep night the shot. He had chills, chills stopped after 16 hours, No appetite, could not have a bowel movement on 23Feb2021 at 02:00 PM. Outcome of chills was recovered on 24Feb2021 and outcome of other events was recovered on an unspecified date of 2021.

Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe, Additional Details: Patient received vaccine, came back after 10 minutes and said he didnt feel good. Sitting BP was 232/112. 6 minutes later it was 245/119. Patient stayed seated, 5 minutes later BP was 247-132 HR 84. Called 911 and EMS responded and brought patient out on stretcher. He remainder conscious the entire time.

D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19 D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia U07.1, J12.82 - Pneumonia due to COVID-19 virus

Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received the 2nd Covid-19 Pfiser Vaccine on Thursday, March 4, 2021. 7 days after second vaccine shot on Thursday, March 11, 2021, patient showed some symptoms of a itchy-horsed throat & a slight dry cough. Called doctors - they said nothing to worry about, drink hot fluids and take couch drops. It went away in 2-3 days. Exactly 4 weeks after second Covid-19 Pfiser vaccine on Thursday, April 1st 2021, patient was sent to the ER for a seizure.

I had the second shot at the same place on 2-11-21. At the time, I only had soreness of the left arm at the injection site and virtually no other symptoms except a mild headache for a few hours. However, during the month or so between the vaccines and post-vaccine period, I developed pain in both shoulders with moderate-severe rotator cuff symptoms. This was pain in reaching in almost any direction. Also, I began to notice heaviness in both upper legs, front and back, which in a week or so progressed to tiredness and then to achiness, and finally to pain when I would squat, bend over, or get up from a chair. I have never had either symptom before.

patient reported numbness in right side of face and tooth pain on the day after his covid-19 immunization. His prescriber evaluated him today and said he has a sinus infection with mild bells palsey. Unsure if related to immunization.

His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.

Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS.

Patient hospitalized with covid-19 late November of 2020. Then received 2 doses of Pfizer vaccine on 1/13 and 2/2 of 2021. He has myelodysplasia and is receiving Vidaza. He was admitted on 3/19/21 with PNA symptoms. last cycle of Vidaza was 2/22/21-3/2/21. he tested positive for SARS-CoV-2 RNA x2 on admission. Uncertain if delayed shedding or reinfection. CXR with LUL Pneumonia. WBC 0.5, ANC 0, Procalcitonin initially 1.14 peaked next day at 14.7. patient was initiated on dexamethasone, piperacillin-tazobactam, and doxycycline. clinically felt to be more of a bacterial process, but could not rule out COVID-19 re-infection.

Headache; He took Excedrin, before the first dose of the covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), intramuscular, administered in Arm Left on 29Jan2021 (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that on Friday he received the first shot of the vaccine. He did not had many side effects. Clarified that he had a headache that night and that was about it. Last night on the 10 PM news it was reported that someone had seen on the internet and called the news media to state that people should not take any over the counter aspirin, acetaminophen, or ibuprofen. According to the news they mentioned that it could block some kind of enzyme and may not have the appropriate immune response from the vaccine. He was calling to ask about what he saw on the news, if that was true. About 3 hours before he received the vaccine he had a headache. He did not read anything that said do not take pain medication before taking the vaccine since it could reduce its effectiveness. He was asking if he received the full effect of the vaccine since he took Excedrin 3 hours prior to getting the vaccine. His headache recovered by the time he went to bed. He did not have a fever and he took his temperature with a digital thermometer. He confirms he had no other side effects. This was very vague. People had aches and pains that they take medication for. Nothing says don't do this or that in regard to medications. Other people were probably scratching their heads as well. It does state that participants did have underlying conditions such as hypertension and that they did receive antipyretic medications for post vaccination symptoms, however it doesn't state if they were taking their regular medications, such as blood pressure medications, or not. There was no data available at this time. Referred caller to his HCP and stated that they will have access to clinical data specifically for health care professionals that may help answer questions. The patient underwent lab tests and procedures which included body height: shrunk, body temperature: he did not have a fever. Therapeutic measures were taken as a result of headache (headache) as patient took two over the counter Excedrin which contained aspirin and acetaminophen. The outcome of the event circumstance or information capable of leading to medication error was unknown and for headache it was reported as recovered. DSU- potential duplicate AE. Follow-up attempts are completed. No further information is expected.

1st shot, none. 2nd shot, 22Feb21 fatigue joint and wound soreness. Soon diminished.. But, I got shot through my throat and shoulder in RVN ?68 and a deep gash to my inner right forearm 11Sep01 exposing my bones and severed arteries. 2 months later I still feel tightness/constriction, soreness in my lower throat and upper lungs when I breath deeply such as running, exercising or sex to the point I have to slow down. Also my right forearm is no longer sore but still feels a little swollen.

Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. 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 has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.

Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. 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 vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021. The patient received antibiotics and diarrhea medication. The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization). No follow-up attempts are possible. No further information is expected.

temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown. Follow-up attempts are completed. 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 event Fever 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.

I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours; have to go to bed and sleep for about 3 hours; Feeling weaker; Fatigue; This is a spontaneous report from two contactable consumer (patient's partner and patient). A 76-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982) via an unspecified route of administration on 04Jan2021 (76-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included sick. Other products were reported as no. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269) via an unspecified route of administration on 04Feb2021 (77-year-old at vaccination) at a single dose for COVID-19 immunization. Consumer stated, "I hope you can, what's happening is I had my COVID shot on my last one on 04Feb2021 (further clarification unknown) and before that even I was sick ( Intent: medical history) and then now it's been 4 months later. This happen to start when I felt before I had the shot. I was like feeling weaker and weaker, there was no strength and then now I am totally fatigue (the start date of the feeling of weakness and fatigue was stated as "That's going to be hard, it's probably, it was in January. I want to look at this. January, probably, in the beginning of January maybe you can say 5th or something like that"), I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours. So, I am looking to you for some help or what can I do." No treatment received. The report was reported as non-serious. The patient was still feeling weak, he was little bit better but he was still very worried about it. The outcome of event feeling weak was resolving, and of other events was unknown. No Follow-up attempts are needed. No further information expected.

Chills, Pain all over the body, Palpitations, loss of appetite.insomnia. Today May 10, finally feeling better. Took Tylenol (1000 MG) as of Saturday night.

Dx Cough ? Nasal Congestion Clinical Support 3/11/2021 RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/11/2021 ? ? 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:

Diagnosed with Covid-19 via Rapid Test on 04/30/2021. Received Pfizer vaccines in Feb 2021. Took Covid Rapid Test (NEGATIVE) on 04/18/2021 prior to leaving for vacation home. Arrived in 04/22/2021 and only went out in public twice, both times masked and social distancing. On 04/26/2021 I started having flu like symptoms, cough, fever (99-100 degrees F), headache, body aches, shortness of breath. 04/27/2021 I lost my sense of smell and taste. 04/30/2021 since I was still feeling unwell, I went to Urgent Care in for evaluation. Rapid Covid test POSITIVE for CV-19. Prescribed rest, fluids, Tylenol for fever and monitor breathing. Returned home 05/07/2021. As of today, 05/13/2021 I continue to have cough, lack of taste and mild shortness of breath and feeling generally lousy.

Chief Complaint Patient presents with ? Cough ? Shortness of Breath HPI is a 76 y.o. male presenting to the ED for assessment of approximately 2 weeks of shortness of breath and cough that has been progressively worsening. Patient's wife did test positive for COVID-19 2 weeks ago. At this time patient has been taking over-the-counter cough and cold medications with no relief of symptoms. Patient does have a history of atrial fibrillation. Patient does take Lopressor daily. At this time patient denies any headache dizziness confusion chest pain nausea vomiting diarrhea abdominal pain dysuria rashes leg pain leg swelling. PCP: , DO

Day #13 following the 2nd shot, patient experienced severe pain in his left knee and began running fevers. Past medical history includes a surgical infection in 1979 leading to 3 knee replacements in this knee. His hardware extends from mid- thigh to his ankle. On 4/21/21 he required a revision of the total knee (the plastic was replaced) after flushing out the wound with antibiotic solution. He is now on oral and IV antibiotics (Rifampin & Vancomycin, respectively). He is being followed mainly by infectious diseases and ortho, but to my knowledge, this has not been reported by them or his PCP.

Chills for two days after the first vaccine. rash on right foot and right arm after the second vaccine which lasted several days and then dried up. At that point I had cold sweats and chills which started today about 10 AM. I texted Dr. who advised me that the rash should disappear in a few days. She was correct and a couple of days later texted that she had no concerns about the cold sweat and chills.

ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) CRNP Last attending ? Treatment team COVID-19 virus infection Principal problem HPI: For complete history and physical see the H&P dictated by Dr. on 4/28/2021. This is a 76-year-old male who presented to the emergency department with upper respiratory symptoms for three days. He reports having cough, sneezing, runny nose and poor appetite. His caregiver had Covid recently and he was exposed. He was admitted for further evaluation and treatment. Hospital Course: Patient was admitted inpatient to the medical surgical floor. He was not on telemetry. Patient reports that his caregiver had recently tested positive for Covid and he was exposed. He has been having upper respiratory symptoms including cough, sneezing, and runny nose. His COVID-19 test was positive. He was started on the COVID-19 treatment protocol which included IV remdesivir and IV dexamethasone. He underwent a CT scan of the chest which showed small patchy areas of groundglass infiltrates in the peripheral portions of the left and right upper lobes and also the posterior aspects of the right lung base. These findings are probably due to pneumonia. Hospital course consisted of gentle hydration with IV normal saline. He was also started on antibiotic therapy oral azithromycin and IV Rocephin. He had completed the course of antibiotics while on the unit, therefore, at the time of discharge no antibiotics were prescribed. He initially was hypoxic and started on nasal cannula oxygen to maintain pulse oximetry greater than 92%. Eventually, oxygen was weaned and pulse oximetry on room air has remained in the 95-96% range. He has a history of diabetes mellitus and while on the unit blood glucose levels have fluctuated. His point-of-care glucose have been in the 80-500 range. He has had numerous episodes of hypoglycemia and insulin has been adjusted. The fluctuations of the blood glucose levels may be secondary to IV dexamethasone. At the time of discharge he will continue dexamethasone 6mg daily for the next three days. He was advised to increase insulin 70/25 insulin five units daily for the next thre days. After that time he can return to his normal dose of insulin. He also had been treated with IV remdesivir and had completed the 5-day course. On examination today he has been asymptomatic. He denies any chest pain, dyspnea, abdominal pain, nausea, or vomiting. The initial lab studies showed an elevated creatinine level, although he has a history of chronic kidney disease. At the time of discharge the creatinine level trended downward and he was advised to follow-up with the primary care provider for possible repeat BMP in 1 to 2 weeks. All other lab studies have been within normal limits. The systolic blood pressure has been in the 120-150 range. The most recent systolic blood pressure was 151/66 mmHg with a heart rate of 66 bpm. He denies any lightheadedness or dizziness. He was advised to continue all of his current medications. While on the unit he was in isolation secondary to COVID-19. At the time of discharge he should maintain social distancing/isolation, mask wearing and good handwashing. He will will need to follow-up with the primary care provider. He was also advised if the oxygen level dips below 89% he will need to return to the emergency department. At this time he is resting comfortably, offers no complaints and is stable for discharge. Patient is alert, oriented answering all questions appropriately. He is continent of bowel and bladder. Heis able to make his own decisions. He is able to performhis own ADLs. . At this time he is in agreement with the plan and feels comfortable to be discharged home. Thank you.

This is a spontaneous report was received from a contactable consumer. A 76-year-old male patient of weight 77.11 kilograms and height 173 centimetres received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration in arm left on 04Feb2021 09:00 AM as 1st dose, single for covid-19 immunisation. The patient's medical history included blood pressure high and history of headaches this was diagnosed 50 years ago, high cholesterol this was diagnosed 30-40 years ago, stomach problems. Concomitant medications were not reported. On 04Feb2021, the patient had headache. He had his first dose of the vaccine yesterday and wound up with a headache later in the day that lasted all night and gets all the time. He heard that Aspirin should not be taken before or after getting the vaccine. So, he would like to know can he take Excedrin to treat his headache since it was one day after the vaccine dose. He heard that it was a general rule that you should not take aspirin with the vaccines and would like to know if this was true. He said he was supposed to get his second dose of vaccine on February 25th and was thinking that the end date on it for the vaccine was March 13th. Vaccine injection was given at 09:00AM yesterday, then it was not until the evening when his headache started the whole day, and it may have nothing to do with the vaccine since he gets two to three headaches a week. Reason for no lot number was complainant does not have the product with them at the time of call. The outcome of the event was unknown. 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

hearing loss; my nose started to run non stop; type of vertigo symptom's; This is a spontaneous report from a contactable other HCP (patient herself). This 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number el3249), via an unknown route, on 01Feb2021 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) on unknown date for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included lisinopril and atorvastatin. The patient received the last shot on 01Feb2021. The next day ''my nose started to run nonstop''. The runny nose lasted for about 6 days. The next thing that happened was a type of vertigo symptom's that lasted for 4 days. On 12Feb2021 ''I woke up and could not hear out of my left ear''. The hearing loss was trying to come back but did not. The events required a physician office visit. She was treated for the events. On 23Mar2021, the patient performed a hearing test, but results were not provided. On 12Apr2021, a nasal swab was done and resulted negative. The patient had recovered from 'my nose started to run non stop' on 08Feb2021 and from 'type of vertigo symptom's' on 06Feb2021. The outcome of 'hearing loss' was not recovered.; 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.

he did not feel well; he then got tested for covid and tested positive for covid; he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed; he did not want to eat but could smell and taste food but did not want to eat it/ loss of appetite; he started feeling drowsy/ kept falling asleep/ dozing off; the next day started feeling very tired/ tiredness; lost about 12 pounds; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Feb2021 10:30 (Batch/Lot Number: EN5318) at the age of 76-years-old as first dose, single in the left arm for COVID-19 immunisation. Medical history included acute pancreatitis, diagnosed about 10 years ago (2011) and cirrhosis liver, diagnosed maybe 7-8 years ago. The patient's concomitant medications were not reported. The patient previously took Hepatitis A vaccine on 03Feb2021 and has no dosage, lot number, expiry date to provide. The patient stated that he was calling about the Pfizer COVID vaccine and stated that he had the 1st dose on 18Feb2021 10:30 and did not get the 2nd dose; stated that he had the first dose and the next day (19Feb2021) started feeling very tired and thought it was a result of the shot and it lasted until the following Friday, 26Feb2021 and he then got tested for covid and tested positive for covid on Friday 26Feb2021. The patient stated that his healthcare professional (HCP) sent him for an infusion that day and hooked him up to the infusion and said it would help him get better faster and the patient does not know the name, dosage, lot, expiry date of the infusion and has none of that information to provide. The patient stated that he was told he can't get the 2nd shot for 90 days after the infusion and heard that he could get it and the infusion center told him he would have to start all over again with the 1st shot of the Pfizer COVID Vaccine and he does not know but has heard different stories and some say he can get the 2nd dose of the vaccine and others say no he has to wait 90 days after the infusion and he called the facility and the HCP said he would have to wait 90 days after the infusion; states the facility said to wait 90 days and he was told they are going by the agency. The patient stated that his patient card for the Pfizer COVID Vaccine says he was supposed to go back for the 2nd dose on 11Mar2021. The patient also stated that when he went home after the Pfizer COVID Vaccine 1st dose he felt fine and got up and went to work and was fine and then noticed at work he started feeling drowsy (on 19Feb2021) and usually works in the street outside but was in the office that day; patient stated that he started dozing off and then the next day on Saturday (20Feb2021), he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed and he went to go to work the following Monday and Tuesday and Wednesday and kept falling asleep in his office and then it was finally Friday. The patient also stated that he did not want to eat but could smell and taste food but did not want to eat it on 19Feb2021 and the following week he took the whole week off of work and lost about 12 pounds; he also stated that the tiredness lasted into the following week and the loss of appetite, dozing off is not ongoing and lasted probably a good three weeks total until he started feeling from the day after the vaccine on 19Feb2021 for three weeks and then he started feeling more like himself. The patient stated that he was fine up until he did not feel well and it was not probably from the vaccine but was just a coincidence the next day when he started feeling tired and he does not know the results from the vaccine but got worse and worse and could not function normally like he is supposed to and just wanted to lay down. The patient stated that he did not have treatment for the reported events. The outcome of the event "the next day started feeling very tired/ tiredness" was recovered on 26Feb2021, for events: decreased appetite and somnolence was recovered on an unspecified date. The outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

tested covid positive; fever; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 21Jan2021 13:00 (Batch/Lot Number: EL0142) as single dose for COVID-19 immunisation. Medical history included patient had 2 stents, stents were placed 3 or 4 years ago (ongoing); diagnosed with blood pressure problems maybe 10 years ago or more, maybe 12 years ago and was ongoing; diagnosed with prostate problems 6 or 7 years ago and was ongoing; diagnosed with cholesterol problems 10 years ago and was ongoing. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN) at one tablet once daily prescribed by cardiologist after stent placement, has been taking for 3-4 years and ongoing; losartan (LOSARTAN) at 25 mg once daily for Blood pressure, has been taking for maybe 5 years, maybe more, maybe less and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) at 70 mg once daily for prostate, has been taking for 6 years, maybe 7 and ongoing; clopidogrel bisulfate (PLAVIX) at 75 mg once daily prescribed by cardiologist after stent placement (2 stents), has been taking for 3-4 years and ongoing; rosuvastatin calcium (CRESTOR) at 20 mg once daily for Cholesterol, has been taking for maybe 5 years, maybe more, maybe less and ongoing; metoprolol (METOPROLOL) at 20 or 25 mg once daily for Blood pressure, has been taking for maybe 5 years, maybe more, maybe less and ongoing. No additional vaccines were administered with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Patient's last vaccine was the pneumonia vaccine in October. AE(s) following prior vaccinations was none. No family medical history relevant to AE(s). The patient received the first dose of the Pfizer covid vaccine on 21Jan2021, had fever for 3 days then on 27Jan2021 he tested covid positive. When they came home after the vaccine on 21Jan2021, the patient had a high temperature/fever for 3 days. The patient took Tylenol to help with fever. After this 3-day period, the patient's wife became sick with Covid-19 and she reported that she did not get the vaccine as she had antibodies and she did not need it. It was reported that she became ill and both she and her husband (patient) were tested for Covid-19 and the patient tested (Rapid Test) positive after receiving the first dose of the Covid-19 vaccine, 5 to 6 days later on 27Jan2021. When the patient tested positive for Covid-19, he felt fine and was no longer running a fever. They cancelled the second dose which was scheduled on 09Feb2021 due to covid. The patient was tested for antibodies on 11Mar2021, but it came back negative; it was 0.9. They wanted to know what to do next, how he can have antibodies for the covid and also about the timing of the second dose. Also asked, if the positive Covid-19 test was a reaction from the vaccine, it was Covid or the test was wrong. AE(s) did not require a visit to Emergency Room/Physician Office. Outcome of the event fever was resolved on 24Jan2021; covid-19 was unknown. No follow-up attempts are possible. No further information is expected.

nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events. Follow-up attempts are needed. Further information has been requested.

he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.

I had a severe reaction to my 2nd Pfizer shot with projectile diarrhea for 3+ days! This seems unlikely since it occurred 9 days after the shot but there's no other explanation. This left me so dehydrated that I went into AFIB and had to visit Emergency Room.

Severe throbbing headache, which lased until visit with doctor on 4/6/2021. Received Toradol injection, Thigh. Headache tapered off, then resumed one week later. Doctor ordered a prednisone taper, which ended the headache. Also, had a two week abdominal rash, beginning 2/27/2021 which was treated with Clobetasol Propionate .05% to resolve severe itching.

started having events of asthmas and coughing type stuff; started having events of asthmas and coughing type stuff; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 28Jan2021 as 1st dose, single for covid-19 immunisation (76 years old when vaccinated). The patient medical history included asthma and chest congestion. Concomitant medications were not reported. On 01Feb2021(patient reported as last night) he started having events of asthmas and coughing type stuff. The patient reported that he would normally get Prednisone for this but asks if it is contraindicated between the vaccine doses. The outcome of the events was unknown. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), on 16Mar2021 at 13:00, after lunch (at the age of 76-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in good health for age 76, as reported. The patient played semi pro sports. The patient received the first dose of BNT162b2 (lot number: EN6200) on 23Feb2021, at the age of 76-years-old, for COVID-19 immunisation. The patient experienced his left arm to be a bit sore and just one tiny little headache in Mar2021. He had no fever or other possible side effects. Patient asked if drinking alcohol had any effect a few hours later the vaccine. He clarified he was not drunk; only for a couple of glasses of wine/beers. The patient clarified that he had a couple of glasses of wine with dinner and had no reaction. He was speaking about having a couple of glasses of wine with dinner and the pharmacist told him that he was pretty sure that would be fine to do. Patient stated he had a lady friend coming over the night of the report and she was getting her 2nd Pfizer vaccine on that day and he was convinced that a glass of wine would not hurt. The patient asked when after the shot you would have the highest level of protection and how long after the 2nd booster of BNT162b2 he would be best protected and if it would be in another week or 2 weeks before full protection occurred. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Lost weight; He had no appetite; Stomach cramps; Dehydrated; Tired; no energy; Confused; Headache; Diarrhea; Not digesting food; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EL9269), in left shoulder on 13Feb2021 06:30 as dose 1, single for covid-19 immunisation (76 years old when vaccinated). Medical history included damaged his thumb a couple of years ago. There were no concomitant medications. The patient reported that he got the shot this morning. After he got the shot on 13Feb2021 he had to wait for 15 minutes before he could leave. While waiting the 15 minute time period he got a slight headache at that time. He later stared to drive home and realized he was feeling confused. He decided to get something to eat and that did make him feel better. However, he felt like he was not digesting his food all day. He felt like he was still bloated. He was not processing the food he had eaten. He added, the food he did eat he thought the eggs were not done. Normally, he would not eat them, but he was in a hurry. After that he did not eat any food. He was unable to eat any food. Later that day he began to have a bad reaction. He felt extremely tired. He then started to lose his body fluids. He would sit down and it would run out of him. He decided to quarantine himself. He stated he could not use the internet because he lives in a place where they do not have internet. He was tired, had no energy. He just kept losing body fluids constantly. He has lost weight. He felt dehydrated. Stated he did not have a fever. He had a thermometer and was checking it every hour. It felt like at the time when events first started he was getting worse and worse and so he just laid there. He stated he does not know his current weight. He was dehydrated so bad. He lost so much weight his shoes does not even fit his feet. Later, he confirmed he no longer has a headache. He last had a headache slightly yesterday. He added that the headache could have also occurred due to lack of eating. He had no appetite. He was unable to provide if recovered completely or recovered with lasting effects when probed for outcome. He stated he just felt ran down. He clarified losing body fluids as he had like water, like diarrhea, it was running right out like it would out of a body bag. He could not stop it from coming. It would happen every few minutes. He confirmed that he no longer has diarrhea. He had started taking Kaopectate. He reported that he last had diarrhea a little yesterday morning. He does not have it anymore. He just has no energy left. He would lay down because he was so tired and then he started having the diarrhea and it kept getting worse and worse. He ate a little this morning, a breakfast roll. The day he got the vaccine he was so tired. He slept a lot. This was early afternoon. He got up because he realized he had made a mess with the diarrhea. He started having stomach cramps the night of 13Feb2021. He had some when he laid down. He still had some last night when he laid down. He does not know if the stomach cramps have resolved yet, stated he is still waiting to see. He will have to see when he lies down. However, he is trying to get out and about to get some things done and get something to eat. He stated he was taking Tylenol, but the Tylenol was mainly for the stomach cramps. By 14Feb2021 he started to feel dehydrated. He felt that by then he had already stopped up the sewage system. He was taking electrodes from (Pharmacy) due to the dehydration. He knew this was going to be a problem. Therefore, someone went out and got this for him. He stated that he feels better overall. He will truly see when he tries to get something to eat. He stated he does not take any medications whatsoever on a regular basis. He added, the guy who gave him the shot caller does not believe he has given too many shots before. He thought he was a rookie. He stated he went too high to begin with. He said that normally, shots don't hurt with him and this time it did slightly. He reported that he gets the flu vaccine every year. He was supposed to get the second shot 06Mar2021, but he was not sure about if he should get it and has questions about that. The outcome of the event headache was recovered while diarrhea, he had no appetite, lost weight and confused was not recovered. The outcome of the event not digesting food, dehydrated and stomach cramps was unknown while the outcome of tired; no energy was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

His sinuses are acting up; feels like he has the flu; aches; Chills; blood pressure has spiked/His blood pressure has been in the 120s on the high side over the 60s. His blood pressure has gone up to 160+ over 80+; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number was not reported), via an unspecified route of administration at the age of 76-year-old on 01Feb2021 as single dose for covid-19 immunization. Medical history included blood pressure abnormal. The patient's concomitant medications were not reported. The patient reported that his sinuses were acting up and he called about the Pfizer covid vaccine. He read the pamphlet on the side effects. He did not have all of the side effects and he felt like he has the flu, aches, chills and did not have a fever and his blood pressure had spiked. The patient reported that he has never had a blood pressure problem except way back. His blood pressure had been in the 120s on the high side over the 60s, but his blood pressure had gone up to 160+ over 80+. He did not know if that has anything to do with the vaccine. The patient that he was on blood pressure medication and he has never had a problem. The patient underwent lab tests and procedures which included blood pressure measurement: spiked. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot. The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered and outcome for other events was unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter

developed flu-like symptoms after two weeks. Nausea. Loss of appetite. Wife admitted for renal failure. Patient admitted for acute on chronic heart failure. Now with gouty arthritis. Patient states it?s too much of a coincidence. They will not take another dose.

Patient tested positive for COVID-19 on 07/09/2021. Sx onset 07/04/2021 (SOB, cough, loss of taste/smell, fatigue, body aches, subjective fever; afebrile at time of testing). CXR has been ordered, pending. Lab contacted to request specimen be held, and requested they contact TN DOH to coordinate with CDC to discuss the case further. Attempting to coordinate monoclonal antibody infusion for this patient.

Itching; Scaliness of the skin, Similar to eczema; Scaliness of the skin, Similar to eczema; swelling of the right leg, Now also swelling in left leg.; dryness of skin; chills; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route, administered in Left Arm on 04Mar2021 at 13:30 (76-year-old at time of vaccination) as a Dose 1, single for Covid-19 immunization. The patient's medical history included diabetes mellitus, blood pressure. The patient received diabetic medication and blood pressure medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. 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 infection. On an unknown date in 2021, the patient had experienced itching, scaliness of the skin, similar to eczema, swelling of the right leg, dryness of skin, chills. Now also swelling in left leg. The adverse event resulted the patient to visit Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19 infection. The patient received antibiotics, benadryl, lotion for skin as treatment medications for the resulted events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving. Follow-up attempts are completed. No further information is expected.

sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER6955, Expiration Date- Jun2021) via an unspecified route of administration in left arm on 05Apr2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 03May2021 as dose 2, single (at the age of 76-years-old) for COVID-19 immunization. Patient medical history included ongoing seasonal allergies, never had an actual diagnosis. He thought there was something wrong with his lungs and said that he was wheezing and the doctor prescribed him something that he did not want to take. Picked up leaves and his throat constricted on him and he said that he diagnosed himself. The concomitant medications were not reported. On an unspecified date in 2021, patient stated he has had both doses of the Pfizer COVID-19 vaccine and reported that the vaccine made him sleepy. He stated he would sleep for 3 to 4 hours after the vaccine. He reported soreness around the arm. He stated he felt great after the nap. He stated he took the Pfizer covid 19 vaccine and feels more at ease now. He stated that his eyes were bad prior to the vaccine and it had no effect on his eyes. He does not like taking medication, but every once in a while would take Benadryl for his allergies. It might have been that he just laid down after the vaccine. He said that he is a old man and can sleep all of the time. The outcome of the events was unknown. Follow up are attempts needed. Further information is expected.

After the first vaccine he suffered a massive brain bleed. Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days. After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia. His balance is off he has memory loss and a lot more.

Received his Pfizer vaccinations 1/26/21 and 2/16/21; he started to have a dry cough on 7/15/21 which has progressed to shortness of breath. He does admit to eating with friends who were not vaccinated while on vacation sometime prior to this. He had a positive COVID test at his PCP office on 7/18 and another positive COVID PCR at our hospital 7/22

vomited; nausea/ felt sick to his stomach; felt woozy; didn't feel well; right deltoid soreness; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received the first dose of BNT162B2 (Lot: EH9899), via an unspecified route of administration in deltoid right, on 24Dec2020 11:30 at single dose for COVID -19 immunization. Medical history included pulmonary embolism half a dozen years ago. He has had no problems with Deep Vein Thrombosis or pulmonary emboli since then, since half a dozen years. He has had a battery of lab tests 2 months ago, his blood glucose was high, it was 106 mg. The potassium was ok. He has had no issues with vaccines in the past. He had an antibody test last Jul2020 because he had bacterial lower urinary tract prostate infection. Concomitant medication included rivaroxaban (XARELTO) at 10 mg a day and cefalexin sodium (CEPHALEXIN) at 500 mg three times a day, well approximately 3, sometimes he forget a dose. The physician reported possible side effects of Covid vaccine. The physician received the vaccine on 24Dec2020 at 11:30 in the late morning and felt fine. He woke up on 25Dec2020 and at 2:30AM he was sick to his stomach and vomited and didn't feel well the rest of the day. Since then he had been okay, he had occasional nausea and vomiting. He clarified that on 24Dec2020, in the late evening, his appetite which was usual, was robust. Then on 25Dec2020 at 2:30 in the morning he vomited, and had no trouble since then. From what he read, nausea and vomiting are observed following the injection. On 24Dec2020 just before bed, he had a light supper, his appetite was robust, then unexpectedly he woke up sick to his stomach and went back to bed on 25Dec2020. He clarified that he had not vomited since the one episode on 25Dec2020. He also added that he has not been nauseous since then. Caller also added that he felt a little woozy on Holiday 25Dec2020, it only lasted up until the evening of 25Dec2020. He had the 1 episode vomiting on 25Dec2020 and felt woozy until late evening of 25Dec2020. His right deltoid where he received the vaccine was a little bit sore on 24Dec2020, and he was still having a little bit of soreness, it is slight, not very tender, he is unable to do usual morning exercises with out noticing the discomfort, the exercise he is doing is chin ups, the soreness is not intense and it never was. The lab test in 2020 included Height: under 5 feet 5 inches. Weight: about 165lbs or 167lbs. He had no positive test for COVID prior to the vaccine. All the tests were negative. The 1st one was nasopharyngeal, and all the next ones after were nasal swabs. He thought they are all reverse transcriptase tests. The last time he had a COVID test they did a nasal swab, it was this morning, and before that was last Monday or Tuesday, but he thought more so Monday. He had one PCR test. The outcome of the events vomited, nausea and felt woozy was recovered on 25Dec2020. The outcome of the event right deltoid soreness was recovering. The outcome of the other event was unknown. The 2nd dose for Covid vaccine was schedule for 14Jan2021.

THE NIGHT OF VACCINATION DAY, RESIDENT BEGAN C/O SEVERE PAIN IN THE INJECTION ARM. THE DAY AFTER THE VACCINE, HE BEGAN HAVING MOOD ISSUES, VERBAL AGGRESSION/OUTBURSTS (ABNORMAL FOR THIS RESIDENT), DIZZINESS AND A SEVERE HEADACHE HE RATED AT 10/10 PER PAIN SCALE THAT DID NOT RESOLVE WITH SEVERAL DOSES OF PAIN MEDS.

THE NIGHT OF VACC DAY, C/O SEVERE INJ ARM PAIN. THE FOLLOWING DAY, HE BEGAN DISPLAYING VERBAL AGGRESSION AND OUTBURST TOWARDS STAFF WHICH IS OUT OF NORMAL FOR HIM, INCREASED DIFF REMEMBERING SHORT TERM, C/O DIZZINESS AND SEVERE HEADACHE RATED 10/10 ON PAIN SCALE NOT RELIEVED WITH SEVERAL DOSES OF PAIN MEDS AND RANDOM DIZZINESS

Chills, low grade fever, generalized muscle aches, headache . Lasted approximately 36 hours. Treated with Tylenol and Inuprofen.

Increased temp of 99.2F oral, extreme fatigue, lethargy, episode of incontinence, hallucinations beginning in the morning and has continued through the day.

fatigue; body aches; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, lot # ELO142), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes and pacemaker. The patient's concomitant medications were not reported. The patient experienced fatigue and body aches on day of injection on 09Jan2021. The event outcome was unknown.

mild runny nose; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. Medical history included hypertension (HTN), diabetes and pacemaker. The patient's concomitant medications were not reported. On 10Jan2021, after the use of the vaccine, the patient experienced mild runny nose (non-serious) with outcome of unknown. Information on the Batch/Lot number has been requested.

Cough, congestion, shortness of breath, diaphoretic, Temp of 99 degrees F, nausea, oxygen saturation dropped to 88% on room air

Flu like symptoms, chills, shakiness, stuffy sinuses and moderate fatigue. Occurred 24 hours after injection and, with the exception of fatigue, have abated for the most part on day two following injection. I received my shot at hospital. It was the Pfizer formula. Injection site upper left shoulder.

He was sent to the ER later that day when he complained of headache and palpitations and his blood pressures and heart rate were unusually high. He had at no time any chest pain. At the ER, he had two serial troponins at 0.06, representing a mild enzyme leak. He had no EKG changes concerning for ischemia or arryhtmia but his BP was noted to be in 170/100's which is higher than his baseline in the 140's. It came down on its own eventually. It was determined that if anything, he may have ha some demand ischemia from his hypertension, and that in the future he should at least get a TTE, or if he can tolerate, a cardiac stress test. He returned without any medication changes.

Narrative: See "Other Relevant History" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:

1- Within minutes noticed a very slight effect on perception. Fogginess. Never mentionned to staff 2- Drove home feeling good but very slight headache. Has continued. 3- The PROBLEM started several hours later. Severe ringing...Tinnitus. 4- Never stops even when I wake up in the middle of night, first thing in the morning and at night. 5- Nothing helps, called my PCP the day after injection. 6- PCP assistant called back next day. Suggested I call an ENT. 7- Called my insurance UHC Advantage to speak with nurse. Gave me a list of ENTs 8- PCP instructions were to give it a day or two to see if the ringing would stop. 9- Tinnitus is very significant and is causing me much distress...Max Words!

Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours. Two days post injection (01/30/2021) 11:A.M. 2 bouts of Diarrhea over two hour period. Two days post injection (01/30/2021) 10:00 P.M. Broke out in a full body sweat, weakness with heart rate 120 bpm. Cooled off by using cool wet towels and rested for two hours. Heart rate down to 75bpm. Heart felt like skipping beats for another hour. Now Sunday morning (01/31/2021) and feel normal

I had my second Covid-19 vaccine last Friday at noon, January 29, 2021. I felt fine until late Friday evening. I woke up around 3am violently panting and trying to get his breath. After what could have been a minute or many minutes, I started breathing normally. My Friday night sleep was terrible. I woke with a temperature around 101. After taking Acetaminophen, my temperature went back to normal. Towards evening my temperature went up to about 101 and I was achy all day. Saturday evening was a good evening and I woke up feeling fine on Sunday.

