Pfizer

Low grade fever, malaise, headache, mild body aches, sort of out of it at times. Stated feeling bad within 2hrs of shot. Tx-rest, lots of sleep, Tamiflu. Felt bad for 2days.

Approximately 2 hours after receiving the vaccine I felt a heat flash, people setting in the area asked if I was OK as my face was red. It cleared in approximately a minute. The 2nd heat flash came on about 5 to 10 minutes later and cleared about a minute later. The 3rd heat flash came on about another 5 to 10 minutes, again clearing at about 1 minute. Next I felt like my head was in a fog, found it very hard to focus, and was forgetting what I was doing. I walked over to the office, my supervisor asked if I was ok as she said it looked like my eyes were glazed over, my head was still in a fog. This cleared by 2:30 p.m.

Approximately 11:00 am I got crazy chills, put on my coat, and turned a heat lamp on, this lasted about 30 minutes. After the chills my mind went in to a fog, found it very hard to concentrate, and felt like I was moving in slow motion. Also had some GI upset, but discharge. The fog lasted until 4:00 pm.

Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.

Approximately 2 hours post vaccination a heat flash came over my body, co-workers setting around me asked if I was ok as my face was red, cleared about 1 minute later. About 15 minutes later a 2nd heat flash came over my body and cleared about 1 minute later. About 15 minutes later the 3rd heat flash came across my body and cleared about 1 minute later. Approximately 30 minutes later my head was in a fog, I could not focus, thoughts left my mind. When returning to my office my manager asked if I was ok and said my eyes were glossed over and my face was red. All this cleared around 2:30 pm.

One week of the vaccine, while having some coffee and cookies. About tens of consuming them, I felt like I was getting a cold and had to keep clearing my throat. I told my wife I feel wired and she mentioned my right eye looked different. In about two more minutes my right was swollen closed and speaking became difficult due to the swelling. My wife drove me to Hospital and I received Epinephrine and Benadryl and fluids.

BODY ACHES, RESTLESS SLEEP AND PAIN DAY OF INJECTION. SLEPT ALL DAY AFTER WORK, BUT FELT BETTER NEXT DAY

Received vaccine at 10:44am. My arm was a little sore almost immediately. Approximately 12:30-1:00pm, I started getting a bit nauseated, pit in my stomach . Lasted until went to bed around 9:00pm. In morning felt fine except my arm felt much more sore at the shot point for about 2-3 hours after I woke up. 10:00am everything is normal.

This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.

Forgetfulness/Lapses in memory; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-years-old male patient received the first dose of bnt162b2 (BNT162B2), lot number EK417, via an unspecified route of administration on 15Jan2021 at 14:00 (at the age of 60-years-old) at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history was none. The patient did not have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other vaccines were in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a nursing home/senior living facility. On 18Jan2021 at 19:00, the patient experienced forgetfulness/lapses in memory. The patient did not receive any treatment for the event. The clinical outcome of the forgetfulness/lapses in memory was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

2nd dose EL8982. About 6 hours after 1st vaccine had visual disturbances in left eye, got a little better after a week or so, but still has a floater in left eye, had 2nd dose and after 72 hours had to leave work (never left work before) to get emergency eye exam - thought I was going blind - diagnosed with "Posterior Vitreous Detachment". Now I still have a BIG thing in field of vision making it hard to see and "thousands" of tiny black floaters. Hard to see out of right eye.

I had a really severe left shoulder ache. I couldn't lay on that side, and I had general body aches and a low grade fever. Some nauseous. Really vivid dreams.

Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his words and mumbling. VS 97% RA, HR 92, temp 99.8, BP 168/92. Pt is conscious but unable to tell me his name or location. Skin is clammy, patient?s hands are shaky. Wife was notified that we are calling an ambulance for further assessment. Ambulance arrived at 11:48 and pt was taken out shortly before noon.

Patient was monitored for 30 minutes after first dose of Pfizer vaccine as he reported rash after taking PO Sulfa medication. Per pt he has had no reaction to flu vaccines in the past. Patient left clinic at 0932 but later returned at 0940 c/o feeling loopy. BP at 0940 180/97 HR 63, Radial Pulse 60, Oxygen saturation 100% RA. BP at 0945 172/96 HR 60 left arm. BP at 0958 left arm 167/82 HR 57. Patient monitored by NP and was advised to follow up with his primary care doctor. Pt reports he had derma filers a few weeks ago. Patient c/o feeling redness and numbing in his cheek bones and feeling loopy. Per pt denied history of hypertension only had 2 cups of coffee this morning. Patient?s husband will pick up patient and take him to Hospital as he was advised to do by his primary care doctor who he spoke with while in clinic. Temperature 97.5 F on forehead. Pt declined feeling any itching. Patient was picked up by husband and he will drive patient to Hospital. BP at 1043 184/94 HR 64 Apical Oxygen saturation 97% RA. Patient denied any itching, stated swelling in cheeks and tingling has improved. NP walked patient out of clinic.

After first dose of vaccine, developed 5/10 persistent chest pain accompanied by diaphoresis. Known history of CAD. EMS was called for transport to hospital for urgent medical evaluation. Per family, the patient was taken to local ED on 2/27/21. Had EKG, blood enzymes x 2 and "everything checked out" and he was discharged home. Family notes that PCP follow up arranged and patient reported anxiety.

AT 1052, patient waited 27 minutes due to elevated heart rate and anxiety. Afterwards, patient stated he felt ok and heart rate was 70. Instructed to go to the emergency room if symptoms resume and persisted greater than 30-60 minutes.

STARTING THE NIGHT AFTER VACCINE, WAS UNABLE TO SLEEP FROM SUNDAY 3/14/2021 UNTIL WEDNESDAY 3/17/2021. BEGAN GETTING A FEW HOURS A NIGHT STARTING WEDNESDAY NIGHT 3/17 - SATURDAY NIGHT 3/20. BEGAN NORMAL AVERAGE NIGHTLY SLEEP SCHEDULE OF 6.5 HOURS STARTING SUNDAY 3/21. DURING THE WHOLE PERIOD OF TIME DID NOT FEEL TIRED OR HAVE MANY SIGNS OF EXHAUSTION. ACTUALLY FELT A FEELING OF REJUVENATION DURING PERIOD. CURRENTLY FEELING AS DID BEFORE DATE OF FIRST VACCINATION.

I have had minor tinnitus for years. It was noticeable when I was going to sleep, but had never bothered me during the day. After getting my first vaccination it has gotten much worse. It makes it hard to get to sleep and hard to concentrate on work during the day.

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

ER Doctor said I have Bell's Palsy. Left side facial paralysis.; I started feeling funny; I started feeling funny and weak; Eye is watering, feels like there is grit in there; Eye is watering, feels like there is grit; Uncomfortable.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 12:15 (at the age of 60 years old) as SINGLE DOSE for covid-19 immunisation. Historical Vaccine includes BNT162b2 Dose 1, 10Feb2021 at 14:00 , Lot number=EL9263 in Left arm Medical history included diabetes mellitus. There were no concomitant medications. The patient has no known allergies. 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 Facility where the most recent COVID-19 vaccine was administered was a Hospital. On 04Mar2021 at 13:15, The patient experienced Bell's palsy. left side facial paralysis (medically significant), started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable. The adverse events resulted in an Emergency Room Visit. Treatment was given for the events. The clinical course is as follows the day after I went to the (Withheld). Patient started feeling funny and weak. Since he was close to a local Hospital Emergency room. ER Doctor said 'I have Bell's Palsy. Left side facial paralysis'. He prescribed prednisone. Have to wear eye patch on left eye. Eye wont close. Can't eat or drink on left side. I was told by my primary care doctor that this could last up to 6 months. And that 85 percent of cases clear up. Eye is watering, feels like there is grit in there. Uncomfortable. Treatment (Prednisone therapy) was given for the events. The clinical outcome of the events Bell's palsy. left side facial paralysis, started feeling funny and weak, eye is watering, feels like there is grit and uncomfortable was not recovered.

About 45 minutes after first Pfizer shot I experienced a feeling like a warm starburst in the center of my head... and got very dizzy. It started in the center of my head and spread in all directions to fill my head. I was driving and had to pull over. It passed after about five minutes. After that I felt a bit weak and slept that afternoon and most of next day.

I don't know if I hallucinated that or not; I feel like I am on drugs like I on 'some acid'; my vision is blurry and it's kind of hard to concentrate on television; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported)\ via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included mental issues since 1988. The patient stated "I am calling about an adverse reaction to the second Pfizer shot. If you guys have anybody called in and find out if anybody is having the same. After the second shot, about a day after the shot, it was terrible. I got the shot last Tuesday and I feel like I am on drugs like I on 'some acid' (not clarified). But I am not hallucinating, I am not seeing things, I am not hearing things, I just physically feel that way. Everything is kind of blurry, my vision is blurry and it's kind of hard to concentrate on television and stuff like that. It seems like some people are playing mind games with it but I don't think they have (further clarification unknown, hence not captured as event). I don't know if I hallucinated that or not (consumer was not sure). That's pretty much here I feel like I am on drugs constantly and it is just kind of scary. I have mental issues since 1988, I take psych meds but it seems whenever I take my psych meds (unspecified medications) I feel worst for couple of hours." Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Woke up feeling foggy, achey, low grade fever (98.8 F). Just moved slow for most of the day, really had to concentrate as I went through my work day. Not as sharp or quick with mental processing and decisioning making. Work from home, so it's really obvious when I am off my game. Drank 6 x water at 12 oz per. Took two ExStrength Tylenol about 130, no fever, knocked down achey joints, head began to clear, but still not sharp. Not sharp mentally continued into morning of 31 March.

He got his vaccine, and on Saturday 3/27/21 started having a slight fever, head cold/foggy head, slightly runny nose, loss of appetite. Had a COVID test yesterday which was negative, but he still continues to run low grade fevers which was 100. He has taken Ibuprofen for the symptoms. His temperature today 4/1/21 at 8:58 AM is 99.5, his blood oxygen has been between 95-97%, his pulse and BP have been a little high as well, and his pulse is 90, his BP was 141/99 yesterday at the store BP machine. He has not called his doctor to report his reactions.

Initially headache, and sore arm at injection site. Only sore on contact and not too bad. Fatigue and loss of muscle strength (I am a hard core cyclist), not detectable during normal activities. A week later it persists. On the fourth evening, I could not stay asleep. As soon as I would drop off I would dream. It would be a violent encounter. I would physically strike out and I would wake up.

stroke; feel "foggy"; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration in left arm on an unspecified date in Mar2021 at 11:00 AM as single dose for COVID-19 immunization. Medical history included none. Allergies to medications, food, or other products: No. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced feel "foggy" on Mar2021 with outcome of recovering, stroke on 14Mar2021 20:30 with outcome of recovering. Clinical course: About an hour after receiving the shot the patient began to feel "foggy", the feeling continued over to the next day. The patient didn't remember how long after that it continued. The patient then had a stroke 5 days after receiving the vaccine. The patient had no health risks prior to the vaccine and the hospital was unable to find a cause or leading indicator of what could have triggered the stroke, leaving the vaccine as the elephant in the room. Treatment received for the adverse events: Everything. The evens resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for feel "foggy" and stroke for 2 days. Seriousness criteria-Results in death/Disabling/Incapacitating/Congenital anomaly/birth defect: No.

Pt anxious and states lightheaded and numbness in mouth area. Pt was in ADA drive thru observation; laid seat chair back, removed mask and encouraged sips of water. Noticed pt had portable oxygen in passenger seat, states he was COVID positive in Jan and was discharged with the O2 to be used prn. Medics evaluated pt; VSS, O2 sats 98%. Pt left but was not in distress.

Constant tiredness for over a week. Lost consciousness in a parking lot and hit head. Bleeding around the brain causing confusion and loss of memory

Developed Pulsatile Tinnitus in right ear which lasted for 3 weeks, causing difficulty sleeping. After 3 weeks, symptoms became intermittent and then stopped after 4 weeks.

AFTER THE VACCINE HE WAS COMPLAINING ABOUT BEING UNCOMFORTABLE. ON SITE EMS RESPONDED, VITALS LISTED BELOW. EMS HAS IT LISTED AS A POSSIBLE ALLERGIC REACTION. HE RECOVERED AND LEFT TO HOME.

My tinnitus symptoms have been raging since I have received my second dose of phizer covid-19 vacination. I can not say 100% that the vacine is the the sole reason for the extreme symptoms but can tie nothing else to the change. The ringing, screeching and high pitch sounds are louder than I have ever e,peri encased in my 15 years with tinnitus. I TS constant, unnerving, stressful, and never ending. Difficult to impossible to sleep and if I do happen to fall asleep the symptoms wake me up within an hour. Kinda at my wits end at this piint.

Vertigo/dizziness. Lost control and fell to the bed on the first symptom morning. Vertigo lasted for 10 days with varying, unpredictable intensity. Then, it was downgraded to occasional dizziness until now, Day 14. The vertigo restricted my movement and driving out of precaution. After reading similar experiences at website and others, started taking Ibuprofen and diphenhydramine, which helped a bit. Currently waiting for my second shot in 5 days warily.

post vaccination pt. reports " sharp pain to right side of chest " on a scale of1-10 discomfort was a "6" initially but is now a "4" continues to originate from mid sternum radiating to right side pt. denies any nausea or shortness of breath Pt. does admit having "anxiety " at times and has had this "pain before" his primary care physician has cleared him for cardiac event in the past After a 15 minute observation period pt. reported chest discomfort was first a "1" then soon after a "0" Pt. was released and continues to have 0 pain upon ambulating

48 hours before my Covid vac, I received my first dose of a Singles vac on March 19, 2021. I received my first Covid vac on March 21, 2021 and within a couple of days i began to develop a fairly serious BRAIN FOG. It was difficult to concentrate and make decisions. This lasted for about 2-3 weeks.

Caller reports ER visit day after getting vaccine for chest tightness and ?extreme sedation?. Caller was discharged and has had some chills since then. Also reports fogginess and tension headaches. States he was in the ER last night and was treated and released.

I've had a mild tinnitus for about 5-6 years. 6-7 days after my first Pfizer shot, my tinnitus has become very bad. In the last week, twice I was awakened by it in the middle of the night and was not able to fall back to sleep because it is so loud. In the past, I never heard it during the day, but now it is very loud even in the daytime. This is very serious. Not being able to sleep and rest at night is very hard to cope during the day. I'm not sure what to do as there is no cure for this tinnitus.

I experienced a very sudden and intense Gout flare up that caused and is still causing an unbearable swelling in my right foot and ankle. I have not had a flare up of this intensity and severity for over 12 years. My Gout has been successfully managed by Allopurinal for over 12 years and I have not experienced any significant events during this time. This time includes over 20,000 miles on my road bicycle and dozens of days over 100 miles. Never have I had a problem. Last Tuesday, I received the second dose of the Pfizer vaccine and I have yet to be able to walk or sleep through the night for six days and counting. This adverse effect should be followed and researched. I also will be requesting reimbursement for out of pocket expenses due to this event.

On 4/28, I was feeling some side affects like tired, body pain and joint stiffness . I work at home and I was finished with work at 7pm. My legs felt like led weights and my right hand had lots of joint pain. I ate supper at 7pm. It was getting towards 8pm and was starting to have signs that Unintentional tremors. shaking in my legs, hands and head. I laid in bed and it was far worse, this was a seizure. was having hard time speaking or breathing at times. I managed to take a clonazepan and with in a hour it starting to calm down.

-12 hours after 2nd Pfizer vaccine, woke up repeatedly throughout the night with bizarre, vivid dreams; also awoke 3 times with eyes open and distinctly heard my cat purring on the bed, even though she passed away two years ago. These symptoms ended after the first night post-vaccine. -18 hours after 2nd Pfizer vaccine, in the morning noticed distinct neck puffiness and swelling, especially just under the jaw line. After 1 week the puffiness persists, but is slightly less. -48 hours after the 2nd Pfizer vaccine, noticed high-pitched buzz (tinnitus) in both ears. In a completely quiet room, I continue to hear it throughout the day and night after one week.

Patient first presented with extreme nausea, vomiting and dizziness about 30 minutes after his second dose. Another 15 minutes later as he has a seizure and then was still very delirious. Ambulance was called but patient refused to go to the hospital.

4 days after 1st shot my husband became ,confused,garbled ,speech,,did not know who the president was or what year it was.admitted to Hospital .Released with a diagnosis of TIA.Went back to work .Sent home due to garbled speech and confusion .Second shot given.Sick for 10 days .Fever 101,diarrhea ,slurred speech ,confusion .awaiting to get second MRI.

flu-like symptoms; Headache; fever / low grade fever after second dose; felt bad all over; face was red; This is a spontaneous report from a contactable consumer. A 60-years-old male consumer (patient) reported for himself that he received second dose of second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW6170) via an unspecified route of administration in right arm on 19Apr2021 at 13:00 at single dose for COVID-19 immunization. The patient had Covid before Christmas. he was active and gets around. He had friends who had Covid (2020) and he had a bad run with it. The patient's concomitant medications were reported as no. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in right arm on 29Mar2021 at 09:30 COVID-19 immunization and felt bad. The patient took second dose of Pfizer covid vaccine yesterday i.e. on 19Apr2021 at 13:00. He felt bad after the first. He felt great yesterday until he started feeling bad in the evening. He went to work today, he was feeling better, but now he was experiencing a low grade fever. Caller was asking if he was a slight risk to his coworkers or if he is a potential carrier of the COVID19 virus. He knows there was no live virus in the vaccine. He was just looking for clarification. He felt like he had the flu, felt like crap. He felt bad all over. Last night his wife told him his face was red. He had an infrared thermometer at his desk, he thinks his temperature is 99.5 to 100 tops. He did not take his temperature last night but thinks the fever started last night. He started feeling flu-like at 10:30 today. He was going home after he gets off the phone. Clarified his temperature was 98.8 degrees, but he felt hotter than it reads. His face was 101.8 degrees on his cheek and 100.4 or 101.2 degrees when checking on another area. He took 3 Excedrin this morning for a headache. The outcome of events was unknown. No follow-up attempts are possible; No further information expected.

Red marks and severe itching mostly on the palms of my hands. Fades at times. Wakes me up in the middle of night and Im scratching

Patient states that he feels anxious .He was observed for 30 minutes before leaving the vaccination site.

Feeling terrible all over; aching all over; his urine started smelling bad; Hepatitis C; His chest was also hurting; Dizzy; his arm hurt just from the shot.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient (weight: 83.91 kg, height: 178 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8734, Expiration date: 31Jul2021) at single dose, in the right upper arm, on 10Apr2021 at 14:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included arachnoiditis adhesive chronic from an unspecified date, in 1999 and ongoing, ulcerative colitis from an unspecified date, in 1996 and ongoing, chronic sinusitis from an unspecified date, venous reflux disease from an unspecified date and ongoing and polyps from an unspecified date (7 surgeries performed from polyps. Last surgery was Mar2016). The patient preciously, on 20Mar2021, at 14:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EP7534, Expiration date: 31Jul2021) in the right deltoid, at single dose, on for COVID-19 immunisation. He was good after the first shot, he had no problems. Concomitant medications were unknown. On 10Apr2021, the patient experienced dizzy ("after the second dose they got home and that evening while getting up off the couch, he got really dizzy") and his arm hurt just from the shot. On 13Apr2021, he developed chest pain (his chest was also hurting) and had hepatitis C ("he got blood work done and just got it back and was told he has hepatitis C"). On 20Apr2021, his urine started smelling bad. On an unspecified date, the patient also experienced generalised aching ("aching all over") and was feeling terrible all over. Relevant laboratory test, performed on an unspecified date, showed the following value: alkaline phosphate high, blood cholesterol high, eosinophil count 5.4 %, hepatitis C positive, low density lipoprotein (LDL) high and infectious mononucleosis (Mono) 13.5. The patient recovered from vaccination site pain on 10Apr2021, recovered from dizzy on 14Apr2021 and recovered from chest pain on 20Apr2021. The patient did not recover from hepatitis C and urine abnormal. Clinical outcome of feeling bad and generalised aching was unknown at time of this report.

Chills body swats extreme aches and fatgue loss of appetite brain fog. Sleeplessness Started 05/02 and continues today. It hasnt gotten better

Admitted 04/30/2021 for increasing slurred speech and confusion; previously admitted to outside facility 04/15/2021 through 04/19/2021 for similar symptoms

2 hours after, tiredness, next morning soreness in arm, insomnia, numb face for 3 days, loss sense of taste

About 1 week following first Pfizer vaccination, I began having achiness in left leg and thought this was possibly from sitting in a chair without enough cushion. I simply could not get leg comfortable. Over a couple days duration the leg continued to be achy and slightly swollen. On December 23rd at night I awoke due to such discomfort in leg and could not get comfortable enough to go to sleep. I went to ED where I was examined and found to be mildly short of breath and in pain. Ultrasound of leg showed large upper leg DVT. CT of chest showed submassive Pulmonary Horseshoe Embolus. I was placed on Heparin and anticoagulated. Hospitalized for several days while anticoagulated and observed for any clot progression or respiratory distress and discharged home on Xarelto for anticoagulation and follow up with PCP, Hematology, Pulmonary medicine.

Immediately after the injection I felt a warm sensation flowing through my body and my head felt warm but I did not have a temperature. This subsided within 20 minutes. Prior to the vaccination I had slight Tinnitus on a scale of 1-10 I would say it was a 2. I had no trouble sleeping at night and did not use any sound machines to mask the tinnitus. I would characterize myself as a great sleeper. About 48 hours after the vaccination in my left ear my Tinnitus went from a 2 to a 5. Now to sleep I must run a fan or noise machine to mask the tinnitus and sometimes have to take benadryl or Tylenol PM to sleep.

On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.

Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical history. LPN arrived on scene after vaccinator was yelling for help. Patient was "in and out of consciousness", awake and alert and then would have LOC for a few seconds and then become awake and alert again. This happened about 4 times with LOC with also some "convulsing like movements in the arms". Emergency responders and clinical lead, RN called. Patient laid back in seat as far as the seat would go, face pale and lips white. Pulse-ox put on and BP taken, 36 bpm (according to pulse-ox) and oxygen level 89%, BP 100/54. LPN gave epinephrine injection at this point at 1151, 0.3mg IM in right thigh. HCP arrived on site, patients VS after epi: pulse 76, 100/76, O2 sats 94% at 1155. Patient awake and alert, oriented to person, place and time. Lips and face pink. Care turned over to Paramedics who arrived on site at 1200.

Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable consumer, the patient . A 60-years-old male patient 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 05Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and he was A-1 healthy specimen. Concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that he was not advised not to drink alcohol, and as this shot happened to be administered on a friday late afternoon, he went home and about an hour later had a glass of Scotch. About an hour after that, he apparently was feeling quite wonderful (loopy)(05Mar2021 at 18:15) but do not remember saying or doing things much at all. The next day the felt nauseous and flu-ish all day long. The patient did not receive any treatment for the event. The clinical outcome of events nauseous ,flu like symptoms and Euphoric mood was recovered with sequelae at the time of the report.. No follow-up attempts are needed. No further information is expected.

Normal reactions sore arm -fatigue lasted 3 days 3 weeks later he was getting some brain fog and little confusion 2nd shot fatigue- sore arm which lasted a week more brain fog more confusion couldn't get his words out. could not work his phone or computer Went to doctorMay 24th

Got 2nd Pfizer vaccine on Tuesday 3/30. Felt bad afterwards. Went to another city next day Wednesday-Thursday-Friday for work. By Monday 6/7 I was very sick with bronchitis. It got very bad, went to ER. Went ER a second time and they did a CT Scan. Found fluid buildup on heart- Pericarditis. Hospitalized, sent to ICU. Two days in a row BP 85/35 HR47. Finally a Thoracic Surgeon agreed to take me to surgery following morning. Drained 300ml fluid off heart. Heart arrhythmia went into afib. Chemically converted- released on 6/22/2021. Chronic cough has lingered for 10 weeks.

urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering. Follow up needed, further information has been requested.

20 hours after shot i became very dizzy and confused i made it to my bed were i slept interrupted with night terrors' upset stomach and shaky legs this continued for two days 5 days later i became strong enough to continue with daily activities

Patient was a previously healthy 60 year old male who developed an acute change in mental status on 4/9/21 after first receiving the Pfizer COVID-19 vaccine; he was ultimately diagnosed to have hemophagocytic lymphohistiocytosis, and other underlying etiologies were ruled out (malignancy, infection, autoimmune disorders) and improved only after initiation of HLH-directed treatment with etoposide and dexamethasone. He is currently in remission. Patient was initially admitted in 4/2021 for fevers, night sweats, weight loss, and worsening altered mental status. Patient symptoms reportedly started in ~ 4/2021. Per patient's wife, there is a temporal correlation between the patient receiving the COVID-19 vaccine and his symptoms worsening. He was admitted in 4/2021 for stroke-like symptoms after his 1st dose and was diagnosed with a TIA. He was cleared to receive the 2nd dose of the COVID-19 vaccine (received on 4/25/21), and he reportedly became worse after this dose as well. He underwent an extensive workup over the last 2 months to further evaluate his symptoms. He was found to have mediastinal lymphadenopathy on imaging. He had an excisional biopsy of these LNs which were ultimately reactive in nature (negative for lymphoma). There was no evidence of a lymphoma or a lymphoproliferative disorder. Patient was ultimately readmitted to hospital on 5/17/21 due to worsening symptoms. His labs were notable for anemia/thrombocytopenia. A bone marrow biopsy and aspirate to rule out suspected lymphoma was performed and his labs/bone marrow were consistent with a diagnosis of HLH. He was found to meet 6/8 criteria (splenomegaly, peripheral blood cytopenias, elevated ferritin, hemophagocytosis noted on bone marrow, fevers, and elevated Soluble IL-2). The hope was to do a PET/CT and LP before starting therapy to rule out secondary causes of HLH. However, his clinical status continued to deteriorate before these tests could be performed and so he was ultimately started on Dexamethasone and Etoposide as per HLH protocol. These therapies were started on June 3rd. His mental status significantly improved once the medications were started. A PET/CT and LP on 6/7/21 were finally obtained ; however, both did not show overt evidence of an underlying trigger for HLH. "Prominent mediastinal, hilar, and RP LNs seen on previous imaging were not FDG-avid." It did show a few small, mildly FDG-avid patchy B/L pulmonary opacities which were likely infectious or inflammatory for which a follow-up CT Chest was recommended. The flow from the CSF was grossly unremarkable. CSF PCR and other viral studies were negative. Of note, it is uncertain at this juncture if these tests are negative because they are truly negative, or if they are possibly falsely negative since patient was started on treatment before they were obtained. Currently, patient's mental status has significantly improved with Dexamethasone and Etoposide. Per the HLH protocol (which is a scheduled over 8 weeks), patient was started on Dexamethasone 10mg/m2 (equates to 20mg daily) and Etoposide 150mg/m2 biweekly for the 1st 2 weeks. Pt received his 2 weeks of biweekly Etoposide while inpatient (6/3, 6/9, 6/11, and 6/15). The remaining Etoposide doses are to be given weekly and his next dose would be ideally due on 6/22/21 (today). He also completed his 14-day course of Dexamethasone 10mg/m2 on day of discharge (6/16/21). Pt was advised to reduce his Dexamethasone to 5mg/m2 (or 10mg daily) on 6/17. Of note, ID was contacted on day of discharge who recommends that patient be placed on PCP PPx while on HLH therapy. He was recommended to start Mepron on 6/17/21.

Extreme onset of arthritis in both hands, numb fingers in both hands with pins/needles with high degree of pain occurring one week after 2nd injection.

Extreme joint pain lasting; Chest painful with every breath; Could not sleep even; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included lung cancer and diabetes. The patient did not have allergies to medications, food, or other products. Concomitant medications included chemoradiation, metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 15:00, the patient experienced extreme joint pain which lasted for 15 hours. The patient also experienced chest pain with every breath and was not able to sleep with Tylenol PM, had to sit up in the chair for five hours, could not stand pain lying down and hence took 3 more Tylenol regular strength 4 hours after first dose. The chest pain then moved to neck area lasted rest of the day with Tylenol helped. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of joint pain, chest pain, sleep difficult and included treatment with TYLENOL. The clinical outcomes of the events joint pain, sleep difficult and chest pain was resolved in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a night, but took 2 and it did not. Told to take Benadryl by cardiologist, which helped sleep. Extreme stomach cramps, nausea, joint pain, sprained ankle flared up again, fatigue. Went to work, but had to leave early because of symptoms.

Severe thrombocytopenia; bone marrow showed hemophagocytosis/Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out); Delirium; Worse after 2nd COVID-19 vaccine; fevers; Lymphadenopathy; Transaminitis; Splenomegaly; Anemia; This is a spontaneous report from a contactable physician. A 60-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8735, expiration date unspecified), via intramuscular route on 25Apr2021 (at the age of 60-year-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient reported she was healthy before vaccination. Medical history included depression and gastroesophageal reflux disease from an unknown date. Concomitant medications (received within 2 weeks of vaccination) included sertraline, lansoprazole (PREVACID), both concomitant medications taken for an unspecified indication, from an unknown start date. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EP7533, expiration date unspecified), intramuscularly on 03Apr2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 60-year-old) and experienced altered mental status. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19 (on 17May2021, Test: COVID-19 PCR, Nasal swab) which was negative. Clinical course of the events was reported as: Previously healthy 60-year-old male, presented to hospital with altered mental status 6 days after the first COVID-19 vaccine, on 09Apr2021. Had a negative neurological work up but continued to decline, worse after 2nd COVID-19 vaccine (fevers, lymphadenopathy, transaminitis, splenomegaly, anemia, severe thrombocytopenia, delirium). Suspected to have lymphoma ruled out but ruled out; bone marrow showed hemophagocytosis, and labs showed high soluble IL-2 receptor (33,903). Met criteria for hemophagocytic lymphohystiocytosis (HLH); other causes triggers of HLH (infection, cancer, autoimmune disorder ruled out). Positron emission tomogram (PET) scan negative for malignancy. Patient improved only after starting Etoposide and dexamethasone, now (as reported) in remission. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 68 days for the events. The events assessed as serious (life threatening and caused/prolonged hospitalization). Outcome of the events at the time of report was resolving.; Sender's Comments: Limited information precludes a comprehensive causality assessment ,however causal of BNT162B2 vaccine cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Constant headache since the nite after the vaccine. Some headaches are really bad, almost migrane level occurring on right side of temple. After a month, headaches are not as bad, still persistent. Dizziness to the point that i have gotten nausea 5 out of 5 times being a passenger in a car, 2 of those times vomiting. Driving a car is fine with no dizziness or car sickness. 2 intense bouts of vertigo, starting 1 week after the vaccine Could hardly walk, bumping into things, like i got off a spinning carnival ride drunk. I took zanax and went to bed, and woke up fine. Overheating, hot flashes, and fatigue also come and go.

Left wrist began to hurt and swell around mid April 2021. I went to Medical Office Building where it was discovered through ultra sound I had blood clots in my left wrist. I was immediately sent to the Advanced Care where I was told that I would not be able to go home and to call a family member because I had to remain for treatment which was an intravenous treatment then had to start immediate injections and medication. My wrist is in constant pain and I am unable to work due to the adverse reaction to the COVID 19 vaccine. Follow up appointment with Oncology 5/19/21, Follow up appointment with Primary Care Physician 6/17/21, US DVT Bilateral with Ultrasound-7/19/21

initial reactions for 5 days: sore arm, tiredness, fuzzy brain, fever, gastric distress. All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days. The real adverse reaction I've experienced and has actually been getting worse is a racing heart. It may have actually started in May but I simply thought I had gotten out shape. I really noticed it going uphill. But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land. I have to stop and rest when I haven't really exerted myself. There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.

I felt light headed, sore arm, head ache and fever at first and that evening. Then woke up the next morning I felt fine but had swelling to the face more swelling to the left side then the right with a heavy feeling to my left side of my face along with pain to the eye. I feel very lethargic and very tired I could not go to work. I feel to bad to work.

Awakened 0300 the next day, Saturday the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea! I felt bad most of Monday. Tuesday today, i feel fine!

left side will blur; Left side of face was sagging/ water leaking out of mouth/Progressive weakness on left side of face/ Swelling on lower left mandible/ diagnosed with Bell's Palsy.; Eye tearing; This is a spontaneous report from a contactable nurse who reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EK5780) in left arm on 26Dec2020 at 08:30 at single dose for covid-19 immunisation (worked in surgical ICU and was over 61 years old). Medical history included Pre-diabetic. Family history included: mother died; mother's side had colon cancer and grandparents and uncles had cardiovascular diseases.Concomitant medication included exenatide (BYDUREON), amlodipine besilate (NORVASC), omeprazole (PROTONIX), hydrochlorothiazide, lisinopril and pneumococcal vaccine on 08Dec2020 and tetanus vaccine on 08Dec2020. It was reported that on 31Dec2020 at 07:30, the patient had eye tearing and water leaking out of mouth, left side of face was sagging, swelling on lower left mandible (eye tearing was first, as reported); on 31Dec2020 he also experienced progressive weakness on left side of face; on 02Jan2021 the patient was diagnosed with Bell's Palsy. Then on an unknown date, left side will blur occurred. All events required emergency room visit and physician office visit. Diagnosis of Bell's Palsy and event eye tearing were serious per disability; left side will blur was non serious. Patient described the events as follows: on 31Dec2020 he was brushing teeth and noticed the water was going everywhere. Left side of face was sagging, noticed some swelling and thought it was from a bug bite. He wasn't sure if it was a stroke or not. In the morning of 01Jan2021 noticed it was progressively causing a problem. Days before noticed tearing of left eye (as reported). On 31Dec2020 before midnight, something felt wrong. He saw four cases on clinical trial with similar side effects (he clarified he had no patient information for the four patients mentioned with similar side effects from Pfizer Clinical trial. He saw this information from a article; stated four from Pfizer and Moderna). In the morning of 02Jan202, he went to Emergency Room (ER) and was diagnosed with Bells Palsy. He was given prednisone 20mg to take 3 times by mouth every day for 5 days, tetracycline 100mg, at 1 capsule by mouth twice a day for 10 days and methylprednisolone (SOLU MEDROL; Lot: 9945776;Exp: Nov2021) 4mg dose pack, started with 6 tablets first day. It was told by doctor it might cause tick problems. He was waiting for results. On 04Jan2021 went to family doctor and more blood work was taken. Because he was taking prednisone, noticed his sugar was up a little bit (date unspecified). It was prescribed Glitizide extended release, 2.5mg one tablet twice a day with breakfast. Patient was checking sugar every 6 hours. It was also prescribed Acyclovir 400mg one tablet orally five times per day for 10 days. 08Jan2021 is last day of prednisone 5 day dose and will follow up with methylprednisolone tablets. Patient had an appointment with a neurologist on 13Jan2021. Patient was still having symptoms. It was really hard for him. Not hard to swallow. Face was still drooping. Eyes were still tearing. Could not work with eyes tearing all of the time. Needed to be alert. When driving, had to focus on the right side because his left side will blur. He had to chew only on the right side because food will be left behind in between his cheeks and gums. If he drank through a straw, he had to cover the left side of his lips so he was able to suck out fluids. He thought symptoms were progressively getting worse, he didn't see much improvement. He clarified swelling was on lower part of mandible on left side. It was slightly bigger than right. When looking at face, the lines on his forehead on the left side were down. If he smiled he cannot raise his left eye brow, when before the COVID-19 vaccine he could. Noticed left side of nose was lower than the right. Cannot raise left side of lips. Outcome of the event Eyes tearing and Bell's Palsy was not recovered; outcome of the other event was unknown. Information on the 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 Bell's palsy, Lacrimation increased and vision blurred due to temporal relationship. However, the Bell's palsy may likely possibly represent concurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and viral serologies, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I'm feeling like I have motion sickness.; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received bnt162b2, lot El0143, via an unspecified route of administration in the right arm on 06Jan2021 14:00 at single dose for covid-19 immunisation. The patient's medical has no relevant medical history. Patient has allergies to medications, food, or other products. The patient's concomitant medications were not reported. On an 07Jan2021 05:00, the patient felt like he has a motion sickness. The outcome of the event was recovering. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.

All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting. Resident had fall 0130 on 1-15-2021, which resulted in laceration with surgical repair. Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583. Resident deceased upon re-check after calling PCP to report status change.

Got the injection around 8:15 AM, by around 2:00 PM started to feel mildly achy and tired. Around 6:00 PM arm was sore, I was tired, not feeling well. Went to bed, started to get chills, nausea, and vomited around 9:30 PM. Did not sleep well. The next day I had a headache, felt tired and wiped out. Started to feel better around 2:00 PM . Lost day of work was able to return to work on 1/21/2021. My arm still ached for several days. It felt like someone had hit me in the shoulder with their fist

Employee described malaise and body aches the day after receipt of the vaccination (1/13/21). The symptoms were bothersome enough to keep the the employee out of work for one day.

I have been have contact with my primary care doctor because of the reaction with the first dose. He advised me to take Benadryl 15 minutes before receiving the injection. I stayed at the vaccination site for an hour instead of 15 minutes. I left the vaccination site and went home and went to sleep, I worked over night. I did not sleep well that day. I got up around 6pm and I went to work at 10pm and I was extremely anxious and tired all night. I was a little confused while at work. I got off work and went to my chiropractor who noticed and my wife also noticed that I was extremely pale, after the appointment I went home and went back to bed. When I woke up I was still exhausted that I ended up calling out out of work that night. I went back to bed and slept all night till 9am this morning. The next morning my color was back and I was looking better. My energy level is slowing improving but still feel tired even when I got a good nights of sleep. I don't know if it related, but I went and brought some new shoes and then my hip started hurting. It is to the point where I set up a doctor's appointment on Monday to have my hip looked at. See VAERS report 906796 for first dose reaction.

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

1/31/21 0730 am confused and low grade temp 99.5, 12 noon Temp 100.6 and sitting in recliner non responsive twitching. Sent to Hospital with EMS to rule out stroke. Admitted 1/31/21.

hives; anxious; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right leg on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home/senior living facility. Medical history included COVID prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced hives and was anxious, the patient was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events hives and anxious was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the urticaria and anxiety. 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.

31 Jan 2021-Sunday-Very weak, diarrhea, migraines,-no diagnosis-pt states nights sweats 1Feb 2021-Monday-Same as above 2 Feb-Tuesday-feeling a little better 3 Feb-WED-more fatigued 4th Feb-TH-home from work-later that day 5th Feb-Fri-no work-at home 6th FEB-Sat-feeling up & up-has a migraine-takes aleve 7th Feb-Sun-still diarrhea-stayed in bed 8th Feb-Monday-**diarrhea-taking Immodium AD

Pt reports he started shaking all over on 2/6/21 and it gradually improved over the next week. He continues to experience problems with short term memory and recall. Headaches, myalgias/arthralgias. Positive for mild nausea, constipation. Dizziness with turning his head started on 2/6/21 but has now resolved.

1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.

he was not comfortable; allergic reaction; dizziness; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime; almost passed out; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9621), intramuscular on the left arm on 22Jan2021 (reported as 07:45 to 08:00) at a SINGLE DOSE for prevent COVID, at 61 years old. Medical history included triple bypass surgery from an unknown date. There were no concomitant medications. The patient previously took morphine and experienced the same thing with his brain, almost identical to what he was experiencing after the COVID vaccine. He reported that the first time he received morphine it was fine and then he got a shot of morphine and he experienced the pressure on his brain after receiving morphine, about 5 or 6 years before reporting time. He stated it was almost the same reaction. He was given a shot of Demerol (he was not sure if it was Demerol) to counteract it. History of all previous immunization reported as none. No additional vaccines administered on the same date. No prior vaccinations within 4 weeks. The patient reported he experienced an "allergic reaction"/ bad reaction to his first dose of BNT162B2 on 22Jan2021. His symptoms included dizziness as soon as he got the vaccine, got dizzy right off the bat, still dizzy, very little; feeling a lot of pressure in his head like his "brain wanted to pop out of his head"/ his brain wanted to swell up; felt like he was going to lose his mind / go crazy; fever; headache is recurring- worse at bedtime. Symptoms (unspecified which) reported as recurring and are notably worse at bedtime. Patient is hesitant to receive the second dose. The patient stated he just went to sleep and prayed and then when he woke the next day, at night it did it again. At night it comes and goes, and he still has it happen but not like the first time. He tried to describe that he was washing his hands and he almost passed out like on an unspecified date in Jan2021, he was going to lose his mind. Last night he went to bed no problem, he felt a little pressure on his brain, stated it is hard to describe, it was not a good feeling. He was running a fever. Last night he had a slight fever, like it was going away. He was not able to drive when this was happening and today was the first day he could drive and he was not comfortable (27Jan2021). The patient declined any treatment. He already talked to his doctor and was told to call Pfizer. He asked if he was to get the second shot, is there something he could to take to make that feeling go away or counteract it. No relevant tests were reported. Events did not require a visit to the emergency room nor physician office. The outcome of the events, allergic reaction, headache is recurring- worse at bedtime, almost passed out and he was not comfortable was unknown. Outcome of the events dizziness, "feeling a lot of pressure in his head like his brain wanted to pop out of his head/ his brain wanted to swell up", felt like he was going to lose his mind / go crazy, and fever was reported as recovering.

THE SAME DAY OF MY SECOND VACCINE AND ONE DAY LATER I EXPERIENCED A KIND OF JUMPS ON MY LEFT CHEK, MY NOSE FLOW MORE THAN NORMAL AND A LITTLE BLOOD CAME OUT OF MY NOSE

Warm red skin of face arms hands feet. Swelling in feet and hands. Trouble sleeping, anxiety, shaky. Prickly feeling throughout body.

Headache, sore arm at injection, leg cramps - evening of injection >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<

patient was given 1st injection and about 5 minutes afterward @ 1205 he started to fell like a warm flushing feeling, and feeling a little fuzzy in the head, heart rate 64bpm, patient blood pressure on the monitor did not appear to be accurate indicating 180/118 and this was also tried on the right wrist. Patient did not have any complaints with the elevated with this blood pressure, patient was conversing and without headache, patient denied any itching or signs of anaphylaxis. patient was monitored for a total of 55 minutes before being released. Patient was instructed to call 911 with signs of anaphylactic reaction and to call his provider with any other symtpoms that he was concerned with.

Had chills, head ache, body aches threw up for three(3) days could not keep anything down took promethazine did not help. Still felt bad a few days after vomiting stopped.

Within 15 minutes of my 2nd covid shot I developed extreme lightheadedness, shortness of breath, disorientation, dehydration and consequently extreme anxiety from the incident. I was taken to an examination room at the vaccination clinic by their nurse director. Blood pressure was high and there was a question if I was having a stroke or heart incident. the director sent me by ambulance to Hospital as they didn't know if I was having an anaphylactic shock or cardiac incident. All this occurred within an hour if the first symptoms.

Fever (up to 101.6), body aches, nausea and headache peaking between 12-18 hours after dose, mostly resolved by 30 hours. Nausea, and headache persisted until about 30 hours (took Tylenol Extra Strength at 24 hours). Pain at injection site, could not sleep on that side. Gradually developed and peaked 12-18 hours after dosing. Still slightly sore at 30 hours.

migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better 8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive

UNKNOWN VACCINATION LOCATION. ADMITTED TO CENTER THE DAY AFTER HIS 2ND SHOT FOR CONFUSION, MENTAL STATUS CHANGES, SYNCOPE VS SEIZURE ACTIVITY, LOSS OF CONSCIOUSNESS. NEURO CONSULTED AND THOUGHT POSSIBLE ADVERSE REACTION TO COVID VACCINE #2 AS NO OTHER REASON HAS BEEN FOUND WITH LABS, IMAGING, ETC. NEURO CALLING IT A 2 HOUR FUGUE EVENT.

On going flu symptoms since the 2nd vaccination. It is going on 8 days and I still have flu symptoms. I feel weak, sometimes low level headache, mostly feel weak and tired. Don't feel like I have a temp. On scale of 1-10, I would say it's around 2-3. It does affect my work ability. Not overly hungry(which can be good).

he is not getting any sleep; he had a rash and hives all over his body; itching; he had a rash and hives all over his body; sore arm; This is a spontaneous report from a contactable consumer reported for self. This 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 in the morning on Arm right at single dose (Lot # EN6205) for COVID Prevention. Medical history included ongoing leukemia CML from 2013, ongoing chronic lymphocytic leukemia from 2013, prostate cancer, white blood cell count runs high anyway, PSA (prostate specific antigen) last time he had blood work done, was 5.1. Concomitant therapy was none. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 26Feb2021 in the morning, in the evening (26Feb2021), he had a rash and hives all over his body, he also experienced sore arm. He states that he had itching sooner. He also has leukemia CML, his oncologist told him to receive the vaccine. He would like to know if he should receive the second dose of the vaccine, and get ready for rashes. He broke out in hives and it was really uncomfortable, and he was not getting any sleep. He states that the hives got so bad, it looks like he has alligator skin. He states that he took Benadryl (UPC: 81131 07825, Lot number: P113775, Expiry: Oct2020, he has been using the product since the expiry date) and used Cortisone, and it helped but did not work 100%, but it helped enough he got some sleep. He stated that he felt like it is getting better, but he was taking Benadryl, and when the Benadryl wears off, it starts doing it again, but it was bad at first, like alligator skin, so he does feel like it is improving some. Outcome of the event hives was recovering. Outcome of other events was unknown.

Tachyacarida/anxiety Pulse Ox: 95 @ 4:23pm Pulse/Heart Rate: 95 @ 4:23, 73 @ 4:26pm Transfered to EMS @ 4:29pm for evaluation, evaluated in back of ambulance, left in personal vehicle

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.

Moderate to severe headache, chills, weakness, and sleeplessness through the night with headache lingering through the next day.

Note: I AM reporting this because I strongly believe that patient's death was caused by his second COvid-19 vaccine. The exact date of the vaccine is unknown. His girlfriend told me he got his second Vaccine at the end of February. I also don't know what vaccine (Moderna or Pfizer) he got, so the Pfizer is just a guess. Patient started feeling bad and looking bad after his second vaccine. He complained that he wasn't feeling well and missed appointments saying he wasn't feeling well during the two weeks or so between the time of his second vaccine and his death.

Experienced temporary short term memory loss after both the first and second doses of the Pfizer COVID-19 vaccine. Symptoms are worse in the days following the vaccine.

Severe chills (unable to hold a glass of liquid). Fever of 101.5. Inability to sleep until 5 am. Tiredness all day the second day.

Pt given Pfizer vaccine at 0810. Shortly after, pt c/o "vaccine pumping through my chest and indigestion." ; No c/o SOB, chest pain, or dizziness.Vitals: 830 89/60 100% O2 HR 81832 97/66 830 89/60 100% O2 HR 81832 97/66; 850 100/68 (manual) HR 81 O2 100%Dr called to bedside for assessment; 900 112/78 100% O2 HR 77910 110/78 100% O2 HR 76; BP stabilized, no c/o SOB, dizziness, chest pain.Dr. updated on patient status and cleared

Approximately 12 hours after the injection I started to get chills headache dizziness and was not able to sleep, it is the next day now and I?m still feeling pretty bad and body aches all over

tinnitus - started at 2nd shot and is still continuing. It is significant enough to get medical treatment and is very annoying. Over Easter I was with family, the TV was on and people were talking. I had significant trouble understanding people talking to me. I had significant joint pain of the left hand, knee's, and ankles which has decreased. I had headaches which have decreased but still continue

Started with a severe runny nose. Runny nose and sneezing lasted approx 48hrs. When nose stopped running breathing got more laborious and a cough persisted. Slight fever and muscle aches for two more days. Trouble sleeping and cough started to produce mucus. It has been over 1 week since symptoms started and I am still experiencing coughing and mucus, as well as a loss of appetite. This was what I have experienced before when I have had a severe cold.

A few weeks after my first shot I've developed ringing in my ears. it gets worse at night trying to sleep.

Immediately have ringing in ears. Bouts of confusion if too many people are talking in a room voices become muffled. I have lost my concentration. I'm a programmer I'm praying I get it back or I will loose my job... Also erratic mood swings. I received the second shot 4/9/2021 and still have these simptoms.

4/7/2021 @ noontime: Began to have cold shakes. Approximately 15 minutes later, began to experience slight headache and some fatigue. Within an hour, extreme shaking, fatigue and worse headache ever experienced in my life. Went to bed, covered up and tried to rest, but headache was too severe. About 6:00pm, took ibuprofen and headache began to subside, but too weak to walk without holding onto support items. Nausea left me unable to eat and drinking water was unpleasant. Fell asleep about 10pm and woke at midnight with cold shakes and did not get back to sleep. Went to work next morning and just felt somewhat fatigue and had no appetite.

About two weeks after the 1st shot I noticed my facial skin was very itchy. This was a constant thing. Two days after I had the shot shot my face swoll up and was very itchy. I was waking up in the middle of the night several times a night because of the itches and I was going my best no to scratch. i rubbed moisturizer in to my face and later started using some over the counter itching creams that would work for a few hours. I began to realize the itching was worse in places where I had five years ago had Bellafill infected into acne scars and deep wrinkles by a licensed cosmetic surgeon. I like the results and have no issue with the doctor or filler, but this stuff itched terribly. I see on the internet some complaints from others, but I wanted to report that I too have this. As of today, weeks later, it is not as bad, but as I write this I want to itch a place above my right cheek bone that was injected with Bellafill. I thought it was a problem with the Bellafill, I am convinced now it is a side effect of the vaccine. Guess this means it is working to adopt to odd things in my body.

Fever and tiredness Can take ibuprofen/motrin/tylenol for fever, use cool compress/wet rag on forehead to help 4/9-Spoke with wife. Patient slept all day yesterday and then woke up this morning feeling fine and went to work. Did not really take anything other than 1 expired ibuprofen.

He received his vaccine, he did have a sore arm but nothing else. When he woke up today at 4/14/21 with an upset stomach, has been nauseated, feeling run down. He has thrown up 3 times. His bones are aching and light headed. He has not taken anything for the reaction, just trying to stay hydrated, very little appetite. Does have an appointment to see his doctor today at 4:20 PM.

Lightheadedness, felt like he was going to black out, he did not faint. He was evaluated by a MD and due to the distance of his drive home was advised to go to ER via ambulance. Seen in ER- no chest pain, nausea, or vomiting. He did have some diaphoresis. Has a history of vasovagal syncope associated with needles. Seen and released without further interventions.

After receiving my shot around 4:00 pm on April 13, 2021, I was restless and did not sleep well that night. When I woke up on April 14, I was tired but otherwise felt fine except my arm was a bit sore. However, after working at home for a couple of hours, shortly before 10:00 am I began to feel nauseous. I rushed to the bathroom thinking I was going to throw up, and almost immediately fainted. My wife and sons found me on the floor and woke me up. I threw up shortly after and felt pretty lousy the rest of the day with low grade fever, chills, body aches, fatigue, and a headache. I began to feel better at night and had a good night of sleep. Today (April 15), I feel fine except I'm a little tired.

I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next morning, my Parkinson's symptoms, overall weakness, "frozen foot" and (left) foot-turned-in-bent-at-ankle, resulting in my needing assistance to walk, get up out of chairs, use the bathroom, worse than I had experienced prior. Normally I have much relief with Rytary, Carbidopa-Levodopa, and deep brain stimulator, but nothing helped. I'm now at 65-70% of where I had been. While I can't say with certainty that my medication failure resulted from the vaccine, I have no other explanation. I would rather risk whatever one vaccine has done for me against COVID, than go through this again, or worse!

muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog; This is a spontaneous report from a contactable consumer reported for himself that a 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733, expiry date: Jul2021) at the age of 61-years, via an unspecified route of administration in right arm on 29Mar2021 11:30 at single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced 7days brain fog, muscle cramp, tightness in chest, shoulders cold sweat with no fever and body weakness. These events started since unknown date (reported as 28Mar2021, pending clarification). No treatment received for the adverse events. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Blistering, wet rashes on legs; Rash and blisters affecting feet; muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine; Fever; Feeling unwell/Wasn't feeling good; Lost a lot of weight; Had to overuse inhaler; joint problems; Couldn't think; Affecting mental health; Blistering, wet rashes on legs; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old-male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 09Mar2021 (received at 61-year-old) as single dose for COVID-19 immunization. Medical history included arthritis, overactive immune system, unspecified mental health issues, and ongoing muscle pain. Concomitant medications were unspecified; the patient stated that he is on 4 vials of different medicine, or maybe 5. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on an unspecified date for COVID-19 immunization. The patient reported that he had the Covid-19 vaccine. He reported that he was given a handout sheet that he read after he had the second dose of the Covid-19 vaccine. It was highlighted in yellow that he shouldn't have taken the Covid-19 vaccine with an overactive immune system. He further reported that the second dose of the Covid-19 vaccine is affecting his mental health. His mental health started being affected about 7-8 days after receiving the second dose of the Covid-19 vaccine. He stated that he is getting blistering, wet rashes on his legs again. He would like to see what he can do about this, but he will have to do it by mail. He reported that he has to get pictures taken of himself. He has an appointment tomorrow where he got the Covid-19 vaccine. He stated that he also has to go back to the dermatologist that is taking care of his immune system. He reported that he has lost a lot of weight. He reported that his weight is 147 pounds or maybe 141 pounds. He has lost a lot of weight since receiving the Covid-19 vaccine. He was given an emergency authorization release after he got the second dose of the Covid-19 vaccine. He noticed that he wasn't feeling good right away after getting the Covid-19 vaccine. When his legs started getting a rash and then blisters, his medical provider took pictures. The rash and blisters are affecting his feet too. The rash on his legs appears about 7-8 days after the second dose of the Covid-19 vaccine on 09Mar2021. He reported that what is on his legs started as rash and then turned into blisters. The blisters popped and it's like poison comes out. The fluid from the blisters smells, and that the fluid is ruining his clothes and is going to ruin shoes. The rash got worse the other day, with blisters forming. The blisters have now popped and there's going to be scars. The patient reported that he now has open wounds on his legs that bleed from the popped blisters. He also reported that it felt like all of his arthritis and muscles were affected. He took something for muscle spasms and arthritis, a muscle relaxant, for his back. Everything hit about the same time, 7-8 days after receiving the Covid-19 vaccine on 09Mar2021. The muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine. The patient also experienced joint problems, fever, feeling unwell on an unspecified date, had to overuse inhaler, couldn't think on an unspecified date. Outcome of affecting his mental health was recovering. Outcome of blistering, wet rashes on legs, muscle pain has been going on for a while, but it got worse after the Covid-19 vaccine was not recovered. Outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Flushing, minor breathing issue, anxiousness occurring about 8 minutes after getting the vacciine. Patient admitted to anxiety discorder. Nurse and EMT assessed patient and obtained vitals. Patient got out and walked and stated that he felt better.

Ringing, buzzing, chirping , humming in both ears general practitioner prescribed allergy medicine, still have this side effect Dizziness - no treatment Ear ache , ears burning - no treatment Flushed feeling in head - no treatment Anxiety and stress - went to ER with chest pains, found nothing wrong with heart

Diarrhea, chills, tiredness, fatigue, anxiety, insomnia, aching joints, aching muscles, headache, dizziness.

sweating; felt cold/intense cold even in his bones; He was told by the professional health care that he had small clots in his blood; death cause: Medication; arm started to sore; Doctor identified he had DVT; her husband during that night was not able to sleep; He started having fever; This is a spontaneous report from a contactable consumer (patient's spouse). A 61-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 21Mar2021 09:00 (Batch/Lot number was not reported) as single dose f(at the age of 61-year-old) or COVID-19 immunisation. Medical history included dialysis, diabetes mellitus, known allergies: A7, Penicillin, Aspirin, Iodine, Povidone, Pepcid, dyes, iodine allergy. The patient's concomitant medications were not reported. The patient previously took Aspirin, povidone and pepcid ac and experienced drug hypersensitivity with all. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced death cause: medication on 18Apr2021, he was told by the professional health care that he had small clots in his blood in Mar2021, felt cold/intense cold even in his bones on 21Mar2021, sweating on 26Mar2021, her husband during that night was not able to sleep on 21Mar2021, he started having fever on 21Mar2021, arm started to sore and DVT on 29Mar2021. The patient was hospitalized for he had small clots in his blood, felt cold/intense cold even in his bones, sweating for 27 days. The event DVT was medically significant. The course of events was as follows: After getting the vaccine in 21Mar2021 her husband during that night was not able to sleep. He started having fever and felt cold. Days later he continued with the symptoms. On 26Mar2021 after vaccination he had dialysis same day in the afternoon. When arriving home the person notifies symptoms of intense cold even in his bones and then he started to sweat excessively on 26Mar2021 (Friday). The reporter decided to take her husband to the emergency room on 28Mar2021 (Sunday) where he had a general checkup. He was told by the professional health care that he had small clots in his blood. After some time he had health complications where they had suggested to amputate some of the limbs because of this, the reporter alleges those complications were due to the vaccine. On Monday 29Mar2021 same symptoms reappeared and he was admitted to Hospital. Had a blood test and notified to health professional that blood presents small clots. His arm started to sore severely after the sample. Doctor identified he had DVT. Doctor decided to proceed with various medications. Patient received treatment and he was injected: Percose, Morphine, Benadryl, Triphetarin for blood clot reduction. The patient underwent lab tests and procedures which included blood test: blood clot in Mar2021, Sars-cov-2 Nasal swab test: negative in Mar2021 post vaccination. The patient died on 18Apr2021. It was not reported if an autopsy was performed. The outcome of death cause: medication was fatal, of the other events was unknown. Information about the lot/batch number has been requested.; Reported Cause(s) of Death: death cause: Medication

Brain fog; Cognitive issues; Fevers; Stated that he had a positive test to Covid; This is a spontaneous report from contactable consumer. A 61-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 on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated that her husband's friend received his first dose of the Pfizer Covid19 vaccine on 25Mar2021 and was exposed to Covid-19 prior to getting the vaccine. Stated that he had a positive test to Covid on 02Apr2021 and he has been having significant Covid related brain fog, like cognitive issues and fevers. He rescheduled his second dose due to the infection and wanted to know if he should wait to take the second dose until he has no symptoms of the disease. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Five days after vaccination, started experience bloating with pain related to pressure. Bloating is very uncommon for me. While there has been somewhat of a decrease in symptoms, I have now been experiencing symptoms for 12 days at a level sufficient to interfere with sleep patterns.

4/21: BPPV & treatment: onset of dizziness symptoms 6 PM 4/19/21, followed by extreme dizziness the next morning 4/20 & and visit to Genesis ready med to check out the dizziness, then doctors office. Meclazine by doctor Diagnosis: for vestibular BPPV. PT issued by doctor. 4/22: PT treatments began but, unable to return to work on Thursday excessive symptoms, doctor provided orders to be off work till Monday the 26th. 4/29: discharge from PT. 53/21: symptoms returned to level of 4 to 7 will contact doctor Monday. Continued Epley maneuver and barbecue roll maneuver with some benefit. 5/4/21: orders for MRI Of the head and follow up visit with doctor two days later to review and determine if more PT is warranted. More; continue epley and bbq roll at home, post PT exercises, continue meclizine. Return to work orders with climbing restrictions

sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19 immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19. Information on the lot/batch number has been requested.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: patient's husband says pt was admitted to hospital with burning in chest, heart, throat swelling, anxiety and trouble breathing.

having heart attack feelings; tightness and pain on the chest; tightness and pain on the chest; nausea; lightheadedness; fatigue; dizziness; shortness of breath; cold sweats; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 09:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was diagnosed with COVID-19. Relevant medical history included type 2 diabetes and high blood pressure. The patient had allergy to some nuts. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 09:00, 24 hours after his first Pfizer shot, the patient thought that he was having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats. These events were resulted in a visit to the Emergency Room. The Hospital Emergency Room diagnosis was "anti-viral reaction to vaccine" for the adverse event. The patient received with IV treatment. As of 24Apr2021, the clinical outcomes of the events "having heart attack feelings where he had symptoms of tightness and pain on the chest, nausea, strong gaging, lightheadedness, fatigue, dizziness, shortness of breath and cold sweats" were resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

On April 27 felt tingle / pulse shoot down left arm, on April 28 felt tingle / pulse shoot down right arm, on May 1 fely tingle in legs knee down to toes and also arms , from that point I have have pins and needles, burn, tingle numb pulsing off and on in arms to fingers, knees to toes and also in face numbness , have seen muscles soften and skin sag and lost autonomic nerve sensation in privates area and have not had bowel movements for over a week and a half other than wit hlaxative until last 3 days have had very small bowel movements , also eyes had been for years but vision has gotten worse , additionally anxiety i high and not sleeping well as worry and concern increases .

Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration 05/23/2021). RN noticed Client turn red and become flushed to the skin. RN provided supplemental nutrition and fluids. Client accepted. At 1740 RN and PHN responded to this event. At 1741, vital signs are blood pressure 150/90, heart rate 100, oxygen saturation 96%. Client reports anxiety, no dizziness, no headache, no blurred vision, no chest pain. Client reports history of hypertension, takes blood pressure medication every morning (today's morning dose was administered via self at home), takes over the counter aspirin as needed, and no known allergies. At 1745, vital signs are blood pressure 144/88, heart rate 101, oxygen saturation 95%. Client reports no complaints with the 1st dose. Per Client had a very stressful day. The flush reaction of the face happened within 2 minutes of administration. RN educated Client in regards to ED precautions and common adverse effects of COVID vaccine. At 1750, vital signs are blood pressure 140/88, heart rate 90, oxygen saturation 98. Client reports symptoms have resolved and skin tone returned to appropriate coloration to ethnicity. At 1800, vita signs are blood pressure 130/88, heart rate 92, oxygen saturation 97%. At 1801, Client stood up with no complaints. At 1802, Client walked out of facility with a steady gait.