Patient began complaining of dizziness and changes in vision (but no loss of consciousness) following 1st dose of COVID-19 vaccine. Patient was also diaphoretic and hypotensive with blood pressures of 82/57, 80/36 mmHg. No wheezing or respiratory distress were noted, and the patient did not endorse any changes in sensation/tingling/itching to face, lip or mouth. Patient was taken to the ED for monitoring. Workup in the ED was negative, and the patient was discharged home.

he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jan2021at single dose for COVID-19 immunization. Medical history includes hearing aids user from unknown date. There were no concomitant medications. On 17Jan2021 Sunday, the patient was freezing to death, had chills and diarrhea and still has them right now. The patient was fully aware that second dose is on 04Feb2021, and wants to know more information, is this going to continue, etc. The patient stated he was real sick, but while being sick, he read the papers, and it actually told him, this was supposed to happen. He was supposed to have chills and fever and all that, and by golly his body has done a good job of that. The real thing is, he is fine with taking it again, but after such a reaction, he wants to know if it is safe to take it again. The patient stated he lost one of his hearing aids, he needs to have another one sent, he had a terrible day yesterday. His symptoms came on in the middle of night, got in clothes stayed in bed. He has no primary care doctor, he has one here but doesn't know if he wants to mess with him. For events freezing to death and chills outcome was the he feels good, he was not chilling or doing anything anymore, but one thing that is bothering him, he doesn't have any energy, he was real low on energy. The freezing to death and chills started leaving yesterday morning, and went away over the day, he is just kind of down with it, just tired. He doesn't know why. The diarrhea didn't hang around a long time. The outcome of the events freezing to death, chills and diarrhea was recovered on unspecified date. The outcome of the remaining events was unknown. Information on the Lot/Batch number has been requested.

6 days ago he got his first COVID-19 vaccination. 5 days ago he started to feel ill. Generalized body aches. Progressive shortness of breath. More recently dry cough. Diminished sense of taste and smell. His symptoms progressed and today, due to shortness of breath, he presented to the ED. In the ED he was found to be hypoxic and have tachypnea. COVID-19 test was positive. He was given intravenous dexamethasone and is referred to the hospitalist service for admission. Patient denies ill contacts. He denies diarrhea. No nausea or vomiting. Since arriving to the ED and getting on oxygen he feels significantly better.

Starting at day three after the vaccination, I experienced significant fatigue. I also have experienced significant and rather violet chills, shakes and teeth chattering. The fatigue lasts all day. The chills come on each afternoon and last for about an hour. My temperature is 101 to 103 during the event, but it is normal the rest of the day. The fatigue and chills continue through today.

Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A 77-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 in left arm, on 18Jan2021 at 14:30, at a single dose, for COVID-19 immunization; and ibuprofen (ADVIL; Strength: 200 mg, Lot Number: DC5474, Expiration Date: May2022), via an unspecified route of administration, on 18Jan2021, at 400 mg, single, as premedication. The patient's medical history and concomitant medications were not reported. The patient's wife was told by a nurse to give ibuprofen before the patient's first shot. So, the patient's wife told the patient to take ibuprofen before the COVID-19 vaccine shot and he took two 200 mg ibuprofen before the vaccine. The patient's wife feels guilty because she doesn't know if the patient is protected or not. The patient's wife gave the patient two ibuprofen before the COVID-19 shot. On 18Jan2021, the patient felt a bit tired and his arm hurt a bit, but he was fine the next morning (19Jan2021). He only felt a little tired that day and the next day, he felt great. It was further reported that the patient's wife gets allergy shots from a nurse, and the nurse told her to take ibuprofen before the COVID-19 vaccine shot. The patient never takes ibuprofen and the patient's wife can't believe she told him to take it. She had a friend who said ibuprofen could minimize the effectiveness of the shot. So, she was asking if the patient should have another shot since he took ibuprofen before his vaccine. It was a very bad advice because the patient's wife just learnt she shouldn't have. The patient's wife wanted him to have a little reaction as she thinks the vaccine is not going to be effective; asked if the patient should take an additional shot. The patient is scheduled for the second dose of the COVID-19 vaccine on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable; and for ibuprofen was post-therapy. The patient recovered from the events on 19Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Narrative: See "Other Relevant History" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of "There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib

fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr in a wheelchair on Monday ,February the 1st. Doctor put him on covid meds and he is still to this date (Feb. 6th) still weak . we had a covid test done and it was negative.

starting at the base of head/shoulder pain goes up head, throbbing can not lift head. Taking Tylenol, applied heat pad to back of neck and head

Patient was vaccinated at 11:30am. By 7pm he started presenting symptoms of fatigue, chest pain. Patient urinated and defecated in himself. Was not feeling well. Patient died at 10:30pm.

Left arm (arm that received injection) was slightly painful when used to left or push push a snow shovel for two (2) days. 3 day was fine. On 3rd day, Sat. 2/6/2021, felt a bit tired and listless most of the day. Next day felt 100%

Headache; Horizontal red line of swelling at the injection site; Horizontal red line of swelling at the injection site; Nausea; Circular rash on the shoulder; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 20Jan2021 (12:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included high blood pressure (HBP); atrial fibrillation (atrial fib.); sleep apnea; heart disease; contrast dye allergy; and mold allergy. Concomitant medications included losartan, carvedilol (COREG) and piroxicam (MAXIDENE). On 22Jan2021 (08:00), the patient had headache; horizonal red line of swelling at the injection site; nausea; and circular rash on the shoulder. The patient did not receive any treatment for all the reported events. The outcome of the events, 'headache', 'horizonal red line of swelling at the injection site', 'nausea' and 'circular rash on the shoulder', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.

Events: Soar arm, chills, slight fever, aching muscles and joints Treatment: Tylenol Outcome: Resolved in two days

Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).

Patient referred having persistent cough and slight shortness of breath that started the day after the immunization which slowly faded week and a half after the immunization.

moderate pain at injection site rt arm. lots of body/ joint pain. chills. headache. no fever . lasting 24 hrs

After mild and expected side effects (stomach ache, mild diarrhea, headaches, tiredness) woke up at 2 am with dizziness on rolling over in bed. Persisted into the morning on arising.

Initially sore arm at injection site, on 2/1/21 continues with drowsiness, sore throat, stuffy nose, productive cough with yellow phlegm, congestion

ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.

Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The arm he received the injection in was tender however progressed to mild to moderately painful/arm was suddenly painful; Shaking; Injection site tenderness; This is a spontaneous report from a contactable physician (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9262, expiry: unknown), via an unspecified route of administration in the left arm on 26Jan2021 15:30 at a single dose for protection from the virus at the Physician Office. Medical history included type 2 diabetes mellitus from 2011 and ongoing. The patient also thought he had a Covid respiratory infection in Feb2020. He had a prolonged moderate to severe respiratory infection. He thought at first that he had the flu, but he had a flu shot. He thinks he had Covid. He had antibody studies in May2020 (last spring) that were negative. The patient has no concomitant medications. The patient previously had influenza vaccine (flu shot). The patient reported hypothermia after getting the first dose of the Pfizer Covid 19 vaccine. On the same day of vaccination (26Jan2021), he had injection site tenderness. The next day, (27Jan2021), his arm was suddenly painful; he began to have chills 29 hours after receiving the vaccine (27Jan2021) and was shaking. He also had a temperature of 93.7 orally, confirmed with two different digital thermometers. He took his temperature with a new electronic thermometer that he purchased at a pharmacy. His temperature was 92.7 on 27Jan2021. He repeated it with another electronic thermometer. The first evening (27Jan2021), his temperature went to 96.5 to 98 degrees. Then it went down to 93.2 degrees. He covered up with blankets and his temperature increased and the chills stopped. He stated that this was hypothermia. He had low temperatures the following day (28Jan2021) as well, his temperature was 93-94 degrees. His temperature was 93.7 degrees. Other times he checked his temperature and it was 96.5 degrees. When his temperature was low the first time, it only lasted for about three hours. The second time it happened he went to bed and covered up. It lasted for an hour or two. He noticed it again two days ago. The patient also stated the arm he received the injection in was tender however progressed to mild to moderately painful when he experienced the chills and low temperatures. The arm tenderness after getting the vaccine was very mild. He noticed it when he rolled over on his arm. He took some Tylenol for it. His son is an internist. He said the hypothermia was medically significant. His son also said hypothermia is equivalent to a fever in the elderly. The patient wanted to know if there have been any reports of hypothermia after the administration of the vaccine. He has concerns about this occurring after the second dose. He is scheduled to receive the second dose on 15Feb2021 or 16Feb2021. The outcome of the event hypothermia was recovered on 30Jan2021 and pain in arm recovered on 27Jan2021. The outcome of the other events was unknown. The events hypothermia, arm pain and injections site tenderness were assessed as related to BNT16B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported hypothermia and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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.

Profound fatigue, loss of appetite, continued unabated for 11 days. Still experiencing mild symptoms now, 14 days later.

my father started experiencing mild headache the night after injection (Sunday night). He lost his appetize the following day (Monday). The symptom did not get any better on the second day (Tuesday) after injection, in addition he felt fatigue so he measured his blood pressure and heart rate and noticed that he had higher blood pressure (145/90 versus 130/80 his normal) and much faster heartbeat (110 versus 80 his normal).

1st vaccine 2/19/21; developed N/V/D abdominal pain and fatigue 2/20/21; seen in ED 2/23/21 for ongoing symptoms

1. Pain at site of injection started about 6 hours post second vaccine injection (7-8 on a 0-10 scale) that lasted for almost 48 hours, most intense during the day following injection. No treatment for that. 2. Significant fatigue on the morning 14 hours following the injection (could have started during the night) . Difficult to maintain balance. Just rested the whole day. Unable to exercise on stationary bike. 3. Low grade fever (just under 99 F; base line for me has been 97.6 F) in the evening following injection, gone next morning. No treatment.

2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021.

Exactly one week following the injection I experienced sudden onset of significant vertigo that required immediate bed rest. There was also minimal nausea and headache, intermittent. Slept well, but had a very difficult time walking from bed to toilet during early morning due to the symptoms. Slightly improved by 7 AM in the morning. Intermittent episodes of the vertigo during Friday and Saturday, decreasing in intensity. Was able to exercise on stationary bike on Friday and Saturday PM. No symptoms Sunday AM (now). Will symptoms recur?

itched everywhere ears, scalp legs and arms.; headache; tired; itchy nose; This is a spontaneous report from a contactable consumer (patient) A male patient of an unspecified age received BNT162B2 (Solution for injection, Lot/Batch number was not reported) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received the first vaccine on 21Jan2021. He had a headache, tired and itchy nose. He took a benadryl and it went away. On 25Jan2021 that he itched everywhere ears, scalp legs and arms. The symptoms went away 30 minutes after Benadryl. The patient was not getting any better and maybe a little worse. The outcome of the events was recovered on an unspecified date of 2021.

Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.

48 hours after the 2nd dose of the COVID-19 vaccine, he had generalized body aches that had worsened, chills, agitation/anxious, dizzy, and hyperventilating/ shortness of breath. He went to the hospital with his wife on 3/1/2021. He stated "I think I'm going to die". Patient had been off Cymbalta for 3 days completely- treating neuropathy (previous daily medication that his primary physician advised him with weaning down the dose). The patient was manic and had tangential thoughts- from crying/angry to laughter. It is believed that the agitation could be due to medication withdraw.

2 days after 2nd dose of Pfizer vaccine pt developed stuffy nose, SOB, but no cough, fever, or chills, then developed an itchy rash on Rt foot that spread to arms and legs resulting in a peticheal rash/lesions on dorsum of feet, shins, thigh, mid abdomen, medial arm and back. Dermatology consult felt due to allergic purpura, and vasculitis possible but less likely. Platlet count in the normal range.

About 24 hours after the injection, I had extreme fatigue and difficulty getting out of bed. along with body aches in both arms and a seizure like blank stare and couldn't move my arms and legs for a short time. Briefly I had shakes in both arms but no fever, chills, or headache. By the next morning the injection arm (left) was achy with no other prominent symptoms.

had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.

Almost 2 weeks after my second covid shot I had a fever, runny nose, fatigue, and general achiness. It started on Wednesday and the fever was gone on Friday morning. I still feel a little fatigue, but am otherwise OK. This may be unrelated to the vaccine I received on February 18th. I am only reporting it because it might have been related.

3-3-21 unable to open jaw, sweating (sweating resolved). 3-4-21 swelling to chin area with redness. took tylenol reports it helped him. asked if he had any fever, wife reports "no". called PCP spoke with his nurse, pending further instruction from PCP and or nurse. Wife called back states her Husband has abscess tooth, so feels maybe related to that. Wife states he was given Amoxicillin yesterday at MD office. She states he is feeling better today, eating slowly.

Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills with rigors. 01/31/2021 03:22 presented to ED for assessment with complaints of abdominal pain and shaking; 01/31/2021 06:29 patient discharged from ED - symptoms resolved; ED Tx consisted of Acetaminophen 1gm IV x 1 dose; chest x- ray (neg); CBC (WBC 12.9); CMP (AST 77, ALT 94); Respiratory Panel 2.1 IVD (BIOFIRE) - Negative; EKG - A-fib rate 108;

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Third day weakness and fatigue.

low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.

Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time for either). I could barely get out of bed (an awkward rollover did it). My tongue was numb (still is) and raw from the presumed chewing on it. Walking was slow and painful as all muscles hurt. If I sneezed or coughed, my back would hurt. Those last problems are still true. I periodically cough up phlegm and lacking a good place to spit it out, I just swallow it. I have for the first time in my life been using a walker for stability. Right arm is almost useless due to pain.

Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when I woke up felt a slight headache , abnormal vision issues that included sparkles, blurred vision and a general tiredness. Did not feel refreshed as I normally do when I wake up in the morning. As the day went on sparkles and vision issues remained and headache got worse. Went to bed earlier than normal and next day when woke up the symptoms got worse, I felt like I had a migraine. Vision issues persisted. Laid down around 11AM and took a nap and when I woke up I noticed a blotch in my left eye reminiscent of the shape of a fish (looked like a shark) and it had different colors. Bright yellow and black almost kind of an iridescent green and orange. The shape was still just the colors were different. I panicked and called the optometrist and explained what happened. They wanted to see me right away. I was able to be seen in the afternoon. They looked at it, did two tests and came with the diagnosis of a branch retinal artery occlusion. I visited my neuro- ophthalmologist on 01/28 and he confirmed the diagnosis had previously given. He then ordered fedrate and a couple of other tests. They also did a visual acuity in the left eye (20/30) and color vision (8/8 normal) and color plates and intraocular pressure (16 OS)

pt stated he had a head ache about 15 minutes after getting the vax but subsided quickly. When he woke up the next morning he had tightness in his chest that last a while and then went away. A couple of days later he had a dizzy spell which would come and go. This lasted about 3 days. He had another episode of tightness in his chest. On 3/7/2021 he developed a red rash on his chest that had a hive in the middle of it that was itchy. He started getting itchy spots on the top of his hands, fore arms, top of his ears, and the top of his head. At this time he only has slight rash on his chest and shoulders that are not itching.

dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.

Insomnia; Chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. This 77-year-old male reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 05Feb2021 at 02:30 (as reported) (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were not specified. The patient experienced insomnia onset at day 8 then thru day 14 and chills day 10. The patient was not treated for insomnia and chills. The clinical outcome of insomnia and chills was recovering. No follow-up attempts are possible. No further information is expected.

Patient reported feeling overly fatigued, abdominal pain and elevated liver enzyme results on lab work.

mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-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, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.

fever and was hospitalized with gastrointestinal bleeding.; fever and was hospitalized with gastrointestinal bleeding.; abdominal pain; vomiting with blood; This is a spontaneous report from a non-contactable consumer. A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot: unknown), via an unspecified route of administration on 26Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient's medical history was not reported. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) taken for a year. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot: unknown) on 05Feb2021 for COVID-19 immunisation. On 09Mar2021, the patient experienced fever and was hospitalized with gastrointestinal bleeding, abdominal pain, and vomiting with blood. The events caused hospitalization on an unspecified date. It was reported that patient had COVID test post vaccination on 10Mar2021 with unknown results. Therapeutic measures were taken as a result of all events. The outcome of all events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Pfizer-BioNTech vaccination given on 2/26/21 and 3/19/21. Presented to ED on 3/27/21 with generalized body aches, shortness of breath, and cough. Was admitted to hospital for COPD exacerbation and COVID-19 infection without hypoxia.

Patient reports that he received vaccine on 03/17/2021. on 03/19/2021 he started to have a headache on the left side of his head. This is the same side he received his vaccine. He also started having an ear ache on left side starting on 03/20/2021. These symptoms are continued however improved.

Fever, hypotension, elevated lactic acid, mildly elevated LFTs 5 days s/p 2nd dose Pfizer vaccine. Similar sxs a few days after 1st dose.

72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.

Mild fever; muscle and joint pain; muscle and joint pain; malaise; This is a spontaneous report from a contactable consumer reported that a 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; age at the vaccination 77-year), via an unspecified route of administration, in right arm on 02Feb2021 12:15 as single dose for covid-19 immunisation. Medical history included covid-19 (prior vaccination). The patient's concomitant medications were not reported. Patient had allergies to penicillin. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient been not tested for COVID-19. On 03Feb2021, patient had Mild fever, muscle and joint pain, malaise. The reported seriousness was non serious. Patient not received treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.

Patient's chief complaint was feeling tired and shortness of breath. Patient was hypertensive. Denied dizziness and chest pain. Patient was offered oxygen supplementation but refused and stated that he felt okay. All symptoms resolved except fatigue and blood pressure remained slightly elevated.

weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.

Fatigue; This is a spontaneous report from a contactable 77-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 10Jan2021 at 08:30 as single dose in right arm for covid-19 immunization. The patient's medical history included have 2 stents for heart condition inserted 15 years ago. Concomitant medications included rivaroxaban (XARELTO), atorvastatin 40 mg, acetylsalicylic acid (ASPIRIN 81), cyanocobalamin (B12) (dose description :500 unk). On 10Jan2021, the patient experienced fatigue. The patient did not take any treatment for the event. The outcome of the events was not recovered.

Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Timeline of events: o No concerns in the past month. o Usual state of health on Friday 4/9/2021 o Received Pfizer vaccine at event on 4/9/2021 o Fatigue, poor PO intake and myalgia on Saturday, 4/10/2021; Received Tylenol at 1 pm o Texted Primary Community Nurse (PCN) (not on call), on Saturday, to share above. PCN followed up Sunday morning and reassured them. o Last seen alive Sunday night, not well from vaccine but does not seem like family was concerned enough to page on call team o Monday morning- found dead in rigor mortis o Cause of death: deemed sudden cardiac death. Etiology unclear. o Unexpected death.

Substantial flu-like symptoms. Chills. Mild ache near injetion site next morning for less than hour. Cured with 1000mg Acetaminophen several hours later.

Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), gout, and lung cancer (remission). Patient has no COVID-19 prior to vaccination. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever and nightsweats on 01Apr2021. The patient was hospitalized for fever and nightsweats for 3 days. The outcome of the events was recovered. Information about lot/batch number has been requested.

Chills; legs didn't work; hip sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no.: EL3247) via unspecified route of administration in left arm on 31Jan2021 at 13:00 (age at vaccination 77-year-old) at single dose for COVID-19 immunisation. Medical history, concomitant medications and past drug history were not reported. No other vaccine in four weeks. On 02Feb2021, patient experienced Chills, legs didn't work and hip sore. Reporter states he was calling to report after the vaccine. Three days later, he states he didn't feel good and was starting to have the chill, so he went to bed. After he went to bed he had the chills really bad, even the bed shook, and when he went to get out of bed his legs didn't work. His legs just folded up and he ended up on the floor. He didn't know if he was having a stroke or what. They called an ambulance and went to the ER in (city). At the ER they gave him some fluids and the shakes went down and later his legs came back. Adds his hips, both hips were really sore and he still has a sore spot on one side today. He has never had this problem before. By 14:00 in the afternoon he felt better and he was sent home. The patient adds that they did a CT scan and some other tests. Adds he was told he might have some signs of diverticulitis and he might have bacteria in his blood and he was supposed to call the doctor today to get some medication for that if he does. He was scheduled to receive the second dose on 25Feb2021. Patient mentioned his weight was between 155 pounds and 165 pounds. Adverse event (chills, legs didn't work) resulted in emergency room but not admitted to hospital. The outcome of event for chills, legs didn't work was recovered on 03Feb2021 and hip sore was recovering.

Patient had COVID-19 exposure and reported having a very bad cold with cough on 4/12/21 to his primary care physician. He was tested and found to be COVID-19 positive at that time. He presented to emergency department on 4/19/21 with worsening shortness of breath. He was admitted to hospital for further management of infection. Patient admitted from 4/19/21 to 4/24/21 and discharged to a skill nursing facility for further care.

loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. 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 experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.

Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new. Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.

Death Narrative: Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.

No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-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 in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. 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. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Vomiting for 3 days, terrible splitting head ache, ear ringing, disoriented, confused. bed ridden for 5, heard things not there unable to eat.

05/03/2021 I awoke and I had multiple joints hurting when I got up at 5:20 to go to work..During the day Monday, I had to take 1 turmeric pill for pain. The pain went away. Monday night I was extremely sleepey, and when I woke up to go to bed about 11:30 I notice some of the joint pain had came back esp the left arm. 05/04/21 , I noticed the area around the v site on the left arm had a red rash about 3x34" and a knot about the size of a golf ball raised and very hard. Joints were hurting in L arm, legs, and right arm and wrist. About 10 AM i took 1 ALEVE and within 2 hours the rash was almost gone on L arm at v site, and the swelling at the v site was also getting smaller. Took 1 more ALEVE at the time point and I felt fantistic. Same as today, great day, no pain.

This 77 year old male received the Covid shot on 1/27/21 and went to the ED on 2/1/21 and was admitted on 2/2/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome) Pneumonia, unspecified organism Acute kidney failure, unspecified

From the day following the injection, I felt to be in a mental fog that has very slowly nearly abated. Uncommonly tired, no headache fever, chills, or neurodeficit otherwise. ( I am a retired physician). This lead to change in gait: slow, foot dragging, unstable. Near accident in driving auto. More than 4 time of urinary incontinence ie incontinence when bladder overfilled. Mental clarity lost. speech impaired by word searching. Obvious change in behavior to those around me.

Patient received both doses of Pfizer vaccine (#1 on 2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on 5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with Hypoxia, Pneumonia due to COVID-19.

Pt with history of recovered Covid, developed sudden absominal pain, distention, emesis, diagnosed with bowel infarct and pneumonia, one day after 1st covid vaccine. Died 1/5/21 in hospice.

COVID-19 Chills Nasal congestion PND (post-nasal drip) Acute nonintractable headache, unspecified headache type Diarrhea 05/06/2021 03:54 PM EDT Phone (Outgoing) COVID 19 MAB Infusion Navigator Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file):05/06/2021 Start of Symptoms Date: 04/29/2021 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease Reviewed present symptoms with patient. Congestion, diarrhea Purpose of Infusion Assessment: Can you tell me why you are receiving this infusion? Reviewed by Physician 1. Date/Time of Infusion: 5/7/21 @12:00. Location of Infusion: Come to unlisted address. Park in the parking lot next to the Medical Office Building, and while in your car, contact the Infusion Center to register over the phone from your vehicle. Once you are registered, you will be directed to the entrance and a nurse will be down to meet and assist you to the suite and infusion room. 2. Confirmed that patient has spoken with his PCP/Referring Physician, patient is in agreement to the MAB infusion and acknowledges understanding and denies any additional questions at this time. 3. Confirmed that the demographics in the chart are correct including phone numbers, address and health insurance. 4. Patient will utilize a thermometer and pulse ox. Explained to patient about collecting temperature and pulse ox daily for 10 days. If applicable, patient will receive any additional assistance with their website access & use by the infusion clinic clinical team. 5. Patient will receive a ride to the appointment if needed. Patient first emergency contact and decision maker is unlisted. 6. SDOH ASSESSED. Key Reminders: You will want to eat or drink like you normally would prior to coming for your infusion. You can also take your medications as you would normally do, unless your physician has told you specifically not to take something.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:30 at 77 years old as 2nd dose, single for COVID-19 immunization. Medical history included hypertension from an unknown date. No medications received within 2 weeks of vaccination. No other vaccine received within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose BNT162B2 on an unspecified date (lot number: EN6200) for COVID-19 immunization on the left arm. On 14Apr2021, it was reported that patient had lost energy to get out of bed. Patient was transported to the emergency room with fevers and altered mental status. The patient was admitted in the hospital for 6 days from 14Apr2021 to 20Apr2021. The reporter considered the events to have caused disability. The patient received an unspecified treatment. Multiple tests were done to the patient on an unspecified date with unknown result. The patient had a COVID-19 test post vaccination via nasal swab on 15Apr2021 with a negative result. The outcome of the events was recovering.

Awoke at 5 AM with extreme nausea and went to bathroom to vomit. Passed out, hitting chin on toilet bowl and chipping front tooth. After vomiting, laid on floor for 2.5 hours before gaining enough strength to return to bed. Slept for the next 24 hours. Unusual fatigue still present daily.

Headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 02 patients. This is 2nd of 02 reports. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. He received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, patient experienced headache. Consumer was not reporting any issue with Pfizer product. Patient did not admit to hospital due to the event. There were no other products that were taken together with those indicated above. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017655 Same drug/AE, different patient

tiredness; fever of 101; had the runs; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old male patient received BNT162B2, (COMIRNATY, solution for injection, lot# EN6206) via an unspecified route of administration, administered on left arm on 09Mar2021 as 1ST dose, single dose for covid-19 immunization. The patient medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine ab-normalities (including diabetes) and obesity, COVID virus in October 2020. The concomitant medications were not reported. Symptoms came on right at the same time, he had second Pfizer Covid vaccine at 10:40 in the morning and by 17:00 in the evening had the reactions. The patient experienced headache on 09Mar2021 15:00, on 10 Mar 2021 woke up about 8:30 and he had all the symptoms start right after that. Tiredness on 10Mar2021, fever of 101 on 10Mar2021, had the runs on 10Mar2021. Outcome of headache tiredness, fever (fever of 101) and had the runs recovered on 11Mar2021. No follow-up attempts are needed. No further information is expected.

headache; fever of 99.9; itching from belly to knees with hives the size of quarters; itching from belly to knees with hives the size of quarters; This is a spontaneous report received from a contactable consumer reported for himself. A 77-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: unknown), via intramuscularly, on 30Mar2021 (at 10:40) single dose on left arm for COVID-19 immunization. Historical vaccination included the patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, on 09Mar2021 (10:10). The patient medical history and concomitant medications were not reported. The patient had COVID in October 2020 and was hospitalized for 17 days. No vaccines were taken prior 4 weeks. On 30Mar2021, by evening (at 17:00), the patient experienced a fever of 99.9, headache that was the worst, itching from belly to knees with hives the size of quarters. All the events lasted for one day. Allegra tablet was taken as a therapeutic measure fore itching from belly to knees with hives the size of quarters. The reporter assessed all events as non-serious. The outcome of the events was resolved on 31Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. 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. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

having tiredness after both the first and second dose of Pfizer's COVID vaccine; elevated plasma cell level; cancer indicator that is usually slightly elevated from his bone marrow aspirate; This is a spontaneous report from a contactable Pharmacist (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249 and Expiration date not reported), via unknown route of administration in upper arm, on 13Jan2021 at 13:30, (at the age of 77 years) as a 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: 19267 and Expiration date not reported), via unknown route of administration, in upper arm on 03Feb2021, at around 14:00, (at the age of 77 years) as a Second DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included heart bypass surgery (around 2015 or 2016), high blood pressure (probably around 2013), multiple myeloma (late 2006) and heart problems. The patient concomitant medications included acetylsalicylic acid (ASPIRINE), clopidogrel bisulfate (PLAVIX), olmesartan medoxomil (BENICAR), lenalidomide (REVLIMID) and zoledronic acid (ZOMETA). The patient states he started the ZOMETA medication after a stem cell transplant, around 2007, and then they did a bone density scan, and started the medication to increase bone strength. On an unspecified date the patient experienced, the patient had tiredness that's not normal for him after both the first and second dose of Pfizer's COVID vaccine (the last dose was in February). Patient staterd it's been a couple months now and he still feels tired. Patient was asking if that has been reported and how frequently and this has gone on for him for a few weeks. Patient had to do extensive blood work every 2 months all of my blood work is normal. He is not anaemic. Everything is normal. Blood oxygen, blood pressure, all of that's normal. Patient's heart rate may be a little bit low because of the medications he took. BP: 118/65 and heart rate in mid-60's. He doesn't know if the vaccine is reacting with Revlimid, but the doctor gave me the ok to get the vaccine. Patient was fatigued with the first vaccine and it went away before the second vaccine. On 03Feb2021, he had his second dose of vaccine, and he feels very fatigued lately. Patient reports he is feeling tired, and very fatigued, which is unusual for him. He reports that his is extremely active, and he is tired lately. He states that he has bloodwork and a urinalysis taken recently for his cancer, and his cardiologist has done tests. he reported that all the blood work is normal, and his cancer markers are steady and normal. he asks if this fatigue is a temporary side effect of the vaccine, and if it has been reported. he reports that he is tired mid-day, and he feels like he wants to lay down and take a nap. He states his primary care doctor will have access on the computer to his other doctors' information. He states he had called Pfizer about a week after he had the first vaccine, and spoke with an agent, that said his symptoms would go away. He states they had a conversation, and he was a Pharmacist. He states that he did not report his event or have a reference number. Fatigue, and feeling tired, ended about 2 or 3 days before the second vaccine and he was recovered enough that he had no concern about taking the second vaccine. He states he had this event, with both vaccines. After second vaccine he does not have a timeframe for the event (fatigue) because he wasn't sure if it was related to the vaccine, and not sure when it started (after lunch), as it has stayed the same and hasn't gotten better or worse. He was scared and his wife, is not as healthy, as he is, his wife has serious lung complications and he didn't want to bring the virus home to her, he was out in public, and shopping, in the pandemic. Reclarified, and explained the precautions he took while he was out of the house to be safe. Patient reported that his medication infusion requires bloodwork, which includes a CMP and CBC every 2 months on a routine basis, every two months he also sends in samples of blood and urine to be analyzed, he has a follow up doctor visit every 6 months, he is part of a research program, at the (name not provided), reports as all of those extensive analysis as normal, nothing is abnormal except the residual from his multiple myeloma, reports there is only one cancer indicator that is usually slightly elevated from his bone marrow aspirate and as an elevated plasma cell level. The patient underwent lab tests and procedures which included BP: 118/65 and heart rate in mid-60's, Blood oxygen was normal, blood tests normal, elevated plasma cells, urine analysis was normal. The outcome of the events was unknown. Follow-up (28May2021): This is a follow-up spontaneous report from a contactable Pharmacist. Updated New information includes concomitant medications, patient history, vaccination dates, age, investigations, patient demographics. Follow up needed, further information has been requested.

Muscle soreness; slight headache on top of head; hearing constant high pitched hissing noise/Wheezing sound in head, not ringing but like wheezing sound like hissing; Sore in my left arm where they give me shot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6201), via an unspecified route of administration, on 03Mar2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's medical history included high blood pressure, high cholesterol, diabetes, gout, sciatica, and penicillin allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9262), via an unspecified route of administration, on 10Feb2021 14:00 PM (at age of 77-year-old), as single in Arm Left, for Covid-19 immunization. The patient's concomitant medications included telmisartan (MICARDIS) at dose of 80mg per day, insulin glargine (LANTUS), clonidine (CLONIDINE), simvastatin (SIMVASTATIN), gabapentin (GABAPENT) and insulin (INSULIN) taken for diabetes mellitus. Prior to vaccination, the was not patient diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient stated that he had second dose on Pfizer, on 03Mar2021 (on last Wednesday). He was a veteran and had the shot 2 o'clock in the afternoon. Then six hours after his shot, he had the sore in his left arm where they give him shot and then he had sore. He had little bit of headache, but not much so he took some Tylenol as a treatment. The next day, Thursday it disappeared, and he had little bit of sore, but his headache seems like disappeared. But, yesterday around noon time he suddenly heard wheezing sound in his head, he thought it was from his ear, but it was not, it felt like inside his head. It was like a wheezing sound, not ringing but like wheezing sound like hissing, something like that. Sometimes it was little bit higher, sometimes it was low. Right now, it was steady on, the sound was still there but he could hear everything plus the sound that made, therefore he called if it was normal or side effect of what he had. He tried to call his doctor today (on Saturday) but he never answered yet, so he had to call and report. The patient confirmed that it was after the second dose of Pfizer vaccine. On 03Mar2021 16:00, the patient experienced sore in my left arm; slight headache on top of head; hearing constant high pitched hissing noise/wheezing sound in head, not ringing but like wheezing sound like hissing; and sore in my left arm. The patient received treatment for the event headache. The patient was provided with the number of Pfizer Medical Information. The outcome for the reported events was not resolved. No follow-up attempts are needed. No further information is expected.

Pt w/no significant PMH p/w worsening symptoms over 10 days of cough, general malaise, nausea, poor oral intake, and sore throat. On admission, was hypoxic on RA & generally ill appearing. CXR showed poss viral pneumonia consistent w/COVID-19 and COVID test was positive despite having received Pfizer vaccine on 01/15 & 2/8/21. Was admitted for acute hypoxic resp failure secondary to COVID and given 3L O2, dexamethasone and remdesivir. Was ultimately discharged 3 days later w/follow-up.

Case developed extreme fatigue and disorientation resulting in a fall. Case was taken by ambulance to Hospital. Case suffered a stroke, admitted to hospital 06/02, then into ICU 06/07/2021.

77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI

2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can't do flight of stairs without being out of breath, sore joints, fatigue

Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS.

Headache, eye pain, doctor unsure of whether it was from blood clot removal or vaccine. Lasted 1 week. Went to neurologist and they thought it was related. Only took Tylenol.

very bad flu like symptoms, couldn't breathe, congestion . stiil down , been 1 1/2 weeks .see dr. on thur ,6/24 follow up .

medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, hypothyroidism, presents to ER after an episode of inability to move for over one hour, unable to move extremeties but was able to talk. reported that had a cough on friday but no sob or hypoxia and did not report fever or chills to hospital, although did report those to investigator. Discharged on 6/3/2021. symptoms of fever, chills, runny nose/congestion, sore throat and cough began on 5/25, none of these symptoms present upon hospitalization on 6/1/21.

Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report from a contactable consumer (Patient reported for himself). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 77-year-old), as First dose, single for Age/COVID-19 immunisation in clinic; warfarin, via oral route of administration from an unspecified date since 15-20 years ago (Batch/Lot number was not reported) and ongoing, at 7.5 mg, daily, (7.5mg by mouth daily) for Blood thinner (anticoagulant therapy). Medical history included cardiac disorder(bad heart) ,back disorder(bad back that is full of metal) from an unknown date and unknown if ongoing. No investigation assessment. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date of the Pfizer vaccine received. No history of all previous immunization with the Pfizer vaccine considered as suspect. Vaccine did not administer at military facility. The patient forgot and did not tell vaccine administrator that he was on a blood thinner prior to getting the vaccine and received the COVID-19 vaccine on Tuesday at clinic. He did not read the papers at first. Later he saw on the papers something that he did not tell them. "What does he need to do." On 03Feb2021, the patient had a fever of 100 degrees,It was down to 98.9 degrees ,He was dizzy. The gland under his arm was painful. He had muscle cramping in his legs. Adverse event did not require a visit to emergency room/physician office. The patient underwent lab tests and procedures which included on 03Feb2021, body temperature: 100 degrees and body temperature: 98.9 degrees. No relevant tests were performed. Therapeutic measure the patient took "Tylenol" as a result of fever, dizziness, gland under arm was painful, muscle cramping in legs and it helped. No product complaint was reported. The outcome of the event gland under arm was painful was resolved on 03Feb2021, outcome of the event fever was resolved on 04Feb2021 and outcome of the events dizziness and muscle cramping in legs was resolving. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.

Chills, fever (99-102), and overwhelming fatigue lasted 22 days. Then the general fatigue became localized in my legs. Whenever I try to walk up a sloping street my legs, esp. the calves, become fatigued and it is difficult to continue. Once I am on level ground or walking downhill normal feeling returns. This is now the fourth month of this condition. Blood test on 03/31/2021 indicated the following values: C-Reactive Protein 93.6; Red Blood Cell Count 3.89; Hemoglobin 11.3; Platelet Count 610. White blood cell count was normal (7.9). A CT scan on 04/17/2021 was normal. Am waiting insurance approval for a cardiac catheterization to determine blockage of the arteries to the legs.

Overnight I developed very significant headaches (hardly ever had a headache before); in a few days I developed edema of my ankles and feet; checked blood pressure after a few days and it was very elevated; Took Tylenol for headaches (not very effective); Doctor had me move from 20mg Olmesartan to 40mg Olmesartan with 25mg hydrochlorothiazide which controlled my blood pressure and eliminated the lower extremity edema. When my blood pressure became dangerously low, I was moved back to just 20mg Olmesartan. Atrial fibrillation had been controlled prior to the vaccination with Multaq. For two days after the vaccination I had A-fib, then it went away. I have been monitoring my blood pressure and EKG since and the A-fib is becoming increasingly common, so that now I seldom had sinus rhythm.

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Works in a quarry. Kills skunks. Could smell the skunks even when it sprayed several time. Loss all sense of smell. Sense of smell hasn't returned. Slight fever after the shot. Upper nasal passages seem to be constricting, has increased in severity. Now it is concerning . Does feel like he is getting any better.

slight fever; chills; tiredness; achy all over; slightly dizzy; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: OW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate and cholesterol. Concomitant medications included atorvastatin calcium (ATORVASTIN), finasteride (MANUFACTURER UNKNOWN) and dexamethasone, tobramycin sulfate (TOBRAMYCIN/DEXAMET) . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 77-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 had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 the patient experienced slight fever, chills, tiredness, achy all over, and slightly dizzy. 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 event slight fever, chills, tiredness, achy all over, and slightly dizzy were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Feb2021 at 13:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart attack and bypass surgery. The patient had a history of allergy to ciprofloxacin (CIPRO). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), montelukast sodium (VICTOR) and metoprolol succinate (METOPROLOL) all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 14:00(at the age of 77-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 24Feb2021, the patient experienced slight headache for a month which was still continuing, muscle cramps for 2 days and had lymph node pain under arm when lying on side with arm under body which started two weeks after shot and continued for several weeks. 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 event muscle cramps was resolved on 20210226. The clinical outcome of the events slight headache and lymph node pain under arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Hives; Bruising; Fever of 102, almost 103; GI problems; This is a spontaneous report from a contactable consumer (patient). This 77-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 05Mar2021 18:00 (Batch/Lot number was not reported) (at the age of 77-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal (was taking blood pressure medications to bring it normal), hard of hearing with hearing aids. Concomitant medication(s) included Losartan taken for blood pressure. Patient received first dose of BNT162B2 on 10Feb2021 06:00 PM (Lot number: EL3247). Patient was reporting a possible side effect from the Pfizer COVID shot in March. Around 02Apr2021 patient had hives, the broke out and he went to different doctor, dermatologist, the allergist, regular doctor. He was in the hospital for 3 days because the hives were actually pretty bad to the point where they were bruising and the blood vessels were 'worsening' from the top of head to the sole to feet, every part of the body. Now patient tried 3 times to get rid of them by using Prednisone given by doctor and the antihistamines. As soon as go off to Prednisone the hives come back and retrieved. Patient did all kind of test for that and never find what's causing the problem, doctors couldn't find the cause of hives. The only thing they point to, is the fact that the month patient had the vaccine shot that developed this, 3 times. Patient got the both shots the first and the second shots and after the second shot, the day after he developed fever of 102, almost 103 and that pretty well went away, they said that could happen and that did. It went away after one day and he was fine, then this other stuff started later. Patient was experiencing lot of GI problems, he thought this is due to COVID shot. Treatment included Prednisone, Antihistamine (Unspecified Medication) as well Allegra, Zyrtec and Benadryl. when he was on prednisone, the hives went away. When off Prednisone they came right back. When went down to lower doses, they came right back again. He was not taking Prednisone anymore. The outcome of Fever was recovered, of other events was not recovered. Information on lot/batch number has been requested.

Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new 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.

Patient got the vaccine around 9:15am and around 1pm he was experiencing chills, sweats, fatigue and started vomiting and vomit was yellow in color. 911 was called and he was taken to the hospital. Nursing home staff notified us that patient did not eat anything that day and nothing 1am the day prior.

I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the muscles in my body seemed to be vibrating. I could still walk but found a comfortable chair. The shakes would rise and fall in amplitude causing my hands and legs to oscillate then recede after about 30 seconds. This lasted for about 20-25 minutes and simply went away and has not recurred. I have had no other symptoms. As chills were a listed side effect, I assumed at first that it was chills or some variant but I was not cold. It was the chills without an apparent temperature effect although I did not measure my temperature.

On 1/18/21, received the vaccine at 1007. At 1035 while working with PT, he became very fatigued and short of breath. Pulse ox was 96%. At 1105, he began shaking uncontrollably and projectile vomiting. BP 100/62, P-100, temp 96.0. 1230: temp 99.0 and still shaking. 1315: temp 100.1, shaking less. 1500: temp 102.0 no other symptoms. 1600: Temp 101.3 no other symptoms. 2000: Temp 99.3 no other symptoms. Temp continued to normalize through the night. Doing well and back to baseline on 1/19/21.

Stated since Xmas he has not feeling well after a family gathering. His wife in hospital for Covid-19 pneumonia. He reports for about 1 week, his SOB worsen, not eating well at all for the past 3 days. Which prompt him to visit the ED. Admitted to Hopital for Dehydration; Dyspnea; Pneumonia due to COVID-19 virus; COVID+ 1/10/21; still admitted

hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.

headache; chills; fever; muscle soreness; injection site soreness; This is a spontaneous report from a non-contactable consumer (wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 14Jan2021 19:00, the patient had headache, chills, fever, muscle soreness and injection site soreness. Outcome was unknown. Information on batch number has been requested.

perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital. Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not 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.

Resident displayed tachycardia, diaphoresis, severe weakness - transfer to hospital from skilled facility

injection site pain to right arm; Chills; Headache; light fever; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELL742) on his right arm, via an unspecified route of administration on 14Jan2021 07:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got injection site pain to right arm, chills, headache and a light fever; all on 14Jan2021 19:00. It was also stated that the injection site pain was severe and is now less. Also reported that the patient recovered from the chills during the night completely. The patient took a couple of aspirin last night and will take some more this morning as treatment. The outcome of the event chills was recovered on 14Jan2021, not recovered for event light fever while recovering for the remaining events.

Lightheadedness; Headache; tightness in his chest; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK4176, via an unspecified route of administration in the left arm/ shoulder area on 15Jan2021 at 11:15 at single dose for COVID-19 immunization. Medical history included ongoing epilepsy, patient has epilepsy that has been controlled since 1977; and issues with his blood pressure. He has no allergies. Concomitant medications included phenobarbital and phenytoin (DILANTIN), both for epilepsy. He takes HTZ TRI something, it is a long word but is basically 2 diuretic. He is also being followed by a cardiologist. Patient has no prior vaccinations within 4 weeks. The patient got the COVID injection 2.5 hours ago on 15Jan2021 and after that he had a slight case of lightheadedness. He was instructed to drink water and walk if he was able, he did that and it helped. The patient relays that he was fasting that morning and thinks that had some degree of relatedness in the lightheaded feeling. He ate lunch and the light headedness resolved but now he has a slight headache. He was reading the paperwork and on the form under severe reactions, it mentions dizziness, weakness, and difficulty breathing. While he is breath ok, he has noticed a slight degree of tightness in his chest. He did not see this listed but wants to know if this is normal or if it would be related to the difficulty breathing. His main concern is if this is a severe reaction. He had lab work done prior to getting the vaccine, then none afterward. The events did not require visit to emergency room and physician office. The outcome of the event 'lightheadedness' was recovered while unknown for the other events.

extreme chills and fever took aspirin Rested fever went down within five to six hours. Fever was 102at the onset

Nausea; Tiredness; Feeling Unwell; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received bnt162b2 (BNT162B2, lot number and expiry date were unknown), on 15Jan2021 at 09:15 AM on the right arm for COVID-19 immunization. The vaccine was administered at a living facility. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history was not reported. He had no known allergies. Concomitant medications included unspecified medications (other medications in two weeks: yes). The patient did not have covid prior to vaccination and was not tested for covid post vaccination. The patient experienced nausea, tiredness and feeling unwell on 16Jan2021 10:00 AM. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovering. Information on the Lot/Batch number has been requested.

site soreness; nasal stuffiness; difficulty breathing; throat began closing up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient (also reported as age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration on 14Jan2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. Medical history included two recent right shoulder surgeries. Concomitant medication included oxaprozin. The patient previously took oxycontin and experienced allergies and an unspecified allergy shot last 06Jan2021 on the left & right arm. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021 at 01:30, the patient was having difficulty breathing and throat began closing up. Patient's wife was going to call 911 but after about an hour, incident appeared to be getting better. On the next day (16Jan2021), the patient felt better with minor site soreness and nasal stuffiness. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.

I am very tired; have been sleeping both day and night since I had my Covid-19 injection; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1293), via an unspecified route of administration, in the left arm on 19Jan2021 at 18:00 PM (at the age of 78-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included oxycodone, gabapentin, morniflumate (FLOMAX), acetylsalicylic acid (ASPIRIN ), and metaxalone. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has known allergies to morphine. On 20Jan2021 at 05:00 AM, the patient experienced being tired. The patient reported "I am very tired, I have been sleeping both day and night since I had my Covid-19 injection". The patient did not receive treatment for the events. The clinical outcome of the events tired and I have been sleeping both day and night since I had my Covid-19 injection was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

terrible headache lasting 3 days after injection; elevated temperature on day 2 of 102; sore and red arm at injection site; sore and red arm at injection site; body aches; This is a spontaneous report from a contactable Consumer. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number PFREL3246), via an unspecified route of administration on 09Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included COPD, Asthma, Atrial Fib, Hypertension, covid-19. The patient previously took levaquin and underwent allergies:Levaquin. The patient experienced body aches, elevated temperature on day 2 of 102, sore and red arm at injection site, terrible headache lasting 3 days after injection. No treatment received. No Covid tested post vaccination. The outcome of the events was resolved.

brainfuzz headache; Aches; woke up nauseous; wobbly Almost fell over twice. Had to steady self; This is a spontaneous report from a contactable consumer, the patient. A 78-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 19Jan2021 at 11:15 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included prostatitis, high blood pressure, and high cholesterol, all from unknown dates and unknown if ongoing. The patient previously had COVID-19 prior to the vaccination on an unknown date to an unknown date (not ongoing). The patient did not have any allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jan2021 at 07:45, the patient experienced brainfuzz headache, aches, woke up nauseous, and wobbly (almost fell over twice and had to steady himself). The patient did not receive any treatment for the events. The clinical outcomes of brainfuzz headache, aches, nausea, and wobbly, were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Fever with Tmax=102.4 F on Day 1 post-vaccination. Fever persisted for ~24 hours, but has since improved and patient has remained afebrile. Loss of appetite starting Day 1 post-vaccination, which lasted for ~2 days.

After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath. Stopped for errand & had same experience. No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106. Went to ER. Had EKG, check xray,troponin levels checked 6 hrs apart. All were negative. Released. Since that time, I continue to have: chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea. Went for Covid test 02/04/21 Results were negative. Just began feeling more normal today--2 weeks after innoculation.

Patient presented with night sweats and shortness of breath the day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.

NUMB CHIN SYNDROME, STARTED ABOUT 30 MINUTES AFTER SHOT. LASTED ABOUT 24 HOURS. NO TREATMENT. FELT FATIGUED NEXT TWO DAYS BUT THAT WENT AWAY AFTER TWO DAYS;

Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered

Pt concerned about mild headache, chills, and fatigue after first dose of covid vaccine yesterday afternoon. Denies pain at injection site L. Deltoid. Denies NVD. States he feels a little dizzy when he stands. Denies chest pain or shortness of breathe.

Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.

chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a contactable consumer reported for himself. This 78-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 22Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included Seizures, low white cell count, enlarged prostate and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 08:00 AM (reported as 18 hours after injection), the patient experienced chills, body aches, fever of 102.9, extreme weakness, dizzy. At 4 am on 25Jan2021 the fever broke and now he was ok. No treatment received for the adverse event. Outcome of the events chills, body aches, extreme weakness and dizzy was recovered on an unspecified date, of the event fever of 102.9 was recovered on 25Jan2021. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria was reported as non-serious. Information on the lot/batch number has been requested.

The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.

Date and time of vaccination: (list both if they received both shots): first jan 19th, second feb 9 coughing is occasional, slightly more than usual started 2/11

First dose given 01/21/21, 2nd dose February 11th 1:30 pm Both first and second dose, first dose only soreness at injection site, second dose had soreness, nausea, cramps in stomach, wheezing, fatigued, chills, vomiting,, diarrhea Symptoms have mostly subsided, just a little stomach craming and fatigue

Flushed, nauseous, serious headache and extremely tired within first hour after receiving the injection. took 2 Ibuprofen and laid down. Ate supper with the family, headache still really bad. Stepped outside for a few minutes and my heart began to race wildly. Called hospital after I couldn't get it to calm down with breathing technique after trying for 40 minutes. Too many bpm for me to count myself.

The evening of the day of vacination, I had bad headache, body ache, chills and body shivers. By the time I went to bed, I had coughing and wheezing. Took atomizer for that. During the night every joint in my body starting to hurt. Took more tylenol and CBD rubbed on hips, shoulders, knees and wrists. By morning I felt better, but some body aches and headache. Lsted for the rest of the day. Ok by the evening.

Patient is positive for COVID-19 and being admitted to the hospital. Patient received dose 1 of the vaccine on 2/11/21 and began feeling ill several days before presentation to the ED. He is unable to pinpoint an exact date but states it has been a few days that he has felt unwell. Presentation to the ED was on 2/23/21 and his oxygen saturation on presentation was in the 80s with mild confusion. Patient is requiring supplementary oxygen. The patient is receiving dexamethasone.

My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.

Low grade fever on 2.24.21, severe pain in the left skin dermatome under the left nipple, redness size of 3x2 inches with several small blisters under the left nipple, area is very sensitive to touch by clothing Tramadol 3 times a day The redness is not getting larger, but the pain is not abating

Appox. 16 hours after injection I started shivering and cold sweats. was weak. and just out of it. Went to bed and by mid afternoon shivers were gone as well as sweating. Slept all day and into the evening, by 10pm or so all seemed back to normal. Mid afternoon I sat up on the edge of the bed to go to the bathroom and passed out falling on my left knee (bad one) and hit my forehead on the bathroom door scraping and bruising same above left eye brow. Walking with pain in left knee but getting better daily.

First day: lethargy all day. Second day, 2-28 starting c 10PM got the shivers and shakes,, had trouble standing. Lasted c one and a half hours. I lay down, it finally stopped

2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Feb 21 lost taste Fri Feb 26 extreme weakness in legs Otho has had side effects THAT OTHERS HAVE NOT REPORTED. Otho received the first Pfizer shot on January 28, 2021 and only suffered a small ache in his arm. Otho received the second shot of Phizer on February 1 8, 2021 adminsted at the same location. Day 1 arm a little uncomftable Day 2 6:00 pm extreme chills Day 3 chills gone, tired, weak Day 4 LOST SENSE OF TASTE Day 9 Legs so weak, could not walk without a walker Day 13 TODAY Still very weak and still connot taste. Otho is a male age 78 yrs. Usually very active. He does suffer from Carcinod Caner of many years. We did visit with our doctor. He prescribed to take two Ibuprifen morning and night to help with inflammation. And if Legs weakness increases to get back to him.

shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.

Severe abdominal cramps/abdominal cramping; Drowsiness; I had a sore shoulder and fatigue; I had a sore shoulder and fatigue; pain; anxiety; small bowel blockage/He had an intestinal blockage; His peristalsis shut down.; bowels are very irritated; He feels bruised; his guts just feel bruised; His blood pressure actually was low while in hospital; Glucose levels were very high while in hospital/when in pain and anxiety his sugar goes up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL3248) injection to upper left arm just below shoulder at approximately on 29Jan2021 10:00 at age of 78 years old at single dose for vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Relevant medical history included: for ongoing asthma and adult onset maybe 25-28 years ago. He did not have when he was a kid. He did not have allergies. Part of problem was lives in an area that had a very high allergy problem; a lot of people in that area have allergies; for sleep apnea, used CPAP machine; for diabetes from 2006 and onset date approximate. A1C is where doctors want it to be. Went through half a dozen pills and stuff for diabetes that worked for short time and stopped: Names/Lots/NDCs/Expiries: Unknown, does not have this information to provide. He was pretty good at judging carbohydrate content in meals to make adjustments to Humalog and Toujeo dosing as needed; for ongoing overweight, weight gain started after oral injectable product for diabetes stopped working, he went on different insulin product and gained 30-35 lbs. Oral injectable product: name/lot/NDC /expiry: Unknown, does not have product or this information to provide. Different insulin product: Name/Lot/NDC/Expiry: Unknown, does not have product or this information to provide; modestly high blood pressure; history of intestinal blockages (occurred quite some time ago, no continuing); had operations in the past. The adverse events (AEs) following prior vaccinations: Adverse Event: He was pretty sure he hit the floor before the needle was even out of his arm when he was administered gamma globulin vaccine which he thinks was around year 1972. The company he worked for at the time had a hepatitis break out, a couple of employees had hepatitis, so they had him receive the gamma globulin vaccine. Vaccine/Brand Name: Gamma globulin vaccine/brand name unknown, whatever it was that was available for hepatitis at the time which he thinks would have been 1972. He is pretty sure in those days they used horse serum in the gamma globulin vaccine; the doctors at the time felt pretty sure that the reaction was to the horse serum aspect of the gamma globulin vaccine. Lot/NDC/Expiry: Unknown, he does not have product or this information to provide. Vaccination Date: Thinks would have been in 1972, further details unknown. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s) was reported as none. 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). There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He was supposed to have the Shingrix vaccine but decided to hold off on that until after he got the Pfizer COVID-19 Vaccine. He had the Flu vaccine around Sep2020 or Oct2020 when the senior version came out. Ongoing Concomitant medications included: losartan 100mg daily from 2019 for high blood pressure, furosemide (LASIX) 20mg daily from 2019 for high blood pressure causing some fluid buildup, fenofibrate 134mg daily for years for triglycerides, finasteride 5mg daily for years for benign prostatic hyperplasia, multivitamins, boosters of other vitamins (advised by PCP since COVID pandemic started), insulin lispro (HUMALOG) fast acting insulin taken as needed for diabetes, insulin glargine (TOUJEO) slow acting insulin taken as needed for diabetes. It was reported patient stated, he had his first dose of the Pfizer vaccine a week ago Friday 29Jan2021 at 10am. He had a sore shoulder and fatigue. At midnight he suffered abdominal cramping by 7am. He took himself to the ER and called his doctor who met him there. He had an intestinal blockage. His peristalsis shut down. He spent a couple days on an NG tube, had x-rays and imaging study, they found a small bowel blockage. It seemed very coincidental within 18 hours of the vaccine. He had them when he was younger. His physician who was an GI specialist said he had 2-3 other patients with similar reactions. He spoke to the safety team regarding this. He was due for his 2nd vaccine a few weeks. Right now his bowels were very irritated, not consistent to bowel movements. He was still on a low fiber diet. Asked if there was any evidence people are having gastrointestinal reaction. He had had blockages in the past, that was his weakness. Asked what to do about 2nd dose. He had asthma, diabetes type 2, mildly hypertensive. This consumer had his first dose of Pfizer COVID-19 Vaccine 29Jan2021 at approximately 10:00. On 29Jan2021 at about 23:30, he had went through usual drowsiness and took a nap. Around midnight 00:00 30Jan2021 he started having abdominal cramps that became very severe. He was taken to the Emergency Room where he was admitted to the hospital from 30Jan2021 until discharged home evening of 03Feb2021. Severe abdominal cramps: His peristalsis stopped, just shut down. As a result he had an intestinal blockage. He had nasogastric tube placed for 4 days. He was scheduled for surgery with a gastrointestinal surgeon who he happens to know personally. He had called that gastrointestinal surgeon before he was admitted to the hospital. The gastrointestinal surgeon thought he heard some sounds, so he delayed the surgery. That night the intestinal blockage broke up. He was discharged from the hospital before they normally would have released him to get people out as quickly as possible due to risk of contagion in hospitals. Both he and the gastrointestinal surgeon are very concerned about him having the second dose of Pfizer COVID-19 Vaccine as scheduled which is due in like 1.5 weeks. The plan at this time is for him to go on a liquid diet 2 days before the second dose so that there is nothing in him to create intestinal block. Outcomes of events: Bowel movements are irregular because just starting to get back into eating really for a few days. The first few days home he was on a soft diet of basically jell-o pudding and broths. He is on an ultra-low fiber diet right now so it's a different diet than he is accustomed to. Some of what he is eating goes right through, other times there is no bulk to come out; he kind of feels like he is constipated but it is just that there is nothing there. Doctor later this week will determine how much he can normalize his diet. Metamucil which a lot of diabetics do, doctor did not want him to take that until everything settles down. He feels bruised; his guts just feel bruised; he thinks from just the pressure there and getting in and out of the hospital bed was horrible. When he called doctor before he went to the hospital 30Jan2021, doctor told him this is coincidence, that this patient was the third that he has had who in 24 hours has had significant intestinal or bowel reaction; that he is not the first who has dealt with severe gastrointestinal problems following the Pfizer COVID-19 Vaccine. Caller clarified he has no first hand knowledge of those other patients/events/products, this was just mentioned to him by the doctor over the phone. He had no further information to provide for this report; but doctor might be able to provide further information. Relevant Tests: they did a COVID test when he was admitted to hospital 30Jan2021, gave results when he left the hospital-took them 6 days-unknown result. They did X-rays and scan of his abdomen to monitor intestinal blockage-results unknown. Blood work done but nothing remarkable there-results unknown. His blood pressure actually was low while in hospital-specific results unknown. Glucose levels were very high while in hospital which he is sure was because they had him on an IV drip that must have had glucose in it because he was not eating anything and when in pain and anxiety his sugar goes up-further details of results unknown. Patient had no further information to provide regarding testing/investigations/lab work, blood work, imaging, x-rays, etc for this report. Outcome of events were reported as unknown.

Patient stated a history of allergic reaction to the influenza vaccine in the past. Patient insisted on receiving Covid vaccination. Patients primary care provider was called and gave approval for patient to receive vaccination. About 10 minutes after receiving vaccination the patient stated sinus pressure which quickly proceeded to complaints of his throat feeling "funny and tight". ERT was called and patient was given a dose of Epinephrine and transferred to the emergency department.

Shoulders was all sore both of them; He was sore all over; Chills; Running 101 fever; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-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 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included COVID-19 (reported as "has had that virus before"). There were no concomitant medications. On 30Jan2021, in the morning after the vaccination, the patient's shoulders were both sore. By the afternoon of the same day, the patient was sore all over, ran in a 101 fever (unit was not reported), and was having chills. The patient did not receive any treatment for the reported events. The outcome of the events, 'shoulders were both sore', 'sore all over', 'ran in a 101 fever' and 'chills', was recovering; patient was feeling better at the time of reporting. Information on lot/ batch has been requested.

lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over arms, chest, waist, REALLY ITCHY Prescriptions taken: Levocetirizin E5 mg --1 tablet daily; Hydroxyzine HCL 25mg --two tablets at bedtime, 1 tab every 8 hours as needed

Developed malaise, runny nose and productive cough with wheezing on day 3 following vaccination. Cough persisted for 5+ days. No fever.

Next day after shot - legs were very weak and I could hardly walk in a straight line. Went for a routine physical with my Doctor at 1PM and never made it there. I had no idea of where I was going or where I had been. Half hour later I remember being in a store buying lottery tickets and the clerk had to help me in my car. Went to bed for the rest of the day and have been improving little by little each day. Was very, very tired at first and still a little tired now.

Pt had HA and left hip pain after sitting in car. Vitals normal o2 sat 97%, HR 92 BP 121/69 noted. Pt was obs in car 20 minutes with pt calling and wanting to go home. No airway issues . Gave juice and patient felt better

pneumonia; strange dreams; While there I went into AFIB; I had a dry cough that I attributed to several bouts of dry heaves; I had a dry cough that I attributed to several bouts of dry heaves; This is spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (lot number EN5318), via an unspecified route of administration in right arm on 08Feb2021 11:45 at single dose for covid-19 immunization. The patient had no relevant medical history. Concomitant medication included metoprolol, lisinopril, atorvastatin (LIPITOR). The patient experienced pneumonia on 10Feb2021, while there he went into AFIB (atrial fibrillation) on 19Feb2021, he had a dry cough that he attributed to several bouts of dry heaves on 10Feb2021, strange dreams on an unspecified date. The event pneumonia was reported as serious per hospitalization. The patient was hospitalized for pneumonia from 19Feb2021 to 21Feb2021. Previously reported side effects along with strange dreams and he would also like to mention a couple of more issues. Throughout 10Feb2021 and 14Feb2021 adverse reaction period he had a dry cough that he attributed to several bouts of dry heaves, Since the cough continued and he wasn't feeling better he went to emergency care facility on the 19th and he was diagnosed with pneumonia and went to the hospital and was admitted. While there he went into AFIB. Pneumonia was located in left lower lobe (infectious organism). Discharged from hospital on 21Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization for 2 days. The patient underwent lab tests and procedures which included covid test nasal swab: negative on 20Feb2021. Therapeutic measures were taken as a result of pneumonia and cough. Treatment included antibiotics. The outcome of events for pneumonia was resolving, for dry cough was not resolved, for other events was unknown. Facility type vaccine: Nursing Home/Senior Living Facility. No other vaccine in four weeks. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination Nasal Swab, covid test date 20Feb2021, covid test result negative. Not known allergy.

Patient received second dose of Pfizer vaccine on 02/26/21. Starting having a fever from 02/27 and shortness of breath from 02/28.

Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever lasting ~24 hours. Symptoms abated after 24 hours and gone by 48 hours after the administration of the 2nd dose or 36 hours after I became symptomatic. NO symptoms other than a slightly sore arm after the 1st dose.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior. No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.

On evening of vaccine, he began to run high fever of 101.5. next day 102. 3 with extended chills, Doctor was called and patient was told to take Tylenol, On second time Doctor was called, he was told to alternate Tylenol with ibuphrofen. Fever came down on 2/28 started back up on 3/2 , went to Er ON 3/4 FOR BREATHING ISSUES, a blood infection was found, went back to ER ON 3/8 FOR ANTIBIOTIC,( DOCTOR HAD WANTED HIM ADMITTED,THIS WAS NOT COMMUNICATED) , next day was admitted to Providence Hospital for IV antibiotics, dismissed from Providence on 3/13, with antibiotics infusion to continue at home.

Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter

watery eyes; runny nose; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 30Jan2021 for COVID-19 immunisation, administered at hospital. The patient medical and concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on 04Jan2021 (also reported as 07Jan2021) for COVID-19 immunisation, administered at hospital and the reporter did not indicate that he had any side effects. The patient experienced watery eyes and runny nose in 2021. He did not experience any headache. No treatment was received. No admission to hospital due to the events. The outcome of events was recovered in 2021, he was fine now. Information about lot/batch number has been requested.

fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm

Case tested positive for COVID-19 on 3/1/2021 by rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on 3/3/2021 for shortness of breath and occult infection. Case was previously admitted and discharged from hospital on 2/22/2021 after a lumbar compression fracture. Case had monoclonal antibody infusions; was afebrile and denied chills, but had a dry cough. Case was a previous smoker, quit 2 years prior. Case developed pneumonia. Case required supplemental oxygen.

3/16 Experienced extreme lethargy. 3/18 noticed injection site swelling and redness. There was also itching.

Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-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 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.

Onset second morning after injection: headache, chills, nausea, loss of motor control in legs ( unable to stand or walk, unable to roll over to get out of bed), profuse sweating. About 1pm my wife assisted me to the bathroom toilet, where I passed out for approx 30 mins. These severe reactions finally started to recede about 6pm, although the sweating continued into Sunday. Mild nausea, and mild headache continued into today Tuesday.

The patient presented to the ED with complaints of fatigue. The patient was found to have an NSTEMI and suspected pneumonia on x-ray. The patient was started on a heparin drip, ceftriaxone, and azithromycin. BP was 176/101, pulse 93, O2 sat of 95% and temp 99.3 F. Patient is being admitted to the hospital for continued treatment of NSTEMI.

Started symptoms of a cough, sore throat, diarrhea, and upset stomach on 03/08/2021. Received monclonoal antibody therapy on 03/19/2021.

Presented to ER - somnolent and lethargic. After morning do dose of inhaler for COPD started to feel congested and short of breath, prompted him to ER. Did not have fever, chills, HA, rashes or allergic reactions. Started on BIPAP. No definitive evidence indicating that this was or was not an ADR to vaccine

myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. In the middle of the night on 3/28 he got up to go to the bathroom and was too weak to get off the toilet - to the point where he had to lower himself to the ground, so EMS was notified and reportedly found him with a fever of 104 Fahrenheit. Hospitalization x2 days. Discharge home.

Multiple pulmonary embolism 100 degree fever Chills incontinence Gout Blood Uric Acid Increase Shortness of breath

fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion because of chronotropic incompetence. 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 vitamins and zolpidem tartrate (AMBIEN), both were taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 18Jan2021 14:00 as a single dose for COVID-19 immunization and experienced sweating, chills and tired. On an unspecified date in Feb2021 after receiving the second dose, the patient experienced fast heartbeat, dizziness, weakness, very tired and slow thinking. No treatment was received for the adverse events. The clinical outcome of the fast heartbeat, dizziness, weakness, very tired and slow thinking was unknown.

I've had chills; I want to sleep all the time/He is lethargic like he wants to sleep all the time; my mouth feels like it has cotton in it; tired; head feels strange/ He doesn't feel good/ He doesn't feel right; The temperature 100.1; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL3248, Expiration Date: unknown), via an unspecified route of administration, anatomical location-Left Arm On 29Jan2021 at single dose for COVID-19 immunization. The patient medical history included high blood pressure, High cholesterol, psoriasis. concomitant medication included Humira 2 days after the first vaccine dose in the belly.The patient experienced chills, lethargic, dry mouth, tired, feeling abnormal, the body temperature 100.1. The clinical course reported as 'He doesn't feel good. He had chills before the shot then he had more chills after the shot. He is lethargic like he wants to sleep all the time. He doesn't if know his immune condition psoriasis, for which he takes Humira has anything to do with it. He doesn't feel right, its the Pfizer BioNtech Covid Vaccine. He wants to know if this is a normal side effect. He has a Temperature of 100.1'. The patient underwent lab tests 03-FEB-2021 Blood test, Body temperature, 100.1, COVID-19 test result was negative. The outcome of event was unknown. Follow up information completed. No further information is expected.

tiredness, fever 98.9 in the morning, 99 to 100.2 in the evening since March 12th, the day after vaccination

Copious bleeding from left nostril, running down throat to the point patient was choking on it. Clott-like material in the sputum. Copiuus bleeding lasted for fat least 1.5 to 2 hours, slowed down only when treeated an packed in the hospital ED. Chemical cauterization with Silver Nitrate at approximately 10:30 PM. ENT follow up scheduled for April 1.

back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

- Tinnitus increased from 2 to 10 in severity - Intermittent stab in pain on lower.back of head slightly above left ear lobe

2 hrs after injection , felt a URGENT need for Bowel movement, while I was having this bowel movement, I had what I think was a severe Panic attack, felt like I was going to die !!! lasted for 5 or 10 min. After which I felt fine , went to work ,after another 2 hrs I had the same episode ,at work. timing was about the same . went home . Had another aproximently 2 hrs from the last ,was less severe . took a nap , BUT was unable to urinate for 6 hrs . Felt OK ,slepted fine. Felt OK the next couple of days Then had mild case of chills, then mild case of feeling poorly. Very slight fever. AS of today I'm more tired then usual but not debilitating .

Fever/temperature was 99.6/ 99.4 /99.3; This is a spontaneous report from a contactable consumer. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on 25Mar2021 09:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. Medical history included heart valve replacement from 13Nov2019 to an unknown date (His heart operation was 13Nov2019 it has been 16 months that he has been inactive), chronic myeloid leukaemia from 2018 to an unknown date, accumulating fluid around the lung sack from an unknown date and unknown if ongoing aortic stenosis (from an unknown date and unknown if ongoing (They changed the heart valve because he had aortal stenosis), heart murmur from an unknown date and unknown if ongoing (He went in to see his general practitioner and a woman there said he had a heart murmur) cough from an unknown date and unknown if ongoing (Caller states he has a little cough. He quit smoking several years ago and has been coughing ever since. The cough was prior to COVID-19 vaccines) fell from Nov2020 to an unknown date (Caller fell the first week of Nov2020 and that is how long the process has taken. He has been in pain for months. Caller clarified that his hospitalizations and fall were prior to getting the vaccine). The patient previously took first dose of bnt162b2 for covid-19 immunisation and sprycel and experienced kidneys were failing. (Caller clarified that the hospitalization he had for 8 days was when he was on Sprycel and he was hospitalized because his kidneys were failing). Caller clarified that he has a fever, but he is not sure what it is because of the thermometer. Earlier today it was 99.6. It is now 2:24PM (State name) time, so it has been 5.5 hours since the vaccine on 25Mar2021. His temperature was 99.6 then 99.4 then 99.3. Frankly he doesn't trust it. He had positive experience both times he got the COVID Vaccine. The patient underwent lab tests and procedures which included body temperature: 99.6 on 25Mar2021 body temperature: 99.4 on 25Mar2021 body temperature: 99.3 on 25Mar2021 white blood cell count: unknown results on (When he went to the doctor to get checked he had unusual white blood cells running). The outcome of the event was reported as unknown. No follow up attempts are needed. No further information is expected.

eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.

Started sweating real bad; It was just unusual the amount that I sweat; This is a spontaneous report from a contactable consumer.A 78-years-old male patient received First dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL9265) via an unspecified route of administration on 12Feb2021 at a single dose for covid-19 immunization.Patient relevant medical history of ulcer from 1968, arthritis pain (about 3 months prior to receiving my vaccine, Patient was having Arthritis pain in right shoulder and a week after receiving vaccine which was 19Feb2021, he put a Heating pad on right shoulder for the Arthritis pain and that night when he went to bed he started sweating real bad, everything was wet his sheet, pillow case from sweating), neoplasm malignant from 2004, Ulcer. Concomitant medications included lisinopril (LISINOPRIL), acetylsalicylic acid (ASPIRIN) and ergocalciferol (VIT D).The patient received second dose on 05Mar2021. The patient underwent blood test and result was unknown.On 19Feb2021, patient started sweating real bad, It was just unusual the amount that he sweat and had not received any treatment. Patient did not received any treatment. The outcome of the event was unknown.

Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure

about a week after shot developed severe facial pain, felt to have trigeminal neuralgia got temporal artery biopsy negative develop FUO hospitalized 4/8 to present

Pt is GCS 15 and A&Ox4. Skin is P/W/D to pt ethnicity. Neuro intact and PERRLA. Respirations are regular/equal and non-labored. pt states he's had left sided facial droop for 2 days and a sore throat for 5 days. pt denies any other symptoms at this time. pt appears to have bells palsy. Dr. was contacted and she ruled out a stroke. Symptoms started 1 week after the completion of vaccine.

Client went to Urgent Care on 4/16 complaining of excessive fatigue, excessive sleeping, unsteadiness and fatigues easily when mobile. He was having trouble getting up and down the stairs. States he had a runny nose and congestion and started taking Mucinex since approximately 4/6. He had some chills on 4/15. When he wakes up in the morning he still feels tired and could go back to sleep. After his initial assessment he was admitted to hospital for treatment and further evaluation.