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

Bad cold; Coughing, from a dry cough at first to a very wet cough; Coughing, from a dry cough at first to a very wet cough; Very large thick solid segments of gelled mucous coming out of my sinuses; could not think as tightly as usual on 19Apr2021; Sinuses became burning; Bad headaches; Unusally tired; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 17:00 (Lot Number: Lot EW0151) as 2nd dose, single for covid-19 immunisation. Medical history included Mild seizure disorder and Hay fever. No known allergies. Concomitant medications received within 2 weeks of vaccination included carbamazepine; oxcarbazepine; diphenhydramine hydrochloride (BENADRYL). The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 in arm left on 20Mar2021 05:00 PM (Lot number: ER8727). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. The patient felt fine following the 2nd shot, for 48 hours on 18Apr2021, but unusually tired so he knew it must had been the shot. The next day on 19Apr2021 his sinuses became burning and he assumed it was hay fever because he had experienced some symptoms of that for the previous two weeks. But the next day on 20Apr2021, Tuesday, it was worst, like a bad cold (which all of this "reaction" may had been), but then the next 3 days he could barely get out of bed and that's unusual because he run every day and nothing stops him, including a cold. he had bad headaches on 19Apr2021 for 5 days or so and symptoms included coughing, from a dry cough at first that Wednesday to a very wet cough and very large thick solid segments of gelled mucous coming out of his sinuses, something he had never seen before. After almost two weeks he felt better but was still coughing, and now three weeks later he was still really tired, could not think as tightly as usual on 19Apr2021. His doctor's office told him not to come in, just to take pain reliever and cough syrup, which he was doing anyway. Test was neg. The adverse event result in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient underwent lab tests included covid test (Nasal Swab): negative on 24Apr2021. The outcome of events could not think as tightly as usual on 19Apr2021, sinuses became burning, bad cold, bad headaches and very large thick solid segments of gelled mucous coming out of my sinuses was recovered and other events was not recovered. No follow-up attempts are needed. No further information is expected.

blood pressure had dropped a lot/blood pressure dropped a good deal; his heart rate was 30 beats per minute; Not feeling well; Sore arm; felt strange; his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 09Apr2021 (lot number: EW0158), as 1st dose, single, for COVID-19 immunization, at a clinic. Medical history included high cholesterol (controlled with diet); bone spur in left heel (bone spur in his left heel began coming on gradually, probably for 10 or 12 years) which has gotten little worse and made it hard for him to walk in the evening, in long distances, it was like a knife in his heel and he would get that real soreness and pulling after a walk; and allergy to sulfa drugs, more specifically sulfa antibiotics (he was given them 25 years ago and had a reaction). The patient has not had any vaccines or shots for years. He reported that he is very healthy and has not had the flu or anything in 25 years. The patient does not smoke and is careful with what he eats. There were no concomitant medications. On 09Apr2021, within minutes of receiving the first dose of the COVID-19 vaccine, the patient was not feeling well, he felt strange. He wondered if it was his imagination or if something was going on. Then it got worse and worse within 12-15 minutes after the COVID-19 vaccine. The staff member sent paramedics over to him. The paramedics set him up with a blood pressure cuff and heart monitor. Apparently, his blood pressure dropped a lot/dropped a good deal and his heart rate went to 30 beats per minute. His heart rate is normally around 65 beats per minute. The paramedics informed him that if his blood pressure and heart rate didn't come up, he was going to have to go to the hospital. The paramedics instructed him to stand up and it seemed to bring his blood pressure and heart rate back up to normal. The patient reported that everything returned to normal within a 15-20-minute time frame. He was then able to leave the vaccination facility. His health care provider advised him not to take the second dose of the COVID-19 vaccine. His physician informed him that he could possibly go into cardiac arrest. The patient did not have any problems after that other than a sore arm later in the day on 09Apr2021. His arm was sore for a day or two. The patient stated that this was the only effect after the incident in the vaccination facility. The patient also reported that on the weekend after receiving the COVID-19 vaccine, in Apr2021, he can walk long distance and his bone spur in his heel quit bothering him immediately. He reported that if he walks a mile and back, it quit the hurt. He reported that he would get that real soreness or pulling after a walk and that kind of stopped. The patient thought this was really strange. The patient reported that he cancelled the appointment for the second dose and did not get it. He was a little apprehensive about the second dose of as he didn't know if his reaction would be worse. The patient asked if the vaccine is 80% effective after one dose, if Pfizer has heard of that type of reaction from others, if his reaction was rare, and if he should get the second dose of the COVID-19 vaccine. He mentioned that he would like to have a second dose of the Covid-19 vaccine, but he is afraid to get it because he doesn't want to go into cardiac arrest. The patient recovered from "blood pressure had dropped a lot/blood pressure dropped a good deal", "his heart rate was 30 beats per minute", not feeling well and felt strange on 09Apr2021, and from sore arm in Apr2021. The outcome of "his bone spur in his heel quit bothering him immediately/he can walk long distance/he would get that real soreness or pulling after a walk and that kind of stopped" was not recovered. No follow-up attempts are needed. No further information is expected.

After receiving the second shot on April 17, 2021 over a month later he still can not lift his arm up all the way, he has been to our primary Dr, twice complaining about pain two weeks after shot. PCP stated could take a month. It has now been over a month went to PCP again 05/24/2021 and gave him a script of pain. Why is he still having this issues over a month later. Please please explain why he can not sleep at night cause when he moves his arm in his sleep i takes him up all night long. There must be a reason for this to still be causing him this much pain.

I had a stroke on April 30, 2021, 10 days after the second dose of Pfizer on April 20, 2021. The stroke was the result of a blood clot. I've never had blood clots until I subjected my perfectly healthy body to the Covid vaccination. On the morning of April 30, 2021, I was suddenly overcome with a sense of disorientation and dizziness. Spouse drove me to the ER. They discovered I had experienced a stroke. Let me be absolutely clear. The Pfizer vaccine is the sole reason I developed blood clots and had a stroke. I was perfectly healthy until I got vaccinated. I now have brain fog, dizziness, and every day is a challenge. I feel so dumb for falling for the get vaccinated garbage.

I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.

First shot induced week and a half migraine headache. Second shot has caused extreme fatigue and every joint in my body hurts to the point I have experiences a severe reduction in quality of life. So, extreme fatigue and pain. I just can't seem to catch up on sleep and have to think twice about the next move due to the pain it will cause.

(Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration on the left arm on 10Mar2021 at 13:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient was tested for COVID-19, since having the vaccine. On 10Mar2021 at 20:00, the patient had experienced terrible ear ringing in both ears(tinnitus) and was not able to sleep. The patient did not receive treatment for the reported events. The clinical outcome of events tinnitus and sleeplessness were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

shoulder muscle pain that has not resolved I did two weeks of tylenol as prescribed by my doctor to no avail It is difficult to lift my arm out from my side which is paunful and makes it difficult to lift items at my work (farming) there is a knot in the shoulder muscle(s) first dose March 10, 2021 second dose April 8, 2021

Headache; Internal shaking when lie down.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ENG206) in the right arm via an unspecified route on 06Mar2021 at 14:45 as a single dose (at the age of 61-year-old) for COVID-19 immunisation. The patients past drug history included allergy to sulfur. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), crestor (MANUFACTURER UNKNOWN), RAPFLO all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Mar2021, the patient had SARS CoV-2 test via rapid nasal swab and resulted negative. On 11Mar2021 at 07:00 am (5 days after vaccination), the patient had headache started with internal shaking when patient lied down. Therapeutic measures were taken as resulted events and included treatment with muscle relaxer. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events headache and internal shaking was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Fever, delirium, stomach pain. Thrombocytopenia, Encephalitis, viral and bacterial meningitis, Rhabdomyolyses, episode of torsades de pointe, pulmonary pneumonia, pneumonitis. Eventual double lung transplant.

Peripheral Neuropathy symptoms; tinnitus/Ringing/buzzing/chirping/humming in both ears; difficulty concentrating; Extreme sensitivity to sound; Vertigo; Dizziness; Earache; Anxiety; Chest pains; Chest stress; Spasms in chest and back; Began to get blur in right eye; Bowel movements changed; Numbness on face: lips, checks, forehead; Muscles have shrunk throughout body; Joints popping; Neck ache; Throat tight; Face and smile have changed; Hair is thinner; Hair gotten gotten more grey since these issues; Feet burning; numbness and tingling sensation in both legs to feet and both arms to hands and extremities; Back aching; muscle weakness; Brain fog; Fatigue - constantly feel like laying down; Difficulty Sleeping through night/Unable to nap throughout day; feet aching in joints; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0150) via an unspecified route of administration, administered in left arm on 30Mar2021 at 14:45 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included finasteride, ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride. The patient previously took augmentin s. On 03Apr2021 at 18:00, the patient experienced tinnitus/ringing/buzzing/chirping/humming in both ears, difficulty concentrating, extreme sensitivity to sound, vertigo, dizziness, earache, anxiety, chest pains, chest stress, spasms in chest and back, began to get blur in right eye, bowel movements changed, numbness on face: lips, checks, forehead, muscles have shrunk throughout body, joints popping, neck ache, fatigue - constantly feel like laying down, throat tight, face and smile have changed and hair is thinner. The outcome of the events was not resolved.

Severe brain fog and ringing ears 3 full months after my 2nd shot. The symptoms started within hours of getting the 2nd shot and have yet to subside. I've been to my doctor twice, have had blood work and most recently a brain scan. Still awaiting the results of the MRI brain scan. I was prescribed Prednisone for a few weeks and I felt instantly great, which tells my doctor I have some swelling in my brain.

Dehydration; Symptoms of the flu; Soreness; Unable to sleep; Aches in joints; Nausea; Fever; Tiredness; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8732) via an unspecified route of administration in the left arm on an unspecified date in Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events dehydration, aches in joints, nausea, fever, soreness, symptoms of the flu, tiredness and unable to sleep were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

shortness of breath chest pain both would come and go i waited about 3 months before i went to hospital i would wake up in middle of the night hyperventilating got to the point i could not walk up a small hill with out going completely out of breath and forced to stop and try to breath

Short of breath 7/19, called EMS and arrived in ED morning of 7/20. While in ED became agitated hypoxic and apneic. Intubated. Diagnosed with PE and admitted.

I was immediately confused about where I was at, when leaving the vaccination site. I immediately felt flush with red splotches on my face. I came home and took a nap just to sleep it off. I woke up with severe tinnitus, a headache, and brain fog. Both the tinnitus and headaches have only gotten worse. The flush feeling, (suspecting higher blood pressure than usual), comes and goes with more frequency as time goes by. The ?brain fog? has been more like brain damage. At first, I just couldn?t think. My ability to think has slowly improved, but it is no where near the same as my abilities prior to the vaccine. My memory has been impaired, both long term and short term. My hand/eye coordination has been impaired. Prior to the vaccine, I didn?t feel my age. After the vaccine I felt like I aged 25 years in a week. I need to figure out what is going on inside my head, and what can be done about it. The degeneration is a serious concern. Both in the severity of the adverse reactions, and in the permanence of the damage. This will be devastating if I?m entering early stages of dementia, decades before the course of natural causes of aging.

Developed tinnitus in both ears.; Had trouble sleeping the past few weeks but am sleeping better; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 12Mar2021 at 20:00 (at the age of 61-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm right on 02Apr2021 at 17:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesterol and blood pressure high. Concomitant medications included atorvastatin calcium (LIPITOR) 40mg and amlodipine (MANUFACTURER UNKNOWN) 5mg from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. After receiving the first dose on 12March2021, the patient developed tinnitus in both ears late Sunday on 21March2021 into early Monday 22March2021. The patient started to take some over the counter supplements to help. The patient's right ear was normal as of 06April2021 but had slight tinnitus in the left ear. The right tinnitus had resolved several days ago. The patient felt that the left ear was bit better as ringing can dissipate during different times of the day. The patient had trouble sleeping for the past few weeks but was able to sleep better at the time of reporting. The patient was still trying to get the left ear line the right. The patient would clean the ears daily with Q-tips (outer areas) and would always see wax and the weirdest thing was that there was no ear wax. The patient got nothing and no wax at all even if the ears were not cleaned for days which was very, very strange. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of tinnitus, trouble sleeping and included treatment with over-the-counter herbs with ginkgo biloba (MANUFACTURER UNKNOWN) and SYNAPSE XT from 22Mar2021 to unknown date. The clinical outcome of the events tinnitus in ears and difficulty sleeping were recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine; Postnasal drip in throat; Feeling warm then really hot; Feeling weak; Clammy; sweaty; As if he was going to pass out; almost like a vagal reaction if you got a needle or were scared; vagal reaction but delayed; Heart might have been beating fast; Experience is like the dizziness related in the signs of a severe allergic reaction; Experience is like the dizziness related in the signs of a severe allergic reaction; Anxiety; anxious; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left deltoid, on 30Dec2020 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing mild intraocular pressure. The patient's concomitant medication included unspecified eye drops for a mild intraocular pressure. The patient previously took tetanus vaccine and experienced vagal reaction and passed out (in his childhood). The patient's past COVID tests were always negative. On 30Dec2020, the patient received it at a facility where he is a physician on staff, and they started giving it that day. It was administered by a pharmacist who was very clean and professional, and everything was fine. The patient received the COVID-19 vaccine in the left deltoid and felt pinched when the vaccine was administered, and he felt fine. He did not have any immediate reaction. He sat down, then got up and was standing talking to some colleagues, and about 10 to 15 minutes later, they were talking and felt a little postnasal drip in throat. His colleagues said that is what they felt as well. About 10 minutes later, the patient was feeling warm then really hot to the point where he felt the need for cool air. He added feeling weak and clammy as if he was going to pass out. He started to feel weak and warm and almost like a vagal reaction if you got a needle or were scared. It was almost like he felt hot, sweaty, and weak and feeling like he needed to get to a cool place and sit down. The patient's heart might have been beating fast, but he did not check his pulse. The patient went outside where the temperature was in the thirties and cold. The patient broke out in sweat and felt weak. The patient sat down, and it was cold outside, and he felt better. It passed and he felt fine after that. The symptoms lasted 10-15 minutes top, and it was resolved after the peak. The patient had soreness at the muscle site which got better overnight; little muscle soreness from the vaccine. The patient then got better and felt no other symptoms. He looked up the side effects and talked to the pharmacist. He spoke with a pharmacist, who provided the information on the reported adverse reaction of the COVID-19 vaccines and the signs of a severe allergic reaction included in the PI. He is not an allergic type person. He is familiar with those reactions and never had any trouble. He wasn't quite sure if it was related but then said it is probably somewhat related. The patient explained that he doesn't have any of the reported adverse reactions in the PI; but his experience is like the dizziness related in the signs of a severe allergic reaction in the PI, and he did feel that his heartbeat was fast. He is fine now though. The patient asked if his event is related to the vaccine and what is the impact on getting the second dose when reacting to the first. The patient was thinking that this event is a vagal reaction but delayed. He also explained that he was speaking with his colleagues, right after receiving the COVID-19 vaccine, regarding postnasal drip reaction. The patient also wondered if anxiety related to this discussion could have triggered his symptoms. Originally, he thought it was just him. But after talking to colleagues, maybe he was just a little anxious. He did not feel anxious going in. He did not need any intervention. He did not take any diphenhydramine hydrochloride (BENADRYL) or anything. He sat and rested, and it passed. He has been fine since. He needs a second dose in 3 weeks. There is not a lot of information about the side effects. It was not like he got a rash. He did not have any swelling of the tongue or throat. He just wanted to find out about if he should get the second dose. He really wanted to get the second dose. He just wanted to know if this was common or a concern and should he take the second dose. There were a lot of people getting the vaccine and this was not anything that stopped anyone from getting it. He is just trying to make sure and see how likely it was that it was related to the vaccine and how does it affect him getting the second dose. The patient was recovering from "Felt pinched when the vaccine was administered; soreness at the muscle site; little muscle soreness from the vaccine". The outcome of "Postnasal drip in throat" and "Anxiety; anxious" was unknown. The patient recovered from the other events on 30Dec2020. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Severe neck and throat pain, throat hurt when breathing. No chest pain, no shortness of breath. Lasted until about 2am. Anxious because concern about being cardiac. Next day very tired and headache.

Abdominal pain, Abdominal distention, severe acid reflux, awake until 4 am with severe abdominal pain,

Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.

Shaking chills onset 12 hours after the vaccine, followed by fever to 101.6, sore throat, dry cough, headache, nasal congestion, muscle aches, and fatigue at 24 hours post-injection. The fever and other symptoms subsided within 48-72 hours, however, I was unable to return to work for 4 days and continue to experience a mild headache.

20-25 min post vaccine pt complains of dizziness, sweating. Patient laid down for approx 10 - 15 min and drank cola. BP taken was 160/120, which elevated but not abnormal. Pulse Rate - 67. After 10-15 min of sitting and cola dizziness improved as well as sweating. Pt. f/u @ 2pm. Feels "off". Not dizzy, but feels ok to work and drive.

Got COVID shot about 10am Friday and started to feel sick about 6pm. Tiredness, headache, muscle pain, fever, nausea. Rough night and still had symptoms all day Sat 1/23/21. By Sunday morning only headache remained, mild compared to day before. Now Monday, and still have light headache and tired.

fever 103.8, shaking chills, extreme fatigue, muscle aches, disorientation, skin extremely sensitive to touch

19th vaccinated; my wife was exposed to COVID on 26th and she developed symptoms on 29th; I developed on 31st and tested Positive on January 2 for COVID; January3, I was admitted to ER for shortness of breath, my oxygen saturation - between 88 and 94; I was in the hospital and discharged on January 8. Remdesivir and Decadron treated with and also Eliquis. I was on oxygen until Wednesday (three days) and then I went home on 8th and continued on Prednisone for last week (Friday). Haven't gone back to work - shortness of breath, fatigue and headaches continue.

Pt had some amazing hallucinations and was actively communicating while I believe he was asleep. He called me on the phone and his voice was slurred and he thought he was being held down by some things that were flying around. I was able to direct him to sit up after ensuring him that he wasn't being held down and eventually get him to walk to the bathroom, turn on the light and look in the mirror and describe to me what he saw (he lives at a different address than I do). By this time, he had "woken" up and his voice was no longer slurred and he was "making sense". My concern was that he had had a stroke or Bell's palsy or something. He was fine and slept well the rest of the night. I will bring him to my home after his second shot just in case this happens again. He hallucinated after his anti-anxiety medications for the first couple of weeks and to a more minor amount with his other medications, again for the first couple of weeks. I am assuming that his brain reacted to the vaccine with hallucinations but I don't know. This may be nothing or it may be something that other patients are experiencing, who the heck knows.

Muscle cramps in lower back area. Feels like Kidney area Cramps started on 1/31/2021. I called out of work on 2/1/2021 Went to urgent care on 2/5/2021. I had blood work done

Blood pressure was high; tired from the night before; Itchy; slight headache; little lightheaded; Heart racing; panic attack; Hot flashes; Sweating; Chills; achy/body aches; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for himself, a 62-year-old male patient who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration (reported as by injection) to left arm on 14Jan2021 at 3pm at single dose to prevent COVID/COVID-19 immunization. Medical history included anxiety. Concomitant medications included antidepressants. The patient received his first dose of Pfizer COVID vaccine last 14Jan2021 at 3pm, and everything went well. When he left the place, he had a slight headache. He had to stay there for 15-20 minutes to make sure he had no reaction. He just got a little lightheaded, he didn't think much, and it didn't get worse. The patient took 2 paracetamol (TYLENOL) and forgot about it. It went away for a while. He took the shot at 3 pm and he took paracetamol at 4 pm. Later that night, about 10 pm, everything kicked in. He was sick again at 10:30 pm, or so, the headache was gone for several hours. He was ok between 4 pm and 10 pm. Then about 10 to 10:30 pm, when he went to go to sleep, his heart started racing, like he was having a panic attack, then he started getting hot flashes, sweating, chills, and aching, and this went all night from like 10 pm to 11 to the next morning. He had a doctor's appointment to get his knee examined for an upcoming knee surgery. The patient clarified that he didn't go to the doctor because of the symptoms, he went for his knee. He asked the doctor, before getting examined, and the doctor said he got off easy, as the doctor himself was sick for 3 days. The patient asked the doctor if he could take something to calm down, as his blood pressure was high on 15Jan2021 at 8 am. They had taken his blood pressure to examine his knee, and the doctor said it was alright. He was prescribed with alprazolam (XANAX), and the doctor said it would be fine. The next day, he was tired from the night before. He had no symptoms the next day. After he took alprazolam, he slept fine, he felt better. The hot flashes, heart racing, body aches, and chills were gone, and he read everything as far as symptoms. The heart racing went away about 11 the next morning because he took alprazolam. The patient stated that he forgot to add one more, he had all the symptoms described as side effects, but he also had itching. He had very mild itching and was given cetirizine hydrochloride (ZYRTEC, lot number: OHE2723, expiry date: Feb2022, UPC: 4122053077), it was like 80% gone. Every now and again he has a little itch, but it was bothering him all night that first night. Currently, the patient felt pretty good. He has no symptoms other than the slight itch. He further stated that his second dose is on 04Feb2021. Out of all symptoms, the thing that freaked him out the most was the heart racing, he asked if he could take diphenhydramine hydrochloride (BENADRYL) before the shot. He has been on antidepressants for a while, he has a lot of anxiety, but the day he went in, he felt good, and didn't take alprazolam. He also asked if this have triggered all that heart racing stuff. He was seeking for information if there was anything to do to prepare him better, he knew you have to sit there for 15-20 minutes to see if there was a reaction. The outcome of the event headache and lightheadedness was recovered on 14Jan2021, unknown for blood pressure high and tiredness, recovering for itchy, and recovered on 15Jan2021 at 11 am for all other events.

Right chest, right shoulder, right shoulder blade pain, extreme to the point where i wasn't able sleep and a burning sensation in those areas as well

diarrhea; whole body aches; He can't sleep; feels like crap; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EL9264 expiry date not reported) via an unspecified route of administration from 31Jan2021 at single dose for covid-19 immunization. The patient's medical history includes ongoing nausea and Not able to eat/ he can't drink or eat. Just thinking about eating makes him nauseated and threw up. Concomitant medications were not reported. The patient experienced whole body aches, he can't sleep and feels like crap on 31Jan2021. The patient also experienced diarrhea on 02Feb2021. The patient mentioned that on the morning of the vaccine, Sunday, he woke up, and tried to drink coffee and threw up. The Sunday morning he was nauseous before the shot. When he drank his coffee that morning. In the mornings, he can't drink or eat. Just thinking about eating makes him nauseated. His body aches started a little while after the shot. It was still Sunday when they started though. He can't sleep the body aches are so bad. Sunday evening is when he started to feel like crap. He has also had diarrhea. The outcome of the events whole body aches, feels like crap and diarrhea was not recovered. Outcome of the event He can't sleep was unknown.

Slight lump in throat, of the kind experienced with previous anaphylaxis episodes, that developed a couple of hours after vaccination, and is continuing.

Patient was seen at Facility 10 minutes after his Pfizer immunization. He had wooziness, and hyperventilation with a breathing rate of 40. He was transferred by wheelchair to a stretcher. Initial Vitals: BP 128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear lungs. He did not recall he had an immunization, and was uncertain of his own age. He did report he was on metformin for DMII. 911 was called. He was transported to Hospital ER by EMTs.

he was excited and/or anxious about getting vax after having Covid in November. vax dose approx 305 pm, by 310 he reported feeling weak with rapid pulse and heart fluttering. Gave water to drink, he declined food. 315 he felt hot sweaty and took off his overcoat. 325 said he felt better after drinking the water and declined to have his bp or pulse checked. Follow up phone call 3/14 to check on condition, said he felt ok after leaving pharmacy and has no allergies, no current illnesses and no vaccines within past month.

Extremely dizzy when got up during night (2 am). Fell twice. Extremely dizzy when got up during night 2nd time (5 am). Fell once. In the morning (about 7:30) I noticed a rash all over his trunk (small pink spots) As the result of the falls, he hit chin and cut it. Hit left temple and bruised it. Back is very sore and painful. May have cracked rib(s). Currently 2:20 pm on March 14. He is no longer experiencing the dizziness. The rash seems to be clearing up (brownish spots instead of pink spots on trunk). He's resting.

Had body aches, cold chills, thought processing was slow and some what scattered, eyes were dilated slightly, loud noises were painful

Fever to 102. Chills. Full body aches, headache. Unable to sleep. Resting heart rate was about 20 beats higher than normal. Mild tinnitus got louder. At 24 hours from shot fever has reduced to 100.

Severe headache, fatigue, very sleepy about two hours after injection. Woke about 1:00 a.m. with severe headache. Gave two Tylenol and cold wash cloth for forehead. Started tossing and turning about five minutes later. Sat up in bed, fell over and struck bedside table. EMT said he suffered stroke around 1:30 am. He passed away on the 5th.

PT (DOB 12/14/1958) received the COVID vaccine (Pfizer dose 1, Lot# EW0150, exp 7/31/2021) at 1525. The client reported feeling dizzy and lightheaded, and his caregiver reported that he was "red and sweaty". EMT alerted the RNs and responded to the client. Upon observation, the EMT observed that the client appeared flushed and diaphoretic. The client was accompanied by his caregiver who reported that the client has a medical history of hypertension, orthostatic hypotension, intellectual disability, schizophrenia, diabetes mellitus 2, and bell's palsy. The client has no allergies and takes the following medications: metformin, lipitor. clozapam, metoprolol, cogentin, iron, prostigmine, and farxiga. At 1530, the EMT obtained a blood pressure of 180/118, with a heart rate of 116, respiratory rate of 22, temperature of 99.1 F and pulse oximeter reading of 94%. At 1536, the client's blood pressure was 172/118, with a heart rate of 116, respiratory rate of 20, and pulse oximeter reading of 95%. At this time, the client stated that he was dizzy and feeling anxious. The client reported that he was feeling dizzy before he was vaccinated but that he "forgot" to tell his caregiver. His caregiver reported that the client had not yet eaten or had anything to drink that day. The client was offered and accepted water. The client and his caregiver deferred Benadryl. Repeat vital signs were obtained at 1542: blood pressure of 166/112, heart rate of 116, respiratory rate of 24, temperature of 99.1 F, and a pulse oximeter reading of 95%. The client practiced deep breathing, denied any difficulty breathing, itching or swelling. At 1550, the client reported no longer feeling anxious or dizzy. At this time, the client's color was improved, he no longer was diaphoretic, and he stated "I'm pretty hungry now." Repeat vital signs were as follows: 156/115, heart rate 108, respiratory rate 20, and pulse oximeter reading of 95%. Client left the facility at 1600 after waiting the recommended 30 minutes from initial symptoms, with symptoms resolved at that time. The client ambulated to his car with a steady gait, escorted by the EMT and his caregiver, and his caregiver drove him home.

I began shaking violently and severe cold chills. I began hallucinating and felt like I was turning inside out. I blacked out and woke 2 hours later with severe flu like pain in my entire body and a severe headache. I do not do drugs and I had no alcohol in the 3 days before I wa vaccinated. It is now 47 hours after the vaccination and I have moderate flu like symptoms.

'blood pressure had been up to 180/increase in blood pressure'; he was freezing; he was cold; ''he is usually up at work every day and he hasn't been able to work the last few days''; feels like he can't think'', ''tired; ''he may be getting in for breathing treatments today''; so sick; feels like he can't think'', ''tired; Feeling lousy; Lethargic; Running temperature; Chills; Hives; Anaphylaxis; fell asleep for 16 hours. Caller reported that he doesn't normally sleep for 16 hours; Throat scratching; Eye itching; Bags under eyes; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number: EN6207), via unspecified route of administration on right arm on 19Mar2021 13:09 as a single dose, for COVID-19 immunization. The patient medical history included Ongoing COPD (about 5 years ago), high blood pressure (about 10 years ago and still ongoing) extensive allergies to food and insect bites. The patient was diagnosed with the allergies when he was a little kid, allergic to penicillin ongoing. Concomitant medications included lisinopril at 20 mg once daily in the morning for high blood pressure and albuterol at 2 pumps in AM and 2 in PM before going to bed for COPD (Chronic obstructive pulmonary disease). The patient previously took historical vaccine ampicillin for infection. On 19Mar2021, the patient experienced, ended up feeling really sick right after the shot. He has a lot of allergies and he was advised to take his Epi-Pen kit and stay an additional 30 minutes past the recommended waiting time after receiving his vaccine. His throat began scratching after getting the shot and lasted for about 3 to 4 hours for which the patient received Benadryl and resolved completely. His eyes were itching and lasted for 24 hours, and bags started to form under his eyes like anaphylactic shock. It was reported that the bags under his eyes would normally stay after anaphylaxis for a day or two. His eyes were still a little puffy at the bottom. He did not saw a rash but started to get hives, the paramedics were called and monitored him for another 30 minutes. The paramedics administered a shot of Benadryl. After the Benadryl was administered, his body and blood pressure started to come down. The paramedics reported that his blood pressure had been up to 180. It was reported that on 19Mar2021, afternoon, when the patient got home, he was sick, laid down and fell asleep for 16 hours. He does not normally sleep for 16 hours. He was unsure if his eyes were itchy in his sleep. Later in the call it was clarified that this might have only lasted 3-4 hours, he was so tired he just went to sleep. It was reported that he was not a sleeper, that he was usually up at work every day and he had not been able to work the last few days. It was reported that he started feeling the side effects of the Covid-19 vaccine at 13:20 on 19Mar2021. On 20Mar2021, he felt lousy ever since he received the COVID-19 vaccine. On the same day, his wife took his temperature, and his temperature was hovering around 100-100.9. He felt lethargic, running a temperature between 100.5 and 100.9 pretty consistent every day. On an unspecified date, his wife took his temperature, and it was 99.9. He felt like his mind was in a fog, intoxicated and he had not felt good since receiving the first dose of the Covid-19 vaccine. It was reported that the mental fog made him felt like he cannot think. The paramedics gave him a test and asked him to add 5+7. The patient answered 14, even though he knew that the answer is 12because he could not think, and he felt punch drunk. He reported that he can concentrate a little more, but he still felt drunk, this was hanging around the same now. It was reported that the paramedics were asking him questions and gave him things to do, addition and subtraction formulas, to keep his mind. He could not finish those formulas and that he told the paramedics that he felt foggy or punch drunk. He spoke with his health care provider at the VA and the provider advised him not to get the second dose of the Covid-19 vaccine. It was reported that the patient was inquired if he had any immunity to Covid-19 without taking the second shot and if he was protected with just the one dose of the Covid-19 vaccine. It was also reported that, the reporter also looked through the list of side effects for Covid-19 vaccine and it was like patient had all of them. The patient experienced chills, he was freezing, and he was cold. The patient had the whole list of them. It reported that he had doctor appointment on Monday, 29Mar2021, and that he may be getting in for breathing treatments today. He was waiting for his insurance to finalize the approval for the breathing treatments in the evening. The outcome of the events throat scratching and eye itching was recovered on 19Mar2021, Outcome of the events bags under eyes and blood pressure had been up to 180/increase in blood pressure were recovering. The outcome of the events feeling lousy, lethargic, running temperature and chills were not recovered. Outcome of the other events was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

mental fog for all the following day; Chills; first dose on 16Feb2021/second dose on 21Feb2021; first dose on 16Feb2021/second dose on 21Feb2021; This is a spontaneous report from a contactable Other HCP reported for self. A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose in Left arm on 21Feb2021 12:30 PM (lot number: EN6198) for COVID-19 immunisation. There was no other vaccine in four weeks, no other medications in two weeks. The patient's medical history included known allergies: penicillium and sulfa. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number: En5318) in Left arm on 16Feb2021 10:00 AM for COVID-19 immunisation. The patient experienced chills and mental fog on 22Feb2021 and for all the following day, no treatment received for the events. No COVID tested post vaccination. Outcome of the events chills and mental fog was not recovered.

Continued soreness in injection arm every day since first injection. Near-continuous cognitive befuddlement / inability to think clearly - only have had this before with severe sinus infection / head cold (I'm a practicing degree'ed engineer - very scary to me). Had a bout of "double vision" for approximately a minute - never had this before - another very scary thing. Two days ago experienced "highway hypnosis" - zoned out while driving for 10 minutes - lost time event / can't remember driving the route I did - never had this before - another very scary thing.

Tough to sleep; Ringing in ears; This is a spontaneous report from a non-contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: En6201) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]) and losartan, both for unspecified indication. On 16Mar2021 at 16:00, the patient experienced ringing in ears and tough to sleep for a couple days. The patient did not received treatment for the events. The events resulted in disability or permanent damage. The outcome of the event was not recovered. The patient did not had COVID prior to vaccination and was not tested post vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.

Woke up next morning, 04/09, after receiving 2nd dose of Pfizer vaccine. Started as feeling like a head cold. Some chills etc. by the time I went to work right side hearing was severely affected with what sounded like phase shifter in my head. No relief through weekend, too dangerous to work due to my job in a busy kitchen. Saw my Dr. on Tuesday 04/13. Treated as an ear infection. 3 day steroid with nasal spray. No relief. By now the ringing, whooshing, roaring and chirping in my right side are extremely disorienting! Started antibiotics on 04/15 with wait and see effectiveness. Today is 04/16 at 10:15am. To date no relief of symptoms.

Initially, the first day as with the first dose, my left arm ached but this time it lingered for about 4 days. I was working a job that requires heavy lifting and at first thought it was the work, but after not working at all for about 3 days, my body would start aching all over. This is approximately 10 days after my second dose of Phizer. My bones ached, sort of like getting the flu. Late in the afternoons is when this pain would begin and by 7-8 at night, all I wanted to do was sleep. Each day, when waking most all the aching would be gone only to start up again about the same time in the afternoon/early evening. Last night, I went to bed about 7 pm and slept up until 6 am. As I am writing this, the aching is beginning in my arms again and I have tons of tiredness. It is 4:25 pm. and day 12 after the 2nd dose of Phizer.

Intense muscle twitching in my lower extremities, especially in the feet and calf muscles of both legs. Abodominal muscle spasms were present but not as prevalent or obnoxious as my legs. Also twitching in my right deltoids, triceps and thumb muscle. Could not sleep for two days . I began to get a headache due to no sleep so I took two 200 mg Advil tablets. I was able to sleep that night because the twitches had greatly subsided. I still have frequent but light twitches .

anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.

Something kicked in like drinking espresso; Everything, all senses seemed like they were amplified/Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced.; Seemed like had more energy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 62-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731) administered in left arm on 13Apr2021 09:15 at age of 62-year-old at single dose for COVID-19 immunization. Medical history was not reported. Prior vaccinations: the only one caller can really think of is when caller was 8 or 9 years old, received the DPT vaccine and had rash and fever of 102. Caller cannot provide NDC/lot/expiration. Caller states he has a Vaccination card for all the vaccines received in the last 15-20 years. The last vaccine caller received was the second dose for shingles in Jul2020. There were no prior vaccinations within 4 weeks. There were no additional vaccines administered on same date of the Pfizer suspect. Concomitant medications were not reported. Caller is a consumer reporting he received the first dose of the Pfizer Covid 19 Vaccine took first dose vaccine yesterday, 13Apr2021 at 0915. Reports this is crazy, he hears a lot of people talking about negative effects, caller had the weirdest side effects that are still going on. Caller states all the symptoms began about two hours after receiving the first dose Pfizer Covid 19 Vaccine. Caller received the first dose Pfizer Covid 19 Vaccine at 0915 and on 13Apr2021 at 1115 something kicked in, like drinking espresso. On 13Apr2021, everything, all senses seemed like they were amplified. Blues bluer, reds redder, sense of smell enhanced, sense of hearing enhanced. Everything amplified, everything kicked into overdrive. It was like caller did not have to drink coffee today. Reports it was a good feeling, it was an awakening. It was just like the whole body seems like its amplified. On 13Apr2021, seemed like had more energy, everything, almost like drinking two doses of espresso coffee, enhanced all senses and everything. Caller states it was like the wildest thing ever experienced with a vaccine. Everybody else is talking about negative side effects and mine is like drinking high potency coffee, energy level spiked up. Caller did not know if the Pfizer Covid 19 Vaccine amped up his immune system or whatever. States he has never had any real problems before. The adverse events did not require a visit to Emergency room or Physician office. Non-serious. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body; hives; he was up until 1:30am for 3 hours on hold last night and didn't get through and fell asleep; The is a spontaneous report received from contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration at left arm on 31Mar2021 as a single dose for COVID-19 immunisation (everyone is saying he should take it). There was no patient history. There were no AE prior vaccinations. There were no prior vaccinations within 4 weeks. Concomitant medications included allopurinol, atorvastatin, gemfibrozil (patient states he takes these). The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Patient stated took the Pfizer-COVID-19 Vaccine on 31Mar2021, last Wednesday around noon, a couple days later Saturday morning he was breaking out with hives and rash. Started getting a rash pretty much all over his whole body. As of today, he has a rash, second dose is scheduled for 20Apr2021, Patient asked have other people reported the rash and gotten second dose. Patient states the rash is over his whole body now and he doesn't know if it is clearing up. States he is taking Benadryl, that he called his doctor and was told to take Benadryl and see what happens. Patient states he has some questions, he is wondering if he should take something else and he is scheduled for his 2nd shot and he needs help with what to do. Patient relays that it seems the rash may be drying up a little and is wondering is he should still get the 2nd shot. Patient relays that the rash started about 48 hours later on 02Apr2021 in the evening, Saturday, Sunday and a little worse yesterday and today he doesn't know if it is drying up but he still has it all over his body. States the card says 0.3mg and believes that is the dose. Patient asking if his healthcare provider is going to know any information as it's a brand-new drug, states he has 3 friends that are doctors and they have all said to call Pfizer. Patient was asking if other people have reported this. Patient states he was up until 1:30 am for 3 hours on hold last night and didn't get through and fell asleep. Report was not related to a study or programme. There was no investigation assessment. The outcome of event was unknown. No Follow-up attempts are needed. No further information is expected.

About 1 week after the 1st dose, beginning on 4/20/21, I started experiencing a significant increase in my tinnitus condition in my right ear. 2 wks later, it also started in my left ear. The ringing, buzzing and whistling sounds have become louder and very difficult to tolerate affecting my sleep and some other daily resting activities. I informed my doctor and was advise to do Audiology test and discuss with ENT specialist.

Hives left hand, left cheek bone and then profound fatigue, bad insomnia and restlessness, severe bone pain in right foot and right arm; heart palpitations and fast heart rate with dizziness and nausea; headache; Day 8 started having muscle twitches and cranial/ear buzzing; Day 8 experienced severe malaise and nausea and lightheadness; Day 18 difficulty walking in straight line; muscle twitches with heart palpitations very bad in evening; localized headache at left temple area, stiff neck and shoulders; eye vision blurry with heavy floaters and eye socket pain; extremely vivid dreams

7:45am April 13th, 2021 at hospital I was very excited to finally get the vaccine ...I was given the Pfizer shot in my upper left arm and felt small pain a the site of injection ...In 5 minutes I felt nauseated, very dizzy and weak to the point of falling off the chair ...they gave me two cups of orange juice and a few fig bars in the hopes that I was just having low blood sugar ...I was offered a hospital bed to lay down ...I experienced numbness in my left arm and in both hands ...also across the lower part of my face ...I was at the hospital for over an hour an was unable to return to work ... A few days later I began experiencing high pitch ringing in both ears that has gotten worse to the point of being so loud I can't hear a person talking to me on the phone ...noises around me are extremely painful to my inner ear ...this high pitch sound wont go away and keeps me up all night ...I have been to the hospital several times to see ENT doctors and I have tried many medications to help me sleep with this 24/7 tortuous ringing sound ...I can keep myself busy all day trying to ignore it yet at night it haunts me like a demon ...please contact me with any help you know of to reduce this sound in my ears ...I am extremely desperate for sleep ...

Soreness on the around the shot site; Severe arm pain up where the rotator cuff is; Severe arm pain up where the rotator cuff is; Has not slept due to pain; cannot sleep, the pain wakes him up; Could not use his arm; 50% deficit with the use of his left arm; After the vaccine, he could not lift his arm above his mid face level; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Burning and tingling down the left arm; went to his hand and fingertips and progressed to the whole left side of his body including his rib line, hip, leg, and foot; Nauseous; This is a spontaneous report from a contactable consumer (patient who is a retired paramedic). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration in left arm, on 30Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included bipolar depression from probably 10 years ago (2011) and ongoing, torn rotator cuff (15 to 20 years ago), and food poisoning in mid-Aug2020 (maybe it was more than that; may get tested to see if he ever had COVID-19). The patient's concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2017 and ongoing (for at least four years) for bipolar depression. The patient has no known allergies. The patient was one of those people who doesn't get sick and he doesn't normally get the flu shot and everyone told him to get this Pfizer vaccine. The patient was not panicking but got the first dose of the Pfizer Vaccine on Tuesday (30Mar2021) around 01:00 PM and saw some things about having soreness on the around the shot site and all of that from that night (30Mar2021). This is going on for three days (from 30Mar2021) with severe arm pain up where the rotator cuff is; if you ever have pulled a rotator cuff it feels like that and he has not slept in almost 3 days due to pain from 30Mar2021. The pain is severe at times that it makes him nauseous (Mar2021). He figured the soreness was normal and later in the evening on 30Mar2021, the pain became an issue when he tried to go to bed that evening. Since the first two nights compared to last night, the soreness is actually improved; every time he tries to sleep with pain as a factor it is not easy. The patient can feel throbbing with his heartbeat and with the circulation there is throbbing pain. The pain was terrible and was throbbing like his heartbeat and similar to like a shoulder rotator cuff injury. For the first two days, on Tuesday (30Mar2021) and Wednesday (31Mar2021) after the vaccine, he could not use his arm or lift his arm above his mid face level. According to the patient, it was like a rotator cuff and he had a torn rotator cuff 15 to 20 years ago and this is the same arm that his torn rotator cuff occurred in; this is very painful and he is comparing it to the torn rotator cuff. In Mar2021, the patient had burning and tingling down the left arm and 3 days no sleep because the pain is worse at night. During the last week (Mar2021), his left leg down to his foot is also tingling and burning. The patient's primary care physician just retired, and he is in the process of finding a new one. The patient had no treatment or physician or emergency room (ER) visit for the reported events because being in the ER field, he can tell right now that it would be a waste of time of the effort to go into the ER as they would do nothing but tell him to take paracetamol (TYLENOL) and that is it. The patient did not like to take paracetamol and hates taking paracetamol. The patient clarified it is generic acetaminophen extra strength (Strength: 500 mg; Lot Number: P119682, Expiration Date: Mar2022, UPC Number: 5084417594) that he has taken (maybe every 6 hours oral) and it does relieve the pain so that is only so good. He does not know if in motion of the course of the day, something happened because at night laying still in bed is when he has pain. The patient did a lot of research before he made this call and the severity of the pain is enough to actually keep him awake for three days. He thought it was severe pain; maybe he should have told them to administer the vaccine in his right arm, but it was administered into his left arm. The only reason he made this call was because he wanted someone to know what he was having which could be just completely normal and he is sure every reaction is different and he expected the soreness because he remembers as a kid having shots. Also, this level of pain he is experiencing is what he wanted to report; imagine having himself going three days without a full night of sleep and he wanted to report this to make sure Pfizer knew this if they were keeping track of numbers of how many people have a similar pain level. The patient also asked if there were other people who called and reported these symptoms and if there is any information or treatment recommendations. As of 08Apr2021, even up to five days after getting the shot, now going on seven days that he has had some pretty severe reactions. The patient called in after 3 nights of getting no sleep. The patient was calling today to see if someone was ever going to call him back and asking will there be a follow up call from someone to see if he's still alive. The patient had some pretty severe reactions and they have actually gotten worse. There also have been new developments. The patient had pain in his arm that pulses along with his heart rate. It is so bad that it kept him up for 3 nights and still wakes him up at night. The pulsing pain in his arm started on the first night and has gradually gotten worse. The pain in the arm that is enough that it keeps him awake at night only starts getting severe when he goes to bed. He has tried sleeping in an upright position and he has tried everything, and nothing seems to alleviate it. The patient took generic acetaminophen which did not work during his last phone call. The patient also tried naproxen sodium (ALEVE) and that doesn't work wither. It was absolutely debilitating at times to where he has a 50% deficit with the use of his left arm (Mar2021). The patient initially reported burning and tingling sensation that was on his left arm and went to his hand and fingertips but now it has progressed to the whole left side of his body including his rib line, hip, leg, and foot. He is a retired paramedic and is pretty sure he is not having a long stroke. The patient feels it is too long to have symptoms from a shot he got. The patient has a lot of friends in the medical field and he's been told even going to a primary care physician, it is kind of gray area when it comes to dealing with COVID-19 vaccines. The patient was having second thoughts about getting the second shot. He had been told he can take NSAIDS over the counter for pain which has not helped him; there is no protocol for diagnosing or treating anything that happens from the shot. People in the medical field have told him there is thin line now to treat side effects because of liability; some doctors won't even get into it, just refer to Pfizer because medical insurance will not cover any services related to COVID-19 vaccine reactions. The patient continues to explain that is why the federal government is the only one that owns the shot due to liability. The patient's main concern is calling and reporting and maybe getting some help in deciding whether or not to get the second dose of the Pfizer COVID-19 vaccine. In his opinion, that is too long to have pain that he cannot sleep, the pain wakes him up. This all happened along with the shot, the same night and there are times where he can't work due to it. The patient asks if anyone is concerned with it and will someone feel bad because he doesn't get the second shot. His main concern is that people are underscoring or even lying about side effects, stating he can't believe he is an isolated case. The patient continued to ask if this is something he's stuck with, or if it is something he would have to deal with from now on from getting this shot. The patient regrets getting the first shot and stated that if he knew then what he would be going through now, he wouldn't have got it. The patient has no sort of history of being a hypochondriac and the feelings he is going through right now are sensations that he has never felt in his life. The patient continues to explain he doesn't even know how to categorize it other than mentally relating it to the shot since it all occurred in line with Mar2021 getting the shot. The patient further commented that if he ran a call with an ambulance right now with a patient telling him what i he was telling the company, he wouldn't even know what to do with them other than getting them comfortable and to a hospital. The patient had not recovered from "Soreness on the around the shot site", "Severe arm pain up where the rotator cuff is", and " Has not slept due to pain; cannot sleep, the pain wakes him up". The outcome of the other events was unknown.

it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown. Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts. Information about lot/batch number has been requested.

Patient states he felt some diffuse palpitation did not feel right and wanted to get himself checked. On arrival patient is somewhat anxious has some diffuse skin erythema over the chest wife is not sure if that is at baseline or if its new. Patient denies any shortness of breath states his chest felt funny earlier but has no symptoms at this time. Reported SOB earlier. Patient is having hiccups. Patient has no emesis has no respiratory difficulty denies shortness of breath saturations are 98% on room air with respiratory rate of 20. Patient has no abdominal pain no other rash to the abdomen torso extremities etc. Patient had first vaccination with no allergic reaction. Patient denies any history of allergies to medication. Patient is symptom free and is able to give good history no change in voice no neurological symptoms. Patient treated with diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Lorazepam 0.5mg IV x1, Methylprednisolone 125mg IV x1; Discharged to home with prescriptions/ OTC for Epinephrine 0.3mg/0.3ml IM, Famotidine 20mg po , Benadryl 25mg po

pervious visit had a "funny feeling" in his face and throat, currently has same "funny feeling" in throat only

within 6 days my brother was sick, everyone said it's the side effects from the Covid vaccine because it was the exact same side effects, chills-headaches, lethargic, just wanted to sleep he said that's all he needed. However that wasn't the case here 4 days later he has brain damage from Encephalitis and meningitis which is so Rare to have together, This all happen to his having the second shot, He was a very health person, body builder/MMA etc now he lays in bed or wonders the room not knowing whats going on this is just Wrong .We're told with his brain damage he won't heal from it. No Short Term Memory.

pt says the next day after taking the vax his arm was a little sore but when he stood up he had a hard time moving around, he was hyperventilating and he felt very exhausted. He got a severe pain in his left hip. He said the pain was so intense he could barely move so he took a low dose pain killer. He was in so much pain he curled up in a fetal position and rock back and forth. He says he was crying and in a hallucination state for about an hour. After that the he said the symptoms seemed to be getting better but was completely exhausted. His eyes were red and had trouble with his vision. On 6/4/2021 he still has some pain and has an ache inside the bone, gets winded w/ moving around but says his symptoms seemed to be improving.

Chills; tired; a dream of going over a glacier trying to slide over the other side; This is a spontaneous report from a contactable consumer(patient). A 62-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, in Arm Left on 06Mar2021 08:30 as 1 DOSE, SINGLE DOSE for covid-19 immunization. The medical history was reported as none. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 16:00 the patient experienced chills, tired (fatigue), a dream of going over a glacier trying to slide over the other side (abnormal dreams). The patient did not receive any treatment. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; The pain is increasing it is really getting worse; I cannot eat from my hand at the back, I cannot lift anything; having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration Date: 31Jul2021) via intramuscular route in the arm left on 10Apr2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history included diabetes and Blood pressure high. The concomitant medications included metformin hydrochloride 1000mg, sitagliptin phosphate monohydrate 50mg (Janumet XR) and Glimepiride 1mg tablet (taking half because diabetes was not that high) taken for diabetes mellitus the morning and in evening and taking for 7 years, lisinopril taken for High blood pressure taking for 3 years, tadalafil; the patient went in surgery in 2020 (start feeling the excursion) So that time the patient was taking medication so would say 3 months and having appointment to continue or discontinue. After that the only thing the patient was taking tadalafil. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: N6207 and Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 for COVID-19 immunization and experienced no adverse event and in 2008, flu shot (lot number and expiration date was unknown) for immunization and experienced was sick, got sick and flu or fever or headache (After that did not take the shot again). On 10Apr2021 after the 3 weeks of first dose the patient received second dose of vaccine and waited for like 20 minutes before leaving the facility, the hospital, and like on third day (may be on 13Apr2021) the patient experienced having a pain in my left hand that I took the vaccine and that is more in the muscle, muscle pain and joint pain. The patient reported that, the pain was not that severe and did not have fever, headache and any other side effect at all. It was just the pain 3 days after, and then it did continue to increase and maybe like one week of joint pain because of that injection and it continue. The patient was feeling pain and then by May2021, the pain was like most and stated that I cannot eat from my hand at the back, I cannot lift anything, so that was new problem, the patient cannot lift anything and cannot turn hand at the back. The patient reported, it was not that very severe that I cannot eat and not that harsh, it was just in the joint and in the muscle. The patient reported, the first day and second day was not that much, the third day was when he started really experiencing and one week after he really feel it. The patient reported that, the pain was increasing. The patient was trying to see maybe within 1 week, within 2 week and within one month but now on 02Jun2021, it was really getting worse, and this was his experience. The patient started really feeling it and thought maybe after 2 weeks it will be going to be over, but it continued, so when it continued, he decided to go to the hospital and so they told me that. The patient took Tylenol and then kept taking Tylenol until for one month after it was lie if he was taking Tylenol it not really hurt maybe it was coming back, he cannot lift of his hand at back and cannot lift anything, the pain was not that kind of pain that it why I was taking. The patient reported that, the pain was continued. On 23Feb2021, the patient underwent laboratory tests, it was a general check-up for Diabetes to check it once and see the kidney, the blood pressure, everything the doctor was checking and then the physician said that that they wanted to check his system the blood work, they did find out that he had COVID 19 symptom on it. Physician told it was not positive. The physician told that, the patient has a strong immune system and if he tested positive, he would not feel anything, and physician told everything was excellent. The patient reported that, he took Tylenol 500mg, and that medication he always takes if he has too much pain. The patient reported that, he takes 2 tablets twice a day and sometimes 3 times in a day, sometimes 2 times in a day. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Severe vomiting during overnight period into next day (approximately 12 episodes in 12 hours), severe cranial pain/headache, open sore in esophagus/lower throat that prevented eating solid foods for 10 days and liquids for at least the first week, even water. Painful area surrounding sternum (uncertain if it was from the vomiting action or possibly heart damage), which also prevented food or liquid to pass down the throat due to spasms, localized pain and possibility of inducing vomit reflex. High blood glucose (ketoacidosis). General overall weakness/lack of energy. Loss of mucous in nose, throat and stomach. Loss of saliva in mouth for first week. Insomnia. High blood pressure.

I have a high platelet level and inflammation from the vaccine caused blood flow problems resulting in trouble thinking clearly as well as walking.

The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of breath, tiredness and interference with my daily interactions. I would get tired about 30 minutes of anything. Whatever the medical term is for when you get tired easily, shortness of breath etc. Just basic AFIB symptoms. The Dr gave me Solital 2x per day and as soon as he did that, within two days the AFIB went away. He took away my blood pressure medication and gave me the Solital. But I still get tired easier than I did before.

Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter). A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered. Follow-up attempts completed. No further information expected.

Fatigue and swelling with joint inflammation in left extremities. Follow-up for polyarthralgia Brief history: Probable reactive arthritis: One week after getting second COVID vaccine (Pfizer, 5/3/2021) he developed chills, sweats, SOB, cough and red/watery eyes. Initially given topical antibiotics for eyes in walk in clinic. Went back and on 5/17/2021 given Medrol dose pack which cleared up symptoms. From 5/10/2021 onward he developed left shoulder soreness and limited ROM. He has had persistent polyarthralgia with morning stiffness. Seen initially in June 2021 with noted joint effusions in left elbow and left knee. Evaluation around that time significant for positive ANA (1:160, speckled), RF (22, normal < 14), SSB, Scl-70 (weakly positive). Other ENA panel and CCP negative. X-ray of left shoulder (6/3/2021) showed only mild degenerative changes suggestive that the limited ROM in shoulder is related to frozen shoulder. Rheum Medications: Celebrex 200mg daily Doxycycline 100mg daily (started about 2 weeks) Interval history: Patient was last seen 6/3/2021. He reports that the swelling in the left calf has decreased. The left knee has been bothering him. The mornings are the worse time of day. He continues to have swelling in the left knee. He has been doing ROM exercises with the left shoulder. At night he is not sleeping because of pain. He has morning stiffness which lasts from 20-30 minutes. He has noticed some pain in the left thumb. No eye pain/redness. No rashes. As in HPI, otherwise 12 point ROS was reviewed and negative

Chronic severe Tinnitus. Non-stop ringing in the ears. Driving me crazy, Causing insomnia. This ringing in my ears is 24/7. Seems to be getting worse.

Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest

Approximately 5 hours after the first jab I became very weak and exhausted. I laid down and got chills to the point I covered up with multiple blankets and started to tremble. Next at the time (unknown afterwards), I experienced the sensation like I was burning up and I began to sweat profusely. I literally felt like I was burning up. I suffer from osteoarthritis and the following day I experienced excruciating pain down my legs and in both hands. While this was occurring my hands became inflamed and I couldn't make a fist. The chills and pain continued over the next four days with the addition of a dull yet present headache in the centre of the forehead. Approximately two days later I experienced the continued swelling in both hands but now the pain lessened and was replaced with needles and pins type tingling in both hands and feet. this lasted about 4 more days. What remained permanent is a trigger finger in the left index finger that is very painful especially in the morning. Also I am have difficulty sleeping

62 year old male presented for 1st dose COVID vaccine with pfizer. 15-minutes post-vaccination the patient complained of having a minor headache. At this time he expressed no other concerns or symptoms. The patient was moved to a shaded area and provided water. Upon further questioning in Spanish the patient reported that his HA was progressively worsening since onset and he had an associated "tightness" and sensation of a growing lump in his throat. Patient denied SOB, chest tightness, difficulty breathing, itching, hives, lightheadedness, N/V. At this time the decision was made to contact EMS. EMS arrived at 1804 and evaluated the patient. During evaluation the patient reported improvement of his HA and throat discomfort. EMS instructed patient to be evaluated at the local ER. However, the patient refused and signed to leave AMA. Patient left the site at 1825 and stated he would take the bus home. Education was provided and patient instructed to follow-up in ER if symptoms re-emerge.

Dizziness cough (allergies, per Pt.) noted; appeared anxious Narrative: c/o dizziness. given juice. HX. HTN. @0945 BP 170/81, P. 93, R 18, O2 96%; @ 0955 BP 143/76, P. 89, R 18, O2 97%; @ 1005, BP 175/82, P. 87, R. 18, O2sat 97%. Sent to ED for further evaluation. Given IV fluids for dehydration. resolved.

About seven hours after I received the second vaccine I had migraine headache foggy feeling in my head a little bit of achiness, same thing the following day not as bad. Two days after the shot I am feeling fine

Pt awoke multiple times in the early morning sleeping period profusely sweating and needing to change of clothes, sheets/blankets and undergarments at times 1:00AM, 3:00AM, 5:00AM, fever, headache. Symptoms have improved with Panadol medicine dose. Pt states since 1st dose feeling of drunkenness' and imbalanced has persisted.

Change in taste (not loss of) in food, coffee, and alcohol. Foggy sensation in head. Increase in metabolism leading to being warm all the time ( no sweating). Two weeks after second vaccine and while experiencing the above symptoms, I had sudden palpitations with a rapid ventricular response ( 186 beats per minute), severe light headedness, ambulance transport to hospital leading to admission for two days. This has never happened to me or any family members before. Discharged from hospital after 2 days in normal rhythm. Also at this time, taste has returned to normal and foggy feeling has improved.

The second dose of Covid Vaccine knocked me out completely : headache, fever ,chills and pain at the injection site . Duration of effects: 48 hours

Following morning patient was "Foggy" in the brain and unable to string words together in a sentence very well. He let me know he could not focus enough to read and retain anything. He wanted to talk but couldn't find the words. He remained very quiet but had no other symptoms of fever, pain, or anything else. 10 days post vaccine and he is doing better but still not feeling normal and not talking and holding conversations as usual. He is able to answer appropriately . The last two days he said all food is tasting bland without a lot of flavor. He has taken a couple Tylenol the last two days and drank Echinacea tea to try and make an improvement. Is there data or information to give us any idea how long this could last?

This was my first COVID-19 vaccine. Second is scheduled for 2 March. Soreness developed at point of injection that evening, but not unusual. I felt pressure in head/neck area and had dry cough that evening. Took Advil PM before going to bed. About 2am that night I started having severe chills. I took temp at 5am and it was 101.7. Took Tylenol and temp went to 99.8 by 7 am. Temp went back up to 101.5 by noon. Had called my workplace medical and they want me to stay out for 3 days due to the reaction.

Fever 101 F; rigors; chills; malaise; nausea; anorexia; arthralgias; myalgia; 36 hours duration Ibuprofen; hydration; bed rest; Work absenteeism x 3 days

Morning after Could not go to work And I have worked 30 years without one sick day. Low grade fever in am with shaking but not cold. Started around 6 AM by 9 AM couldn't stand very weak slightly lightheaded Threw up till almost choking. At noon my temp hit 103.7 Took tylenol all AM and wasn't lowering temp. That was the highest temp Then gradually began to come down At 5:00 PM temp at 100 and able to put soup down. Woke up 4 AM next day in total sweat that had to move to other side of bed Soaked but felt OK On 23rd Got headache above right eye to side of frontal lobe, Not any strong headache at all Dull Like a 2 out of 10. My concern is I still have the exact same headache as I did three weeks ago Not a smidgen lower at all SAME. And I booked second vaccine for Sat 2/27th I am concerned as I have heard second can be worse. I have never had the flu and this was my first ever vaccine of any kind Please advise

Body aches, chills, muscle soreness, fatigue, GI upset for 48hours, no measurable fever but feeling feverish, lack of appetite, severe back soreness which has escalated in the last 5 days to severe back pain, severe insomnia, fatigue is severe.

Pain in left arm/ runs/ cotton mouth/ Very poor ability to sleep for everyday after/some light headed/ cough / chills/ shakes/ extremely warm/poor appetite

body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever; mildly sore arm; Bad prostate and bladder infection; Bad prostate and bladder infection; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team and Pfizer-sponsored program COVAX US Support. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ lot number: EL9269, Expiration date: Unknown, NDC number: Unknown), via an unspecified route of administration in left shoulder area on 08Feb2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included ongoing asthma for about 60 years, ongoing high blood pressure for about 3 years and was on blood pressure medication, issues with thyroid for about 3 years and was on thyroid medication (ongoing). Concomitant medication included ongoing thyroid medication. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient experienced bad prostate, bladder infection, sore arm on an unspecified date in Feb2021. On 11Feb2021, the patient experienced body aches, feeling worse, shivers, headache, mild fever. It was reported that, caller received his first dose of bnt162b2 on Monday 08Feb2021. He's reporting adverse events and would like to know: If he takes Tylenol to treat his symptoms, would it decrease the effectiveness of the vaccine or not. Also, if he were to go for a COVID-19 viral test, would the fact that he was received the vaccine interact with the test and cause a false positive result or not. Patient was reporting that yesterday, day 4, he started with body aches, headache, and "when he got in bed, he had chills and shivers real bad, little chilly" so possibly a mild fever. Enquired could these all be side effects of the vaccine or not. If he go for the COVID test - would it be positive or not. He also states he has a history of asthma and has been hypervigilant about avoiding COVID infections. Caller, reporting on the COVID vaccine and who explains that he got the first shot on Monday and he had a mildly sore arm- this lasted 2-3 days, no big deal. Then 5 days later he had really bad body aches and a headache. He went to bed cause he was feeling worse but before going to bed he noticed he had shivers really bad, uncontrollably almost which lasted over an hour. He presume they are fairly normal side effects but wants to confirm this could happen after five days. Also, he was told not to take Aspirin or Tylenol before getting the vaccine because it could affect the efficacy, but he wants to know could he take a Tylenol now 5 days later for the headache and body aches. He was better now than he was doing. Caller clarified the event was 4 days after the shot, the shot was Monday and events started Thursday. On Thursday evening, 11Feb2021, was when he had the bad body aches, headache, and shivers. At this point he still has the headache and body ache. He felt like, last night, he had a fever, but he didn't check it. At the same time, he had the chill and the shivers. Those feelings were resolved by this morning. Caller received COVID vaccine on 08Feb2021-Internal Infection-Bad prostate and bladder infection. Adverse events did not require visit to emergency room and physician office. No relevant tests. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the events mild fever, feeling worse, bad prostate, bladder infection was unknown, recovering for body aches, headache, recovered on 12Feb2021 for shivers, recovered on an unspecified date in Feb2021 for sore arm.

difficulty speaking... hesitancy. Fuzzy thinking. Dizzy. Achy. Laying down and watching TV was about all I could do. constipated Started when I awoke and was mostly done by 5 PM The next day I spent quite a bit of time on toilet.

Twenty-Four Hours after the vaccine I experienced severe headaches, muscle aches, and fatigue including fever 101-102, reducing to moderate levels after 6 hours but persisting for 7 days. Symptoms varied in severity over days but significantly impacted ability to work.

could not sleep that evening, ran a temperature of 102 for most of the next day, chills, ongoing headache; fever broke about 8 p.m. next day

About 10 minutes after receiving vaccine the patient developed tightness in his throat,anxiety,redness in face and hands and shortness of breath.The patient was given epinephrine 0.3 mg intramuscularly in his left lateral thigh at 11:10 am.The patient responded nicely to the epinephrine and vs at 11:20 were bp 138/68,pulse 102,pulse oximeter 95%.His treatment occurred at the vaccination site. He then was transferred to our local emergency room and was observed for 2 hours.His symptoms abated and he was discharged. He informed us that he had received a moderna vaccine on 01/28/2021 without complications.We learned this after his vaccination.

Extreme bout of peripheral neuropathy that lasted 4 days - still occurring Brain fog that lasted 3 days

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient came to our pharmacy to pick up prescriptions for Diclofenac 50 mg and Norco 5/325, and informed me that ever since he received his Covid vaccine, his right shoulder has been in pain to the point that he could no longer sleep at night. I have called Store 4742 and informed the pharmacist on duty about this report from the patient the same afternoon.

At 1023 patient was into post vaccine approximately 10 minutes when complaining of feeling light headed. He did not eat prior to vaccine. Pt vital 136/118 Pulse 62, Pulse Ox 98%. Patient given juice and crackers. After 4 more minutes, patient stated he feels if he stood up, he would pass out. Emergency Response called for further eval. Patient refused further eval via ER. Left facility at 1036, still feeling "something wasn't right".

he just feels bad; white blood cell count is high; both him and his wife have body aches; flare up of an infection in his scrotum; I am crippled and I had not it before; I am sick; he has a rash on his scrotum; I am crippled and I had not it before; I am sick; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Not Reported), via an unspecified route of administration on Arm Right on 18Mar2021 at single dose for COVID-19 immunisation. Medical history included spinal injury, an infection in his scrotum, some neurogenic things, white blood cells (his white blood cells and scrotum started prior to him getting the vaccine). There were no concomitant medications. It was reported that, the consumer stated, "my wife and me went to hospital and we got a COVID vaccine first one, we had some, my wife had terrible side effects, I am crippled, and I had not it before in Mar2021, she is ok, but she is just sick, I am sick, but she is very sick and she got bad stuffs (rash)." Caller states that both him and his wife were having some side effects, although his wife was having the worse trouble. Caller states that last night, him and his wife were up all night. Caller was up because his wife was up so sick. Caller states that both him and his wife are sick and disabled, that is why they got the shot. Caller reports that he is retired and disabled because he got hurt at work. Caller states that what he is experiencing, is he just feels bad on 18Mar2021. Caller states that he did previously go to a doctor to do a blood study, the doctor is looking for blood diseases or cancer in the caller, and caller thinks that taking the COVID shot just exposed his weak spots. Caller reports that both him and his wife have body aches. Caller was wondering if there was anything, he can go get over the counter at the pharmacy to help. Caller reports that he cannot call his doctor, because they are all out on Fridays. Caller states that him and his wife are not planning to take the second dose of the product. Caller states that they have a lot of hurricanes where they live. Their house got tore up in one, and they sold it to one of their sons, and the caller and his wife moved out to their beach house for a while. He had an infection in his scrotum, something stung him, and that is what the doctors are looking for in him now, because his white blood cell count is high, and he has a rash on his scrotum in Mar2021. It was infected. Caller states that this infection in his scrotum has flared back up since getting the COVID vaccine yesterday, so caller had thought it went away but he guesses it never went away. Caller confirms that the issues with his white blood cells and scrotum started prior to him getting the vaccine, but the caller thinks that the vaccine was exposing the caller's weak spots, and maybe that is a god send because it is all flared up now, and the caller will be able to tell his doctor that. Caller states that he has been getting high white blood cell count readings since the stuff with his scrotum first started, and that is why his doctor sent him to an Oncologist for all this blood testing, so maybe this will be a b lessing in disguise for the caller, in finding out what is wrong with him. The outcome of the events was reported as unknown. Information about lot/batch number has been requested.

I just feel it is like had a weigh on my entire body/ I am feeling like I got run over; Chills; Fever; This is a spontaneous report from a contactable nurse (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 16:00 at single dose for COVID-19 immunisation. The patient had no medical history and no concomitant medications. On 30Jan2021, when he woke up in the morning, he felt like had a weigh on his entire body and got up and he just instantly started having chills, and fever usual (statement incomplete). He looked at all the symptoms of getting the vaccine and he had like 98 percent of them that was just normal, just like a flu. But he was travelling tomorrow morning at 5am and he don't want to travel right now. He still have a fever on and off. He doesn't know if it was safe enough to go on a plane after getting my first dose and how long the symptoms will last. The patient felt like he got run over. His wife got her second dose a couple of days ago and had really bad reactions like flu and could not move all day and that was a Moderna one. Patient stated that he was 6 ft; however, not appropriately paraphrased and clarified. The patient received unspecified treatment for the events. The patient considered a causality between the event because of the vaccine. Outcome of event fever was not recovered; outcome of the rest of events was unknown. Information about Lot/Batch number is requested.

Rash covering the majority of my face when I woke up the next day. No hives and did not itch. Red patches and blotches. Not really bothersome. Got a little better every day until it was hard to see any a week later. Momentary dizziness, also the next day, like a three second flash, when rising from laying flat, laying flat from standing or sitting, or rolling over while laying down. Passes and I can sleep and not notice it unless I am awake enough, and cognizant enough, to notice it when I roll over. Once standing and moving about there is no problem except a feeling, I have seen described as brain fog, of being a little off mentally. Not sharp, but no dizziness. Can maintain normal activity that includes bending over, kneeling down, driving and riding in a car without any dizziness. Have tried eply maneuver, something I can do, but have not had any improvement. Brain fog seems to improve with normal daily movement and I have been trying to avoid my normal caffeine intake.

Pt came to the ER via ambulance with SOB, difficulty breathing, confusion and combativeness which had gotten worse over the day 4/3/21. He had a rash all over his body.. After the respiratory treatments failed, pt was intubated and transferred to a higher level of care and expired on 4/4/21

Around 330 on 4/6, I started feeling bad and arrived home around 530pm and had a slight Temperature (99) with hearing loss in both ears. But the right one had complete hearing loss. Thinking it would be a short term side effect, but realizing on Thursday am with was not, I called my physician office on Thursday and they called back on Thursday for a Friday 9am appt with the PA. She said it was sinus related , fluid in the ears was pushing the ear drum back and gave me a prescription for Fluticasone and to take my Zyretx and Sudafed. Call her in a week if symptoms did not away. On 4/12/21, I still have massive hearing loss and pain, so called a ENT for an appt and received a 1:15pm on the same day. This was the first day I had balance issues.

Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the left side of my left eye was/is bloody; It's been about 2 days and for the first day and a half I experienced the normal flu like symptoms.; dazed; when I leaned back to put eye drops in eye I lost my balance a little which does not normally happen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534), via an unspecified route of administration, administered in left arm on 27Mar2021 14:30 at single dose for COVID-19 immunisation. The patient's medical history included asthma, prediabetic, low thyroid, overweight but not obese, and capillary in the white part of his eye bust (right eye) about 4 months ago. The patient's concomitant medications included alprazolam (XANAX), colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and levothyroxine sodium (SYNTHROID). The patient previously took cryproheptadine hydrochloride (CYPRO) and had known allergies. The patient also previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had no COVID prior to vaccination and has not been tested for COVID post-vaccination. The vaccine facility type was Public Health Department. The patient has no other vaccine in four weeks. On 29Mar2021 at 14:00, it's been about 2 days and for the first day and a half, the patient experienced the normal flu like symptoms. Now after about two days (29Mar2021 at 14:00), he feel just a little out of it, dazed. Also when he leaned back to put eye drops in his eye, he lost his balance a little which does not normally happen. Also within about 12 hours after taking the vaccine, a capillary in the white part of his eye bust and the left side of his left eye was bloody. No treatment was received for the events. The outcome of the events were not recovered.

When Patient presented for his 2nd dose of vaccine he stated about 2 hours after receiving the 1st injection he noted he had slurred speech, was incoherent and was not able to move. Symptoms lasted about 24 hr. and resolved completely in 24-48 hr. Patient denied any history of hypertension or heart disease. He did not report this to his PCP. 4/13/2021--2nd dose of Covid vaccine NOT given per recommendation of Chief Medical Officer--Patient and spouse instructed to contact PCP for additional evaluation and to reschedule appointment for 2nd dose.

R41.82 - Altered mental status I63.9 - CVA (cerebral vascular accident) (CMS/HCC) D70.9 - Neutropenia (CMS/HCC)

Chills, headache, body ache, fever, coughing, disorientation, loss of appetite, dizziness, extreme fatigue

tingling and jolting pain down left leg starting in lower back, pain level 10 out of 10, unable to work remainder of day and the following day, pain resolved later Tuesday, back to work Wednesday

Severe diarrhea, extreme abdominal gas and bloating, this caused a pause in radiation treatments, nausea, chills, insomnia, cognitive impairment

Mild soreness in art for about 1 day after first dose About 12 hrs. after receiving 2nd. dose, fatigue, exhaustion, but could not sleep. I felt cold and had chills with movement (but not severe chills). Adverse effects subsided after about 12 hours and another 24 hrs. required for complete recovery (36 hrs. all together).

full blown Respiratory infection; sore throat; feel poorly; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7934), via an unspecified route of administration, administered in Arm Right on 28Mar2021 10:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced full blown respiratory infection, sore throat and feel poorly on 31Mar2021 17:00. The patient did not received any treatment for the events.The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was not recovered.

I've had mild tinnitus for several years. Shortly after getting the first Pfizer shot, the tinnitus got much worse. The buzzing is much louder than ever before. It's now a constant buzz that impacts my sleep, concentration and just trying to relax.

high fever (over 102, 103.7, 102.7, 99 or 100); Blurred vision; shaking like crazy; has no energy; it was double vision, like looking in a fun house mirror; he is still freezing; does not feel like himself; Had been feeling tired and rundown; Headache; horrible chills; night sweats; This is a spontaneous report from a contactable consumer (sister). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient medical history: no. Family medical history: no. The patient's concomitant medications were not reported. Vaccination facility type: hospital. Vaccine administered at military facility: no. The patient experienced high fever (over 102, 103.7, 102.7, 99 or 100) on 04Apr2021, blurred vision on 04Apr2021, headache on 2021, horrible chills on 2021, night sweats on 2021, shaking like crazy on Apr2021, has no energy on Apr2021, had been feeling tired and rundown on 2021, it was double vision, like looking in a fun house mirror on Apr2021, he was still freezing on Apr2021, did not feel like himself on Apr2021. On Saturday, her brother was out shopping with her and stated that he felt very tired and run down and had a headache. He started running a high fever but stuck it out at home. On 04Apr2021, he was taken to the emergency room and admitted to the hospital. They had been running test after test and can't seem to find anything wrong. The doctor thought that it was some kind of reaction to the vaccine. The patient was still running a high fever over 102 and was still experiencing fatigue and headaches on and off, and horrible chills and night sweats. The patient wanted to wait until the day after Easter to go to the hospital but started experiencing new symptoms. He was starting to experience blurred vision. Was then taken to the emergency room. The fever went down with Tylenol but continued to go up again when Tylenol wears off. Temperature was 103.7 at one point and has mostly been over 102, stating that this morning was 102.7. It had been one week that he was still having these symptoms. It was strange because the patient was feeling all right for the first 2 weeks. At the hospital, they kept giving him Tylenol to bring the fever down. He had been shaking like crazy. Had horrible chills and night sweats. He had no energy. He had not had the second dose. They cannot find anything else wrong. He was a health nut and run five miles a day. Took good care of himself. He seemed ok the first 2 weeks. Had been a week that he still can't break the fever. When looked up the symptoms, he had everything except for nausea. He also had blurred vision. They did a spinal tap, echocardiogram, EKG and blood work. He had seen 5 different doctors. The fever was highest at 103.7 and has consistently been over 102. With Tylenol, it had gone down to 99 or 100 but always shoots back up. 2 weeks after the shot, he took his temperature and wasn't feeling good all day. He stayed home from Wednesday until Sunday when he started experiencing new crazy vision symptoms. Stated that started Saturday. He was taken to the hospital on Easter and was admitted to the hospital, and was still there. The vision problem was new and it started to develop Saturday night. It was double vision, like looking in a fun house mirror. He still experienced the double and blurry vision now but only occasionally, when he tried to get up. It was on and off when he had to get up to go to the bathroom. He was still freezing and had shake and chills. He got night sweats and fever, chills, and did not feel like himself. The reporter didn't think he had high cholesterol or high blood pressure, diabetes, or anything like that. Tests: They did bloodwork, CT scans, MRI of the brain, echocardiogram, EKG, spinal tap. There were no white blood cells found in the spinal tap and that the echocardiogram was good. Everything came back normal. He had seen cardiologists, neurologists, gastroenterologists, primary care doctors, and no one can find anything. They did another kind of test regarding his vision. Her brother was depressed and wanted his energy back. It had been a whole week. The outcome of the events high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision was not recovered, outcome of the remaining events was unknown. The patient was hospitalized for high fever (over 102, 103.7, 102.7, 99 or 100) and blurred vision from 04Apr2021 to an unknown date. The reporter was not sure if this was happening because of the vaccine. Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.

severe chest pain and left shoulder down to hand and neck; severe chest pain and left shoulder down to hand and neck; internal swelling; Feeling discomfort; unable to perform daily activities; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), via an unspecified route of administration, administered in arm right on 30Mar2021 13:00 (at the age of 63-years-old) as a single dose for covid-19 immunization. The vaccine was administered. The patient medical history included diabetic and blood pressure. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), administered in arm left on 09Mar2021 11:30 PM (at the age of 63-years-old) for covid-19 immunization and had left shoulder joint pain for about 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was reported that after the second dose, on the second day (reported on 02Apr2021 at 06:00 AM) had to go to emergency hospital due to severe chest pain and left shoulder down to hand and neck. Developed internal swelling 10 times more than normal. Feeling discomfort and unable to perform daily activities. The events resulted in Emergency room/department or urgent care, Hospitalization for 1 day. No treatment was received for the events. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill; high fever" of 104; really bad pain in his arm; delirious and out of it; This is a spontaneous report from a contactable nurse (patient's wife). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sick from Dec2019, down to the eye, diarrhea and fever. There were no concomitant medications. The patient experienced high fever" of 104, had really bad pain in his arm, was delirious and out of it and he was very ill on 08Apr2021. The reporter also stated that the patient also was unconscious at times, perspiring profusely, had bad cough, was coughing until he throws up on an unspecified date. The event pyrexia was assessed as life-threatening and pain in arm was assessed as disability by the reporter. The patient underwent lab tests and procedures which included fever: 104 on 08Apr2021. Therapeutic measures were taken as a result of pyrexia included Tylenol. Outcome of the events was unknown. Information on about lot/batch number has been requested.; Sender's Comments: The information currently provided is very limited, hence the reported events are conservatively assessed as related to the administration of the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Chills, Fever, Chest Pains, Lungs Hurt to Breathe, Extreme Weakness, Joint Pains and Burning, Heart Racing, Headache, Neck Pain, Diarrhea, Slight Swollen Thyroid. Arm Soreness With my first shot, all I had was a sore arm for 4+ days. The second shot I has diarrhea the day before going to be only to wake up in the middle of the night with all of the above symptoms at 4:00 AM, By Noon that day, I was fatigued but able to go to work. A week later, I had chills again and lost my taste and smell which I had a majority back from having COVID-19 3 months earlier.

Started with moderate arm pain about 11 hours after injection. Progressed to fatigue, moderate muscle and joint pain and slight fever over the next 12 hours. Felt terrible for about 24 hours and slowly began to feel better within 48 hours.

Slurred speech, drooping left upper lip, feeling funny. One episode at @ 9:00 am, second episode @ 3:00 pm on the same day. Treatments at ER: Plavix, IV fluids

got shot around 10 am . At 7pm i was in bed and had a peak temperature of 104.6 . Next day i had fever of 102+ even after 2000mg of Tylenol . Temperature still 101+ that evening . Next day still felt bad and had temperature over 100 . have normal temperatures today

Less than 24 hours later experienced severe dizziness, almost passed out. took me 20 minutes to regroup to be able to drive back to jobsite. The next day ,I was shakey ,but I got threw half of the day. On friday ,I drove from Cape Cod to Maine. I was doing fine ,but I had another spell

First: April 25~27: Sore Arm, similar to a bruised muscle. Second: April 27 my right forehead just below the hairline and in the right ear area where the top of the ear meets the head, had minor itching and were turning red. On April 28. Hives began on my left arm's lower wrist and in the general area of my right leg's knee. The hives became more numerous in these areas until a general red rash condition was appearing between them as well. By Saturday Morning May 1 the knee and wrist areas were noticeably red like a rash and hives were also appearing with itching below the right knee on the upper half of my shin, above this knee, on my right lower wrist and on my left lower fore arm. My right ear was starting to swell at just the top. I tried putting Gold Bond Medicated Powder on these areas, but it didn't reduce the itching much. Sunday May 2, I called my mom who is a Registered Nurse about this. She advised going to my health care provider to substantiate these symptoms. Monday May 3 I visited my health care provider's office after work and got an appointment for Tuesday at 10:15 from a cancellation. One of their RN's looked at my hives and rashes. New hives had now also formed on my left leg just below the knee on the back side. It was a red string of itching a couple inches long. I called my boss Tuesday so I could take the day off for the appointment and he agreed that I should do this. At the doctor's office, PA-C after extensive questioning and examination said he thought this was an allergic reaction possibly related to the polyethylene content of the vaccination. He further advised that I not get the second shot until I was checked by an allergist. He put in a referral for this. I think I picked up cold-like symptoms (sore throat and cough) from the doctor's office that were minor. Wednesday morning I had much worse symptoms. I was weak, groggy, couldn't think without great effort, was more itchy, and my right knee was starting to ooze. I called my boss at work to take the day off since I was quite sure driving would be risky, and that I would have to leave work early for lack of energy. My right front thigh had a new area of hives along with my right and left fore arms. I started treating all my affected areas with Caladryl topical Analgesic and taking generic Benedryl. I had breakfast and then slept until 2:30 PM, had lunch and slept until evening. By then my forehead and right ear areas had reduced in severity. I had lost (2) days of work. The rest of the week, all my symptoms diminished. As of this writing Sunday May 9, my knee is still tender, sore, and red, and left wrist hives are still pronounced.

patient stated that he took the vaccine on 3/24/21 and a few days later is when he started to experience ringing in the ears. He stated he thought he slept wrong on his neck and maybe the ringing was due to that. He doesn't c/o any other symptoms besides trouble sleeping and hearing (a high pitched sound). Patient stated he's tried tylenol and ibuprofen and its not helping.

Received first vaccine on 3/17/2021 - had mild shoulder pain. Received 2nd dose on 4/6/2021. After second dose I have had severe shoulder pain - both shoulder and mild hip pain on both sides. The shoulder pain is severe enough that I can't put on my own shirt, coat and trouble with putting on socks due to shoulders leaning forward. Shoulder pain is in the area where shoulder and upper arm connect. I saw a internal medicine physician on 5/7 and he is sending me to sports medicine physicians 5/14 - my pain is not due to an injury, it was mild after first vaccine but has been severe after 2nd vaccine. I am taking no medication besides Aleve before bed but in pain while sleeping and when I get up. Pain is constant when moving shoulder or hips. If I drive for more then 1 hour, my hips are in pain and I need to get out of car and walk around.

You gave me shingles thanks alot for the warning. Severe muscle pain entire upper body. Rash from outbreak. Inability to sleep due to not being able to rest for 5 days. Hard to breathe. Worst 5 days ever for a totally healthy person.

A blast of pain in the right side of my head woke me up out of a sound sleep, i think i heard a slight pop right before and as soon as the intense pain came, it radiated outward and away from between my temple and right ear upward and was gone in a matter of 2 to 3 seconds. I have never felt anything like this, or scare me as much to make me think it might be life threatening as this. I couldnt sleep right after for 1.5 hours and I emailed my primary doctor immediately. In the morning, I spoke on the phone to 2 Nurses at my docs office before bs. hours who advised me to go to the emergency. rm for a CTA and did. I've never really had headaches that have amounted to much.

Diagnosed with a blood clot; Diagnosed with stroke; not feeling well; wakes up at night; Numbness of left hand and mouth; Numbness of left hand and mouth; Constipation; severe headache, described as he felt his eyes were exploding out of his head.; Temperature of 100.2; Could not sleep; This is a spontaneous report from a contactable consumer (spouse reporting on behalf of husband). A 63-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing rheumatoid arthritis started few years ago, ongoing back pain (for many years), ongoing pain (for many years) (patient is a farmer 'seeing another doctor' for back pain/pain, testis cancer from 1986 and ongoing. Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from an unspecified start date ' a few years ago.' and ongoing; tramadol (TRAMADOL) taken for back pain from an unspecified start date ' for years' and ongoing. Vaccine was not Administered at Military Facility. No other vaccines were given within 4 weeks. No additional vaccines were administered on the same date of the Pfizer suspect product. The patient experienced diagnosed with a blood clot, diagnosed with stroke, numbness of left hand and mouth on 12Apr2021, severe headache, described as he felt his eyes were exploding out of his head, temperature of 100.2 (in the evening.) , could not sleep on 03Apr2021, constipation on 05Apr2021, not feeling well and wakes up at night on an unspecified date. The patient was hospitalized for stroke and blood clot from 12Apr2021 to 14Apr2021. The patient underwent lab tests and procedures which included body temperature increased: 100.2 on 03Apr2021; computerized tomogram: first cat scan, a blood clot was diagnosed on unspecified date., computerised tomogram head: unknown result on an unspecified date, electrocardiogram: unknown results (husband was not having a heart attack) on 12Apr2021 , laboratory test: unknown results an unknown date , sars-cov-2 test: negative on 12Apr2021, computerised tomogram: negative on an unspecified date. Treatment was given thrombosis, Stroke, Headache, Insomnia. On an unspecified date patient contacted his primary care doctor and was told to take some extra Motrin, twice a day but Motrin was not effective for his headache. The patient was not feeling well he went to his primary care doctor. Caller states her husband was at his doctor on 07Apr2021, and he went to radiology for a Cat Scan on an unspecified date and the results was negative. He had lab work drawn and a CT of the head. Her husband was given a medication to help him sleep, medication not specified. Caller mentioned she rescheduled her husband's second vaccine. On 12Apr2021, in the evening when he was getting out of the shower, he developed numbness in his left hand, and added later in the report, numbness of his mouth. Patient went to the emergency room, where they performed several tests, Multiple Cat Scans. Results of the first Cat Scan, a blood clot was diagnosed, and an EKG because they thought he may be having a heart attack but it was confirmed he was not having a heart attack.. When her husband was in the emergency room, they did a Covid test and it was negative. The patient was diagnosed with a blood clot and got Tissue plasminogen activator. At 7:33 pm, when he was given tissue plasminogen activator. After the treatment, the headache went away, but she is not sure if he has lasting effects. He was admitted to the Intensive Care Unit and was in the hospital for two days and diagnosed with a stroke, but he was able to walk out of the hospital. The patient still gets an ache in his head, and it comes and goes. Caller states it seems that these events were not coincidental, as they all happened after he got the vaccine. Since her husband has been home from the hospital, he is sleeping better but normally does not get a full night of sleep, and he usually wakes up at night and husband gets constipated when he takes Motrin. Caller mentioned that her husband is not fully constipated anymore, but he feels that his system is not back to normal. Caller assumed the stroke has cleared up, but is not sure. Caller rescheduled her husband's second vaccine, and she is not sure her husband should get the second vaccine. Caller states if these events were caused from the Covid vaccine, what will happen in the future? The clinical outcome of the events Clot blood, Stroke, malaise and wakes up at night was unknown; Numbness of left hand and mouth was recovered on 12Apr2021, Fever was recovered on 04Apr2021, while headache and Constipation was recovering. Follow up attempts are needed. Further information has been requested.

He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to the Parkinson's. He got more confused, more dizzy, and worsening of his Parkinson's. He was very thirsty and drank a lot of water (4 liters of bottled water). He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body. He was urinating more than he normally does. He started getting harder for him to breath. He noticed he had a bad taste in his mouth similar to when he had the COVID virus. He got a horrible splitting headache/migraine type that kept coming and going. He still has the taste in his mouth, and it affected the taste of food. These were all symptoms similar to when he had COVID. The headache was worse than when he had the virus. No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half. He is not having to drink as much as he did before and not feeling like he was dehydrating. Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved. He also had a sore throat which he still has. He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two. He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease. His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.

Soreness and pain, sometimes very sharp, in upper arm in area of injection since receiving first dose. Arm was still sore when second injection was received on 5/5/2021. Upper arm area around injection area is still very sore. Sharp pains are a constant. Pain makes a sound sleep almost impossible at night. Pain disrupts sleep and must put my arm above my head to help lesson the pain. I will be making an appointment to my primary health care provider in near future.

Continued soreness and sharp pain in upper left arm since first dose; Disrupts sleep and concentration; Disrupts sleep and concentration; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left arm on Apr2021 10:00 am as 1st dose, single dose for COVID-19 immunization. The patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration in left arm on May2021 09:00 am as 2nd dose, single dose for COVID-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. The patient's concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. 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 Apr2021, the patient experienced continued soreness and sharp pain in upper left arm since first dose. Disrupts sleep and concentration. The events were assessed as non-serious. The treatment was not received for the events. The outcome of the events was reported as not recovered.

uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6203), via an unspecified route of administration, administered in Left arm on 04Mar2021 16:45 as 2nd dose, single dose; and previously took 1st dose of BNT162B2 for COVID-19 immunization. No covid prior vaccination and no known allergies. The patient medical history and concomitant medications were not reported. No vaccines within 4weeks. On 04Mar2021 17:00, 18 minutes after vaccination, patient upper Right lip began to swell, slowly. 30 minutes later when home it was very noticeable and uncomfortable. patient reported it was only point of concern. 6 hours later after 2 Tylenols, the swelling has decreased, Somewhat. No covid tested post vaccination. Patient reported no treatment was received. Patient was not recovered from events. No follow-up attempts are possible. No further information is expected.

Within 2 hours of 1st Pfizer COVID injection pt had sudden onset left-sided paralysis with facial droop and slurred speech and then brief loss of consciousness with loss of bowel and bladder function. This happened on 5/21/2021. His wife is here giving the history. Him and his wife have the first Covid injection by Pfizer on 5/21/2021 at 3:30 PM at pharmacy. Within 2 hours they were back home sitting on the porch relaxing and he had the sudden onset of stroke like symptoms as noted above. EMS was called. Apparently by the time EMS arrived he had recovered to baseline and they advised him he did not have to go to the hospital for evaluation if he did not want to apparently. Since that time he has had no further stroke like symptoms but has continued to feel a bit foggy in the head with a slight dizziness.

Joint pain, unable to raise arm over head, then some improvement, now seeming worse- pain sleeping on shoulder, pain using shoulder, limited range

Intermittent chest pains starting 3 days after second injection lasting about 7 days. Pain was sufficient to disrupt sleep and was more noticeable during period of rest / low heartrate. Also had intermittent severe fatigue over same 7 day period.

Inflammation around sinus area, ears, eyes, and lower back of head. Dizziness and balance problems. Brain fog (impaired thinking). All symptoms continued to get worse for 2 weeks after initial dose. Took 1600 mg of ibuprofen daily to reduce symptoms with limited success. Stopped ibuprofen after 1 week due to upset stomach. Used natural anti-inflammatories (alpha lipoic acid 600 mg).Dizziness and balance problems improved and were mostly resolved by the end of week 4. Brain fog slowly improved and mostly resolved by the end of week 5. Inflammation in head still present around right ear even after week 7. Inflammation is the worst sleeping flat on back. Must sleep in reclined position.

feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away. On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.

COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT. CANT SLEEP AT NIGHT AFFECTING MY JOB . MISSING TIME FROM WORK. NECK PAIN LEFT SIDE. PAIN IN MY CHEST LEFT SIDE. PAIN IN LEFT SIDE ARMPIT.

At 8PM the day after the shot I felt chills as if I had a fever. I went to bed and woke up at 2AM. The fever was gone but I felt a swelling in my left armpit (the arm in which I had the shot). For several days I could not raise my left arm more than half-way. On the 5th day after the shot I could raise my arm straight overhead, but it was difficult and painful. By the 8th day the arm and armpit were back to normal.

On the week of March 14, symptoms started mild and by the following week they were unbearable. On both legs, my muscles from my hips to my ankles became fatigued and got burning sensation when I was just standing up or sitting down. The pain was mostly relieved when laying down. I did not sleep well. Also, I got fevers only at night when asleep. Measured about 101 degrees temperature. Got up with tee shirt wet with sweat. On March 22, I went to my doctor and did some blood work and was told I had a lot of inflamation. Started on Prednisone. Went to RA doctor at Rheumatology on March 30, and went to an infectious disease doctor. I was told that I had an auto-immune response. I was on Prednisone from March 25 to May 16.

This is a spontaneous report from a contactable consumer or other non HCP (patient himself). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (at the age of 63-years-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus diagnosed decades ago and wasn't feeling good from Dec2020 to an unknown date. The patient's concomitant medications were not reported. The patient took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 10:00 AM as 1st dose, single for COVID-19 immunization and no reaction on exposure to vaccine. The patient had no history of previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated he went to the hospital because he wasn't feeling good in Dec2020 of last year and all the test results were fine, so he got his first vaccine, believes it was, 05Apr2021 for the first dose and 27Apr2021 for the second one. After that, the patient had extreme itching in his body and his liver enzymes are off and he just wanted to report what was going. The itching began after the first shot in Apr2021. He had to go to the hospital one time, and he had to go to the doctor 3 times, they say liver enzymes are off. He has a copy of the test. The patient stated prior to that, they were way higher when he went to the doctor. The patient's blood urea nitrogen (BUN) was 25 high, Aspartate aminotransferase (AST) was 100 high, Alanine aminotransferase (ALT) 176 high, alkaline phosphatase was 318 high, albumin was 3.2 low. He was also lost like 30 pounds. He has been experiencing extremely dizzy. Sometimes he stands up and he feels very dizzy and sometimes he feels strange, he has no other way to explain. He doesn't feel himself. He stated 8 days after the shot, he started feeling bad. It all started all together. The patient stated Pfizer can get that information from the doctor, he doesn't feel so good to keep up with that. The patient stated the extreme itching and extremely dizzy was worsened, that's why he had to go to the emergency room on 11Jun2021. Regarding the liver enzymes were off the patient stated, Pfizer can speak to the doctor. His doctor knows who he was and will give specifics. According to his doctor, the doctor was going to report it wherever it has to be reported to. He doesn't feel good, he was itching, and he doesn't know what to do about it. The event extreme itching and extremely dizzy required emergency room and physician office visit. The outcome of the events extreme itching and extremely dizzy was not recovered. The outcome of the events liver enzymes are off, lost like 30 pounds and he feels strange was unknown.

the patient experienced left knee joint pain and creeking; I wanted to die rather than endure the pain any longer; 6 hours of all joints pain and body aches; Worried I won't be able o walk or use my hands again; 6 hours of all joints pain and body aches/Left knee joint pain and creeking/Now right knee and all joints hurting all the time.; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: En 6198 en 6207) via an unspecified route of administration, in left arm on 18Mar2021 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 27Mar2021 at 03:00, the patient experienced left knee joint pain and creeking. 6 hours of all joints pain and felt like he wanted to die rather than endure the pain any longer. He said that right knee and all joints was hurting all the time. Worried he won't be able to walk or use his hands again. Have read online of others the same. On 12May2021, the patient underwent lab tests and procedures which included negative sars-cov-2 test (nasal swab). The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Patient received steroids as treatment for the reported events. Outcome of all events was not recovered. Information on the lot/batch was available, Additional information has been requested.

Day after 2nd shot I had most all my covid symptoms (heavy fatigue, brain fog, bad constipation, stomach pain. severe joint pain that moves all over my body. 5 plus nights get chills and bad head fever. My breathing progressed worse as time went on and was hospitalized 7/1/21 with covid pneumonia, they worked hard and got it controlled fast and was released late 7/2/21. Now I am working from home on oxygen and quarantined.

Started with chills/fever spike, loss of touch/feeling in extremities (fingers, toes). These started approx 12 hours after injection. Has now been 2 and a half months. Have issues with anxiety, muscle aches, weakness in legs. Experienced pulled tendon in left arm accompanied by extreme bruising down arm. Developed cancerous lesion on lower lip (squamous cell carcinoma).

Prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and Antibody Blood test came negative; Prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and Antibody Blood test came negative; Shocked and disturbed that vaccine will not work; incredibly dangerous circumstance; Vaccine no longer viable; This is a spontaneous report from a contactable other hcp. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 15Apr2021 as dose 2, single, dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included Diabetes type 2, obesity. Concomitant medication(s) included prednisone (PREDNISONE) taken for skin disorder, start and stop date were not reported. On an unspecified date the patient experienced prednisone taking and received vaccine; should not been vaccinated; vaccine completely ineffective and antibody blood test came negative, shocked and disturbed that vaccine will not work; incredibly dangerous circumstance; vaccine no longer viable. He was prescribed by a Dermatologist with # Steroid Prednisone and he is been taking it since March till present but in Apr2021 he receives his first dose of Pfizer Covid-19 vaccine and as directed later he received his second dose, but he became fully vaccinated against Covid-19 virus in the Month May2021. was taking prednisone each time when he received Pfizer Covid-19 vaccine shot which was administer to him at that point of time. There was absolutely never any warning that he should not been vaccinated while taking # prednisone. And mentioned that he heard a tragic story of a women who took immunosuppressant drug and who was also vaccinated for Covid-19 vaccine at that time when she was taking immunosuppressant drug. She subsequently learned that Covid-19 vaccine was completely ineffective because she was taking immunosuppressant drug at that time she was vaccinated where the story was in the news title about 3 weeks ago after that story the consumer learned prednisone just not steroid but also classified as a immunosuppressant drug. he had a discussion with two Medical Doctors in last couple of weeks the results of Covid-19 antibody test that he had yesterday showed that prednisone he had been taking rendered his Pfizer Covid-19 vaccine ineffective. He was on Prednisone 10 mg tablet white in colour bearing the twice a day and every other day that was prednisone dosage and He has been taking steroid that is the prednisone over a year at various dosage to manage Dermatological disorder as it is a result of ingredient in a Blood Pressure medication, and he had his second Pfizer Covid-19 Vaccine shot on 15Apr2021. The patient underwent lab tests and procedures which included antibody test was negative. The outcome of events was unknown. Description of Product Complaint: Reporter stated, "He was saying that it is not effective because of vaccine drug interaction the antibody test negative. There is also nothing else. Consumer stated that he had a discussion with two Medical Doctors in last couple of weeks the results of Covid-19 antibody test that he had yesterday showed that prednisone he had been taking rendered his Pfizer Covid-19 vaccine ineffective." Information about lot/batch number has been requested.

it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown. Information about lot/batch number is requested.

Patient/patient's wife reported reaction as "inflammation" and lack of energy/stamina with things such as climbing stairs, difficulty with normal activities that require exertion. Reports that normally he is active, fit and healthy, and that he has been having issues since the day after his second shot. Was treated by urgent care with prescriptions for azithromycin and prednisone filled 6/12/21, saying Dr. at urgent care was thinking possible pneumonia, but treatment did not help per Gregory's wife. This was reported to pharmacy today 7/19/21. Wife reports that he is still not improved.

SECOND SHOT: He felt nauseated; His hiatal hernia had gotten worse since his car accident; Reported his neck was injured; my head just Spun; I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up; might have messed up my certain position of my neck and I had neck issues; SECOND SHOT: he had gotten real dizzy; SECOND DOSE: He passed out behind the wheel of his 2015 Mitsbushi Eclipse the day after he had his second Pfizer COVID-19 Vaccine; SECOND SHOT: he felt antsy after he got the vaccine shot; FIRST DOSE: with his first Pfizer COVID-19 Vaccine shot, he was down for a week; FIRST SHOT: he felt antsy after he got the vaccine shot; SECOND SHOT: He felt really weak now; This is spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0161 and expiry date 31Jul2021) via an unspecified route of administration on 15Ap2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: EW0176 and expiry date 31Aug2021) via an unspecified route of administration on 06May2021 at 12:00 hours (at the age of 63-year-old) on right arm as dose 2, single for COVID-19 immunization. The patient's medical history included Stomach cancer, 14Feb2021 after being exposed to heavy metals. The patient's concomitant medications were not reported. Reported he had an adverse reaction to the Pfizer COVID-19 Vaccine. He said it had been one heck of a ride, and he felt like the Pfizer COVID-19 Vaccine almost killed him. He passed out behind the wheel (of his 2015 Mitsubishi Eclipse) the day after he had his second Pfizer COVID-19 Vaccine, and he knew it was the Pfizer COVID-19 Vaccine shot because he felt antsy after he got the vaccine shot. He said he felt antsy after his first Pfizer COVID-19 Vaccine shot, too and with his first Pfizer COVID-19 Vaccine shot, he was down for a week. Reported his doctor seemed to be the least concerned about him being knocked out. His doctor did not appear to be receptive to what his complaints were after he received his second Pfizer COVID-19 Vaccine shot. His insurance company was aware he was going to change doctors. The patient reported that he collapsed on 14Feb2021 after being exposed to heavy metals, and was hospitalized, stating his primary care doctor had not helped him at all. On an unknown day he felt nauseated. It was reported on 07May2021, the day after his 2nd Pfizer COVID-19 Vaccine injection, he felt antsy by the time he got home, threw his body in bed, and was down for a day. He felt nauseated, but (on 07May2021) did some sheets at the laundromat. While coming home he had gotten real dizzy, and passed out. He ended up flooring the gas pedal on his car, and bounding over the curb in his apartment complex's parking lot. He bounced his head on the front passenger side seat. He clarified he passed out over the center console of his car, and his rib cage went over the car's center console. His head bounced off of the passenger seat. He said his rib cage was pushed up inside him when it hit the car's center console, and had to do something to his insides. He said it was a one car accident, and his apartment manager may have the car accident on film. He was looking in three directions and my head just Spun, I get the sick feeling. Reported his car accident caused a tear in his hiatal hernia in his stomach and he needed surgery. Reported his neck was injured. He had follow ups with his doctor since then, and his neck had been getting worse. He felt like something foreign was stuck in his throat, so he went to the Emergency Room (on 22Jun2021). The patient needed to see an endoscopy doctor to be ruled out for stomach cancer. He was told by the Emergency Room doctor that he had a mass in his stomach, and his hiatal hernia needed repair. His hiatal hernia had gotten worse since his car accident. He stated that he went home and laid down after his car accident. He said he felt ok and had his own pain medication to take to help recover from the car accident. He clarified he took Hydromorphone that was prescribed by his pain doctor. He did not have the Hydromorphone , Lot, and Expiry Date. He had an appointment on 23Jul2021 to see doctor for a new Hydromorphone prescription. No further details provided. The patient reported he was concerned about the stomach thing. He recalled his stomach swelled up after his car accident. He tried to take oxygen through a CPAP machine after the car accident to help him feel better and using the CPAP machine was not normal. His CPAP machine worked perfectly before the accident, but now he had a problem, and could not take the CPAP machines pressurized breathing. He now fought to get a breath while the CPAP machine was pushing oxygen in because he was trying to push his breath out at the same time. He felt really weak now, and the CPAP had helped all along. I did passed out behind to wheel of my car and 'it doesn't stopped'(Further not clarified) and I didn't have any information to you because all the information I had is in back of my car. The first shot I was given 09Apr2021 no 15Apr2021 looks like, I think this was she said worked down 15Apr2021 (Further not clarified), second shot I received on May 6, but on 07May2021 at 5 pm I just passed out upon pulling into my Apartment complex and the snakes you known 'just slow you down'(Further not clarified) you know of course I didn't have any problems to slow down but there were 4 cars behind me, I am looking at the cars, I am looking at the rare view and I am looking ahead of me to make sure , you know I am following 'snake' and everything's being cool and I am been forced to go fast what I mean I was driving car but I was looking to those 3 different areas my head just Spun, I get the sick feeling and passed out and my head ended up in the passenger seat and bounced up and I think I might have messed up my certain position of my neck and I had neck issues, that happened on 07May2021, the day after the second Covid shot, I think if I had not gotten, if I stayed down may be the thing better but First time I got the first shot, it was 3 months the same thing I felt the same like I have to be really careful you know what I did, if I did it (Further not clarified, hence event not captured ). The second one I didn't feel that way. The patient required emergency room and physician office visit. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

11 days after 1st shot, I woke up not remembering anything or knowing were I was. An ambulance transported me to the hospital with stroke symptoms. At the hospital I was diagnosed with a mild stroke, TIA. My memory of the events never came back but my consciousness returned about 10-12 hours later. I was released from the hospital when stable to my Son's care, a medical doctor to watch me. I also had a fever for three days after the second shot which was 3 weeks after the first shot.

After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has severe pain in area. This limits pt's mobility.

small stroke; TIA; blood clot; completely blind; went blind in his right eye; weakness in his left arm; headaches; Fatigue; was sleeping 12-14 hours; did not feel right/kept telling everyone how bad he felt; dragged left leg; not able to raise his legs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient (height:173 cm, weight: 74.84 kg) in perfect health received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8737) at 0.3 mL, single dose, in the left arm, on 07Apr2021, for COVID-19 immunisation. Relevant medical history included stent placement on an unspecified date (had just had stents put in before getting COVID-19 shots). The patient previously, on 16Mar2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6268) at single dose, in the left arm, for COVID-19 immunisation. The patient did not experience any adverse reaction after the first dose. No problems with vaccines in the past. No further details provided. The patient received concomitant medications (unspecified). On an unspecified date, in 2021, the patient had small stroke/ transient ischaemic attack (TIA), blood clot, experienced blindness (he went blind in his right eye for about 30-40 minutes, completely blind), weakness in his left arm, headache, fatigue (became very fatigued), he was sleepy (was sleeping 12-14 hours), he was feeling bad (did not feel right/kept telling everyone how bad he felt), leg dragging (he dragged left leg) and he was not able to raise his legs. The patient went to emergency room and they said it was a small stroke or TIA. It was reported that it was a blood clot that went through his head and that was where the blindness came from. A lot of blood work were performed at the hospital (unspecified result). Clinical outcome of the adverse event blood clot was unknown, while clinical outcome of the other events was recovering at time of this report. Follow-up attempts are completed. No further information is expected.

Confusion, numbness right cheek bone area, difficult to talk and concentrate for around 15-20 minutes. Felt better and didn?t seek treatment till next day, never heard back from Dr.

Headache, Myalgia, injection site pain Narrative: Side effects began the day after Injection: site pain, significant myalgia and arthralgia, could not walk his dogs, rigors without fever, chills-has to take Acetaminophen every 6 hours, frontal headache. States fatigue is "disabling" Has had to take time off of work.

I felt slightly light headed; I felt a slight disorientation; a very heavy feeling in the center of my chest; hip joint pain sever enough; This is a spontaneous report from a contactable consumer reported for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PFREH9899), via an unspecified route of administration at left arm on 29Dec2020 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing Chronic hip joint pain. Concomitant medication included celecoxib at 100mg once daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Dec2020 at 16:30, after patient left the observation tent, while walking to his car, He felt slightly lightheaded. Upon reaching his car he felt a slight disorientation and a very heavy feeling in the center of his chest. These symptoms lasted until he reached home which was about a 15 min drive. Once at home he experienced hip joint pain sever enough that he had to stop being mobile. All symptoms disappeared within 1-2 hours except for the heaviness in the center of his chest. This lasted for about another hour. After that no more issues. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.

Moderate left arm pain at injection site. Diffuse muscle and joint aches, migratory lasting 36 hours. Headaches,24 hours Increased nasal congestion 24 hours Moderate fatigue 36 hours Insomnia 2 nights Chills for 4 hours beginning 30 hours after injection Low grade fever beginning same time as chills and lasting for next 12 hours terminating with sweats

tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontaneous report from a contactable Physician (patient). A 64-year-old male patient reported received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176 and expiry date: Mar2021) via an unspecified route of administration on 10Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history bypass surgery (10.5 years ago, in June it will be 11 years ago) and hard of hearing. Patient said he used to be 5'7" but right now he is 5'6" or 5'5". He says that change in his height happened before he got the vaccine, that is effects of being short. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and simvastatin. It was reported that the patient had been healthy all his life, he doesn't have any medical conditions which could have contributed to side effects. He does not think they would have contributed but he takes Simvastatin and Baby Aspirin. The patient got the vaccination, the first one (BNT162B2 for COVID-19 immunization, on unspecified date) he did not have anything happen, no side effects or nothing. It was as if he didn't receive any vaccine. The second dose he received it at 8:45 AM on Sunday (10Jan2021) and Sunday night he began experiencing tiredness and then chills, fever, generalized aches and could hardly sleep through the night. It was reported as the worst night in his life and then, fortunately during the day on Monday, gradually, the intensity and severity of the symptoms began to subside but he was not able to do any of his normal functions. Then last night Monday night (11Jan2021) he slept well and today on Tuesday (12Jan2021) he was okay, this morning everything was fine. On Tuesday night he took Acetaminophen for pain, he clarified that was Sunday night after he had gotten the vaccine he took Acetaminophen and he still had the problems then Monday night he thought it would be the same so he put the medicine next to the bed on the night stand but he did not need to take it. He slept and woke up this morning and his back to work. Now it is like nothing has happened. He has recovered completely from all effects. The outcome of the event could hardly sleep through the night was recovered on 11Jan2021 and all the other events recovered on 12Jan2021.

feels tired; Exacerbation of anxiety; feels shaky; feels flushed; feels like his pressure his up; Jitteriness; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 at single dose on Left arm for covid-19 immunisation. Medical history included ongoing anxiety (had for many years), Quadraple Bypass from 2008, TAVR valve replacement from 2020, Pegylation of lung from Mar2020. There were no concomitant medications. The consumer reported he took Covid 19-vaccine (Verbatim): for protection from Covid-19 because he has comorbidities, had a few ailments. The patient experienced feels shaky, feels flushed, feels like his pressure his up, jitteriness on 11Jan2021, feels tired and exacerbation of anxiety on 12Jan2021. The event outcome of feels tired was recovering, outcome of other events were not recovered. Information on the Lot/Batch number has been requested.

fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one. He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.

He states that he received the vaccine on 2/20 and three days later developed a red rash on his chest and back that has not completely gone away. He states that on 1/25 he developed nausea and vomiting to the extent that he missed work both of those days - this has resolved.

15 minutes after second dose of COVID 19 vaccine patient was brought to nurses due to lip swelling. Patient took personal liquid benadryl prior to nurses. Unsure of dose patient states took "2 large swigs". VS taken. 911 called by patient refuses ambulance dispatch. Patient denies need to go to hospital states already took own benadryl and they will not do anything else. VS monitored q 5 minutes by nursing. House supervisor called and down to speak with patient. Patient denies difficulty breathing. Continues to deny need for ambulance to hospital for assessment. Patient alert and oriented and carrying on conversation without difficulty. No further increase in lower lip swelling noted by nursing. Nursing noted some flushing to face, patient states he does that from time to time but does not notice it but coworkers will tell him he has flushing. No increase in lip swelling but states now feels some nasal congestion. Patient continues to deny difficulty breathing. Patient does states still does not feel "quite right". Patient encouraged by multiple nurses to allow 911 transport. After 15 minutes of monitoring patient now agreeable to be assessed by ER and 911 called. Patient did notify spouse by phone that he was going to requested hospital- hospital Patient continued to be monitored by multiple nursing staff until ambulance arrival and transport to hospital.

After vaccination, patient was okay until the 8 minute remaining mark. At this point patient became lethargic, clammy and passed out. Patient was revived with smelling salts, for a few seconds and the faded in and out of conciseness. Sternal rub was preformed in order to attempt to keep patient awake and present. Vital signs where taken, BP was elevated at 155/ 115. Patient was still not coherent at this point patient was team lifted to wheel chair and taken to the ER. Patient remains in the hospital at this time admitted for observation.

Fever (to 103F), Encephalopathy (Confusion, somnolent) - improved with resolution of fever (with Tylenol)

he has cold like symptoms; Stuffed up nose; doesn't feel really good; pain in the site area; slept a lot and was tired; slept a lot and was tired; his stomach is nauseous and queasy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in Jan2021 (also reported as "around 19Jan2021" or "19Jan2021 or 20Jan2021", pending clarification) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first COVID dose around 19Jan2021 (also reported as "19Jan2021 or 20Jan2021") and now he has cold like symptoms. Stuffed up nose, doesn't feel really good and wanted to know if this part of the COVID vaccine. On the first day, he had pain in the site area, slept a lot and was tired. It has been 10 days since the shot and he had symptoms of a cold and his stomach was nauseous and queasy (also reported as squeezy). The reporter wanted to know if this was a part of the side effects or does she need to call his primary care. She was told about symptoms to watch for within the first seven days and this was well beyond the seven days. The outcome of the events was unknown. Information on the lot/batch number has been requested.

The patient reports fatigue beginning the day of the vaccine, and persisting to the time of this report. He had residual episodes of fatigue (1 per week) after his stroke 11/20, however after the vaccine he has been fatigued all day. His neurologist changed his Plavix to Brilinta on 2/11/2022 due to fatigue, without effect. During these episodes he sleeps excessively He does not report insomnia, dysarthria, focal weakness/numbness, dizziness or fainting, or new memory issues.

I initially felt unease then I felt swelling in my throat with dry mouth and some difficulty swallowing

Pt reported "feeling funny" Pt was brought back to extended recovery room for closer monitoring. At 9:15 vitals were; 134/70 HR87. Pt reported he did not eat breakfast and is "afraid of needles" at 0930 pt vitals were; 118*68 HR 80. Pt declined any further monitoring or treatment and was d/c at 0935 via ambulation accompanied.

PATIENT FELT EXHAUSTED AND SLEPT FOR 2 DAYS. WAKING TO EAT AROUND 8:00 PM. FELT BAD IN HIS BODY, DESCRIBED AS LIKE A HANG OVER AFTER DRINKING. BUT HE DOES NOT DRINK. COULD NOT MOVE AROUND.

Patient was in recovery area per protocol. Patient developed light headedness, diaphoresis, irritability and then collapsed into chair and then floor (helped by nursing staff) patient appeared unconscious but was breathing, oxygen applied, emergency response initiated

Extreme chills started at +/- 8:30 pm. Patient went to bed - fell asleep at about 8:45. Woke up periodically during the night drenched with sweat. Got up the following morning at about 8:00 am. Arm was sore but tolerable. Temperature was 98 F.

Client verbalized feeling of anxiety after receiving the vaccine. Full assessment done by Paramedics. Client was released for home at 4:33 pm. Per paramedics no further evaluation needed. Symptom resolved.

Patient complains of dizziness and balance concerns. This lasted for at least 5 days following vaccine administration. He has not been able to drive.

63yoM with PMH Anxiety, Depression, GERD, Arthritis here for evaluation of rash x 2 days. Pruitic in some spots. Started on L wrist yesterday. Awoke with red spots on face today. Got 2nd COVID19 vaccine (pfizer, with Norton) 48 hours ago. Called hotline and they advised coming for evaluation. Has applied no therapies. Took a single benadryl last night for pruritis. Denies chest pain, dyspnea, wheezing, dizziness. Did yard work 4 days ago and history of contact derm to plants, otherwise no prior history of rash like this.

Next morning I had a static or whooshing noice in my left ear only. Sometimes it is worse than others.I thought it wasn?t cell phone problem and went to repair outlet. It wasn?t that . The sound / ringing in left ear is bad enough that I can?t have a conversation. My right ear is fine.

Patient presented for Second dose vaccine and was vaccinated without incident. During 15 minute observation time patient complained of chills, body ache and stiff neck. BP at 12:45 was 180/100; HR 76. Patient states he is anxious, worries about side affects from vaccine. Denied SOB, no diaphoresis. Patient denied history of hypertension. BP at 12:50 200/100, HR 76, R 18; 12:55 pm BP 180/100 and EMS was called despite patient denying SOB or dizziness. 1:10 PM EMS arrived. BP 176/100, HR 80. Declined transport to hospital and left site at 1:15 ambulatory.

a few hours after getting vaccinated, I got a HUGE migraine headache, nausea and later a rash on my face. I couldn't lay down, had to keep my head elevated. It last almost two day. I felt brain fog for 4-5 days.

Initial shot had no pain on day one. Sore Arm at injection site on day 2 & 3. Feeling chills (feeling cold) in 75 degree weather with blankets on. Night sweats and chills in bed. Insomnia has lasted 3 weeks (sleep about 4-4.5 hours and CANNOT go back to sleep). ZERO History of insomnia before vaccine.

Kidney stone; Blood all over him; Falling down; Wobbliness; No energy; Could not sleep at all; Sweating like crazy; No appetite; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose (at the age of 64-years old) via an unspecified route of administration in the left arm (reported as injection in left shoulder) on 11Mar2021 at 13:00 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative from 1982 and ongoing, ongoing seizure (he had seizures for about 6 years and they got worse, probably it has been 6 or 7 years he has had seizures), high blood pressure, heartburn and insomnia (comes and goes). Concomitant medication included atorvastatin (manufacturer unknown, Tablet) 40mg strength, oral administration, 20 mg daily (half a tablet at bedtime) taken for an unspecified indication from an unspecified start date and ongoing; cholecalciferol (manufacturer unknown, Tablets) oral administration, 2 tablets in morning taken for colitis ulcerative from an unspecified start date and ongoing; escitalopram (manufacturer unknown), oral administration, 20 mg once daily taken for seizure from an unspecified start date and ongoing; lacosamide (manufacturer unknown) oral administration, 200 mg twice daily taken for seizure from an unspecified start date (for approximately a couple of years) and ongoing; lisinopril (manufacturer unknown), oral administration, 20 mg daily taken for high blood pressure from an unspecified start date and ongoing; mesalazine (MESALAMINE, Tablet), oral administration, 4 tablets a day taken for colitis ulcerative from an unspecified start date and ongoing; omeprazole (manufacturer unknown) oral administration, 20 mg as needed (two or three pills daily as he feels like he needs) taken for heartburn and ulcerative colitis from 2001 (approximately 20 years ago) and ongoing and zonisamide (manufacturer unknown) oral administration, 100 mg twice a day taken for seizure from an unspecified start date (for a couple of years) and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the vaccination on 11Mar2021. After he received his first dose of the vaccine he experienced a bunch of symptoms which he listed as sweating, he could not sleep at all the first night, he was falling down, he had no appetite, and had no energy that same day. This occurred after the 15 minute window of waiting after getting the vaccination. On 11Mar2021, after the vaccination, the patient went to the store to buy groceries and started sweating like crazy. He could hardly carry the groceries to the car. He also had wobbliness. On 11Mar2021, the patient fell down and passed out coming home that night and he had blood all over him. He later clarified that he did not pass out, he got into the house and fell down and somehow landed on the recliner. He was covered in blood and all kinds of stuff. On 11Mar2021, he could not sleep at all that first night and his prescription Melatonin (Manufacturer Rugby) 3mg did not help at all. The falling down occurred roughly that same night on 11Mar2021. The patient stated that they told him they thought he was having seizures again but he was not. He had imaging which showed no seizures and Xray of his brain with unknown results in Mar2021. He had to have another Xray to make sure he did not have bleeding on the brain. Xray of his stomach showed kidney stones on 12Mar2021. The patient was not admitted to the hospital. The patient was scheduled to return for the second dose 01Apr2021. The patient inquired if he should get the second dose of the vaccine. The outcome of events kidney stone, blood all over him, could not sleep at all and wobbliness was unknown. The outcome of events sweating and falling down was recovered on 11Mar2021 and no appetite was recovered in Mar2021. The outcome of no energy was recovering. The lot number for the vaccine was not provided and will be requested during follow up.

light headed, somewhat faint feeling. Continued intermittently for over 3 weeks. Intermittently get weird feeling/sensation, like a surge and get weak. Intermittent gurgling basically daily since vaccine. Feels sometimes like heart beats stronger or like maybe racing.

SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite, difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected. LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.

Felt a ball to the throat. B/P 155/88, HR 87, O2Sat 98%, T 97. 12:42pm Patient left Park stating that he feels better.

approximately 24 hours after the second vaccine, I noticed 3 swollen lymph nodes in left neck, same side as vaccine administered. at approximately 30 hours after the vaccine, pain became about a 4-5 on a scale of 10. not unbearable but too uncomfortable to sleep. by 4/4, approximately 6 days after the vaccine, one of the lymph nodes became large and very firm requiring a Dr. visit. My primary care physician immediately referred me who performed a needle biopsy on the reactive lymph node on 4/6. Test results show no cancer cells and determined it was most likely a benign reactive node. It is not known if this is a direct result of the vaccine.

He started to be disoriented while I (daughter) was driving the car. He thought we were in Fort Lauderdale. When we got home he said he was disoriented and did not remember the month we were or the name of our dog. He was checking the phone saying he did never send the messages that were sent by him some minutes ago and did not remember the conversations he had in the morning. He never have had problems like this and we were very surprised. He rested a bit and the disorientation stop about an hour later. He is now feeling fine. My aunt, who is an MD said he should take a cardio aspirin and that's what he did. His blood pressure and temperature were always well. As a reference, he had COVID in March 2020 and was hospitalized due to it but recovered well. He then received the first covid dose in March 19, 2021 and had some fever, chills, and headache but was otherwise fine.

feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.

There was a big amount of blood in the stool and the next day there was blood too; scared; This is a spontaneous report from a contactable consumer (patients son). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6266), via an unspecified route of administration in the left arm on 06Mar2021 at 08:30 as SINGLE DOSE for covid-19 immunisation. On 27Mar2021, at 08:30 the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration in the left arm as SINGLE DOSE for covid-19 immunisation. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 09Mar2021, three days after getting the first shot of vaccine, there was a big amount of blood in the stool and the next day there was blood too, he was scared and never mentioned until 30Mar2021. The event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The clinical outcome of events was unknown.

Received first vaccine on 3/25/21 and had elevation in blood pressure, increased anxiety and had report made out. After 30 minutes, his blood pressure had decreased but stated that he gets almost like a panic attack. Shortly after receiving his 2nd Covid 19 shot, he started to feel very anxious but not at the same level as the first one. VSS at 1:32 pm 150/72 RA sitting; 97% pulse ox-90 HR. He stated that he was anxious just right after receiving the shot.

Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Felt \"unwell\" for 4 days-Medium, Error: Incorrect Reconstitution, Additional Details: Patient states that his right arm feels weaker than normal and is impacting him at this job.

Injection was given on top of shoulder instead of back of arm. Shoulder joint and arm started hurting 30 minutes after injection radiating down arm. Extreme exhaustion and sleepiness but unable to sleep due to pain. Nausea and stomach upset.

I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lot of weird going on/ feeling odd; This is a spontaneous report from a contactable consumer (patient) via support team. Follow-up (08Apr2021) received from a contactable consumer was processed together with initial information. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient received 1 Pfizer dose on an unspecified date three weeks prior to second dose as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 after receiving second dose the patient contracted COVID-19. Further details are as follows: Patient was notified a few hours later that a niece he spent time with on 02Apr2021 just tested positive for COVID. Patient had been feeling odd and attributed it to allergies but after hearing news of his niece he scheduled a COVID test the next morning on 07Apr2021. He got the results that same night that he was also positive. On 06Apr2021, the patient has been feeling alright but have had feeling of allergies kind. The next day he was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so he just assumes what it was. After testing positive the patient spoke to contact centre and he was informed that she had never heard of anybody doing that. Patient was having anecdotes individual here just one case, but it is kind of unusual. He doesn't mind testing for the variant he was having. Patient stated he is having symptoms to the onus. The symptoms of the onus he experienced, Monday 5Apr2021. Outcome of events was unknown. Information about lot/batch number has been requested.

Strong chest pain that lasted several days. One day was so intense I had to sleep upright. I would get winded walking up a flight of stairs. Normally I run 3-4 miles for workouts. I had pericarditis in my 30s and it felt very similar.

Started with a stiff neck turning to the right, then two days later woke up with a feeling of concussion syndrome, vertigo, head nausea, brain fog and then buzzing in both ears, this has been on going since the first vaccine, it got worse after the second vaccine on February 21st . I have had a brain MRI, and Neck MRI both appear normal, I have been checked by ENT for ear issues none noted, being treated by neurologist now for all the head symptoms

Severe feminist in both ears 24/7 with dizziness. Dr. prescribed z pack and a week later thinking it might be allergy related he gave me Flonase. I have had no relief and experience insomnia, anxiety, dizziness and tinnitus 24/7.

Racing thoughts, inability to concentrate, mood swings, confusion, severe insomnia, hyper activity, irritability, explosive anger, etc.

On 04/22/2021, a patient was determined to have pericarditis, possibly secondary to COVID-19 vaccination. The patient received his first COVID-19 vaccination (Pfizer) on 2/27/2021. The patient reported feeling poorly and presented to ER on 03/02/2021 with chest pain and dyspnea. He states the chest pain he is experienced this week is similar to the 2 episodes of chest pain he had after each of the two-step Pfizer COVID vaccination that he received in February 02/27/2021 and March 03/15/2021. He underwent a stress test on 03/11/2021 which did not show any reversible perfusion defects. Of note, the patient had COVID-19 back in October 2020 which manifested with night sweats, malaise for a few days and then cleared completely without any "long hauler" symptoms. The patient was treated with ibuprofen and colchicine. I did not find any evidence suggesting a relationship between pericarditis and covid-19 vaccination. In clinical trials, pericarditis was not statistically significantly different between treatment arms. Other potential causes of pericarditis include atrial fibrillation.

SOB w/exertion, feels foggy in the head, nausea, bodyaches, joint pain, dry cough & severe intermittent L side "ache" (feels like a pulled muscle) Pneumonia due to COVID-19 virus - carvediloL (COREG) 3.125 mg tablet; Take 1 tablet (3.125 mg total) by mouth 2 (two) times a day - HYDROcodone-acetaminophen (NORCO) 5-325 mg per tablet; Take 1 tablet by mouth 2 (two) times a day as needed for moderate pain or severe pain

Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.