Cold like symptoms day after first shot. Cold like symptoms only lasted for a day then went away. I have several of these one day cold before my second shot. The day after my second shot I came down with what I thought was a cold and it has continued non stop. Had a appointment at medical center (04/09/21), they said it was not a cold but pollen allergy. Prescribed Claritin and Fluticasone and it did not change anything. Called 04/19/21 for a appointment, waiting to hear back. They said the Covid shots had nothing to do with it. I am 79 years old and have never had allergies in my life, its my feeling the Covid shots effected my immune system and are the cause if my allergy.

Presented to hospital with shortness of breath for one week on 4/13/2021. Additional symptoms reported include productive cough with blood tinged sputum, diarrhea, and food tasting like salt. Supplemental oxygen, tocilizumab and remdesivir treatment initiated

This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation. Other diagnoses include: J18.9 - Pneumonia R77.8 - Elevated troponin

dehydration; Fatigue; chills; headache; fever; nausea; body ache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN5318) via unspecified route of administration in left arm on 26Jan2021 at 11:00 AM (at the age of 78-year-old) for COVID-19 immunization and other unspecified pfizer vaccine (Lot number EN538) in left arm on same date 26Jan2021. Medical history included blood pressure and covid. Patient had no known allergies. Concomitant medications included unspecified blood pressure medications (in two weeks). No other vaccine in four weeks. Patient experienced fatigue, chills, headache, fever, nausea, body ache on 26Jan2021 at 04:00 AM and dehydration on an unknown date. Adverse event resulted in emergency room/department or urgent care. Treatment was received for all events. IV treatment was received for dehydration event. Patient had covid prior vaccination, Patient did not test for covid post vaccination. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterday. ? Neck Pain right side. Yesterday noticed a facial droop without any arm weakness or change in gait. No headaches. Using some artificial tears but eye is getting more red and matting of eyelashes. Having more right rhinorrhea, but that's been a chronic issues. Feels like hearing is off in his right ear. More neck soreness on the right.

Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: S/P PROSTATE CANCER, TAKES LUPON INJECTION EVERY 6 MONTHS AND IS NOT SURE IF THIS DATA HAS SOMETHING TO DO WITH HIS PROLONGED SYMPTOMS, NEXT DOSE OF LUPON DUE IN A COUPLE OF WEEKS FROM TODAY.

I have developed a very painful region in the left deltoid muscle and the right deltoid muscle is less severe. It prevents me from lifting my arm(s) higher than the elbow, and significant weakness in the both arms, especially the left. My kneecaps also have significant weakness and pains and makes standing difficult. this developed the day after the shot. I also have significant fatigue all the time since receiving the shots. The second shot (Right arm) was given March 5th.

Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10

Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.

dehydration; Chills; low fever; nausea; body ache; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, second dose) solution for injection intramuscular in the right arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and overweight. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EN5318) for COVID-19 immunisation on 26Jan2021 and experienced dehydration, fatigue, chills, headache, fever, nausea, body ache, and cough. On 19Feb2021 at 18:00, the patient experienced dehydration, chills, low fever, nausea, body ache, fatigue, and headache which resulted in an Emergency Room visit. The patient was treated for dehydration. The outcome of the events dehydration, chills, low fever, nausea, body ache, fatigue, and headache was recovered in Feb2021. Information on Lot/Batch number was available. Additional information has been requested.

muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and a half

After receiving the injection, patient had not been feeling well. Low appetite, lightheaded, fatigued, difficulty breathing. They had been traveling and returned on 3/7. He was tested for covid and the test was positive. He presented to the ED on 3/25/21 and was subsequently admitted to the hospital for 4 days with pneumonia.

Arm was sore. I started taking Advil the evening of 5-4-21. The next morning, I woke up with chills and weakness. I was unable to lift arm to shoulder without discomfort. I took more Advil. I had a 101.5 fever. I actually felt worse than I did when I had COVID back on 12-10-20. I spent the next 4 hours in bed. I got up at 11:00 am and went to the couch to lie down for most of the day. I started feeling slightly better around 5:00 pm. I had dinner and laid around. I went to bed at 10:00 pm. Everything lasted a period of 23 hours. I'm feeling back normal today.

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening diarrhea, weakness, fatigue. wife is positive. Clinical Support 3/5/2021 COVID-19 virus infection Dx Medication Infusion Reason for Visit Encounter Date: 3/5/2021 ? ? Signed Arrived to the ambulatory infusion site alone via car. Reports intermittent diarrhea, dry nonproductive cough, fatigue.

ED 3/7/2021 MC MC Source Organization Encounter Summary 78 y.o. Male; born Jan. 03, 1943January 03, 1943Encounter Summary, generated on Apr. 02, 2021April 02, 2021 Reason for Visit Reason Comments Shortness of Breath Fever Encounter Details Suspected COVID-19 virus infection (Primary Dx) ED Provider Note Patient Chief Complaint Shortness of Breath and Fever History of Present Illness 78-year-old male, PMH is documented below, presenting to the emergency department with fever, cough and shortness of breath. Patient reports that he has been ill since Tuesday. He developed a productive cough bringing up some clear sputum. States he has some shortness of breath with exertion. He denies any chest pain. He denies any palpitations, lightheadedness or syncope. No headache or neck stiffness. States that he has been afebrile until today. Patient had a temperature of a 101° for EMS he has also been having some diarrhea. States he has no loss of taste and has chronic loss of smell. He has not come into contact anybody with COVID-19. Denies any history of DVT or PE. No lower extremity pain or swelling. Patient had his 1st Covid vaccination, but has not received his 2nd. Office Visit 5/7/2021 Family Medicine Cough +1 more Dx Cough Reason for Visit

first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.

Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.

ED to Hosp-Admission Discharged 3/28/2021 - 4/2/2021 (5 days) Treatment team. Acute hypoxemic respiratory failure due to COVID-19 Principal problem Discharge Summary (Physician) Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 3/28/2021 PCP: (doctor) Length of Stay: 5 Days Discharging provider: (doctor) Discharge Date: 4/2/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 Yes Cardiomyopathy Yes Obstructive sleep apnea syndrome Yes Essential hypertension Yes Type 2 diabetes mellitus Yes Presence of automatic (implantable) cardiac defibrillator Unknown Pneumonia due to 2019 novel coronavirus Yes Stage 4 chronic kidney disease Yes Pneumonia of both lungs due to infectious organism, unspecified part of lung Yes Atrial fibrillation with rapid ventricular response Yes NSTEMI (non-ST elevated myocardial infarction) Yes Hospital Course: Patient is a pleasant 79-year-old male admitted due to acute hypoxic respiratory secondary COVID-19 pneumonia. He was continued on dexamethasone for the COVID-19 pneumonia however the medicine was relatively contraindicated due to renal failure. Patient was seen by cardiology continued on aspirin beta-blocker and statin for non-STEMI and already was anticoagulated with Xarelto which is continued. Patient's oxygenation requirements did improve and he was set up for home oxygen prior to discharge. Patient was continue with PT and OT and slowly did well he was doing well clinically at this time may be discharged home for convalescence as per protocol. Patient may follow-up with PCP and specialist as noted

ED to Hosp-Admission Discharged 4/16/2021 - 4/19/2021 (3 days) Hospital Doctor Last attending - Treatment team COVID-19 Principal problem Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Hypercholesterolemia Yes Hypertension Yes Type 2 diabetes mellitus Yes Major depressive disorder Unknown Acute respiratory failure with hypoxia Unknown Hypertensive urgency Unknown Presenting Problem/History of Present Illness/Reason for Admission COVID-19 Hospital Course (Patient) is a 78 y.o. male with medical history of hypertension, type 2 diabetes on insulin, and hyperlipidemia presents with SOB and she was admitted for acute hypoxic respiratory failure with sepsis .Patient was diagnosed with Covid on 4/15 and repeat COVID-19 was positive on admission. Acute hypoxic respiratory failure likely from COVID-19-improving o On admission satting low 90% ,required supplemental oxygen, normal lactic acid & CRP, elevated LDH 263 o CXR (4/16/21): mild basilar atelectasis. o Continue remdesivir (4/16-4/21, Day 4) and dexamethasone (4/16-) since O2 sat <94% on room air, requiring supplemental oxygen o Patient currently satting 95-97% on 2 L nasal cannula. Bedside study does not qualify patient for home oxygen while resting and/or ambulating. PT recommends safe discharge home. Patient clinically stable to be discharged home today. Patient to follow-up with PCP. Sepsis likely from COVID-19 -resolved o On admission HR >90, RR >20 + source of infection COVID= sepsis, procalcitonin neg- antibiotics not indicated Elevated D-dimer likely from SARs-COV-2 o On admission D-dimer elevated 0.59, patient was tachycardic o CTA significant for No pulmonary embolism. No lung consolidation. Hypodense renal lesions. Hypertensive urgency - resolved Essential hypertension o On admission BP >180/120 o Continue home losartan and amlodipine. Diabetes mellitus type 2 o A1c (11/18/20):7.9, repeat A1c 6.7 (4/17) o Home meds metformin 500 BID, Novolin 70-30 : 40 unit AM, 75 unit PM. Home novolin 70-30 = lispro 34 units, glargine 80 unit approximately o Started SSI, lispro TID 5 units, Glargine 10 units BID, confirmed dose with pharmacy based on his home Novolin 70-30 conversion. Patient to continue home medications and follow-up with PCP. MDD-Continue home paroxetine, venlafaxine Hyperlipidemia - Continue home statin Treatments: steroids: Dexamethasone 6 mg and remdesivir 100 mg, benzonatate capsule 100 mg Procedures: None Consults: pulmonary/intensive care Pertinent Test Results: CXR: There is mild atelectasis at the lung bases. There is no effusion or pneumothorax. The cardiac silhouette is normal size. The trachea is midline. The osseous mineralization is normal. CTA: IMPRESSION: 1. No pulmonary embolism. 2. No lung consolidation. 3. Hypodense renal lesions as described above. ED to Hosp-Admission Discharged 4/26/2021 - 5/6/2021 (10 days) Hospital Doctor Last attending ? Treatment team Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Principal problem HPI: (Patient) is a 78 y.o. male with past medical history of T2DM, HTN, HLD, and depression/anxiety who presented to the ED on 4/26 with COVID pneumonia and acute bilateral PE. Orthostatic Hypotension. Improved with IV fluids. No orthostasis this morning. TTE done yesterday showing preserved EF. Acute hypoxemic respiratory failure secondary to Covid 19 Pneumonia with some contribution from PE. Patien.t now on room air. Patient completed Remdesivir. Completed 10 days of Dexamethasone. He will be transitioned to prednisone 20 mg daily for 7 days, 10 mg daily for 7 days then 5 mg daily for 7 days. He was givenTocilizumab: 8 mg/kg, 4/29. He is not a candidate for convalescent plasma. Acute bilateral PE: Mild clot burden without evidence of RV strain. Was initially started on therapeutic Lovenox, transitioned to Eliquis 4/29. Eliquis priced and affordable to the patient. T2DM: On lantus 23 units nightly and Humalog to 10 units with meals HTN: Continue losartan and amlodipine with holding parameters HLD: Continue statin Depression with anxiety: Continue paroxetine and Effexor BPH: Continue Flomax Suspected OSA: Per his daughter concern for OSA. Will need outpatient sleep study.

difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all events 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. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. 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.

checked my B/P and it was 165/99/ blood pressure measurement: staying elevated in 140's ever since; his blood pressure was 168/99, and it has been fluctuating ever since; HA/had a really bad headache; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EL8982), via an unspecified route of administration in arm left on 31Jan2021 14:00 as 2nd dose, single for COVID-19 immunisation. Medical history included, cardiac pacemaker insertion from 12Mar2019 to an unknown date, blood pressure abnormal, anticoagulant therapy, blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium taken for blood pressure abnormal from an unspecified start date and ongoing, hydrochlorothiazide taken for blood pressure abnormal, start and stop date were not reported, aspirin taken for anticoagulant therapy and ezetimibe taken for blood cholesterol abnormal from an unspecified start date and ongoing. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had events reported as "checked my b/p and it was 165/99" then at 10:00am it was 148/84 and it had been staying elevated in 140's ever since/he took his blood pressure, and it was 165/99. it has been in the 130 to 140 ever since then, had a really bad headache, his blood pressure was 168/99, and it has been fluctuating ever since on 01Feb2021. The patient's blood pressure was recorded as 165/99 on 01Feb2021, 130/71 on 02Feb2021, 168/99 on 03Feb2021, 123/69 on 04Feb2021. On unknown dates, the patient underwent blood pressure measurement and results were reported as 148/84; staying elevated in 140's; 168/99; fluctuating ever since; it has been in the 130 to 140 ever since then. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Description of complaint: Consumer reporting an AE for the second dose of the Pfizer COVID 19 vaccine, while providing concomitant products caller mentions he used to take a statin called Atorvastatin before he switched to Ezetimibe three years ago. He does not have any product or information to provide NDC, lot or expiration date for Atorvastatin he used to take. The outcome for the events was reported as recovered for events Blood Pressure increased and headache. Outcome of the event blood pressure fluctuation was reported as unknown. Follow-up attempts are completed. No further information is expected.

chills, vomiting,fever,dark urine. Went to clinic and was given rx for nausua after 1st vaccine. After 2nd vaccine went to Doctor and had a series of blood tests and ct scan. Symptoms subsided after a few days, dark urine for a couple of weeks. Tests showed: ast(sgot) 90 , alt (sgpt) 210

This is a spontaneous report from a contactable consumer. A 78-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm on 18Jan2021 14:00, at 78 years of age, (Batch/Lot Number: EL3249) as single dose for COVID-19 immunization. Medical history included chronotropic incompetence from an unknown date and unknown if ongoing, cardiac pacemaker insertion because of chronotropic incompetence on an unknown date. Concomitant medication included Vitamins and zolpidem tartrate (AMBIEN) taken for an unspecified indication since an unknown date. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, he has not been tested for COVID-19. On 21Jan2021 13:00 the patient experienced first shot sweating, chills and tiredness. No treatment was received. The events outcome was unknown at the time of the report. Follow-up attempts are completed. No further information is expected.

loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events. 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.

Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered. Information about lot number cannot be obtained and no further information is expected.

The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day following his second COVID-19 vaccine. Noted o have a transient thrombocytopenia. Presented with severe weakness and unable to get up. He was able to provide some history. His wife provided additional history. He received second dose of mRNA vaccine on 6/5. Developed weakness afterwards and brought to the hospital for further evaluation. Admitted with dehydration low-grade temperatures. Tmax 100.4. Denies bleeding.

This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: EN6207), via unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient was not allergic to medication, food and other products. Prior to 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 vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN), hctz (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), finasterid (MANUFACTURER UNKNOWN) for unknown indication. On 13Mar2021, the patient experienced cough with mucus and fever 99.3 in the morning. It was reported that the patient did not receive treatment for the event. The clinical outcome of the events cough and fever were resolving. No follow-up attempts are needed. No further information is expected.

Started with a fever Fri the 11th of June through June 21 so far.....Fever starts higher in the Am and usually calms more in the afternoon and evening. Fatigue along with headache. Have been to the doctor 3 times with many many tests done with no results.

had a temperature of 100.4; pain in his shoulders and neck/has joint pain across his neck; he has joint pain across his shoulders and neck and that he cannot turn his head/ pain in his shoulders and neck; he has joint pain across his shoulders and neck and that he cannot turn his head; This is a spontaneous report from a contactable consumer. This 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 05Feb2021 (at age 78-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, Caller stated that he had his first Pfizer shot Friday 05Feb2021. Stated that he had a temperature of 100.4 that went back to normal. Stated that he had pain in shoulders and neck since he got the shot. Clarified that it was for Pfizer Covid 19 shot. Stated that it may be normal or if others felt this way. Clarified that he had joint pain across his shoulders and neck and that he couldn't't turn his head. Wanted to know if this was serious. Patient underwent lab test includes body temperature for which result 100.4 was reported. The outcome of event was resolved for body temperature increased, whereas unknown for all other events. Information on lot/ batch number has been requested.

it was 1 day he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days; he is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy; This is a spontaneous report from a contactable consumer or other non hcp (patient wife). A 78-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9262, expiration date unspecified), via an unspecified route of administration on 30Jan2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL1283, expiration date unspecified), via an unspecified route of administration on 09Jan2021 as 1ST DOSE. SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date it was reported that the patient took pfizer first it was fine the second, he took, patient had, it was 1 day patient was tired, and it lasted a day and half, and he was fine so, he was fine for 3 days, now it seems like he have another repeat of what happened the first time, on the second dose, the patient is on Immunotherapy, would that have any affect with the shot, have had on effect on of him being on Immunotherapy. The outcome of the event he was tired, and it lasted a day and half and he was fine so, he was fine for 3 days was reported as recovered, while for the other event it was reported as unknown at the time of report. Follow-up attempts are completed. No further information is expected.

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

Pfizer COVID vaccine EUA Pfizer Dose 1 2/13/21 (EN6201) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 5/24/21 5/24/21: 78-year-old man brought to the emergency department for further evaluation of worsening shortness of breath and cough. He was in his usual state of health until approximately 11 days ago when he started to have upper respiratory symptoms characterized by congestion, rhinorrhea, sneezing episodes. Symptoms gradually worsened until 5 days ago when he started to have for productive cough accompanied by shortness of breath. He denies accompanying fever, chills, nausea or vomiting. His sister who accompanied him has been checking on him daily and has noted worsening bouts of coughing as well as shortness of breath, unable to keep up with ADLs. Upon checking on him today she noted that his lips were blue, brought in to the emergency department by private passenger car and in trial urge his oxygen saturation was noted to be 64% on room air. He was immediately started on supplemental oxygen via OxyMask, nebulizer therapy. COVID-19 rapid antigen test was subsequently positive, CT pulmonary angiogram was done which is negative for PE but also did not demonstrate any evidence of pneumonia. He is fully vaccinated against COVID-19 since March, denies any known contacts being treated for or with symptoms suggestive of COVID-19 infection. While in the ED continued to deteriorate requiring increasing amounts of oxygen via OxyMask, desaturating to 82-85% on 15 L OxyMask. Has been started on NIPV and will be admitted to the ICU for further treatment and evaluation. Of note, he reports that he and 5+ of his family members were all fully vaccinated and all tested positive to COVID around the same time. 6/14/21: The patient presented to the hospital on May 24 with cough and shortness of breath, COVID-19 test positive, initially he was hypoxic requiring 6 L of oxygen then his oxygen demand increased until he require to be on BiPAP and high-flow nasal cannula, then on May 29th require endotracheal intubation the ICU and started on Remdesivir, Decadron, but he was not candidate for Acterna, on June 3rd the patient had a fall with dislodged endotracheal tube require immediate re-intubation and his CT show simple nondisplaced skull fracture and subgaleal small hematoma without intracranial hemorrhage. Patient extubated on June 6 to BiPAP then the oxygen requirement taper down. The patient post extubation kept having shortness of breath and cough, sputum culture grow Klebsiella pneumonia and he was on Zosyn which cover it and will complete the antibiotic on June 15th. The patient is hypercoagulable with elevated D-dimer 2 to COVID-19 infection and will continue Lovenox b.i.d. with his aspirin and Plavix for CAD with pantoprazole. Will continue his chronic steroid. The pulmonologist recommend to keep the patient in isolation due to prolonged virus shedding. On per oral Vanco for C diff prophylaxis due to history of recurrent C diff infection and he is currently on antibiotic. Echocardiogram showed normal EF without significant valvular disease. Patient had episodes of dysphagia and swallow studies show some aspiration and he placed on pureed diet/dysphagia level 1. Sign-out given to SELECT LTAC team, they will follow on management.

Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21

Whole boy itchy skin; Skin felt like sun tan burn; Headache; Some itchy welts on stomach; This is a spontaneous report from a contactable consumer (reporting himself). This 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks of vaccination. The patient did not experienced COVID prior to vaccination. The patient did not test for COVID post vaccination. The patient was allergic to penicillin. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On 17Feb2021 at 14:00, the patient experienced whole boy itchy skin, skin felt like suntan burn, headache, some itchy welts on stomach which was more severe than first dose. The evets resulted in doctor or other healthcare professional office/clinic visit. The patient took allergy consultation, prescriptions and Benadryl as treatment medication for the events. The patient not recovered from the events. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received 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 the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all 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 the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. 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-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. 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 sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Had fever of 102.6 for 3 days and then the fever drop down to 100; He'd work a little bit and then had to lay down and take a nap; This is a spontaneous report from a contactable consumer, the patient. This consumer reported for a male patient (husband). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: Unknown), via an unspecified route of administration in right arm on an unknown date in Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications included aspirin and Tamasol which was a blood thinner. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 for COVID-19 immunization. The second shot was 2 weeks later, now she could not remember the date on that. It was the beginning of Mar (about 3 weeks ago) and he had no reaction to the injection or the injection site. Patient had fever of 102.6 for 3 days and then the fever dropped down to 100 and then slowly after the second for two weeks, patient had fever and fatigue. Patient would work a little bit and then had to lay down and took a nap, he had been to the doctor 4 different times and they ran all kinds of test and they never came up with anything. Chest X-rays were done to make sure there was nothing going on with his chest. They checked him mosquito bites and all kinds of different diseases and stuff and nothing, absolutely nothing showed up. The patient did not receive any treatment. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Still experiencing extreme nausea; Exhaustion weeks after; Headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 10Mar2021 at 15:00(at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney pain and cancer. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) and magnesium (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 16Feb2021 at 18:00 (at the age of 78-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 14Mar2021 the patient experienced extreme nausea, exhaustion weeks after and headache. The patient was not a person who got nausea at all and was active normally. The patient did not receive any 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 event extreme nausea, exhaustion weeks after, headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and nausea. Extreme symptoms of gout w/pain and cramping in feet / ankles. Did not eat for 4 days - fatigue, low energy. these symptoms lasted for 4 days. After the second shot on 6-3-21 - Became weak and ill the next day and was taken home from work with extreme pain in right foot and knees. Extensive all over body painful muscle cramping, weakness. Fatigue. To this day has not been able to carry on his normal walking routine. Had consulted with physician.

Presented to ED with SOB/fatigue, symptoms started 2 days prior. Was hypoxemic on NC so was placed on NRB, titrated to HFNC 40 L at 90%. over 48 hours and subsequently required intubation. Remains intubated. Received tocilizumab/steroids/remdesivir. Remains intubated but off CRRT.

has a temperature of 100.8; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 24May2021 at 10:30 am as dose 2, single dose for covid-19 immunization (at the age of 78-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 03May2021 at 10:30 am as single dose for covid-19 immunization (at the age of 78-years-old). It was reported that after receiving the second dose of vaccine, the patient had a temperature of 100.8 on 25May2021 morning. He also stated that he had no other symptoms and was asking what he should do. On 25May2021, the patient underwent lab tests and procedures which included body temperature which result showed 100.8. The outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: Within fifteen minutes of receiving vaccine patient experienced lightheadedness and dizziness. Remained awake alert and oriented and able to stand and ambulate. Initial vital signs were within normal rnage except blood pressure 152/67 mmHg. Patient denied chest pain, palpiatations, shortness of breath, difficulty breathing, nausea, vomiting, and pain. Patient stated they had not eaten yet that day and was immediately given juice, food, and water. One hour after vaccination patient stated symptoms were resolving. One hour and fifteen minutes after vaccination patient stated lightheadedness and dizziness returned and were slightly worse and developed a new symptom of "ear and head pressure". Repeat vital signs were within normal ranges except blood pressure was 139/92 mmHg. After discussion with healthcare provider decision made to transfer patient to urgent care/emergency department.

loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.

Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.

Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms

Started with severe myalgias, back pain, leg pain and fever T 104 He was taken to Urgent Care with Covid neg, Influenza A/B neg. UA and CXR negative Symptoms lasted 72 hours He has never had fever before and he is 79 years old.

Two days after receiving the injection, I began to run a low grade fever (100 degrees) along with chills and fatigue. Symptoms were relieved with acetaminophen (1000 mg) no more than two or three times/day. I try to limit dosage if I can. After about one week of this, I phoned my PCP to report my symptoms to him and was told that he had several patients that were also having post-injection symptoms similar to those that I was experiencing. Today, Sunday Jan 24th is the first day that I am finally symptom free after experiencing these side affects for eleven days.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports. A 79 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were none. On 11Jan2021 the patient was tested positive for COVID 19. He was sick before then but did not get tested until 11Jan2021. Events outcome was unknown.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 05Jan2021, and COVID-19 test positive on 11Jan2021. 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. He was sick before then but did not get tested until 11Jan2021.,Linked Report(s) : US-PFIZER INC-2021021527 same reporter/drug/AE, different patient

Generall body aches, headache, fever (never got over 99.5), fatigue. Started late Friday, 1/22/2021, stayed in bed all day on Saturday and slept (1/23/2021), and felt much better by Sunday noon (1/24/2021). No problems since.

Threw up 4 times; Had diarrhea 3 times; Tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) at 79-year-old via an unspecified route of administration in the left arm on 14Jan2021, 9:03 AM at a single dose for COVID-19 immunization/ because people are dying. The patient's medical history was not reported. Patient however stated he is familiar with cancer, epileptic seizures, and heart attacks (pending confirmation if referring to medical history). The patient lives alone and has nobody. Concomitant medications were not reported. On 15Jan2021, from 2:00AM, the patient threw up 4 times, had diarrhea 3 times, and was tired. The patient recovered from the events "threw up" and "diarrhea" on 15Jan2021 (time unspecified). Outcome of the event "tired" was not recovered. It was reported that the patient was scheduled for his second dose on 04Feb2021 at 3:30 PM. Information on the lot/batch number has been requested.

fever of 100 to 101; Congestion; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the 2nd of the two reports. A 79-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), 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. The patient received the first dose of the COVID-19 vaccine on 09Jan2021 and started having fever and congestion on 14Jan2021. The patient began to have a fever of 100 to 101 and congestion yesterday, 14Jan2021. The reporter stated she is giving her husband Coricidin and Vit C with Zinc and is taking her husband to see a healthcare professional (HCP). The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046098 Same reporter/drug/event; different patient.

3rd day after shot had lots of phlegm in morning lasting about a week. Easy to cough up. Green/yellow. More than a teaspoon. No breathing problem but did feel fatigued. After coughing up in morning, no other phlegm all day. Then, for a week, I had trouble with balancing, like walking after too many drinks. That has essentially resolved itself. OK now. Really don't know if adverse reaction or possibly a 'bug'. Thought it best to let you know.

COVID(+) Narrative: Patient developed COVID-19 symptoms on 1/16, approximately 2 days after receiving dose #1 COVID vaccine. He was admitted on 1/30 with worsening symptoms of fatigue, low grade fever, myalgias, dyspnea, and productive cough and found to be COVID(+) via Cepheid test. Patient was treated with supplemental oxygen and oral dexamethasone therapy.

Profuse rhinorrhea beginning between 11 AM and noon. It was clear and colorless. It began to subside about 8 PM. It had stopped by 10 PM.

meningioencephalitis; Severe headache; severe nausea; migraine; small subarachnoid hemorrhage postulated; This is a spontaneous report from a contactable Physician (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 07Jan2021 at 02:30 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included hypertension, hypercholesterolemia, hypothyroidism and dust allergy. Concomitant medications in two weeks prior to the vaccination included levothyroxine sodium (SYNTHROID), chlorthalidone and rosuvastatin calcium (CRESTOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 PM patient experienced severe headache with severe nausea requiring emergency room (E R) visit and intravenous (I. V) morphine, toradol and ondansetron. Computed tomography angiography (C T A) of head performed on unknown date was normal. Pain unbearable. Lumbar puncture (L P) not done. Pain persisted four days later, though diminished. Diagnosis (Dx) uncertain but possible migraine with right (r) eye preference or small subarachnoid hemorrhage postulated. Another troublesome possibility could be vaccine reaction (meningioencephalitis). Events resulted in Emergency room/department or urgent care. Treatments received included IV morphine, zophran (as reported), ketorolac tromethamine (TORADOL) and metoclopramide hydrochloride (REGLAN). Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient recovered with sequel from the reported events.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events meningoencephalitis, headache, nausea, migraine and subarachnoid hemorrhage. 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.

Chills and general body aches. Took two tylenol , went to bed. In bed almost all of next day. Unable to eat.

PATIENT REPORTED BODY ACHES, HEADACHE, NAUSEA AND THREE EPISODES OF VOMITING. HE WAS TREATED WITH IV FLUIDS, ZOFRAN, AND TYLENOL AND REPORTED SIGNIFICANT IMPROVEMENT IN SYMPTOMS.

REPORT GIVEN BY HIS WIFE. DAY ONE: ITCHING IN ODD AREAS OF BODY (UNDER ARMS AND BACKSIDE). NEXT DAY FEELING TIRED. FRIDAY HE DID FEEL WELL AND O2 LEVEL 91% - 88% THEN A RASH WAS NOTED FROM NECK DOWN TO LEGS. WIFE TOOK HIM TO THE HOSPITAL SATURDAY MORNING. IN ER FOR ALLERGICE REACTION, BUT THEN TOOK A TURN FOR THE WORSE AND WAS PLACED ON BI PAP MACHINE FOR ABOUT 5 HOURS. DISCHARGED AFTER 5 DAYS IN HOSPITAL. ALLERGIST CALLED I N TO CONSULT-

The normal site pain from the needle stab, and several minutes later a sympathetic pain in the right shoulder. Sounds crazy, but the same thing happened to my sister and one of her friends. Sometime later after arriving home, I developed chills. At 10:30 pm I took two extra strength acetaminophen capsules (500 mg, ea.). That eliminated both the chill and the right shoulder pain by 11:30. Today, the 18th, I am feeling fine except for the injection site pain.

(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night

Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

Feeling fatigued/unwell; Feeling fatigued/unwell; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3248; dose 1) via an unspecified route of administration on 20Jan2021 at 15:00 (at the age of 79-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had an allergy to morphine. 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 vaccine. The patient experienced feeling fatigued and unwell on 21Jan2021. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive treatment for the event. The outcome of feeling fatigued and unwell 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 needed. No further information is expected.

Cold chills; Fever; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on his left arm, intramuscular on 19Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had Cold chills, fever and not feeling too well. He took one Tylenol for fever. The outcome of the events was unknown.

Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.

Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.

slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the 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 outcome of the events fatigue and left arm soreness was recovered in Jan2021.

feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients

not been feeling well at all; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL9262, expiry date unknown), via an unspecified route of administration at the left arm on 29Jan2021 13:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he had an injection site pain on 29Jan2021. It was still sore after 3 days and the day afterwards he was not been feeling well at all on 30Jan2021. He was not sure if it has any effect on it, but had a pacemaker put on the right side of his chest in a week before getting the shot so he was not sure if that could affect how he was feeling. The outcome of the event 'injection site pain' was not recovered and the outcome of the event 'not been feeling well at all' was recovering. The vaccination facility type was hospital. The vaccine was not administered at the military facility.

Flu like symptoms, with no high temp since original vaccination and continued with 2nd vaccination. Muscles, joints shoulder neck, head. Tonge very sensitive to any acidic , spicy or rough food

Severe flu like symptoms; fatigue; muscle and joint pains; muscle and joint pains; headache; fever and chills; This is a spontaneous report from a contactable physician (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number LTM 2), via an unspecified route of administration (arm right) on 04Feb2021 00:00 (12 AM) at SINGLE DOSE for covid-19 immunisation, at 79 years old. Medical history included prostate cancer from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. No allergies to medications, food or other products. 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 experienced severe flu like symptoms; fatigue; muscle and joint pains; headache; and fever and chills on 04Feb2021. Treatment was not received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.

After receiving vaccine I felt slow and nauseated, then started having pain in rib cage that lasted a while, i ended up forcing myself to throw up and felt a little better, the pain moved up and i was running a fever. The next day I felt better.

Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day temperature of 101.3F. Very debilitating, making it difficult to dress and to sleep. Hand to take anti anxiety drugs to help sleep for 8 days. I had COVID -19 and was hospitalized from Nov.16 to Dec. 4 2020. Then 2 weeks in bed before able to walk downstairs. Not a pleasant experience!

increased heart rate/slight increase in his blood pressure and heart rate post vaccination/a 97 heart rate; feel very weak; blood pressure is steady now but pulse is always elevated/slight increase in his blood pressure and heart rate post vaccination/It was 139 over 78 with a 61 heart rate/Next morning at 10 am my blood pressure was 139 over 95; tired; I think I had a reaction to it; This is a spontaneous report from a contactable consumer (patient). A 79-(unit: unknown)-old male patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, NDC number, UPC number and Expiry Date: unknown), via an unspecified route of administration on 28Jan2021 13:00 at single dose for covid-19 immunisation at the vaccination facility. COVID Vaccine was a Pfizer product. COVID Vaccine manufacturer was unspecified. Reason for no lot number of COVID Vaccine stated by consumer as he don't know. He stated "I had little card Pfizer EN5318 (further not clarified). There is another number here, I think it D-6152061100." Medical history included a heart disease (A-Fib) (Intent: History) for which the patient takes Eliquis, losartan ,metoprolol and pravastatin and a heart condition. Concomitant medication included apixaban (ELIQUIS), losartan, metoprolol, pravastatin; all for A-Fib. Caller (patient) stated "I receive my first dose of Pfizer COVID-19 vaccine on 28Jan2021. I felt really tired (in Jan2021) for a week after receiving the vaccine. I have a heart disease (A-Fib) for which I take Eliquis, losartan, metoprolol and pravastatin." He noticed a slight increase in his blood pressure and heart rate post vaccination. He had the tendency to monitor his blood pressure and heart rate on regular basis but had been monitoring closely post vaccination. His normal vital signs were around Blood pressure:120/70 to 80 and Heart Rate: 50 -60. However he noticed his BP was high as 139/95 (in 2021) and heart rate 95-103 (in 2021) which is not his normal. His blood pressure is steady now but pulse is always elevated. On 11Feb2021 patient stated "Started to feel very weak. My blood pressure had gone up; Blood pressure was 139 over 95. Heart rate almost doubled: 97 heart rate. Patient stated, "I took the COVID first shot and my age is 79. I took the first shot of the COVID Vaccine on 28Jan2021, around 1 pm in the afternoon at the vaccination facility (a 2 year college, they were doing it outside of the college). I think I had a reaction to it (in 2021). Normally my blood pressure is 110 to 125 on top and I don't know 65 up to 80 on the bottom and my heart is normally between 50 to 65. That's my normal heart rate. I am pretty healthy and I do a lot exercise and lot of power walking, so my heart rate is 'not so' low. That afternoon (28Jan2021) I walk, my power walk training miles. I started to feel very weak and at night I took my blood pressure it wasn't too bad. It was 139 over 78 with a 61 heart rate and then next morning I woke up and my blood pressure had gone up to medically and heart rate almost doubled. Next morning (29Jan2021) at 10 am my blood pressure was 139 over 95 and a 97 heart rate. It kind of continued, I have been writing this all down and monitoring it and blood pressure has come down to some degree but my heart rate continue to be elevated but my blood pressure like this morning, I do in January because I have heart condition and I have Afib (Intent: History). I took the Pfizer vaccine." I am scheduled to get the second dose on the 18th and I am concern about the elevation of my heart rate and elevation of my blood pressure." Outcome of event 'tired' was recovered in 2021; 'Blood pressure raised' was unknown; 'Heart rate increased' was not recovered; 'feel very weak' was unknown; 'I think I had a reaction to it' was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

drowsiness; reduction in the chronic mucus phlegm in his air passageways; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Relevant medical history included chronic congestion, which he had for many years; hard of hearing; and he was about 10 pounds overweight (he had weight of 219; further reported that he was good, but during this COVID stuff, all he did was to eat the whole day), from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE, the cortisone nasal inhaler) and formoterol fumarate, mometasone furoate (DULERA, a Merck product); both taken for his mucus and congestion, start and stop date were not reported. The reporter got some good news about the Pfizer COVID-19 vaccine shot and it was very positive. The patient received the shot actually about 49 hours prior reporting (on 15Feb2021) and within that 30 plus hours, he noticed a reduction in the chronic mucus phlegm in his air passageways. The patient had chronic congestion for many years and this was a congestion, for which he was on his other regimen, Flonase and Dulera. The patient wanted to report that this was a very positive thing as it really helped reduce his mucus in conjunction with ingesting of the other 2 drugs (Flonase and Dulera) that he was taking. The patient had no adverse side effects other than drowsiness from taking the shot on an unspecified date. The outcome of the events was unknown. Information on the batch/lot number has been requested.

After two days a low grade fever and terrible body aches. My fever has gone but body and joint aches have continued for three weeks. I have been able to some what control by taking a non steroid prescription drug periodically when the pain get bad. It seems to be an inflammation of my nerves. When will this go away?

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a contactable consumer (patient). A 79-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 03Feb2021 at 12:05 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient previously administered first of BNT162B2 on13Jan2021 for covid-19 immunisation and experienced Headache, loss of taste, very tired, arm sore. The patient experienced headache, very tired, arm sore, loss of energy on 03Feb2021 and patient again experienced loss of energy on 04Feb2021. The patient did not received any treatment for the events. The outcome of the events arm sore was reported as unknown and other events was reported as Recovered. Information of Lot/ Batch number have been requested.

Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain. He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism. He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued. He notes that he has not been very active since receiving the vaccine. CT PE study showed an increased RV to LV ratio 1.2. He had no elevation in his troponin or BNP. His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time. He will need a 6 month course of Eliquis. Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus. Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.

Long term tiredness lasting over 2 weeks since first vaccine. Second vaccine scheduled next week on 04/08/2021

sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021. No follow-up attempts are possible. No further information is expected.

I am in bad shape here, I have had everything it's a bad situation; I have been in bed for two days; Swelling; Chills; Headache; Muscle pain; Joint pain; Slight fever; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received BNT162B2 (Formulation: Solution for injection, NDC number/UPC number: Unknown (there was nothing over here, there was nothing on the card), Expiry Date: Unknown (it was not there)) via an unspecified route of administration on an unspecified date at single dose to his right arm for Covid-19 immunization. The patient's medical history included ongoing blood pressure. Concomitant medication included hydrochlorothiazide (HCT) from an unspecified date and ongoing at 50 mg once a day for blood pressure. Consumer stated, "it was a pill" (not clarified further). It was reported that, about two days ago on 10Feb2021, he was in bad shape here, he have had everything it was a bad situation. He had been in bed for two days. On 10Feb2021, the patient experienced swelling, chills, headache, muscle pain, joint pain and slight fever. Consumer stated "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." Consumer stated "he just reported all the symptoms that, he took vaccine and he was in bad shape here, he had been in bed for two days. He got swelling, chills, had everything, it was a bad situation, got headaches, muscle pain, joint pain slight fever, right he got all." Consumer confirmed it was Pfizer vaccine, however name was not clarified. When probed for age, consumer stated, "he started feeling the symptoms about two days ago. He did not understand." Consumer stated, "about two days ago 10Feb2021." (not clarified further). When probed for the name of the Centre where patient was administered the vaccine, consumer stated, "The VA, that's the service, he was in the service the (state name) VA." Regarding lot number, consumer stated, "It looked like lot number L8982 and then the next one was, it was two lot number on here, the second dose is 813248." (Not clarified further). Consumer stated, "he did not see dose." When probed if still experiencing the problems (event not specified), consumer stated, "yeah, it was been improving a little bit, not much". (not clarified further). The patient received paracetamol (TYLENOL) as a treatment for the events. Regarding the treatment, consumer stated, "he did not know, he took it over the counter that's all he knew." Outcome of the events was unknown. Information of lot/batch number has been requested.

Three days after the second Pfizer shot I had high temperature, sore throat, breaking out on the skin on the neck and face, hands, which has lasted for the past nine days

he felt drowsiness.; it hurts to turn his head and he cannot drive safely; muscle pain went over to the other shoulder and basically spread out all over his upper body; he's been having muscle pains; This is a spontaneous report from a contactable patient. A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982 and Expiration date not reported), via intramuscular route of administration in the left arm on 28Jan2021 07:30 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not allergic to anything. It was reported that patient was generally in good health in 79. He knows there may be some adverse effects. Last Thursday (on 28Jan2021) he got his first dose of the Pfizer covid vaccine and he's been having muscle pains. The only thing that has happened to him was a lot of muscle pain, quite a bit. Through the day he started to feel the muscle pain and through the night he felt some stuff (referring to the muscle pain), very lightly enough to be a nuisance. States from the waste up he felt drowsiness. The first night he slept some but not much since he could not get in a position where he could sleep very much. The next morning the muscle pain was much more severe, more pronounced on his left-side, which is the side he had the shot, particularly in several areas like right underneath his armpit and between his arm and elbow. By the end of 2nd day, the pain had spread to the right hand and the day after that, it was concentrated on the left arm on the injection site. The next morning the muscle pain went over to the other shoulder and basically spread out all over his upper body. It has since worsened by then. He broke down last night and he took two Advil, and he got a really good night sleep. This morning he got up and the muscle pain gradually came back but not quite a s bad, states maybe the Advil was slowly wearing off. States it was a funny sensation, a lot of them. Patient feels it on the bottom of the side of his rib cage and neck. He was asking how long the muscle pain will go on. He hates to combine anything he will experience from the second dose with what he was currently experiencing. Patients understanding was that the second dose will worse. Patient ask can he take the 2nd dose on his opposite arm (right), he do not want to feel pain on the same side again. He has a card that states when he was supposed to get his second dose. States it hurts, it hurts to turn his head and he cannot drive safely. States his wife got her vaccine two days before him. He puts his glasses on to read the con-tact details from his hcp card. When querying outcome of drowsiness, he reports it occurred a few times off and on and it comes and goes, it does not stay around. Prior to vaccination patient did not take any other vaccines within 4 weeks. The patient experienced he's been having muscle pains, he felt drowsiness, it hurts to turn his head and he cannot drive safely, muscle pain went over to the other shoulder and basically spread out all over his upper body. The outcome of event was not recovered for myalgia, condition aggravated and unknown for somnolence, impaired driving ability. Follow-up activities have been completed and no further information is expected.

Fevers up to 102.8, chills, sweats and extreme fatigue including sleepiness .alternated between Tylenol 500mg and Ibuprofen for fever

Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported.

Pt began experiencing metallic taste in mouth after 1 st shot on 3/31/21. Pt worked the rest of his shift that night. Pt spouse called in to work on 4/1/21 stating pt felt crummy, arm swollen, and headache.

Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated.

runny nose a day or so later; little diarrhea; had a cough; post nasal drip; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included allergies and diarrhea. Concomitant medications were not reported. On an unspecified date a day or so later after receiving BNT162B2 the patient experienced a runny nose and a little diarrhea. The patient was not sure if it was from the vaccine or not. The patient also had a cough and said it could be from post nasal drip. The outcomes of runny nose, diarrhea, cough, and post nasal drip were unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........knees , shoulders , hands , fingers , wrists....Have not been seen by Dr...his office told me there was nothing they could do ......situation has not improved and doing normal things hurt like hell ...getting up and sitting down painful, getting in and out of car hurts .......I need and use a cane to walk.......how long does this side effect go on?????

Fever and diarrhea following a couple days after the vaccine Being administered. The day prior to hospital emergency admission uncontrollable throwing up extreme side/Stomach/chest pain. Was taken by ambulance to emergency.

Fatigue; Fever; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: E19267), via an unspecified route of administration in right arm on 17Feb2021 at 02:30 PM at single dose for COVID-19 immunisation.The patient's medical history included high BP, high cholesterol and diabetes. The patient was allergic to Mobic. It was reported that prior to vaccination, the patient was diagnosed with COVID-19 and the patient did not get tested for COVID-19, since the vaccination. The patient's concomitant medications included celecoxib (CELEBREX), metformin, allopurinol and pravastatin. On 18Feb2021 at 6:30 AM, the patient experienced fatigue, fever and muscle aches for 36 hours. The patient did not received any treatment. The outcome of the events was recovered.

wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.

Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,

HPI: Patient is a 79 y.o. male who presents with the chief complaint of progressively worsening of shortness of breath associated with cough and fever which has a started 2 days ago. Patient states that he has been otherwise in his usual state of health. In the past he used to use oxygen supplement therapy at home but he has not been using any oxygen recently since his respiratory condition had improved. Patient has followed up by pulmonary consult as an outpatient but he has not seen any physician recently. By the time EMS arrived at home patient was noticed to be hypoxic and started on CPAP. On the way in the hospital hospital but he had 2. Patient on nonrebreather mask and in the ER patient was initially started on BiPAP ventilation which was switched to Patient denies any loss of consciousness no nausea vomiting abdominal pain no diarrhea no constipation. Patient denies any coffee-ground vomiting no rectal bleeding no flank pain no hematuria no dysuria no frequent urination.

Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis

history of hypertension, mild cognitive impairment. Prior COVID pneumonia treated as an outpatient November 2020. Completed dose 2 of Pfizer vaccine 4/11 with progressive fatigue low-grade fevers and white count of 14 CRP elevated at 4 (see this would equate to a CRP of 40 with most other lab references) on 04/27. He was admitted and treated for community-acquired pneumonia with ceftriaxone and azithromycin. He was discharged 04/30 and then presented again 5/5 with progressive right greater than left consolidative ground-glass opacities and hypoxemic respiratory failure requiring up to FiO2 80% of high-flow nasal cannula. Infectious workup has been negative. He has been too unstable to bronch. COVID-19 testing has been negative. He was started on high-dose steroids 5/8 with stability and slow gradual improvement.

chest pains; cough; rash; This is a spontaneous report from contactable consumer (patient) via Medical information Team. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:15 (Lot Number: EL3248) as single dose; dose 2 via an unspecified route of administration, administered in right arm on 12Feb2021 at 14:30 (Lot Number: EN6201) at the age of 79 years as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 the patient experienced chest pains, and cough, which required hospitalization from 05Mar2021 to 08Mar2021. The patient informed that he had some stress with son and daughter to point where he had some chest pains. After a week or two of conversation involving patients son and granddaughter culminated into this. The patient informed that when he went to the hospital because of chest pains, patient was already use to that and wasn't worried about it. The patient stated he didn't want to go to the hospital, called the doctor but because of Covid, the doctor wouldn't see the patient. The patient stated he shouldn't have been in the hospital at all. In terms of the cough, he simply called the doctor because the patient wanted cough medicine or something for that, temporary thing coming on. Patient stated the cough did not linger, and it was never treated. The hospital got into the chest pain and jumped on the heart situation and patient thinks they saw dollar signs or something. The patient wasn't very happy with them. The patient informed that he was given a blood thinner, Heparin IV during time hospitalized. The hospital decided to hold the patient over and they gave the patient Heparin IV for a good part of three days. The patient reported that he was discharged on 08Mar2021, and on 10Mar2021 the patient noticed the rash. The patient reporting experiencing rash after receiving both doses of the Pfizer covid-19 vaccine. The patient was thinking the combination of Plavix and heparin only three weeks after having the Pfizer Covid Vaccine could possibly be a side effect of rash. Therapeutic measures were taken as a result of rash. The doctor gave the patient Clobetasol Propionate and patient did treat rash with that. The doctor said to apply for 2 weeks and come in on one week. It has already improved. The patient mentions that he was also taking Calamine lotion and some spray and they all seem to be working. Patient didn't want to keep taking Clobetasol because it is a steroid and he had been using for a month and didn't want to do that. The clinical outcome of rash was recovering. The clinical outcome of the remaining events was unknown.

Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

ED Discharged 3/28/2021 (4 hours) Hospital ED MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Clinical impression Diarrhea ? Cough Chief complaint ED Provider Notes MD (Physician) ? ? Family Medicine Expand AllCollapse All Chief Complaint: Chief Complaint Patient presents with ? Diarrhea ? Cough CT of chest shows no pulmonary embolism but is positive for Covid pneumonia. Clinical Impression: Impression is Covid pneumonia. Patient looks well clinically stable sats look good no need for admission. He is taking steroids he has read the protocols and has steroids at home. I told him that the protocols usually are for inpatient I cannot really say with absolute certainty that this will do anything positive as an outpatient I think given how well he looks and not sure that he needs to continue that. Otherwise however return immediately if things worsen I will see him as an outpatient MD 03/28/21 1826

Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizziness and then felt nauseated, weak, and diaphoretic. Patient left ED.

Inpatient Discharge Summary Admission Date: 3/22/2021 Discharge Date: 3/27/2021 Principal Problem: COVID-19 virus infection Hospital Course s a 79 y.o. male who presented to the hospital with a complaint of 1 week of shortness of breath and fever. He was managed for- COVID19 pneumonia with acute hypoxic respiratory failure, POA - CTA negative for PE; there is evidence of COVID19 pneumonia - given a unit of convalescent plasma - Remdesivir daily x 5 days (last day 3/26) -Will be sent on 4 days of Decadron to finish total of 10 days of Decadron. - inflammatory markers have improved - procalcitonin is negative x 2 - Mucinex/is/opep - wean oxygen as able, encourage patient to prone. - patient weaned down to room air. Home oxygen evaluation was done he did not qualify for O2 at home. AKI - Cr 1.36 upon presentation, improved to 1.0. - avoid nephrotoxic agents- d/c mobic. Did get contrast on 3/23 - continue to monitor renal function 5 beat run vtach - Patient does have hx of osa and was using CPAP machine - electrolytes were normal - continue telemetry monitoring - discussed outpatient ECHO Transaminitis - ?secondary to remdesivir vs covid virus Commend to repeat the LFTs in 3 days and follow the results with the PCP.

who sponsored the Vaccine site. Adverse event: Was starting to drive and was kind of lethargic and was slow reacting. My wife was asking questions but I was having slow responses. She said I had glazed stare and I was a little off balanced and the ambulance was called but the symptoms had subsided by the time the ambulance got there: Blood pressure - a little elevated; Blood Sugar was fine . At that time could follow finger across eyes (before when symptoms were still there, had not been able . Ambulance left and just said to keep an eye on him at home when I refused to go to hospital. We called the family doctor and she said to go to ER immediately. No return of symptoms since that episode.

Pt received vaccine 3/3/2021. Pt began with congestion and shortness of breath 03/17/2021. Pt admitted to hospital 3/23/2021 with DVT and PE. Pt was fully ambulatory and no recent procedures prior to this

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

they both felt tired and after a day or two that went away; headache across the eyebrows that was progressively becoming worse; Sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 Immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9266, Expiration Date: 31May2021) on 04Feb2021 single dose for COVID-19 immunization. It was reported that he has developed a headache across the eyebrows that was progressively becoming worse in 2021. He thought it was spring-time allergies at first but never had them before. Patient felt tired in 2021 and after a day or two that went away. He thinks but he doesn't know since he has gotten the second COVID Vaccine, he has been getting headaches, usually in the morning and at night. It's like a sinus headache across his eyebrows. He has never had anything like this in his life. was it common to get a reaction to the vaccine like this? He started getting these headaches and sinus pressure a week or two weeks after getting the second shot in 2021. It was getting worse. Every day it gets worse and worse. Patient states worse time was in the morning when he get up around 7 a.m. and in the evening around 7 p.m. He does use a saline spray, which helps a little. The outcome of event felt tired was recovered in 2021, remaining events were not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Patient presented to the ED with dehydration, elevated lactic acid and seizure, and was subsequently hospitalized for elevated troponin and seizure. This is within 6 weeks of receiving second covid vaccination.

pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by heart palpitations on day four. Palpitations continued for several weeks and then slowly cleared. BP, heart beat all normal. Palpitations were infrequent, then increased in frequency and the slowly diminished.

chills; fatigue; low grade fever; This is a spontaneous report received from a contactable 79-year-old male consumer (patient). A 79-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route on 17Feb2021 (at the age of 79-years) as 1st dose, single dose in the right arm for covid-19 immunisation. The patient medical history included major radial prostatectomy on 04Feb2021. The patient had no allergies. Concomitant medications were not reported. On unspecified date, the patient experienced reaction of chills and fatigue, low grade fever but in a couple hours that went away which lasted about 7 hours. On 11Mar2021 he got the 2nd dose of the Pfizer vaccine. He was fine. He had no problems until 15Mar20201 (4 days afterwards). He started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. He wouldn't be calling you but this has not subsided. It's been 3 weeks now and He was not feeling well. It ebbs and tides. He been taking a diary. He went to the ER last Monday because He was wheezing in the morning and had shortness of breathe in-between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder. Patient stated that ‘They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7F but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels... I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday... please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice... that I'm not nuts... something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took a (your vaccine) vaccine. I need someone to get back to me'. He reports he did have major surgery about a week before receiving the first injection of the Pfizer covid-19 vaccine. After the first injection, he reports only have mild reactions that went away. After the second dose of the Pfizer covid-19 vaccine, he has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer covid-19 vaccine that would be causing his symptoms. The difference is this hasn't gone away, its now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. Patient stated about Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. The Only thing he thinks could be relevant, on 04FEB2021 he had a major radial Prostatectomy, he was then discharged the following day, he thinks maybe his body never fully recovered from the procedure, but one ever told him anything. The patient underwent lab tests and procedures which included covid test which was negative, chest x-ray showed bronchitis. The patient took Tylenol (Lot SSA042 Expiry Oct2021) for events. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Wasn't felling heathy/Wasn't feeling well/not feeling good/Felling ill/Feeling sick; Using a bathroom number 2 four times a day, regular stool not soft; Back hurt; Slightly dizzy; I worry about how I am feeling until I know it is from the shot or not I am not going for another shot; Maybe nauseous; Feeling down; This is a spontaneous report received from a contactable consumer (patient) reported that: A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0123; Expiration date: unknown), via unspecified route of administration on 02May2021 (at the age of 79-year-old) as first dose, single dose COVID-19 immunisation. The patient medical history included atrial fibrillation and the concomitant medications included blood thinner for atrial fibrillation. The patient took pfizer shot 3 weeks ago. The patient experienced was not felling heathy, I wasn't felling a 100 percent; Was not feeling well/not feeling good, using a bathroom number 2 four times a day, regular stool not soft, back hurt, Feeling ill, Feeling sick, Slightly dizzy, worry about how he is feeling until he know it is from the shot or not, patient not going for another shot, May be nauseous, Feeling down on unspecified date in May2021. The patient stated that he got the shot 3 weeks ago and patient was due for second shot tomorrow but he have a concern, he do not think he is going for it, 2 days after he was not well about 8 days and then he felt better and then about 4 days ago he felt the same thing again, The patient stated that "he did not really care to report it but what he was calling to see his second shot is tomorrow and he is not going for it, but he would like get it may be when he feeling mentally after it, Could he take it couple of weeks later, if that ok?" the patient had a reaction to the flu shot (Unspecified Flu Shot) and he was feeling ill for about another 9 days it went away, but then it came back 4 days ago; didn't feel well/ not feeling good. The patient was scheduled for my second shot this morning I did not go because he is not feeling that great. The patient said he got the flu shot 3 weeks ago and 2 days after this shot, he did not feel well for about 7, 8, 9 days and then it went away, he felt okay and then about 4 days ago he got back the same feeling, not feeling good, slightly dizzy, maybe nauseous. Using the bathroom, number 2 frequently 4 times a day and he was scheduled for my 2nd shot this morning I did not go because he was not feeling that great. The patient stated that he took the vaccine three weeks ago and he was scheduled for his second shot this morning, he did not go because he is experiencing some side effects(Further not clarified hence captured as verbatim) and he was concerned to see this is related to the vaccine (confirmed as Pfizer COVID vaccine) or not?" He got this vaccine shot 3 weeks ago two days after he was not feeling well, he was feeling down for about 8 or 9 days and then it passed, the patient felt better then 4-5 days ago the same thing come back, this is 3 weeks now. The patient did not receive any treatment for the events, the outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Burkitt's Lymphoma, Pain in Abdomen, Lethargy, Weight Loss, PET Scan, Chemotherapy, Mass discovered in Lymph Node in abdomen CT Scan - May 18, 2021 Blood Work - May 19 and 27, 2021 Tissue Culture and Biopsy - May 19, 2021 PET Scan - May 27, 2021 Echocardiogram - May 28, 2021 Chemotherapy start date - June 2, 2021

Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two 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. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.

low oxygen; high heart rate; cough; This is a spontaneous report from a contactable (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262, Expiration date: Unknown), via an unspecified route of administration on 25Jan2021 (at the age of 79-year-old) as dose 1, single for covid-19 immunisation in hospital. Medical history included diabetes mellitus from 2011 and ongoing (10 years ago), chronic obstructive pulmonary disease from 2016 to an unknown date (5 years ago), high blood pressure from 2011 and ongoing (10 years back) , prostate issues (10 years ago). Concomitant medication(s) included METFORMIN 500 mg, twice a day taken for diabetes mellitus; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication from an unspecified start date and ongoing; FINASTERIDE 5mg, once a day taken for an unspecified indication; TAMSULOSIN once a day taken for an unspecified indication; METOPROLOL 50mg, once a day taken for hypertension all from an unspecified start date and stop date, ATORVASTATIN once a day taken for an unspecified indication from 2016 to an unspecified stop date. On an unspecified date in 2021, the patient experienced low oxygen, high heart rate and cough. He went to emergency and he was treated there, and he was okay the next day. Patient reported that he experienced side effects after his first dose of the Pfizer covid 19 vaccine that he received on 25Jan2021. Patient reported that he had a high heart rate low oxygen and a cough the next day. Patient went to the ER for 4-5 hours. Patient stated that he tested negative for covid, but his MD told him he probably had covid. Patient wanted to know if he should get the second dose due to the side effects and due to him possibly having covid. Patient stated, he just wanted to report adverse effect he had from his first Pfizer shot and he was wondering if he should get the second one or if he can wait for 3 months. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date, heart rate: high: reported that he had a high heart rate low oxygen and a cough the next day, on an unspecified date, oxygen saturation: low on an unspecified date, sars-cov-2 test: negative on an unspecified date: Patient stated that he tested negative for covid, but his MD told him he probably had covid. Therapeutic measures were taken as a result of the events. Regarding treatment the patient stated that, he did not know. They gave him an IV in the hospital. That's all he did remember. It was not like he was dehydrated. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Patient hospitalized due to hypoxia, shortness of breath and dry cough. Arrived on 15L and put on BiPAP at 100%

Patient admitted on 15L of O2 and placed on BiPAP at 100%. Shortness of breath with dry cough. Hypoxic on room air

Patient states he was out looking for a new car when he felt Palps states he did not think anything of it at this time as he just assumed this was possible Anxiety/stress as he was "running around" in search of a new car. Patient states he often however notice he had become more and more fatigued. Shortly after patient presented to the office for evaluation. Patient had an EKG on 5/28/21 at his annual physical. When patient presented for the Palps on 6/16/21 another EKG was performed. This EKG showed changes which included Atrial flutter. Patient was then referred to (Electrophysiologist). From there he was advised and scheduled for Cardioversion, this is scheduled for 7/28.

1 significant episode of asymptomatic Supraventricular tachycardia; transient ischemic attack; seizure-like shaking; shaking episode arms going up and down; extremely tired; This is a spontaneous report from a contactable physician (patient himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) at the age of 79-year-old male as single dose for covid-19 immunisation. Medical history included ongoing diabetes type two from 30 years, ongoing hypertension from 15 or 20 years ago, depression from 20 years ago, hyperlipidemia from 15 to 20 years, orthostatic hypertension (had it off and on for years; but it got bad in the last couple of months), pain and radiculopathy. Concomitant medication included metformin (1000 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); glipizide (4 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); lisinopril (10 mg) taken for hypertension from Mar2021 and ongoing; duloxetine (60 mg) taken for depression and pain from an unspecified start date and ongoing (taking for years); gabapentin (NEURONTIN) taken for radiculopathy, start and stop date were not reported. The patient previously took flu shot for immunization and took dose 1 of bnt162b2 in Jan2021 for Covid-19 immunization at the age of 79-year-old. Physician was calling regarding the Pfizer BioNTech COVID 19 vaccine. He had a very strange experience; added he was a physician and in reasonable good health. He had mild side effects, not much; the one side effect he did have was one week after the second shot he and his wife both felt extremely tired the whole day from Feb 2021. Physician mentioned that 4-6 weeks after getting the 2nd dose, he had a 3-5 minute episode of seizure-like shaking, shaking episode arms going up and down on 21Mar2021 and that he was just blankly staring and non-responsive. He had no other symptoms to suggest a seizure; no biting; no urination. This episode lasted three to five minutes. During the episode his wife said he was just staring ahead and he was non responsive to his wife who was only six inches away speaking to him. Then he started to vaguely he heard his wife's voice in the distance and then he woke up and then he was fine. Later that day he was hospitalized, they did a work up and discharged him about 4 days later. While in the hospital he thought he had a Blood work, CAT Scan; MRI; holter monitor; EEG but they were all normal. He had no other complications and the effect completely went away. Adds he was completely recovered when it went away. At discharge they put him baby aspirin, 81mg enteric coated aspirin once daily, and gave him a tentative diagnosis of transient ischemic attack (TIA). This further resulted to being hospitalized for 3 days but his physicians were not able to see anything significant on his MRI, 72 hours EEGs and telemetry tests (everything was normal). However, during his out-patient visit, his physician mentioned that he had 1 significant episode of asymptomatic Supraventricular tachycardia that may be causing the seizure (inconclusive). They further specified to him that it was not much of a tonic clonic seizure. He also verified that he only had 1 episode of the mentioned event, no other side effects experience and been feeling fine since then. After discharge he had a work up on the outside including a 72 hour EEG; 72 hour holter with the only thing that was abnormal that one run of 3 beat supraventricular tachycardia that was asymptomatic. His doctor put him on Metoprolol 12 mg once daily at night by mouth to help prevent arrhythmias as well as control his blood pressure. He had previously taken lisinopril. He added the only thing he knew that he never had anything like this before in his life. Patient mentions he was at a good weight now as he lost 40 pounds last year for his daughter's wedding. He added sometime in the last 6 to 8 months he had severe left side radiculopathy and was taking small dose of gabapentin. He did not remember if it happened before or after the vaccine but he went to see a pain specialist. The medication worked and he tapered it down and discontinued it. It may have been before the vaccine, he is unsure. But the medication worked like a miracle as he had intractable pain down his leg. All events resulted in emergency room. In line with this, he would like to know in relevance to the news of Pfizer releasing a possible booster dose, if there are any reports of anything that may be related to seizure and/or Transient ischemic attack (TIA) of cardiac origin or a like. Extremely tired was reported as non-serious, other events was serious and caused hospital from 21Mar2021 to 24Mar2021. Outcome shaking episode arms going up and down was recovered on 21Mar2021, of extremely tired was recovered in 2021, of other events was unknown.; Sender's Comments: There is no reasonable possibility that the events supraventricular tachycardia, seizure, tremor, and transient ischemic attack happening 4-6 weeks after vaccination were related to BNT162b2. It is more likely to be complications of pre-existing conditions of hypertension, hyperlipidemia, and diabetes. Advanced age may have been contributory as well. 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.

Within 2 days of second shot, Patient exhibited extreme fatigue. This continued for the next several weeks culminating with the inability to move which resulted in admission to Hospital the week of 2/22/21. After weeks to stabilize vital systems, a diagnosis of multiple myeloma was obtained. Patient continued to decline until multiple organ failure occurred within 30 days of admission. Death occurred on 3/25/21. It is not clear whether the vaccine potentially caused and/or exacerbated a previously undiagnosed condition (multiple myeloma). However, the proximity of an immune cell related cancer which resulted in rapid decline and death within 60 days of vaccination should be noted in case there are any other previously undiagnosed blood cancers being found in newly vaccinated individuals.

Sx onset 7/21/21 with cough. Visited son, his wife & newborn in . Son and DIL are both + cases. Tested on 7/26/21 which resulted as positive.

Sx onset 7/21/21 with cough. Visited son, his wife & newborn. Son and DIL are both + cases. Tested on 7/26/21 which resulted as positive.

Nausea, H/A, took 2 Tylenol. At 10pm started feel ill, achy, Had trouble breathing over night. The albuterol didn't help. Heart beat was fast. 1/13/20 in the am had a H/A, took 2 Tylenol. The breathing got better around noon.

Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.

Received vaccine on 1/16/21, on 1/17/21 started with coughing, white phlegm, SOB and on 1/18/21 developed fever to 101 and increased need for oxygen. Home requirement increased from 3L O2 to 6L O2. On 1/18/21 presented to hospital. Quickly defervesced with steroids and cefepime. Possible post-obstructive pneumonia vs immune response to vaccination.

Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

Mild flu like symptoms, slightly elevated body temperature, body aches, tiredness, shoulder ache, first day. 2nd day body aches, tiredness, sore shoulder, administered Tylenol. 3rd day body aches administered Tylenol

1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-verbal at baseline, hands cold, wearing gloves; (Given warm compress for hands) 1:43: Back to baseline per family, BP: 131/54, MAP: 67, continued observation 1:50: Observation ended, left with 2 family members

Pfizer-BioNTech COVID-19 Vaccine EUA On January 28, 16 days after receiving the first vaccine dose, I experienced an extremely sore throat and subsequent sinus and respiratory infection. This was diagnosed as a bacterial infection and I was prescribed a 10 day regimen of Amoxicillin 875 mg. I started this regimen on January 28. I'm scheduled for the second COVID-19 vaccine shot on February 2. I had my flu shot in October 2020. The aspect of this that alarmed me was the fact that I have not had such an infection in decades--I simply don't get sick. Could the COCID-19 vaccine have negatively affected my immune system?

he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, "I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?" The outcome of the event chills was resolved, of other events was unknown.

trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.

Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.

Experienced shills for 1 - 2 hours beginning around 11:00pm the day of the vaccination. Subsequently experienced severe headache throughout the night. Took 2 Tylenol Extra Strength capsules approximately 24 hours after the vaccination.

Roughly 9 hrs after shot malaise. During next 30 hours loss of balance, incontinence, nausea, mild headache. By 40 hours symptoms had diminished and I could eat, although sparingly, again

On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there was increasing difficulty moving and talking. That night the patient began hallucinating,. Later at night the patient awoke and couldn't move at all. By the morning, things were better and patient could get out of bed and eat. Ity sounds like a dopamine reaction which the aptient has previosuly expeicned, however, there was no irregularity in L-dopa dosing.

Later in evening I had intense muscle pain in legs and chills. It progressed later in that day to a piercing headache and 100 degree fever. Ibuprofin helped to lessen the pain. The following day the pain was greatly improved but I was very lethargic and tired.

Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out "oh no!" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads "Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation." The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.

ABOUT 12 HOUSR AFTER GETTING THE SHOT I GOT THE SHAKING CHILLS THAT LASTED ABOUT 20 MINUTES.. ON 02/18/2021 ABOUT 3 PM I CHKED MY TEMP, AND IT WAS 101.2 F. AT 4PM TOOK A TYLNOL ( 500MG) AND AT 4:45 MY TEMP WAS 98.5 F. FEELING BETTER.

Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding to questions. Symptoms began around 11:30 a.m. on Feb. 21. Administered one Tylenol at 2:30 p.m. on Feb. 21. By 6 p.m. on Feb. 21, the fever and headache abated. But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

Fatigue swollen lips mouth and tongue sore lips bleeding chest burning No treatment Lasted one week

SOB, Diaphoretic, Tachycardia, hypotension, Decreased Heart Rate, Decreased oxygen saturation. PT was taken to the ER.

Pt received first dose of Pfizer COVID-19 vaccine on 2/9/2021. Pt developed COVID symptoms and presented to hospital, tested positive 2/25/2021 via SARS-CoV-2 PCR NP. Symptoms: generalized fatigue and malaise, max temp 103, confusion with hallucinations, needed supplemental O2. Admitted on 2/25/2021.

Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

Moderate allergic reaction; itchy skin; itchy eyes; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9263), via an unspecified route of administration in right arm on 24Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included Diabetes2, HiBloodPress and HiCholesterol. Concomitant medication included lisinopril, simvastatin, and unspecified diabetes medication. On 26Jan2021, the patient experienced moderate allergic reaction, itchy skin, itchy eyes and headache. The patient was taking antihistamines with some relief for moderate allergic reaction, itchy skin, itchy eyes. There was no treatment for headache. The outcome of the events was recovering. Prior and since the vaccination, the patient was not tested for COVID-19. The events were assessed as non-serious.

weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.

knocked out due to fatigue; legs were just worked up/area where he had arthritis (knees and wrist) were affected the most/knee joints were so bad/knee joints were so bad that he could barely walk/wrist joints were also bad; This is a spontaneous report from a contactable consumer (patient) reported that an 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing arthritis which the patient had for 10 years or so and blood pressure. The patient has a positive COVID test on Sep2020. Concomitant medication included methotrexate (manufacturer unknown) for arthritis, losartan (manufacturer unknown) for blood pressure, hydroxychloroquine sulfate (PLAQUENIL) for arthritis and acetylsalicylic acid (CARTIA, reported as 'kartia') for blood pressure all ongoing and levothyroxine sodium (SYNTHROID) from an unspecified date to an unspecified date. The patient stated that he was okay the first day. Then the next day, it knocked the legs right from underneath him. His legs were just worked up and he knocked out due to fatigue. Mainly the area where he had arthritis (knees and wrist) were affected the most. He was in bed for a couple of days. At one point, his knee joints were so bad that he could barely walk. His wrist joints were also bad as he has arthritis in both knees and wrists. It lasted from the 28Jan2021 to the 30Jan2021. He has recovered from it. His knees are good, and his wrists are back to their normal aches and pains. During the time of the report he was feeling pretty good. He was concerned about the second shot and would like more information. He wanted to know if the second shot will cause more severe side effects. The outcome of the events was recovered on 30Jan2021.

extreme fatigue; feeling of faint; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) at the hospital, via an unspecified route of administration on 03Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included 10 nerves killed in back lumbar region on an unknown date (reported as '5/02'). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (manufacturer unknown), gabapentin (manufacturer unknown) and tamsulosin hcl (manufacturer unknown). 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. The patient experienced extreme fatigue and feeling of faint on 05Feb2021 at 07:00. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. The events were reported as non-serious.

10/5 :Fri 2:00 PM Nausea,9:30 PM Fell down and could not get up without assistance, unable to walk or setup, Dizzy and confused, bad itchy rash on body including large red spots(stomach, back, legs, arms, head , neck) Sat 10/6 admitted at Hospital tests results dehydration. Continued problem with walking. Tues 10/9 visit with primary doctor. Pictures were taken of his body and entered in computer at Clinic. Walking issues getting better.

Chills, body ache, headache, possible fever. All except headache were from 12a - 4a. Headache and "run over by a Mac truck" feeling continued throughout March 9. Feeling 95% normal on morning of March 10.

Drenching night sweats; This is a spontaneous report from a contactable physician (patient). An 80-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3249) intramuscular at single dose at left arm on 04Feb2021 08:30 for COVID-19 immunisation. Medical history included hypertension, gout, no known allergies. The patient had not experienced COVID -19 prior vaccination. Concomitant medication in two weeks included metoprolol (manufacturer unknown), irbesartan (manufacturer unknown), allopurinol (manufacturer unknown), ASA (manufacturer unknown). The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EK9231) intramuscular at single dose at left arm on 15Jan2021 09:00 for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced drenching night sweats on 06Feb2021 01:30. Course events was as follows. drenching night sweats 2nd and 3rd nights. This report written morning after 3rd night, so the reporter did not know if sweats will continue. No treatment received. COVID was not tested post vaccination. The outcome of event was recovered in Feb2021 at time of reporting.