Shortly after taking the pfizer vaccine I suffered from blackout faint feelings off and on for more that 18 to 20 hours after taking this vaccine. server swelling of my entire body especially inside my head and heart pains. I also, suffered from episodes of memory loss even now. Problems with my balance when walking....never ever suffered from anything like this in my entire life. this vaccine is extremely dangerous and should not be given to everyone. nearly 19 hours later my face and feet numb.

having a heavy headache continuously...include when I sleep/continuous and severe headache; having problems concentrating on my job, read, work on the computer; Neck and back pain; Neck and back pain; Fever; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW5318, Expiration date not reported), via an unspecified route of administration in arm left on 30Jan2021 18:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history allergies to medications, food and other products was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included fish oil (FISH OIL) and tocopherol (VITAMIN E [TOCOPHEROL]) both taken for an unspecified indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date not reported), via an unspecified route of administration in arm left on 09Jan2021 11:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Beginning (24/36hs), after the vaccination the patient experienced neck and back pain, neck and back pain and fever on 31Jan2021 22:30, (01Feb2021) Monday, Tuesday, Wednesday, Thursday I'm having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer on 01Feb2021. The patient received Tylenol for 24 hs as treatment for neck and back pain and fever and no treatment received for having a heavy headache continuously include when i sleep/continuous and severe headache, having problems concentrating on my job, read, work on the computer. The seriousness of all the events was reported as non-serious. The outcome of all the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

he was needing a little extra coffee because he was so tired during that 5 days; he was drinking like 3 cups of coffee daily; Suddenly he kind of went back to normal but felt very energetic; Felt tired for 5 days after the vaccine; Has had headaches; Stuffy nose; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration, administered in right arm on 20Jan2021 at 14:00(at the age of 64-year-old) as 1st dose, single dose for Covid-19 immunization. The patient's medical history included Prediabetes from unknown date and was ongoing. The patient had diabetes-went diet, lost 60lbs- pretty much reversed it. Now in Prediabetes. A1C was going down point every month from 11 something, to 6.7,6.3. Lost 15lbs by skipping breakfast, 5 weeks later down 35 lbs pretty much held off; gained 15lbs had rash put him on steroids, got very serious about fasting, not cheating down 65lbs at about 60lbs down now. Got a little stuffy sometimes with allergies from unknown date and ongoing, allergies in the air, pollens and stuff; he thinks there's some foods; He did not want to get all the needles for allergy tests to check again; he had one when he was young but does not remember the results, his mom does not remember results; allergic to all this regular stuff that was unknown. The patient's medical history does not include diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's family history was reported as none. Past medications included: Pneumococcal vaccine a few months back. Prior vaccination the patient was little leery of vaccines because he had gotten a little sick from flu vaccine in the past for a day or two. The patient's concomitant medications included tamsulosin (TAMSULOSIN) 0.4mg extended released capsule taken once daily for prostatectomy, finasteride (FINASTERIDE) 5mg tablet one by mouth daily taken for prostatectomy, cyclobenzaprine (CYCLOBENZAPRINE) 10mg-prescribed was for 1, twice daily as needed usually takes 1 night for leg cramps previously. Now taking 5mg sometimes 1-2 5mg, daily. The patient's doctor just upped to 10mg which was his previous dose. Vaccination facility type was reported as hospital clinic. No additional vaccines were administered along with Covid vaccine on the same day. The patient was neither visited emergency room/visited physician office nor hospitalized. On 21Jan2021 kind of early that daytime, he experienced onset of feeling tired which continued for about 5 days; On 27Jan2021, he then suddenly he kind of went back to normal but felt very energetic. He also had onset of headaches which are ongoing-not sure which date (in Jan2021) these started other than toward the end of the 5 days of feeling tired. He was not sure if the headaches are due to a stuffy nose, or because he was needing a little extra coffee because he was so tired during that 5 days; he was drinking like 3 cups of coffee daily. The reporter stated that, he was going to see his mom and dad who are 93 years old; he did not want to end up doing anything to them, so he got vaccination. The reporter wants to know the expected immunity level following the first dose. The reporter wanted to know if the side effects from the second dose are expected to be the same or worse as the first. The outcome of the event tired was recovered on 26Jan2021, the outcome of headaches, stuffy nose was not recovered and unknown for rest of the events. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program. Added patient's demographics, medical history, concurrent conditions, concomitant medication details, suspect drug details, events details, and reporter comments. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

He got his vaccine, he had the localized pain for a day or two. Then about the 3rd day he noticed the pain was still there and when he holds the phone for a long time talking he starts feeling the pain. Also when he's laying down on the left arm after a while it starts hurting and he has to turn over to get rid of the pain, and this happens all the time and when he's laying down every night he has the pain. He cannot hold his phone in his left hand for a long time due to the pain. The pain is localized around the injection site itself. He has a friend that is having the exact same symptoms as well. He has not taken anything for the pain/reaction or called his doctor. This has been going on for almost 2 months and wonders if he has a blockage in that arm. This pain wakes him up at night and he has to switch locations in order to get rid of the pain.

Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild, Additional Details: No immediate reaction after vaccine administration. He was sweating profusely and momentarily lost consciousness/not responsive. He came around after a minute or two. He was shaking, so we got him down onto the floor & had him roll to his left side. We called the paramedics to check him out. He was responsive & was answering all questions. He said that he was tired. We questioned him about his medication schedule & he said he takes his blood pressure meds in the pm. He had not eaten.

01/27/2021 I woke up achy had a fever of 103.0, chills and I slept, this lasted 3 days, every time I woke I still had a fever and chills, but it did subside.

Had no decent sleep for the last few nights; His mouth wide open which then makes him dehydrated of course; His mouth wide open which then makes him dehydrated of course; Moving so slow and had lower back and thigh tightness; shoulder aches like someone took a bat and hit it/ feels like he was 80 years old/ it looks like it is something with air in his bloodstream; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Has no energy and the pain is like it is hitting a nerve where he barely can pick up 5 pounds; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/it hurts from his elbow down to his shoulder and it aches; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps/his shoulder area on the right side is a little bit in pain; Had intense pain and soreness to his upper body, shoulder blades, and neck area, biceps and triceps; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; he has some pain and there was pain in his triceps, he also has pain between those muscles, it hurts, and It was maybe where he had the COVID vaccine; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He is sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him; He rotates his head and looks around, neck pops frequently; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), second dose via an unspecified route of administration on 17May2021 (at the age of 64-year-old, Batch/Lot Number: EW0177) as a single dose for COVID-19 immunisation. Medical history included was walking pneumonia twice and other than that just a typical flu. The patient races dirt bikes so he was tough. Also, he had carpel tunnel from his job, and he had left over pain pills from that, and he had been taking them to help reduce the pain since he cannot really do anything about his side effects. Concomitant medication included pain pills, no other products reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EW0162) as a single dose for COVID-19 immunisation and on an unspecified date in Apr2021, experienced muscle stiffness and soreness that was in left arm and around his buttocks and his thighs and reported felt soreness for a few days afterward. This report is not related to study or programme. It was reported that, honestly, he wishes he never got it because he cannot do anything. He was on the fence about getting it since we are at the end of the pandemic and the hospitals are not as overwhelmed anymore. Everyone thinks that he was still in his 50's, he was very healthy, and he has no medical or health issues and he works out all the time, which was why he was so concerned about why it was affecting him like this. He has had his second dose of the COVID vaccine, and he wanted to report what was going on with his body. It was reported that, then he got the 2nd dose and within a day or two he was sore, and he was at the 11th day of experiencing this. He was sore and tight on his upper body like his chest, both arms, his shoulder blades, biceps, triceps, lower neck muscles and on his shoulder blades behind him. He had his 2nd dose not last Monday but the Monday before that. It did dissipate during the day. He jokingly said it was like the Pfizer vaccine retreats and hides during the day. Because of this he has had no decent sleep for the last few nights. His shoulder aches like someone took a bat and hit it. It feels like that on his left arm too but a little less pain. He was a side body sleeper, and he cannot sleep on his side because of this so then he ends up sleeping on his back with his mouth wide open which then makes him dehydrated of course. he has no energy, and the pain was like it was hitting a nerve where he barely can pick up 5 pounds. This was an extending issue and he just wanted to report and see if anyone else has had this before. The hospital said that they have not had anyone else report this before. It was slowly dissipating but he did not understand why it reinforces itself in the evening. Yesterday, he had to go service a customer and he was moving so slow and had lower back and thigh tightness. His upper body was sore and tight so when he got home, he was walking around trying to get his blood flowing and stretching some but then in the middle of the night those reserves came out and he gets attacked. The stiffness, soreness and pain were all concentrated mostly on his upper body. Also, his neck pops and he has never had that happen before. He looked it up and it looks like it was something with air in his bloodstream or something and when he rotates his head and looks around it makes a pop sound, and it has been doing it ever since his 2nd shot. He says this started probably on 18May2021 right after the vaccine. The patient clarified that for the side effects after his second dose that began soon after the COVID vaccine and he states that it was like all hell broke loose. This has gotten a little bit better but not a lot. Maybe 10% better or maybe 15% better. As he was sitting there his shoulder area on the right side was a little bit in pain. He feels like he was 80 years old, he was walking slow, and his body was stiff. No further details provided on the pain pills. He says he was flexing his bicep and he has some pain and there was pain in his triceps. He also has pain between those muscles, it hurts. It was maybe where he had the COVID vaccine. He also has this same pain on the left side except his bicep doesn't hurt but his tricep does and it hurts from his elbow down to his shoulder and it aches. On a scale of 1-10 his pain was at a 3-4 but at night it was worse. The patient and health care professional consent to be contacted was reported as yes. Investigation assessment was reported as no. The outcome of the events Sleep deficit, oral disorder, dehydration, hypokinesia, feeling abnormal was unknown and for all other events recovering. Information on Lot/Batch number was available. Additional information has been requested.

Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; Lethargic; cant sleep night; sense of feeling of a warm oil running through his veins; He still feels terrible; This is a spontaneous report received from a contactable consumer (patient) (this is 1 of 3). A 64-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177) intramuscularly in left deltoid on 14May2021 at 11:40 (at the of 64-years-old) as unknown, single dose for COVID-19 immunization. Medical history of the patient included COVID-19 in the first week of Sep2020. High blood pressure (after covid-19 it has been high as 200/130 and 180/120). Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration, from an unspecified date in Feb2021 and ongoing at unknown dose and frequency for blood pressure high. Patient had no prior Vaccinations (within 4 weeks) of COVID vaccine and had no AE(s) following prior vaccinations. On 14May2021, within an hour after vaccination, the events started, patient was not feeling well. He stayed at the pharmacy for a while to make sure there wasn't an immediate reaction. Once he got home, he wished he hadn't taken the shot. He felt pressure in his hands; he already felt comprised. Events were still ongoing but are at different times of the day, they were happening off and on throughout the day. Patient also gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time. After three weeks of vaccination patient was still feeling sick, lethargic, could not sleep at night, and has a sense of feeling of a warm oil running through his veins. Patient went to his medical doctor (physician office visit due to events) and he was basically sent on the way. Patient also went back to the Walmart where he got the shot and they told him there was nothing that could be done, it would just have to work through his body. Patient still feels terrible. Patient reported that it wouldn't be so bad or he wouldn't be so concerned if it wasn't already 3 weeks since having the shot. He was worried and so was his wife. The clinical outcome of the feeling sick, he felt pressure in his hands, he also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time, lethargic, cant sleep night, sense of feeling of a warm oil running through his veins, he still feels terrible were not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Immediately within two minutes, strange disoriented feeling, heavy sweating and weakness. Sitting down I lost vision in my right eye (just dark grey with a tiny blurry spot of light in the center). Left eye could not focus. After about twenty minutes, both eyes became very sensitive to light (like a pupil dilation test in an eye exam). This lasted about additional 10 minutes. I remained pretty weak for the next hour but was then ok. The next day I felt 100%.

I had painful breathing in the upper right quad of my abdomen. The deeper I took a breath, the more it hurt. The onset was on that Thursday. I am a right side sleeper and I couldn't sleep on that right side. I went back to the surgeon who removed my gallbladder. No treatment was given because no cause of the pain could be found. I started feeling less pain while breathing while I was in the waiting room. Over the next 3 days, the pain got gradually less to a point where it was not hurting at all.

getting suicidal thoughts; lymph nodes have large balls like an egg on his neck; really incapacitated/ He can't move; joints are swollen; freezing and is hot and cold all night; voice didn't sound like normally./ sounds like he smokes four packs a day; This is a spontaneous report received from a contactable consumer. A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in arm single dose for COVID-19 immunization on unknown date at 64-year-old. The patient medical history included paranoia. He was an easily over sensitive dude. The patient's concomitant medications were not reported. The patient was really incapacitated. His joints were swollen. He couldn't move. He was freezing and was hot and cold all night. Tuesday it was hot and he was outside on the deck in a hoodie and was freezing. His voice didn't sound like he normally did. It sounded like he smoked four packs a day. His lymph nodes had large balls like an egg on his neck. He won't go to the doctor or emergency room and he was scared. The patient wanted to commit suicide, just said that four days ago. It was not an emergency at this time. The patient was getting suicidal thoughts, but that was part of his paranoia anyway. He felt like he was being used as a test victim. His mind went nuts because he was paranoid, it was before he received the vaccine. Maybe the patient would take enough time to breathe and have logic to seep into his brain. All symptoms started immediately and were all ongoing. The reporter confirmed that by symptoms he was referring to 'his friend's joints being swollen', 'freezing, hot and cold all night', 'sounded like he smokes four packs a day', 'lymph nodes were large balls like an egg on his neck'. Outcome of the events getting suicidal thoughts and really incapacitated/ can't move was unknown, outcome of the other events was not resolved.

I started to feel like the in the morning that I felt weird and like my whole world was off. I took my blood pressure, and it was high. I talked to my doctor and they advised that I should go to the ER and I went to the ER and they diagnosed me with vertigo. My balance was completely off. He did give me medicine for the dizziness. He advised to have a follow-up.

Two days after receiving the 2nd shot, began to experience inflammation and pain in joints from head to toe. These both have been debilitating, hard to move around, hard to get out of bed, hard climb stairs, hard to use hands due to swelling, hard turn head and cannot kneel down. Life has become very hard and painful. Gabapentin was prescribed and did nothing. My doctor prescribed celecoxib for the pain and inflammation. I've only been using it for 3 days and am having moderate relief, but too soon to tell.

Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had the feeling of being tired; blockage in the lower intestines.; Hard time going to the bathroom; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot number:ER8732) via an unspecified route of administration administered in left arm on 16-Apr-2021 at 10:30 (at age of 64-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient underwent lab test and procedures include cholesterol and result was unknown on unspecified and colonoscopy on 10May2021 result was unknown. It was reported that the patient received the first dose of the Pfizer covid vaccine and was in the hospital for blockage in the lower intestines on 17Apr2021. The patient wanted to know if that is associated with the Pfizer covid vaccine. He stated his nephew was a police dispatcher and got a call where someone else have reported similar issue what the patient has experienced. The patient did not know what vaccine that person had or age and gender of that person. The patient wanted to know about if Pfizer was going to get the FDA approval for the Covid vaccine. The patient reported that he had both doses and he was fine right now but when he had the first dose he was, he got it 16Apr2021 and he had some side effects the next day, on 17Apr2021 he was having cramping and he woke up and was feeling hot and cold and ended up in the hospital with a blockage in his intestine and he was wondering if that could have been anything that was related the vaccine. The patient has lost weight in the hospital, he thinks he was about 145 lbs now. It was reported that the patient was fine the whole day he got the vaccine, he ran errands and did things he needed to do, he went to bed and woke up and felt hot and cold and on 17Apr2021, he was having hard time going to the bathroom. He called his son and told him he wasn't feeling well on an unspecified date in Apr2021 and his son came over and called his other son who is a fireman and he told them to call the ambulance so they did and they took him to the hospital and they couldn't figure out, he was asking them and they had no answer, he just seen on the website and he has been wanting to call but he wasn't going to but he did so that they would have it documented. He confirms when the cramping and feeling of hot and cold and difficulty using the bathroom began it was after midnight and the date was 17Apr2021. When asked if the feeling of hot and cold is ongoing, he says he was in the hospital for 8 days. When asked if the feeling of hot and cold is ongoing or has it recovered, he says he just had the feeling of being tired on an unspecified date in Apr2021 and out of it even after the fact. He does not if it had to do with vaccine or if it was something, he had going on prior to that. The ER doctor told him it was possible that when he got the vaccine whatever could have been going on and put his system in overload. He confirms he was admitted to the hospital due to blockage in the intestine supposedly, the lower intestine. He says that is recovered, everything got taken care of, he had to schedule a colonoscopy after he got out of the hospital. He does not know why they couldn't have done it there while he was in the hospital. He was contemplating the second dose; it was scheduled on 07-May-2021 and he had his scheduled colonoscopy for 10-May-2021 and he didn't know what he should do. People were telling him do it or not to do it but his doctor told him to go ahead and get it so he followed what he said and he did get it. The hospitalization dates were from 17Apr2021 until 24Apr2021 was the day that he got out. He had blood work done for cholesterol in the hospital and he sees a cardiologist doctor for the cholesterol. They did blood work in the hospital every day, he has no idea what the results were. The events feeling hot and cold, cramping and hard time going to the bathroom after midnight and the middle of the night lead the patient to emergency room visit. He didn't know whether to call but it has been playing on his mind. He is sure they have given millions of doses and he did not know if it could be anything to do the vaccine. The outcome of events blockage in the lower intestines, feeling of hot and cold was recovered and outcome of other events was unknown. Follow-up attempts are needed: Further information has been requested.

I developed vision abberations such that when i focus or concentrate (e.g. reading a book or computer screen) my vision would 'jump' or 'blink' or flicker causing me to not follow words I had been reading. Very clearly concentration of attention driven. This condition came on slowly. It took weeks after injections for the symptoms to develop. They remain. And seem to be getting more severe. My opthamologist has refered me to a neuroopthamologist. I can not think of any other causative factor in the last years, month, and weeks that could account for what I am experiencing. I have had NO illnesses. I have not had Covid-19 to the best of my knowledge. (Note: date & time given for #5 above is approximate)

Flu-like symptoms; Stiffness; Mental fogginess; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable company representative, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no allergies to medications, food, or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); both were taken for unknown indications from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 20:00, the patient experienced flu-like symptoms, fatigue, stiffness, body ache, headache and mental fogginess. 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 flu-like symptoms, stiffness, mental fogginess, fatigue, body ache and headache were resolved on an unknown date of Mar2021. No follow-up attempts are needed. No further information is expected.

Severe burning pain of left leg. Upper thigh above near hurts as a severe muscle pull. From knee cap down to ankle burning pain with occasional deeper burn pain up and down shin . Very uncomfortable. Hardly able to sleep

New Polymyalgia Rheumatica: Got Pfizer-BioNTech Covid vaccine #1 4/26/21. Then 5/9-5/15/21 both thighs developed stiffness (R>L) in morning with AM stiffness for 1/2 day, and finally wore off day before second shot. Then, got 2nd shot 5/17/21, with fever first day, body aches starting the next day. After few days, felt better. However, Friday morning 5/21 woke up with pain in biceps, triceps, could not abduct arms above 7 o'clock position due to severe pain -- bedridden 4 days, felt like someone beat him up or got hit by a car, then improved sligthtly. 1 week later, developed stiffness in low back, hips, and thighs. Also with night sweats few nights.

Fully vaccinated patient admitted through ED with COVID positive test upon admission. Admitted 06/28/21 for weakness, confusion, difficulty urinating, and decreased oral intake. Found to have MSSA bacteremia. No s/s of COVID throughout stay.

extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; extreme pain in his head, back, shoulder, arms, and lungs feeling crushed; heart attack; Myocarditis; Heart racing; 20% loss of memory; light chest pain/pressure; foggy; severe headache; light chest pain/pressure; ill; horrible cough; Dizziness; High temperature; tiredness; This is a spontaneous report received from a contactable consumer (patient) reported for himself. This 64-year-old male patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right shoulder on 20Apr2021 at 12:25 (Batch/Lot Number: ER8735) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. There was no additional vaccines administered on same date of the Pfizer suspect. The patient received the first dose and after he had a horrible reaction and he had to go to the hospital. By 03May2021 he was in the ER and they were saying he had a heart attack; they were going to do emergency surgery to place a stent in his heart; but when they did the tests they found that a virus had caused the heart attack; he had myocarditis. Add then he had various medical care to keep him alive those two days. The doctor confirmed that he had myocarditis from a virus. He was still on mediation for his heart. The patient also mentioned his memory comes and goes now. Mentions the beta blocker his is prescribed is Metoprolol 25mg. Adds he was instructed to take one half of a 25mg tablet and then move up to 25mg, but he blacked out for a day when he took the 25mg, so he had to go back to one half of 25mg. Adds his heart races really fast and he has to have this medication to control it. He is also taking 81mg ASPIRIN. He was taking Atorvastatin 20mg once daily, but the other doctor told him to stop it because it is not doing him any good. The patient states he kept a journal of his symptoms after the vaccination on 20Apr2021. From 20Apr2021 to 22Apr2021, for two days he felt tired, slept all night on 21Apr2021, awake for two hours then back to sleep. From 22Apr2021 to 27Apr2021, he felt fine. On 28Apr2021 he was tired. On 29Apr2021, tired, dizzy, horrible cough, fever of 100 / high temperature. On 30Apr2021, the patient took off work, bad cough, resting, dizzy, ill. On 02May2021, ill, temperature. On 03May2021, ill, temperature 100, when he got out of bed at 05:00AM he had extreme pain in his head, back, shoulder, arms, and lungs feeling crushed so he went to the emergency room. The did two COVIDs tests that were negative. Blood tests that showed the heart attack need for a stent; but when they got in there with the camera it showed he had a viral attack on his heart that caused the blood flow to slow; EKG abnormal, mentions an MRI; and troponin level off the charts. The priest came in to talk to him and he had a horrible cough that has now gone away. He was in the hospital overnight and discharged 04May2021 at 15:00. After that he noticed he feels light chest pain/pressure all the time on 04May2021; the first week he was foggy on 04May2021 and had severe headache on 04May2021 and noticed about 20% loss of memory. The patient mentioned he made medical heart parts at work and he went back to work on 10May2021 but he just sat at his bench and examined the parts. He thought the vaccine activated his really good immune system and caused it to attack his heart. He had another EKG and the doctor said his right ventricle is damaged in his heart last week. Mentions he has had at least 30 different blood tests. Everyday for three weeks he thought he was going to die but his doctor did give him some hope. The event was hospitalized for myocarditis from a virus, heart attack and extreme pain in his head, back, shoulder, arms, and lungs feeling crushed from 03May2021 to 04May2021 at 15:00. Treatment received for myocarditis from a virus and heart attack. The outcome of tiredness, light chest pain/pressure was not recovered, of horrible cough was recovered. The outcome of other events was unknown. Heart racing results in Physician Office visit with follow up. Follow-up attempts are completed. No further information is expected.

hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything; not been able to use hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. can't grip anything; not been able to use his hands; wrist to hurt; peripheral vision bad, his vision was bad; visual distortion; peripheral vision bad, his vision was bad; visual distortion; given a drug to take when they flared up (migraines); pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; pains in upper thighs, felt like in muscles. Felt like little bubbles like they are going to pop; hands are numb, tingling, feel swollen, can't bend them or hold things for maybe a couple of minutes and can't grip anything was worsened; hardly walk/ lower back got so painful; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG206), via an unspecified route of administration in right arm, on 17Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. Medical history included heart attack from 1994, left side kidney removed in 2015 and single functional kidney on right side from 2015. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINATION; lot number: ENG202), via an unspecified route of administration in right arm, on 24Feb2021 at 13:00 as dose 1, single for COVID-19 immunization and experienced headache, stiff neck, peripheral vision was bad, migraine and swelling of hand and feet. The patient previously took (UBRELVY) for migraine and visual distortion. The patient had a headache and stiff neck really for no apparent reason and they continued. Then he noticed that his peripheral vision and vision was bad with visual distortion in Mar2021. He called his primary care provider and told him about this, and he was prescribed a steroid pack and for 2 months he was provided a muscle relaxer to help. They provided some relief but didn't get rid of it. Believes the steroid was a Zpack for inflammation and was unable to provide the name of the muscle relaxer or the NDC, Lot, or expiry for either Zpack or muscle relaxer given. Eventually, they continued and after he had the visual distortion, he went to an eye doctor to make sure nothing was wrong like a tumor that was causing the headaches or stiff neck. Eye doctor told him nothing wrong with his eyes and they were fine, not tumor, he just had migraines and he never had migraines before. He saw a neurologist and was diagnosed with migraines. On the first neurology appointment, they gave him an injection in the stomach, but he does not know the name of it. The second visit was given shots in the back of head and back of neck. On that next visit, he got a shot in the stomach and most of it was quiet down with the migraines and the visual distortion and he still had them. The patient was then given a drug to take to help when they flared up, for break through migraines in 2021. It was 100mg. He was given the free ones and he could only take up to 10 in a month. He was given 4 of them and only had to use 2 of them and the migraines and visual distortion has gone away. Provides NDC, lot number 1843724 and expiry of Jul2022. He started this in Apr2021 or in May2021 after his first visit with neurologist, (withheld). During the same time, he had the migraines and also started having pains in his upper thighs, felt like in his muscles. States imagine little bubbles like they are going to pop was how it felt in 2021. They went away and stopped. He then started to have back stuff, pains that started in Mar2021 or Apr2021. They stopped after 7-8 days later and then they were gone. He was then sent to a nerve specialist and they did a conduction nerve test to see if what happened affected his nerves and the test was fine. Then all of a sudden, after one thing happened and went away another one would start and then his lower back got so painful so that he could hardly walk and went to an orthopedist thinking it could be a pinched nerve in 2021. They did x-rays but could not see anything that caused this kind of pain. They didn't give him anything, but 7 days after that he was fine ever since, and it just went away. He also had pains in the upper arms that felt like someone was giving him shots at the same time in both arms and also a kind that hurts and stays hurting. Felt like they didn't pull out the needle, like someone was pressing the needle in the arm, directly in the area you are getting a shot, but this feeling lasted much longer. Had this very same feeling in the top of both shoulders and they were intermittent. One minute he would have them and the next they could last about 5 minutes, or it could be gone for 5 hours and show up again in 5 minutes. It was not consistent and happen every hour. This also resolved in May2021 along with the migraines. Patient had pains at top of shoulders fell in line with his neck, where the soft spot between the collar bone is which was like getting a shot in his arm. Again, he no longer has these symptoms and no problems with vaccines in the past. Provides he had second dose on 17Mar2021 in left arm and lot number of ENG206. No further details provided. Started in the beginning of Jun probably, it's been about two and half weeks. He had not been able to use his hands. They are numb, tingling, feel swollen, he can't bend them or hold things for maybe a couple of minutes. He can't grip anything in Jun2021 and also got worsened in 2021. Extending from the tip of his fingers all the way up to the shoulders, in his left arm especially causes the wrist to hurt in Jun2021. It hurts all up to the left shoulder. In the right arm it only goes up to the bicep and these have gotten worse and are continuing to get worse. The patient was given tramadol for that pain and unable to provide NDC, Lot, or expiry from orange pharmacy for tramadol bottle. He takes 50mg, 1-2 tablets by mouth four times daily. It was prescribed 16Jun2021 and expires 16Jun2022. These pain pills help some, it takes the pain away, but does not allow him to grip with his hands or anything else. Now it may sound crazy, but when he coughed it would make him feel like the inside of his biceps were going to explode. It went away and only lasted a week. After a week this went away, but to touch it hurts after he coughed. Still had tenderness in both sides in the muscles, but at that time it felt like they were exploding outwards. Again, mentions he no longer has this. His feet are swollen up and he has never had that before now. Went back to see his heart doctor. He had gone to have a Covid test and heart test in Jan2021. With the swelling in the feet, he felt it had something to do with the heart and he went to see the cardiologist where they asked about testing which was done by primary care provider and also had antinuclear antibody testing done with primary care and that test came back with no arthritis in the hands on an unknown date. The patient mentioned he had a heart attack at age 38 before he had COVID vaccine, since he is 64 now. He didn't have any chest pains and didn't fall under those heart symptom questions asked. None had anything to do with his heart and the provider felt symptoms probably due to with the vaccine, but there is not enough information out there on it yet. He saw about 6 specialist and they all say the same thing. The patient still had his feet and hands swelling. He had a heart attack in the past or how it will affect his muscles in his heart because he does not want to find out later that it had affected his heart, and nobody knew. The patient also had an magnetic resonance imaging (MRI) of the brain, blood vessels and nerves ordered by his Neurologist as well. The outcome of peripheral vision bad, his vision was bad; visual distortion was recovered in Mar2021; pains in upper thighs was recovered in May2021; lower back got so painful so that he could hardly walk was recovering; felt like bubbles in muscles like they pop was unknown while the other events was not recovered.

Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 02Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both for an unknown indication and from an unknown date. The patient previously received levaquin for an unknown indication and experienced drug allergy. 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 02Apr2021 at 16:00, the patient experienced headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of events. The clinical outcomes of the events headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Fuzziness in head; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker for accelerated afib. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO), simvastatin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ), all for unknown indications from an unknown dates. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 11:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient previously taken mustard (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 16:00, the patient experienced fuzziness in head, not dizzy or losing balance since the second dose but just not normal. The clinical outcome of the event of fuzziness was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

He just feels crappy today, and he feels bad; sore throat; runny nose; achiness; dizziness; soreness; sweating; chills; headache; This is a spontaneous report from a contactable consumer. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWO179, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 05:00 (age at vaccination 64 years) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included zolpidem tartrate (AMBIEN)taken for to go to sleep at night (has been on for 15 years); diphenhydramine hydrochloride (ANTIHISTAMINE ALLERGY RELIEF) taken for seasonal allergies. (Concomitant Products Brand Allergy Relief D 12 Hours: reporter states he takes Allegra and then states it is actually the Brand Allergy Relief D 12 Hours. He has been for many years, many many years). The patient took historical influenza vaccine (Flu shot) (He gets the flu shot every year and had the same effects as with those shots. He gets that every year at .) Persist Headache within minutes, he got a headache right away. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took flu vaccine vii for headache. On 18May2021 the patient experienced headache, on 19May2021 dizziness, soreness, sweating, chills, sore throat, runny nose, achiness, on an unspecified date he just feels crappy today, and he feels bad. Patient stated, soreness means his knees, and his ankle, and his elbows, everything, his neck, and everything. he talked to a few people, he is a mailman, and they have the same symptoms. He is going on a plane tomorrow, and he hopes he will be alright. He asks if he should see his doctor. Sore throat and runny nose he adds that this has also been the same and not gotten better or worse. he gets the flu shot every year and had the same effects as with those shots. Patient did not receive any treatment for occurred events. The outcome of event he just feels crappy today, and he feels bad was unknown, rest of all events outcome was not recovered. Additional Context: Caller is calling about the Pfizer Covid-19 Vaccine. He got the shot Tuesday, and he guesses he was reading the side effects. He just feels crappy today, and he feels bad. Caller adds he was going to call his doctor. Caller states by feeling crappy he means he got dizziness, achiness, sweating, and chills. Caller adds that is it, and should he call his doctor. Information on Lot/Batch number was available. Additional information has been requested.

Received vaccine on 12/28/2020 and c/o jitteriness on 12/29/2020 and dizziness with jitteriness on 12/30/2020. BP 152/83 HR 78. States he felt like he was floating when walking to his car this morning

Cheek swelling; Periorbital swelling/swelling around his eyes; feeling wiped out; Muscle pain; Joint pain; Chills; Fever; General malaise; low grade headache; Sweating; injection site pain; This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received bnt162b2 (BNT162B2) at single dose at left deltoid on 02Jan2021 17:00 for covid-19 immunisation, administered an injection team that is part of the local hospital system. Medical history included controlled hypertension and he has been taking the blood pressure medicine for a long time. The concomitant medications included unspecified medicines for controlled hypertension. History of all previous immunization with the Pfizer vaccine was none. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. No additional vaccines administered on same date of the BNT162B2 vaccine. On 02Jan2021 the patient experienced injection site pain. On 03Jan2021 the patient experienced cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, chills, fever, general malaise, low grade headache, sweating. No event did require a visit to Emergency Room or Physician Office. No relevant tests performed. Therapeutic measures were taken as a result of chills, fever, general malaise, low grade headache, sweating. Course of events: He said initially he had no adverse events after receiving the COVID-19 Vaccine, except injection site pain. He said he thought the injection site pain could be from the COVID-19 Vaccine being viscous, and didn't think anything else about the injection site pain. On 03Jan2021 he started to experience some. He stated he did not normally take vaccines, like the flu vaccine. He said he has been a podiatrist for 39 years, and realized the importance of getting the vaccine to protect his patients. He then developed chills, muscle pain, fever, and general malaise. He said he experienced every side effect listed on the received COVID-19 Vaccine paperwork, except he had no lymphadenopathy. He said all the side effects he experienced appeared 24 hours to the minute from when he received the COVID-19 Vaccine. On 03Jan2021, he had swelling in his cheeks and around his eyes. He did not get sick often. He said he had a rough night on 03Jan2021 and on 03Jan2021 he still felt wiped out. Treatment: he took 2 Tylenol 325mg at the start of the side effects, and then took another 2 Tylenol 325mg at 2:00AM. He said he woke up soaking wet with chills and sweats. He said his fever broke, but he did not know how high his fever was. He took from a fresh bottle of Tylenol 325mg. The outcome of injection site pain, cheek swelling, periorbital swelling/swelling around his eyes, feeling wiped out, muscle pain, joint pain, general malaise was recovering, of chills, fever, sweating was recovered in Jan2021, of low grade headache was not recovered. The reporter considered there was a reasonable possibility that all events were related to bnt162b2 vaccine. He was scheduled to receive another COVID-19 Vaccine injection in 3 weeks. Information about lot/batch number has been requested.

He described having a lump in his throat as well as hives and itching 1 hr after his first vaccine. Then, had taken Benadryl and sx were self limited. For the 2nd vaccine, he premedicated with Benadryl with a plan to observe 30 min. Approx 23 min after injection, developed L arm burning and redness. He developed a lump in his throat. BP 137/90, HR 71, SpO2 97%. He was directed to the ER where he received Benadryl, Solumedrol, Pepcid and was discharged home.

1ST EPISODE, 01-15-21 10AM, it happened at the hospital where I work. I was walking flight of steps when i felt i was not getting enough air, i went to sat down and was unable to recover and went to the therapy office to sit down, where a coworker said i didn't look good, my BP 148/92. I felt sleepy, global weakness throughout my body. they took me to the ER where i had an EKG, CBC, thyroid test, angiogap glucose test. The EKG was normal and I stayed about 6hrs in the ER but went home. As the day passed my BP was 122/88 when i got home. I wore a holter monitor for 5 days but don't have results yet. I felt fine for the next 6 days. SECOND EPISODE 01-21-21; i woke up at 5am feeling so sad with despair and feelings of loneliness. I went to work 11:45am, felt fine, sat down to do some work on my computer and I could feel it come up again, went to nurse station and checked my BP 144/90, i could feel my heart pounding and went to the ER again. I felt super foggy and unable to process things. They did a CTA of my neck and chest and a CT with perfusion which was normal. They did lab work and all was normal. THIRD EPISODE 01-25-2021, i was at home happened around 9am, felt fine all morning and then i felt another episode come again. Same symptoms just not as dense as before and texted my wife. I had body aches, felt like I had the flu. I saw my PCP 01-25-2021 (same day as my third episode)and set up an appointment with a neurologist.

On 1-23-21, less than 24 hours after the vaccine was administered, the person developed facial numbness, slurred speech, memory difficulty. BP: 200/100. This occurred again on day 3. Hospitalized a total of 6 days. Discharged home on 1-29-21. Diagnosis: TIA, possible seizures. No history of either. Positive history for controlled hypertension.

Sensation of tongue swelling after 10 minutes thinks it may have been anxiety about the vaccine 14:34: BP 120/78 HR at 60 RR 16 Tongue midline, not enlarged no lymphadenopathy color normal - not pale sitting upright S1 S2 at apical

Injection at approximately noon on 2/4/21. Began feeling poorly with flu like symptoms about 11 PM Fitful Sleep.Extreme soreness at injection site. Awoke with fever (100.7), joint pain, nausea, lethargy. Took 400 mg of ibuprofen. Took "Nyquil" the next evening to help with symptoms. Fitful sleep and extreme sweating. Awoke Saturday feeling a bit better. Temperature (98.6) Rested all day. Better sleep Saturday night. Did not take any medication. Some sweating overnight. Awoke Sunday feeling better. Still not 100 percent Temperature 97.4.

Patient received his first covid shot this past Saturday and about 20 minutes following he noticed a right sided facial droop. Droop began to worsen, and he had difficulty moving his right eye lid, so he decided to go to Urgent Care and was diagnosed with Bells Palsy. He was started on Prednisone and Valtex which are reducing his symptoms. Symptoms are almost resolved. He does feel fatigued and slightly anxious.

Patient is bedbound at home after multiple strokes. He also has dysarthria at baselin. Was in usual state of health. Received vaccine at medical facility on 1/29/21. Caregiver reported that he subsequently had behavioral change the following day and stopped oral nutrition intake. He was subsequently admitted to Hospital on 2/6/2021 with encephalopathy and severe dehydration.

Stabbing pain over the right first metatarsophalangeal joint. Intermittent. No relation to activity. Progressed to nightly burning over the area, waking me up from sleep or preventing me from falling asleep.

Tremendous fatigue, slept for 12+ hours, followed by overall general achy back, joints, some light headiness, unstable when standing at times.

pt anxious has flushed feeling; face red; has previous anxiety observed for 15 minutes; pt says he has ipipen and will go to er if symptoms worsen or still present in24 hrs. insisted on leaving.

started at 2 in the am I woke up with headache and nausea lasting all day, I tried alternating tylenol and ibuprofen didn't help. EOD I was having severe body aches chills headache and nausea no fever, Saturday symptoms were worse, saturday night i added vomitting and temp spiked 101.3 or something like that. Continued low grade temp through wednesday running 99.3 99.8... and I didn't not work those days I stayed home, I was tested for covid and came out negative, I worked thursday and Friday and for the next week I continued with a low grade fever, I went to my primary after and he said it was most likely a reaction to the vaccine. 3 weeks total until I was back to normal.

Twenty minutes after injection mental fog, then onset of headache which became debilitating, requiring 5mg of Oxycodon every four hours for five days to be functional. Woke up every night after four hours, from pain, took meds, an hour later able to sleep again. Stabbing knifelike pain over right eye, Able to transition to naprosyn, Advil and Tylenol after five days, but still in constant pain eight days later, even with meds. No sensitivity to light, some mild nausea for first few days.

He received his first dose of Pfizer COVID vaccine today at 12:30 PM. Has h/o Ancef allergy with hives. No h/o anaphylactic type allergies. Waiting in observation area for 15 min. After ~15 min, c/o feeling "shaky". Pt brought back to cot room. BP elevated. Denies unusal SOB, scratchy or swelling in throat. Denies tongue swelling, mouth numbness or tingling. No c/o rash or itching. No visible rash noted. Reports that he has chronic respiratory issues. Brief history reviewed with patient. He reports that he takes glipizide, but can't remember if he took it this AM or not. States he only had one cup of coffee all day. Symptoms progressed to feeling light-headed. Visible shaking of hands with lifting arms. Reports that symptoms were somewhat worsening. After ~15 min more of observation, First Responder was called. ED personnel arrived within minutes. Blood sugar per finger stick was 212. Patient able to ambulate to wheelchair. C/o tingling in scalp and feeling light-headed. Agreed to be transported to ED for further monitoring and possible treatment.

After not sleeping well Monday night I woke up on the 23rd of February not feeling 100%. So around 8:00 AM I took two Bayer Back & Body. Around 8:15 / 8:20am I began feeling very dizzy and unable to stand up on my own. I couldn't walk down the hallway without holding onto the wall. This went on all day, long after the effects of the Bayer Back & Body would have worn off . Even at dinner time I was uneasy / unstable walking around. The only time I felt well was when I was lying in bed. By the next morning, Wednesday the 24th, I wasn't 100% that morning either but I went to work and did the work. It was very difficult but by afternoon I was feeling much better. It wasn't until Thursday that I was feeling 100%. I had never felt this way in my life. No it was not Epilepsy related and I had been taking Bayer Back & Body FOR YEARS without problem except maybe taking two, occasionally would feel the caffeine.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Mild, Additional Details: Pt had anxiety about 30 minutes after dose. said \"he just needs some air\". EKG taken by EMT was normal. Did ortho stats and he was tilting and dehydrated. he takes HCTZ and does not like urinating often so does not drink much. HR was in 130s but after giving two glasses of water patient was fine and HR was down in 90s. He is diabetic and BS 236. Had just eaten.

Sore arm at injection sight begging about 4 hours after injection continuing till day 3, Diarrhea beginning day 3 about 4:30 Am continuing into the afternoon. Diarrhea not severe, but prevented me from leaving the house to perform scheduled activities.

6 days after the shot I thought I had a sinus infection. I received a steroid shot and z pak prescription on the morning of February 18. Was still feeling bad and checked myself into a local ER February 22 where I was diagnosed with congestive heart failure. Never had heart issues. I was in the hospital 6 days. I feel much better and now worried about getting second shot.

Side effects began almost 1 week after 1st dose. Patient had severe motion sickness and nausea resulting in vomiting, sporadic moments of fever chills and muscle aches. Symptoms persisted for 2 days, tapering off on the 3rd day. Side effects for 2nd dose appeared night of injection, include fever chills and muscle aches. Symptoms disappeared the next day.

Pt describes feeling light headed and "floaty" approx 5 minutes post vax. Denies other SX. 1540 - BP - 128/90, P - 58, O2 sat 97% - provided water, rest 1555 - States sx resolved, BP - 130/84, P- 56, O2 sat 95% Pt leaves clinic.

Patient woke up at 10:00PM, out of a sound sleep, having an acute asthma attack and generalized itching. No rash. Used Albuterol inhaler twice, 5 minutes apart, and took Prednisone 20 mg orally. Within 60-90 minutes, symptoms completely resolved and did not reoccur. He did not seek medical attention at the time of this reaction, but called this office on 3/11/2021 so that the reaction could be documented. That prompted today's office visit and the completion of this VAERS form. Patient does have monthly allergy injections, but last injection was on 2/23/2021.

Initially some flu-like symptoms a few hours after getting the vaccination, but felt fine Friday morning. Late Sunday evening, developed a intense headache followed by chills overnight and restless sleep (1-hr periods thru the night). Continued Headache thru 3/18 with general body aches and weakness. No pain at injection site after first night. Lightheadedness when standing with loss of focus (brain fog). Occasional and temporary feeling of nausea.

101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatigue for first 10 days. As soon as eat breakfast have to go back to bed for 1-3 hours. Same with lunch, eat, go back to bed about 3 hours and same with dinner. Then go to bed for evening. Extreme brain fog and forgetfulness. Can't think of words or make sentences. Can't remember anything. Feels like a very heavy feeling in head like head weighs a lot and very cloudy. Pain from shot in arm moved up to neck, ear and jaw the day after shot. Arm quit hurting but couldn't lift it. Pain stayed in neck, ear and jaw for a week and now is a stiff feeling. I think the lymph nodes are swollen. Effects eating, hard to keep food down. Nausea and stomach pain. I have appetite but have to eat while nauseous and pain. Still severely fatigued every day and have to sleep most of each day or at least sit and rest. So exhausted. Also night of shot started getting hot and cold chills. Still have them over 2 weeks after shot. Bad tinnitus started night of shot and still have it over 2 weeks after shot. Very loud and nothing makes it go away. Bad headache started morning after shot. I have had a headache pretty much everyday, all day since the shot over 2 weeks ago. I feel sick like I have flu.

Initially a low-grade fever but after a few days, my arthritis in my hip became very painful radiating to my knee and lower back to the point where I could not sleep or walk very well. I am still experiencing pain and difficulty walking or standing for more than a few minutes.

PT with history of previous syncopal events to both vaccinations and blood draw. 3 min after vaccine PT became unresponsive, arrived immediately at carside, supported airway, patient quickly regained consciousness. Vitals stable, refused transport.

Got his vaccine, his arm hurt after the vaccine, but nothing severe. He tried to go to sleep but he cannot sleep at night, has insomnia. He threw up and ate something in his stomach, but has an aura of a high that he is having. Doesn't know if he can stay awake or go to sleep. He has soreness in his arm still.

66 yp, states hes having shortness of breath. Pt is CAO x 3, airway is patent and self maintained. Pt was moved to exam area and vitals were stable. Patient has a history of anxiety, and denies any swelling rash or hives. Present crew determined patient had a panic attack. Crew was able to calm the patient, and care was transferred to ambulance unit.

The patient is a 65 yr/o male with a history of Afib on Xarelto and HTN presents via EMS for evaluation of AMS that was noted by wife this am. The wife states as soon as the pt woke up he was altered mainly acting confused and not speaking normally. She also states that his side of the bed was wet this am but is unsure if it was sweat or urine. LKW 2200 last night before the pt went to bed. Upon EMS arrival the pt was sitting on the floor, playing with a toilet brush, and speaking non-sense. While en route to the ED the pt reportedly had convulsive seizure like activity and was non-responsive 15-20min following the activity. He is now awake but not verbally responsive and still acting confused. No hx of seizures per wife. Hx otherwise limited as pt is non-verbal at this time

Felt kind of nauseated/ nausea; Could not think/his mind was blank/ couldn't think to do anything; felt like he was in slow motion; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 probably around noon (at age of 65 years old; lot number: ER8730) as single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed about 10 years ago and diabetes type 2 diagnosed about 10 years ago (as of 24Mar2021). He caught COVID a few months ago (as of 24Mar2021) and was sick for 3 weeks and then came out of that and at that time got a rash and came out of that and wanted to get the vaccine because he was age 65 and did not want this thing to kill him. Concomitant medication(s) included gabapentin 300mg, 1 capsule three times per day by mouth, taken for neuropathy in his hands and his hands hurt from 22Mar2021 and ongoing. He was given the gabapentin to stop his hands from hurting. He also had medications he took every day and had diabetes type 2, and also had high blood pressure that he took medication for. No additional vaccines were administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks of the Pfizer vaccine. The patient reported he saw his healthcare professional (HCP) for the first time the same day he got the Pfizer Vaccine on 22Mar2021 and saw the HCP that morning. When he left he felt fine that day 22Mar2021 and felt fine that night. That night he tore up his bedroom and cleaned it and felt fine. Then the next morning (23Mar2021) he went to work and felt fine for a while and then got to building. He started working and then felt like he was in slow motion and couldn't think and it was crazy and his mind was blank and he could not think and felt like he was in slow motion; couldn't think to do anything. The feeling like he was in slow motion and not being able to think began yesterday morning on 23Mar2021 and stopped yesterday 23Mar2021 also. Yesterday he came home because he runs saws at work and stuff like that and he couldn't think and couldn't be around stuff like that because he was cutting things and could get hurt. He had not had this happen before and the feeling as if he couldn't think and felt in slow motion was not ongoing today, 24Mar2021. Today he now has nausea and the nausea was ongoing and about the same as when it began. Also stated as today (24Mar2021) he felt kind of nauseated and couldn't do anything again today and thought he would stay home because of these small side effects of the vaccine that he wanted to report. He had no treatment for the reported events but just went home and laid down. The events did not require an emergency room visit. Regarding whether the events required a visit to physician office the patient replied "Yes", he saw his HCP the morning of the day he got the vaccine on 22Mar2021. Patient was going to call the HCP to see if the medication she gave him would have these side effects and he had not taken the Gabapentin before; stated the HCP issued him Gabapentin that he began taking on 22Mar2021. He was calling the HCP to see if the reported events were related to the gabapentin as he had not taken that before. "Feeling like he was in slow motion and not being able to think" was recovered on 23Mar2021 and patient had not recovered from nauseated.

Extreme fatigue, sleeplessness, body aches, sore arm where vaccination given. Lasted three days so far. Some relief with Tylenol

Dissiness, nausea, headache, preassure in head, extreme tenetus, feel as if I am spinning, unsteady on my feet (could fall), tingling of all left side of my body, mostly in joints, sleuring speech, brain not connecting to mouth...slow.

EXTREME muscle pain in legs starting 4 days after the injection - 4/3/21. The pain started the day after a routine 5 mile run. By routine, I mean a run that I have done thousands of times without muscle soreness. At first, the pain was treatable with a 400mg dose of Ibuprofen but gradually worsened to the point where over the counter NSAIDS were no longer effective. Moving to 200mg Celecoxhib 2x day was only modestly effective. The pain was so intense that I am unable to get adequate sleep and has consolidated in the left leg.

Reported that 4-5 hours post vaccine he became very dizzy and unable to walk. HIs eyes at that time became sensitive to light; to this day he is still experiencing tenderness in his vision. His mind is foggy and feels anxious that he is not feeling better as of 04/14/2021. He went to his PCP on 04/13/2021 who referred him to a neurologist.

Patient stated that they will refuse the second dose of the Pfizer vaccine based on side effects experienced since. Complications include pain that felt like "lightning bolts", temporary loss of vision, and that their "mind went black" which has improved in the past few days. Pt. believes that his recent cognitive decline is directly attributed to receiving the vaccine and expresses concern with whoever else gets it.

My thyroid went hyper 5 days after the first shot. I had high anxiety, and high blood pressure. The doctor said I had thyroiditis. Then 5 days after the second shot the same anxiety, and high blood pressure again. I am still being treated.

mind and memory depression; mind and memory depression; tired; sleepy; back pain got worse; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, intramuscular in right arm on 26Feb2021 10:15, at 65 years of age, (Batch/Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included knee surgery on 23Jan2019, some tiredness, disability (reported 40% on back and 30% on mental) and mental depression since 1978 and ongoing. The patient had previously received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 05Feb2021 at 10:15 AM (Batch/Lot number: E23247), via intramuscular route in left arm and one dose of Flu vaccine on 14Jan2021 in left arm. Concomitant medications included acetaminophen 500 mg twice daily for back pain, lithium carbonate 1 tablet 300 mg for depression and lamotrigine 25 mg 1 tablet daily for depression, all taken since an unknown date and an unspecified medicine for Disability 40% since an unknown date. On 26Feb2021, 8 hours after the second vaccine dose, the patient experienced tired and sleepy "skeleton" and back pain got worse and shoulder pain and, on an unspecified date, he experienced mind and memory depression. No treatment was administered to the patient for the reported events. The events tired and sleepy resolved on 28Feb2021, the event shoulder pain was resolving, whereas the outcome of the events back pain got worse, mind and memory depression was unknown at the time of the report.

urinating constantly; up all night, back and forth; This is a spontaneous report received from a contactable female consumer (Wife) reported for her husband (Patient). This consumer reported similar events for two patients. This is the second of 2 reports. A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose bnt162b2 on 05Mar21. On 28Mar2021 patient got his last shot with wife. The wife and patient have been urinating constantly, up all night, back and forth. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374640 Same reporter/ product, similar event, different patient

Extreme fatigue, loss of appetite, dizziness, some confusion of surroundings. Lasted about 24 hours.

I was unable to perform any usual daily activities. I had a severe headache, joint aches, chills and extreme fatigue. I slept for 36 hours. I'm reporting this because I had the same reaction to my first dose. I had COVID in December but I'm otherwise very healthy. I would not be willing to receive another dose of this vaccine.

Pt reported to me on 4/23/2021: dry mouth, difficulty getting out of bed, h/a, fever and chills, feeling like was going to fall, some memory difficulties and ringing in ears. Reported that the sx gradually resolved and are completely resolved by date of reporting (4/23/2021)

Salivary gland reactions; Was told by this doctor that he has seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination; Sleeplessness; I can barely breath; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on left arm on 04Feb2021 at single dose for covid-19 immunization. Patient also received zolpidem tartrate (AMBIEN) and mirtazapine (manufacturer unknown) for unknown indication. Medical history was not reported and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: it looks like ELR84), via an unspecified route of administration in the Left arm on 14Jan2021 at unknown time as a single dose for COVID-19 immunization. On 25Feb2021, almost exactly 3 weeks after receiving his second dose of the Pfizer BioNTech COVID-19 vaccine, the patient started experiencing horrible dry mouth conditions for 6-7 weeks. He stated that due to this persistent dry mouth, he had only been able to sleep on average 3 to 4 hours a night for the past 6 to 7 weeks. Patient reported that he hasn't come back from an ENT specialist regarding this and was told by this doctor that he had seen 6 other patients with similar dry mouth who have had the COVID-19 vaccination and/or COVID-19 itself. It was stated that his doctor also referenced an article in a journal that came out a few days ago that stated COVID-19 was shown to infect the salivary glands. He stated that his doctor was unable to give any further recommendations other than gave him things to keep him comfortable such as Salagen. He also mentioned that after receiving the vaccine, he was being awoken every 20 minutes all night long and many times had to urinate but reported that this side effects has subsided. He stated he read on the internet about a woman who also had COVID-19 who reported having bad dry mouth and was urinating more often than he had in her whole life. He called at the recommendation of her doctor nasal and throat surgeon who said he was going to speaking with his peers about this, but he suggested that he call him too. So, it would appear that he had and several of his patients had similar symptoms to him. He had been suffering from the extreme and when he said extreme, he said the most extreme case he had seen in his 45 years of medicine. Extreme case of might be dry mouth or sleeplessness to this point when he can barely breath. He had maybe 3-4 hours of sleep over the last 6 weeks. They kept thinking that she was allergic that the medication that she was on, but she did not off that medications for a week. They thought of food, he was ingesting they removed every food stuff he finally saw an ENT and he said well, he was the 5th patient he had seen like this, this month and she was telling them he cannot swear by it but it was COVID. He said the only thing that made any sense had seen medication before and they just don't know yet. This was not just enough information and he showed him an article for that he just found the other day that said this enough, COVID was infecting salivary glands or was believed to be so it would seem this might be something that was being recorded yet and might be somebody wanted to take a look at mine. He doesn't know but it was he can't find anything anywhere about this. He can't either except the story that he saw just a few days ago which was professional (Name) journal about COVID now infecting salivary glands that was exactly they know he was suffering it somewhat of freak salivary gland reactions that could be it or could had been COVID (Further not clarified hence PC filed conservatively). When probed for the Date of Vaccine administration for both COVID Vaccine shots, Patient stated that second dose was Feb 4th, and the second dose would be 4 weeks before that. When probed for the exact date of Vaccine administration for both COVID Vaccine shots, patient stated, if they hold on, she get her vaccination card. It would be there right. It was in January, he doesn't knew it looks like 14Jan2021. When probed whether the Vaccine was purchased or she got injected at the clinic, he stated that he got injected. The first on, it looked like ELR84 that was the first dose. When confirmed LOT# as ELR84: he stated, it looked like A but their writing was terrible. He though, it was A it said, or could be G. For second one, EN9581. (Hence second dose LOT captured in tab). Dose for both shots of vaccine: patient stated, that doesn't say. No one say about that. When probed for the site of administration for both shots of vaccine, she stated left arm. When confirmed the vaccine was administered on left arm both the times, stated, she did not remember. (Later confirmed as yes). When probed for Other medications, he stated that not now, no, he had been. (Further clarification unknown) Names of medications: he stated, that was taking Myrbetriq none of these were taken very long they expected these were causing the dry mouth. So, he stopped taking them. it was reported that It was Oxybutynin, let him get it. thought the dry mouth was being caused by the medications. So, they tried switching medications. He had several drugs in that stage for few weeks. So, Oxybutynin was the first one. He took Myrbetriq on February 25th 50 mg, Oxybutynin 50 mg tablet, 1 tablet her mouth daily and then they had Peficare that was for sulfonation and 5 mg,(Further clarification unknown) Tolterodine that was standard Detrol that was 4 mg, Darifenacin,(Was not clarified further hence not captured as concomitant medication) than there were sleep medications none of which worked, none of which solved dry mouth problem, they were Ambien that was Zolpidem 5 mg, Mirtazapine (hence captured as suspect) 50 mg and there was one more, looking that. On an unspecified date, the patient underwent laboratory tests, he was tested for Sjogren's Syndrome for the markers of Sjogren's Syndrome, and they were negative. It was approximately a 1 week ago, 7 days ago and here her result came like he cannot give them the exact date. The outcome was persisting. He was prescribed (further not clarified) Salagen (treatment) in order to generate more saliva. He stated that than there were sleep medication none of it worked, solved dry mouth problem, they were Ambien, Zolpidem 5 mg, Mirtazapine(treatment) 50 mg and there was one more, looking that. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Patient was anxious and reported history of syncope 2 days prior. States he feels dizzy while sitting. His blood pressure was elevated at 179/100 mmHg. Heart rate and oxygen saturation were within normal limits. Retook blood pressure a second time 165/91 mmHg. Third blood pressure 165/87 mmHg. Fourth blood pressure 164/84 mmHg.

the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/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. The patient experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Right after the injection, I felt flushed. For the following 2 days, I felt: chills, headache, a light/dry cough, light nausea, balance was off, concentration was off, fatigue, and joint pain (esp. in hands and fingers). Symptoms cleared by 2/15/2021 except for headache, which remained present every day and Intesified. i told my wife for the first time about it on 2/22/21, then told her that I worried it was a symptom of a stroke on 3/1/2021 and she told me to call my doctor. I met with PA on 3/3/2021 and had a CT scan on 3/9/21. I met again with PA on 3/9/21 and was told that my CT scan indictate normal brain abnormalities due age and an inflamation in the sinuses.

massive itching; There is resolutions till date its painfull itching sleep interupted.; red rashes all over body and face swollen/red rashes erruptions.; face swollen/worsen with swelling; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received he second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration at the age of 65-year-old at arm Left on 14Apr2021 14:30 at single dose for COVID-19 immunization. Medical history was reported as no illness ever before, Prior to vaccination, the patient wasn't diagnosed with COVID-19. Concomitant medications were not reported. There were no other medications the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP7534) at the age of 65-year-old at left arm on 26Mar2021 01:15 PM for COVID-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Since the vaccination, the patient hasn't been tested for COVID-19. In 8 hours of receiving vaccin second shot on Friday (as reported) red rashes all over body and face swollen on 14Apr2021. Went to Urgent care on Saturday (as reported) the hospital on Sunday (as reported) as situation worsen with swelling and massive itching and red rashes erruptions on 17Apr2021 12:00. There was resolutions till date its painfull itching sleep interrupted on 17Apr2021 12:00, over two weeks now. The patient was hospitalized for one day for events. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment (steroid intravenous then oral till date) for the adverse event. The outcome of events was not recovered.

Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; Fainting,pain,itching,fatigue,headache,nausea, Lost of smell, short term memory off and on,; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 12:45 PM at the age of 65-years-old (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Herniated discs L4,L5,S1,C4,C5C6C7, type 2 diabetes from an unknown date. Concomitant medications included apixaban (ELIQUIS); dipyridamole (METROPOLYN) and bupropion, all taken for an unspecified indication, start and stop date were not reported. The patient previously took lidocaine and experienced allergy. 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 29Apr2021 01:15 PM, the patient experienced Fainting, pain, itching, fatigue, headache, nausea, Lost of smell, short term memory off and on. It was unknown if treatment received. The outcome of the events was resolving. Information on the lot/batch number has been requested.

Patient received vaccine on tuesday 5/4. Patient developed a rash surrounding both ankles. Patient and wife dismissed this as possible side effect of vaccine. The patient had difficulty breathing and dismissed it as a panic attack on 5/10. Symptoms continued for several days, went to walk-in clinic on Wednesday 5/12 for tests and inconclusive. Thursday 5/13 the patient continued to experience these symptoms and elevated pain, tightness and cramping in legs and went to the ER where he was diagnosed with bilateral pulmonary emboli. Patient was admitted for 2 days and treated for clots. Upon discharge the patient was instructed to discontiue meloxicam, carbidopa/levodopa and started on eliquis for 6 months. After 6 months the patient will follow-up with a hemotologist.

Extreme pain in shoulder, interrupted sleep, chest heavy, left side. pain spreading spreading left to right

feeling of light headedness for 3 straight days; felt fatigue; hard to focus; This is a spontaneous report from a contactable consumer or other non hcp.A 65-years-old male patient received second dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 10:30 as SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Historical vaccine includes patient received first dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 11:00 as SINGLE DOSE for covid-19 immunization. Patient did not get other vaccine in four weeks and no other medications in two weeks. Patient does not have covid prior vaccination and does not tested covid post vaccination. Patient does not have any other allergies. On 14Feb2021 12:00, after 2 days of the second vaccine patient felt fatigue and a feeling of light headedness for 3 straight days hard to focus. The outcome of the events was resolved. Information about lot/ batch number has been requested.

Injection precipitated a Lyme's Disease episode: fatigue, confusion, dizziness, low grade fever, ringing in the ears. Treatment: Amoxicillin. 1000mg twice a day. Continued anti-biotics for 30 days. Symptoms receded after 30 day treatment ended

Urinating blood; very depressed; tired for one week; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 27Feb2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were not reported. On 06Mar2021 06:00, the patient experienced urinating blood and very depressed and tired for one week. The treatment received for events was unknown. The outcome of the events recovered. No follow-up attempts are possible. No further information is expected.

lost a few pounds; Stomach pain; Vomited; Loss of appetite; Feels like he is in a fog; Twitching in left ankle; Injection site pain left arm; feeling very unwell; Headache; very tired; Feverish; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EW0177), via intramuscular route, in left arm on 27May2021 at 16:25 (at age of 65 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included cancer (family medical history), cholesterol, blood pressure and heart attack from an unknown date and his father had heart attack in his 50's but he chain smokes. AE(s) following prior vaccinations: When he was 16, he got the flu shot and got severely sick. The patient concomitant medications were not reported. Patient received the first shot on 27May2021. The next day on 28May2021, he had all the symptoms such as injection site pain, very tired, headache, chills, Feverish, feeling very unwell. The next day on 29May2021, it seemed like he was fine. Now, ever since then, all he wanted to do was lay down. He doesn't feel well. He had stomach pain. He was kind of in a fog. He just wanted to lay in bed. He did vomit one time. He had loss of appetite. He wanted to know if someone could provide advice, that he should get second dose or not. He lost a few pounds in the last week. He was still in a fog. Injection site pain went away the following day. Other than having stomach pain, he doesn't feel that bad. The headache lasted 3 days. Therapeutic measures were taken as a result of headache. He has been on Tylenol. Stomach pain was not as bad as it was for 4 days. He was feeling feverish though. Regarding loss of appetite, he did eat something for breakfast, but that was it. The foggy feeling lasted until 02 Jun 2021 (yesterday as reported) and improved on 03Jun2021 (today as reported). All of symptoms kicked in on 29 May 2021. He added that in his left ankle, he does not know how to describe it. It was not like an electric shock but a twitching. It only lasted one day and went away. The injection did not hurt and did not hit bone. He feels sure it was given in the muscle. He took blood pressure medication and never had any reaction. He did not think it was relevant. His cholesterol and blood pressure were good now. He had a test for his heart a couple of years ago. The doctor said one of his arteries for his age looks like it was pretty normal, but one had a build-up in it. The case was assessed as non-serious. Outcome of events Muscle twitching, Feeling abnormal, Decreased appetite, Vomiting, Pyrexia, Fatigue and Malaise was recovering while outcome of Abdominal pain upper was not recovered and unknown for weight decreased. Patient was recovered from Vaccination site pain and Headache on an unknown date and Chills on 29May2021.