'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.

within minutes I began coughing, this lasted until after midnight with heavy mucus with gaging and coughing. I took Mucinex a sleeping pill and got some sleep. The next day got up for breakfast and went back to bed sleeping and still groggy at 4 p m

I had no trouble at all with the first shot. I had the second shot at about 3:30 in the afternoon. I woke up at 6:00 the next morning with wicked chills. I solved that with a heating pad and raising the room temp a couple of degrees. Didn?t last long. But I was dragging all day and had a very mild headache (I think). I do not get headaches. That night at about 7:00 I decided to take my temp and it was 100. The next day I was perfectly fine with a waking temp of about 98.1 (which is actually a slight temp for me). And I was perfectly fine after that.

Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion

mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through the day and was not feeling well. He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance. He got up at 9pm and fell in the bathroom. He was dizzy. His wife assisted him back to bed. He was not able to sit, he would fall over. On 3/6 his balance was still off. His wife assisted him to the car and took him to the Hospital. They treated him for dehydration and discharged him. On 3/7 he developed a rash over his body, "big red spots". 3/8 his wife called the physician , who saw him the following day, on 3/9. He was advised not to take the 2nd Pfizer vaccine. The rash lasted 5-6 days. At the time of this report, his symptoms have resolved. His wife reports she completed a VAERS. His report number is 346254

Fatigue, temp elevated approx 1.2°, no appetite, most of the day following vac. (3/11) Normal temp, slight fatigue, on 2nd day (3/12) All normal by mid- 3/12. No healthcare sought. (Spouse only.)

Chills, body ache, headache, fever for approximately 3 1/2 hours, then chills and body ache throughout the day April 1. All cleared up by April 2. These conditions were identical to the reactions to Shot #1 on March 8, 2021.

fever of 102 was reported as worsened; fever of 101- 102 , 102.6 now; feeling like the flu; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old male patient (reporter's husband) patient received first dose of BNT162B2 (Solution for injection, lot number: EL9262, Expiration date; unknown), via an unspecified route of administration in left arm on 08Feb2021 11:15AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had temperature (fever), of 102 was reported as worsened. and feeling like the flu worsened on 08Feb2021 at 08:00PM or 09:00PM. Patient temperature 102.6 higher than 07Feb2021. Patient taken vaccination facility in mall. Mentions patient got the two-tear shingle shot in Sep2020 and had fever for that and didn't feel well. They had no product or information to provide NDC, lot or expiration date for the shingles vaccine. Mentioned he does have an appointment with his primary care doctor today at 4:15 PM. He was scheduled to received the second dose on 04Mar2021. The outcome of event was not recovered. No follow up attempts are possible. No further information is expected.

Went to the Medical Center for chest pain, fever, shortness of breath one day after receiving the vaccine.

Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atrial fibrillation, hyperlipidemia, coronary artery disease s/p stent, and BPH. Patient comes from urgent care after being found hypoxic. He refers that for the last 3 weeks felt weak, with loss of appetite and poor oral intake. He went to a to the urgent care to get it evaluated and he could get some IV fluid because he felt dehydrated. Patient refers that in the past when he gets severely dehydrated had episodes loss of conscious and this time he wanted to avoid that. He states that on February 4th got tested positive for COVID-19 because his fiancee tested positive the previous day. He quarantined and was asymptomatic. On February 27nd got first dose of COVID-19 vaccine. But since he tested positive feels that has no energy. Besides this patient denies fever chills shortness of breath, chest pain, abdominal pain, diarrhea nausea, vomiting, headache, lightheadedness, loss of sense of smell or taste.

Fever for 3 days, Shortness of breath and Weakness increasingly, Dizziness, became very pale, and so on... Visited PCP on March 24, 2021 . Blood work showed 4.8 Hemoglobin. Was hospitalized on March 25, 2021. Diagnosis - Autoimmune Hemolytic Anemia due to IgG.

Soreness at site of injection, slight headache and nausea, general body aches and pains. Lasted for two days then subsided. Temperature 100.7 degrees F at 7 AM on 04/16/2021 declined to 97.6 degrees F. by 4 PM 04/17/2021 (normal for me)

4/12 Patient was brought by family to ED for excessive fatigue, dry cough and poor PO intake. He was positive for SARS CoV-2 and had some hyponatremia. Date of onset of symptoms: ~Approximately 5 days Date of covid positive test: 4/12/21 Symptoms: dry cough and fatigue Imaging: Chest x-ray?No significant abnormality Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Of note it has been reported the patient is approximately 2 weeks out from second Covid vaccine injection. His son reports that one day about 2 weeks ago he escaped out of his home into a crowded bar and apparently there were 7 others there who tested positive. . Appreciate Dr's assistance - reswab sent for CT value. CT values were 18.5/19 which are consistent with concern for active disease. He was given monoclonal antibody in-house on the day of discharge

Could not sleep for two days; Sweaty; Chills; Face and palms got really red; Indigestion; Constipation; deathly sick over the weekend; This is a Spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM6207), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 15:00 (Batch/), single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Diagnosed with COPD 3-4 years ago and is not taking any medication for it, (blood pressure) hypertension from an unknown date and unknown if ongoing had been taking Atenolol for blood pressure. Concomitant medication included atenolol. The patient had the first dose of bnt162b2 vaccine (Lot EN6023) on 27Feb2021 for covid-19 immunization and experienced hypertension aggravated. He went back to doctor and had been taking Atenolol for blood pressure. It has always been dose 50/25. His blood pressure was up just a bit and he cannot verify who this girl was that changed it to 100/25. He did not like the way he felt and eliminated it and went back to the previous dose. He had two over a period of 2-3 days. It is in a pharmacy vial. He does not have a lot or expiration for the Atenolol 100/25. The date his blood pressure was up was for the past couple of times.Usually, it is 120/60-70 and then it jumped up to 150/60-70 and that is why it needed to be changed. It was filled on 18Mar2021, which was after first vaccine but before second dose. Patient got deathly sick over the weekend on 02Apr2021. He had the shot on 20 Mar 2021, and it has been more than the two days you could have a reaction. He was deathly sick. On 02Apr2021, he had just about all of the symptoms; sweaty, chills, face red, and hands red, indigestion, constipation and could not go to the bathroom. He was about as sick as he had ever been. He know it is not supposed to be that long. He could not sleep for two days. His face and palms got really red. He did not have a fever. He walked the floor and only slept 2 hours in two days. On 31Mar2021, he goes to a pain center and got shots in his neck. He asked the doctor if his shot had anything different than he had been getting and he confirmed that it was no different. He never had a reaction before the one he got on 31Mar2021, and thought it may have been the virus shot. He said one other thing happened and is not sure if it had anything to do with it or not. He just started to feel worse and worse. Today is the first day he felt better. He is 80 and has not been this sick. It got really bad but today it is much better. He did not sleep for two days and last night he slept and feels better. For the indigestion, it got worse before it got better. For constipation, he got relief last night and that is why he feels better today. NO ER or physician's office required- He had a previously scheduled office visit for pain center. The outcome of the events was recovering. The event insomnia was assessed by the reporter as medically significant. Information on Lot/Batch number was available. Additional information has been requested.

not feeling well and short of breath on 2/11/21, 2/12/21 more short of breath ambulance came. Went into PEA in ambulance with CPR. They gave TPA for suspected blood clot. He initially improved. He did not recover and died 4/4/21. He spent the entire time in hospital or TCU with complications. We brought him home 4/2 to die at home.

Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific. Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait. Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0. He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated. As of today, he has had 5 consecutive days of plasmapheresis. Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3. Now awake, alert, and oriented. Eating and ambulating with physical therapy

Pfizer-BioNTech COVID-10 Vaccine - case of COVID-19 resulting in hospitalization. Pt presented to ED of facility on 4/20/21 with dry cough, malaise, altered sense of taste/smell and worsening dyspnea. Afebrile (T=98.6 F). Symptoms began approximately 4/13/21. Reportedly was hypoxic at PCP's office prior to presentation to ED. S/P 2 doses of the Pfizer-BioNTech COVID-19 vaccine - 1/29/21 and 2/19/21 (dates obtained from database). Admitted to inpatient unit 4/20/21. Treated with dexamethasone 6mg po daily, remdesivir (x2 doses prior to discharge). Transiently required increase in oxygen by nasal cannula but remained on baseline of 3L oxygen majority of admission. Discharged home 4/22/21.

shortness of breath; body aches; weakness in arms and legs; headaches; chills; This is a spontaneous report received from a contactable consumer. A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shortness of breath, body aches, weakness in arms and legs, headaches, chills on 03Apr2021 with outcome of recovered on 06Apr2021. Therapeutic measures were taken as a result of events included Acetaminophen and Ibuprofen. No follow-up attempts are needed. No further information is expected.

S/P pfizer vaccination for COVID-19 about 6 weeks ago with progressive confusion, new fevers and encephalitis with parkinsonism Appears to be consistent with inflammatory encephalitis

Diagnosed with COVID-19; Diagnosed with COVID-19; Nausea; Tired; Unable to eat; Diarrhea; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 (15:15) (Lot number: EM9809; Expiration date was not reported) and the second dose on 01Mar2021 (Lot number: EN6203; Expiration date was not reported), both on the right arm as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included myasthenia gravis and diabetes. The patient had unspecified concomitant medications. On 05Apr2021, the patient had nausea; was tired; unable to eat; and had diarrhea. On 10Apr2021, the patient was diagnosed with COVID-19 (tested positive for SARS COV-2 RT-PCR nasal swab). The events had resulted into doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The patient's computerized tomogram (CT) value was 16.1-33.0 on an unspecified date. The outcome of the events was not recovered.

fever, sore throat, and severe cough, chest congestion, phlegm in throat Tylenol for aches and pains and fever Encourage plenty of fluids such as water hot teas soups

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

Altered mental status, confusion, subdural hematoma. Was lifeflighted to Clinic and remained there about 5 weeks, developed a stage IV pressure ulcer on buttock. Diagnosed with multi organ failure. Went to a SNF for rehab after being discharged. Wife said then patient received 2nd dose of vaccine about 2 weeks ago and is currently at Hosptial in town for a GI bleed, passing frank blood and clots. He was admitted 5/9/21. Patient is still confused and lethargic. Before the vaccine, he was taking care of his farm and home. Now he doesn?t even know his wife or what is going on.

headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-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 on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown. Upon follow-up on 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.

Office Visit 3/27/2021 PA-C Family Medicine COVID-19 Dx Cough ? Sore Throat ? Poor Appetite Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/27/2021 ? ? Signed Cosigned by: MD at 3/28/2021 9:14 AM Expand AllCollapse All MDM Nontoxic-appearing 80-year-old male presents with URI symptoms. Rapid Covid testing house was positive. Patient has had his first dose of Pfizer SARS-CoV-2 vaccine and is due for his second and final one in 7 days. Patient was advised to follow-up with PCP today to discuss monoclonal antibody infusion. Strict supportive care and isolation instructions reviewed in detail. ED precautions reviewed with patient. 1. COVID-19 Patient was seen today for cough, sore throat and poor appetite. Diagnoses and all orders for this visit: COVID-19 - POCT COVID-19 Antigen Clinical Support 3/30/2021 RN COVID-19 virus infection Dx Encounter Notes All notes Progress Notes from RN Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team: Primary Care Physician: The physician that referred you for the infusion and who will conduct the follow-up appointments related to your infusion. COVID-19 MAB Navigator: The person who will schedule you for your infusion, ensure your follow-up appointments are scheduled and that you have all the necessary tools to track your health. COVID-19 Navigator Contact Information: MAB Infusion Follow-up Plan: Day of Infusion: o You will be discharged from the Infusion Center to home. o You will begin recording your temperature and oxygen levels (pulse ox). You will receive prompts from the monitoring program you selected. Follow the prompts for when to record your temperature and pulse ox. Day 2-3 after Infusion: o You will receive a follow-up call from the COVID-19 Navigator to schedule your 7-day follow-up video visit with your Primary Care Physician. Day 8-14 after Infusion: o You will receive a follow-up phone call to assess your overall health. Day 15 after Infusion: o You will receive your final call from the Navigator, and you will graduate from the Infusion Program. You will resume your routine appointments with your Primary Care Physician. When to call your Primary Care Physician: o Please call your Primary Care Physician if you have pre-existing health conditions that you feel need medical attention and are unrelated to your COVID-19 diagnosis and symptoms. o If you are experiencing non-life threatening COVID-19 symptoms and have additional questions. When to call the COVID-19 Navigator: o Please call the COVID-19 Navigator if you have general questions regarding the infusion you received today, questions concerning follow up appointments, or home monitoring procedures & equipment. o You should receive a follow-up phone call from the Navigator within 2-3 days of receiving your infusion. o If you do not receive a follow-up phone call, please call the Navigator. When to call 911 or Proceed to the closest Emergency Department: If you are experiencing life threatening COVID-19 symptoms including but not limited to: high fever, trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake or stay awake, blueish lips or face.How to Improve Your Breathing with COVID-19 Try to spend as little time as possible flat on your back! The largest part of your lungs are in the back of your body. When you lay on your back this causes fluid to pool in those parts of your lungs making it harder to breathe. Laying in different positions or sitting up will allow all the different parts of your lung to expand properly. You may notice it is easier to breathe immediately or soon after changing positions. One of the best positions for this is called 'prone position' which is laying face down on your belly. This position makes it easiest for the biggest parts of your lungs to expand easily. This is called 'proning' and the more time spent proning the happier your lungs will be. Laying on your sides or sitting up in a chair is also helpful for breathing and changing positions helps keep your skin healthy. Tips to Help with Repositioning ? Try placing pillows under the chest, hips, and lower legs when lying face down ? Trying different arm and leg positions can assist with comfort ? Eat your meals sitting up in a chair when possible ? When laying on your side, a pillow behind you will help you not to roll on your back if you fall asleep ? If a position is too uncomfortable move on to another; comfort and rest are important parts of recovery ? Switch positions in a rotation to help all the areas of your lungs expand After Visit Summary (Printed 3/30/2021) Additional Documentation Vitals: BP 158/83Important (BP Location: Right arm, Patient Position: Sitting) Pulse 58Important Temp 36.9 °C (98.5 °F) SpO2 95% More Vitals

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? 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 ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.

his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection was given in; I got a lot of headaches and I still have them./unbelievable headaches; More back pain than usual; My blood pressure went up a little bit but not much; This is a spontaneous report from a contactable consumer (patient). Follow-up information received on 17Feb2021 was processed together with initial information. A 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: UNKNOWN), via an intramuscular route on 08Feb2021 (at the age of 80-years-old) as single dose in the left arm for covid-19 immunization. The patient medical history included and back pain. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced blood pressure went up, More back pain than usual and on unspecified date experienced Stiff neck, Headache, pain in arm the injection was given in, pressure on his eyes, cold. The clinical course of the event was as follows: blood pressure went up a little bit but not much. It was reported that blood pressure was up which he was told by the nurse was normal. It was just a little bit high. The nurse at the facility said it was not that concerning and that it was fine. The facility let him stay a half an hour and then he was able to driven home. He hadn't wanted to stayed long because it was very, very cold. He had a lot of back pain. He does have back pain all the time, but not that much. It was more back pain than usual. The pain in his back increased/doubled, and the pain is still high. He clarifies he has had problems with his backed and have had backed pain normally, but after the shot it was liked a lot of pain in his backed and his neck was stiff very, very stiff hasn't knew if it's from vaccine or what. Patient stated that before the vaccine, he was okay and was able to worked in his house and outside. He believes the stiff neck began after 2 or 3 days of receiving the vaccine and it have had worsened. Patient stated that pain in his armed where he received the shot went away completely. He clarifies further the pain in his armed went away the second day. He got a lot of headaches and he still had them. The headaches began right away, and the headaches still c continued. He mentions the headache got a little better last night. He was really worried about it and hadn't knew what to did. It was reported that he told his son everything and his son said to not went to hospital because there was a lot of people that had been in contact with covid and it's going to have been worse. He states his son told him to drink a lot of water and saw if he got better. He did that and he did got a little better but not that much. Patient mentions that he had a lot of pressure on his eyes. The patient did not went to emergency room because he was told it was normal to had headaches but they went away and his should went away in 2-3 days. His armed where he received the vaccine was also okay the next day. The patient did not visit to physician office. Patient mentions that he took blood pressure medication, and everything was under controlled and he took 10mg of a cholesterol medication. Patient declined to include these medications for the report, stating he gave all of this information at the facility he received the vaccine at. He had to filled the paperwork out. He confirms he hasn't had any NDC, lot number or expiry date for these medications at this time. It was reported that patient had a blood tests done about 3 weeks before he received the vaccine and the doctor said everything was okay at the time. The outcome of the events headache was recovering, backed pain and neck was stiff was not recovered and other events was unknown.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms

slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date/ UPC/ NDC number: Unknown), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 80 years. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient experienced headache and i was weak on 02Mar2021. Additional Context received as, the patient stated, "I got the vaccine, I got the first shot last month and I got the second shot on 01Mar (clarified as 01Mar2021), and I feel nothing on the 02Mar2021, I was okay. Then on 02Mar (not clarified), all of a sudden, I get a headache, not so bad but still a headache and today, in the afternoon, I was weak. I thought I had a fever but I have no fever, I just have a headache but now it is going away. Today, when I wake up, it was fading away and I got it in vaccination facility. When probed to clarify if consumer want to know that headache wais related to the Covid vaccine, consumer stated, as yes. For treatment in response to events, the patient stated, that was yesterday, today, I feel little better. No, I did not take anything. Outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.

Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.

R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9 - Pneumonia, unspecified organism

Mild headaches; This is a spontaneous report from a contactable consumer (patient himself). A 81-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 15Feb2021 (at the age of 80-year old) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took 1st 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 (at the age of 80-year-old) as 1st dose, single dose for covid-19 immunisation. The patient stated that he got his second dose of the Pfizer Covid-19 Vaccine last 15Feb2021, but he was still experiencing headaches even after a few months. He wanted to know if headaches were among the reported adverse events (AEs) after getting the PFIZER-BIONTECH Covid-19 Vaccine. No information on headache as an AE on post-authorization experience. The patient stated it was mild headaches. Never used to ever get headaches but he gets them since his 2nd shot. The reporter stated that the events as non-serious. The outcome of the event was not resolved. Information about lot/batch number has been requested.

Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath , "pins and needles" in bothe hands at the same time as each other, loss of balance when walking, stomach pains only in the evening after eating a Small amount of food as I have put on weight recently even though I am eating the same amount ( less recently as above) as normal for the last 70 years.

81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness. Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride). He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms. Of note, pt is 3 days post op from left upper extremity AV graft placement. Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing. He had lung infiltrates. He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist., Diabetes management, vascular surgery, Pulmonology. Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.

Primary Physician recommended I see a Dermatologist, which I did on 06/16/2021 and she concluded the malady was a result of "bruising". I believe I have "Covid Arm" which I experienced the first day after the first shot. Initialy it was just my right arm, but following the second shot I developed it in both arms. I have a rash on my upper and lower right arm and a rash on my lower left arm. My hands and ankles often itch. I also have recurring red areas which were present on the second day after the first and second shot and only in my biceps area. I experience days of tiredness, and sometimes fatigue. I currently have all these symptoms. DOB is 05/30/1940.

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of 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 body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/31/2021). Patient was admitted to the hospital on 7/5/21 for cough, poor appetite and dizziness for at least 3 weeks and tested positive SARS-CoV-2. On admission patient was febrile to 100.3, O2 SAT 95% on RA but desaturated to 89-90% with ambulation. He did not receive any COVID specific therapies and was discharged in stable condition on 7/7/21.

Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional tingling in my fingertips; Mouth irritation; This is a spontaneous report form a contactable consumer. This 80-year-old male patient reported for himself stating that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration into the left arm on 11Mar2021 14:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Have a surgery but have seem to get a clean health, thinks that all was good. He has no other health problems really, nothing other the old age, no problems. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop dates were not reported, takes one of them every day. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration into the left arm on 18Feb2021 16:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced mouth irritation. On an unspecified date, he experienced sour tongue; sour taste in his mouth 24 hours a day, diarrhoea like symptoms, tiredness and occasional tingling in his fingertips. The patient underwent lab tests which showed magnetic resonance imaging on 10Jun2021 and positron emission tomogram on 15Jun2021, both as negative, they could not find any cancer, correct. He spoke to several doctors since his changes of taste were occurring and had constant mouth irritation, sour tongue since, third week from his first COVID shot. Did not know how to describe it but it was a sour taste in his mouth 24 hours a day and it seems to he does not know what else to say about it expect talked to doctor several times and couples of other specialists that he has been seeing and they think it possible that it could be linked to the COVID shot since it was the sourness that he feels in his mouth was one of the symptoms of COVID. He had a couple of other side effects but few weeks ago they went away, for about a month from that day he was going to call loose bowels, not terrible but diarrhoea like symptoms and they lasted probably 3 weeks. Had tiredness that he experienced and was not experiencing now. Seemed to be quite good about that and occasional tingling in his fingertips but that seems to be helped, it was almost gone but once in a while. Those all sort occurred at same time but the sour taste in his mouth and tongue was constant or just do not go away. No other medical conditions. Treatment for event included that he went to doctor several times and he just suggested nothing to do about it.no prior vaccination. He was thrilled that he was able to get through there that day. Outcome was not resolved for event sour tongue; sour taste in my mouth 24 hours a day and was unknown for rest of the events.

shortness of breath; The shortness of breath has continued and has gotten a little worse; Nasal congestion; Coughing; heaviness in chest; It was like lumps; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 12:10 (at the age of 80 years old) (Batch/Lot Number: EL9269; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (at the age of 80 years old) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. Medical history included Heart bypass, it was 18 years ago. It was a aortic valve replacement, ongoing lymphoma cancer, and it is gone at this point, had shingles on the right side in 2015, skin cancer in both ears in 2016. Concomitant medications included ongoing warfarin sodium (COUMADIN), ongoing warfarin deanol, ongoing carvedilol, ongoing atorvastatin calcium (LIPITOR ORIFARM), ongoing atorvastatin, ongoing hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), ongoing gabapentin (GABAPENTIN) taken for restless legs syndrome, ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing turmeric and bromelain, ongoing ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) taken for macular hole, ongoing loperamide hydrochloride (IMODIUM) taken for diarrhoea, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), ongoing potassium, ongoing Calcium citrate magnesium zinc all in one pill 80mg Magnesium, 500mg Calcium, 10mg Zinc, 20mg B6 taken for restless legs syndrome. Has been on his normal medications for years and nothing has changed. Has been on all of these medications at least 15 years, or more than that, maybe 18 years. The patient experienced shortness of breath since Feb2021 (at the age of 80 years and 6 monthes). He received both doses of the Pfizer Covid-19 Vaccine and received his second dose 13Feb2021. He has been to his doctor and has been treated with antibiotics and Prednisone. He wanted to know what he should do about it. Caller's shortness of breath began a couple of weeks after his second dose in Mar2021, where it became noticeable, and it continues. The patient would like to know if others have reported shortness of breath after receiving the Pfizer Covid-19 Vaccine. He has been experiencing shortness of breath since Feb2021. Maybe it is a side effect of the Covid vaccine, he does not know. First stated that it was around 15Feb2021 or earlier, when he first went to the doctor. He stated that he did start experiencing it before then. He wouldn't of went to the doctor if he didn't have that. Wife was brought on the phone to describe the event further. Stated that 01Mar2021 is when he first went to the doctor. They went on vacation on an unspecified date in Mar2021 and his wife had to take him to a clinic there that it was around 09Mar2021. He has had 4 series of antibiotics and prednisone since that first visit in Mar2021. When he got home, he went to the doctor again and they gave him more antibiotics and Prednisone. Then again in May, he had another round of it, and is still experiencing shortness of breath. He had also had other symptoms at that time. He had a lot of congestion. It did not stop but that has kind of subsided. The shortness of breath has remained. He had heard a news report stating shortness of breath symptoms have been reported regarding the COVID vaccine. He had his last shot 13Feb2021, he thinks it was. Soon after, he started having the shortness of breath. At first, he didn't relate it to the Covid shot. He does have heart problems. The first antibiotic was Azithromycin, it was with the Prednisone, It was the ZPack. He took it for 6 days and then tapered one every day. In Mar 2021 he took Medrol pack, which was 4mg tablets. They were different Prednisones and different antibiotics each time. The last one he took was Doxycycline, which was 40mg and he took it for 4 days. Can't remember what the other one was. Caller states that he had the Zpack from the clinic and his doctor gave him Doxycycline after he came home. It was a different amount of Prednisone each time. He had a lot of allergy like symptoms with nasal congestion and coughing. States that it was clear congestion and was probably 3 times as thick as with normal nasal problems. It was like lumps, was clear and was coughing it up. The congestion started when he was coughing up stuff. The last time his doctor gave him nasal spray, Azelastine HCI, which was in a spray bottle with 30ml. He stopped it after a period of time. He still has some congestion every day, but it is not near what it was before. The Prednisone and antibiotic lessened the problem along with the nasal spray and really helped. The shortness of breath has continued and has gotten a little worse. He used to be able to walk 3 quarters of a mile every day but now he probably can't walk 4 blocks. Sometimes, just sitting on the couch, watching TV, he gets heaviness in his chest. He has to breathe really deep to get it fixed. When he had his oxygen level tested, at the doctor's office, it is always 98, 99 or 100 percent. The doctor listens to his lungs and he doesn't see or hear anything that is going on. He had an X-ray for his lungs they didn't see anything there either. Had a chest X-ray, blood tests by his primary care physician and heart doctor. Had blood tests by his oncology doctor. All of those came out normal, with no problems. Feel free to ask for those results. No other additional vaccines were administered on Same Date of the Pfizer Suspect. The patient has not received any other vaccines within 4 weeks prior vaccinations. The adverse event shortness of breath resulted in visit to urgent care and physician office. The patient underwent lab tests and procedures which included chest x-ray: normal on an unspecified date. Therapeutic measures were taken as a result of the adverse events. The outcome of the events was unknown.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events "Dyspnoea, Nasal congestion ,Cough, Chest discomfort " and the 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 re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Cough; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 80-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 left arm on 01Apr2021 at 12:30 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation, bypass surgery, mitral valve replacement, chronic obstructive pulmonary disease (COPD) and COVID-19 and hospitalisation (due to COVID-19) in Dec2020 and did not suffer as much pain and discomfort as the side effects. The patient was not aware of any known allergies to medications, food or other products. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and torsemide (TORSEMIDE), all medications received on unknown date for unknown indications. 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 01Apr2021, the patient experienced cough 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 events cough and soreness at injection site was resolving at the time of reporting. No follow-up attempts are needed. No further information is expected.

got symptoms of mild cold; running nose; cough; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, unspecified route to administration on 23Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and mild diabetes Concomitant medication included nebivolol hydrochloride (BYSTOLIC), clonidine, hydralazine, losartan, nifedipine. The physician got symptoms of mild cold, running nose and cough in Dec2020. "It just came a last two days and it's been cough and runny nose. I don't have a fever." Outcome of the events mild cold, running nose and cough was unknown.

Patient tested positive for COVID-19 3 days post vaccination. Patient tested due to facility wide testing. Patient noted to have sore throat, low grade fever, and cough at the time of testing. Patient continues with these symptoms. Droplet isolation initiated.

tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well

My 81-year-old father, and my brother received the first dose of the Pfizer covid vaccine at the Hospital on Wednesday January 13, 2021. Within a couple of minutes of them returning home, my father collapsed. As it turns out, he'd had a silent heart attack. He is still in the medical center area Hospital this morning. A cardiologist who was filling in for my father's primary cardiologist thought maybe my father had a blockage and might have needed a stent. But when Dr. performed a cardiac catheterization, he only found a little plaque. Medical personnel are not too sure what caused the heart attack. My was very dehydrated when he was admitted, and he has underlying health conditions including diabetes, high blood pressure, dementia and a history of blood clots. Those are just a few of his health issues. His primary cardiologist, Dr is back in town. He plans to see if my father has AFib before they release him. I believe Dr. an internist at Hospital, said my father's INR on admitting was 1.2. My father's hematologist, Dr., had told us to let the person administering the vaccine know that my father is on blood thinners. I was not present when my father and brother received the vaccine, but I assume my brother passed that information on to them.

fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.

Patient had full body hives starting on 1/25/2021 (mainly on arms) Hoarseness in throat and congestion Child treated with Benadryl Advised treatment from PCP was/is as of 1/28/2021 Zyrtec 10 mg AM + pepcid 20 mg AM Zyrtec 10 mg PM + pepcid 20 mg PM Limit benadryl but if give it then only at night and replace it for the zyrtec

Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Chills; Tired/ tiredness/exhausted; achy; This is a spontaneous report from a contactable consumer (patient). This 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 20Jan2021 at 10:30 at the age of 81-year-old at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history was none. There were no concomitant medications. On 20Jan2021, the patient experienced chills and in Jan2021 he experienced tired/ tiredness/exhausted and achy. The patient specified that he was not panicked. He got the first dose on 20Jan2021 and he was really tired. He had the chills in the night. He was just exhausted. He did not have a fever. Corrective treatment taken as a result of the events included acetylsalicylic acid (ASPIRIN). The patient was recovering from chills and he had not recovered from fatigue and pain. Information about lot/batch number has been requested.

not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization. The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.

Brain fog; anxiety; (minor) sudden brief sharp headache; soreness at injection site; This is a spontaneous report from a contactable consumer reporting for self. A 81-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL9261,via an unspecified route of administration on 19Jan2021 15:30 (at the age of 81-years old), Dose 1, as a single dose, left arm for COVID-19 immunization. Medical history included high cholesterol and hypothyroidism. The patient had not been diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, guaifenesin (ROBITUSSIN), and rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccinations in the 4 weeks prior to the COVID-19 vaccination. On 19Jan2021 at 15:45, the patient experienced brain fog and anxiety, which lasted approximately 20 minutes. Also (minor) sudden brief sharp headache and soreness at injection site. There was no hospitalization for the events. The patient received treatment for the events, reported as "Calming talk, deep breathing, rest." The events were reported as non-serious. The patient recovered from the events brain fog, anxiety on 19Jan2021 at 16:05 and recovered from sudden brief sharp headache and soreness at injection site on unspecified date(s). The patient had not been tested for COVID-19 since the immunization.

Sore injection shoulder extending to the other shoulder; 2 degree temperature; chills. Lasted about 24 hours. I also had some scattered, small red bumps over my arms and legs and several tender bumps on my head. The toes on my left foot had a reddish appearance. These symptoms lasted about 5 days and may or may not be related to the vaccination. At my age, random unexplained symptoms are not unusual.

1/20 i was tired for about 2 hrs. 1/21 I had a little different bowel movements . about 8 days later. started to get a little wobbly getting out of chair. 3 days later i had to use a cane to get around. and then the next morning i was fine.

Minor headache began within 24 hours of injection; resolved within 48 hours of onset of symptoms Slight loss of balance

lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.

On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening. The following morning, he woke up early and was still burping and not feeling well. At around 5:00am, he collapsed. My mother called 9-1-1 and began giving CPR. The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack. He was healthy.

High fever at night (up to 103.9) persisting from January 30 until present, night sweats, chills. Lower fever during the day (100- 101.4)

Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.

Ongoing low blood pressure hovering around 100 systolic and as low as 95/59. Also quite a lot of fatigue.

nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.

Anaphylaxis symptoms began approximately 6-7minutes post vaccination with patient having difficulty breathing, palor, lethargy, sweating, and stating throat was closing/tightening-patient immediately given epi and ems called...patients symptoms improved significantly in about 2 minutes post epi and ems arrived within 11 minutes and took over patients care..patient transported to local ER per EMS for further evaluation and treatment

Severe nausea and vomiting General body aches, but more severe lung/chest area pain, but with NO shortness of breath Overall fatigue

The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.

1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.

Patient has history of COVID19 infection on November 2020. He received first dose of pfizer COVID 19 vaccine on 2/2/21. Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting. Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia. Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy. Throughout the patient's stay, his respiratory function was stable on room air. Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE. Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19. Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.

headache; not eating; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included headache on 26Jan2021. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She reported that a day or two after the first dose he was achy and didn't feel like himself. Then on 26Jan2021, he got a major headache; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him paracetamol (TYLENOL) 650 mg one by mouth and it didn't help. He got the second dose on 27Jan2021 between 07:00 and 09:00AM she was unsure of the arm. He came home and is sleeping now and had a headache on 27Jan2021. She was asking what can she give him for the headache. She also stated that he also was not eating on an unspecified date in Jan2021. She wanted more information on what to do for him. The events did not require a visit to the physician or ER. The outcome of the event headache was not recovered while the outcome of the event not eating was unknown. Information about lot/batch number has been requested.

Day after vaccine given, large red bump appears over RIGHT eye. Then non stop throbbing headaches (still up til today), teary eyes. Then on 2/25/2021 very large (size of half dollar coin) red bump appears over LEFT eye. VERY swollen shut. Hurts, throbs and itches. Took photos and having tele med call with physician today at 1:50 pm. More bumps appearing higher up on scalp and skin on bump is red and pealing. Very swollen L. eyelid and swollen under eye as well. Hot to the touch. Bumps coming and going behind left ear.

injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.

Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021229604 same patient/reporter, different AE/first dose

Patient reports he received his 1st Pfizer COVID vaccine on 3/1/21 at about 1:30 pm, and reports within two hours he had extreme fatigue and memory issues "like in a fog". Patient reports on 3/2/21 and 3/3/21 he continued to feel like he was in a fog, and "today 3/4/21 he almost feels like he ought to be in a senior citizen home, forgot how to get his voicemail(s), and feeling like someone drugged the patient and patient reports he does not drink or take drugs". Patient reports "he is an intelligent man and normally exercises 7 days a week". Patient denies fever, pain/redness/swelling at the injection site, and any reaction to vaccines in the past.

tested positive for COVID; fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. An 81-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 20Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever, and was taken to hospital for a different issue and subsequently tested positive for COVID. The adverse event resulted in emergency room/department or urgent care and hospitalization. It was unknown if other vaccines received in four weeks. It was unknown that patient received treatment for adverse event. No covid prior vaccination. Covid was tested post vaccination in Feb2021. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

shortness of breath Hypoxia Pneumonia of both lungs due to infectious organism, unspecified part of lung History of COVID-19

Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt was experiencing SOB at approx 811am . Upon questioning Pt stated this was his normal breathing and needed to use inhaler. Pt stated he has been experiencing this SOB for several weeks. Used inhaler was stared was feeling better. RN went to get grandson from parking lot, he stated that pt was SOB this AM when he picked him up. Pt was being questioned by RN when he became diaphoretic and less responsive. 911 called at 819am. VS attempted difficult to get BP via dianamap. Pulse was present. 4L O2 placed on pt . Pox per dianamap was in the 60's. Paramedics arrived at approx 823 am and left at approx 826am . Pt opened eyes and responded to name on way out to ambulance.

On February 20, 2021 in the early evening my husband began to experience chest pain and pressure, took Tylenol, however did not relay the symptoms to me. About 6:50 AM on February 21, 2021 told me that he did not feel well, had chest pain and pressure in his chest. An ambulance was called and my husband was transported to the Hospital. I was contacted by the treating physician and was told that my husband suffered with a Pulmonary Embolysm (sp?). He was started on Heparin and admitted to the hospital. Later that evening his medication was changed to Eloquis. He was released from hospital the following evening. He has since followed up with his primary care.