Symptoms: Numbness in fingers and hands; pain in arms, shoulders, lower back, hips, buttocks, and legs; sharp, jagged pain in hands and inability to form a fist in both hands; inability to walk, stand, sit for more than 15 minutes, dress self, inability to wash and groom self; total body weakness Treatment: Two one-week treatments of Medrol, pack of 21, Lioresal EQ 10 mg, Tramadol 50mg; one week treatment of Prednisone pack of 78, ortheses bilateral hands for carpal tunnel syndrome Outcomes: Some relief from hand and wrist pain

Cerebral venous thrombosis; bilateral intracerebral hemorrhage in the left, greater than the right; tonic-clonic seizure; brain swelling/cerebral edema; headaches; overall imbalance/having balance problems; he had a decline; kind of getting worse/ had the worst symptoms; His prostate is enlarged; patient's mental status is altered; This is a spontaneous report from a contactable physician. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EN6203) as 0.3 ml single for COVID-19 immunisation. Patient age at vaccination was 65 years old. Medical history included hyperlipidemia and high cholesterol. Historical vaccine included 1st dose of BNT162B2 (LOT: EL3247) on 03Feb2021 for COVID-19 immunisation. Concomitant medication included pravastatin (strength: 10 mg) taken for an unspecified indication from an unspecified start date and ongoing. Reporter did not know all of the symptoms that the patient had and cannot get the history, because the patient's mental status was altered (from unknown date in 2021). It was reported that he was having symptoms for at least 2 weeks with some increasing over the last 2 weeks. Knew that he had an overall imbalance and was having headaches, both from unknown date in May2021. He had been having symptoms for weeks and went to his doctor as an outpatient. He had initial imaging that was concerning and he went to the hospital because he had a decline (from unknown date in 2021). He had declined and had a hemorrhagic hemorrhage with cerebral venous thrombosis, both from 04Jun2021. He was admitted to the hospital 04Jun2021, and 05Jun2021 he was transferred to the ICU. He had declined since his initial presentation and had been kind of getting worse over the last couple of weeks. Stated the patient was stoic and does not have a lot of medical problems, but everyone knew he was having symptoms over the last 2 weeks. 02Jun2021 he had the worst symptoms and was basically having balance problems. He was getting concerned and had called to get an appointment with his primary care physician. They had done an outpatient CT scan which found the cerebral venous thrombosis and he went to the hospital and was placed on Heparin. While in the hospital, he had a generalized tonic-clonic seizure and had further decline on 04Jun2021. Repeat imaging showed that he had bilateral intracerebral hemorrhaging, the left greater than the right, and they had expanded a bit. He was still on heparin and now (Jun2021) had some cerebral edema due to it but was not on a ventilator. He was still in the time period where he was continuing to have small declines. He was therapeutic on heparin. He had a central line and was getting hypertonic saline for the brain swelling and cerebral edema. Patient previous health condition was reported as he did not have a real significant past medical history. He maybe carried a diagnosis of hyperlipidemia and high cholesterol. He was pretty healthy; regularly went to the doctor and was otherwise pretty stable. Reporter did not even think his LDL was that high. He had never been on any blood thinners or anything like that. They did a full scan to look for cancer and had no history of blood clots. They did a scan that was negative for any types of masses or any concerns for cancer. His prostate was enlarged (from unknown date in 2021) and they had spoken to the family about it and they said he had been worked up with a biopsy which had been negative. Physician Office? Yes, He was directly admitted to the hospital from primary care. He presented to the clinic because he had these symptoms and headaches. The imaging was done and then he was admitted. He never went through the emergency room. Cerebral venous thrombosis, bilateral intracerebral hemorrhage, overall imbalance/having balance problems, he had a decline, headaches resulted in Physician Office Visit. Outcome of cerebral venous thrombosis, bilateral intracerebral hemorrhage was not resolved; outcome of tonic-clonic seizure, brain swelling/cerebral edema, headache, overall imbalance/having balance problems, he had a decline, kind of getting worse/ had the worst symptoms, enlarged prostate and mental status was altered was unknown. Causality: Cerebral venous thrombosis: Can't say for sure because reporter does not know the timeline but can't find any other reason, he would have cerebral venous thrombosis.; Sender's Comments: Based on the temporal relationship, the association between the events cerebral venous thrombosis, intracerebral hemorrhage, tonic-clonic seizure, and brain swelling with BNT162b2 can not be fully 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.

Symptoms (24x7, for last 15 weeks) o Feels like pressure inside my head. Occasionally headaches, but mostly pressure. o Best description is that I feel slightly "hung over" every day. Or like I have the flu or some other virus o Constant light headed, balance issues – Worse in morning , a little better later in the day o No dizziness, no vertigo o Memory and cognitive skills not at 100% (forgetful, using wrong words occasionally, foggy) o Ringing in ears; vision changes o Exhausted, weak o Get car sickness which has never been a problem before o Stiff, painful popping neck o Nagging cough for months o Possibly increased nasal congestion o Occasional palpitations – seem slightly more frequent than before but unsure o Occasional headaches behind my eyes

Out of sorts and dizzy; Out of sorts; Heaviness in his upper chest and shoulders; Heaviness in his upper chest and shoulders; Felt wobbly; sneezed 4x in rapid succession then he felt like he couldn't breathe; Felt like his heart or left lung was going to burst; Aches and pains in his body like he had the flu; Sneezed 4x in rapid succession then he felt like he couldn't breathe; This is a spontaneous report from a Contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264) via unspecified route of administration, administered to right shoulder, on 04Feb2021 at 9 AM, as unknown dose, single for COVID-19 Immunisation. Medical history included bipolar disorder. The patient's concomitant medications included testosterone undecanoate (AVEED) taken for hypogonadism, start date was unknown and it was ongoing; Lithium Carbonate taken for Bipolar disorder, start date was unknown and it was ongoing; Valproate semisodium (DEPAKOTE) taken for Bipolar disorder, start date was unknown and it was ongoing; lurasidone hydrochloride (LATUDA) taken for Bipolar disorder, start date was unknown and it was ongoing; Levothyroxine sodium (SYNTHROID)taken for Hypothyroidism, start date was unknown and it was ongoing; Pantoprazole taken for Gastrooesophageal reflux disease (GERD), start date was unknown and it was ongoing; quinapril taken for blood pressure high, start date was unknown and it was ongoing; Metformin taken for diabetes, start date was unknown and it was ongoing; Mirabegron (MYRBETRIQ) taken for Urine abnormality, start date was unknown and it was ongoing. Caller stated that he had adverse effects immediately after getting the injection. On 04Feb2021 (also reported as: less than 30 seconds after the injection), the patient experienced like out of sorts and dizzy. He stood up and walked to the observation area and had a heaviness in his upper chest and shoulders and felt wobbly. After 15 minutes, he stood up and went to his car and felt almost normal. When he got home, about 2 hours later, he sneezed 4 times (4x) in rapid succession then he felt like he couldn't breathe. Stated that he had to try to stay calm and tried to relax, and almost immediately it felt like his heart or left lung was going to burst, but it went away after a second. Stated that about 2 hours later he had aches and pains in his body like he had the flu, and that lasted for about 30 minutes, then they went away. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 04Feb2021 at 2:30 PM, the outcome of the events were recovered. Follow-up attempts completed. No further information expected.

I was working at a university and that is why I got the shot there. 30 minutes after my 2nd shot, I was driving home and my heart started beating rapidly and it felt like I was having a asthma attack. I drove the apartment and laid down. I had the rapid heart beat and tiredness for several days. I had days where I was so exhausted I called in sick or worked from home. I still get tired easily , have rapid heart beats for up to an hour at a time and some days just take it easy. I resigned from my job because I felt I could not function and I wanted to be closer to home where my doctors were located. I had only taken a day or two sick leave before my injection, but took many days after the shot. I feel much better other than what I described above. I am reporting this because all news is talking about younger individuals. But I had/have the same symptoms and over 65.

can't really sleep; injection site pain to his right arm; pain at the top of his arm going down his arm/ the whole arm itself just hurts; pain at the top of his arm going down his arm/ arm hurts/when he turn had pain up his armpit; when he turns his neck to the right he has pain up his armpit; This is a spontaneous report from a two contactable consumer (patient and his wife). A 65-year-old male patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: unspecified), via an unspecified route of administration on 30Jan2021 (age at the time of vaccine 65-year-old) as 1st dose, 0.3 mL, single dose on right arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were not specified but taking for blood pressure unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the pfizer suspect. On 01Feb2021, the patient experienced pain at the top of his arm going down his arm/ the whole arm itself just hurts/when he turns his neck to the right, he had pain up his armpit. On an unspecified date, the patient could not really sleep and had injection site pain on his right arm had kept him awake. The patient stated he was calling about the Pfizer BioNTech COVID19 vaccine and stated he had been having a reaction of side effects and asking how long the side effects could last. The patient stated that for the first couple of days after getting the vaccine he had nothing and then the pain started a little bit on Monday and then on Tuesday the pain got a little worse; stated that last night the pain was beginning to keep him up from sleep. The patient stated all the adverse events are ongoing. The patient's wife stated the indication for which the patient received the vaccine was they are trying to be safe, and the patient's HCP called him and asked the patient if he wanted to take the shot. The patient's wife stated they both received the vaccine. The patient stated he was given paperwork down at the site location where he got the shot but was given the paperwork after he was administered the shot and the paperwork was a list of side effects; stated if he had seen the list of side effects before, he was administered the shot, he probably would not have taken the shot. The patient's wife stated the patient received no testing or treatment for the reported events. The patient did not visit emergency room. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

So, I started to have some epidermis outbreaks about a week after the second vaccine. Shortly, after that I had a poison ivy reaction, but this reaction was different in which it started to go, which is odd for poison ivy. I was having an overaction to certain irritants as well. I also would have an abnormal amount of warts that were showing up. I have a lot of epidermis outbreaks. I also have had terrible joint pains also which started a week after the second dose. I was not able to lift things or do normal activates. I am still having trouble with my joints.

Back pain; Leg pain; Right knee swelling; foot numbness in both left and right feet; Light headed; Felt odd; Tired; Queasy; Sore Arm; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route of administration in right arm on 12Mar2021 at 13:00 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The medical history included lower back disc surgery on 12Mar2014 was successful but had low level pain on right side and constant slight numbness in right foot 3 small toes and high blood pressure. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril (MANUFACTURER UNKNOWN) 20 mg daily for high blood pressure. The patient received no other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 12Mar2021 at 13:15, the patient felt light headed and felt odd initially after injection. At 1-3 days felt tired , queasy and experienced sore arm. On 15Mar2021, at 3-4 days the patient experienced back pain and leg pain, right knee swelling, foot numbness in both left and right feet which made the patient difficult to be active and experienced continued same symptoms as day 1-3. At 7-10 days, the patient was mostly back to normal. The patient did not receive any treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of light headed, feeling abnormal, tiredness, queasy, painful arm, back pain, leg pain, swelling of right knee, numbness in feet was recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Arthritis; pain down to the knee and lower back; pain down to the knee and lower back; hardly sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on 04Mar2021 at 09:15 hours (at the age of 65-years-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension (controlled), cholesterol (controlled) and allergies to intravenous pyelogram (IVP) contrast dye (iodine based). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included ezetimibe (ZETIA) 10mg once and omeprazole (MANUFACTURER UNKNOWN) 20 mg once a day; both from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Mar2021 (after four days), the patient experienced a serious arthritis episode in the right hip with radiating pain down to the knee and lower back which as of this submission was still giving him problems. For a week, the patient could hardly sleep. The patient reported that even now (as of report), it hurts just lying on the bed. The patient had a doctor's appointment but cannot get in until 29 March (after the second shot). The patient did not receive any treatment for events. The clinical outcome of events arthritis, knee pain, lower back pain and sleep unwell were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.

65 y.o. African American male who suffered from COVID-19 PNA earlier this year, as well as MRSA endocarditis with septic brain emboli and fungal empyema. He was in rehab and presented to SMC ER with persistent cough without fever x 1 week, and associated chest pain. He states he was unable to produce sputum for some time, but he has finally been able to expectorate clear/ yellow phlegm in the last day or so. The cough disrupts his sleep. He notes pulmonary wheezing.. He smokes 2-3 cigarettes per day at this time and does not use any inhalers. He also reports persistent diarrhea and new right foot swelling which started morning of admission. Patient reported being fully vaccinated for COVID19 and was found to be positive via PCR. His CXR showed CM, central vascular congestion, RT small effusion/atelectasis, but no infiltrates and no clear pneumonia. The patient was discharged to a SNF 7/2/21.

Dreams every time i fall asleep (Day or Night) Reoccurring mild headaches and light headedness which last for a few seconds at a time

After the second shot I started getting what feels like cramps in my thighs, buttocks, and calves along with pain in my lower back; at night it's hard to sleep with the pain and the leg stiffness that accompanies the pain. Getting up in the morning is agonizing as my legs are stiff and almost immovable. Symptoms usually appear late in the day, especially before bedtime! Pain is bad, and I've been going to my doctor but all he wants to do is give me painkillers that have bad side-effects, so I'm getting by with OTC pain relief products, both oral and topical.

he couldn't take a deep breathe; smothering feeling; felt an out of body; light headedness; This is a spontaneous report from two contactable physician received via Medical Information Team. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right shoulder on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that: "on 23Dec2020, a minute after vaccination he felt as if he couldn't take a deep breathe, it was like a smothering feeling, then he felt an out of body and light headedness, this only lasted for 3 minutes". The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test which resulted negative and SARS-CoV-2 test: no positive results for the COVID Test prior to the vaccine. The patient outcome of the events was recovered. Information on the lot/batch number has been requested.

Absolutely no problems after the vaccination until about 24 hours later: Then sudden onset malaise, fever, myalgias (including injection site pain which was not previously present) arthralgias, headache, nausea, malaise to the point where I could not continue to work. I went home, took 600 mg ibuprofen, 25 mg of benadryl and slept for 4 hours. I felt better when I woke up and feel good today, as if nothing happened

No immediate post vaccine symptoms other than slight clear rhinorrhea and mild sneezing for a few hours. By evening about 12 hours post vaccine felt fatigue and some increase in mild baseline myalgias. During night sleep significantly disrupted by generalized myalgias, along with some strange transient paresthesia. Such that at about 4:30 AM I texted my 3 workplaces that I did not expect to go to work that day. Went back to bed, woke up around 9:30 AM 1/8/2021 and nearly all myalgias resolved, still fatigued but better. Paresthesia's were transient and resolved. Went to work after all. Today, Saturday 1/9/21 woke up and all symptoms resolved.

Approximately 9 hours after injection, I was awakened with heart pounding in my chest and it felt fast but I did not check it. Watch did not show higher than 84 through the night but I could not sleep much due to the heart pounding. Arose for work at 6:15 and felt tired but the palpitations did not bother while standing. Temperature 98.8. about 90 minutes later, while at work, HR was 130-148, I was breathing deeply, otherwise okay. Chills started about 17 hours post-injection and temperature rose as high as 102.4 in the next 3 hours. HR lowered to about 110 about 16 hours post injection and did not get below 100 for another 12 hours. some coughing throughout this time, not productive. Heavy night sweats around 34 hours post injection. I had mild chills about 48 hours post injection, and fine since then. The palpitations were very uncomfortable but stopped once the HR lowered to about 110

Excessive thirst after both vaccines, just after second vaccine, face becoming bright red and blood pressure low, two days after second vaccine, unable to sleep, passed out when standing up X 1, nausea, fatigue

After the first dose I had no side effects but after the second dose I had various reactions: - about thirty minutes after the shot I developed a strange sensation on the left temporal area of my head extending to behind my eye. This went away after a few hours but when it started I thought of Bell's Palsy. - Later my arm got extremely sore at the site of the injection it still hurts and in a large area of the arm 5 days later - Painful area below the left armpit and in an area about 3 inches in diameter (area of the lymph node). Still have pain although less after 4 days.

The vaccine was given on 1/28/2021. The patient reported to the Medical Center ED on 2/7/2021 with complaints of worsening bilateral lower extremities pain, swelling, numbness L>R leg for about a week. He reports significant purple discoloration of his legs, "purple spots on lower legs", pain in bilateral legs worse with rest and standing still and associated DOE. Denied chest pain, abd pain, palpitations, fever, chills, NVDC, sick contacts, recent trauma/falls/injury. Denies regular use of NSAIDs, antiplatelet meds or chronic anticoagulation, clotting or bleeding disorders, history of DVT or PE. Patient was seen here by the ED staff on 2/3/2021 after a syncopal event at home where he described feeling light

Thirty minutes after 1st vaccine administered mental foggiest and headache and acrid taste in mouth. Then three days post vaccine return of brain fog and headache. Gradually headaches subsided within ten days.

102F temperature, chills, headaches, tiredness, can't sleep at night. The headaches are weird in that I will get a sharp pain in my head that goes away in a second.

Severe Sinus drainage starting 2 days prior to second dose. Constantly fatigued. Brain fog, or delay in being able to respond to questions. Trembling of hand and of body at times. Anxiety also at times.

slipped in parking lot on cold day while transferring to car Narrative: pt, after this fall and ER trip that happened on the day of the vaccine, -pt had a history of metastatic lung cancer and was admitted to outside hospital with altered mental status and found to have brain mets, is now in hospice. Low likelihood that covid vaccine was responsible.

According to staff....Recipient received the above vaccination and went to sit for 30 minutes. He had already explained to the staff that he had had previous reactions to bee stings that required epinephrine so the nurse practitioner had instructed him that he was to wait for 30 minutes vs the usual 15 minutes. It is unclear exactly how many minutes into the post-vaccination period passed before he began to report numbness around his lips. The nurse practitioner then indicated he began a "rash" on the back of his neck. The recipient reported that this was feeling very much like his previous allergic reactions. They took his BP and it was reported to be around 180/100 at that time. He did not report feeling SOB but reported his throat felt like it had in previous allergic reactions. Recipient remained alert and oriented the entire time. It was decided by the two nurse practitioners on site that he be given the epinephrine and Benadryl IM. His BP remained elevated and then, following the epinephrine, he became very shaky and a bit foggy. 911 was then notified for further assistance from the EMT's and possible evaluation at the local hospital which was about 5 minutes away. Paramedics evaluated the recipient and agreed that evaluation at the hospital would be warranted. He never lost consciousness or required oxygen or other assistance. He was able to place himself on the gurney and was speaking with his wife (that was present)as he was taken out the door. The transfer was done out of an abundance of caution. We do not know if the hospital kept him following the incident.

Muscle soreness and joint pain with headache the following day for most of the day. Two days after the injection ,and for two days I experienced severe dizziness and abdominal pain producing yellow bile. I was unable to stand up for more than a couple of minutes for most of those two days. I was unable to eat and had only Pedialyte for most of those two days. I started to hallucinate mid day and had fever dreams that inhibited sleep. No treatment was given.

Awoke March 8 with vertigo dizziness such that I could not walk without assistance or plus asthma symptoms. Took meclizine and stayed in bed till March 10. Symptoms subsided on March 11 but continued absence from work & very limited activity until the 12th. Symptoms are better but still not completely recovered

He woke up this morning and felt awful; He is mainly fighting fatigue now and feeling rough; His sinuses shut down yesterday; muscles hurt and legs hurt; muscles hurt and legs hurt; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; The shortness of breath and chest pain were gone when he woke up this morning about 5AM; This is a spontaneous report from a contactable consumer reported for himself. A 66-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9269 via unspecified route of administration at the left shoulder on 08Feb2021 11:00 AM (at the age of 66-years-old) for COVID-19 immunization. The patient received the vaccine at hospital. Medical history included a bypass surgeries (18 stents), a chronic obstructive pulmonary disease and he donated a kidney in 1997 and immunosuppressed. The patient had COVID at the end of December.Concomitant medications included acetylsalicylic acid (ASPIRIN) at 81 mg, 1x/day, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) 1x/day (200/25 one puff), sacubitril valsartan sodium hydrate (ENTRESTO) twice a day, fenofibrate 160 mg, 1x/day, isosorbide mononitrate (IMDUR) 120 mg, 2x/day, metolazone 5 mg, 1x/day, as needed, metoprolol 100 mg, 2x/day, famotidine (PEPCID) 40 mg, 2x/day, clopidogrel bisulfate (PLAVIX) 75 mg, 1x/day, potassium (POTASSIUM) as needed, 10mEq, evolocumab (REPATHA) 140 mg, biweekly, ranolazine (RANEXA) 1000 mg, 2x/day, montelukast sodium (SINGULAIR) 10 mg, 1x/day, torasemide as needed(40mg up to 160mg ), colecalciferol (VITAMIN D [COLECALCIFEROL]) 50,000 units once a week, nitroglycerin. On 08Feb2021 about midnight, he woke up and had shortness of breath and chest pain, he took 6mg Nitro and he took two at midnight; He took another one at 1:00AM and it had pretty much gone away. Around 2:30AM the chest pain hit again big time, he woke up on morning and felt awful. On 08Feb2021 his muscles hurt and legs hurt. He was mainly fighting fatigue now and feeling rough. His sinuses shut down on unknown date. The patient recovering from muscles hurt and legs hurt and recovered from chest pain. The outcome of the other adverse events was unknown.

Anxiety. Severe concern about how I felt at the moment, lying in bed. Started at about 2:30 am. An electric feeling. Hard to describe. I thought I might be having a heart attack. It happened several times, resolving to a normal state after 40 min or so, being ok for maybe 1/2 an hour then returning. After 3 or 4 worrisome crescendos, I decided to go to the Emergency Room at 4:30 am. Observed there, released with analysis being it was anxiety, not a heart problem.

Swore arm at injection site and serious fatigue at ten pm after shot that continued through the following day and evening until feeling better on Wednesday morning after 12 hours of sleep! Also I noted that the 2nd covid-19 dose recorded on the15th of March is identical to the one I received on February 22, 2021, leading me to believe that the person who administrated the second shot simply copied the lot number information from the first shot that was recorded on card.

Pt presented after an episode of amnesia/ confusion at home with possible facial droop, & headache. Found to have bite mark on tongue & cheek Evidence he fell onto face & broke glasses. Suspect 1st time Seizure with postictal confusion as MRI brain showed no stroke. Admit to hosp for further eval and treatment.

3-14-21 Knot in neck on left shoulder felt like golf ball, 3-14-21 pain was so bad could not go to sleep I was up 28 straight hours before I slept, 3-15-21 After massage by girlfriend (has therapist license) moved to upper neck/spine area, pain was severe but felt like a large marble, 3-16-21 same pain 3-17-21 pain still there and make any head movement extremely difficult almost paralyzing, 3-18-21 pain subsided some, slight sweating periodically and experienced occassional chills. The neck issue is the worse problem I am having. Ending tis report at 9:50 PM on 3-18-21. I have been tested twice for covid 19 in 2020, both tests were negative.

EXTREME tiredness, headache, body ache. Unable to work or carry out daily activities. Still having "symptoms" 14 days after vaccination.

Trembling, loss of consciousness periodically, memory lapse, nervousness after 15 mins of the vaccine administration

2/27 Patient presented to a Clinic with ~4 days of nausea, chills, muscle aches and fatigue. He was diagnosed with COVID-19. He continued to feel poorly and 3/1 was started on doxycycline as an outpt. 3/3 was started as outpt on dexamethasone. 3/6 Presented to ED w/ worsening symptoms including SOB. RA pulse ox was 88%. He was admitted for COVID/COPD exacerbation and was changed to IV azithromycin/rocephin and dexamethasone. He was maintained on oxygen. He was unable to be weaned off oxygen and was discharged to home on 3/9 on oxygen.

After 3 hours of vaccine, extreme diarrhea lasting 1 evening. Normal stools the next day. Normal activity until 03/20/2021. 03/20/201 had coffee at 6:30 am didn?t feel good. Didn?t take meds, had 2-3 hours nausea, had fluids, then vomited. No food for a day and a half. Had soup on the 21st and tuna and had more diarrhea that night and Monday morning. Other side effects include chills, brain fog, body aches in the back and legs, rash development on left knuckle, itchy head and body, slight headache. The red spot where the needle went into the left arm. Temperature 98.4. blood pressure 140/90 pulse rate 80.

Hallucinations; severe abdominal pain; producing yellow bile; severe dizziness; fever; muscle soreness; joint pain; headache; first dose 13Feb2021 - second dose 02Mar2021 which is 17 days; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 02:15 PM (lot number: EN6202), at the age of 66-year-old, as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, no allergies to food or medicine, allergic to dogs, cats, tree pollen, grasses, dust mites, mold, horses. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; azelastine taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 on 13Feb2021 01:45 PM on Left arm (lot number: EL9267). The patient did not have COVID prior vaccination. On 03Mar2021 07:00 am, the patient experienced muscle soreness, joint pain and headache. On 04Mar2021, the experienced severe abdominal pain producing yellow bile, severe dizziness with hallucinations and fever. The patient was unable to stand for more than a few minutes for most of that 48 hours. The outcome of the events severe abdominal pain producing yellow bile, severe dizziness with hallucinations and fever was recovered in 06Mar2021; while the other events was recovering. No treatment was received for the events. The patient was not tested for COVID post vaccination.

I have never passed out prior; 1 in.laceration above the right eye along; food is less flavorful and does not excite me; Feeling queasy; bruising to my upper arm, leg and back; don't feel right; About 10 hours after the second injection began to have chills and a low grade fever.; About 10 hours after the second injection began to have chills and a low grade fever.; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6203), via an unspecified route of administration (on left arm) on 06Mar2021 12:00 (at the age of 66 -years-old), single dose for COVID-19 immunisation. Medical history included Diabetes Type 2 (Doctor stated that I really do not fit either profile. Concomitant medications included pioglitazone, metformin, lisinopril, ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). Patient stays away from all Opioids they make him very nauseous. Patient typically gets a low grade fever (100-101) and chills 4 hours after a Flu Vaccine that last almost exactly 24 hours. The patient had the first dose of covid vaccine on 11Feb2021 for covid-19 immunisation and experienced only minor soreness at the injection site with the first dose. Experience only minor soreness at the injection site with the first dose. About 10 hours after the second injection began to have chills and a low grade fever. Sunday morning 07Mar2021 started feeling queasy. Patient thought that if I took a shower that I might feel better. As Patient was getting toward the end of his shower Patient just thought, Patient don't feel right. The next thing Patient remember Patient was picking himself of the floor of the shower. Patient have never passed out prior to this episode. Patient received a 1 in. laceration above the right eye along with bruising to his upper arm, leg and back. Patient basically ate nothing the remainder of Sunday nor Monday. It is as if the food is different. Even though he is a Diabetic and keep his blood sugar under control. Patient knows that this may sound weird, but it is as if the food is less flavorful and does not excite him. As 09Mar2021, he still does not feel together. The outcome of the events was not recovered. No treatment for any adverse event. No Covid prior vaccination, not Covid tested post vaccination.

The patient's wife noted he began to experience: 101F temperatures, muscle aches, headache, feelings of impending doom or that everyone is out to kill him, mumbled to himself (not normal)

at first it was pain across my shoulders and to my wrists, next added pain in my legs (not my feet) and light headedness. I could hardly sleep all night from pain and aches. The next morning I had a hard time using my legs and could hardly lift anything, that lasted all day wednesday into thursday. Thursday the pain lessened and the weakness became less but I started getting pain in my hips and heavy painful bloating feeling in my intestinal area. That lasted all day and into Friday (today). Today (Friday) the pain in my arms subsided, legs got better (no pain but still weak) but the intestinal issues are keeping me incapacitated and the top of my hips ache.

high fever; high heart rate; low oxygen; high blood pressure; chills; he was confused and out of it; did not have as much confusion as he did with the first dose; weak; This is a spontaneous report from a contactable consumer reported for her father. A 66-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 11: 00 am for covid-19 immunisation. Medical history included sleep apnea from 2010 and ongoing, hypertension from 2011 and ongoing, polycythemia vera from 2015 and ongoing, two strokes (both in 2016), myasthenia gravis from 2019 and ongoing, mass on kidney (right kidney, Found in 2020 and being monitored), COVID-19 from Dec2020. The patient was negative for COVID as of "13Jan2013" (as reported). The patient was hospitalized for COVID for about a week in Dec2020. Concomitant medications included levothyroxine from 2019 and ongoing for Thyroid maintenance, azathioprine from Aug2020 and ongoing for myasthenia gravis, clopidogrel from 2016 and ongoing for Stroke prevention/ blood thinner, hydrochlorothiazide from 2019 and ongoing for hypertension, nifedipine from 2015 (maybe) and ongoing for hypertension, bisoprolol from maybe like 2015 and ongoing for hypertension, atorvastatin from an unspecified date and from Mar2020 and ongoing at new dosage (unspecified) for blood cholesterol, hydroxycarbamide (HYDROXYUREA) from 2015 and ongoing for polycythaemia vera. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 for covid-19 immunisation, experiencing tested for COVID and he tested positive at that time with symptoms on 12Feb2021, unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital on 12Feb2021 at 14: 00, muscular weakness and confused and out of it/confusion on an unspecified date. The patient got flu shot in Oct2020 and that was the last vaccine prior to COVID shot. The patient had both doses of the COVID vaccine, and both times he ended up in the hospital with a reaction. The reporter stated that the doctors were not calling the patient's reaction an allergic reaction, but the patient had a high fever, a high heart rate, low oxygen, high blood pressure and he would have chills and he was confused and out of it. Caller stated that the patient was currently in the hospital. For the second dose, the patient got the reaction occurred a little quicker, it started around 10 pm yesterday, but it was not really bad until today at 10am, and so that was when the caller called 911 again. Caller stated that today, the patient did not have as much confusion as he did with the first dose, but he was weak, had a high fever, high blood pressure, high heart rate and low oxygen. Caller stated that the patient was sent home after the first dose with a nasal cannula and oxygen but his oxygen was low. Caller reported that the patient went to the ER this morning, he had not yet been discharged but he also had not been admitted to the hospital at the time of this phone call. The patient had covid test on 12Mar2021 with positive result. The reporter stated that she didn't really think anything had been abnormal, other than, she knew the vaccine did not cause someone to get COVID, but the week before his first does, the patient was tested for COVID, and he was negative. The reporter reported that the day the patient went to the hospital on 12Feb2021, he was tested for COVID and he tested positive at that time. Caller reported that she took the patient to his primary care doctor a few days later, and the patient had two tests, both the mouth and nasal swabs and those were both negative. Caller stated that everything else that the hospital tested the patient for, looked good. Caller stated that he had bloodwork done, and cultures and a Chest Xray and everything looked clear and normal. Caller reported that the only thing abnormal was that one COVID test on 12Feb2021, and the caller had him tested again a few days after that, and 10 days after that, and those tests were all negative. The patient was not admitted to the hospital after the first dose, only was in the ER. The patient was currently in the ER and it was unclear if he will be admitted to the hospital or not at the time of this call. Outcome of the events was unknown.

muscular weakness; he was confused and out of it/confusion; he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital; tested for COVID and he tested positive at that time with symptoms; This is a spontaneous report from a contactable consumer reporting for her father. A 66-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 13:45 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation . Medical history included sleep apnoea syndrome from 2010 and ongoing , hypertension from 2011 and ongoing , polycythaemia vera from 2015 and ongoing , cerebrovascular accident on 2016 , myasthenia gravis from 2019 and ongoing , renal neoplasm from 2020 to an unknown date , covid-19 from Dec2020 to an unknown date (Hospitalized for COVID for about a week in Dec2020) , thyroid disorder from an unknown date. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from 2019 and ongoing; azathioprine (AZATHIOPRINE) taken for myasthenia gravis from Aug2020 and ongoing; clopidogrel (CLOPIDOGREL) taken for prophylaxis, anticoagulant therapy from 2016 and ongoing; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2019 and ongoing; nifedipine (NIFEDIPINE) taken for hypertension from 2015 and ongoing; bisoprolol (BISOPROLOL) taken for hypertension from 2015 and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from Mar2020 and ongoing; hydroxycarbamide (HYDROXYUREA) taken for polycythaemia vera from 2015 and ongoing. The patient experienced he was unresponsive like he could answer questions but he was unable to get up to get out to the car to go to the hospital on 12Feb2021 14:00 with outcome of unknown , he was confused and out of it/confusion on an unspecified date with outcome of unknown , tested for covid and he tested positive at that time with symptoms on 12Feb2021 with outcome of unknown. The event Unresponsive to stimuli was considered an Important Medical Event. The patient underwent lab tests and procedures which included blood test: everything looks clear and normal , chest x-ray: everything looks clear and normal , culture: everything looks clear and normal, Sars-cov-2 test: positive on 12Feb2021, Sars-cov-2 test: negative on 22Feb2021. Course of the event Caller reports that her father had the first dose of the COVID vaccine on 11Feb2021, at 1:45PM, and about exactly 24 hours later, his reaction started at 2pm on 12Feb2021. Caller reported that after the first dose, her father had muscle weakness and confusion, he was unresponsive like he could answer he questions but he was unable to get up to get out to the car to go to the hospital, so the caller had to call 911. Caller reported that her father was not actually admitted to the hospital, he was taken to the ER and was there for maybe 6 hours before his body just snapped out of the reaction, and he was discharged home that same day. Follow up information has been requested.

Five days after my second vaccine, at about 8 am, I developed fairly diffuse abdominal pain, and retching. I left work and went home. This lasted for about 3 to 4 hours, then let up, but then developed about 45 minutes of profound rigors, which then let up, then my temperature (had been normal) went up to less than 102 F. For the next six days I continued to run fever, never higher than 103, chills, and some migrating abdominal pain, no diarrhea, normal stools, constipated if anything. Stayed home from work obviously. On Sunday, and Monday am, still running fevers, my pain seemed to settle into my right lower quadrant. My wife, a family physician, helped arrange a CT scan Abdomen and Pelvis, as we were concerned about appendicitis, maybe an abscess. The scan revealed normal appendix, but several lesions in the right side of the liver thought highly suspicious for "metastatic disease." MRI recommended, and had this Wednesday that week, and it confirmed the lesions, with characteristics suspicious for metastatic tumors. By Monday afternoon, my fever abated, and I felt much better. Able to return to work. The abdominal discomfort was improved, maybe due to constipation. Friday of that week, I was able to get to see my primary provider, who is in Omaha, NE to review the situation, and we agreed a liver biopsy was needed. A week later, Friday, Jan. 29, I had CT guided liver biopsy at hospital in Omaha. 16 cores taken, and no malignancy found, but significant inflammatory cells, especially lymphocytes. Meanwhile I have felt fine. Decided to do a follow up MRI of liver, which was done Friday, April 2, and all the areas have resolved. There is an entity called "Inflammatory pseudotumors" of the liver, and my condition fits with this. It is very rare. A consideration would be whether it would be possible to stain the biopsy to see if the lymphocytes carry antibodies to the corona virus.

Symtoms: headache, loss of vision in left eye, vertigo. Stroke took time to diagnos, I thought it was a vision problem. Long time delays occurred while scheduling further testing (CT and MRI). Summary from MRI: "Study Result Impression: There is diffusion restriction along the left thalamus consistent with subacute ischemia, greater than 6 hours in etiology but less than 2 weeks." Outcome: Vision is slowly improving, headache is mostly gone, vertigo & mental status slowly improving.

Ischemic stroke. Presented to ER with confusion and altered mental status at Hospital. Transferred to another hospital for possible CVA

Last seen normal 9pm on 4/14; on 4/15 patient had altered mental status, fever (105.3 F), and hypoglycemia. Presented as a sepsis-like picture. Patient required D10% infusion for hypoglycemia. Diagnostics did not reveal any source of infection (CTA negative for PE and pneumonia, CT abd/pelvis negative, head CT negative, urinalysis unremarkable, chem port site did not appear infected). Troponin was elevated (up to 10.8) with bedside echo showing EF=35% with severe apical wall hypokinesia (previous echo was 60%); EKG was similar to baseline. Patient went to cath lab; coronary vessels were not occluded.

Evening day of injection: Fatigue, chills and muscle aches. Mild headache. Night: Muscle aches worse, very little sleep all night. Next day: Whole body aches, all muscles, bad headache, hot then cold chills off and on all day. Spent the entire day in bed. Slept better at night finally. Second day a little less severe and mostly gone by the third day.

After the second vaccination on April 3, 2021, I started having a low-grade fever on Tuesday, April 6. The fever was oscillating between 97 and 99.8°. On April 10 the fever got worse and went as high as 101.8°, and I started to develop a cough. I called my local general practitioner for advice on Monday, April 12. Should recommended A Covid test. Over the course of the week I continue to have symptoms of fever oscillating between high and low temperatures (chills and fever) and an increasing development of the cough. Over the course of the illness mornings seem to be better and the temperature with spike in the afternoon. Sleeping was difficult because of the persistent cough. It is currently April 19, 2021 and I still have the persistent cough and intermittent low-grade fever. I had an appointment with my my doctor Dr., she indicated that although the duration is longer than a normal lease see that this would appear to be an adverse effect two of the Covid vaccination. She requested that I report the symptoms that I was having.

Female who presents to the office today stating last Thursday on 2/25/2021 she received her first Covid vaccine which was Pfizer. She reports premedicating herself before the vaccination with 1 Pepcid and 2 Benadryl. However unfortunately within 13 minutes of receiving the vaccine she started to experience a and irritation of the tongue/throat with tingling sensation followed by throat hoarseness, a cough and a red face. She was experiencing a little bit of chest tightness in addition to a little bit of shortness of breath and therefore used her albuterol inhaler. Shortly thereafter her red face improved. EMS was called to the scene however by the time they arrived she was improving and was sent home. She took a Benadryl at home later in the evening and the following day on Friday she started Pepcid daily since that time. She states since the vaccine she has felt poorly describing exhaustion and feeling achy all over with continued raw throat. She has not warranted use of her albuterol inhaler since last Thursday and ran out of Benadryl Thursday evening only utilizing Pepcid daily and continues on her other medications. She reports a history of allergies to petroleum products including polyethylene glycol which is suspected to be the cause of her allergic reaction

Neurologist agreed that the vaccine has attacked nervous system; They thought he was having a stroke because the left side of his body was twitching and numbness all the way from the arm to the feet; He had some kind of palsy where his face was not reacting bilaterally; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; He hasn't been able to work since 25th; He cannot coordinate his thoughts and fantasies; Dizziness; He felt his head was spinning; Nausea; He couldn't stand up without falling; Pressure in his brain; Pain in the rear of his head between the neck and the cranium; Inability to speak/Slurring his speech; twitching and numbness all the way from the arm to the feet; twitching and numbness all the way from the arm to the feet; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 2 via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The Reporter stated, her husband had the Pfizer vaccine and the second dosage he got really sick 18 hours after it and it lasted for like two days where he was really, really sick, all sorts of symptoms. He got very sick. the Reporter stated, there was a problem and it's recurring and the vaccine was affecting people neurologically and if they have had something like concussion or any neurological damaging the path was attacking their nervous system. So, this was major, and this was happening not just 3 people we know and the doctors were agreeing that this was happening from the Pfizer vaccine. The Reporter stated, the patient had been in emergency 3 times, patient thought he was going to die. He hasn't been able to work since 25th and he has been in emergency 3 times they have done MRI's and CT scans. And he was very sick, he cannot coordinate his thoughts and fantasies. He was not dead; he was very sick. On Mar2021, the Reporter stated that, Everything CT scans, MRI, ear exams, audiology test was done it. On Mar2021, the reporter stated that, the patient was hospitalized 1 night in emergency for observation. He was hospitalized about three days ago. He was discharged the next day, but he was in emergency overnight. He was hospitalized for the vaccine he took, and the neurologist agreed that the vaccine has attacked nervous system. The Reporter again stated that the patient had some of the symptom's dizziness, he felt his head was spinning, they thought he was having a stroke because the left side of his body was twitching and numbness all the way from the arm to the feet, he thought he was having a stroke. He had some kind of palsy where his face was not reacting bilaterally, he had nausea, he couldn't stand up without falling, pressure in his brain, pain in the rear of his head between the neck and the cranium and inability to speak, he was slurring his speech. The outcome of the events was reported as unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.

2nd shot received 2/1/2021. Shingles seen 02/18/2021. Blisters broke 02/19/2021. Visited doc 02/20/2021. Rx Valacyclovir (7 days). Pain lasted 2 weeks. Fatigue since then has caused me to have to nap almost every afternoon, 1.5-2 hours. Unable to concentrate for as long as I used to. Shortness of breath and inability to walk as far as normal (regular 1.5m walk now a challenge). Worsening tinnitus.

I have been sick since the day after the first the first Pfizer shot. 24 hour head ache, drowsy, lost concentration, ringing in my ears and just cant seem to wake up. I have been to the doctor three times and had mutable blood labs, and am now seeing a neurologist who has ordered a MRI of my brain. The problem is none of the doctors have any experience dealing with these adverse symptoms from the injection, does anybody? So who is going to help me before the lights go completely out?????

I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264). Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing. The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.' Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head. It is like a crown headache. I have never had problems with headaches before this vaccine. The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of neck pain and headache. Information on Lot/Batch number was available. Additional information has been requested.

Muscle and joint pain; Muscle and joint pain; headache; extreme fatigue; sore arm; chills; unable to sleep; Overall just don't feel well; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on left arm on 08Feb2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history included pacemaker, replacement knees and left hip. The patient had known allergy with cipro and vancomycin. The patient had COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. The patient was not tested COVID-19 post vaccination. On 09Feb2021 at 02:00, the patient experienced muscle and joint pain, headache, extreme fatigue, sore arm, chills, unable to sleep. Overall, the patient just did not feel well. The patient did not receive any treatment for the event. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

SEVERE HEADACHE, TINITUS, DROWSY/GROGGY FEELING ( all day ) , LOW CONCENTRATION, FORGETTING ALOT OF COMMON THINGS. He states he has been taking Motrin 800mg 1 TAB, PRN. HE STATES HE HAS GONE TO SEVERAL DOCTORS FOR THESE ISSUES. THE FIRST DR. VISIT WAS ON 05/03/21 PCP- Dr. referred him to a neurologist... Dr. visit with neurologist was on 05/13/2021- MRI, LABS .. on 05/24/2021 - conclusion , MRI/LABS (normal). Dr. recommended B3 vitamin and B12, states he started taking both of the vitamins yesterday.

He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.

48 hours after the second dose he began running a high fever with body aches. His fever lasted almost 3 weeks using Ibuprofen and Tylenol twice a day ever day with his fever rarely breaking. I took him to the ER at Hospital on Monday, May 10th. They diagnosed him with Colitis after reviewing a CT scan of his abdomen. He was discharged back home later that evening where he continued on to oral antibiotics: Flagil and Levaquin for 10 days. He was in bed for over 4 weeks with no appetite and lost approximately 15 pounds. It made his chronic vertigo worse with increased memory loss and loss of dexterity in fingers.

After 1st and 2nd shot Mild flush face sore arm same night no other problems Until on or about 5/1/21 Headaches dry throat rapid heart beat legs angels swelling cold not flashes can not sleep every night and sometimes in morning

Erythema multiforme; Hives over parts of the body growing and changing shapes; itchy; painful to touch; high fever 104.5; intense night sweats; chills; cough; wheezing; fatigue; body weakness; muscle pain; headache; cannot sleep; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 19Mar2021 19:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Diabetes type 2, CAD (coronary artery disease), BPH (benign prostatic hyperplasia), osteoarthritis, gall stones. Concomitant medications included metformin; eicosapentaenoic acid ethyl ester (VASCEPA); ezetimibe (ZETIA); fenofibrate; ursodiol. The patient previously took morphine and known allergies to morphine, the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 66 years old, administered in arm left on 26Feb2021 18:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Covid-like symptoms (high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep) from 18Apr2021 and had a covid test (Nasal Swab) on 22Apr2021: negative. The patient also experienced hives over parts of the body growing and changing shapes, itchy, painful to touch - erythema multiforme on 29Apr2021. All events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of all events and included amoxicillin sodium, clavulanate potassium (AUGMENTIN), azithromycin (Z-PACK), ibuprofen (ADVIL), paracetamol (TYLENOL), diphenhydramine hydrochloride (BENADRYL), cetirizine hydrochloride (ZYRTEC). The outcome of the events high fever 104.5, intense night sweats, chills, cough, wheezing, fatigue, body weakness, muscle pain, headache, cannot sleep was recovered on 27Apr2021, of the other events was not recovered. Information about lot/batch number has been requested.

Pt is a resident in a SNF. He went for dose 2 of his Pfizer Covid series at 950am on 6/2. At 12:30am on 6/3 he became weak, anxious, SOB and required oxygen supplementation. He was shaking and weak and transferred to hospital via ambulance.

I got the vaccine in the morning. That night I was unable to fall asleep the whole night. A few weeks went by and then I started experiencing occasional insomnia. I would wake up in the middle of the night and be unable to go back to sleep. It kept getting worse such that I could not fall asleep without taking a sleeping pill. What happens is that when I lay down after about 10 to 15 minutes I start to feel a surge of energy. My body gets hot. It is not a fever. My heart seems to beat faster and my mind is racing. My doctor prescribed both Ambien and Lunesta. I take one or the other and eventually I go to sleep. I am averaging about 4 hours of sleep at night after I take the drug. The stress of not being able to sleep well has given me some anxiety issues. In addition, the anxiety has led me to develop high blood pressure. I am now taking high blood pressure medicine. I am not the kind of person who has anxiety normally. I believe the vaccine introduced something into my system that is triggered every night now preventing me from natural sleep.

I'm thinking... I'm having covid; chills; body malaise; fever/100.4 temperature; worse in the evening Friday; I'm scared; feeling cold; This is a spontaneous report received from a contactable consumer (Patient). A 66-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613, expiration date date: Jul2021), via an unspecified route of administration in left arm on 18Mar2021 at 14:15 as single dose for COVID-19 immunization. Medical history included Gout. Concomitant medications included Febuxostat for uric acid. On 19Mar2021 at 01:00 pm (Friday) at lunch time, the patient felt cold and had chills, around lunch time, body malaise all over later in the day. The patient had fever around that time, which worsened in the evening of Friday. On Saturday in the morning, the patient stated that fever was a little bit better around lunchtime to the evening and the same thing happened on Sunday and Monday too. The patient stated that fever gets worse in the lunchtime also in the evenings. The patient stated that fever had been the same for the past 3 days. The patient stated that he felt ok in the morning and as It was only 9am in Hawaii, he doesn't know how he will feel today. The patient stated that in the first 2 to 3 days he was not sure if he really had a fever or not because he didn't had a thermometer. The patient stated that yesterday he had a fever of 101.4. The patient stated that he did not take any ibuprofen or Tylenol. The patient stated that he can always bear with it. The patient stated that he was scared to get the 2nd dose as it was scheduled on 08Apr2021. The patient stated that he has been healthy all this time and now after he got the shot, he was thinking that he had covid. The patient wanted to know whether this was normal and what he could do to make it better. The caller stated that he was bearing it for now. The patient did not receive any treatment medication for the events. The outcome of the event thinking that he had covid was unknown and not recovered for other events. No follow-up attempts are needed. No further information is expected.

I was not feeling good; cold sweats; the cramp started from dehydration in every muscle of my body; could not walk; muscles cramps; He lost 15 pounds in 3 weeks or less since he has had the vaccine; shaking; Nauseated; I got sick; Vomiting; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out.; Diarrhea; Cold, sweaty feeling; Cold, sweaty feeling; Dizziness; Fell off a ladder; both legs feel weak/Arms weak; anxiety worse; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EP7533), intramuscular, administered in arm right on 03Apr2021 as 1st dose, single dose for covid-19 immunisation. Medical history included gastroparesis from Jan2010 to an unknown date, helicobacter pylori from Aug2020 to an unknown date and Cdiff. The patient's concomitant medications were not reported. On an unknown date, the patient experienced not feeling good, cold sweats, the cramp started from dehydration in every muscle of his body, could not walk, muscles cramps, lost 15 pounds in 3 weeks or less since he has had the vaccine, shaking and nauseated. On 03Apr2021, the patient experienced anxiety worse. On 04Apr2021, the patient fell off a ladder and both legs feel weak/arms weak. On 05Apr2021, the patient experienced, cold, sweaty feeling and dizziness. On 06Apr2021, the patient experienced, vomiting, muscles were dehydrated and had cramps in fingers and toes cramped with his left arm going straight out and diarrhea. On 06May2021, the patient got sick. Patient stated: he got sick on 06May2021 in the middle of the night, at 2:30 AM and he layed on the floor for almost 6 hours vomiting and finally he didn't have anything left, then the cramp started from dehydration in every muscle of my body, luckily not his heart, and that was with cold sweats, he could not get warm he kept trying he did everything. Also it was so uncontrollable that he could not walk either, the muscles cramps, he finally did - he fought that at 66 years of age, which sounds young but he was old, that he couldn't control number 2 either, because it was fully out of control and peeing, everything was just going out of his body, he could not stop it, there was no blood. He didn't know where he was. He finally fell asleep. He got up after that, got my cane and got into the kitchen I got a Water with nutrients and vitamins, that night he went to bed, everything was back to normal he was still having cold sweats and then eventually that went away, and he was not feeling well until the first week of May, not feeling himself. He received second dose late because he live by himself, he getting dizzy he need to go back and sit down, this is weird, he already disabled, he been disabled like this he forgetting things like this too, his daughter was a Nurse and told him he forgetting things, his mouth was getting dry ,one more question that's all how long? he have nausea a lot, he is on on medication for nausea - it crosses blood-brain barrier and he don't like it, but That's not even working anymore. How long does this nausea effect, what he felt wasn't all the time but now it's all the time, it's not a heavy nausea it's not like he going to throw up, it just feels like he have it all the time. He have systemic sporosis, he have raynaud's (disease), he have gastroparesis and an implant (stomach). He was been sick a long time, he used to being sick, nothing he can do about the headache and nausea, but he want to do this to help everybody with disability and children, his disabilities make it all worse. He was having symptoms and wants to know if they are normal. He does not see if on the paperwork. He feels bad. He was disabled and has gastroparesis, which was prior to getting the vaccines. He has nausea and everything else from the gastroparesis, but the cold, sweaty, and cold feeling occurred since the first shot. First shot was on 03Apr2021. He could not get another shot because he was too sick with his illnesses that he has. He has a Pacemaker for his stomach. All were prior to getting vaccine. He stated he was in the hospital twice for his dizziness but later clarified that he was only kept overnight once. They originally thought he had benign postural vertigo. They did the emily movements in physical therapy to move the crystals in your ears. It seemed to work ok, but today, it feels the same. He walks around and won't go too far. He is hoarse, but does not have a temperature and is not sore. No further details provided. He goes from being soaking wet to soaking and freezing. He said he is in a good mood, just does not feel good. He lost 15 pounds in 3 weeks or less since he has had the vaccine. He was not trying to. He was laying on the floor and a bunch of other things. On 06Apr2021, at 02:30, he woke up and was so sick. He had to vomit and could not get to the bathroom and had a trashcan. He was soaking wet with sweat, shaking and could hardly walk if at all and then not at all. He was on all fours. He grabbed nearest blanket and sat on top of that with a trash can on all fours. He had a heating blanket and threw it over the top to warm up and was shaking. He could not control anything. He was too shaky. Finally, he layed down on the floor, covered up and stayed warm. He kept wiping sweat off. People that have gastroparesis are immunosuppressed and he was scared of what would happen when he got the shot. He got first shot on 03Apr2021. 0n 04Apr2021, he fell off a ladder. On 05Apr2021, he started getting dizzy during the day. He was nauseated most of the time and still is up until now. He had prior hospitalizations on 23Feb2021, and 24Feb2021. No further details provided. He stated that he is not too "with it." This started after the vaccine. No further details provided. He later stated he feels he is having Dementia since COVID lockdown. The other reason he got the vaccine is he was disabled and has an autoimmune condition and wanted to be safer. It changes day to day and he can catch anything. The second hospitalization he was not kept overnight. He found out Meclizine worked. It was not benign positional vertigo. No further details provided on Meclizine. Dizziness came back at the time of report and was persisting with walking. He can walk ok, but still feels woozy. His legs feel weak today and were not previous day. His arms also feel weak. He used wheelchair for first two days after receiving the first dose. Then it improved. His arms stayed the same. Vomiting started 02:30 am. It was the worse that he had in his life. He could not catch his breath and started having diarrhea after that. He had complete muscle dehydration. His fingers and toes were cramped and his left arm was going out straight. He layed there an tried to untie everything. He drank Essential water to get everything back in his body. The cramps went away later that day. He was feeling good by the end of 06Apr2021. During that time, he thought he was going to have a heart attack because all of his muscles were cramping. He gets dehydrated quite often. This was prior to taking the vaccine because of his gastroparesis. He said he got C-Diff because the antibiotics they gave him for helicobacter pylori killed everything off. He only remembers the name of one of the antibiotics that did that, flagyl. He does not remember the names of the other one. He does not have the dose, manufacturer, lot or expiration. He tried two and the third one worked. That one that worked was divicid. He was unsure of the spelling. Transcribed as provided. This was all prior to receiving the vaccinations. He did not have a manufacturer, lot or expiration for any of them. He has had anxiety all of his life. He was on medication for the anxiety and he has had to take more of it since getting the vaccine. He takes clonazepam and has been taking it since 2016. They are 1mg tablets and he takes 1 1/2 tablets by mouth twice daily. He would not be willing to send a sample. Count size is 90. They are in a pharmacy vial with no lot or expiration. He would like to know if it is normal for dizziness and his eyes being blurred. How long will it last. The clinical outcome of the events got sick, not feeling good, cold sweats, the cramp started from dehydration in every muscle of his body, could not walk, muscles cramps, fell off a ladder, he lost 15 pounds in 3 weeks or less since he has had the vaccine, shaking and nauseated was unknown. The clinical outcome of the event dizziness was recovered on an unspecified date of Apr2021 and recovering for other events. Information on Lot/Batch number was available. Additional information has been requested. No follow-up attempts completed. No further information is expected.

Patient had an acute cognitive decline less than 24 hours post 1st vaccination. This includes: weight loss, confusion, loss of ADLs (inability to dress, shower without assistance, with urinary and bowel incontinence), agitation, personality change, and impulse control issues. Unable to determine if patient will recover from this decline and may end up in hospice.

Patient's wife stated Husband 2021/03/12 muscle pain in legs, fever 2021/03/14 (100.4), chills (Treated temp down 99.8), stomach/muscle pains. Contact with Dr. 2021/03/17 (Fever 100.7) phoned. No treatments for nausea, headache, muscle pains. Hospital visit ER with confusion/hallucinations. Temp 100.4 BP 136/110, *8:30am 2021/03/19. Home incident of falling, EMS called (vitals normal) admitted in Hospital. Transferred to another Hospital (Covid Neg.), stated bad infections. Death 2021/03/21

I would fell asleep for three hours and wake up and not able to go back to sleep again; I would get in to bed every evening and not able to sleep at all, not even for one minute; I have the energy so I am thinking the vaccine somehow affected my adrenal glands I guess; insomnia; This is a spontaneous report received from a contactable consumer or other non hcp. A 66-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Left on 03 Mar 2021 (at the age 66-year-old) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 vaccine on 10Feb2021, experienced sore arm for couple of days and few days a little bit tired on an unspecified date. The patient experienced insomnia on 21 Mar 2021, "i would fell asleep for three hours and wake up and not able to go back to sleep again; i would get in to bed every evening and not able to sleep at all, not even for one minute on an unspecified date, i have the energy so i am thinking the vaccine somehow affected my adrenal glands i guess". Consumer stated, "I am calling about Pfizer-BioNTech COVID-19 Vaccine. I was told and I have been waiting for close to an hour and this was the the number given to report the vaccine symptoms. I have some symptoms. I was fine, I had really no symptoms after the first vaccine just there was sore arm for couple of days and for a few days a little bit tired more than I normally would be. I got the second vaccine and then around the beginning of the third week like on Sunday 21Mar2021, I started which would be beginning of the third week after the vaccine, I don't know which I have never had before, I started getting every single day insomnia. I would fell asleep for three hours and wake up and not able to go back to sleep again and then that happened for two days. Then every two days, I would get in to bed every evening and not able to sleep at all, not even for one minute and then for another one or two days maximum of two to four hours of sleep when I usually get eight to nine. So, for next couple days not one minute of sleep and since last night, I didn't sleep for 1 minute and I still haven't slept at all." When paraphrased the concern, consumer stated, "I have got insomnia but I have the energy so I am thinking the vaccine somehow affected my adrenal glands I guess. I have no issues, I take medicines for nothing, no adrenal gland issues, nothing at all. I am in perfect health. I don't take any medicines for anything. I just have coffee whenever and didn't sleep well and and never have I had insomnia. Also, I am grateful for having both first and second shots of the vaccine. I hope that it ends, this insomnia." Consumer further stated, "I want to report the symptom and also I would like to know how many people have reported the insomnia and what would be the reason. I haven't slept, so I would like to know some of the factors affecting my adrenal glands or whatever something is wrong." Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

The next day after vaccine, I experienced all symptoms of COVID 19 except for sore throat. I went in to see my family practice doctor, got tested for COVID 19. It came back negative. These symptoms lasted for a month. I thought I was going to die. I still have fatigue, wheezing and a cough. I have been shaky and have fallen several times. I have lost 40 pounds since I received this vaccine. My family practice sent me to a GI doctor. I have also been referred to an oncologist and cardiologist to do CT scan and figure out why I still experience fatigue. Cardiologist appt on 07/13/2021.

About 4 hours after my 2nd dose, I was driving on my way home and all of a sudden I felt like I was hallucinating. I saw what looked like a bug infestation coming across my vision line. It was a swarm of black spots. I had to stop and re-evaluate my situation on the way home. When I gained control again, I realized it wasn't a hallucination. It was my actual vision. When I got home I basically crashed for the rest of the day. The next day I contacted my optometrist and I went in for an evaluation. They said it was a cloud of floaters. I asked if there was any chance that it was a side effect of the vaccine. They told me no. They sent me to an ophthalmologist. He told me that it will never go away. I went back to my optometrist and they said it would go away. All that they could come up with is that it is a coincidence. I have also had dizzy spells. They weren't strong, but it was like a constant dizziness. I still have all of the symptoms going on. The floaters in my eye seem like they are starting to dissipate. I have had some mild nausea. I can take a nap and it seems like it dissipates. This all came on at one time. I have been extremely tired lately. I take 2-3 naps a day and that is just not like me. It's like the feeling of being hungover, but I haven't had a drink in months.

Progressive neurological issues, including short-term memory loss, and hand trembling. Tingling more often from the foot up to the knee has diabetic neuropathy. Symptoms have progressively worse since the vaccine.

Very very Tired.; Approx. 11 hours of sleep; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, pneumonia and minor case of epilepsy. The patient did not have any allergies to medications, food or other products. Concomitant medications included carbamazepine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021, the patient experienced very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work. Approx. 11 hours of sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events very very tired and would go to bed as soon as got home from work, and slept until got up the next day for work were resolved on 28Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient states he awoke on 7/22/21 with complete memory loss; didn't know his wife or even who he was. Memory returned after 15 minutes. He did not seek medical care.

Breakthrough case after full vaccination. Per report from the prison, patient reported he felt awful and was having trouble breathing. Reports onset 9 days prior. Reports vomiting. Weight loss of 12lbs since 7/8/21. Reported diarrhea x 7 days. Reports cough and chest pain with coughing. Patient was transported to local ER via EMS.

Symptoms of fever (Tmax 102.9), diarrhea, and altered mental status started ~ 24 hours after vaccination. No evidence of septicemia with negative blood cultures Minimal improvement over 3 days, transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care.

vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs, staff stated resident was "different". Vitals taken and 02 sat was low, O2 in room and applied via NC @3L, O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt, stated he felt "okay". Resident exhibiting some shakey movements and clearing throat, states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation, voicemail left. 1/9/21 11am- resident has been making a "growling" noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital, resident firmly states "no". vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p- resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name, or the year, resident cannot state where he is currently or birthdate.

chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.

On 01/28/21 at 8pm began feeling: - heavy fatigue - "buzzing" under the skin all over the body - significant dizziness - Slight nausea - 97.1F Temp This lasted until about 5pm on 01/29/21. On 01/30/21 I felt: - Slight fatigue - Slight dizziness - Slight nausea Then on 01/31/21 awoke feeling feeling: - very heavy fatigue - slight "buzzing" under the skin all over the body - severe dizziness - Significant nausea - 97.0F temp - Slept most the day

PATIENT WAS IN WAITING AREA AFTER THE VACCINE. HE HAD REDNESS IN HIS EYES, HAD DIFFICULTY BREATHING, RASH ON BOTH ARMS, AND WAS SLIGHTLY WARM TO TOUCH. WIFE REPORTED PATIENT HAS HISTORY OF ANXIETY ATTACKS, ASTHMA ATTACKS, AND ALLERGIC REACTIONS TO FOOD.

Patient felt weak and weird, along with nausea. BP 158/89, 135/79, pulse 74, O2 sat 96%. EMS called, Benadryl 25 mg PO given, patient felt better.

Vax at 1645hrs on 07 Feb 2021. At about 1830hrs starting feeling hot, upper left arm sore, mild shaking, decided to sleep it off. I went deeply under. At various times after I would become aware I was home, alone, on couch, unable even sit up. On one occasion I determined it was 1437hrs, Tuesday, 08 Feb 2021, and sent two text messages with great difficulty just saying HELP. IT was actually 0237hrs, Monday, 08 Feb 2021. Both HELP messages had been replied with questions about what the problem was. At 1200hrs, Tuesday, 09 Feb 2021 I became lucid again though at first I believed it to be Wednesday, 10 Feb 2021.

11:30 after receiving vaccine client states he is feeling foggy. Vital signs obtained by EMS: BP 150/83, Pulse 74, O2 sat 97%. 11:30 am client states he if feeling better. Client discharged home by EMS.

Patient received 2nd dose on 2/2 at 0733. Patient missed worked on 2/3/21 due to "effects from COVID vaccine". Patient was unable to go to work due to disorientation, confusion, headache, and chills. The patient's employee health department advised the patient's family to send patient to be seen by ED. Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and TIA. Provider admitted to make sure he was not having further seizures or TIA. Patient was observed and discharged on feb 5. Per discharging provider the patient had some mild low-grade fever with negative cultures. Provider unsure if fever due to vaccine or mild case of bronchitis-patient discharged on a Zithromax pack.

Violent shivering/ague, intense muscle/joint aches, like flu or maybe mono but but much worse, feeling freezing cold, couldn't get warm enough. (Temperatures were in the 80's) a feeling of nerve irritation under the skin that moved from place to place. unsteadiness on my feet, lack of focus, a basic, total shut down. I curled up in fetal position under a pile of covers for 24 hours. Didn't fully recovery for 3 days All simptoms hit me more or less simultaneously within 5 minutes, about 12 hours after 2nd covid shot. Didn't seek medical attention, just plowed through it. I imagined a biological warfare agent would have felt like that. "I thought I was gunna DIE!"

My husband has had a fever and extreme exhaustion every day, all day. for 16 days, since he go the Pfizer vaccine. He is retaining water, does not sleep at night, has heavy night sweats, and is emotionally spent. He has no appetite and forces himself to eat. He tastes what little food he eats. He visited his family doctor, a gastroenterologist, and has been in the emergency room two times for sheer exhaustion and pain. He was released both times after tests. Each time, no one could find a cause and no one sent him to other doctors for help. They would not admit him because there was no guarantee he could see other doctors any faster than if he were at home making appointments. He was referred to an infectious disease specialist by the gastroenterologist, but that appointment isn't until March 9, 2021. He will have faded even more by then.

brain fog immediately after vaccination, 2 hours later blood pressure and heart were elevated. Around 11:00 pm went into extreme Atrial Fibrillation and risk of stroke for 10 hours. Heart rate went from 55 bpm before vaccine to 90 bpm after vaccine. Blood pressure went from 120/70 to 145/80.

2/21/21 woke up 2:30am with severe shoulder/neck pain, felt like a broken collar bone, pain intense with a headache. restless could not sleep. next day extreme fatigue, constant coughing, chills, aches and pains unable to work, had to go back to bed every 2 hours for a 2-3 hour sleep. this same pattern has continued up until today thursday 02/25/21.

Heard through a family member had some feeling badly and some respiratory symptoms. We do not have any real information. This is a coroners case.

I received the Eli Lilly monoclonal antibody infusion on Feb. 12 after testing positive for COVID-19 on Feb. 10. I received the Pfizer vaccine on Feb. 5, and had muscle aches, chills and a cough. I passed out at home on the 10th, cut my forehead, and had to receive stitches. That is when I tested positive for COVID-19. I continued to by symptomatic and opted for the monoclonal infusion. About 5 hours after I received the infusion, I became completely disoriented. I was unable to stand and did know where I was. My wife summoned an ambulance, and I was taken by ambulance to a local hospital. I received fluids intravenously. I was released from the emergency room about 6 hours later.

Injection site pain; not sleeping; it still hurts, it is very sore by his bicep; sheer exhaustion; is very uncomfortable sitting; This is a spontaneous report from a contactable consumer reporting for himself. A 67-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686, Expiry date: 31Mar2021), via an unspecified route of administration (arm left) on 18Jan2021, 12:00 (noon) at SINGLE DOSE for COVID-19 immunization, at 67 years old. Medical history included torn rotator cuffs from an unspecified date. The patient previously took Flu shot for immunization. Patient stated his last vaccination he had was the flu shot 6 months before on an unspecified date, that was a while back. Patient had pain in his left arm at the injection site. He is not sleeping because the pain is waking him up. It has been more than a week at 10 days, and it still hurts. It is very sore by his bicep. Events occurred on 19Jan2021, reported as started hurting the next day maybe, it was not immediately after. He says since then he has had pain, and in the past, he has had torn rotator cuffs, and those hurt, but he was not sleeping due to this pain now, he fell asleep at 06:00AM this morning from sheer exhaustion (Jan2021). He says he is very uncomfortable sitting, he can't lay on that side, and he can't get comfortable. He was taking MOTRIN 800 mg as needed, and he put ASPERCREME on it. He says that his MOTRIN was prescribed by a doctor, it was the only thing working for the pain for this. He says he also tried Naproxen, then says it's Aleve actually, he has only taken this once. It was 220 mg, he took one by mouth, one time. He applied the ASPERCREME to the injection site about three times last week, he says he was experimenting here, he does not know. He says he tried ice which helped a little bit, ice always helps, but when it wears out it comes back. He stated he feels the pain walking, when he is putting his shirt on, sitting in his recliner, it is constant. His vaccine card is handwritten, there is no NDC written on there. It has no information about the syringe that was used, NDC/LOT/EXP information were unknown, they didn't put it down or the information on the card for his wallet. Patient stated he saw a doctor but not for the injection site pain. He stated if it was just initial pain, he wouldn't be asking but it has been 10 days now, he thought it would be gone by now, he tried to see how long it could last on the paper they gave and called the number from the paper. He says he had no swelling, it was just really sore, he would like to know if this is normal, if so, he can hang on and tough it out. Treatment was given in response to the events. Outcome of the events Injection site pain, not sleeping, it still hurts, it is very sore by his bicep was not recovered. Outcome of the events sheer exhaustion and is very uncomfortable sitting was unknown.

fever; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; bronchitis; This is a spontaneous report from a contactable Pharmacist. A 67-year-old male patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 07:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old. Lot number was EL3248. Medical history included Cerebrovascular accident (CVA), Hypertension, Coronary artery disease (CAD), Transient ischaemic attack, Myocardial infarction, migraine induced stroke like symptoms, seizures. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX), atorvastatin calcium (ATORVASTATIN), cetirizine hydrochloride (CETIRIZINE), Clonazepam, Diclofenac sodium, valproate semisodium (Depakote), docusate sodium (COLACE), lansoprazole, lisinopril, metoprolol succinate (TOPROL XL), morniflumate (FLOMAX), tadalafil (CIALIS). The patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old; lot number EL0140. Patient missed worked on 03Feb2021 due to effects from COVID vaccine. Patient was unable to go to work due to disorientation, confusion, headache, and chills on 04Feb2021. The patient's employee health department advised the patient's family to send patient to be seen by emergency department (ED). Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and transient ischemic attack (TIA). Provider admitted making sure he was not having further seizures or TIA. Patient was observed and discharged on 05Feb2021. Per discharging provider the patient had some mild low-grade fever with negative cultures on unknown date. On 03Feb2021, nasal swab resulted negative. Provider unsure if fever due to vaccine or mild case of bronchitis (04Feb2021), patient discharged on a ZITHROMAX pack, antibiotics-one dose of Zosyn, Vancomycin, Rocephin. The patient was treated for the events. The patient recovered from the events. The patient did not have covid-19 prior to vaccination; the patient was tested for covid-19 post vaccination (nasal swab, negative). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Mild headache staring at 6 pm 2-25-2021 followed by extreme headache at 8 pm with fever and chills and uncontrollably shaking. Disorientated and almost lost conciseness. Slept that night and Friday 26th, unusually tired. Did not seek medical help.

Head ache, unable to concentrate, Blurred vision, cannot focus double vision. Started approx. 4 hours after the injection and is still an issue 7 days later.

Pt reported feeling flucs/"wierd" in the face. vitals at time of reporting; 188/84 HR 92 O2 100. 5 min post reporting 158/72 HR 82 O2 99. At 10 post reporting pt stated "feeling much better" 148/69 HR 80 O2100. Pt ambulated out to vehicle without assistance and declined any further needs at 30 post vaccine administration

Arm sore, head aches, very tired, restless, lack of sleep, flu symptoms, fever, swollen leg left side, knee swollen and foot, made neuropathy worse, sweat a lot, hard to walk, knee giving out while standing, vision blurry, nose running more, been out of work 2 days a week since shot, body aches, just cough

PI Patient is a 67 year old male who presents with dizziness and left facial droop. The patient reports that he woke up this morning and felt very unsteady on his feet and dizzy. That has since subsided. However, he noted some slurred speech and left facial droop. He woke up at 7:30 AM. He went to bed last night at 11 PM. Last known well is 11 PM, as he woke up with his symptoms. He reports some weakness of the left upper extremity and left lower extremity. Acute left arm, leg, face weakness, slurred speech and buring eyes. Symptoms came and went over 42 hour period.

Anger, big increase in talking, aggression, sleep issues He received second vaccine dose on feb 23, symptoms were much worse after that, no more than 2 hours sleep, total personality change, wants to yell at everyone, bigger increase in talking, cannot interrupt him, cannot reason with him, thinks he no mores than doctors, starting discontinuing some of his meds. He was taken to the hospital by ambulance. He is now 68. He was diagnosed with Manic (Mania) for the first time. Has since been admitted to hospital (behavioral facility) and is not cooperating with treatment. I've been told they have never seen onset of Mania at his age, and they cannot determine a reason.

Patient reports that he noticed chest pain after getting his COVID19 shot on 3/7/2021. While patient admits that his arm felt sore, he reports that he was surprised to find mid chest pressure developing and persisting long after the shoulder pain resolved. Patient describes the pain as a pressure-like sensation mid chest with some radiation to the shoulder, overall fairly mild in intensity (3/10). Patient states that the pain seems to be brought on by "every day activities" Patient reports that he walks but does not engage in strenuous activity typically. Patient denies experiencing acid reflux. Patient reports that the pain was resolved by nitroglycerin.

3/12/21 around 10:00am episode of severe vertigo with the room spinning and nauseous. Happened again 11:00 pm -1:00 am Vertigo and nausea unable to sleep lying down. Had to sit up in a chair to sleep.

Patient felt poorly for the two days following the vaccine. Severe abdominal pain developed by about day #3 after first dose of the vaccine.

Pfizer-BioNTech COVID-19 Vaccine 3 minutes after vaccine, patient complained of chest pressure, flushing and felt clammy. A medical response was called and pt was placed in a recliner. He is alert and oriented and feels shaky. His wife is with him and states this is a normal reaction to similar situations in the past. Just not always something that happens. 1538 BP 158/78, HR 65, resp 20 1542 BP is 163/78, HR 60, resp. 20. Skin is warm and dry, he states his lower lip is numb and has a bit of trouble drinking from a bottle of water. Medical response felt he was improving and plan was to keep him in recliner for another 20 minutes. Was given a few sips of apple juice. No oximeter was available to check O2 sat. @1558 he again complains of mid-sternal chest pain, skin warm and dry, speech clear and moving all extremities without difficulty. Complains of tongue and cheek tingling. Brief episode of nausea. ER staff was called and patient was transferred to ER via Wheel chair. He at times complained of dizziness and trouble with keeping his eyes open. Denies pain in his arms. BP 190/84, HR 62, R 18. At ER: EKG with sinus bradycardia, no acute ischemic changes. Troponins x 2 are negative. Symptoms resolved. Discharged from ER after evaluation.

Severe pain throughout left arm, numbness, extreme high blood pressure, inability to sleep on account of pain. Lasting so far from Mar. 8 through today (Mar. 17).

They came one after another for about 36 hrs. then cleared up. Sore arm lasted 3 - 4 days. Very sore arm, mild fever (100.5), headache, body aches, weakness/sleepiness, chills, mild mental fuzziness

* Sinus congestion within 24 hours * Coughing w/ Phlegm * Shortness of breath. Just walking across room caused heavy breathing. Not normal for me * Very noisy breath when laying down. In particular on left side * Headache from poor sleep/breathing * No fever * Lasted for 2-3 weeks. * After 2 1/2 week, Dr. prescribed Prednisone. This cleared up the condition within 3 days

Not being able to sleep at normal bed time; Fall asleep during the day; Circadian rhythm seem to be disrupted; no energy during the day; fatigued; wide awake at 9 to 10pm; This is a spontaneous report from a contactable (consumer). This 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 30Jan2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included multiple vitamins from unknown dates for unknown indications; the patient also reporting starting ixekizumab (TALTZ) 2 weeks after vaccination for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported not being able to sleep at his normal bedtime and falling asleep during the day; further reporting his circadian rhythm seemed to be disrupted; awake and energetic at night, sleepy and no energy during the day. He reported it started 2 days after the vaccine and had been getting worse. Three weeks since the vaccine he was wide awake at 10PM, normal bedtime, could not sleep until 5 or 6AM then slept for 6 or 7 hours. He reported being wake and very fatigued during the day and getting wide awake at 9 to 10PM. The events were reported as non-serious and did not require hospitalization. Treatment was not provided for the events. The clinical outcomes of not being able to sleep at normal bedtime, falling asleep during the day, circadian rhythm seemed to be disrupted, no energy during the day, fatigued, and wide awake at 9 to 10PM were not recovered. It was also reported the patient was not tested for COVID-19 since vaccination.

- Sore left arm for about 48 hours; took Tylenol; seemed to help a little. - About 13 hours after vaccine was administered came down with severe chills and body aches; lasted about 6 hours; unable to sleep most of the night; exhausted that morning; groggy, achy, and hard to focus during the day; took a nap and got extra sleep that night; felt a little tired the following day but other than that, felt 100% (even got in a workout at the gym).

his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114; Sweating; he woke up in the morning, and the room was spinning / Vertigo symptoms; dizzy/extreme dizziness; he felt lightheaded, and was afraid he might fall; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; things were a little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room; he was only nauseous when he was dizzy; Reported he eyes were not that good while he was reading the paperwork from the Emergency Room; he thought he had a heart attack; This is a spontaneous report from a contactable consumer (patient) A 67-year-old male patient received the first dose of the bnt162b2( PFIZER-BIONTECH COVID-19 VACCINE, Lot Number:EN6198, Expiration Date: Unknown), via an unspecified route of administration, left arm at single dose for Covid-19 immunization On 03-MAR-2021 (between 11:30-12:00). Additional vaccines administered on Same Date of the Pfizer Suspect was none. The patient medical history included depression reported he was diagnosed with depression years ago and has been on Wellbutrin for a while. No further details provided, Tinnitus he self-diagnosed himself a hissing sound mostly in his right ear for less than a year. He said he looked up his symptom on the internet and found someone else who had the same symptom as him, and that person said it was Tinnitus, Seizure he had a seizure about a year ago. Reported he had a seizure about a year ago. He said he had a brain scan afterward, and the doctor didn't find anything wrong. No further details provided. Concomitant medications were not reported. On 03Mar2021 Patient received his first Pfizer COVID-19 Vaccine (on) and was fine. He said about a week after getting his first COVID-19 Vaccine, he woke up in the morning, and was sweating, and the room was spinning, and he was dizzy. Little fuzzy in his head, and he couldn't remember exactly when he had gone to the Emergency Room: He said the room spinning and him being dizzy had been continuing to go on. He said he thought he had a heart attack, and went to the hospital (Emergency Room). He said his blood pressure was high. He said he was nauseous too. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around, if he lowered his head below his shoulders, the dizziness gets really bad. the dizziness won't go away. the Emergency Room doctor thought his dizziness may be due to his inner ear. The Emergency Room doctor told him he should see an ear doctor about his dizziness. He said the his dizziness happened directly after he got his first COVID-19 Vaccine. Reported he went on the internet, and read that other people who got the COVID-19 Vaccine were experiencing same thing he was. No further details provided. It was Reported patient blood pressure was very high. He clarified his blood pressure reading that was taken in the ambulance on his way to the hospital Emergency Room was 190/114. He said he believed his blood pressure was taken again, and his blood pressure was a little bit better. He said his dizziness hadn't stopped. He said the dizziness gets so bad, he can't get around. He said if he lowered his head below his shoulders, the dizziness gets really bad. He said the dizziness won't go away. He said he was nauseous too, but only when he was dizzy. He said his dizziness was fine last night, but then he got up this morning and the room started spinning out of control. He said he felt lightheaded, and was afraid he might fall. He said if he tried to pick up something off the ground, his dizziness really comes on. He said the Emergency Room doctor thought his dizziness may be due to his inner ear. He said the Emergency Room doctor told him he should see an ear doctor about his dizziness. He had an EKG done in the Emergency Room, and since the doctor didn't say anything about his EKG, he assumed there was nothing wrong with the EKG results. He stated that he went to hospital as he was fearful he was having a heart attack; it was determined that he was not. However, he was advised him to consult a specialist as he may be suffering from vertigo. Treatment was given a low dose of oral Lorazepam 0.3mg to calm him down. He stated he did not have the Lorazepam 0.3mg NDC. He said his paperwork from the Emergency Room listed his diagnosis as Vertigo symptoms, and it was recommended he go for a hearing test because his dizziness maybe caused by his inner ear. The outcome of event was unknown.

loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.

Fatigue beginning on Sunday and growing stronger for the next two days. Couldn't get any energy. Slept 12 hours each night. Grew nauseous w/o vomiting on Monday. Had multiple bouts of diarrhea Monday and Tuesday. Slight headache. Lost eight pounds from no hunger and diarrhea. Grew dehydrated and felt more malaise. Symptoms began to resolve by Tuesday night. Slept another twelve hours. Felt much better by Wednesday, enough so to eat a fast food meal that evening. Today, 1 April I feel normal and took the dogs on a three mile hike.

Pt stated he felt short of breath, shaky and had a fast heart rate at about 1 minute after the vaccine was administered. Initial blood pressure was 168/108 with a HR of 112, lung sounds were clear in all fields. Pt was laid down on a stretcher and assessed immediately after the incident. Subsequent vitals were BP 148/94, HR 108, LS clear. Before leaving pt stated he felt better. Advised to seek emergency medical treatment if symptoms returned or worsened. Pt's wife drove him home.

Patient had onset of chest tightness 8 minutes after vaccine. Felt kind of short of breath. He admits anxiety. he was not observed to be short of breath by nursing personnel. This resolved spontaneously after 10 minutes. Blood pressure was 166/82 pulse 71, resp 20 and pulse ox 97%.

Pfizer-BioNTech COVID-19 Vaccine EU. Excessive urination started about 12:30 am 4/8/2021 (about 14 hours after 2nd dose. Had to urinate 12:00 midnight, 12:30am, 2:30, 3:30, 4:30, 5:00, 5:30, 7:30, 9:00, 10:00. Didn't sleep much because of it. Normally I have to go 2-3 times a nite, not nearly as much as this. It's starting to get better mid day 4/8/2021. Nothing too serious, just wanted to inform.

He assumes he has COVID as well since he has the same symptoms and lives in the same household; He assumes he has COVID as well since he has the same symptoms and lives in the same household; Sharp needle type pain that went through heart side of chest; felt bitterness in stomach and mouth and was uncomfortable; felt bitterness in stomach and mouth and was uncomfortable; stomach and mouth and was uncomfortable; headache; fever/ highest was 104 degrees; Chills; Bone aches; leg and lower back pain; leg and lower back pain; panic; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203; Expiration Date: 30Jun2021) intramuscularly (in the muscle) in right shoulder on 14Mar2021 at age of 67-year-old at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ibuprofen for an unspecified indication, but the reason for taken this drug was "get up and get moving", the patient took it for many years. Received call from consumer regarding the Pfizer COVID vaccine. He would like to speak with someone about the effects he had and any suggestions Pfizer may have to help him. There was no prescriber for the vaccine. He received the first dose on 14Mar2021 and on 19Mar2021, he started experiencing side effects. He said all 4 people in his household all got the vaccine and all had side effects. The moment the patient was helping his wife he felt like a sharp needle type pain going through the heart side of his chest. They were little ones, but it was uncomfortable. It caused him to panic. He hanged on to it and it went away in a bit. But 2 hours after that, he had chills and crawled in blankets and stayed until the rest of the night. He has not gotten up since 19Mar2021. He has bone aches and leg and lower back pain aches. He has a headache on 19Mar2021 and started checking temperature on 25Mar2021. The highest was 104 degrees on 25Mar2021 and ever since (Mar2021) then he had 101 degrees or 100 and something. It also reported he began to have fever on 19Mar2021 (pending clarification). He was told to use Tylenol for fever reducer and started taking it. It also reported he has been taking Tylenol for the headache and fever only and it has not been working, it has actually caused him to have a rash on his face and skull causing dandruff and severe itching and bleeding, so he stopped it. He would like to take Ibuprofen and wanted to know if he could. When he stopped taking Tylenol, his daughter gave him a lotion for face. Face is clear and only one place is left that is behind his neck on head. No further details provided for lotion that he put on the rash. He provided information on Tylenol Extra Strength 500 mg each. He took 2 for rash on 2 occasions every 6 hours and then he started only taking 1 because he has not eaten and felt bitterness in stomach and mouth and was uncomfortable (19Mar2021). The Lot is SSA011 and expiration is Oct2024. He has been taking Ibuprofen for many years and only taking one tablet instead of two. He needs to get up and get going and takes it to help him every day. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. He would like to know if he can postpone next dose or can he quit. Will this get better. If he could take Ibuprofen instead of Tylenol. The outcome of events "sharp needle type pain that went through heart side of chest" and "chills" was recovering, of "fever/ highest was 104 degrees", "bone aches", and "leg and lower back pain" was not recovered, of other events was unknown.

While asleep, Mon, 03-15-21, woken by severe shills, shaking, and tremors of the arms and hands. While asleep, Wed, 03-17-2021, woken again by severe shills, shaking, and tremors of the arms and hands. Thursday, 03-18-2021, rising from a chair I was suddenly stricken by severe pain and weakness in my lower back, hip, groin, and thigh, at about 10:00 PM.

Extreme vertigo/dizziness causing sudden fall. Ringing/tinnitus in ears. Pressure in head with a fogginess feeling. Unable to function, work or drive, for 4 days. All symptoms still present after 3 and a half weeks but have subsided to the point I can function.

At approximately 10 minutes after receiving vaccination, patient reported difficulty breathing and felt like his throat was closing up. He became visibly anxious and sat on the floor in a tripod position. Patient was immediately assessed by medical personnel. Pt remained Alert and oriented x 3, PERRL, mouth and throat assessed without evidence of tongue, throat, or uvula swelling, patient tolerating oral secretions well, lungs CTA, resp with ease; no increased work of breathing. BP 158/82, pulse 80, Resp 18, FSBS 204, SaO2 97% RA. Pt had spontaneous improvement after 5 minutes with complete resolution of symptoms. Pt declined to be transported by EMS for further evaluation at local emergency department. Pt left facility accompanied by wife in stable condition after additional 30 minute observation and complete resolution of symptoms.

Headache; Major fatigue; Felt like going through Covid all over again; Body sensitivity and aches; Body sensitivity and aches; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 03.30 pm as a single dose for COVID-19 immunization. Medical history includes allergies and prior prostate CA. Prior to the vaccination, the patient was diagnosed with COVID-19. There was no COVID-19 test post vaccination. Patient was not had other vaccine in four weeks. Patient had no known allergies (medications, food, or other products). Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) and fluticasone furoate (ARNUITY ELLIPTA) 100mcg. On 27Mar2021 patient experienced headache, major fatigue, body sensitivity and aches. Felt like going through COVID-19 all over again. The patient did not receive any treatment for the events. The clinical outcomes of the events are unknown. No follow-up attempts are needed. No further information is expected.

He woke up panicked; Vision loss; Visual disturbances; Difficulty breathing; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 31Mar2021 as a single dose for COVID-19 immunization. Medical history included: heart attack a few years ago and takes maintenance drugs for the heart condition and asthmatic and takes medication but the medications come and go depending on how he is physically. Concomitant medications were not reported. This case was from the same reporter; this case is for the husband. On 2Apr2021 he experienced difficulty breathing and they did not know if it was attributed to the vaccine but he did not have any breathing issues until he got the vaccine but it was a general feeling of something was different but did not think it was severe until the vision thing. Reporter stated there is no medication her husband takes that is related directly to the episode he experienced. On 5Apr2021, he woke up from being asleep, asked if the TV was on (which it was) because he could hear it, but could not see it. His symptoms have also resolved. He had no history of anything like that happening previously with the first dose pfizer covid vaccine. Hi wife stated that he experienced visual disturbances since then, with no prior history of vision impairment. The outcome of the events could not see, Visual disturbances was recovered; the outcome of Difficulty breathing was not recovered; the outcome of the event He woke up panicked was unknown. Information on the lot/batch number has been requested.

I can't sleep at night; arm hurts so it has settled in joints, shoulder, and up neck to down to elbow; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, in right arm on 13Feb2021 as single dose for COVID-19 immun-ization. Patient's medical history and patient's concomitant medications were not reported. On 14Feb2021, Patient reported, I can't sleep at night and arm hurts so it has settled in joints, shoulder, and up neck to down to elbow. Patient wanted to know that how long this will last. Treatment for the events was Tylenol. LOT#: Patient stated that Pfizer GN5318, it looked like. Outcome of the events was unknown. Information on the lot/batch number has been requested.

severe grand mal seizures; he only has half of his memory; some of his levels were high last week in his bloodwork; This is a spontaneous report from a contactable consumer (patient's wife). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730 and expiration date not provided) via an unspecified route of administration, administered in left arm on 30Mar2021 13:10 as a single dose for COVID-19 immunisation. Medical history included ongoing hypothyroid which he have had for 15 years. Concomitant medication included ongoing levothyroxine for hypothyroid which he had been taking for too long to remember, over 10 years. The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) in the left arm on 08Mar2021 for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The reporter (patient's wife) called about the Pfizer vaccine for COVID 19. She called to report that her husband almost within 24 hours after receiving his second vaccine, he a had severe grand mal seizure and had to be hospitalized from 31Mar2021 to 02Apr2021. She confirmed that he have had severe grand mal seizures on 31Mar2021. She said that he did not regain conciousness afterwards and that this was within 24 hours after receiving the 2nd vaccination. When probed for end date, the reporter stated that they could not find anything wrong with him. She said he only has half of his memory on an unspecified date. There was a lasting memory effect. He is on seizure medications, he is not allowed to drive for 1 month because he had the seizure, he has a zoom call meeting with his doctor on 19Apr2021. She says not driving is a problem, he is trying to work from home. She said upper arm for shot location then consulted her husband in the background who said both shots were in his left arm. She said he takes low dose thyroid medication. She consulted her husband in the background for some information. After giving some information she says no he doesn't take anything else. He is never sick and he's never ever been hospitalized. This is his first time ever. She said her son says when the body gets into that condition, it enters fight-or-flight, he went into fight, 5 firefighters had to hold him so they could give him the calm-you-down medications in the ambulance. One was his son, he said that he had the power of 10 men. She said her husband doesn't remember any of it. She says he is very healthy. For investigation, she said, well everything turned out negative. She says he had a CT scan, MRI, EEG, bloodwork, urinalysis on an unspecified date in 2021 and they can't find anything wrong. She said that they just said everything was normal. She said some of his levels were high last week, on an unspecified date in 2021 in his bloodwork and his doctor wanted him to do bloodwork again in 3 weeks. She said several things were high. The events required a visit to emergency room. She said that the fire department took him. She did not visit the physician office until after he got out of the hospital where he saw his primary doctor. She said she wanted to include on the report that it scared the crap out of her. She said, she was holding his neck up and tilting his head up to make sure he was getting air. She wanted to let everyone know what happened. The outcome of the event Grand mal seizure was recovered with sequelae on an unspecified date while the outcome of the rest of the events was unknown.

Left little finger is numbed up real good and is going down to the palm; he felt like he was stuck in an elevator and couldn't get out; he was real nervous.; At one point, was real anxious and aggravated; This is a spontaneous received from a contactable consumer (patient). A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expire date: 30Jun2021) via unspecified route on left shoulder single dose for COVID-19 immunization on 05Mar2021, . Relevant medical history included: ongoing chronic obstructive pulmonary disease (COPD), ongoing depression. Concomitant medications included: lisinopril 20mg tablet once a day for blood pressure for 4 or 5 months; amlodipine 10mg once a day for blood pressure; carvedilol 6.25 mg tablet for blood pressure; budesonide, formoterol fumarate (SYMBICORT) inhaler twice daily for COPD for 6 years; salbutamol sulfate (ALBUTEROL SULFATE) inhaler blue every four hours for COPD about 6 years; all ongoing. Left little finger was numbed up real good and was going down to the palm now. This started 05Mar2021 when he got the vaccination, that night (05Mar2021), he felt like he was stuck in an elevator and couldn't get out. He was really nervous. At one point, the patient was real anxious and aggravated. Numbness was still lingering. Treatment not until 15Apr2021. The most he had been taking was acetylsalicylic acid (ASPIRIN). Emergency room or physician's office not visited. Outcome of the event numbness was not resolved; outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

soreness at injection site; Light headed/dizzy; Felt very anxious and tense; Tense; Heart racing; This is a spontaneous report received from a contactable consumer (reporting on himself). A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK9231; Expiration Date was not reported), via intramuscular route of administration in Arm Right on 23Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included prostatomegaly, drug hypersensitivity both from an unknown date and unknown if ongoing. Concomitant medication(s) included finasteride (FINAS-TERIDE); ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19. On 23Jan2021 12:30, he received his first dose of the Pfizer COVID vaccine. Patient states he felt fine at the clinic after 15 mins and then after he left he felt lightheaded and dizzy and this continued on. Patient says his reaction was about 20 plus minutes after his injection, which he was fine when he got the injection, he became lightheaded and that has kind of continued on. He says it was pretty bad on the first day, then the second day it went away. He says a couple days later it came back, with his heart kind of racing, and he was still experiencing that though it was getting better. This was not something he had be-fore and he feels anxious and body is tight with dizziness. He says he experiences it periodically, and today it was not bad, but yesterday it came back again. He says he was concerned about that, but he hasn't passed out or anything. He says he went to the doctor and had an EKG and blood work done, which were all ok. He says it has been off and on, and he was kind of very anxious and tense as well, his insides are tight and jittery, sort of. He says he didn't see that listed as a common side effect. He says he had soreness at injection site, that went away, and he had no fever or any-thing, just the lightheadedness. He says he wants to see about the lightheadedness, if it had been reported by others, since he didn't notice it as a common reaction, to see what is going on there, since it has been over a week and it hasn't totally gone away, so he is concerned about having his second dose. Am doing better now. Went to the doctor for tests on 27Jan2021 (Wednesday). Test results were okay. Patient states these are not some of the common side effects he has seen or read about. He would like to know when will his symptoms go away. Patient would like to know if he should receive the second dose that was scheduled in less than two weeks. Patient states he called his doctor had an EKG and blood work done and his tests were negative. The outcome for soreness at injection site was recovered on an unspecified date and for rest events was recovering.

Day after shot - low grade fever 99.5, extreme fatigue & body aches. That evening - pain under left arm, could not sleep on left side. Next morning swelling under arm. Large area swollen, still painful.

At 0900, pt received 2nd Pfizer covid vaccine, chatted with staff, and sat down in a chair. At 0925, pt asked nurse, "Is it normal to have a headache after the injection? I feel warm and heavy all over." In response to the nurse's questions, pt stated that he had orange juice in the am, then stopped speaking. His eyes remained open and he continued to sit upright in his chair without slumping. Pt did not show any signs of distress (i.e., rapid breathing, diaphoresis, etc.).. A "team alert" was called for emergency response. Approx 4 mins after first sign of altered level of consciousness, pt started speaking "I don't know what just happened. I could hear you but wasn't able to speak." Pt denied losing consciousness. Denied any nausea, dizziness chest pain, itching, diaphoresis or sob. Vital signs: 152/89 bp, 70 hr, 18 resp, 98% O2 sat on RA. Response team accompanied pt to the ER for further evaluation.

Severe headache; psychosis; paranoia; resting heart rate 108; fever; extreme anger; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Er8729), via an unspecified route of administration in the right arm, on 17Apr2021 at 13:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), zinc (MANUFACTURER UNKNOWN), and other unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oseltamivir phosphate (TAMIFLU) and experienced allergy. The patient experienced severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger on 17Apr2021 at 19:00. The patient underwent lab tests and procedures which included resting heart rate: 108 on 17Apr2021. The patient did not receive any treatment as a result of the events. The clinical outcome of severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger was recovered with sequel (reported as: recovered with lasting effects) in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

tinnitus had gone up; hard to sleep.; blurry vision; This is a spontaneous report from a contactable consumer reported for himself. A 67-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (on Friday 8:30 am) as single dose for covid-19 immunisation. The patient medical history included tinnitus for several years. The patient's concomitant medications were not reported. The patient experienced after his first shot, tinnitus had gone up, hard to sleep, Friday night started getting a blurry vision. The patient asked what the efficacy after the first dose was and he was not planning on getting his second dose. He read online after the vaccine tinnitus can get worst. So many people have reported tinnitus post vaccination. Also Friday night he started getting a blurry vision. He closed eyes for 20-30 minutes and it got better. It felt like he was staring at a screen for 10 hours. It was odd. Outcome of the event blurry vision was recovering, of the other events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

He got his vaccine, he sat down for 20 minutes, he felt OK, went to his car and sat in his car and started feeling dizzy headed. He felt like a panic attack, and felt uneasy driving. He got home and sat for a while and noticed that his body was getting sore, and felt like he had the COVID virus and felt fatigued, joint pain that was worsening. He did not have a fever and then had diarrhea and vomiting that lasted for a week. He called an center after he talked to his doctor the first time, and they told him that he had to hang in there as 20-25% of their patient's were from the vaccine and that it would go away in a couple of weeks or so. He possibly was exposed to COVID from somebody working in his house. He took Ibuprofen for pain and soreness. He is still having the fatigue and brain fog and sometimes can't get his words together. He works part-time and is not able to do so at this point as a substitute teacher. The symptoms are getting better, but he is still not back to his normal self. He has lost a lot of coordination at this time, was an athlete and gets out of breathe walking 50 yards to his mailbox.

11:35am Patient C/O hands very shaky. 11:47am Pt reported feeling much better. BP 159/102, 88. 11:47am Patient reported feeling much better. Patient was advised that if symptoms return to call 911 or urgent care. Patient verbalized understanding.

fever; I felt like (was drunk); unbalanced to dizzy; unbalanced to dizzy; sweating profusely; This is a spontaneous report from a contactable consumer (Patient) reporting for himself. A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EW0170) via an unspecified route of administration on 08May2021 as 2nd dose single for COVID-19 immunization. Medical history included depression, type 2 diabetes mellitus and migraine. Concomitant medications included citalopram hydrobromide taken for depression, metformin hcl taken for type 2 diabetes mellitus, gabapentin taken for restless legs syndrome, muscle spasms, nortriptyline hydrochloride taken for headache, migraine, metoprolol tartrate taken for an unspecified indication. It was reported that, the patient had the vaccination the 2nd one on 8May2021 Saturday. On 08May2021 the patient experienced fever, I felt like (was drunk), unbalanced to dizzy, sweating profusely, and dizziness. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

HEART RACING SENSATION; ANXIOUS MOOD; Nausea; This is a spontaneous report from a contactable Healthcare Professional. A 67 years old male patient received BNT162B2 (COMIRNATY; Lot Number: EN6207), via an unspecified route of administration on 15Mar2021 (at an age of 67 years old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Its unknown whether Prior to the vaccination, the patient was diagnosed with Covid-19 or not. On 15Mar2021, the patient experienced slight nausea, heart racing and also was in anxious mood during the 15 minutes waiting period after the injection (vaccination). Patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness and hoarseness. Patient did not receive any treatment for the adverse events. Patient was stable to go home and agreed for follow up with PCP. The clinical outcome of event slight nausea, anxious mood and heart racing were not reported. No follow-up attempts are needed. No further information is expected.

Client verbalized feeling anxious and his heart was racing. Client was observed/evaluated by Fire Rescue. Client was observed for additional 15 mins. Client was cleared to exit the facility at 11:26am. Per Fire Rescue, client stable no further evaluation needed.

Fatigue,, brain fog, malaise, aching joints starting on day 14 after injection (Wed May 26), lasting four days and diminishig on Sunday May 30. Symptoms cleared until acute onset on June 1, 4 pm beginning with sharp pain thoracic spine. Awoke at 3 am June 2 with increased persistant pain in back (4 out of 10 intensity) and unable to sleep until taking 400 mg ibuprofen. Developed shingles rash just before noon, right side from pain origin on spine around right side across lower ribs to mid line. Painful, itching, deep aching.

I start having brain fog, difficulty with small motor control. I couldn't button my shirt. Overall weakness. I saw a neuro doctor and he order an MRI and they saw brain lesions and swelling. They did a brain biopsy 04/04/2021 and they was looking for cancer. The results was inconclusive. The did a second biopsy on 05/20/2021, they sent samples, no cancer was detect in the sample but it shows abnormal tissues. Now just waiting to see another doctor because they don't know what is causing the lesions.

have burning sharp pain at joint of right foot /ankle mostly on standing and must limp and limit wieght started yesterday on rising. general irritability.

Injection into left arm, pt has had pain and discomfort since, irritating per pt reports. Impacting sleep and cannot sleep on arm, notices discomfort when moving arm. No issues with 2nd dose if right arm.

This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217), via an unspecified route on 13Jun2021 (at the age of 67-years) as 1st dose, single dose in the left arm for COVID-19 immunization. The patient medical history included fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, gastroparesis, diverticulitis, depression, anxiety, migraine, headache. Concomitant medications included Bupropion, Gabapentin, Nortriptyline, Quetiapine, angelica sinensis root, cimicifuga racemosa root, dioscorea spp., glycine max (PHYTOESTROGEN). The patient previously took flu shot last year. In Jun2021, the patient experienced soreness in the arm. He got vaccine in left arm and having pain in his right arm and his right toes, then his right foot the big toe was giving him some weird sensations, the small toes. It was just a weird sensation like tingling and also having a headache in the back on my head and neck. He had fibromyalgia, he knows how that pain feels like, but this was a different kind of pain. He had pain like headache on the back of my head and my neck and like just some soreness that could be considered medicinal like he had fibromyalgia and chronic fatigue, so he know the difference in what he fell from the fibromyalgia and when it is something different and then on my right arm, he got the shot in my left arm the pharmacist said it was better to get it on the non-dominant arm in case you have a problem and he understand that he could get the fatigue but he had just kind of concern about other stuff, neck pain and headache and having symptoms that are just different from my regular fibromyalgia and also that right foot. He took Tylenol for pain, but that was years ago. The events were still persisting that means still going on. The outcome of the events was not recovered.

Fatigue, Weakness in legs, Leg Muscles, Pain in Bones, Neuropathy 3 times worse, .Knees very Painful, hard to sleep

PATIENT CALLED TO INFORM OF SHORTNESS OF BREATH IN THE MIDDLE OF THE NIGHT BEGINNING A FEW DAYS POST-VACCINATION AND CONTINUING EVERY NIGHT SINCE (ABOUT 3 DAYS SO FAR). IT WAKES HIM UP IN THE MIDDLE OF THE NIGHT AROUND 2 AND 3AM EVERY NIGHT. PATIENT STATES HE DOES HAVE HIGH BLOOD PRESSURE AND EXPERIENCING SOME ANXIETY LATELY. I INFORMED HIM TO ALSO CONTACT HIS PHYSICIAN FOR FURTHER REVIEW.

Chills; fatigue; muscle aches; body ache; did not feel like myself after this first injection; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982), via an unspecified route of administration on 15Mar2021 at 08:30 (at the age 67-years-old), as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient had no allergies to medications, food, or other products. Concomitant medications included diltiazem (CARDIZEM) and apixaban (ELIQUIS); both for unspecified indication from unknown date. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, about 4 to 6 hours after the vaccination, the patient experienced chills, fatigue, muscle aches, body aches. The patient did not feel like himself. The patient had been known to have a very good immune system. The second dose was due on 05Apr2021 (as reported). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of chills, fatigue, muscle aches, body aches and feeling abnormal was recovered on an unspecified date in Mar2021. No follow-up attempts are needed. No further information is expected.

wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; wakes up in the middle of the night having chills, fever and bad headache; This is a spontaneous report from a Pfizer sponsored program. A contactable other hcp 67-year-old male Nurse (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on Jun2021 (age at the time of vaccination 67-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Jun2021, the patient experienced wakes up in the middle of the night having chills, fever and bad headache. Patient stated, the events had for 2 days. The patient took Tylenol to reduce fever. The outcome for all the events was recovered on an unspecified date 2021. Information about lot/batch number requested.

Per family had progressive decline post vaccination with agitation. Significantly worse than prior baseline. He was hospitalized and transitioned to inpatient hospice. Time/Date of death 7/22/21 at 23:03pm

The reaction where there were no reaction for five days, then had extreme dizziness and completely passed out because my heart had stopped, I couldn't move my fingers legs or head but only mumble. they noticed that my heart beat was intermittence. It stopped my heart and I was driving and totaled my car. I have a pacemaker now and barely survived, and that was two months ago. I contacted the governs office, my doctor, both federal centers and Pfizer is not hearing about it. I was pretty much dead and revived, everyone is saying there's no red flag, it's crucial to hear what I have to say, I contact Pfizer I was pretty much dead. I've been trying to reach someone since the second week in February, over a month and a half now. I have dealt wit h brain fog for three months, issues with writing, had noise in my ears that wakes me from my sleep and sometimes unbearable.

very tried; legs felt weak; foggy; could not breath; This is a spontaneous report from a contactable consumer or other non-HCP. A 67-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 13Apr2021 08:35 AM (age at the time of vaccination 67-years-old), as a single dose for COVID-9 immunization. The patient's medical history included PAD, has had an operation on each leg; bypass on each leg, had to have a bypass on each leg; and COPD, he may have COPD as well they are still doing tests to see. The patient's concomitant medication was not reported. On 13Apr2021, the patient experienced very tried, legs felt weak, foggy, and on an unspecified date 2021, the patient experienced could not breath. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 test: he didn't have it, he was having bad coughing spells. The outcome for all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

? 10:15 while he was still waiting outside he had some anxiety and was worried he had a panic attack as he has had a lot going on in his life recently. No tachycardia as he was checking his Apple Watch and no other symptoms. ? 10:20 he drove home and called his wife can kept her on the call as he drove. He them experienced some mild tingling in his ears, face and lips. ? 10:30 he got home and his lips were mildly swollen, more so on the upper lip, not as much on the lower lip. ? 10:45 he took an Allegra and about 30-40 minutes afterwards the lip swelling started to calm ? 5:45pm I spoke with him. He said he has no more symptoms. A little tired perhaps from the day or the Allegra (though it doesn?t cause too much drowsiness compared to Benadryl) ? He also reported he had a flu and shingles vaccine back in early November so it has been more than a month.

Agitation and insomnia for a few hours Confusion when I woke up Injection site tenderness Weakness for 3 days

Caregiver was vaccinated and observed for the required 15 minutes. Caregiver left the building and went to drive home. Caregiver stated, "on my way home I did not feel right - so I came back." Caregiver was shaky and slightly confused. Caregiver was immediately taken to the ED across the parking lot by wheelchair and the ED department was notified that Caregiver was on his way, accompanied by Registered Nurse.

Shot administered Wednesday morning. Sore arm, but not particularly bad. Thursday and Friday I was feeling a little fatigued, and took a nap (very unusual for me) Friday. That night i felt a little strange, light-headed. Saturday around 10 AM I developed a moderate headache, and then was mildly short of breath, and most concerning, a little bit of afib. My heartbeat was steady (nothing like the afib I first had about seven years ago or so), but I missed about seven or eight beats in a minute (my pulse is usually around 60). That was not regular. My wife thought I might be having a migraine (I have had about five in my life), but if so it was very mild. On her advice I had about a quart of water over a couple of hours, and both symptoms resolved. Currently fine.

The patient fainted ~20 minutes post-vaccine while talking to his colleague. I immediately assessed the patient for s/sx of anaphylactic or severe reaction. He woke up within ~30 seconds of fainting. He was breathing and speaking fine. He told me he was anxious and also did not have anything to eat or drink all day and believes this is the cause of why he fainted. I had him take a few deep breaths. Injection site looked normal and no issues with breathing. Called EMS to assess him: glucose, blood pressure, & vital signs were all normal. While being assessed he passed out in chair so EMS took him to the hospital. He was discharged from the ER the same day per RN, at the facility. They did not find anything wrong with him and also believe it was due to nerves/lack of eating. No significant medical history per form patient filled out or that he verbally stated.

Administered 2nd COVID vaccine Friday 1/29/2021. Nothing out of the ordinary. The next morning on Saturday 1/30/2021, he was found on the floor in his room- responsive, but disoriented. He could not move his left side. The ambulance was called immediately.

shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.

When he went to the bathroom it was like diarrhea, watery, and had blood; He also had pains in his stomach; he could hardly move; Last night he sweated, the sheets were all wet; Pain on the right side of his back/ night before he had it on his left side/ he moved it hurt so bad; He only slept for 4 hours; Fever and chills; Fever, temperature was only 100; his blood pressure went up; Stomach problems; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL9265), via an unspecified route of administration at the left arm on 27Jan2021 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history included ongoing high blood pressure and ongoing cholesterol. Ongoing concomitant medications included lisinopril for high blood pressure, amlodipine for high blood pressure and atorvastatin for cholesterol. The patient previously took montelukast and dries up his sinuses. On 27Jan2021 he received the first dose in the afternoon about 5 o'clock or a little after. It started with stomach problems on 27Jan2021. He kept feeling like he had to go to the bathroom all throughout the night on 27Jan2021. He slept through the night and was okay. He had a little something going on in his stomach. The next day (28Jan2021), that evening, around 7pm he had fever and chills and his blood pressure went up. His temperature was only 100. It never went over that. And he was having to go to the bathroom. In the morning, it was fine but at night he was having to go. Normally he has a bowel movement in the morning. When he went to the bathroom it was like diarrhea, watery, and had blood. It was not dried blood, but blood. It happened twice. He then had to go again. The same thing happened again and then it stopped. He also had pains in his stomach. He went to sleep and the next day he went to the bathroom the first thing in the morning and it was normal. The reported also mention that stomach problems were worse on 28Jan2021. He only slept for 4 hours on 28Jan2021. The next day, 29Jan2021 he was fine. He only had a little bit of a fever and a little bit of chills. Then the chills and fever went away that day. He did not feel ill or weak at all when this was happened which is why he did not go to the doctor. He did not feel that the symptoms were bad enough. He felt okay once they were over. He had to get it out. On 31Jan2021, he also had fever and pain on the right side of his back. It was a really sharp pain and he could hardly move. The night before he had it on his left side. He made himself get out of bed. When he moved it hurt so bad. On 31Jan2021, he sweated, the sheets were all wet. He slept 4 hours. He has been using ice packs and icing it down. The pain on the right side has gone away but the pain on the left side is still there. It has improved and there is only a little pain. He iced it down first thing this morning. He walks everyday. The outcome of the event diarrhea bloody was recovered on an unspecified date, stomach problems and his blood pressure went up recovered on 28Jan2021; pain back was recovering; outcome for all other events was unknown.

7:30 the night after the vaccine he got very lethargic and dizzy. And about thirty minutes later he couldn't he lift his right arm or right leg. He was extremely dizzy and not completely coherent. I took him to the hospital where they ran CAT scans and labeled it a TIA.

"This message is to inform patient that you have been successfully scheduled for your first dose of the Pfizer COVID-19 vaccine. You are scheduled to receive the vaccine on Saturday February 13, 2021 at 12:45 PM." Almost immediately after, I was ro take my wife for her 1st dose (Saturday February 13, 2021 at 2:15 PM); however, I was already disoriented and had trouble picking her up. My wife called police to try and find me. When I finally go home, I couldn't remember anything of the events of the day. The following morning (Sun. Feb. 14th) @7:00AM, I collapsed in the kitchen and 911 was called as my heart stopped. 10 minutes passed by and I was turning blue. I still can not remember getting the vaccine or any of the events of 02/13/2021.

Numbness and pain in left arm after injection, radiating down arm. Improved with ice pack. Also reported having anxiety being in large crowds so took ativan that he had from home. Wheelchaired out safely in car.

Within an hour of receiving 2nd dose started experiencing headaches and dizziness. In addition to the headaches and severe dizziness I started having significant bouts with diarrhea, malaise, loss of appetite and have not slept well. Within a couple days I noticed pronounced tremors in my right hand and I started losing weight from 180 pounds to 157, around 23 pound loss. I contacted my physician and was alerted to make this report and have an appointment on March 1.

1246: After receiving Covid vaccine, pt stood to leave after 15 mins and felt "disoriented" 1248: BP 128/77 HR 77 SpO2 96% 1250: Water given 1254: Stood up again, feeling better 1255: Walked home

Immediately felt light headed, like seeing double and I can't explain it. It is still continuing now but not as bad. The next day I had chills and my fever went up to 101, I took about 6 Tylenol and 6 Advil to bring the fever down. The following day I was feeling better. The yesterday I woke up with a weird feeling on the left side of my lower lip, it is like numbness, like just it feels weird. I have an appointment with my doctor tomorrow.

About 11 hours after the second shot, nauseated, vomiting, low grade fever(99.6), chills the worst I have ever had. Headache, diarrhea, lost of balance, dizziness, and confused. Lasted about 24 hours. I though I had Covid again. 48 hours later I feel much better except my body feels like a truck hit me and no energy.

I didn't sleep last night; parts of face and under chine was swollen; BP102 at 3pm blood pressure was 132/82; This is a spontaneous report from a contactable Other HCP. A 68-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261), via an unspecified route of administration on 05Feb2021 08:15 at single dose, right arm for COVID-19 immunization. Medical history included high blood pressure, Crohn's disease and mental health issues. Known allergies included valproate semisodium(DEPAKOTE) and fluoxetine hydrochloride(PROZAC). The patient's concomitant medications were not reported. The patient didn't sleep last night. Parts of face and under chine was swollen, blood pressure(BP) 102 at 3pm blood pressure was 132/82. Noticed after waking up at 2:30PM. The patient went to sleep at 9:30pm. Events start date was 05Feb2021, 03:00PM. Events resulted in: Doctor or other healthcare professional office/clinic visit. There was no covid prior vaccination, no covid tested post vaccination. No treatment received for the events. The outcome of the events was recovering.

Feels like I have the COVID Virus again. Fever, chills, shakes, sore throat, restless, weak, no appetite, 102 fever on first day 101 fever second day. Tylenol to relieve fever and sever body aches.

Intense dreams every night. Last night was the sound of a door slamming that woke me up. I don't usually dream much at all. However since being vaccinated I have intense dreams every night.

On 03/12/2021 at 0630 fell out of bed, wife witnessed tonic clonic seizure of 5+ minutes duration, when EMS arrived patient was postictal (confusion).

Slight headache about 30 minutes after receiving shot at 11 AM, Saturday, 3/6/2021. About 5 hours after shot I started feeling like I was coming down with something, like I had a mild fever and headache was a little more pronounced, but still mild. By 8pm I had fever of 102F, headache was now uncomfortable, so took 2 Tylenol and went to bed. Fever broke about 3-4AM, but still retained a very mild fever of 99F with very mild headache, muscle aches and joint stiffness/pain for the following day and the day after. By Tuesday 3/9, head was starting to clear and feeling like I had mild fever was gone. Headache was no longer. Each day thereafter, my head seemed to be more cognitive/clearer and looking back, I could tell I was not thinking clearly, with difficulty remembering things. Since I was not working, fogginess had zero impact on my lifestyle. I should note the first shot, received on 2/13/2021, I had no effects at all. Nothing. Since I was not feeling very well during this time, I tended towards comfort foods which elevated my blood sugar, but that returned to normal levels by 3/9/2021.

Very Sleepy right after shot. I had trouble driving home. Slept for 2 1/2 hours when I arrived home.

Lyme symptoms, which had been dormant for 5+ years, began in earnest. Pain, fatigue. Unable to work a full day (he is still working full time). As days progressed the pain worsened as well as the fatigue. After the second vaccine (booster) he became lightheaded and dizzy. Passed out at least once. Needed help with shower. Dizziness comes and goes, but is active more than inactive. Appetite is small.

Started feeling "fuzzy" on Wed March 17 in the afternoon and felt warm. (did not take temp at this time) on Thursday March 18 around 11:30 am, laid down until 2pm as i was feeling "fuzzy". took temp around 2pm . it was 100.4 took advil and nyquil at bedtime (around 9pm) on Friday March 19 around 10:30 felt a bit fuzzy but not warm. . Experienced some chills around 4:30 so i took some advil. Around 7pm temp was 99.4. On Saturday March 20 at 5:30am took some advil as i was feeling warm.(did not take temp). at 9:20 am temp was 98.1. Went to Urgent care as i was still feeling fuzzy. They administered a covid test and checked breathing. no issues found.

First hands are numb. Then legs are extremely weak and it is hard to walk, they are very unstable. When I cough or sneeze, I have shooting electric type pain through my arms and across my chest. This has been consistent since right after my first shot. Doctors are saying that it is only arthritis. They have run blood work and xrays. But symptoms continue to affect me and I am unable to work due to severity.

1/18 vaccination Within 4 minutes, my husband started with tremors in his hand. Feeling funny. Felt like something was wrong. He was trying to hold hands still but then other extremities started to shake. He passed out. Honked for help. It took both ambulances to tx my husband and onto the stretcher and strapped in. Grand Mal Seizure. It started to fade when he got into but then had another one after he was in the ambulance, worse then the first one. He continued to have seizures for 4 more days. Every couple hours, give him the kepra and topomax to help. 1/20 orthopedist 1/25 PCM 1/26 Neurologist 1/28 home health nurse 2/8 PCM, mental health 2/10 orthopedist 2/12 home health nurse 2/17 home health nurse **stated he cannot have 2nd vaccine. 'if he has another grand mal seizure it will kill him'

Immediate whole body severe sweating, eye pupils extremely dilated, skin color and lips became very pale, dizziness, disorientation, tremor in the hands, thirst, a bit of nausea, fainting . No treatment received except for ice pack. Neither doctor or nurse was present on the site.

All of the following symptoms have lasted for 3 weeks and 1 day. Severe fatigue Headache Stomach pain Fever 99.5 to 102.5 Painful joints, especially knees New back pain Brain fog First ever episode of Afib As I stated, all of these symptoms have lasted 3 weeks

3 hours after receiving the vaccine, coworker found patient hunched over in his stool. Patient appeared pale and very weak, still verbal but unable to understand responses

still felt bad along with shortness of breath; received his first vaccine dose yesterday and began feeling unwell; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration Date were not reported) via intramuscular route of administration as a single dose in Arm Right on 31Jan2021 13:00 for covid-19 immunization. Medical history included Allergies to medications: Ace inhibitors, HHT(Hereditary hemorrhagic telangiectasia )/High Blood Pressure, Eye conditions, Parkinson's Disease. No other vaccines received within 4 weeks prior to the COVID. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other medications the patient received within 2 weeks of vaccination: Men's Multivitamins, Amlodipine, Tamsulosin, ferosul Iron, Ropinirole, Stool Softener. On 31-JAN-2021 21:00 the patient began feeling unwell. On 01-FEB-2021 08:00 still felt bad along with shortness of breath. No treatment received for the adverse event. Outcome of events at the time of last observation was not recovered/not resolved. Information on the Lot/Batch number has been requested.

Very loud and constant Tinnitus in right ear. Constant extremely loud. Tinnitus also in left ear but not as loud. But an increase in pain from Hyperacusis in Ear and side of my face. Symptoms have increased since I got my second dose Friday night. Very hard to concentrate and sleep through the night.

Death Narrative: Death on 03/21/2021. 2nd dose administered 46 days before serious event. Patient had been admitted to the hospital for AMS of unknown etiology concerning for sepsis with multiple sources and was on comfort care measures only. There are no indications that death was related to the vaccine.

fever 101, heart rate over 100, joint and muscle aches, chills, unable to sleep. lasted from 10 pm until 8 am next morning. Temperature reduced to 99, other symptoms reduced. 48 hrs after injection, back to normal.

Fever; aches; confusion; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the right arm on 12Mar2021 10:45 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) but had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine was administered in a public health clinic/veterans administration facility. On 14Mar2021, the patient had fever, aches and confusion. These events resulted in an emergency room/department or urgent care and hospitalization for 4 days (Mar2021). It was unknown if the patient received treatment. The patient has been tested for COVID-19 since vaccination, a nasal swab with the result of negative on 17Mar2021. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Shortness of breath; headache; Felt like at least 100 degree temp/slight fever; lack of appetite/completely lost appetite/No appetite; Body aches; Joint aches; Tiredness; Delirious; Chills; cold sweats; felt weak; flu-like symptoms; feel almost as miserable; can't taste food as well/lack of taste; diarrhea; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration, administered in the right arm on 16Mar2021 at 10:20 as a single dose for covid-19 immunization. The patient's medical history included deep vein thrombosis (DVT) in from 2017 to 2017. Patient always had swelling on the leg where he got the blood clot. The patient's veins in his leg were damaged and the doctor takes care of his legs. He has very poor blood flow in the affected leg, that all the fluids and waters, the heart was having a hard time pumping it back up. He uses compression stockings, physical therapy, and that he raises his legs in the evening. The caller mentioned that vessels in his affected leg are damaged for good. Patient was in a treatment facility for alcoholism. Patient reported that he hasn't had a drink in 2-3 years but still has to go to treatment, caller was released from the treatment facility because he got sick with COVID. Patient had Covid-19 on 15Dec2020 to 08Jan2021 (the side effects experienced after the first dose of the Covid-19 vaccine weren't as severe, that the real virus is pretty bad). Concomitant medications included blood thinners (unspecified) and a couple of other medications. Patient reported that he skipped some doses of his regular medications while he was feeling poorly. On 16Mar2021, the patient experienced delirious, chills, tiredness, body aches, joint aches, cold sweats, felt weak and flu-like symptoms. On 17Mar2021 patient had headache, felt like at least 100 degree temp/slight fever, lack of appetite/completely lost appetite/no appetite; can't taste food as well/lack of taste and diarrhea in Mar2021; and shortness of breath on an unspecified date. It was further reported that the adverse events that he was experiencing were as bad as his experience with COVID-19 except he could breathe. Gradually over the next 24 hours and the night of 16Mar2021, he started getting chills and fevers, getting very tired, and experiencing flu-like symptoms. He had fatigue, cold sweats, slight fever, headache, diarrhea, and the lack of taste or appetite. He said that his adverse events started 10 hours after getting vaccinated. For the next few days, he felt weak and had to exert a big effort to get out of bed. On the second day of vaccination, he developed diarrhea and completely lost appetite. Patient also reported that he experienced body aches. He experienced body aches and joint aches. Patient had no appetite, that he still hasn't eaten much the last few days but that he has started eating today. He described his experience to be severe but not severe enough for him to be hospitalized. He said that he missed 3 days of work because of his symptoms. It was on the 6th day since he got vaccinated and everything has subsided and he was getting his energy back but he is still recovering. Patient called his physician and the nurse he spoke with stated that the first 3 days following the Covid-19 vaccine the side effects could be very severe and that the side effects could continue over next 3 days. Caller reported that he is on the 6th day now since he got vaccinated and everything has subsided as he was starting to feel better, he was coming around, but it was not 100 percent. So patient was inquiring about the second dose of the product. The patient further mentioned that the side effects following the first dose of the Covid-19 vaccine caused him to feel almost as miserable as he did when he actually had Covid. Patient also stated that he was close to calling ambulance the night of 16Mar2021 when he began experiencing AEs. The patient was delirious, he wasn't sure what was going on, that he was trying to grab his phone and text but couldn't use his phone. Patient was wandering around his room. Patient would get cold sweats at night. Caller reported on the morning of 17Mar2021, he woke up soaked in sweat. Patient called his doctor's office that he just needs guidance on whether or not to get the second dose. The headache went away gradually and was gone probably late Saturday, 20Mar2021 or Sunday, 21Mar2021. for the event tiredness, patient stated that he's still trying to regain his full strength but, 22Mar2021 was the first day that he has been able to sit up and do things and that he hasn't had to lay down all day long. Felt like at least 100 temp, patient reported that he doesn't have a thermostat. He reported that he felt feverish at least the first 3 days following the first dose of the Covid-19 vaccine on 16Mar2021. Body aches/joint aches, reported that the body aches and joint aches have almost completely subsided. Patient stated that he doesn't really feel them, that he is 68 and at that age you're going to feel some aches regardless if you're sick or not. Caller reported that he can barely talk, that he still doesn't feel completely right. No appetite: caller reported that when his symptoms were severe that he did not want to eat. Caller reported that he did hydrate. The decreased appetite has improved but that's still not quite what it was. Caller reported that he was trying to eat to improve his energy level. Can't taste food as well, mentioned as that everything tastes the same, whether he eats a grape or a banana. Caller reported that he noticed that he wasn't able to taste food as well the third day after his symptoms began, but states it was improving. Patient reported that the diarrhea began on 18Mar2021 or 19Mar2021 and that he can't hold it too long. He ate cereal in the morning and immediately had to use the bathroom and it's getting a little better. Patient reported that he took 1000 mg of Tylenol for 2 to 3 days in a row. He took two 500 mg tablets three times because of headache and chills. Patient stated that the only difference between the side effects he experienced following his first dose of the Covid-19 vaccine and having the Covid-19 virus was that he doesn't have any problems struggling to catch his breath. The patient recovered from the events chills on 20Mar2021, headache and felt like at least 100 degree temp/slight fever in Mar2021; recovering from tiredness, body aches, joint aches, can't taste food as well/lack of taste, lack of appetite/completely lost appetite/No appetite and diarrhea; not recovered from shortness of breath; and unknown outcome for all the other events.

Pt c/o feeling tired, warmth in chest and 2/10 chest tightness. Pt states "I just don't feel right". Pt arrived in med obs @ 09:27 accompanied by wife. Vitals obtained and continually monitored. Pt found to be hypertensive. Chest tightness easing up. No reaction noted at vaccine site. Pt and wife agreeable to being transported to hospital via EMS. EMS arrived @ 0955. Report given to paramedic. Pt left vaccine site @ 0957. Vitals as follows: 0927 BP 210/123 HR 94, RR 20, spo2 98% 0930 Manual BP 205/120 HR 88 RR 20 spo2 98% 0935 Manual BP 210/120 HR 95 RR 20 spo2 98% 0944 Manual BP 190/110 HR 93 RR 20 spo2 98% 0949 BP 199/100 HR 94 RR 20 spo2 98%

Tinnuitis. Started Apr 7, 2021, about 1 week after 2nd vaccine dose. Rt>Lt ear. Increased Sinus Pressure. ER Apr 8/9. CAT Scan positive for congested sinuses. Placed on Amoxicillin for 7 days + Pseudofed bid. No real relief. Saw Primary DR. Apr 13, 2021. Removed ear was rt ear-this helped a bit. Told to stop pseudfed and start Mucinex and continue with Amoxicillin for e additional days (total 10 days). Minimal relief. Still have buzzing in my ears. Plan to see an ENT DR. Will call4/19/2021. Unable to sleep!!!