About 2 weeks after his first covid vaccine, he developed stomach pain, bloating, diarrhea and fatigue. Normally a very active, energetic patient with no history of GI disease. Developed anemia of chronic disease which was confirmed by hematology consult. On 2/18/2021 he had a colonoscopy which revealed Microscopic Colitis (collagenous colitis) proven by biopsy. Started on oral Entocort with the improvement of his symptoms and anemia

Patient received his 2nd dose of the Pfizer vaccine at on Monday, February 15. That evening, he experienced visual disturbances with slightly blurred vision. Not thinking anything of it at the time, the vision cleared, and he continued about their evening/week without telling anyone of his visual disturbances. On Sunday, February 21, he experienced additional visual disturbances including double vision and dizziness, and we had him visit a local ER for evaluation. He was discharged with a diagnosis of dehydration and vertigo. No scans were performed. The visual disturbances cleared up the following week and the only persistent symptom was a slight dizziness. An eye exam was performed on Friday, February 26 with no problems found. An MRI was performed on March 3, and he was diagnosed with the below conditions. Impression (3/3/2021) 1. Small acute to subacute infarcts in the left splenium of the corpus callosum and parasagittal left occipital lobe. 2. Trace subarachnoid hemorrhage in the parasagittal left parietal lobe. 3. Mild chronic microvascular ischemic disease. He was admitted to the hospital and remained there until Saturday, March 6. Follow-up scans and testing were performed with no underlying reason for the stroke being determined. Prior to the stroke, he had been a very active individual with osteoarthritis as is only health complaint. He was not on any prescription medication prior to the stroke. While in the hospital, the tests for high blood pressure, high cholesterol (LDL 92 MG/DL), sugar inadequacies (glucose 93 mg/dl, A1C 5.7%), etc. came back without major concerns. His follow-up CT scans also did not reveal the stroke shown on the MRI. No inquiry was made by any of his doctors or hospital staff as to his COVID vaccination status/dates to even consider the connection. Below are the results of the last CT scans: Impression (3/4/2021) 1. Age-related volume loss and white matter disease similar to prior exams. 2. Small infarct seen on MRI are not well seen on CT. 3. No acute intracranial abnormality demonstrated on the CT scan. Impression (3/5/2021) 1. No evidence of acute infarct or intracranial hemorrhage. No significant change. 2. Periventricular white matter disease is likely secondary to chronic small vessel ischemic changes.

The patient has been tired since the vaccine was given. The patient slept for 3 hours after vaccination and was nevertheless tired. His forehead looked hot.

Janssen COVID-19 Vaccine EUA; patient reports intermittent blurry vision and fatigue after vaccination. Presents to infusion center for chemotherapy, experienced blurred vision, found to be hypotensive and bradycardic, and transferred immediately to emergency department (ED). In the ED diagnosed with acute left lower lobe segmental pulmonary embolism and thrombocytopenia. Admitting to hospital for further management.

difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown. Information on the lot/batch number has been requested.

Injection site pain; tiredness; chills; feeling unwell; administration date=02Feb2021, dose number=2/ administration date=16Jan2021, dose number=1; This is a spontaneous report from a contactable consumer (patient himself). A 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown), via an unspecified route of administration in left arm on 02Feb2021 at 14:30 at 14:00 at single dose for covid-19 immunization. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in left arm on 16Jan2021 at 14:00 as a single dose for covid-19 immunization. Patient's concomitant medications were not reported. Patient was not performed lab test. 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. On 02Feb2021, the patient experienced On 02Feb2021, the patient experienced administration date: 02Feb2021, dose number:2/ administration date:16Jan2021, dose number:1 on 02Feb2021 14:00. Also, he had injection site pain, tiredness, chills, and feeling unwell on 03Feb2021. The outcome of event injection site pain, tiredness, chills, and feeling unwell was recovered on an unspecified date while for another event it was unknown. Information on the lot/batch number has been requested.

blood pressure went up to 180/96; fatigue; headache; cough; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EM9809), via an unspecified route of administration on 08Mar2021 11:30 (at 81-year-old) as single dose for COVID-19 immunization. Medical history included Stage 4 kidney failure, Frequent premature ventricular contractions, allergy (Allergies to medications, food, or other products:Yes), COVID-19 (Prior to vaccination, the patient diagnosed with COVID-19). The patient's concomitant medications were not reported. The patient had the expected side effects of fatigue, headache and cough from 08Mar2021 16:00 for 48 hours. But what he did not expect was that his blood pressure went up to 180/96 and stayed that way from 08Mar2021 16:00 for two days. He was not on blood pressure medication and his blood pressure has never been that high. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event blood pressure went up to 180/96 recovered on an unspecified date (duration 2 days); while for other events was recovered on 10Mar2021 16:00. No follow-up attempts are possible. No further information expected.

Patient presented to the ED and was subsequently hospitalized with pneumonia within 6 weeks of receiving COVID vaccination.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

headaches; This is a spontaneous report from a contactable physician. An 81-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 02Feb2021 16:00 as single dose and had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 12Jan2021 16:00 as single dose for covid-19 immunization. Patient medical history included known allergies: Penicillin and concomitant medications were not reported. No immediate effect for 2 days. The patient began to have headaches and now severe headaches lasting up to 8 hours at a time and persistent on 05Feb2021 14:00. No other vaccine in four weeks. No treatment given for the adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Client was feeling generally weak, off balance and chilled starting on 5/1. Subsequently, he developed body aches and a non productive cough. He has no sore throat, chest pain, or shortness of breath. On 5/4 the client presented to the emergency department with generalized weakness, lightheadedness, chills, cough, and fever. He received Tylenol and IV fluids while in the ER. Covid test was negative. Client admitted to hospital for further evaluation.

muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.

his pressure went up to 168/90; headaches; This is a spontaneous report from a contactable consumer. An 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for hypertension and carvedilol hcl taken for hypertension. Patient reported that he had his vaccine on 08Feb2021 and 2 days later his pressure went up to 168/90 and it has stayed up. Caller reports that he usually takes Carvedilol and Lipitor for his blood pressure and asks if elevated blood pressure is a side effect of the covid vaccine. Caller states he got the Pfizer vaccine on 8Feb2021, everything was great and the next day it was good, on the second day after the vaccine, clarifies 10Feb2021, states his blood pressure went up and got headaches. States tomorrow he has an appointment with cardiology. States Second dose is scheduled on 3Mar2021.Caller wants to know if this is normal. The caller gave additional Information for Concomitant Products Lipitor as couple years. The caller provided the dates for blood pressure went up and has headaches as 10Feb2021 to Ongoing. The patient underwent lab tests and procedures which included blood pressure measurement: 168/90 on 10Feb2021 Caller reports that he had his vaccine on Feb 8th and 2 days later his pressure went up to 168/90 and it has stayed up. The outcome of the events was not recovered/not resolved. Information of lot/batch number have been requested Follow-up attempts are completed. No further information is expected.

admitted 5/5/21 with increased sob/cough/aches and pains. Dx with COVID 19 pneumonia on 5/1 . temp 98.3

Resident received vaccine at 10am and was observed for 15 minutes post vaccine with no reaction noted. Pre and post vitals were at baseline. Upon rounds at 12pm, nurse noted resident with increased respirations and an elevated temperature (Resp 40, Temp 103.5). Nurse notified nursing supervisor and MD called. Patient was transferred via 911 to Hospital at 12:25pm.

continuing hissing noise that is quite bothersome, and does somewhat disturb my sleep; woke up with severe hissing in head and realized it was Tendinitis; woke up with severe hissing in head and realized it was Tendinitis; This is a spontaneous report from a contactable consumer (patient himself). An 81-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL3247), via an unspecified route of administration administered in arm left on 12Feb2021 09:15 am as single dose for covid-19 immunization. Patient did not take other vaccine in four weeks. Medical history included high blood pressure which is under control and had put two stents in 2003 and concomitant medications (other medications in two weeks) included omeprazole, losartan, atorvastatin, metoprolol and acetylsalicylic acid (ASPRIN). Caller stated that on 14Feb2021 on Sunday morning at 4:23 he woke up with severe hissing in head and he realized it was Tendinitis. He further stated that he has a touch of this over the years, never for long period or continuous. At 08:30 am the heavy hissing noise died down, however he has since then hear a continuing hissing noise that is quite bothersome and did somewhat disturb his sleep. The patient did not receive any treatment. Patient did not received treatment for AE and not COVID prior vaccination. He was not COVID tested post vaccination. He had no known allergies. The outcome of the events was unknown.

Son reports that the case was not reacting the same after taking his usual blood pressure medications-disoriented, fatigue, complaints of not feeling well and blood pressure was not responding as normal to the medications. THus son took this case to the hospital for his hypertension around 700pm on 05/21/21. He was never in the mechanically ventilated nor in the intensive care unit.

experienced a headache; This is a spontaneous report from a contactable consumer (Patient's wife). A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Apr2021 as 1ST DOSE, SINGLE for a covid-19 immunisation (Age at the vaccination 81-years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. Reporter wanted to know if her husband can take any pain reliever. It was reported that she called doctor's office and they said it was ok. It was also mentioned she went to have her second Pfizer vaccine today and they told her to wait 24 hours before taking any Advil/Aleve/Tylenol. It was reported that patient took Motrin 5 hours after he had the vaccine. The outcome of event was unknown. No follow up attempts are possible. Information on lot/batch number cannot be obtained.

Symptom onset began on 4/29/2021. Tested (+) on 4/29/2021. Symptoms included fatigue, congestion, cough. Case was interviewed by public health department on 5/3/2021 and family reported he was in hospital and was admitted on 4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically ventilated.

Systemic: Exhaustion / Lethargy-Severe, Systemic: "arm tested positive to be magnetic"-Severe, Systemic: Vomiting-Severe, Additional Details: patients family called to report that the patient had experienced side effects with the 2nd dose. they took the patient to the hospital because he was tired and vomiting. they ran tests and a test showed that his arm was magnetic where the vaccine was given

PT ADMITTED TO HOSPITAL FOR COVID PNEUMONIA ON 6/17/21. RECIEVED PFIZER VACCINES ON 1/29/21 AND 2/24/21 (UNSURE WHERE THESE WERE RECEIVED). 1.5 WEEK HISTORY OF DECLINE IN FUNCTION INCREASED CONFUSION, CHRONIC PAINS, DECREASED ENERGY, SUBJECTIVE CHILLS, CONGESTION AND DECREASED APPETITE. SAT 89% ON RA UPON ARRIVAL. PUT ON 8L/NASAL CANNULA. REMOTE HX OF LYMPHOMA S/P RADIATION AND CHEMO 3 YEARS AGO. WILL GET REMDESIVIR AND DEXAMETHASONE HERE

Fully vaccinated patient hospitalized with positive COVID PCR. Patient admitted from ED after a fall at home on 05/20/21 which patient attributed to weakness. COVID swab in ED for admission testing was positive for COVID. Weakness only notable symptom at that time. Patient d/c'd home and readmitted on 05/28/21 per recommendation of Homecare due to increased shortness of breath and O2 in 70's. Chest X-ray showed PNA. Patient discharged with Homecare on 06/02/21.

rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus.; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021((at the age of 81-years-old) as single dose for COVID-19 immunization. The patient's medical history had diabetes. He was diagnosed his first year in medical school in 1968. Concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EL3246) on 12Jan2021 as historical vaccination as single dose for covid-19 immunization. On 03Feb2021 patient experienced rash on all four extremities and trunk/he has a pruritic rash covering all 4 of his extremities and most of his trunk/scratchy/itchy sensation in the throat, rash and pruritus. Clinical course of events: within 24 hours, after the patient had the second shot patient had no symptoms until late next day, then rash on all four extremities and trunk/ had a pruritic rash covering all 4 of his extremities and most of his trunk. It was not on his face. Then atter night, it got much worse next day. He states that he has taken a Benadryl and Pepcid which was helped with the itching but the rash has not gone away. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

81 yo male patient with a history of leukemia, diabetes, renal failure, htn, hyperlipidemia, and nephrolithiasis presents with increasing weakness over the last several days. The patient states that he received his second pfizer covid vaccination on Monday. Since then has felt weak and tired. Has been short of breath with any exertion. No fever or chills. No chest pain. Has had a cough when he breathes through his mouth. He states he is only short of breath when he breathes through his mouth. No nausea or vomiting. Had one episode of diarrhea. No blood in the stool or black stool. No abdominal pain. No urinary symptoms. Has been eating. Has been exposed to a known covid positive contact at home between

Same as I had when I had Covid-19 seven months previously: extreme fatigue and total loss of appetite, but this time it lasted only 13 hours instead of 10 days or more. I tested positive for Covid-19 antibodies 2 weeks prior to the shot.

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Patient not feeling well, decrease in oral intake, general weakness, abdominal pain, nausia. Diagnose with moderate to high grade small bowel obstruction. Patient was given IV fluid, Zofran, Steroids and pain meds. Patient still in hospital

Patient is a 82 y.o. male presenting with shortness of breath and nausea and vomiting. Patient has a past medical history of bladder cancer, COPD on no home oxygen, hypertension, chronic UTI, BPH, and Pfizer vaccination from COVID-19 on 1/4/21 and 2/5/21. Patient was symptomatic with shortness of breath and nausea and vomiting since 07/13/2021. Patient went to urgent care and tested positive for COVID-19 on 07/19/2021. Patient went to the ER and received a fluid bolus as well as Zofran; the wife states that the Zofran does not help with the nausea and vomiting. At home, patient denies fever, muscle aches, chills, chest pain, abdominal pain. Patient admits chronic cough, chronic headache, and pain with urination, most likely due to BPH. Patient denies known history of sick contacts. COVID-19 pneumonia, tested positive 7/19/21, currently requiring 1-2 L of oxygen, baseline room air

been tired, with decreased energy; been tired, with decreased energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis. (Manu-facturer Control No:NUS2021US104132_NC). A 81-year-old age male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. No medical history reported. No concomitant medication reported. Patient reported that he had been tired, with decreased energy and stated that these symptoms began after he received the COVID-19 vaccine in April. The outcome of Events was unknown. Information on Lot/Batch number has been requested

First dose 08JAN2021 and second 29JAN2021. Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

palpitations, dizziness, chills and "wet from head to toe". Note; patient did not eat yet today and arrived at 5am.

Clammy; feels heated from the waste up; Chills; 98.8 degrees/mostly hot on the inside; kidney trouble; Creatinine high; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration in left arm on 06Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included gout from Dec2020 and ongoing. Concomitant medication included probenecid tablet from 29Dec2020 and ongoing, allopurinol tablet from 15Dec2020 and ongoing, both for Gout. Prior Vaccinations (within 4 weeks): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Vaccination Facility Type: Public Health Dept. Vaccine Administered at Military Facility: No. Reported her husband had Gout, and was prescribed 2 pills. She clarified her husband was diagnosed with Gout in Dec2020. She said her husband had a doctor's appointment on 13Dec2020, and on 15Dec2020, he got a prescription for Allopurinol 100mg, once a day. She said the Allopurinol is dispensed in a pharmacy bottle and does not have the NDC, Lot & Expiration Date. She said the word "Accord" appeared after the dose, and may be the name of the Allopurinol manufacturer. She said on 29Dec2020, her husband went to the Emergency Room because he had real bad pain in his legs and feet. She said her husband was prescribed an additional Gout medicine, Probenecid, at that time. She said she doesn't know the Probenecid dose, but he takes it once a day. She didn't have the Probenecid NDC, Lot, and Expiration Date listed on the pharmacy bottle. Her husband received his first dose of the COVID-19 Vaccine on 06Jan2021. And on 07Jan2021, he got chills, felt hot on the inside, and was clammy. He felt heated from the waste up. She said her husband said inside his body feels hot. She said she checked his temperature a while ago, and his temperature was 98.8 degrees. She said her husband said if he could just cool his brain, he could cool himself down. She clarified on 07Jan2021, her husband got chills, felt hot on the inside, and was clammy. She stated her husband is mostly hot on the inside now. Reported her husband had an x-ray of his leg recently, and blood work to check his creatinine. She said her husband's creatinine was high, saying her husband has kidney trouble. No further details provided. Any AE require a visit to: Emergency Room: No, Physician Office: No. The patient underwent lab tests and procedures which included creatinine: high in Jan2021, body temperature: 98.8 in Jan2021, x-ray of his leg: unknown result. Treatment: Declined any. The outcome of the events clammy and felt heated from the waste up was not recovered, for the event chills was recovering, for the other events was unknown.

DEVELOPED COLD SYMPTOMS ON DAY OF VACCINATION. DAY AFTER, TESTED POSITIVE FOR COVID AND COMPLAINED OF EXTREME WEAKNESS, FATIGUE, DIZZINESS, CHEST CONGESTION, AND COUGH.

DAY OF VACCINATION, DEVELOPED COLD-LIKE SYMPTOMS. TESTED POSITIVE FOR COVID ON 1/27/21 AND COMPLAINED OF EXTREME FATIGUE, WEAKNESS, DIZZINESS, SINUS CONGESTION, CHEST, CONGESTION, AND COUGH.

PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH SYMPTOMS OF FEVER, CHILLS, AND GENERAL MALAISE TWO DAYS POST VACCINATION. PATIENT HAS HISTORY OF COVID+ IN NOVEMBER 2020. PATIENT WAS NOT GIVEN MEDICAITON AT HOME PRIOR TO ARRIVING TO EMERGENCY DEPARTMENT. PATIENT HAS PRIOR HISTORY OF SHORTNESS OF BREATH AND REQUIRES OXYGEN WHILE HOSPITALIZED BUTH HAS NOT HAD ANY ARTIFICIAL OXYGENATION SINCE. NO COUGH, NO SHORTNESS OF BREATH REPORTED AT EMERGENCY DEPARTMENT. PATIENT ADMITTED FOR FURTHER WORKUP. PATIENT STAYED 1 NIGHT - RECEIVED 2 DOSES OF CEFTRIAXONE IVPB FOR SUSPECTED PYELONEPHRITIS, WHICH WAS EVENTUALLY RULED OUT. PATIENT FOUND TO HAVE AKI. PATIENT DISCHARGED ON 1/28/2021 IN STABLE CONDITION AND RENAL FUNCTION IMPROVI

Feeling very lethargic ("can barely walk"); Feeling very lethargic ("can barely walk"); Severe tiredness; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In the morning of an unspecified day in Jan2021, the patient was feeling very lethargic. The reporter (patient's wife) stated that they both received the vaccine at 2AM on Saturday and was asking if the event was common. It was also reported that the patient had severe tiredness all of a sudden after receiving the vaccine. The reporter stated that it had been about 55 hours since the shot and she wanted to know if this was a time frame to expect this; stated that it came on so sudden. Outcome of the events was unknown. Case was reported as non-serious. Information on the lot/batch number has been requested.

Complete body ache, nauseous, sweating, fever.......I felt like someone beat me up with a baseball bat....couldn't even get out of bed it started about 12:30 AM and lasted about the rest of the following day...

Event: Individual received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine. Outcome: No side effects observed/reported @ 1 hour post-vaccination. One individual reported a brief period of chills/shakes @ 24 hours that quickly resolved. No side effects/adverse effects were observed/reported @ 48 hours post vaccination.

Fever, chills, Fatigue beginning night of vaccination until 1week later when it resulted in ER visit.

Was in the hospital for his heart condition; he had something around his chest area, some kind of pressure on his chest area; Chills; He ran a temperature of 100.4/running a temperature of 100.8; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration on the left arm on 27Jan2021, at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter (patient's wife) stated that both (patient and patient's wife) had the Vaccine shot on Wednesday, 27Jan2021. After that she was okay but he was not, he had something around his chest area, some kind of pressure on his chest area on Thursday (28Jan2021), he was in the hospital for his heart condition. Patient was done with stress test was good, had another test (unspecified) and he was okay. He had some temperature on Thursday while he was in hospital, next day on Friday (29Jan2021) he was relieved, then he was doing fine. He came home on 29Jan2021, and he started getting aspirin (given in hospital) and took cardiac medicine (unspecified). Everything was okay until few hours later, around 7 o'clock he started getting chills with running a temperature of 100.8 and then by 8 o'clock he ran a temperature of 100.4 (on 29Jan2021). Then call to nurse and the doctor, nurse said to give him the Extra Tylenol which was given at 9 o'clock and then patient's wife took his temperature again last at 11 o'clock, it was 99.55. Then this morning (30Jan2021) at 8 am it was 99.5 and patient had Tylenol and then also at 11 o'clock this morning it was 98.2, this afternoon at 2:45 it was back up to 99. At then at 3:53 it went up to 100.2, so at that point at 4 o'clock, given him Tylenol. He had some chills with it (Clarification unknown), chills were going back and forth. Seriousness of the events heart condition and chest pressure was reported as hospitalization. Outcome of the events was unknown.

WOKE UP AT 3:00 A.M. WITH INTENSE PAIN IN ARM OF THE INJECTION AND SHIVERING. TOOK ACETAMINOPHEN AND BUNDLED UP. GOT UP ABOUT 9:00 A.M. AND TOOK IBUPROFEN EVERY 4 HOURS UNTIL BEDTIME. WAS SORE, COLD AND ACHEY FOR REST OF DAY. SLEPT GOOD THAT NIGHT. IT WAS ALL OVER WHEN I WOKE UP THE SECOND MORNING AFTER INJECTION

Discussed with ER provider last night about this patient. The abdominal findings and mild elevation of WBC gave us a hope to manage it with antibiotics alone because of his age, COPD, AAA. He was admitted to be kept NPO, and IV Zosyn was started. The understanding was to reassess the patient this morning and make appropriate decision Surgeon's H&P 1/10/21, Admitted from ER: Admitted with sudden onset of right lower abdominal pain started yesterday morning. Not associated with vomitings, diarrhea, fever Was seen in ER last night WBC 13K and CT scan showed appendicitis with multiple appendicoliths. This morning he is having pain, slightly worse. Not hungry WBC 11.3K. Afebrile

Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine. There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.

Woke at midnight the following day with chills headache and shaking.Very fatigued. No fever. Rested the next day .felt better no fever.but still tired.Next day. (Fri) woke up with swollen neck gland on the left side.Still tired but improving

chills on and off for 2 days, with temperatures of 99-101.5 started on 2/18/2021; cough and exhaustion started on 2/21/2021, urine turned dark, symptoms lasted for 3 to 4 days; cough is ongoing, but it is intermittent and may be due to pollen

1-21-21. Got first COIVID-19 vaccination at 7:15 AM (Phizer). No reaction whatsoever. Pfizer Lot:EL3249 2-11-21. Got second vaccination at 7:05 AM. Felt normal all day. Pfizer Lot:EL9264 2-12-21. Felt good early. Played tennis and worked out. About 2 PM, started feeling very poorly. Took 90 minute nap. Woke up nauseous and dizzy. Threw up several times. Could not drink or eat dinner. 2-13-21, Continued to feel badly. Threw up after arising. Couild not drink or eat breakfast. About 1:30 PM, was able to keep yogurt and cottage cheese down. Nibbled off and on. Ate light supper. 2-14-21. Woke up dizzy. Was able to eat normally. Still felt badly. Had bad headache (very unusual for me) before supper. Ate normal supper. Canceled tennis for following week. 2-15-21. Started feeling much better than day before. 2-16-21. Felt much better than the day before. 2-17-21. Best day since 2-11 ? the last 5 days. 2-18-21. Began to feel rocky. Slightly dizzy. Low energy 2-19-21. Felt worse than the day before. Low energy, short dizzy spells, little appetite. 2-20-21. Felt really bad. Very dizzy all day. Drippy nose for 5 hours, but nose okay by bedtime. Very tired all day. 2-21-21. Felt a little better. Still dizzy when I got up. Recovered enough to go to church at 10 AM. Note that it had been 10 days (at 7:05 AM) since I had my second shot. 2-22-21. Got up to the bathroom at 2 AM. Was dizzy. Got back to sleep until 6:30 AM. Was and am better than the last 4-5 days. Still feel a little shaky if I move quickly or get up out of my chair quickly. Very tired all day. 2-23-21, Doing better. Still wobbly on my feet. Only mildly dizzy. 2-24-21. Best day since 2-17. Still a little weak. Worked out in the late AM. 2-25-21. Felt a little dizzy in the AM. Better after lunch. Did light workout. Good day overall. Felt fine. 2-26-21. Felt good in the AM. Worked out. Feeling stronger than yesterday even. 2-27-21. Felt good 2-28-21. Felt tired all day 3-1-21. Did not sleep well. Worked out in the AM and then was very tired. Felt a little dizzy after returning home from the gym. Took short nap before lunch and am doing better in the PM.

2/25 - loss of taste 2/26 - dizziness/woozy, severe flu like symptoms all day (no energy, ache) 2/27 - continuing dizziness, minimal energy 2/28 - continuing dizziness, wheezing/trouble catching breath (needed oxygen to calm)

2/24/21 10:00 AM-2:30 PM, chills; 5:00 PM-10:00 PM, 101 deg. fever. 2/24/21-2/25/21 oxygen saturation dropped below 90 and pulse rate went from mid 70's to low to mid 90's. All vitals returned to normal by the morning of 2/26/21. No treatment performed. Self monitored for the term of the reaction.

Flu like symptoms fever 101.7, tired yeah ache, body ache. Lasted 24 hours. Reduced fever with ibuprofen

Vaccine at 2;00.Problem started at 4:30 with a sudden tickle sensation in left nostril. Caused sneezing 8-10 times. Runny nose, eyes red with tears, phlegm required constant blowing of nose. Stuffed cotton up left nostril and breathing through mouth gave some relief. It is now 8;15 and doing much better.

extreme dehydration and electrolytes imbalance; dehydration/extreme dehydration and electrolytes imbalance; fatigue and dehydration; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (at age of 82-year-old male) as single dose for covid-19 immunisation. The patient medical history reported as none. Family medical history relevant to events was none. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) as single dose for covid-19 immunisation. The patient experienced fatigue and dehydration from 24Feb2021, extreme dehydration and electrolytes imbalance from 10Mar2021. Caller states that her husband had the Pfizer shot, stated since he had taken the second shot which was administered of 09Feb2021 he has gone (place withheld), stated on 24Feb2021, went to ER with fatigue, he was dehydrated to the point of not walking, state the ER sent him home, that they could not find anything, stated finally it came to a head on 11Mar2021, stated he was hospitalized with extreme dehydration, stated this took all of the salt and magnesium out of his system and screwed up his electrolytes, stated he was on deaths door, stated on 08Mar2021, they did not think he was going to make it, that they called the whole family in. Stated he was discharged from the hospital on 12Mar2021, that he was improving but they are not out of the woods yet. States the patient's weight at the time he went to the emergency room was 156 lb. Caller clarifies that some time between 03Mar2021 and 05Mar2021, he went back to the ER and was admitted overnight for dehydration as well. Caller stated she did not have the exact dates for this hospitalization. The patient was hospitalized for extreme dehydration and electrolytes imbalance from 10Mar2021 to 12Mar2021. The outcome of the events was recovering.

Fever; This is a spontaneous report from a contactable consumer (the patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6203), via an unknown route of administration on 20Feb2021 (at the age of 82-years-old) as a single dose for Covid-19 immunization. Medical history included glaucoma from an unknown date. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Jan2021. The patient's concomitant medications included timolol (MANUFACTURER UNKNOWN) and latanoprost (MANUFACTUER UNKNOWN), both from an unknown date for glaucoma. On 21Feb2021, the patient experienced fever and "all of the side effects is listed on the website". Treatment for the fever included aspirin and a lot of water. The clinical outcome of the fever was unknown.

1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

Pt started sweating after vaccination, per sister pt is a diabetic and he sweats when he is nervous, pt's HR was at 122 BPM, and went down to 111 BPM before pt left after 30 min of observation.

patient reports completing 2 shot series of Pfizer covid vaccine, 1st shot given 1/11 per wife, 2nd shot complete 1/25 per wife, but maybe actually given in February? Both shots were taken, interval just unclear from family. Patient admitted to Medical center on 4/9 with cough, fevers and coughing. Reported that his daughter was diagnosed at end of march and him and his wife had symptoms 4 days prior to admit and was positive for covid.

After the 2nd dose my arm was very sore (muscle ache) and fever; After the 2nd dose my arm was very sore (muscle ache) and fever; My arm was very sore; The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that, A 82-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 2 intramuscular, administered in Arm Left on 22Feb2021 15:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) from 2000 and ongoing Enlarged Prostate from 2000. Historical vaccine included bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: EL5982) dose 1 Intramuscular, administered in Left Upper Arm on 02Feb2021 1:10 PM for COVID-19 immunisation. Concomitant medication included tiotropium bromide (SPIRIVA) taken for chronic obstructive pulmonary disease from 2000, salbutamol (ALBUTEROL HFA) taken for chronic obstructive pulmonary disease from 2000 and ongoing, budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease from 2000 and ongoing, terazosin (TERAZOSIN) taken for prostatomegaly from 2000 and ongoing and finasteride (FINASTERIDE) taken for prostatomegaly from 2000 and ongoing. The patient experienced after the 2nd dose my arm was very sore (muscle ache) and fever and my arm was very sore on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included positron emission tomogram: unknown on 22Feb2021 Slightly radioactive spinal fluid culture. Outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Rapid COVID test was positive/Next day long test came back negative and was quickly moved out of the COVID-19 unit; Hemoglobin Anemia; difficulty breathing; fast heartbeat; dizziness; weakness; tiredness; over all feeling of unwell.; This is a spontaneous report from a contactable consumer (patient). An 82-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 19Mar2021 10:00 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization. Medical history included lower left lung lobectomy in Mar2019 and cancer in May-Jul2019 treated with chemotherapy 4x. The patient previously had first dose of BNT162B2 in the left arm on 26Feb2021 10:00, lot number: EN5318 for COVID-19 immunization. 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. On 20Mar2021 06:00, 1 day later had side effects of tiredness and over all feeling of unwell. On 22Mar2021, 3 days later, the patient had additional side effects of difficulty breathing, fast heartbeat,dizziness and weakness. On the 6th day, the patient went to ER 26Mar2021, the patient was admitted to the hospital. Rapid COVID-19 test was positive and sent to COVID-19 unit. Next day long test came back negative and was quickly moved out of the COVID-19 unit. The patient was diagnosed with hemoglobin anemia. Over all, hemoglobin dropped from normal base line of 14 to 6.1. The patient was given 2 units of blood, was given a shot of prednisone and then put on 60 mg of prednisone daily. Release from hospital after 6 days with hemoglobin of 9.9. Still being followed by doctor and follow up blood work. Continuing 60mg of prednisone daily until hemoglobin reaches normal range. If prednisone does not work, next step is an infusion of Rituxan. The patient underwent lab tests and procedures which included haemoglobin: 9.9 on unspecified date, haemoglobin: dropped from normal base line of 14 to 6.1 on 27Mar2021, long test: negative on 27Mar2021 and Nasal swab/Rapid test: positive on 26Mar2021. All events were reported as life threatening. The outcome of the events was recovered with lasting effect

This morning my temp rose to about 99. this morning my temp rose to 100 (normal 97.5), Had chills, shakes Went away after 5 hours 9last night my temp rose to 100

Resident developed 101 F fever and lethargy 5 days after receiving a dose of Moderna erroneously. Patient has been completely vaccinated with Pfizer prior. Patient was sent to hospital for further evaluation

now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment he experiences chills; temperature is in the high number and he has a little chills right now while speaking; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the male patient of 82-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 01Apr2021 13:00 (Batch/lot number was not reported) (at the age of 82-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Th patient family medical history relevant to events includes none. Concomitant medications included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect includes none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in arm left on 11Mar2021 for covid-19 immunisation and experienced very itchy episode, chills and runny nose. On an unspecified date in Apr2021, patient stated it was not going on now but sometimes early in the morning when he wakes up and until he gets the temperature up in his apartment, he experiences chills. Patient stated if the heat was on, he does not notice chills but if the heat is not on, he does notice it. The temperature was in the high number and he has a little chill right now while speaking. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included Covid-19 antibody test which showed negative (on not exposed to virus) on an unknow date in 2021. Therapeutic measures were taken as a result of event chills included Tylenol. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Chills; very itchy episode; Runny nose; This is a spontaneous report from a contactable consumer, the patient via PPDi. An 82-year-old male patient received first dose of BNT162B2 (BioNTech COVID 19 vaccine, solution for injection, lot number: caller could not locate the lot number, NDC number: Unknown, Expiry Date: Unknown) on 11Mar2021 at 13:00 as a single dose for COVID-19 immunization. Patient took the second dose on 01Apr2021 at 1pm (unknown NDC number, for lot number and expiry date: caller could not locate the information). Caller stated both doses were received in the left arm. Patient had no family and medical history. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any prior vaccination (within 4 weeks). relevant to AE(s). There were no AE(s) following prior vaccinations. For concomitant products caller stated "no" because he took his regular medication from his primary care doctor. Caller clarified that the antibody test was given at the church and he was given the number to find out results of the COVID-19 antibody test, which was 2 weeks before the first dose. Caller stated the antibody test was not Pfizer. He got a telephone number (Withheld) that he called which was who told him the results for not being exposed to the virus. Caller stated he was not exposed to the virus and decided to follow up to get the Pfizer vaccine and he received the first dose on 11Mar2021 and the second dose on 01Apr2021. Caller stated he was calling about the BioNTech COVID-19 vaccine. Caller stated he took the shot at Church. The runny nose started a day or two before the first shot, he clarified it was around 10Mar2021 this started, which was still ongoing. Caller stated he was experiencing a very itchy episode right after the first shot of the COVID 19 vaccine which was on 11Mar2021. Caller stated those are the two items he was complaining about. Caller stated chills started in between the two doses. Caller stated it is not going on now but sometimes early in the morning when he woke up and until he got the temperature up in his apartment, he experienced chills. Caller stated if the heat was on, he does not noticed chills but if the heat was not on, he does notice it. The temperature is in the high number and he had a little chill right now while speaking. Caller stated the outcome is the same. Patient took one except for Tylenol. He has taken a couple of Tylenols, he clarified he had just been taking tablets of Tylenol for chills. Outcome of the events very itchy episode was not recovered while that of chills and was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

felt very tired/feeling exhausted/tiredness; Headache; muscle and joint pains; muscle and joint pains; Hot Flashes; Chills/cold chills; nauseous; he felt so hot; thought he had a fever; cramping all through the night to the point he wanted to cry; Couldn't Sleep; He specified the pain was in his hands, legs, feet/sore arm; weakness to the point he couldn't get up to go to the bathroom.; Feeling unwell; Dizzy; but everything else was sore too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as "EUO150"/"LU0150"), via an unspecified route of administration, administered in arm left on 13Apr2021 11:15 (at the age of 82-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included blood pressure, allergy, glucose-6-phosphate dehydrogenase deficiency (G6PD), liver genetic deficiency, and had allergy mice, cat, dust and trees. The patient previously took sulphur and aspirin and makes him bleed because his blood was already thin. Concomitant medications included amlodipine taken for blood pressure; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication; all were start and stop date were not reported. An 82-year-old caller received the first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (13Apr2021), around 11:15 am. He added he was monitored for 15 minutes post injection and then used the public transportation to run some errands and return home. He said he received the injection on his left arm had soreness in this arm after vaccination. He explained around 3-3:30 pm he was walking to get the bus and then felt very tired to the point he wanted to sit on the pavement. He also described it as feeling exhausted. He explained he was so tired on the bus that he was falling asleep and almost missed his stop. He said he also began having joint and muscle pain on the bus. He specified he got home around 4 pm and he then experienced tiredness, headaches, muscle and joint pains, hot flashes, chills, and felt nauseous but didn't vomit. He specified he felt so hot, he had to turn off the heat and remove his clothes, but then he had chills/cold chills and had to turn the heat back on and thought he had a fever. He said around 11 o'clock he had appetite. He added he had cramping all through the night to the point he wanted to cry. He couldn't sleep. He specified the pain was in his hands, legs, feet, and joints. He also said he felt tired like he had worked for 12,000 hours and was not able to move. He said he had weakness to the point he couldn't get up to go to the bathroom. He said he had the headaches all through the night. He was feeling unwell, dizzy. He explained he felt like he was going to die; he was worried about his body. He said he still feels tired. They told him he would only have a sore arm, which he did, but everything else was sore too until about 08:00 today (14Apr2021). He explained that he didn't have all these issues before vaccination. He explained how disappointed he was with his reaction to the vaccine given that he was reluctant to the unapproved vaccine at beginning because he wasn't the person that take a lot of injection and medications, and so finally after his primary physician to influence him to get the vaccine. He mentioned he lives alone, healthy, vegetarian, never smoked, never took recreational drugs, does acupuncture, and takes little medications. He explained most people and his acupuncture doctor said he shouldn't get much reaction from the first dose and the reactions to the second dose are more prevalent. He added he was told that people have mainly experienced soreness in their arm after this vaccination with the first dose. He asked if his symptoms were reported after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. Everyone told him the first vaccine is a whiz. That it was easy. The second vaccine is the one that have side effects on. He also stated that he almost called to get an ambulance to take him to the hospital. Said that if he had these reactions with the first one, he does not want to take the second vaccine. Sometimes he regret that he have taken it now because he did not expect all of this to happen to him and they just told him that he will have a sore arm on left arm. He was in kind of shock to experience all of this and he was G6PD (Intent: History). He cannot take Sulfur and Aspirin because that makes him bleed because his blood was already thin but that would be no problem also have a liver genetic deficiency (Intent: History). He was allergic to mice, cat, dust and trees (Intent: History). So, he told all what he had that they knew in the beginning they said none of those things will affect. He take B12 (Intent: History) too once a month, he get injection for allergies for his cats and trees and grass once a month but they told him none of the things will affect him. The outcome of the events was unknown. Information about the lot/batch number has been requested.