My first dose of the vaccine was administered on March 11th 2021 at Walgreens Pharmacy, Pfizer Lot number EN6199. The side effects from this dose were mild nausea, shakes, chills, dizzy, somewhat disoriented and "foggy" brain. These disappeared the next day. My second dose was on April 1st. at the same facility. This time I had no reaction. On the morning on April 11th I woke up feeling miserable. The symptoms were identical to the side effects of the first dose, except worse. This time I also had a low grade fever. These symptoms dissipated in 36 hours. On April 13th I woke up to the same symptoms again, though milder, lasting about 8 hours. Today, April 21st,, I woke up with the symptoms one more time, lasting about 5 hours. As I am writing this I feel fine again. As a lay person I have no idea if these are all related. The whole scenario seems rather odd to me. For your information, I had my yearly physical in late March 2021, all tests were normal.

Sub acute cognitive dysfunction over 8 weeks with dramatic accelerated decline over the last two weeks. Patient suffers from confusion, memory loss, difficulty understanding/comprehension, balance. MRI showed abnormal areas of cortical diffusion restriction involving portions of the parietal lobes, left occipital lobe, and left medial temporal lobe with subtle FLAIR hyperintesnsity. Since this has suddenly occurred, there has been no prior evaluation or workup for dementia or memory loss. Possible considerations: CJD, encephalitis, vasculitis, other. Expectations for Hospital: Additional testing, diagnosis, treatment.

Anxiety the next day. It is Tuesday and still feel it; This is a spontaneous report from a contactable consumer. A 68-year-old male patient 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 left arm on 06Feb2021 12.45 as single dose for covid-19 immunization. Patient was 68-years-old at the time of vaccination. The patient's historical condition included blot clots on warfarin. The patient's concomitant medication included duloxetine hydrochloride (CYMBALTA), mirtazapine, mirtazapine (REMERON) and atorvastatin. On 07Feb2021 12:00 the patient had anxiety and still feel it. Patient was not treated for the adverse event. The outcome of the event was reported as not recovered. Information on the lot/batch number has been requested.

sleep was restless; chills; This is a spontaneous report from a contactable consumer.(patient himself) in response to Non HCP follow-up letter sent in cross referenced case . A 68-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810,), via an Arm left on 03Feb2021 at 10:00 am as a single dose (Age at Vaccination: 68 years) and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249), via Arm left on 13Jan2021 as single dose for Covid-19 immunization. Medical history included: Hypothyroidism on an unspecified date in 1990 treated with low dose levothyroxine. Concomitant medications include: Levothyroxine which the patient have been taking for many years and is still ongoing. Dose #2 also resulted in chills 14 hours after injection on 04Feb2021. Chills lasted longer and sleep was restless on 04Feb2021, on by next day. patient felt fine. Admission to hospital due to the event was no. No Problems following initial minor side effect of chills. Second dose received 03Feb2021 at 10:00 am. During the following night sleep was fitful and chills were again experienced and they were more severe. During the day (04Feb2021). Patient felt fine and as of 05Feb2021. there are no problems. The reported issue occur after use of a Pfizer Product was yes Therapeutic measures were none. Outcome of the events was recovered.

serious pain in shoulders; difficulty sleeping/Could not sleep; Major pain in groin area, shoulder and general leg; Major pain in groin area, shoulder and general leg/could not lift my legs to get out of bed without severe pain; arm weakness; Sometimes at night had severe chills; pain was very high; My temperature was usually between 98 and 99; This is a spontaneous report from a contactable consumer (patient). A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 07:30 (Batch/Lot Number: el9269) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension (medical history: High BP), CIDP in 2006. Concomitant medication(s) (in two weeks) included amlodipine besylate taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported. Historical Vaccine include BNT162B2 (Lot number: e13249, Administration time: 01:30 PM, Vaccine location: Left arm, Dose number: 1) and experienced Minor arm soreness at time of injection, 2 weeks after first injection sore neck and shoulder, soreness in upper body. The patient experienced serious pain in shoulders on an unspecified date, difficulty sleeping/could not sleep on an unspecified date, major pain in groin area, shoulder and general leg on an unspecified date, major pain in groin area, shoulder and general leg/could not lift my legs to get out of bed without severe pain on an unspecified date, arm weakness on an unspecified date, my temperature was usually between 98 and 99, sometimes at night had severe chills on an unspecified date, pain was very high on 23Feb2021. Adverse event: Minor arm soreness at time of injection. 2 weeks after first injection sore neck and shoulder. Neck so bad had to sleep upright in chair for several days. Was not consistent all time. 3 weeks after first injection, neck pain was better but overall soreness in upper body. 1 weeks after my second injection I had serious pain in shoulders and had difficulty sleeping. 2 weeks after 2nd injection had major pain in groin area, shoulder and general leg and arm weakness. Could not sleep. This continued off and on for 18 days after my second injection. My temperature was usually between 98 and 99 (normal is 97 or less). When temp spiked close to 99, pain was very high. Sometimes at night had severe chills. Been taking Tylenol for 5 days to keep temp down. I am slowly feeling better, but still have shoulder and groin soreness. At my worst with side effects, could not lift my legs to get out of bed without severe pain. The issues were not constant. Prior to vac, excellent health/active. Adverse event start date: 29Jan2021, Adverse event start time: 07:30 AM. If treatment AE: No. If covid prior vaccination: No, If covid tested post vaccination: No. Known allergies: no. Facility type vaccine: Hospital. If other vaccine in four weeks: No. The patient underwent lab tests and procedures which included body temperature: 99 on 2021. For all events, outcome was recovering and, for my temperature was usually between 98 and 99, outcome was recovered on an unspecified date.

My arm was quite sore from the shot which was not surprising. However, It has continued to hurt for 7 weeks now. If I take Advil, it hurts less. But it continues to bother me every day and night. If I wake at night, it usually hurts more, probably from moving it or laying on it.

Following the first shot I had typical flu-like symptoms - fever, aches in joints and muscles, headache and brain fog. The second shot had the same symptoms as the first but after about 22 hours I apparently had some type of anaphylactic reaction - I remember going to the bathroom - but I woke up on the floor by the bed, and could not think how to get back in bed. My wife called 2 neighbors who helped me up. It was difficult to form complete sentences. I was transported by ambulance to ER. The ER ran a battery of blood tests, CT scan and chest x-ray. The ER doctors and oncologists concluded that I must have had a delayed reaction to the vaccine. Today, April 28, things are back to normal.

brain fog; vicious chills; Really Hot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6100 and expiration date not provided), via an unspecified route of administration, in arm right, on 19Feb2021 (at the age of 68-year-old), at single dose, for COVID-19 immunization. Medical history included ongoing asthma, brain injury, concussions (patient stated he had three. The most severe was three years ago. Patient stated he was knocked completely unconscious and was unconscious for a while), pneumonia from 1980 to 1983. Patient got pneumonia back in the 1980s, around 1983; and after that he had asthma. Patient was having issues seeing things as he went to the eye doctor today and they dilated his pupils. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318 and expiration date not provided), via an unspecified route of administration, in arm right, on 29Jan2021 16:00 (at the age of 68-year-old), at single dose, for COVID-19 immunization; and experienced brain fog and tired. The patient experienced brain fog, vicious chills, and really hot. Patient stated that he also had 1-2 instances of vicious chills and 1-2 instances of being hot. Patient said the hot and chills definitely happened after the second vaccine. Patient stated it happened somewhere in the 7-10 days after the vaccine and then was gone. Patient had brain fog after first dose vaccine. It never went away completely. After the second injection the brain fog returned stronger again. Patient stated that if he was to rank his brain fog on a scale of 1-10 with 10 being not able to function; at it's worst he would rate it as a 6. Patient said he could function but would be working and be in the middle of an email and typing and would get lost in the middle of a sentence. Patient said it had improved; as of now he would rate it as a 3-4 on the same scale. No additional vaccines administered on same date of the Pfizer suspect. The outcome of the event "brain fog" was recovering; of events "vicious chills", "really hot", was recovered on unknown date. No follow-up attempts are possible. No further information is expected.

received 1st covid vaccine 2/12/21 2nd dose 3/5/21 at hospital admitted to medical center for covid symptoms including hypoxia, fever, and altered mental status testing positive for covid 5/4/2021

Pain at injection site, fatigue the day after vaccination, then pain in joints, that started in the left hand, and then spread to other joints, which has continued and grown worse since vaccination almost 1 week ago. My sleep has also been affected, not sleeping soundly.

hallucenagetic type dreams repeating in constant loop; fever 101.5F; chills; uncontrollable shaking; sore / achy body and joints; achy body and joints; headache; no appetite; numb tongue; taste like metal; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular on 21Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Apr2021, the patient experienced fever 101.5F and chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, hallucenagetic type dreams repeating in constant loop effects began approximately 10 hours after injection. There was no treatment for the events. The outcome of the events fever, chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, and hallucenagetic type dreams was recovering. The patient was not tested post vaccination for COVID. No follow-up attempts are possible. No further information is expected.

Extreme fatigue, severe malaise, body aches, feeling of impending doom, shortness of breath, high heart rate, high blood pressure.

Weakness; difficult breathing; fatigue; Dizziness; general malaise; rapid heart rate; a sense of impending doom; This is a spontaneous report from a contactable consumer. A 68-Year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route in left arm on 04Feb2021 15.15 as SINGLE DOSE, for covid-19 immunization (age at vaccination: 68-Year-old). Medical history included Heart Failure, PAD, CAD and Fibromyalgia. Concomitant medications included alirocumab (PRALUENT), aspirin [acetylsalicylic acid, hydrocodone bitartrate, paracetamol (NORCO), perna caliculata extract (LYPRINOL), ca [calcium] and diphenhydramine hydrochloride (BENADRYL). Patient was allergic to food allergy, dairy products, sulfa drugs and soy. Patient not had Covid prior to vaccination. On 06Feb2021, the patient had weakness, difficult breathing, fatigue, dizziness, general malaise, rapid heart rate and a sense of impending doom. The events resulted in emergency room/department or urgent care. The patient has tested for covid 19, nasal swab on 06Feb2021, the test result was negative. The patient had not received any treatment for adverse events. The outcome of the events was reported as not recovered.

Hissing popping crickets loud muffled sounds and ringing in my left ear. Vertigo confusion head spinning hearing words but not being able to understand them. Hearing sounds but can?t tell where they are coming from feeling extremely disoriented.

He got his vaccine, and had to go from the roof to the parking lot. He was in his car and thought he had put his car in park, but it was in neutral and he hit another car, which he thought he was hit. The gentleman informed him that he was the one that hit him as he had watched him slowly advance to hitting him. He did not know or was aware that he was even moving. He has headaches normally but they have gotten worse since then. He also has motion sickness but has learned to deal with it and get used to the side effects. He also has blurry vision and just not feeling normal. He did go see his PCP and she put him on Meclizine for the dizziness, which works about 50%, but not completely. He did have the 2nd vaccine on 2/22/21 and still had the symptoms, which have stayed since then as well. He then saw his PCP a week ago and she is scheduling for a CT scan to see if he has any blood clots. He did have an aneurysm in his brain 28 years ago and they felt that he would not be able to survive it and deemed that he would be left as a vegetable, but has survived that and does have a little residual headache, but nothing severe. He now is still having these three symptoms that he did not have prior to the vaccine.

Grand mal seizure; Neurological problems; could not talk; he knew the answer but he could not verbalize the answer; Massive migraines; anxious he starts stuttering; anxious he starts stuttering; This is a spontaneous report from a contactable consumer. A 68-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6204, Expiry date: 30Jun2021) via an unspecified route of administration on left arm on 18Mar2021 14:40 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient never had seizures until after taking the COVID vaccine. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. The patient was not administered with any other additional vaccines but was taking vaccinations for the flu, pneumonia, and everything his whole life and has never had reaction to any one of them. The patient had not received any prior vaccinations within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM9809, Expiry date: 30Jun2021) via an unspecified route of administration into the left arm on 25Feb2021 as single dose for COVID-19 immunisation. On 20Mar2021, the patient stated that the problem was that he started developing neurological problems where he could not talk for about two days after he got the second shot. He stated his wife did not notice the symptoms and the work he does 99% of the time, he does not have to talk to anyone. But the problem was, the last day he worked which was over two weeks ago, he almost jeopardized two major accounts because he did not realize what he was saying. He spent a week in the intensive care unit (ICU) and had lost over two weeks of work well actually closer to three weeks. The patient was barely getting back to the point of feeling normal and he could not tell about all of the neurologists he had talked to but it had been at least four and he had to go see his personal neurologist now. He Stated that he had to be put on medication and was in the intensive care unit for over a week and the reason was is because he had to be put on medication to stop the seizures. He stated he has to take medication for the rest of his life and also had a hospital stay in the intensive care unit and this continued until he went to the intensive care unit and was transported by ambulance on Tuesday 04May2021. He could not talk when someone asked him a question, he knew the answer, he could sit there and hear someone but he could not verbalize the answer, this stopped and was taking medication that stopped it. But on 04May2021, he had a grand mal seizure and his wife called 911 and he was taken to the hospital and then transferred to the ICU for a week. The event Grand mal seizure resulted in hospitalization and was in hospital from 4May2021 to 11May2021. He stated he had to be put on medication to stop the seizures. He had some more grand mal seizures in the hospital. He stated that he was taken to Hospital where he was in the emergency room from 9 o'clock to 2:30 in the morning and then was transferred to Hospital where he was admitted to the intensive care unit. He does not have these anymore but he was not sure exactly when his last one was but he was in the hospital. On 20Mar2021, he also has had massive migraines a couple of times a day (two times a day) and then he got to the point that if he got anxious he started stuttering. He stated the symptoms started about two days after the second shot, so suspect product was the second dose. The patient took the COVID 19 shot because they said he needed to. The events resulted in Emergency Room visit and Physician Office. There was no relevant laboratory tests reported. The treatment included that he confirmed that he was given medication in the hospital for his symptoms and was taking medication at home. The outcome of the events Neurological problems, could not talk was unknown. The event Grand mal seizure was recovered on an unspecified date in May 2021, While other events Massive migraines, anxious he starts stuttering was not recovered/Not resolved. Information on Lot/Batch number was available. Additional information has been requested

I push-mowed for an hour in late morning, following shot. Over the course of the remainder of the day, seemed to having some increasing fatigue. In the night, had frequently interrupted sleep, chills, body aches, mild nausea. The following day, tired all day; last night, had chills, felt abnormally warm, had reduced appetite. Took Ibuprofin around 11:00 p.m. Felt better. In repeated thermometer readings, highest temp was 98.6, is normally in 97-range. Had some chills and sweating which interrupted sleep a bit, but slept better than the previous night. Still feeling a little tired today, but overall feeling better.

SEVERE JOINT PAIN IN MY RIGHT KNEE ,MY LOWER BACK, AND MY NECK CAUSING SEVERE PAIN DOWN BOTH MY ARMS AND MY HANDS ,, CONFUSION WITH MY MIND RACING OUT OF CONTROL IN A FOG FOR OVER 2 WEEKS, INTO THE 3RD WEEKS I HAD SEVERE SCIATIC PAIN ON MY RIGHT SIDE INTO MY RIGHT LEG CAUSING SEVERE PAINFUL CRAPPING ,,MY DOCTOR GAVE ME DEXAMETHASONE, AT MY REQUEST AFTER I READ ABOUT THE SCIENTISTS RECOMMENDING THE STEROID BE GIVEN TO PEOPLE SUFFERING FROM SEVERE INFLAMMATION AND PAIN FROM THE VACCINES ..IT ONLY TOOK 4 -1 MG PILLS TO GIVE ME RELIEF ,, I DONT UNDERSTAND MY THE LYING CDC IS NOT BEING HONEST ABOUT THESE VACCINES ,,CVS PHARMACY. TOLD ME THERE WERE NO SIDE EFFECTS TO THE VACCINE ,,AND IM THINKING ABOUT SUING THEM FOR THAT CRIMINAL LIE ,,I WILL NEVER HAVE ANYTHING GOOD TO SAY ABOUT CVS AS LONG AS I LIVE AND BREATH ON THIS PLANET ,,EXCEPT TO SAY THEY ARE LYING NAZIS !! EXPERIMENTING ON PEOPLE INSTEAD OF INFORMING THEM ,

Minor muscle aches; Sore arm; Minor chills second night; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; Sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently.; This is a spontaneous report received from a contactable consumer(patient). A 68-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0185), via an unspecified route of administration in left arm on 03Jun2021 at 14:30(at the age of 68-years-old) 2ND DOSE SINGLE DOSE as single dose for COVID-19 immunization. The medical history of the patient included diabetes II, hypertension, a-fib and COVID-19 on Dec2020. The patient allergic reactions included hay fever. The concomitant medications of the patient included apixaban(ELIQUIS), diltiazem(DILTIAZEM), atenolol(ATENOLOL), sitagliptin(JANUVIA) and melatonin(MELATONIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in left arm on 14May2021 at 14:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. After the second dose the patient experienced minor muscle aches, sore arm, minor chills second night and sig increase in neuropathic leg/feet pain plus restless leg interrupting sleep frequently on 03Jun2021 at 18:00. The patient stated that notes from his initial infection with COVID last December show the same intensification of neuropathy symptoms for several nights. It was reported that no treatment was received. The outcome of all the events was reported as resolving.

felt a little weird; feeling foggy; couldn't walk/felt like a drunken sailor, that's how bad the walking and gait pattern were; couldn't do any of his work, couldn't take phone calls; couldn't concentrate; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0182, Expiration Date: not reported) via an unspecified route of administration in upper left arm on 17May2021 09:30 (at the age of 68-year-old) as 1st dose, single dose for COVID-19 immunization. Patient did not received any other vaccinations within four weeks prior to the first dose. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and was not administered with additional vaccines on same date. Medical history included ongoing spinal stenosis diagnosed 5 years ago. Concomitant medication(s) included codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for spinal stenosis. The patient experienced feeling foggy, couldn't walk/felt like a drunken sailor, that's how bad the walking and gait pattern were, couldn't do any of his work, couldn't take phone calls, couldn't concentrate on 31May2021, 2 weeks after first shot and felt a little weird on an unspecified date. AE(s) did not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included magnetic resonance imaging: spinal stenosis on an unspecified date diagnosed 5 years ago. It was reported, according to the MRI 5 years ago, had supposedly been suffering for over 30 years and they just discovered it 5 years ago. It was reported that, his second dose was scheduled this coming Monday, 07Jun2021. He stated the first 2 weeks between 17May2021 and 31May2021, he was fine and had no side effects, not even a pain at the injection site in his left arm, until 31 May. He suddenly started feeling foggy, couldn't walk- he was walking "like a drunken sailor", couldn't do any of his work, couldn't take phone calls, and couldn't concentrate. He was getting a little better- still had a little trouble walking and still feeling a little foggy. He have spinal stenosis and wasn't sure if that had anything to do with it but said the nurse he spoke to before said she didn't think it had anything to do with it. He wanted to know if anyone else reported that. He also had concerned about the two week delay in side effects. He stated his 29 year old son took the vaccine the same day and had no reaction what so ever. He did not said if his son had concerned about efficacy because of that or not. Patient enquired if he should go ahead and take the second dose. Patient stated at the moment, he didn't had a primary care doctor and he hadn't been to a doctor in over 5 years. He suffered or had debilitating condition, spinal stenosis and he never discussed it by the nurse and it didn't come up on the questionnaire. He still had a problem walking, he can't walk a straight line, it was very strange. He improved slightly, it was all terrible on Monday, he was like a drunken sailor, that's how bad the walking and gait pattern were and he had gotten a little bit better, but it was still a problem. Patient was curious and have concerned about his second dose as he has heard stories from people that the side effects are worse. His concern was as he got a reaction to the first shot, he going to experience on his second shot. The outcome of the event felt a little weird was unknown and for rest of the events it was resolving.

very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021. No follow-up attempts are possible. No further information is expected.

The knee and his neck are still in pain; The knee and his neck are still in pain; sick; his neck had always caused him grief; his energy level increased; Unexpected therapeutic benefit.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old-male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry Date and NDC number: unknown), via intramuscular in left arm on 12Feb2021, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Unknown, NDC number unknown), via an unspecified route of administration in right arm on an unspecified date, as 2ND DOSE, SINGLE DOSE on 05Mar2021 for COVID-19 immunization. The patient underwent a knee surgery in Dec2020. Patient received the Pfizer BioNTech COVID-19 vaccine (30 days after contracting the virus) after testing negative for the virus. Patient mentioned that the virus attacked his joints but did not alter his taste and smell. Concomitant medications were not reported. After receiving the Pfizer BioNTech COVID-19 vaccine, patient stated that some side effects from the virus minimized, improvement was noticed, joints did not hurt as bad and energy level increased. Patient's experience after receiving the Pfizer BioNTech COVID-19 vaccine had been pretty positive. Patient was healing well, but once he caught the virus everything, they did to fix his knee turned bad. Patient had to have a complete knee replacement now because of the COVID-19 Virus. While he was sick, he had just had knee surgery and his neck had always caused him grief, and the virus exacerbated all of that. The knee and his neck were still in pain. After he got the vaccine, some of those effects from the virus had reduced, they were not gone entirely, but there was an improvement. Patient felt an improvement, but he still had residual symptoms from the virus. Pfizer BioNTech COVID-19 vaccine helped alleviate some symptoms from the COVID virus. The outcome of all events was recovering. Investigation Assessment: No Follow-up attempts are completed. No further information is expected.

Pt reported some left arm pain that began about 24 hours after the injection. Assuming it was a typical reaction we provided reassurance and warm compresses. He progressively then expressed that the pain was radiating down the entire arm to his fingers and that he is unable to sleep. He then appeared confused with inability to dress himself, getting lost in the house and not knowing how to get to bathroom. We checked his blood sugar and blood pressure which were at his baseline. He complained of excruciating pain that did not respond to Aleve, Indomethacin, Tramadol or local lidocaine. He described it as knifes in his arm. He did not seem weak but he had no coordination to eat with arm or button his coat. After watching this for 2 weeks with no improvement we went to the emergency room on March 19, 2021. He is uninsured so we were really trying to avoid going in but he was only getting more confused. He was admitted and had several tests listed below without any acute causes found. He was given Gabapentin in the hospital and that settled his pain for the first time in 2 weeks. He was discharged on March 20th as the treating doctor felt he might benefit from spinal tap but was not sure.

I got the 2nd shot 10 am at the store location which is a 3 1/2 hr drive from my house. After the 15min waiting period with no issues. I was able to get in the car and head home. The injections site did not bleed and the nurse didn't need to use a band aid. My wife and I went to an outdoor restaurant and had dinner I came home and everything was fine. I went to bed and when I woke up, I was very lethargic and out of it. Sometime during the day, I noticed my 3 middle fingers on each hand and the middle knuckle on those hands were painful and stiff. On my right hand the middle knuckle was swollen and noticeably large. These symptoms lasted for about a week or two. The pain and swelling in the middle knuckle lasted the longest. I was advised by my doctor I have slight arthritis but it does not prevent any of my daily activities. I noticed several weeks later around the 1st week in May as I would wake up in the morning, a pain would shoot throughout my entire right leg. I would get up and the pain would be gone for the rest of the day, The pain got progressively worse during the first 2 weeks of May. By the third week of May the pain had gotten so bad I could hardly walk. I made an appointment with my orthopedic surgeon with the idea I may need hip replacement surgery. Then I noticed during that 3rd week the pain completely went away. I called to cancel my appointment with my orthopedic surgeon. Around the last week of May and the first 3 weeks of June I would wake up in the morning I would have to run to the restroom because I had a lot of gas and some diarrhea. On the 17th of June my wife and I took a trip and as we walked around the town, I noticed there was something going on with my digestion and we rushed back to the hotel. During this period of time I would have to go to the restroom 2-4 times in the morning and maybe 1-2 times in the afternoon, This was mostly caused by gas with a bowel movement happening in small amounts throughout the day. I've noticed that these adverse reactions are impacting areas the body where I have may have been compromised previously.

I feel dizzy and confuse for few minutes but after I went home I was ok. However two weeks after the first shot I woke up at 2:oo in the morning with the noise in my head. I thought I was going to get a struck and I was no able to sleep after that. I have to wait for the weekend to be over. I make an appointment with the doctor and I get referrals to a cardiologist and a ENT. I got US of my carotid artery both sides with normal results. I had a hearing test and they said I has lost of hearing but in my daily life I have not experience problem with my hearing. The ENT sent me for an MRI of the brain and inner ear but came out normal. Since April 14, 2021 I can not sleep at night because of the ringing in my ear. I spoke with others with this problem after the vaccine and I check on line and learn about others with similar effects and for that reason I am sending this report.

Patient states that when he got the vaccine he did not feel the pharmacist give it to him, so he does not think it went into the muscle. The next day following vaccination the patient had a sore arm similar to what he experienced with the first dose. This sore arm progressively became worse and has not gotten any better since the pain began and it has now been over 3 months since he received the vaccine. Patient has a decreased range of motion and experiences severe pain that lasts approximately 2 minutes anytime he moves his shoulder. He states his quality of life has diminished because daily tasks like putting on a t-shirt are very painful and the chronic pain meds that he already takes regularly do not help. He mentioned the shoulder pain during a virtual pain management visit today and the nurse practitioner suggested that he may have bursitis due to where the vaccine was injected. I recommended the patient follow-up with his PCP for the possibility of being referred to physical therapy.

No adverse events reported but patient previously received two doses of Moderna on 2/14/21 and 3/15/21 at a different pharmacy. He wasn't aware that he was already fully vaccinated. He asked for and received first dose of Pfizer on 6/25/21 and we discovered that he shouldn't have when he came in for his 2nd dose of Pfizer. Patient reported no side effects or issues. However, he was very confused.

May be a coincidence, but symptoms began an hour after the 2nd vaccination, and I have no history of sciatica. An acute sharp pain started in the left hip, radiating down the front of my to the left ankle. The best diagnosis at the moment is sciatica due to Left L5 radiculopathy. Treatment sought at urgent care facilities, then a specialty sports injury and orthopedic clinic. Treatment in each case was a course of prednisone and methocarbomol, and physical therapy. Three months in, the pain is reduced, but still prevents a number of common activities, like driving. Physical therapy continues, and more tests are scheduled.

Severe pain on surface of skin. At first, it felt as if my muscle was rip from my rib cage. Then the pain moved to my lower left chest. Doctors did an EKG and various blood test but could not pinpoint source. The same symptom moves to my left upper arm, then move to my upper abdomen. Now it is in both arms towards wrist, which is causing severe shales in both arms. In all cases my flesh is sensitive to touching, and the recovery times was an average of 3-to-4 weeks. I am active person, and now this ailment which seems like some nerve damage, is crippling. I can only link these symptoms to some byproduct of the vaccine.

My husband attempted suicide by overdose - he emptied out his medicine tray by taking all the pills - Paramedics came out he refused transport on the day of the overdose - and they left. My husband was home with our children and one of the children had a psychotic episode - I had been at the hospital on Tuesday afternoon with my child. My husband was against getting inpatient treatment and he did it (suicide attempt) to get me to try to come home. I came home that night at 10:30. There was no treatment that night. Volunteered to go to detox - Thursday for detox at local hospital - 10:30 morning - he was there until Sunday. I don't know what treatment there was because I was not allowed to visit him. Was transferred on Sunday to a different hospital- and he was there for Wednesday morning - 2 1/2 days - He was talking with a therapist there. As far as I know he had two appts. He is currently - sees his therapist every two weeks and sees his psychiatrist once a month. They have changed his medication - the Risperidone done to 1/4 milligram twice a day. He is trying to get him to stop sleeping all the time. On the past Friday, Medical Center - for chest pain and seizures. They gave him fluids by mouth - no IV fluids. It took them about 24 hours to get blood out of them - they had to get him hydrated enough for that. He's not moving much - he still sleeps most of the time.

Next day air headed (zombie like); Hives around vaccine entry left arm to arm pit; Hives at armpit and lower rib cage above stomach; hours after falling asleep repeatedly; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), SUPER BETA PROSTATE and multivitamin from an unspecified date for an unknown indication. The patient was allergic to amlodipine (MANUFACTURER UNKNOWN) and oxybutynin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 14:00, the patient experienced falling asleep repeatedly. On 29Mar2021, on the next day of vaccination, the patient experienced air-headed (zombie like) and hives around vaccine entry left arm to arm pit and lower rib cage above stomach was seen at bedtime. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event hours after falling asleep repeatedly, air headed (zombie like), hives around vaccine entry left arm to arm pit and hives at armpit and lower rib cage above stomach was recovered on an unspecified date 2021, at the time of this report. No follow-up attempts are needed. No further information is expected.

Pericarditis, moderate to severe chest pain, treated with 200mg Ibuprofen TID, currently out of work due to continued nausea, headaches and feeling light headed.

Her father is scared either way; Her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's daughter). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 28Jun2021 (at 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included had multiple health conditions and concomitant medications were not reported. Reporter calling about her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use. Caller stated that her parents got their 1st dose of vaccine on 28Jun2021, however, they were informed on 02Jul2021 that the vaccines were expired (start date 28Jun2021). According to them, the vials was supposed to expired in Aug2021, but the vial has been stored in the fridge for 38 days and you're not supposed to use it after 31 days. The vaccine shot that was in the refrigerator for 38 days was still given to reporter's parents. The patient (her father) was the very concern and had multiple health conditions and was afraid of allergic reactions. The patient wanted to make sure that if he doesn't get revaccinated, he was still protected. The patient was scared either way on unspecified date. Reporter wanted to know if they should be revaccinated or to resume the vaccination series as scheduled or was it safe to use the 38 days; and let's say they want to get revaccinated and decided to go for the full MODERNA series instead of Pfizer because they fear getting Pfizer again since they already got one shot, what was the data Pfizer have on people getting one shot of something and change to a different COVID Vaccine. Information on lot /batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021865048 same reporter/drug/AE, different patient

I have begun to experience covid symptoms, achy; Fever; Tired; No appetite; Cough; Cant sleep on 10Jul2021 for 3 days now; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 11May2021 17:30 (age at vaccination: 68-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive other vaccines within 4weeks prior to vaccination. Patient had received other medications within 2 weeks prior to vaccination. Patient had no allergies. Patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as (age at vaccination: 68-year-old), as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. On 10Jul2021 the patient experienced I have begun to experience COVID symptoms, achy, fever, tired, no appetite, cough, can't sleep on 10Jul2021 for 3 days now. The outcome of the events pain, pyrexia, fatigue, decreased appetite, cough, insomnia was not recovered. No follow-up attempts are needed. No further information is expected.

Sedation, Myalgia, Fever, extensive fatigue, low grade fever, and myalgia reported Narrative: Employee needed to leave work second to symptoms

01-09-2021 Very confused, nauseous, sweating profusely. sent to hospital- admitted with encephalitis, severe cognition decline. 01-13-2021 still in hospital, cognition Improved.

low grade headache; minor disorientation that continues to persist; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, via an unspecified route of administration on 06Jan2021 14:00 at a single dose on the left arm for COVID-19 immunization. Medical history included heart rhythm (heart rate abnormal). Concomitant medication included metoprolol for heart rhythm and an unspecified statin. The patient received the first dose on 06Jan2021, and on 12Jan2021 he experienced low grade headache and minor disorientation that continues to persist. They started on the same day in the morning, unable to provide exact time. The low grade headache was lasting all day. He is scheduled to get the second dose on 27Jan2021 and was afraid of taking it due to these side effects. The outcome of the events was not recovered.

Within an hour of receiving vaccine, left eye became swollen and lids discolored. Feeling of increased intraocular pressure within the eye. Pain inside eyeball. Lids painful to touch. Clear/white ocular exudate extruded from eyeball. In middle of night, eye began "weeping". Seem to decrease pressure within the eyeball. Eye still swollen and discolored but not as painful 01/30/2021 0830.

4 hours after vaccine, developed aching in joints and muscles which disappeared after 1 day. 15 days later, woke up with all the same COVID-19 symptoms he was sufferering from a few months ago: nausea, aching, feverish, sweating, chills, and brain fog. Some shortness of breath. Patient saw me a few days later feeling like he was dying. He was treated with steroids and vitamin C along with glutathione IV treatment. Started to feel better the next day. A week later, felt nearly back to normal.

Left leg muscle and joint soreness. Started 48 hours after injection. Difficulty walking. Unable to. sleep until discomfort mostly relieved with Advil 400mg.

12 hours following the injection I developed a severe anaphylactic reaction including extreme swelling of lips, tongue, soft palate; difficulty breathing when reclined; difficulty swallowing and difficulty speaking coherently. My wife called 911 and I was transported by ambulance to the ER at Hospital. While enroute I was given epinephrine and Benadryl. I was admitted to the hospital overnight for observation. On February 4th I was evaluated by an allergy specialist who ordered a RAST blood test for food allergies since I had eaten shrimp that day. Tests for all food allergies were negative.

9 hours after vaccine, was confused for an hour. Then sudden chill, then blacked out for a few seconds, confused for another 30. minutes. EMTs checks signs -- normal.

Pain/swelling at injection site, low-grade fever, chills, body aches and pains, mild nausea, severe headache, loss of energy, insomnia

I have had continued fatigue and exhaustion, which sometimes are accompanied by sore throat, chills, short term memory issues that seem to come and go depending on the day or time of day. However, more serious the last few days.

Began feeling poorly at 1:30pm as if physically drained; pain in every joint and large muscle group; excruciating light sensitivity/pain in eyes; approx 5:30pm upper back muscles in great pain; then pain in lower body including backs of thighs, scrotum, and anus; approx 6pm stiffness and pain shifted to fingers and toes; by 6:30pm entire body feels dull heaviness/pain/extreme fatigue. Slept less than 2 hours, now 6:45pm.

Almost immediately after vaccination patient started feeling poorly. Lightheaded, dizzy, "just felt weird". Able to drive home but continued to worsen, looking back should not have driven but was not thinking clearly. Feeling terrible once home, throwing up violently, Within an hour of injection started hallucenating, making strange uncontollable noises, "lost touch with reality", reports not being able to move. Wife called 911 and they arrived within 15-20 minutes. Wife reported to EMS that patient had just been vaccinated. EMS administered epinephrine and IV Benadryl. Transported patient to hospital

Patient received his second COVID pfizer vaccine on 2/27 and 10:30 AM. Several hours after receiving the vaccine pt become more lethargic with increased AMS and reached a fever of 103 and came to the emergency room on 2/28 around 3 AM. Pt had a prolonged course of COVID in May 2020. All other infections ruled out and pt now stable. However this is believed to be febril illness post-COVID vaccination

Terrible burning sensation immediately after injection; Weird taste in mouth; Fatigue; Very thirsty; Mouth was dry; a little weak; Has a little anxiety every now and then; This is a spontaneous report from a contactable consumer (patient). A 69 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263, expiration date:May2021), via an unspecified route of administration (on left arm) on 31Jan2021 09:15 (at the age of 69 -years-old), single dose for COVID-19 immunization. Medical history included ongoing chronic kidney disease and asthma. The patient's concomitant medications were not reported. Patient had Sore arm, left arm. Confirmed left arm received the COVID-19 Vaccine. Arm is still sore, but not as bad as the first and second day. Terrible burning sensation immediately after injection. Asked if that was normal. Felt injection going in. Patient had weird taste in mouth, very thirsty, mouth was dry. Could have been nerves because has a little anxiety every now and then. Today can taste blueberries and oatmeal. Almost like taste buds are back to normal. Patient had fatigue after he got home from the injection. Felt a little weak. Subsided for the most part and felt better yesterday afternoon. All the events started 31Jan2021. The outcome of the event vaccination site burning was not recovered, other events are unknown. No prior vaccination within 4 weeks, no adverse events following prior vaccinations.

A short time after getting up in the morning (10 -15 minutes) I felt light headed and unstable on my feet. I couldn't walk or stand without holding on to something, touching the wall, a chair, or kitchen counter top, etc. It looked like everything was moving sideways. I measured my BP and O2; BP = 119/77, HR = 80; O2 = 98%, HR =77. I also felt nauseous and only had a piece bread with butter. I took a Nautamine tablet and slept for about 2 hrs, until 10:30. Things were better, I could move around and back to normal by 2 pm.

Pfizer first vaccine- high fever, body tremors, chills, delirious, oxygen 82 heart rate 130, blood pressure extremely high, ambulance called and he was rushed to critical care ER. He has sepsis, kidney function worsened, on BiPap. He was absolutely fine prior to vaccination. He is still. in isolation Hospital as of the date of this report. May have aneurysm in leg as well.

My reactions were : Mild Injection Site Pain, Tiredness, Headache, Severe Muscle Pain, Some Chills, Feverish, feeling Unwell, Sinus issues and Coughing. Very Erratic and disrupted sleep for Days. The Major Adverse effect is that these Reactions are within the Range of Published and known Effects. I treated them at home with Rest and Some Tylenol, but was not really capable of normal functioning or to be Employed.. But they were Persistent for 6 1/2 Days.... I have spoken to No One who have had the symptoms last this long. It seemed and felt like descriptions of Real Covid or past Influenzas but the symptoms seemed more severe and longer. I have spoken with many who have had real Covid who's symptoms and length of illness were milder... I did contact my Physician to advise of this event.

Each day after second COVID-19 vaccination I had an upset stomach and aches; but was not that severe. However, last night (3/18) the stomach pain and aches got intense and kept me up.

Patient lost memory. Couldn't remember his job, his grandchildren's ages,etc.; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 05:00 PM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included known allergies: mango, no other medical history. No covid prior vaccination. The patient's concomitant medications in two weeks were none. No other vaccine in four weeks. The patient lost memory. Couldn't remember his job, his grandchildren's ages, etc. Adverse event state date/time on 04Mar2021 18:00. AE resulted in emergency room/department or urgent care, hospitalization (1 day). It was unknown if treatment was received for the event. Outcome of the event was recovering. Information about lot/batch number has been requested.

Nausea, chills and hot flashes, Extremely Dizzy, needed help to use restroom. Fatigue lasting for 2 days or more. Slight pain at injection site.

Pfizer-BioNTech COVID-19 Vaccine EUA Felt very speedy, as if had taken some kind of amphetimine. Unable to sleep that night and the next night. Gradually lessened over the next two days.

February 27 some soreness in left arm and a headache. February 28 feeling muscle aches and woke up early (3:30AM) in a cold sweat. March 1 went to work but felt a little 'flu' like symptoms. Got home from work approx 10:45PM went directly to bed. March 2 woke up in cold sweat, with body aches and shivers with fever. Skin hurt to touch and had blood in my mucus when blowing nose. Called out from work stayed in bed only to get up to drink water with Emergen-C. Didn't have any appetite, ate a partial PB&J. I had these symptoms until approx March 12 then I just felt 'foggy'. I didn't feel 85-90% better until March 13 but still had a slight fever and woke up in cold sweat. I went back to work March 15 feeling okay 85-90% but out of shape.

After 2nd vaccine my husband started getting confused. Worse and worse. Had him get a fasting blood draw and was supposed to see his dr the following Monday. His 2nd shot was 2/11/2021. He Died 2/27/2021. Took away my life and husband of 35 years! Would?ve been 70 years old today!

On 4/6/21 @2.30 i had first dose and see no effect,next day (4/7/21) at work from 9am start feeling strange and could not finish my lunch and start feeling like i am going to throw out,I left 3pm and at 3.15 I vomit and next one 4 when i get home ,no tempt,on 4/8/21,felt same way like I am going to Vomit,but no,at late night on 4/9/21 around 11am feel like I am about to vomit,but no and I went to bed,get up on 4/10/20,same way feeling that I am about to Vomit ,but and it look like it is going to come out.Burp comes once a while.It is uncomfortable and worry situation.. What we can do to stop.Vomiting is one of side effect listed on this site Thanks

I became and felt very medicated with glassy eyes. That lasted for four days. During that time, I experienced slight chill for about 30 mins/one day, and headaches off an on for about three days. I also felt somewhat tired - as if I never slept. That lasted about three days off and on albeit I went about my normal activities. For the headaches, I just took aspirin. The rest I let go it's course. I began to feel my real self about the fifth day, and then everything was fine.

Client verbalized feeling hot and flustered. Client denies other symptoms. Client seen and assessed by EMT and VS are BP 150/98, HR 74, O2Sat 98%. Client verbalized that he was ok and felt no need for further evaluation and cleared to go home by EMT.

slight headache; joints have been really achy; hot and cold; feeling a little foggy; flu- like symptoms; This is a spontaneous report from a contactable consumer (patient himself). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 06Apr2021 at 08:10 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. On 07Apr2021, the patient reported slight headache and stated that his joints have been really achy. The patient also had flu- like symptoms and stated that he was hot and cold, and felt a little foggy. Patient stated that his light Headache started this morning around 9:00 and has eased up a bit. Joint ache started around midnight last night, have eased up a bit and was not as bad as last night. Patient also stated that he got the shot yesterday about 8:00 in the morning and the symptoms have eased up but were not as bad as last night. The patient stated that he was a little foggy this morning and last night he was in bed, so he wasn't sure and feels it more whenever he got up and moves around. Patient stated that when he was lying in bed, he didn't notice it as much. The patient in clarifying flu-like symptoms, stated that achy joints, headache, nothing in the nasal cavity, just all in his body and felt like he's been run over by a truck. The patient stated that he had some extra strength Tylenol, and he didn't know, what he could take for comfort. Caller stated that, he was just wondering if he could take something for the events. The patient queried whether he could use extra strength Tyelnol to treat his side effects or if it would interact with the vaccine. The outcome of the events was resolving for headache, joint pain, feeling hot and cold and not resolved for feeling foggy and unknown for flu like symptoms. 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.

The night after my first COVID vaccine, my Poly Myalgia Rheumatica (PMR) flared up. My joints and muscles hurt so bad I couldn't sleep. I experienced weakness and pain in my neck, shoulders, arms, back, hips and knees. Reported to my Rheumatologist and she increased my Prednisone from 1mg to 10mg. It has not completely eliminated my pain and weakness.

could not remember how to stand; would fall down when trying to walk /He was unsteady; would fall down when trying to walk; made no sense and could barely be understood; so sometimes he does not make sense. Saturday it was exacerbated; peed the bed; This is a spontaneous report from a contactable consumer reporting for 4 patients. This is Report 1 of 4 for reporter's brother-in-law. A 69 years old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on16Apr2021 10:00. Relevant history included Parkinson's with associated dementia, which comes and goes. Relevant concomitant drugs included oxybutynin for bladderwhich had been taking for at least over a year, 'ropinirole' for parkinsons, and modafinil 100 mg for focusing; to help her brother-in-laws brain focus. The reporter stated the patient (her brother-in-law) only had the vaccine on Friday (16Apr2021). He could not remember how to stand, would fall down when trying to walk, peed the bed: callers husband got her brother-in-law up and when he would walk, he would fall down. They got him up and down to go downstairs to breakfast and have coffee. He was unsteady. All of this occurred on 17Apr2021 when they went to wake him up in the morning. The patient also peed the bed. The patient just does not always make sense. On Saturday, he did not make sense. Sunday, he was better and almost everything was back to normal. He was fine on 19Apr2021; he was himself. The reporter stated that the patient (her brother-in-law) has dementia anyways, so sometimes he does not make sense. Saturday it was exacerbated, he would ask what to do next or where the bathroom is and this is all stuff that he knows. The patient still had his appetite, the reporter and her husband always say that when her brother-in-law can not eat or does not ask for food then the end is near. The reporter stated the drug Modafinal worked wonderful, he was great on Friday, and he was wonderful before he got the shot. Relevant test was none. The outcome of event made no sense and could barely be understood was resolved. The outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

sudden onset severe tinnitus, woke me from a sound sleep. has gotten worse since the onset. It is there all the time.

Blood clots; Delirious; Oxygen was down to 80%; Sepsis; E. coli/sepsis with cultures of E. coli; C-diff; sick; Shaking uncontrollably; Achy; Extremely high fever/a high fever of 103 F; Chills; Aneurysm in his leg; Bleeding from somewhere; weak; missed his second dose of the Pfizer COVID-19 vaccine; Caller says her husband's kidney was failing too while he was in the hospital; This is a spontaneous report from a contactable consumer reported for her husband. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 11Mar2021 18:00 (Lot Number: EV6206) as single dose for covid-19 immunization. Medical history included Kidney transplant from 1998, same kidney all these years, on immune medication, polycystic kidney disease from 1998, the transplant saved him in 1998, blood pressure high went along with the polycystic kidney disease, had it for a while, Type 2 diabetes mellitus this was diagnosed probably about four years ago and immunocompromised. There were no concomitant medications. The patient had the first dose of the Pfizer vaccine on 11Mar2021, "he felt okay first evening, Friday was okay, Saturday 13Mar2021 achy, Sunday running a high fever of 103 F, he started to get chills. Then Around 3am (Early Monday on the 15Mar2021) called the ambulance, oxygen was down to 80% he was shaking uncontrollably, temperature was still 103 F when they took it and even at the hospital was the same temperature. He was delirious on 15Mar2021. When he got to Emergency Room he was in critical section, had to put on BiPAP with 100% oxygen, When in the ambulance they tested for covid and was negative each time he was tested for covid he was negative. He was in the hospital from 15Mar2021 to 24Mar2021, in critical care unit. He Turned out having sepsis, E.coli, had to put him on strong antibiotics. He developed CDIFF on 15Mar2021, and an aneurysm in his leg in Mar2021 and needed a blood transfusion. They were trying to rule out blood clots and did sonogram and found it. His blood was going down, he was bleeding from somewhere and had to have a transfusion. They did a procedure on the leg to break up the aneurysm twice. On BiPAP for a few days and then did the medium one and then able to take off oxygen when he went home. He came home on antibiotics and tons of medication. Should he get the second vaccine? Is it related? Is it to late to get the second vaccine? following Sunday he had an extremely high fever and was shaking uncontrollably on 14Mar2021. He was told to get the shot by his provider. She had to call an ambulance, he almost died, and she didn't know if it is related to her husband getting the vaccine. They put her husband on a BiPAP with 100% O2 when he went to the hospital by ambulance and was admitted on 15Mar2021, which he was on the BiPAP a couple days then went on to the second level, then right before he came home he was weaned off of oxygen. They kept testing him for COVID every day, because the symptoms were similar but they tests kept coming up negative. On 15Mar2021, the patient had sepsis, with cultures of E. Coli, and very contagious C-diff, he was sick from the 15th to the 24th for all those things. She didn't know if the vaccine brought it on if it was brewing in him before that, or if it had to nothing to do with vaccine. He also had an aneurysm in his leg and had a medical procedure where they had to go in and take care of it to break up the aneurysm. The patient's kidney was failing too while he was in the hospital. The patient missed his second dose of the Pfizer COVID-19 vaccine due to his hospitalization from 15Mar2021 to 24Mar2021. She would like to know if it would still be recommended for the patient to get the second shot of his COVID-19 vaccination since he is past the deadline to get it, is it going to be too late for him to get the second dose to be fully vaccinated and effective to get it after waiting this long? His first dose was injected about 06:00PM in unknown arm. The patient had a fever Saturday evening, clarified to being 13Mar2021, which was higher the next day on 14Mar2021 and reached 103 degrees Fahrenheit, and he went to the hospital by ambulance at 03:00AM 15Mar2021. His fever started getting higher late Saturday to Sunday and he got progressively worse. The patient had had serious complications before related to his health problems, but she had never had to call an ambulance before this. The patient had chills on Saturday 13Mar2021 and then Sunday evening he was shaking and it wouldn't stop so she gave him Tylenol, then she called the ambulance Monday morning. The patient can't take anything more than Tylenol, and he never usually takes anything. The patient's kidney function was getting bad while he was in the hospital, his Creatinine went high and was 3.8, which is high for someone with a transplant. The patient was doing better, he was still very weak, he was under a doctor's care, he was on very strong antibiotics for a month, Vancomycin and other medications which also make him weak. The patient was on IV antibiotics at the hospital and then came home on oral. The 3.8 for the Creatinine was probably at the beginning when he went into the hospital. The outcome of the event Sepsis was Resolved with Sequel and the outcome of the other events was unknown.

Clinical impression: Dizziness. ED Physician Note; Chief Complaint: Patient presents with Dizziness. History of Present Illness: Patient is a 69 y.o. male with hx of hypertension, anxiety, presenting to the ED with reports of dizziness which began upon waking up this morning. Patient states that he was recently diagnosed with COVID-19 viral infection on 3/19/2021. He states he was primarily tested secondary to a family member having confirmed infection. He states he has not had any significant cough, shortness of breath, fevers, chest pain, or difficulty breathing over the past few days. He additionally denies any dizziness or difficulty ambulating until this morning. He states this morning when he woke up he felt as though he was having an unsteady gait, reports "feeling like I am drunk". He denies any sided weakness, numbness/tingling, changes to his speech, or additional symptoms at this time. He additionally is denying any urinary symptoms, changes to bowel movements, or black/bloody appearing stool. He denies any prior history of vertigo or dizziness in the past. Exposure to COVID-19 virus.

Headache; head felt like it was going to explode/head seemed full; blood pressure was higher; feel like I am racing and I can't relax, like I drank a bunch of caffeine drinks; a red area the size of the band aid/impression of the bandaid was all reddish; still black and blue from vaccine shot/arm was still bruised; This is a spontaneous report from a contactable Consumer or other non health professional (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EL3247 and expiration date were not reported), via an unspecified route of administration, administered in arm left on 28Jan2021 at 09:25 as 1st dose, single for COVID-19 immunisation. The patient medical history included prostate cancer from 02Dec2020 to an unknown date, diabetes from an unknown date and unknown if ongoing , blood pressure from an unknown date and unknown if ongoing (blood pressure was higher), blood thinner (anticoagulant therapy) from an unknown date and unknown if ongoing , neuropathy from an unknown date and unknown if ongoing, cholesterol from an unknown date and unknown if ongoing, allergy: trees grass and pollen mold, from an unknown date and unknown if ongoing. Family history included stroke from an unknown date and unknown if ongoing (dad had a stroke 20 years ago). Concomitant medications included insulin aspart (FIASP) at an unknown dose, daily (sliding scale dose; take with meals by injection daily) for diabetes (taking 8 years) from an unspecified start date and ongoing; insulin glargine (LANTUS, injection) at 14 mL once daily by injection for diabetes (taking 8 years) from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) at 100mg/12.5mg once daily by mouth (orally) for blood pressure (taking for 8 years; added the HCTZ 3 years ago; no product to provide information for the old product, added the HCTZ to his Losartan product about three years ago. He has none of his old Losartan product to provide NDC, lot or expiration date) from an unspecified start date and ongoing; pentoxifylline at 400mg three times daily by mouth (orally) as blood thinner (taking 4 or 5 years) from an unspecified start date and ongoing; gabapentin at 400mg three times daily by mouth for neuropathy (taking for 5 years) from an unspecified start date and ongoing; atorvastatin at 10mg once daily by mouth for cholesterol (taking for 5 years) from an unspecified start date and ongoing; Align Daily Probiotic Supplement at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing; calcium at 500mg twice daily by mouth for an unspecified indication from an unspecified start date and ongoing; aspirin (acetylsalicylic acid) at 81mg once daily by mouth for an unspecified indication from an unspecified start date and ongoing; fish oil at an unknown dose for an unspecified indication from an unspecified start date and ongoing; vitamin D3 at an unknown dose for an unspecified indication from an unspecified start date and ongoing, multivitamins at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing, and products allergy shots at an unknown dose by injection monthly for allergy: trees grass, pollen mold from 1994 and ongoing. On an unspecified date in Jan2021, the patient experienced headache, head felt like it was going to explode, blood pressure was higher, feel like I am racing and I can not relax, like I drank a bunch of caffeine drinks, a red area the size of the band aid/impression of the bandaid was all reddish, and still black and blue from vaccine shot/arm was still bruised. The clinical course of the event was reported as follow: the patient received 1st dose of the COVID vaccine last Thursday, 8 days ago (as reported), he got headaches, and he inquired how long do they last. Headache started a couple days after, his head felt like it was going to explode, his blood pressure was higher, base line was 120/70 - 130/75, it went to 150/. The doctor turned off the light and it went to 130/. He had not had it that high in a long time, his dad had a stroke 20 years ago and inquired if all of this related to the vaccine. He felt like he was racing and he could not relax, like he drank a bunch of caffeine drinks. This started just after getting the vaccine, could be a coincidence, but could be something else. He got an allergy shot today at 10:00 am eastern time, in the arm where they did the vaccine. It was still black and blue from vaccine shot, the band aid the person put over it, he asked if he was allergic to latex. He reported that where the band aid was, it was a red area the size of the band aid. He questioned that there was latex in his vaccine or was this due to the band aid, making a red mark after he had taken off the band aid for 7 days. Going to healthcare professional on Monday (as reported), he talked with his medical assistant and set up an appointment. He also inquired if increased blood pressure was side effect and how long did it last. The patient mentioned he asked his son who was a pharmacist and he did not know the answer to his question about his headache. Patient stated his head seemed full and now after a week he still had a headache. He added it felt like his head was going to explode. It was still there but better now but it came and went. His blood pressure was up too. Usually, it was only 130 at the top but now it was 130 to 150 on the top. Added he felt like he was racing all the time and could not relax. He was unsure how long after the vaccine he noticed these effects but stated it had been going on for several days. He was scheduled to get the second dose 18Feb2021. Patient went to get his allergy shot today (as reported) and when the nurse went to do the shot, his arm was still bruised and where they put the bandaid over there was an impression of the bandaid was all reddish. No events required a visit to physician or ER (emergency room). No prior vaccinations (within 4 weeks) were reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none.The outcome of the event headache was recovering, outcome of the event head felt like it was going to explode was unknown, and outcome of the other events was not recovered. Follow-up attempts are completed. No further information is expected.

After doing routine activity on May 4, cutting grass and then playing Pickleball, on morning of May 5th woke in extreme debilitating pain in hands, arms and feet and lower legs. Went to ER but they found nothing. Also had issue with stomach that may have contributed to 10 pounds of weight loss in April that started after 2nd vaccination. Went to ER on May 19th to try to assess issues with pain, found nothing. Entered Hospital on May 21 to have neurologist evaluate issue. Nothing found. Dr. advised to report this issue to you.

Feeling down a little bit emotionally; Soreness in the left arm, where he received the injection; Persistent fatigue that becomes overwhelming at times, feeling tired, periods of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 18May2021 (at the age of 69-years-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient experienced soreness in the left arm, where he received the injection, having persistent fatigue that became overwhelming at times, felt tired, felt down a little bit emotionally, periods of exhaustion out of the blue which were periodic, not all the time and the events had gone for probably 5 to 6 days. The events were assessed as non-serious. Patient reported that he will receive the second dose on 03Jun2021 or 06Jun2021, (earlier than the recommended 3-week period) and he asked if he should wait for side effects to resolve before receiving the second dose. He also provided his prescribing physician's information. The outcome of the events was unknown. Information on the lot/batch number has been requested.

stomach was upset; stomach nauseous; Felt out of sorts/ didn't feel right/ flipping and flopping; Really bad headache; very tired; Poison Ivy; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0171), dose 2 via an unspecified route of administration, administered in arm right on 01May2021 as single dose for COVID-19 immunisation. Medical history included pulmonary embolism shower, cholesterol and arthritis. Concomitant medication(s) included rivaroxaban (XARELTO) 10 mg 1x/day taken for pulmonary embolism from 2013 and ongoing; simvastatin 40 mg 1x/day taken for "to keep my cholesterol under control" from 2010 and ongoing and oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) taken for Arthritis (and because of the blood thinners he could not take any other NSAIDs) from 2013 (started taking it right around time he got on blood thinners) and ongoing, 325 mg/5mg, 2 pills a day, sometimes less and sometimes more depending on his pain levels. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0153), administered in right arm on 01Apr2021 as single dose for COVID-19 immunization and Zithromycin topical. The patient neither receive any other vaccines on same date of the Pfizer suspect nor within four weeks prior to the first administration date of the suspect vaccine. The patient reported that he had COVID like symptoms after getting his second shot and was taking prednisone along with the shot after going to urgent care for poison ivy. The patient wanted to know if this would be an adverse event. The caller was also taking Zithromycin topical. On 05May2021, 4 days after the vaccination, he went to urgent care where he was told he had poison ivy. Urgent care started him on Doxycycline and Prednisone. The prednisone was tapered from 60mg for 4 days, 40mg for 4 days and 10mg for 4 days. A week ago (Saturday), his niece visited him and they hugged and stuff. The patient's niece was not vaccinated. They sat outside. On 27May2021, the patient started feeling very tired, his stomach was upset and was very nauseated. The patient further reported that he was doing yard work a week ago this past Thursday and he thought he didn't feel right so he took shower and laid on couch in the dark all day. He stated that his stomach was nauseous, he felt out of sorts, he was flipping and flopping. That night he went to bed and woke up with a really bad headache to the point of where he thought of taking pain medication for the headache. He never had a fever. The patient did not want to take any COVID tests if it were to come back positive because he heard about the baseball players getting the Johnson and Johnson shot and having COVID and not having any symptoms and one of them had symptoms, but it only lasting for a day or two. The patient's brother-in-law and sister, who he lives with, also received the vaccines and were fully vaccinated at the time of his nieces visit and were in close proximity to niece. They didn't had any effects from hugging her so that was why he thought maybe it was related to him taking prednisone. The patient did not require a visit to emergency room but required an urgent care for poison ivy. There was no family medical history relevant to events other than brother-in-law and sister-in-law didn't have any side effects after hugging niece. The patient did not undergo relevant tests. The outcome of the event stomach nauseous, feeling abnormal and really bad headache was resolved on 28May2021; while Poison Ivy, very tired and stomach was upset was unknown. The patient thought his symptoms (stomach nauseous, felt out of sorts/ didn't feel right/ flipping and flopping, really bad headache, very tired and stomach was upset) maybe related to the Prednisone. Follow up attempts are needed. Further information has been requested.

COVID 19 antibody test result was less than 1.00 units index/ negative antibody test; His Lipase level also has gone up to 231; extreme fatigue; not being able to sleep; his blood sugar dropping to the 50s when he's diabetic; This is a spontaneous report from a contactable nurse (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 07Jan2021 at 10:00 (at the age of 69-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history included diabetes mellitus type 2; kidney stones from 7-8 years ago, the most recent kidney stone had to be surgically removed a year ago (2020); hypothyroidism, depression, and prostatic hypertrophy. Concomitant medications included levothyroxine sodium from 2001 for hypothyroidism, venlafaxine hydrochloride (EFFEXOR) from 2006 for depression, tamsulosin from 2017 for prostatic hypertrophy; metformin from 2015 for diabetes mellitus type 2, which were all ongoing; and other unspecified medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 at 08:00 (at the age of 69-years-old) at 1st dose, single dose for COVID-19 immunization. He also previously received flu vaccine on an unspecified date in 2020 for immunization and experienced body aches. On May2021, 2 weeks ago, the patient noticed extreme fatigue, which was not enough for him to be immobile, but he felt like a wet noodle. He was able to function and see patients, but it takes it out of him. There was no correlation to time of day or activity. The fatigue just comes and goes. He was also unable to sleep on May2021. He had a lab test on 19May2021, where his COVID-19 antibody resulted in less than 1.00 unit index. The doctor said he never saw an antibody response this low and had no idea how to interpret it. The patient did some study himself and was still unsure what that means. He was asking for information about the antibody results. He then added that as a first responder nurse, he sees oncology patients and was very concerned about having no antibodies to COVID 19. His main concern was the negative antibody test. The patient also reported a new increase in lipase to a dangerous level, it has gone up to 231 (reference level: 60-70) on 19May2021. His last lipase level was in Dec2020, but he was unable to locate the results at this time. He was now scheduled for an MRI of his pancreas on 16Jun2021. The patient also noticed his blood sugars dropped down all of a sudden when he's diabetic on an unspecified date in 2021. They were 50 to 70 or 75 (2021) and this was asymptomatically. He collected his blood sugar result and checks it a dozen times a day. It has no relation to food. His two-hour postprandial can be 80 (2021) and then it drops back down. His A1C was good (2021) and there seems to be no explanation from the labs. The patient went to his doctor on 27May2021 in response to the events. The outcome of the events "extreme fatigue" and "not being able to sleep" was not recovered and unknown for all other events. The events "extreme fatigue", "not being able to sleep", "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test", and "His Lipase level also has gone up to 231" were reported as serious, medically significant. Relatedness of the events "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test" and "His Lipase level also has gone up to 231" to the drug was stated as related and unknown for all other events. Information on lot/batch number has been requested.; Sender's Comments: The events "extreme fatigue", "not being able to sleep", "COVID 19 antibody test result was less than 1.00 units index/ negative antibody test", "His Lipase level also has gone up to 231", and "blood sugar decreased" are likely due to underlying medical condition and are unrelated to suspect product BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

Where he got the injection he was sore for a day or two; Ears were stopped up, they would not pop, having a little trouble hearing; feeling blah; Headache; Arm soreness; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265 and Expiration Date not reported) via an unspecified route of administration, administered in Arm Left on 02Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included coronary artery disease from Oct2016 and ongoing. The patient concomitant medication included apixaban (ELIQUIS) start date is unspecified and Unspecified Stop Ongoing, atorvastatin (LIPITOR [ATORVASTATIN]) start date is unspecified and Unspecified Stop Ongoing and acetylsalicylic acid (BABY ASPIRIN) start date is unspecified and Unspecified Stop Ongoing. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248 and Expiration Date not reported) via an unspecified route of administration, administered in Arm Left on 08Jan2021 as DOSE 1, SINGLE for COVID-19 immunization and experienced sore in arm. The patient received second dose of the COVID Vaccine on 02Feb2021, last Tuesday. The patient yesterday at about 4PM experienced got a bad headache and want to know can that be a side effect 5 days later. He also said that where he got the injection, he was sore for a day or two. Caller clarifies that this was with the first and the second dose. On the second or third day after his second dose, his ears were stopped up like when you fly on a plane and they would not pop. He has never had any trouble with his ears, but he could not get them to pop that day. He was having a little trouble hearing. The next day he was fine and asked that could that be side effect. Caller stated that he was already feeling much better right now on the phone. He is unsure of specific dates. He also felt like he was about to feel bad or about to get a fever. He never took his temperature, but he did not feel like it he had a fever. Just that maybe one was coming on. He just felt a little blah. All of those (the ears and the feeling blah) last about a half day. He has recovered completely from those. Again, he felt a little better right now, but he still feels kind of bad. Talking on the phone makes it hurt a little bit. Yesterday he felt great, went for a run at about 2 pm in 30 degree temperatures. He felt great. Then 2 hours later, suddenly, the headache hit him. He has overall improved. The patient also read somewhere that should not take Tylenol before the vaccination to prevent headaches/anything because it could interfere with your immune system and asked that was that right. On an unspecified date, the events where he got the injection, he was sore for a day or two, ears were stopped up, they would not pop, having a little trouble hearing, arm soreness, feeling blah was resolved. The outcome of headache was resolving. Follow-up attempts completed. No further information expected.