On April 24, patient started not feeling well while away from home in the early afternoon. Later noticed some balance issues and some memory problems. The next day, balance issues continued and had noticeable mouth drooping on left side first noticed by daughter who was visiting and son-in-law. Was taken to the hospital and diagnosed with a stroke.

Fever Cellulitis Elevated troponin Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present"

high fever/High temperature; tested positive for COVID-19; tested positive for COVID-19; No taste or smell; No taste or smell; This is a spontaneous report from a contactable consumer via team and Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were reported as none. On 05Mar2021, the patient tested positive for COVID-19 and has been hospitalized twice with a high fever, high temperature: 103.5. The patient has been in and out of the hospital. The reporter was asking, "Does he have to start over from scratch with the second vaccine dose since it has ben over 6 weeks from the first?" The patient also had no taste or smell on 05Mar2021. The patient was hospitalized from 05Mar2021 to 07Apr2021. The patient recovered from the events fever in Mar2021 and also recovered from the event COVID-19 on unspecified date. The outcome of no taste and smell was not recovered. Information about lot/batch has been requested.

Cough 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.

sore arm hours after shot; fatigue/tired; runny nose; coughing/slight cough; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm 05Feb2021 11:15 (82-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diverticulitis (surgery), kidney cancer small area excised, and prostate cancer radiated. There were no known allergies. Concomitant medications in two weeks included allopurinol, fenofibrate, tamsulosin, and amlodipine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 15Jan2021 11:15 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On 05Feb2021 15:00, patient experienced sore arm hours after shot, fatigue, runny nose, coughing, no temperature the next day. Symptoms abated second day after shot. Still tired and a slight cough. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After my father received the second COVID vaccination he started complaining of headaches. He had lung cancer, but he was in good condition. Within weeks his health deteriorated and when we bought him for a scan the beginning of March he had two small brain bleeds. The cancer had spread to the brain and he had a mass. They put a shunt in on March 18th because they said he had fluid, and this was the only treatment. Ten days later he was back in the hospital and after a week we had to take him home on hospice. I think the vaccine could of escalated his cancer this rapidly. Especially because he had two brain bleeds.

COUGH ED to Hosp-Admission Discharged 3/5/2021 - 3/7/2021 (2 days) Hospital DO Last attending ? Treatment team Rectal bleeding Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 3/7/2021 Admission Date: 3/5/2021 Length of stay: 0 Days PCP: MD Discharging provider: DO Discharge diagnosis: Hospital Problems POA * (Principal) Rectal bleeding Yes Glaucoma Yes COVID-19 virus infection Yes Overview Signed 3/5/2021 11:11 PM by MD Asymptomatic Disposition: Home CODE STATUS (LOI): Full Code Consulted Services: none Hospital Course HPI: Rectal bleeding Hospital Course: Patient was hospitalized bright red blood per rectum without evidence of acute blood loss anemia. He has a history of radiation colitis with lastest unrevealing colonoscopy in December 2011. He feelss improved with stable hemoglobin and did have normal bowel movement by next day. Likely this is internal hemorrhoids, probably isolated; no intervention warranted. Incidentally, patient had COVID positive but exhibits no symptoms. No CXR obtained; he will have second vaccination shot in 2 days as per previous scheduled. Disposition plan was discussed with patient's daughter over the phone on March 6. Hemoglobin was 12.6 upon discharge on March 7 when patient was deemed stable to transition out of hospital. _

Went to ER for headache. Got CAT scan. Scan showed nothing but ER doctor said to watch it because it might come back. Headache lasted gir two weeks thereafter and balance was affected.

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

The patient, began suffering from extreme fatigue about 4 weeks ago and has now been admitted on an emergency basis to Hospital. He has blood clots in his lungs and his heart rate is sustained at approximately 140 beats per minute. No cause for the clots has been determined as of yet and the possibility of the COVID 19 vaccine causing the clots as an adverse effect can not be ruled out. This case needs to be investigated. Patient is still in the hospital as of 5/18/2021.

COVID-19 SOB (shortness of breath) Cough Suspected COVID-19 virus infection Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file): 5/8/21 Start of Symptoms Date: 5/6/21 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease ED to Hosp-Admission Discharged 5/10/2021 - 5/18/2021 (8 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Discharge Summary Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 5/10/2021 Discharge Date: 5/18/2021 Discharge Diagnosis Medical Problems Hospital Problems POA * (Principal) Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Yes Overview Signed 5/14/2021 10:50 AM 05/11/2021 Dexamethasone 05/11/2021 Remdesivir Essential hypertension Yes CLL (chronic lymphocytic leukemia) (CMS/HCC) Yes OSA (obstructive sleep apnea) Yes Persistent atrial fibrillation (CMS/HCC) Yes DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 82-year-old male with past medical history significant for CLL, obstructive sleep apnea, obesity and persistent atrial fibrillation who presented to the ER on 5/10 for evaluation of progressively worsening shortness of breath after recently being diagnosed with Covid?19. ER work-up concerning for severe sepsis with acute hypoxic respiratory failure for which he was admitted to the PCU under the hospitalist service. Hospital Course He was treated with dexamethasone and remdesivir but remained hypoxic requiring alternating trials of high flow nasal cannula and BiPAP for which pulmonology was consulted on 5/12. Unfortunately, he did not tolerate prone positioning. Despite his advanced age and several risk factors, he slowly but surely progressed from a pulmonary standpoint. He was weaned off high flow oxygen 2 days ago and deemed stable for downgrade to MedSurg with telemetry at that time. Since then he has continued to recover well, now requiring 6 L of oxygen with activity and 4 L at all other times. He is anxious to be discharged home and appears medically stable to do so with home health care services, remote patient monitoring and outpatient pulmonology follow-up with PAL as prior to hospitalization. Prior to discharge, all questions were answered and patient and his son expressed understanding, appreciation and agreement with the discharge plan at this time. Treatments: IV hydration, analgesia: acetaminophen, cardiac meds: metoprolol, furosemide and aldactone, anticoagulation: eliquis, steroids: dexamethasone, respiratory therapy: O2 and remdesivir

pain; low energy; mild headache; mild nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: E99261), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age 82-year-old) as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache and mild nausea on 02Feb2021, low energy on 03Feb2021, pain on an unspecified date. Reporter stated that "He is calling about the covid 19 vaccine. He had his first shot yesterday afternoon at 2. He slept great. He had a mild headache last night and mild nausea. This morning he got breakfast, and it wasn't excruciation but still felt pain, as well as the nausea, and his energy level was not normal. As far as the headache, would it be okay to take Tylenol, and for the nausea can he take Phenergan or Dramamine, its not extreme but just uncomfortable. His First Dose of the Covid Vaccine was on 02Feb2021 at 2PM or 2:05PM. The mild headache started last night the same day. The Nausea started last night was mild, on the same day also. The energy level being low started today 03Feb2021". Caller confirms that "after the onset of events he took 2 tylenol last night at 7. He had a little sinus problem and took 1 of coricidin hbp sinus over the counter medication last night. Taking both together made him anxious. Thats why he is calling to find out in the morning. He does not want to take things close together". Outcome of the event pain was unknown and other were not recovered. Follow-up attempts are completed. No further information is expected.

see above....chills lasted for months until hot weather started, headaches still on going taking asprin each morning, weak and getting weaker, fatigue use to walk 6 or 7 miles 4 or 5 times a week now 2 or 3 miles twice a week and feeling tired

presented with a cough, difficulty breathing, sinus congestions and headache on 2/7. tested positive for COVID-19. admitted to the hosp. completed 5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21

SKYLINE ICU DOD 5/2/21 VENT REQUIRED14 DAYS, PNEUMONIA, ARDS, HX OF HTN, CAD, THROMBOCYTOPENIA, HYPOCALCEMIA, HX of TIA and Cereb Infarc with resid dysphgagia, Major Depressive Disorder single episode unspecified

Diarrhea; Joint pain; Chills; This is a spontaneous report received from a contactable consumer. A 82-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 28Feb2021 at 13:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. The patient had medical history included diabetes, high blood pressure and stroke. It was not sure if the patient had allergies to medications, food, or other products. It was not sure whether any concomitant medications was taken by the patient. 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 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date of Feb2021 (at the age of 82-year-old) at 13:30 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. On 01Mar2021, at 02:00, the patient experienced joint pain and chills. On 03Mar2021, two days later patient developed diarrhea. 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 of joint pain, chills and diarrhea was recovered on an unknown date at the time of this report. Information about lot number cannot be obtained. No further information is expected.

Very lethargic for 3 days followed by headache, dizziness and shortness of breath. Has continued up to today but the symptoms have lessen each week. Most common is headache and dizziness. Went to emergency in May thinking I was having a heart attack but they could find nothing wrong.

Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-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 05Mar2021 at 14:00 (at the age of 82-years 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report. Information on the lot/batch number has been requested.

Really tired for 3 weeks following the shot; Sick; Weak; Sleepy and couldn't stay awake; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, at the age of 82-years-old, as single dose for COVID-19 immunisation. Medical history included ongoing blood pressure; suffered from cramps (ongoing). The patient was in good health Family medical history was none. Concomitant medication included blood pressure medication for blood pressure from an unspecified date and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). It was reported that the patient was really tired for 3 weeks following the shot. He was sick and weak. He was sleepy and just could not stay awake. Right after the patient got the shot, his symptoms started. The patient did not go to the doctor or the ER. He just got through it. He had no relevant tests done. Outcome of the events was unknown. Information on lot/batch number has been requested.

Dx: Pericarditis s/s: Dyspnea on exertion, edema, fever/chills unknown symptom onset date, patient poor historian. diagnosed with pericardial effusion, suspect pericarditis. viral panel negative. etiology not defined defined as acute on chronic dyspnea and acute CHF

issues with his memory and being more confused/Confusion; tiredness/Fatigue; He feels like he is not getting enough oxygen, has had a cough, runny nose, issues with his memory and being more confused; cough; runny nose; Having problems with memory; Not Feeling Right; Muscle pain; Pain areas have been more painful/pain; Sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1685 then says someone changed the 5 to a 6), via an unspecified route of administration in left arm (left shoulder) on 05Jan2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included he had two ablations, close together 4 years ago, blood pressure issues from Dec2020 and ongoing, ongoing thyroid condition from several years, ongoing acid reflux, has been on medication on and off for this condition for 5-10 years. Concomitant medications included levothyroxine sodium, 75 mcg once a day for thyroid disorder taking this medication for several years; losartan, 0.5 mg once a day per for blood pressure abnormal from Dec2020 and ongoing, he used to take half a tablet; started taking a full tablet 08Mar2021; omeprazole, 40 mg twice a day for acid reflux, he has been on and off this medication for 5-10 years. Started taking it regularly in the past year. Also increased it to twice a day in the past year. He was on Eliquis for blood thinning. He was started it 01Mar2021. He had been on hit previously for quite a while and had an ablation and was able to stop taking it. Blood pressure went up so he was put back on it in Mar2021, before then he had taken it about 2-3 years ago. He currently takes 5 mg twice a day. Caller also mentions unspecified vitamins and herbs; no further information provided by the caller. The patient previously received flu and tetanus vaccines in Oct2020 and shingles vaccine in Aug2019. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The month ago (or more) he has been experienced tiredness, fatigue, pain, although he stated that he always has some kind of pain because he was 82 year old but it has been worse in the past 2 weeks. He felt like he was not getting enough oxygen, had a cough, runny nose, issues with his memory and being more confused. He stated that the tiredness and fatigue started out as intermittent about a month ago and said that it would "come and go" but now in the past couple of weeks it has been much more frequent. He also stated that he has been experienced a runny nose, cough and congestion for the past couple of weeks. He stated that since he got it; and for about a month or two, he has not been feeling right. He has tiredness, fatigue, all of his pain areas have been more painful, muscle pain. He doesn't seem to be getting enough oxygen; he really has to suck in air. His overall biggest problem was the fatigue. He stated that right after the shot he had no issues other than soreness in his arm on Jan2021; he has been going down hill since then. Tiredness and fatigue it has gotten worse gradually. It started a month or more ago. It has gotten worse over the last 2-3 weeks. He has pain all the time, he was 82 year old and something that always bothering him. Increased in pains started along with the tiredness and has also gotten worse over the last 2-3 weeks. He stated that his tiredness and fatigue was intermittent, but now it was more frequent. Before he had more good days than bad days. Now he has more bad days than good days. His feeling of not getting enough oxygen also went along with the tiredness. It has also gotten worse over the last 2-3 weeks. Cough and runny nose seem like it started in the last few weeks and has gotten worse. He has difficulty in answering the questions because his memory has been giving him problems and he's been confused more for about a month or so. It was gotten worse. The patient received second dose of the Covid vaccine (Lot Number: EL3249) on 26Jan2021, He was pretty sure that it was given in his left shoulder. He would like to know if he should go back to the VA where he received the Pfizer COVID-19 vaccine to be evaluated for these symptoms. The patient did not visit to emergency room or physician office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of sore arm was recovered on an unspecified date in Jan2021, while with other event was not recovered. Information about Lot/Batch Number has been Requested. Follow-up (05Jul2021): 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 completed. No further information is expected.

I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Crohn's aggravated; Chills; Aching joints; This is a solicited report based on the information received by Pfizer from Manufacturer (Mfr. control no.: 21K-163-3936556-00). A contactable 82-year-old male consumer (patient) and a non-contactable consumer (Patient's wife): A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg, 1 in 2 wk) for crohn's disease.The patient previously received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) vial intramuscular route of administration on 13Jan2021 as dose 1, single for COVID-19 immunization.The patient medical history include hypersensitivity, Crohn's disease, Anxiety, pain, Supplementation therapy. Patient's wife stated that the patient was allergic to two medications to improve his bone density but could not recall the specific medication, bone density abnormal, Abstains from alcohol, Sesame Seeds and Oil allergy manifested by red face and throat swelling and Sulfa Drugs Allergy. The patient was non-tobacco user.Concomitant medication included ciprofloxacin (CIPROFLOXACIN) for crohn's disease, azathioprine (AZATHIOPRINE) for crohn's disease, lisinopril (LISINOPRIL) for crohn's disease, balsalazide (BALSALAZIDE) for crohn's disease, venlafaxine (VENLAFAXINE) for anxiety, oxycodone (OXYCODONE) for pain, betacarotene;calcium carbonate;cyanocobalamin;folic acid;nicotinic acid;pyridoxine hydrochloride;riboflavin;sodium ascorbate;thiamine hydrochloride;tocopheryl acetate taken for supplementation therapy, hyoscyamine for crohn's disease and valsartan taken for an unspecified indication. On 04Feb2021, the patient experienced Chills, Aching joints and Crohn's aggravated.On an unknown date, the patient underwent lab tests which included computerized tomogram: unknown results. The action taken in response to the event(s), for adalimumab was unknown. On 07Feb2021, the patient recovered from chills and Aching joints and had not yet recovered from Crohn's aggravated. Causality as per reporter for event chills and aching joints as probable and for Crohn's aggravated not reportable No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in narrative, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the reported events of Crohn's aggravated ,chills and arthralgia 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.

Feeling tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown. Follow-up attempts have been completed and no further information is expected

1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB on 1/14/2021 at 1325

on 1/14/2021 out for appointment with family. Returned cold, clammy,m lethargic, thick tongue. POx = 84% on room air. pulse = 44, BP = 110/46. Blood sugar = 120. No fever. No signs/symptoms prior to this

Violent chills the evening of the day of vaccination followed by a day of extreme fatigue requiring bed rest. Condition improved the next day

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

LEFT SHOULDER STARTED HURTING ON THE FOLLOWING THURSDAY MORNING, WAS IN UPPER CHEST AREA BY THE SAME EVENING. FOLLOWING MORNING INCREASE IN TEMPERATURE. TOOK TO EMERGENCY ROOM FRIDAY EVENING, DIAGNOSED WITH PNEUMONIA. LEVAQUIN PRESCRIBED. SATURDAY COVID19 TEST NEGATIVE. INCREASE IN CHEST DISCOMFORT NEXT FEW DAYS, NO TEMPERATURE. TEMPERATURE OVER 99 AGAIN ON 1/26/2021, TOP PORTION OF CHEST, NECK AREA HURTING, WOKE AT 10:30 PM COMPLETELY DRENCHED. 1/27/2021 AM FEELING A LITTLE BETTER.

LEFT SHOULDER PAIN STARTED MORNING OF 1/22/21, INCREASED PAIN WITHIN THE NEXT 24 HOURS AND INCREASE IN TEMPERATURE. TOOK TO ER ON 1/22/21 AFTER TEMPERATURE 100.4. DIAGNOSED WITH PNEUMONIA, LOWER LEFT LUNG. LEVAQUIN PRESCRIBED. COVID-19 TEST ON 1/23/21 BOTH RAPID AND PCR NEGATIVE. INCREASE CHEST PAIN OVER NEXT FEW DAYS, NOT TEMPERATURE AGAIN UNTIL EVENING OF 1/26/21. AWOKE FROM SLEEP AT 10:30PM ON 1/26/21 DRENCHED. 1/27/21 FEELING BETTER IN THE AM, BUT STILL EXPERIENCING CHEST DISCOMFORT.

Arm very sore chills for one night fever for one night loss of appetite general feeling of not feeling well general feeling of fatigue second day/ feeling slightly better but not back to normal

not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing. The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.

Nausea; aches; tiredness; This is a spontaneous report from a contactable consumer (patient). A 83-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) , via an unspecified route of administration on 21Jan2021 18:30 at SINGLE DOSE at left arm for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nausea, aches, tiredness on 22Jan2021 17:30. No treatment for the events. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination

Still dealing with it on day two following the 2nd vaccination. Fever persists but not getting over 100°

Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.

Day 1 after receiving vaccine he started to notice redness on face and fatigue. Day 2 woke up face was swollen and eyes almost swollen shut and hot, started taking benadryl and sleep most of the days. Denies SOB. Day 3 continue benadryl, zyrtec and pepcid. Day 4 came to PCP as it's gotten worst. Swelling of bilateral ears, face, and forehead.

Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

Arm discomfort 2/10, arm and shoulder discomfort 2/11, 12, 13, neck discomfort 2/14, 15, 16, headache neck pain 2/17, 18, 19 worse. Hurts to move head.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.

on 15th he had body aches and a temperature(102) and extremely tired and fatigued. went to the ER on 2/20 and took chest xrays and blood work, temp was 98.1, O2 was normal, pulse was normal.

Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436

Fever of 101, chills and profound weakness. Patient was unable to ambulate. Patient was admitted due to these symptoms

At 8:30am, 2/26/21, He was asleep on chair in dining room. Very hard to wake him up! I got him to a recliner, but then he had to throw up. He said he was "foggy" and went to sleep when he got back to the recliner. At 11:45am, his blood pressure was 66/47, then 71/48 in his left arm. In his right arm, 74/51. He did have some top ramen soup and was feeling better. I took his temperature earlier and it was 96.1.

Shot at 10 am on Saturday 2/20/21 and at 3 PM became very lethargic. At 9 PM temp was 101.1. At 10 PM was 99.1 after taking two Tylenol. Sunday to Tuesday regain strength vitals were normal. Tuesday 2/23/21 visited doctor and tested for COVID-19 and flu. Also received a chest X-ray. Tuesday to Saturday regained strength and vitals are normal.

slight pain in his arm the shot was given; if he moved his arm, he would have slight discomfort; some slight tenderness in his shoulder; Yesterday, his temperature was 97 something. This morning, he got up at 6am and his temperature was around 98.8; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261; expiry date: unknown) via an unspecified route of administration in the left arm, on 26Jan2021 at 8:30 to 9 AM, at a single dose, for Covid-19 immunization. Medical history in Mar2020 included had a temperature for 7 days. He tested positive for COVID and it took a while to test negative. At the end of Mar2020 until the first of Apr2020, his temperature was 97 something. He has checked his temperature every day since then. There were no concomitant medications. The patient had no previous immunization with the Pfizer vaccine. He did not receive additional vaccines on the same date bnt162b2 was given. The patient had his first COVID-19 shot yesterday morning about 8:30 or 9:00. He hadn't really looked at the list of side effects, but yesterday afternoon (26Jan2021), he had slight pain in the arm where the shot was given. If he moved his arm, he would have slight discomfort. The pain was mostly gone today. He also had some slight tenderness in his shoulder, but it's certainly less than what it was yesterday. He saw other things that were listed including fever. He wanted to know if Pfizer had any information as what to amount of fever people typically experience after having the shot. Yesterday (unspecified date in Jan2021), his temperature was 97 something. This morning, he got up at 6 am and his temperature was around 98.8. And then he had to take his wife to therapy and when he got back 3 hours later, he took it now and his temperature was 99 degrees. He was just wondering if Pfizer had an idea of how much fever is normal from the shot? He hasn't had any other reactions. The events did not require Emergency Room or Physician's Office visit. The patient underwent lab tests and procedures which included body temperature: 97 something on 26Jan2021, 98.8 and 99 on 27Jan2021; sars-cov-2 test: positive on an unspecified date in 2020 and negative on an unspecified date in 2020. Outcome of the event "slight pain in his arm the shot was given" was recovering, while for the other events was unknown.

some temporary diarrhea; felt tired; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration on 30Jan2021 (at the age of 83 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date at a single dose for covid-19 immunization. On unspecified date in 2021, the patient experienced some temporary diarrhea and felt tired for about 15 hours. Outcome of all the events was recovered on unspecified date in 2021.

general feeling of unwellness; chill; headache; loss of balance; This is a spontaneous report from a contactable consumer (reported for himself). An 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL9262, expiry date not reported), via an unspecified route of administration on 26Jan2021 10:30 at a single dose in the left arm for Covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included quinapril at 5 mg, cyanocobalamin (B-12) at 2500 ug (2500 mcg), and atorvastatin at 40 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 08:00 pm, patient experienced a general feeling of unwellness, chill, headache, and loss of balance. 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. No treatment received for the adverse events. The events recovered on an unspecified date in 2021.

On the 2nd day, I got chills, exhaustion, headaches, dizziness & weakness in the legs and coordination walking.

Awoke feeling achy, tired, warm, chills, headache on 3/2/21 Bright red rash down right arm , warm to the touch, swelling of arm and hand on 3/4/21 Arm Itchy and swollen, slowly dissipating since 3/4. Minor symptoms of arm and neck still today 3/8/21

severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin. The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.

Sneezing bout of 10-15 minutes following injection. Fine until after dinner when I felt a liqiud draining in my right nostril. I suspected it to be mucous but was surprised when I wiped and blew my nose, red blood was on the tissue. It stopped bleeding and no longer bled. No other symptoms occurred. The injection site was tender but no erythema. I have not had an episode of epistaxis in over a year. Will be given 2nd dose on Teusday 3/16,21.

Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.

he has a congested cough that has increased recently; nausea; fatigue/ still very tired; He had chills; fever/ mild temperature; This is a spontaneous report from two contactable consumers (patient's wife and patient himself). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EK4176, expiry date Jul2022) via an unspecified route of administration in arm right, at the age of 83-year-old, on 26Jan2021 12:00PM, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (for 15 years or more), ongoing spinal stenosis in his lower back for about 15 years or more, and rotator cuff syndrome (left arm). Concomitant medication included ongoing sertraline hydrochloride (ZOLOFT). The patient did not receive other vaccines within 4 weeks. The patient experienced nausea on 28Jan2021 with outcome of not recovered, fever/ mild temperature on Jan2021 with outcome of not recovered, fatigue/ still very tired on 28Jan2021 with outcome of not recovered, he had chills on 28Jan2021 with outcome of not recovered, he has a congested cough that has increased recently on Feb2021 with outcome of not recovered. The patient went to his eye doctor for an eye exam, and he was not real comfortable because he was semi-nauseous. The patient had experienced fatigue, tiredness, and nausea since receiving his first COVID-19 Vaccine dose. The patient reported he also had chills. The patient had an increase in a congested cough recently. The patient continues to feel fatigued, tired, and nauseated. The patient felt like he should have gone to the Emergency Room, or seen his doctor when he experienced the side effects after the vaccine, but he didn't go. The patient has been taking cough medicine. The patient has COPD and takes the cough medicine at night before he goes to bed. The patient clarified that he started taking the cough medicine because he had an increase in a congested cough recently. The patient clarified he has a sticky, yellowish phlegm that he coughs up. The patient said recently the phlegm changed to a reddish-brown color. The patient said his phlegm will go back and forth from the yellowish color to a dark brown color. The patient said he started the cough medicine about a week or so ago. The patient said it was a 4 ounce bottle of cough medicine. The patient said he takes a 20ml dose at night, so he doesn't start hacking while he sleeps. The patient just finished the 4 ounce bottle of cough medicine last night. The patient takes over-the-counter Tussin DM Max cough medicine. The patient is scheduled for his second COVID-19 Vaccine on 15Feb2021.

Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism

Dry cough (short bursts especially during sleep and has continued for 18 days); This is a spontaneous report from a contactable consumer (patient himself). An 83-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 on 03Feb2021 at 09:30 as a single dose for COVID-19 immunization. Relevant medical history included hypertension from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination, which included unspecified high blood pressure drugs. 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 03Feb2021 at 23:00, the patient experienced dry cough (short bursts especially during sleep and had continued for 18 days). The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event. Information on the batch/lot number has been requested.

Dizzy, throwing up, sore arm, chills, sweats, headaches, loss of appetite, could not stand due to dizzy or open eyes, temperature variance from 97 to 100.

Resident began to feel ill at 2:30 am the night after he received 2nd dose of COVID vaccine. Suffered from weakness, chills, and nausea. Felt ill for approximately 2 days, but then symptoms subsided.

Very sore injection area; Temperature of 100.4 degree; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: not available), via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient had no known allergies. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. No covid tested post vaccination. The patient had no other vaccine in four weeks. The patient received other medication in two weeks. On 09Feb2021 at 15:00, the patient experienced very sore injection area for two days. Temperature of 100.4 degree and down to 99 degree after 36 hours. The patient did not receive any treatments for the events. The clinical outcome of the very sore injection area was recovered and Temperature of 100.4 degree was recovering. Information on lot/batch has been requested.

Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms. He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered. Follow-up attempts were completed. No further information was expected.

fever/My dad reached up to a 103; My dad was sleepy and tired after he got the shot yesterday in the morning; My dad was sleepy and tired after he got the shot yesterday in the morning; This is a spontaneous report from a contactable consumer via Medical information team. An 83-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 13Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 for Covid-19 immunization. reporter (daughter) stated, "I am calling for my mom and dad, both of them received the second Pfizer shot yesterday and they both have the same age, they both (birth year withheld) born. They both had fever just last night like this early morning. My dad reached up to a 103. My dad was sleepy and tired after he got the shot yesterday in the morning. He was sleepy and then in the evening he starts getting fever on 13Feb2021. They took tylenol for it. The patient underwent lab tests and procedures which included height: 5'5, 5'3 as well, temperatures: 103 and Weight: about 200 lbs on an unspecified date in 2021. The outcome of the events was unknown. Information on Lot /Batch Number has been requested.

Approximately 1 hour after completion of an IVIG infusion (his 17th dose in the past 22 months) the patient experienced severe chills, altered mental status, temperature of 103.0 and was unable to stand or ambulate. His wife called 911 and the patient was admitted to the hospital.

Positive COVID + 5/2/2021 Admitted with extreme lethargy and syncopal episode, hypoglycemia, increased dyspnea with hypoxemia

Swelling face; Chills; Face is deep red; following day my face started getting red; Swelling is going down a little bit now, but it itches; Swelling is going down a little bit now, but it itches; I have been sleeping for 2 days; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history included Blood pressure. Concomitant medication included VITAMINS NOS. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1686; Expiration Date: unknown) on 21Jan2021 for COVID-19 immunization. The patient experienced swelling face, chills, face is deep red; following day my face started getting red swelling is going down a little bit now, but it itches, I have been sleeping for 2 days. The patient underwent lab tests and procedures which included blood test and results was unknown on 21Jan2021. The outcome of events swelling face, chills, face is deep red; following day my face started getting red, swelling is going down a little bit now, but itches was unknown. The swelling is going down a little bit now was recovering. The outcome of event I have been sleeping for 2 days was recovered on an unspecified date.

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

She had a pfizer vaccine and had a reaction where her BP went up high she had rapid heart beat and palpitations. Tachycardia and blurry vision. Had a headache overnight. Initial troponin elevated, follow up was less. No chest pain now.No dyspnea.

Arm soreness Joint pain shoulder pain stiff neck involantary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor appmt. Went to ER because of hand and foot swelling. Diagnosed with Poly Myalgia rheumatica or PMR. Being treated at this time by Dr.

Patient reports daily headaches after second Pfizer vaccine 1 day after second vaccine for the past 2 months. His headache is stable and controlled with daily acetaminophen.

Tiredness; feeling unwell; joint pain; chills; muscle pain; This is a spontaneous report from a contactable non-health care professional (patient). An 83 Year(s) old male patient received BNT162B2 (Pfizer-BioNTech COVID Vaccine), batch/lot number# EL9269, via unspecified route of administration on his left arm as first dose, single on 07Feb2021 at 12:45, (age at vaccination 83 years) for Covid-19 immunization. Patient's medical history was not reported. The patient was allergic to Thimerosal, lactose and cucumber. Concomitant medication included lisinopril 10 milligram (mg) for chest congestion relief PE. Patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 09:00, the patient experienced chills, feeling unwell, joint pain, muscle pain and tiredness. He did not receive treatment for the events. The patient was recovering from all the events. No follow-up attempts are needed. No further information is expected.

Chills; Fever; Weakness; I had couple of days when I had cough at night and little bit of this and that; I am worrying about the reaction because I didn't realize that I probably had Covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive; Muscle ache; Tired; I had like laryngitis type like my vocal cords were little bit swelled; Aches; This is a spontaneous report from a contactable consumer (patient). An 83-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 on 12Apr2021 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure and mild case of COVID-19 both from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date was not reported. On an unspecified date, the patient experienced chills, fever, weakness, i had couple of days when i had cough at night and little bit of this and that, I am worrying about the reaction because I didn't realize that I probably had covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive, muscle ache, tired, I had like laryngitis type like my vocal cords were little bit swelled and aches. It was reported that the patient had his first Pfizer shot last week and Monday, he had quite a reaction about four to five hours later and had chills, fever and weakness and so forth. He called one of the pharmacists about it and was asked if he had COVID before. The patient said that he was checked in for that but last month or so and was not checked down but he had couple of days when he had cough at night and little bit of this and that and he suspected that he might have something. The patient had COVID before he got the first shot within 5 or 30 days and that is why he got that reaction when that shot hit him. Now, the patient was concerned about the second shot, like if he will have a problem with that too, he was worrying to go to from about 2 or 3 days for that shot which was scheduled for next Monday, believed it is 3rd of May. The patient was really bit apprehensive about getting the shot simply because they usually recommend 90 days, in other words, after someone had COVID, to not get vaccination until at least 90 days afterwards. So, he was not sure what to do. The patient took as recommended for the fever, he took Tylenol and it was helpful as far as the aches, muscle ache and all that. Also, he was still very tired and the fever that he got after the shot was only for one day or he got it that night and lasted maybe till the next day and he was sure that it's going to come down and he will feel better. The weakness that linked, had a cough anyway, was going through this cough a little bit and had muscle ache. He also had like laryngitis type like his vocal cords were little bit swelled but was now getting better and it took like a good week like week and a half and that's why he was concerned about the second shot. The patient thought what he was hoping to do, was to stop a week or two and give it a little bit of time because he may be close to the 90 day window, it appeared the best way to do that but he thought that it was what the experts should be able to tell him. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative on 23Feb2021. Therapeutic measures were taken as a result of events fever, muscle ache and aches included TYLENOL. The outcome of the event I had like laryngitis type like his vocal cords were little bit swelled was recovering and the outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient received what he believes was the Pfizer covid-19 vaccine x 2 in March 2021. He generally felt poorly since receiving the vaccine and was eventually tested for covid-19 in mid-May 2021 as an outpatient, which was positive. He was admitted to hospital on 5/23/21 with pneumonia. Transferred to Bigger hospital on 5/26/21 for ICU care.

About 4-5 hours after he received his 1st COVID-19 Vaccine dose, he had sharp pains in his head. The pain was mostly behind his eye.; About 4-5 hours after he received his 1st COVID-19 Vaccine dose, he had sharp pains in his head. The pain was mostly behind his eye.; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date: was not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 08:00 as single dose for COVID-19 immunization. The medical history included cardiac disorder from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations prior within 4 weeks. On 01Mar2021, about 4-5 hours after vaccination the patient experienced sharp pains in his head, the pain was mostly behind his eye; on 03Mar2021, the patient experienced mild headache. The clinical outcome of the events sharp pains in his head was resolving and mild headache was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Fatigue; lightheaded; temperature around 99.3; This is a spontaneous report from a non-contactable consumer (patient himself). A 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9261; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient had not any known allergies. Patient had not received any other vaccine in four weeks. Concomitant medications included levothyroxine, pregabalin, mirabegron (MYRBETRIQ), zinc and vitamin b nos (B-COMPLEX [VITAMIN B NOS]) taken for an unspecified indication. It was reported that on 29Jan2021 patient experienced fatigue, lightheaded and temperature around 99.3, required 2 days of bed rest. Symptoms began 4 days after receiving the first dose. Therapeutic measures were taken as a result of fatigue, lightheaded and temperature around 99.3 as patient had received paracetamol (TYLENOL) and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: around 99.3 on 29Jan2021. Patient was not diagnosed with COVID-19 prior and since the vaccination. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Pt w/hx significant for B-cell lymphoma & interstitial lung dx (on 4L O2 at baseline) p/w 5 day hx of SOB, cough, congestion, and diarrhea. COVID test was positive (6/15) despite receiving Pfizer vaccines (1/15 & 2/6). Was admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. Received dexamethasone, plasma, and tocilizumab during admission with improvement, however, pt is still hospitalized and feels SOB w/any exertion and desaturates w/cough.

~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home.

Fully vaccinated 83 year old male admitted with Covid-19 pneumonia. Symptom onset with cough, dyspnea, fatigue, lethargy on 6/5.

Presented to hospital for increased SoB and weakness. Diagnosed with COVID-19 on 7/8. Discharged home on 2L O2 and dexamethasone. On 7/12 presented again with hypoxia, elevated WBC/ D-dimer. O2 titrated to 5 L NC and transferred to our facility on 7/12. Oxygen requirement continued to increase and patient admitted to ICU on 7/14. Currently receiving dexamethasone and received tocilizumab 7/13. Received remdesivir initially but was discontinued on transition to HFNC> Currently on HFNC w/NRB 50 L at 90%