Slight fever (99,5) and pain at injection site after second shot. Both resolved quickly and not of concern. However, perhaps 5 days to a week after first injection began to have skipped beats with great regularity. I do have a history of these, but not with such regularity. At first I thought they were from indigestion but they have been very consistent and frequent for the past 5 weeks and am now concerned . On three occasions I had so many of these palpitations from skipped beats that I could not sleep and needed to take lorazepam (which helped). One of these incidents was the day of the second shot accompanied by slight fever and small elevation of heart rate. My HR is slow, 43-49 when sleeping (smartwatch) and often below 50 when resting. I will often have these skipped beats several times per minute and THAT is unusual. And disturbing. So far, have not noticed them significantly during exercise (running et al...).

Random severe muscle joint tendon pain. Extreme fatigue. Brain fog. Episodes of serious chills despite ambient temp in the 90s. Fine one day, next day can barely walk. Attempt to exercise beyond easiest levels will result in the 1 or more of above 1-2 days later. Depression. No problem with lungs, breathing. Times of elevated heart rate and / or low oxymeter readings (89-90 where 92-94 is expected) I want to think I'm getting better, but then this morning another chills and fatigue episode motivated this report. Ps as a longtime serious cyclist, I know how to suffer all kinds of setbacks. I know how my body responds to various exercise loads.

Transient ischaemic attacks; memory was shot; balance, cognitive abilities were greatly reduced; confusion; loss of balance; memory loss; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 69-years-old) at 09:15 as first dose, single for Covid-19 immunization. Medical history included staph infection in his heart in Dec2014, obesity, onset date: Whole life or within the last 10 years, blood pressure. Concomitant medication included carvedilol and lisinopril both taken for blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced transient ischaemic attacks.It was reported that patient had adverse reaction neurological, similar to TIAs after the first dose. On 11Mar2021, the patient experienced memory was shot balance, cognitive abilities were greatly reduced (they stayed reduced for weeks and weeks, gradually he began to remember things, very gradually, his cognitive abilities became gradually better, he was still not back to normal, but it was subtle at the time of reporting), confusion, loss of balance, memory loss. Patient went to emergency room the next morning and side effects continued for weeks. The patient underwent lab tests and procedures which included computerized tomogram head: nothing new on an unspecified date. The outcome of event memory was shot, cognitive abilities were greatly reduced, confusion, loss of balance, memory loss was recovering while the outcome of event transient ischaemic attacks was unknown.

Daily morning queasiness with trembling, weakness, diarrhea and anxiety that disappeared by 10:30am. It lasted for 10 days and never re-occurred.

Was so ill after took the Covid shot; has been so ill and feeling so bad since taking it; Did not feel good; This is a spontaneous report form a contactable consumer (patient). A 69-year-old (also reported as 69 1/2 years old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 69-years-old, via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:00 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunization. Medical history included 2 unspecified cancers that was why his doctor told him to get vaccinated. No family history. There were no concomitant medications. The patient stated that he had gone back to the doctor and because he was so ill/ did not feel good after he took the Covid shot. He has been going back the doctor and they told him to call Pfizer because there was nothing else, they can do. Literally that shot just about killed him. He has been so ill/not feeling well and feeling so bad since taking it. His life was literally destroyed, and he does not know where to go or what to do. He has also sent an email to the website and has not heard anything back. Again, stated he does not know what to do because he has symptoms. Does not clarify symptoms had. Has had a CAT and PET scans and bloodwork and he knows his body. He was almost 70 years old and after taking this shot, he has been down for the count. Does not know what else to do and called to ask Pfizer what else he can do. His doctor advised him not to get the second dose. He had 2 cancers in past before Covid shots and with his immune system was told by doctor to get it. No other vaccines given the same day or 4 weeks prior. No history of problems with vaccines in past ever. The events resulted to a visit in a physician office. The outcome of the events was not recovered.

Headache; Chills; tension around the chest/ heart; Nausea; felt uncomfortable; Confused; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 02Jan2021 at 13:02 at single dose in left arm for covid-19 immunization. Medical history included ongoing prostate disorder, ongoing blood pressure abnormal, ongoing cholesterol abnormal. Concomitant medication included tamsulosin 4mg tablet once a day by mouth for prostate disorder, losartan 50mg tablet once a day by mouth for blood pressure abnormal, atorvastatin 20mg tablet once a day by mouth for cholesterol abnormal; all ongoing. The patient experienced headache, chills, tension around the chest/ heart, nausea, felt uncomfortable, and confused on 02Jan2021. Event details: The patient reported that he took the vaccine a few days ago, on 02Jan2021, he felt uncomfortable and a lot of things were going on. He clarified that he experienced headaches, light chills, tension around the chest/heart, nausea and disconnect. He felt like something was going on with his brain. He felt uncomfortable with himself. He asked himself if these were his eyes and states he was confused. He put his car in reverse when he was supposed to be driving forward, stated the curb stopped him. He did not feel totally like himself. His lady said he was normally like that but he felt there was something heavy, totally different. He did take a covid test about 3 weeks prior to getting the vaccine, the result was negative. The patient underwent lab tests and procedures which included covid test: negative in Dec2020, weight: 190 to 192 pounds on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Dizziness, Tachypnea, NauseaVomiting, HYPERtension, no other events occured Narrative: Employee c/o dizziness and nausea after 15 minutes of sitting, and then using the restroom. Sits back down and vs obtained. b/p 212/128 manual and machine. pulse and o2 normal. Patient continues to feel poorly, wants to lie down. Patient tachypneic, with some SOB. Has high b/p baseline, but says he took his b/p meds this AM. Hasn't had reaction to vaccines previously. Epi administered and 911 called, as patient agrees to this. A&O,pleasant and anxious. Transport to hospital for eval with paramedics.

Narrative: Patient seen in ED 1-17-21 with c/c of "bloated with epigastric pain". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been "feeling kind of bad all day". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report.

Pt had numbness and tingling in arms after vaccination. No treatments given besides monitor for 1 hour and tingling went away. No difficulty breathing, swallowing or chest pains. Vitals normal with slightly elevated (168/78) blood pressure which he stated was normal because he felt anxious. Sats 98% on room air, RR 16, HR 68. He was comfortable and wanted to go home after an hour of observation and tingling resolved .

Patient's wife called reporting finding her husband in bed and he was shaking and not able to move. Altered mental status. Temp 102 B/P and blood sugar within normal limits. 911 was called for patient and he was transfered to the ER.

HE received his vaccine and was in the post vaccine area for approximately 10 min. The paramedic and I looked up and noticed a sudden change in mental status- dropped his phone and started making slight grunting noises as well as turning pale. We rescued the patient, got the stretcher and he became lucid. His activity was seizure like (petit mal). I called the ED charge nurse, provided report, and the patient was transported via paramedic X 2 to the ED for an evaluation.

Got shot at 8am 22 Jan. Slight soreness in arm developed later the same day, but no problem. Everything was normal and went to bed. Woke up approximately 2-3 h later with extreme vertigo, dizziness, imbalance, completely clogged left ear, tinnitus in left hear and nausea. Within about an hour I was hyperventilating and had cold tingling sensation in hands and feet. About 2am went to hospital. They did a bunch of tests including a CT scan which revealed nothing adverse. They kept me over night and gave me an MRI the next morning. Again nothing adverse found. I was released that next day with orders to see PCP. Got an appt 2 days later. PCP immediately started me on Prednisone and referred me to ENT doctor. Got an audio test 2 days later and because of the severity of my symptoms (sudden, acute tinnitus and complete hearing loss in left ear) ENT prescribed higher dose and duration of prednisone. I am on day 5 of the 24day course prescribed by ENT with no appreciable improvement. Still have no hearing in left ear and tinnitus, imbalance and trouble focusing and walking. No causal link has been ascribed to the vaccine, but I am terrified of having the booster shot which is schedule for 12 Feb.

Starting the second day after the shot, I experienced deep anxienty and depression symptoms. I suffer from this on a regular basis and have dealt with this since 1974, but this was the worst I have had in many years. It lasted for two days and then today it has cleared. There is no other reason why I would have this except for the vaccine. I am OK now and did not contact anyone about it. I wanted to report this because I did not see it on the list of side effects and it would be nice for others to know it was coming. Please feel free to contact me if necessary. Thank you for getting me the vaccine and keep up the good work.

Fever (chills), body ache, nausea and generally feeling bad - Extreme on the first night (couldn't get out of bed.). Lessened the next day.

EMS reported around 3:30 pm, patient started not feeling right. He had some tingling sensation in his left arm. Per family patient had slurred speech was not acting right. He did slide out of the chair he was sitting in. He was ambulatory on scene. Symptoms lasted approximately 5 minutes and then gradually resolved. Upon arrival to the emergency department symptoms had significantly improved. Patient reports he is feeling a lot better. Patient did receive his second covid vaccination 2 hours prior to arrival. His never had a stroke in the past. Patient was otherwise feeling at baseline earlier today. No chest pain shortness breath nausea vomiting diarrhea comes patient fever chills headache.

At times, moderate to severe pain in left arm, left elbow, left wrist and fingers ,At times, a searing, burning pain that comes and goes. Also went into left chest muscles and left shoulder. Kept me awake a few nights after the shot. When pain was bad, little or no strength in left arm.

Patient experienced throat tightness and a chunky feeling in his throat shortly after receiving the 1st dose of Pfizer vaccine. Patient was given 25 mg of benadry with some relief. Patient was sent by ambulance to emergency room and was treated and released. Noted that the emergency room doctor prescribed an epi pen.

About twelve hours after shot (10pm) began to feel uncomfortable. By 10:30pm was shivering with temperature of 101 fahrenheit, headache, sinus congestion with clear liquid running out of nose and nausea. Took two acetaminophen at 11:00 pm. About two hours later, nose stopped running and just had nasal drip. Could not sleep. At 3:30 am (Tuesday morning) nausea subsided. At 10:00 a,m Tuesday still in bed but felt better. Checked temperature and still 101. Continued to take acetaminophen every six hours as recommended. Checked temperature in the afternnon and it was 99. Checked temperature again at 9:00 pm before going to bed and it was exactly 98.6. Decided not to take more acetaminophen. Got up around 3:00 am (Wednesday morning) to use restroom and checked temperature. It was 100.2. Took two acetaminophen and went to bed. That was the last time I registered an elevated temperature. Still feel weak and tired six days later.

Started out as very mild itching just above both ankles but below the knees. Starting on Friday, six days after receiving the shot, the itching was a little more aggressive. I started to use over the counter Hydrocortisone .5% level, which helped. The inching is not severe just agitating .

70-year-old male who presents to the emergency department for evaluation of abdominal pain. The patient was awakened from sleep this morning with severe sharp, stabbing pain in his epigastric region. Pain radiates into his lower abdomen and his back. He associates his symptoms with a bloating sensation. He took omeprazole with mild relief of symptoms. Symptoms recurred a few hours later. States that he became confused and diaphoretic at that time. He called EMS to transport him to the emergency department. The patient was found to have an objective fever at that time. He was given Zofran; Notes COVID vaccine several days earlier; on antibiotics, will need cholecystectomy while in hospital

My right hip starting aching with a dull pain like at the hip joint. It also felt like a nerve was being pinched causing a discomfort down to my ache and foot. Felt like my foot was trying to go to sleep and tingling. This feeling woke me up about 1 am in the morning ( 2/26) and unable to get comfortable to go back to sleep. Cause me to limp , unable to put full weight on the leg. This lasted all night and during the day has improved. It feels somewhat weak, but I can put weight on the leg with a light limp. My foot feels like it has recovered from going to sleep and now has blood flowing, less tingling.

Started feeling a little tired shortly after shot was given. It has been 72 hours since the shot was given and I am still feeling tired like I did right after shot was given. I am a light sleeper and some nights I will toss and turn and get a poor nights sleep. Last night, Sunday 2-28-2021 was that kind of night. As I type this I am not sure if my tired feeling is from the vaccine shot or the poor nights sleep. I can still function as I always do but being sure I don't run myself ragged. I have called my primary doctor and I am supposed to be getting a call back tomorrow.

3-4 days after the first vaccine, pt noticed "shockwave" going down right leg. After nap, when he got up, his legs gave out underneath him. As the day progressed, he fell several times. Has hx of problems with balance and would use cane most of the time but since vaccination, has had to use walker and wheelchair. Pt has pins and needles feeling in hands and feet, numbness, can't grasp papers in hands. Also states has been feeling depressed since vaccination, crying "out of the blue"

severe hypoglycemic event (POC=38)/hypoglycemia; chest pain; He was found driving the wrong way down the highway; no memory of the event; This is a spontaneous report from a non-contactable pharmacist. A 70-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9265) intramuscular, on 01Feb2021 at 08:00 (at the age of 70 years old), for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021, after vaccination, the patient experienced severe hypoglycemic event (POC=38)/hypoglycemia and chest pain. He was found driving the wrong way down the highway with no memory of the event, once stopped by authorities. He was admitted to the hospital with hypoglycemia and chest pain. His home diabetes coverage was an insulin pump and there was denial of decreased PO intake. The insulin pump was stopped once the patient was admitted. His glucose improved and insulin regular SSI was initiated. He was brought for cardiac cath on 02Feb2021 with no new issues seen. The patient was stabilized, was set for follow-up with PCP and endocrinologist and discharged on 04Feb2021. The events resolved on an unspecified date in Feb2021. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Headache and uneasy feeling for 4 days. Occasional chills, then fine for a day then again uneasy feeling in the head also felt congested and with breathing out hot air with dry nose. Thursday 2/25 went for a covid test that showed negative result. Feel normal on 3/3. Tylenol on 2/23 did not help much. Advil evening of 2/25 made me feel better on 2/26 uneasiness returned on 3/1 no chills but headache.

Insomnia,agitation at 11pm 3/4/21 continued until 8am 3/5/21. Myalgia's and arthralgias began 8am 3/5/21 continued until 10pm 3/5/21. Temp to 100F 2pm 3/5/21 until 10pm 3/5/21 Upset stomach 4pm until 11pm 3/5/21 Soreness at injection site Alternated acetaminophen and ibuprofen q8h

Information provided by facility director. Resident told medical provider on 3/3/21 at routine visit that he had not felt right since receiving vaccine on 2/11/21. No specific complaints and no findings reported by provider. No specific complaints reported prior to nurse at facility finding resident unresponsive and breathing at approximately 6AM on 3/5/21. 911 initiated. EMS, police and coroner responded.

18-20 hours following the vaccination, after going to bed, I started experiencing chills, followed by intense, all-over body aches. This was accompanied by either bizarre dreams or hallucinations during the night. When I awoke in the morning I was very unrested and very unstable. My morning coffee did not taste appealing. By 30 hours after the vaccination I had returned to feeling better, albeit with a mildly sore injection site, and was able to return to normal activity. No treatment was sought. No further issues presented themselves.

20 hours after vaccination: significant fatigue, body aches, decreased memory function, severe vertigo, poor balance, significant muscle weakness, tremors

Overall achiness, typical of fever. Fatigue. Slight disorientation. Temperature, however was 98.6 Typically, my temperature is about 97.8

Received COVID vaccine 1/26/21 and 2/12/21, and didn't have symptoms right after vaccine. Symptoms started Wednesday February 2/24/21 - started at 9PM that night preventing him from sleeping. Stated the chest pressure was like something "sitting on his chest". Also had body aches, chills, fever, fatigue, cough, and mild shortness of breath. Found to have heart failure, EF 25%

The night of the 8th of march I slept fine, however the night of the 9th,10th, 11th,and 12th were total insomnia hence very tired and sleepy during the day specially in the evening, the 13th I slept fairly well and by the 14Th, I finally slept great.

COVID 19 Vaccine reaction Pts reports his BP spiked during observation period (within 1 min) for his first dose of the Pfizer COVID 19 vaccine. BP went 180s/80s. Pt experienced lightheadedness/dizziness, felt he was floating. Pt wife felt pt was in distress, pt too 'out of it' per wife to realize how off he actually was . BP returned to baseline with in 1 hour. Pt was unable to drive home.

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on rump x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to the hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

Pt is a 70 year old male who received first dose of Pfizer COVID-19 vaccine on 02/06/2021. Pt describes that he was doing well for a few days after receiving the vaccine; however, on Friday February 12, 2021 pt states he began to feel poorly at dinner. His initial symptoms included back pain, myalgia, and fatigue. Pt got tested for COVID-19 and received positive results on 02/14/2021. Pt presented to ER on 02/15/2021 due to weakness, dizziness, fatigue, and confusion. Pt also reports dry cough, fever, chills, and loss of apetite. Pt was discharged on 02/16/2021 after improvement was observed.

visual blurriness/visual disturbances; headaches; tiredness; muscle/joint aches; muscle/joint aches; dizziness; panic attacks; depression got worse; nausea; fell once, almost fell at least 5 times; visual hallucination; My blood pressure has been elevated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (lot number: EM9810), via an unspecified route of administration, administered in right arm on 11Feb2021 15:00 (at the age of 70-year-old) at single dose for COVID-19 immunization. Medical history included depression, diabetes, arterial sclerosis, panic attacks, high cholesterol/ blood pressure, and enlarged prostate. The patient had no knpown allergies. Concomitant medications included clopidogrel bisulfate (CLOPIDROGEL SANDOZ); clonazepam; tamsulosin; and ramipril. The patient previously received the first dose of BNT162B2 (lot number: EL3247) via an unspecified route of administration administered in right arm on 21Jan2021 at 4:00 PM (at the age of 70-year-old) at single dose for COVID-19 immunization. The patient had no other vaccine in four weeks. Soon after the 2nd shot in Feb2021, the patient started having headaches, tiredness, muscle/joint aches. Three (3) days after it on unspecified date in Feb2021, he started having dizziness, panic attacks, visual blurriness, and his depression got worse. This last week on unspecified date in Feb2021, the dizziness with nausea, the visual disturbances increased to the point where the patient fell once, almost fell at least 5 times but caught himself, panic attacks increased, and on unspecified date in 2021 (also reported as yesterday) the patient had what was almost like a visual hallucination while riding in the car. Still dizzy today. His blood pressure has been elevated on unspecified date in 2021- most likely due to the worry about all of this. He does not know if these are related to the shot or something different is going on. There was no treatment for the adverse events. The events required physician office visit. No COVID prior vaccination and was not tested wih COVID post vaccination. The outcome of the events was not recovered.

My left arm muscle located on underarm between elbow and injection site, halfway between elbow and injection site higher up became extremely sore to the touch and prevented me from lifting my arm to preform functions. Today is much better and function has mostly returned. The reason I am reporting is because I just (jan.29 2021) tore my rotator cuff on right shoiulder and the loss of function is similar. Function is returning on left arm so no worried, the right shoulder will need shoulder replacement surgery. But that was the effect on this adverse event. Loss of function to left arm about 3 days with improvement after 36 hours. Kind of a delayed response, so not sure its related. But I didn't injure the left so probably related.

Woke up from sleep around 1am with uncontrolled shaking, lasting approximately 1 hour. Feeling sore with headache most of next day. Stayed in bed all day with no appetite. Only drank water.. Sore shoulder and neck lasting a few more days. Feeling fine now.

Patient presented and was admitted through the ED for with altered mental status and respiratory distress. COVID positive today. On arrival to ED patient was obtunded, nonverbal and was orally intubated. Patient has history of chronic atrial fibrillation and on arrival to ED patient was significantly tachycardia. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Adverse events: Fever (104 degrees Fahrenheit unresolved by medication) Fatigue Weakness Confusion High Blood Glucose (350) Loss of motor control (shaking, inability to hold posture or to sit, stand, or walk without assistance) Elevated white blood cell count Low blood sodium Lab results indicating liver health were not good Jaundice Treatments: IV saline solution, antibiotics, steroids, increase Prednisone, change intake of insulin Outcome: The patient returned home after a week of hospitalization experiencing less confusion and no fever. Motor function has improved since hospitalization and complexion shows less jaundice. Liver numbers have improved and the patient has decreased Prednisone dose. The patient still experiences fatigue and body weakness.

blood clot formation that went to my brain; stroke; numbness; paralyzed; vision is messed up; trouble concentrating; This is a spontaneous report from a contactable consumer (patient) . This 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, may be EN8199 or EN6199), via an unspecified route of administration on 11Mar2021 at single dose in right arm about 16:00 for COVID-19 immunisation. Medical history included ongoing probably overweight and blood clot about 20 years ago. The patient's concomitant medications were not reported. It was reported that, the patient who was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 11Mar2021. He reported on 14Mar2021 he got a blood clot and had a stroke. He asked if he should or should not still get the second dose of the Pfizer-BioNTech COVID-19 Vaccine related to these events. He had in the hospital from 14Mar2021 to 15Mar2021. He was supposed to have an appointment with his Family Care Physician, Doctor next Monday or Tuesday. He had to go to the emergency room because of these events where he was admitted to the hospital from 14Mar2021-15Mar2021 when he was discharged home under family care. They let him go so soon on 15Mar2021 because he insisted on it, if he was just going to be laying in the hospital he could be laying at home. There was not much they could do in the hospital except observe him, monitoring symptoms of when his numbness and the being paralyzed like in the face for improvement, then they figured the clots were clearing up. They put him on an Aspirin and other unknown things to keep events from reoccurring soon after these events. He was still does not feel 100%, his vision was messed up, he has trouble concentrating, vision was blurred sometimes; that was what happened, he knew he had a stroke when his vision went south on him on 14Mar2021. While in the hospital they did everything except no x-rays; he had CT scan, lots of bloodwork and stuff like that. He does not have further information on those tests or results. The seriousness of the events blood clot formation that went to my brain, stroke, numbness and paralysed was reported as serious (hospitalized). The outcome of events was reported as unknown. Information about lot/batch number has been requested.

Muscle pain that already existant due to skeletal misalignment (neck, back, hips) increased by a lot, making everyday activities difficult: getting out of bed, bending over, turning my head, walking, etc. This started the third day after the shot, and continued until it started to lessen 7 days after shot, now almost gone.

I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I have excruciating hip pain which my Dr diagnosed as bursitis of the left hip; I couldn't walk, sit, or lay on that side; I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed; I'm unable to work at my physical part-time job, and have extreme difficulty sitting for 8 hours for my banking job; It hurts to stand too long; I'm miserable; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 05Mar2021 at11:15 (at the age of 70 years old); (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included stroke, high blood pressure, overweight. The patient has no known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)), ; lisinopril (LISINOPRIL); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); atorvastatin (ATORVASTATIN). Facility in which the vaccine was a Public Health Clinic. No other vaccines were given. Since the vaccination the patient had not been tested for COVID-19. On 06Mar2021 at 18:00 The patient experienced Bursitis, Pain in hip, Unable to walk, Pain, Impaired work ability, Difficulty in standing and Feeling miserable. The events were reported as a disability. The clinical course is as follows The day before, the patient was totally healthy. Day after, I have excruciating hip pain in which the patient's doctor diagnosed as bursitis of the left hip. I couldn't walk, sit, or lay on that side. I have had tremendous pain for two weeks only being able to hobble to the bathroom as needed. Oxycod/Acetamin only barely takes the edge off. The patient was unable to work at his physical part-time job, and have extreme difficulty sitting for 8 hours for his job. It hurts to stand too long. In short, I'm miserable and need help. The adverse events resulted in Physician Office Visit . Treatment given for the events include alternate hot/cold packs, oxycodin/acetamin. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.

fell out of his bed; her brother was incoherent when he was found by the ambulance staff; her brother was very weak at the time he was found; Her brother wasn't responsive in his hospital bed; her brother tried to get up from the floor and somehow wiggled under his bed and got stuck; had lost a lot of weight before his fall.; brother had some health problems recently; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6200; expiration date: Jun2021, via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 as single dose for Covid-19 immunisation. Medical history included hypersensitivity and not feeling well. The patient's concomitant medications were not reported. The patient previously took Aleve and Advil and experienced allergy. It was reported that the patient took his first Pfizer COVID-19 Vaccine on Wednesday, 10Mar2021. On Monday, 15Mar2021, the ambulance staff found the patient, who had fallen on either Friday 12Mar2021 or Saturday 13Mar2021. The patient was very weak and incoherent at the time he was found. The patient was in bed and fell out of his bed. He tried to get up from the floor and somehow wiggled under his bed and got stuck. The ambulance staff estimated the patient was on the floor for 2 days before he was found. The patient doesn't drink, do drugs, or smoke. The patient may have a glass of wine every 6 months. It was reported that there was one time when the patient wasn't responsive in his hospital bed. The hospital staff shook her brother, massaged his hand, and yelled really loud in his ear before he became awake. The patient was discharged to a rehab center on 19Mar2021 and was going to be at the rehab center for 20 days. It was also reported that the patient had lost a lot of weight before his fall. The patient had some health problems recently. The outcome of the events weight loss and general discomfort was unknown. The outcome of other events was recovering. Follow up attempts needed. Further information is expected.

Per triage note of 4/7/2021: "Chief Complaint: pt presents with Nausea & vomitting, ha, body ache, unable to sleep, swollen feet. Symptoms started 3/25 after he recieved his 1st covid vaccine. has had to use a walker and gets SOB. pt had COVID 11/2020" Assessment reveals mild CHF, positive troponin, myocarditis per physician's notes of 4/7/2021 Patient treated with Zofran 4 mg IV and given 500 ml NS IV then Lasix 40 mg IV. Patient transferred to Medical Center 4/7

reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; he noticed his "mental acuity [was] reduced; reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness; He said he also has "drowsiness" which is getting more significant; cut his thumb while chopping asparagus He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had.; ut his thumb while chopping asparagus He added he bled terribly; This is a spontaneous report from a contactable consumer reporting for himself. A 70-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Mar2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer after the second vaccine doses noticed his "mental acuity [was] reduced". He also described/referred to it as: "reduced attention to details, diminished alertness, being cloudy headed, and clouded headedness". After the second dose, this experience was "worst, more significant and continues to get more significant". He explained he drives a large tracker truck for (Company name) and had to take days off work due to his symptoms. He specified the following details post-vaccination with his second dose: Monday night, he was preparing diner around 8 pm and cut his thumb while chopping asparagus. He added he bled terribly, therefore he grabbed a clean paper towel, stanched the bleeding, and had to "seal" the wound with all the white first aid tape he had. He then said he called his physician on Tuesday who returned his call around 5:30 that same day, and who recommended to go to the ER since stiches were needed. He added he resisted to go to the ER because of his symptoms affecting his driving but went upon his HCP's encouragement. He explained once at the ER, the doctor there said he wouldn't recommend stiches since this may seal in the bacteria from the improper dressing he had, which will affect the make the healing period and scaring. He added they cleaned and sealed his wound nicely then they offered a tetanus shot, which he got. He described his thumb as a "flap finger". He explained when driving back home he almost had an accident due to not paying attention to details, which he wouldn't have done in his 40 years of driving experience. He said he also has "drowsiness" which is getting more significant. Events outcome was unknown. Information about lot/batch has been requested.

death Narrative: 70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.

Acute episode of delirium with diagnosis of encephalitis, specifically, Immune mediated encephalitis. Patient had acute confusion beginning 10 days after his second Pfizer Covid Vaccine dose. Extensive work for metabolic encephalopathy was negative. CSF studies showed autoimmune encephalitis. He was treated with Plasmapharesis for 4 days, High dose steroids, 1000mg three day Sina row and then weekly, IVIG and Ritiuxan without any resolve. Patient remains in delirium state. He was initially in hospital in (HOME CITY) then a specialist clinic.

12 hours after the 2nd dose, symptoms were : high temperature (near 104 degrees), extreme fatigue (slept 20 hours out of 24); mild confusion; low pulse oxygenation (83-88 without cpap; 88-90 with cpap); extreme body aches and pain (states he hurt so bad he could hardly move); no appetite. This all lasted 24 hours (fever and pain improved to a manageable level with intermittent tylenor and advil, alternated) and lots of hydration. Fever returned to normal, achiness calmed to more mild, fatigue for another 24 hours.

Flu like symptom; body aches; joint pains; headache; weakness; chills; feeling unwell; tiredness; anxiety; injection site pain and redness; injection site pain and redness; stiffness in legs and fingers; stiffness in legs and fingers; This is a spontaneous report from a contactable consumer (patient himself). A 70-years-old male patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/lot number: EN5318, Expiration date unknown), via an unspecified route of administration in left arm on 04Feb2021 at 15:30 at a single dose for COVID-19 immunization. Medical history included prostate cancer, autonomic nervous system imbalance, arthritis, drug hypersensitivity from an unspecified date and it was unknown if ongoing. The patient had allergies to medications, food, or other products included Keflex, Sulfa, Citalopram, Levofloxin, Nitrofurantoin Macrocrystalline, Alpha-D-Galactosidase, Famotidine, Metoprolol Tartrate, Doxycycline, and Morphine. Concomitant medications included lorazepam acetaminophen, diltiazem, aspirin (acetylsalicylic acid), simeticone (GAS-X) were taken for an unspecified indication. Neither the patient received any other vaccines within 4 weeks prior to the COVID vaccine nor tested for Covid-19. The patient was not diagnosed with covid-19 prior to vaccination. On 05Feb2021 at 12:00, the patient experienced flu like symptoms body aches, joint pains, headache, weakness, chills, feeling, tiredness, injection site pain and redness, stiffness in legs and fingers. The patient did not receive any treatment for these events. The outcome of events was not recovered.

COVID-19 test was positive; COVID pneumonia, COVID-19 test was positive; slight delirium; Arrhythmia; Abdominal pain; hypoxic; achy; myalgia; This is a spontaneous report from a contactable Physician reported in response to HCP letter sent via telephonic follow-up activity. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 12Mar2021 (age at vaccination 70-year-old) for COVID-19 immunization. Medical history included hodgkin's disease (HD) for 7 years, diabetes for 40 years/controlled, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), non-responder to hepatitis B vaccine, dialysis on 05Apr2021 from 6 years, asthma in youth, arthritis, right hip replacement 1 month ago on 20Feb2021 and developed deep vein thrombosis (DVT) and cerebrovascular accident (CVA), atrial fibrillation (Afib) also started at that time in Feb2021. Concomitant medication included carvedilol (COREG) 6.25, furosemide sodium (LASIX) 40, APIXABAN (ELIQUIS) 5mg twice daily, multivitamin, iron twice a day, atorvastatin calcium (LIPITOR) 80 mg, insulin 18 u at night, calcium acetate 667 mg 2 tablets 3 times a day w/meal, famotidine 20mg daily, calcitriol (CALCITROL) took 3 times a week (was on dosing algorithm depending on phosphorous and vit D levels). Past drug history included amlodipine, ibuprofen, lisinopril with reaction allergies, metformin with contraindication to patient on dialysis, not a true allergy and patient previously took first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation. No prior vaccinations within 4 weeks. The patient experienced COVID-19 test was positive, COVID pneumonia, slight delirium, arrhythmia, shortness of breath, tachypnea, abdominal pain on an unknown date, hypoxic on 14Apr2021, myalgia and achy in Apr2021. It was reported that patient in her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed with COVID-19. Patient COVID results were sent to the local health department for genetic sequencing (pending) and SARS titers were drawn (pending). He presented to HD unit with SOB on 05Apr2021 and routine COVID-19 test was positive. He was hospitalized for COVID pneumonia and put on high flow oxygen, he was still in hospital. He came in for dialysis on 05Apr2021 and was very short of breath. Patient reported that the night before they felt myalgia and achy. No fever. Sent straight to the ER from the dialysis unit to check fluid levels and was admitted. He was tested for Covid and was found positive. His oxygen saturation was at 90. Required 2-3 liters of oxygen and next day on 06Apr2021 graduated to high flow oxygen for several days. on 14Apr2021, the patient became more hypoxic and was transferred to ICU. Patient had slight delirium and was not acting like himself. He underwent lab test included respiratory rate (RR) greater than or equal to 30 breaths per minute, heart rate (HR) greater than or equal 125 beats per minute, use of vasopressors to maintain BP, SpO2 less than or equal 93% on room air, PaO2/FiO2 less than 300 mm Hg on an unknown date, dialysis, chest X-ray showed bilateral fluffy infiltrates, covid test positive, CT scan had classic ground glass look for covid, CT of chest w/ contrast and no embolism, white cell count 6.2, hemogolbin 11.2, hemocrit 34.6%, platelet 110, sodium133, blood urea (BUN) 38, creatinine 3.7, brain natriuretic peptide (BNP) 1962, troponin 0.125, albumin 2.9, aspartate aminotransferase (AST) 49, alanine aminotransferase (ALT) 27, Pulse O2 low at 90 on 05Apr2021 and blood immunoglobulin G, blood immunoglobulin M (IgM /IgG) had unofficial result as a titer of 1 on 06Apr2021. He displays clinical signs at rest indicative of severe systemic illness. He came in slightly tachycardic about 120 bpm. Hypotension caused by hospital pulling too much fluid not by disease. No mechanical ventilation needed. Patient required oxygen because O2 saturation was at 90. Required 2-3 liters of oxygen initially and next day graduated to high flow. He was complaining of severe GI distress. Sonogram was negative. CT scan scheduled for tonight. He was on anticoagulation from prior DVT. Patient received treatment with remdesivir for COVID-19 and hydroxychloroquine/chloroquine, azithromycin, corticosteroids, decadron steroid for other events. No immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Adverse events were resulted in emergency room, hospitalization and admitted to an Intensive Care Unit. The outcome of event COVID pneumonia was not recovered, whereas unknown for all other events. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Muscle pain in left thigh and right calf. Tensed muscles.tingling sensation. Most intense around 13 hours after injection. Difficulty falling asleep due to discomfort. Less painful next morning (today) but still uncomfortable and tingling.

brain fog; "tipsy", floor appears to move; difficulty standing; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 15Apr2021 10:45 (Batch/Lot Number: EWO169) as SINGLE DOSE for covid-19 immunization. Medical history included vestibular disorder from an unknown date. Concomitant medications included insulin (INSULIN), lisinopril (LISINOPRIL), acetylsalicylic acid (ASPRIN), lysine (LYSINE), ibuprofen (IBUPROFEN) and simvastatin (SIMVASTATIN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took gabapentin and experienced drug hypersensitivity. The patient experienced brain fog, "tipsy", floor appears to move and difficulty standing on 15Apr2021 10:45. It was reported that the events resulted in Disability or permanent damage. Outcome of the events was not recovered.

left arm hurts real bad occasionally; permanently damaged nerve endings in his ears; it's hard to fall asleep as he hears it all the time; the tinnitus interferes with his hearing/hearing loss; noise in his ears/tinnitus in both of his ears; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6201 and expiration date not provided), via an unspecified route of administration, in arm left, on 17Feb2021 (at the age of 70-year-old), at single dose, for COVID-19 immunization. Medical history included cholesterol issues (not bad) and diabetic type 2, and patient had been taking the same medication for diabetes and cholesterol for 5 years. No prior vaccinations within 4 weeks. Concomitant medications included medications for diabetes and cholesterol. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL9268 and expiration date not provided), via an unspecified route of administration, in right arm, on 27Jan2021 in the morning (at the age of 70-year-old), at single dose, for COVID-19 immunization.The patient experienced the tinnitus interferes with his hearing/hearing loss in 2021; mini stroke; noise in his ears/tinnitus in both of his ears in 2021; left arm hurts really bad occasionally; permanently damaged nerve endings in his ears (treatment received); it's hard to fall asleep as he hears it all the time. Patient stated he had the 2nd vaccine about 2 months ago and a month later he got tinnitus in both of his ears. Patient stated he didn't think it was the vaccine. Patient stated his hearing was perfect but the tinnitus interferes with his hearing. Patient stated it was a month and a half when the tinnitus came on, he woke in the morning and had noise in his ears and thought what was that he must be getting old and found that it didn't do that, it happened in one ear or the other it's never both ears equal amounts. Patient relayed that his left arm hurts really bad occasionally. It's been going on since it was put out with tinnitus and losing hearing since the beginning. Patient stated he contacted doctor about hearing loss and tinnitus and something going on. Patient stated when he lays down he had it too. Patient stated he was assuming the worse and he has permanently damaged nerve endings in his ears. Patient stated he saw a doctor, a specialist for a second opinion. Doctor stated he can't explain either why both ears at the same time and that doesn't work in nature, patient don't lose his hearing in both ears at the same time. Patient stated he had the CT and the hearing test and one doctor said he thought he had a mini stroke and the other doctor said no there would be more evidence of that and can't explain it. Patient stated the medication did it and damaged the nerves. Patient stated it was persisting and annoying, it was day and night and when he was talking he can hear it still and it's very bad. Patient stated it was after 27Feb2021 and he doesn't know the date. Patient stated his ears plug easily and he got them drained and had a hearing test done and he had noise in his ears and then went back to the doctor and was ordered a CT scan. Patient stated he thought it was age and it came on and he didn't know tinnitus doesn't come in both ears at the same time and he did research and found it doesn't, it's never at the same time, it's impossible. Patient stated he was told the CT looked great for his age and doctor said his hearing was real good and both doctors said his hearing was real good and they don't have a reason to explain it. Patient stated he would not take the vaccine if he knew about hearing loss and can't reverse the damage that is done. Patient stated he was not happy his hearing was screwed up and it's hard to fall asleep as he hears it all the time. Patient stated he got a B12 shot and the nerve endings required B12 and the doctor gave him an injection 2 weeks ago and it didn't help. The patient underwent lab tests and procedures in 2021, which included hearing test revealed hearing was really good; CT scan looked great for patient's age. The outcome of the events "the tinnitus interferes with his hearing/hearing loss", "noise in his ears/tinnitus in both of his ears" was not recovered; of other events was unknown.

Initiall extreme exhaustion within about 2 hours. Fell asleep and could not be woken up for about 2 hours. Companion monitored me - respiration normal, pulse normal, mild low grade fever. Woke up on my own after 2 hours and ate dinner. No loss in appetite or taste. Body cranky and restless. Slept reasonably that night. A bit exhausted the following day. Slept well. All symptoms gone second day following vaccine. Average arm soreness for vaccine.

Back started itching then front stomach area and spreed to both side and neck. then hives started appearing. followed by Jagged spots with white ares and jagged round ring. Welt on butt x. chills, on and off. followed buy hot spot ankle side of shins and side of thighs. Went to ER IV Benadryl Took blood sample. Did CBC & Differential. Comprehensive Metabolic Panel. After a few hours the Red color in my forearm started to disappearing. Gave me a prescription for Benadryl and Famotidine 20mg ,Prednisone 50mg. Returned to ER next day as swelling started back up. IV Benadryl sent me home. No improvement. Dr changed to Hydroxyzine 25mg. home no improvement and Most of my body was covered. I had hot spot. Hot spots feet, shins, thigh, fore arms. Put wet towels on hot spots to stop pain and itching. change ever 30 minutes no sleep for days Finally got in to DR he increased the famotidine to 40mg. Around 3am I finally slept, When I woke My lip was swollen and my throat was tight had a lump in it. drank water and ate a cookie. would not clear gaged down the Medication some dissolved before I could get them down. Drove to hospital. They gave me injection in my thigh and IV Benadryl. Added Loratadine and had me get a Epinephrine Pen. Dr increased the medication. Very slowly the welt, and hives started changing to red rash, hot spots and itching continued. only got short sleep during the day and night at times exhausted. coughed several times for minute non stop. Slight fever followed by chills and some shaking. Very nervous at times. As thing started getting better I took some pictures. Could not believe what my body was going threw. March 18 finaly starting to go away getting better skin wise but still cold and hot. Mouth all this time would go from no taste to bad taste. Throw up feeling at times had to fight it off. March 16,17, after I would fall asleep I had very bad pounding headache took Aspirin and Tylenol. after three hours put a wet towel on my forehead. finally let up and was able to sleep a little. the second night same thing except after I went to sleep the towel dropped my core temperature could not get warm took temp 94.4. Turned heat back up to 78 degrees Wrapped upper body as had to keep lower legs in open air with wet towels on hot spots. Stopped taking my Blood Pressure and switch to from Hydroxyzine to (Banophen Diphenhydramin ) The spots are finally getting smaller. Feet are still swollen and are hard to walk on, still have to go everywhere in open slippers and pant legs rolled up. blisters broke on ankle finally getting better. March 20 left foot still swollen and stiff, right foot swelling going down a little. I could not handle filling this out until now. My memory and even my eye site was affected. I had to write it down in case some one asked me. When they asked me I couldnt remember everything. has to look and my notes to remember. Finally got a referral to infectious disease and a allergist.

Got 2nd shot around 11 AM 4/15/21, Went home ate lunch and sat on couch to relax around 1:30. Thought he was just sleeping, tired to wake him up around 4:00. Hard to get awake, words garbled, head was pounding, could not move either arm nor leg. Called 911 Ambulance took him to hospital ER, they ran test listed below and decided to keep him overnight. Thought he may have had a stroke They were supposed to to MRI next mornng, 4/16. He was better and able to finally move arms and legs, did not do MRI let him go home followed up with Dr PCP on 4/19 . Very tired with no energy for about a week after was a little forgetful for a few days. Dr ordered more test, he wasn't sure it was a stroke. had a lingering headache for over a week, finally feeling a little better, still not alot of energy

he had some issue not like headache just mental issue that he didn't feel like in head; he started smoking after again after quitting; This is a spontaneous report from a contactable consumer. This consumer reported for a 70-year-old male patient. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0171 and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 27Apr2021 at 16:27, as a single dose for COVID-19 immunization. The patient's medical history included COPD, Schizophrenia, UTI (took antibiotics), traumatic brain injury (when he was 16 or 17) and indwelling urinary catheter. Concomitant medication included Haloperidol for Schizophrenia, salbutamol (ALBUTEROL) for COPD, Diazepam, Trazodone for sleeping, and Ipratropium (Nebulizer). The reporter (care giver) stated that, the reporter spoke with a gentleman this morning about the adverse reaction that the reporter's partner had, he was nonverbal that's why the reporter was calling to check. The patient had his vaccine in the evening at 04:27, on 27Apr2021. He had around 08:30 quarter 9 and we were driving home around 9 o'clock and the reporter asked to patient that was he feeling weird, and the patient said yes. The reporter asked how the patient feeling weird. The patient said, in his head because he had this problem with his brain from his accident done, it was a little tricky because it was been years to start functioning in a way that he could relate to. The patient felt weird and low and he said his head, so he had some issue not like headache just mental issue that he didn't feel like in head, and he said today that's starting to go away that because the reporter asked him the question so the reporter just wondering if, he suggest when the reporter talk to the man early this morning and reported it. An hour, he took all the medicine he was taking and also his information. The reporter was wondering, he told the reporter to contact him for medical information and he gave the reporter this no to call him and he transfer the reporter and the reporter already too busy. The reporter already been over the phone so, the reporter would like to know if the reporter could help him to move this out of his system if that happen and the reporter would probably ask him not to have the second vaccine. The reporter wanted to know how he feel about that. When the reporter goes off, he was not the happy person actually. The patient started smoking after again after quitting 20 years ago after the vaccine. The reporter also stated that the patient said he was little better. The patient took little bit of Ganja by mouth not smoking it, that he made Ganja medicine and took little bit of that. He was taking it some of the local dispensary CBD and THC. The patient did not receive any treatment for the events. There was not a product complaint to report. There was a medical information request. Information on Lot/Batch number was available. Additional information has been requested.

My last attempt to describe the adverse event timed out in the middle of my responding to the question. To summarize the adverse reaction, I spent the night shivering under many covers and experiencing a degree of body pain that almost had me calling 911. Now I have lingering joint pain, headache, profound fatigue, and brain fog.

According to the client's caregiver, his daughter picked him up the day following his vaccination to drive him to a visit with the his elderly father a few hours away. The client apparently displayed increased confusion and was unable to walk. Care was sought at a nearby healthcare facility and the client was admitted for observation. He was feverish and a chest x-ray showed mild Pneumonia. The client received fluids and IV antibiotics. His confusion improved during this period. The client's caregiver added that, according to a physician's note following his first dosage of COVID-19 vaccine, he had no side effects.

No injection site trauma. No different than annual flu vaccine. Onset of symptoms noticed next morning. Barely able to get out of bed, extreme exhaustion and apparent loss of brain function. Dazed. These continued over the next few weeks, lessening over time. What occurred during that time were aches in different joints.Knees, elbow, shoulder etc. Extremely old injuries were brought back. 3rd week most of muscle and joints aches subsided. To this day there are sudden bouts of lethargy and exhaustion. occasional joint aches but how much of that could be related to old bones. The brain confusion continues. No seeming trigger to bouts.

Episodes of confusion and loss of thought continue, with no seeming trigger.; Episodes of confusion and loss of thought continue, with no seeming trigger.; Exhaustion; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Extreme lethargy and loss of brain function. Barely functioned for 24hr.; Week after shot were days where different joints would ache, very old injuries were brought back; This is a spontaneous report from a contactable consumer (patient). A 70 years old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 23Mar2021 19:30 (Lot Number: ER2613) at age of 70 years old as 2nd dose, single for covid-19 immunisation. Medical history included possible lactose intolerance developing. The patient previously took the first dose bnt162b2 on 01Mar2021 for covid-19 immunization at age of 70 years old and took Flu vaccine for Immunization. The patient's concomitant medications were not reported. No trauma at injection site, no different than annual flu vaccine. Symptoms noticed after second injection next morning on 24Mar2021 07:15. Extreme lethargy and loss of brain function. Barely functioned for 24hr. Week after shot were days where different joints would ache, very old injuries were brought back in Mar2021. To date there are sudden bouts of lethargy or exhaustion. Episodes of confusion and loss of thought continue, with no seeming trigger. Talked with Doctor and was told to monitor conditions. Take ibuprofen as needed. No treatment received for events. The outcome of event Episodes of confusion and loss of thought continue was not recovered; outcome of other events was unknown.

LISTLESS; NO MOTIVATION; TIRED/SLUGGISH/FATIGUE; LIGHT HEADED/WOOZY; OFF-BALANCE/UNSTEADY; FEELING LOUSY; DEPESSED; OVERWHELMING ANXIETY/DREAD; LETHARGIC; EXHAUSTED. STILL EXPERIENCING EFFECTS THOUGH TO LESSER DEGREE. UNABLE TO FOCUS/CONCENTRATE ON WORK ASSIGNMENTS...FEELING OF BEING IN A 'FOG'. WONDER ABOUT THE HOUSE AIMLESSLY.

63 PMH: HTN, multiple sclerosisALL: deniesVS: 96%, HR 54, BP 171/84 (no meds taken today) Symptoms: This is Dose#270yF developed immediate dizziness, heavy feelin in her body and legs. Felt like someone was squeezing her throat but denied difficulty breathing and mouth swelling. She felt slightly disoriented and said she had a recurrence of her speech difficulty which happens with her MS.She refused epinephrine administration for throat tightness but accepted 25mg IM benadryl. Assessment: slightly flushed appearing, complete sentences, coherent, alert and oriented. chest is clear, good air entry bilaterally, no respiratory distress or facial/oropharynegeal edema noted. Heart rate mildly decreased on auscultation. No distress. Treatment: 25mg IM benadryl Patient observed for 30 minutes with symptom resolution and driven home by companion.Repeat vitals O2- 97%, HR- 57, BP - 131/69

Pt was admitted from the ED for altered mental status on 4/5/21 after receiving the second dose of vaccine on 3/31/21. Per guidelines, all hospitalizations are reported.

Gastric issues; Headache; No energy; Pain in the eyes, eye lashes, eye brows; Sensation that the wall is moving away/previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating; Vomiting; Not being able to sleep; This is a spontaneous report from a contactable consumer (patient's son). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown), via an unspecified route, administered in Right Arm on 27Jan2021 09:30 AM (at an age of 70-year-old during vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included hand pain, Diabetes, Sleep disorder, Iron deficiency, Blood pressure abnormal and blood thinner condition. The patient's family history was reported as none. The patient concomitant medication included metformin taken for diabetes from a long time and ongoing, paracetamol (ACETAMINOPHEN) taken orally for hand pain from two or three months and ongoing, lisinopril taken orally for blood pressure abnormal from a long time and ongoing, acetylsalicylic acid (ASPIRIN) taken for a long time and ongoing, atorvastatin taken for blood thinner from a long time and ongoing, cyanocobalamin (VITAMIN B 12) from a long time and ongoing, ropinirole taken for sleep disorder from a long time and ongoing, ferrous sulfate taken for iron deficiency from an unspecified start date and ongoing; insulin detemir (LEVEMIR) injected to his stomach at night daily for diabetes mellitus from a long time and ongoing. The patient was vaccinated at hospital not on other facility. The patient had not received any additional vaccines administered on same date of COVID-19 vaccine. The patient had not received any other vaccine with 4 weeks prior to COVID-19 vaccine. On 28Jan2021, the patient was not being able to sleep since the day of the vaccine. After one day (29Jan2021) he noticed gastric problems/gastric issues, headache on the top of his head, and no energy. His gastric problem gets better in the day and worse at night. He had been vomiting a lot after eating. Also complained of pain in the eyes, eye lashes, eyebrows, and the sensation that the wall was moving away. Added he was previously able to watch TV for a long time, but now after 5 minutes it looked like it was rotating. The patient was scheduled to get the next dose of the vaccine 18Feb2021. The reporter called on behalf of his father and mentioned that his father was diabetic, and he had some questions about his medicine. He wanted to know if the symptoms of his father had after getting the vaccine are related to the vaccine or to his usual medications and what was needed to be done. The patient was neither visited physician office nor emergency room. The patient had not undergone any relevant test and investigation assessments. The outcome of the events was not resolved. Follow-up attempts are completed. No further information was expected.

pain in his left shoulder; this pain "seems to be moving around", "in the tendons of the upper muscles", but generally is "on top of the shoulder".; "cannot put his arm in his sleeve" or "put his arm over his head when sleeping".; his HCP suggested that the vaccination provider may have "hit a nerve" during the injection.; he can't sleep at night; This is a spontaneous report received from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (LOT:EN6201) on 12Feb2021 in left arm for covid-19 immunisation and had no adverse effect. Prior Vaccinations (within 4 weeks) was none. The patient didn't experience anything from the first dose, yet since the second dose he has been having pain in his left shoulder on 05Mar2021. He specified this pain has being persisting for 10 weeks. He added he cannot extend or use his left arm since it caused agonizing pain in his shoulder joint. He explained he therefore cannot put his arm in his sleeve or put his arm over his head when sleeping". He mentioned when his arm is down he is fine. He added this pain seemed to be moving around, in the tendons of the upper muscles, but generally was on top of the shoulder. He went to the doctor and he said at 6 weeks in, his HCP suggested that the vaccination provider may have hit a nerve during the injection. Yesterday he had an X-ray taken because it was almost like it was frozen and the doctor looked at it and didn't see anything wrong, yet he said he still has this excruciating pain. He explained he was recommended to apply an over the counter Bio-Freeze, which does do much for the pain. Patient avoids taking pain killers, like Tylenols, because he is afraid of the side effects that may results from these drugs. He can't sleep at night and he can't move his hand to move it under his head or if he puts on a shirt it is agonizing. No emergency Room. Physician Office visit, said the person that injected it must have nicked a nerve. Treatment included Bio-Freeze (Lot: 800621-66 Expiration: JAN2024), he tried to do that but it had little effect. The outcome was not recovered.

Ringing in ears with pressure; Hard to go to sleep; This is a spontaneous report received from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 14:30 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food or other products. Concomitant medication included simvastatin (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 10702), via an unspecified route of administration in the right arm an 08Feb2021 at 13:30 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 at 16:00, 2 hours after vaccination, the patient got a ringing in his ears with pressure. It was reported that patient ears rang all the time and had not let up yet at the time of reporting. It made it hard to go to sleep and the ringing was 24 hours a day. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the ringing in ears with pressure and hard to go to sleep was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.

The second shot was administered 5/15/21, 7:10PM at right around 3 ;30AM 5/16/21 I was awoken by excruciating pain in my hip and groin of my right leg. I assumed the pain would go away but it has been about 6 weeks now and it only getting worse

has been in bed x16 days; his breathing is worse; he had the weird prickly headache again; he is really having a hard time breathing; tired; has no appetite; the patient said he feels like he has been hit by a big truck.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 16Mar2021 at 12:45 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 23Feb2021 (at time of vaccination 70-years-old), as a single dose for covid-19 immunization and experienced having a hard time breathing; in bed for 8 days and couldn't get out of bed; couldn't hardly eat, and had no appetite; really bad headache, a prickly headache; sweating but wasn't running a fever; really tired; and he was in bed for 8 days and couldn't get out of bed. The patient's medical history included COPD, diagnosed at least 10 years ago; and High Blood Pressure, Diagnosed maybe 15 years ago. The patient's concomitant medications included Felodipine for High Blood Pressure, 5mg once a day; Pro-Air for COPD, 90mcg PRN, Rescue Inhaler as needed, been on for at least 5 years; Spiriva for COPD, 2.5mcg 2 puffs a day, been on for at least 5 years; Breo for COPD, 200mcg one puff a day; and Albuterol for COPD, 0.083% use 1 vial, up to 4 times a day as needed. On 16Mar2021, the patient experienced he had the weird prickly headache again; he is really having a hard time breathing; has been in bed x16 days; tired; has no appetite; the patient said he feels like he has been hit by a big truck; and on an unspecified date his breathing is worse. The treatment received by the patient was started taking Advil a couple of days ago and it is dulling it. States she read that he should not be taking anything right away because the body needs to react to vaccine. States he is using his normal medications and increasing the frequency of his nebulizer. The outcome of event his breathing is worse was unknown and for all other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Malaise, myalgia, fatigue. Began about 4 days after the 2nd Pfizer vaccine. Lasted 10 days. I presumed it to be a viral syndrome but it was atypical and felt strange. It felt like when I had COVID in Nov 2020 but milder and without the respiratory symptoms or loss of smell. It finally resolved after 10 days or so. Later, after reading about the delayed local reactions to the Moderna vaccine, I thought that a delayed SYSTEMIC reaction was also possible. In my best clinical judgement this was a DELAYED SYSTEMIC REACTION.

Pfizer\BioNTech COVID-19 Vaccine On Jan. 27, late in the morning I started to develop a stiff neck which was mild at the beginning, but in the afternoon became very strong that I could not turn my head. It progressed to hurt considerably by the time to go to bed that I had to support my head with a towel around my neck. I took a Flurbiprofen 100mg before going to bed and I had the my neck massaged with Aspercream. I sleep on the sides and moving from one side to the other I had to support my head with my hands. This morning (Jan. 28) the pain went a little down, but looking to the sides was painful. Around noon I took another Flurbiprofen. Tomorrow? Will see. Now, in the evening, the pain slightly increase again and spreading toward the shoulder blades and lower on the spine.

Thirteen hours after the injection there was a sudden onset of joint and muscle pain as well headache. The intensity was severe enough to prevent sleeping for over eight hours. This was accompanied by chills alternating with feeling hot without a measured fever. Six hours after the onset of pain two 500 mg acetaminophen were taken with some blunting of the pain though minimal improvement. After the initial eight hours the pain in in the joints and muscles subsided over about four hours. The headache that was akin to migraines in the past persisted for another six hours and was eventually relieved by two doses of ibuprofen 600 mg six hours apart.

Two episodes of delirium, vomited twice/two times now woke up delirious not knowing where he was; Two episodes of delirium, vomited twice; Got sick; Couldn't get up; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on the right arm on 19Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included liver cancer and chemo. There were no concomitant medications. It was reported that for two times, the patient woke up in the morning delirious, did not know where he was, hollering for his wife, couldn't get up, got sick and vomited, after he got up he felt pretty good. States he fell asleep on couch that night, toward morning he rolled onto floor, flopping around on floor like a wet seal, flopping arms around tried to roll over, pulled muscle in rib cage, after he got back up, got sick and had to vomit. Once he got up and went to the bathroom and all of that went away, wanted to know if this is this related to the Covid vaccine. This morning (unspecified date) he laid on the couch and he was about half scared to lay down because he was afraid something would happen again. The patient confirmed that he experienced this twice the day after or a couple days after the vaccine (unknown date). The patient stated that it has not happened again. The outcome of the events was unknown.

Confusion; General "Don't feel right"; Seizure; Low Sodium level; This is a spontaneous report from a contactable consumer (reported for himself). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration on 27Jan2021 11:15 at single dose in left arm for COVID-19 immunization. Medical history included High Cholesterol; No known allergies. Concomitant medication in two weeks included atorvastatin. Facility type vaccine was Hospital. No other vaccine in four weeks. On 30Jan2021 23:00, the patient experienced Seizure, Low Sodium level, Confusion, General "Don't feel right". The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The number of days hospitalization was 3 (from unspecified date in 2021 to an unspecified date in 2021). It was unknown if treatment received. No covid prior vaccination. Covid tested post vaccination: Nasal Swab tested on 01Feb2021 with the result of Negative. The outcome of the events was recovered on an unspecified date in 2021.

Had a near death one night; crawled from the bathroom to the couch, and his wife would help him walk; blacked out a couple times; Palpitation; Lower Legs started to get numb; Diarrhea; Nausea; Getting itchy, entire body; Weak/Weakness; This is a spontaneous report from a contactable physician (patient) A 71-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3248), via an unspecified route of administration in the left arm on 25Jan2021 at single dose for COVID-19 immunisation. Medical history included seasonal allergy. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (Batch/lot number: EK9231) on 04Jan2021 at single dose in left arm for COVID-19 immunisation and experienced non serious slightly sore arm lasted for 2 to 3 days. On 25Jan2021 the patient experienced blacked out a couple times (serious due to disability, life threatening), palpitation (serious as life threatening), lower legs started to get numb (medically significant) with outcome of recovered on 25Jan2021, diarrhea and nausea (both medically significant) with outcome of recovered on 26Jan2021; Getting itchy, entire body and weak/weakness (both medically significant) with outcome of recovering. The patient has also a near death one night with outcome of unknown. The patient reported that received the second was on 25Jan2021, and about 10 hours later, he started getting itchy, his entire body was itchy, this was all in about 20 minutes, he was weak, then he got diarrhea, nausea, he blacked out a couple times, he had the weakness, then he crawled from the bathroom to the couch, and was afraid and his wife would help him walk, as he didn't think he would make it, he was on the couch with palpitations and was itchy all over, and after an hour he fell asleep, and he came within seconds of going to the ER, the palpitations got worse, and he has no heart problems in the family, but it was a terrible reaction, he didn't think he would make it through the night, and he was not an allergic person, the only thing he was allergic to was seasonal, in the spring time. Also, his lower legs started to get numb in between all that. Started to get itchy 10 hours after the second shot. He was much better the following morning, he just has a little weakness from the havoc on the body. Numbness in lower legs lasted only about 10-15 minutes.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021082193 Same Reporter/Patient, Different Dose of vaccine/Event

sleeping 40 hrs; Severe diarrhea; vomiting; Unable to walk without help; This is a spontaneous report received from a contactable consumer (patient himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Unknown/ not available at the time of report completion), via an unspecified route of administration on right arm on 23Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included liver disease and "chrons". Patient had no allergies. Concomitant medication included paracetamol (TYLENOL). The patient experienced severe diarrhea, vomiting, unable to walk without help and sleeping 40 hrs on 28Jan2021 01:00. Patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The seriousness of the events was reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was reported as not recovered. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.

altered mental status and vomiting after receiving Pfizer vaccine Narrative: This is a 70 y/o male with past medical history significant for end stage renal disease on dialysis, diabetes, diabetic foot ulcer, ischemic cardiomyopathy, hypertension, status post left below knee amputation and severe peripheral vascular disease. He received Pfizer covid-19 vaccine on 1/11/21. Patient's sister reported that on 1/12/21 patient complained he "couldn't think straight; his mind was not there" after receiving the vaccine. Sister also noted patient had vomiting and then became progressively weak. On 1/18/21 (1 week later), the patient was brought to the Medical Center emergency room as patient had "fever, diarrhea as well as cough". The patient has h/o covid-19 positive on 7/28/20 but most recent covid-19 test was negative on 1/18/21. On 1/20/21 blood culture showed Staphylococcus aureus (2/2 sets). MRI of the brain on 2/3/21 showed "small focus of acute ischemia in the left occipital lobe".

walking is still very bad; lower back pain; he reported lower back pain, that has migrated more to the right hip and into the glute; he reported lower back pain, that has migrated more to the right hip and into the glute; it might be kidney pain; arm pain; This is a spontaneous report from a contactable other Health Professional (HCP). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), intramuscular on 22Jan2021 15:10 at 0.3 mL, single (0.3ml by intramuscular injection left shoulder) for COVID-19 prophylaxis. Medical history included ongoing high blood pressure (diagnosed about 21 years ago), ongoing gout (Diagnosed about 2 years ag), ongoing ankle spur right foot, ongoing diminished cartilage both knees, joint pain. The concomitant medications included torsemide. The patient reported adverse event (AE) after his first Pfizer-Biontech covid19 vaccine at 15:10 on 22Jan2021. He reported arm pain starting 3 hours after vaccination until noon the next day (23Jan2021). When he woke up on 23Jan2021 he reported lower back pain, that has migrated more to the right hip and into the glute. The pain inhibits walking, standing, etc. He did note that he is >300lbs and has had joint pain in the past, but the hip pain is new. He also thought it might be kidney pain, as he takes a daily diuretic. He stated he has been treating with Aleve twice a day, but that walking is still very bad. The patient is an optometrist that was calling about the Covid-19 vaccine and said that he did not know if the Lot number written on the vaccination card is EL3302, E13302, or EI3302. He got the vaccine on 22Jan2021 and reported that he got a sore arm about 3 hours after receiving the injection. He woke up with a sore lower back pain. He is 5ft 9.5 and 310 lbs and he is on Torsemide, a pretty strong diuretic. He woke up with the back pain and stated that it moved right and middle to his buttocks, a little lower than the end of his spine and to the right. He did not think it was his kidneys. He said that Torsemide can make kidneys work overtime. His knees were pretty shot, the left worse than the right. No further details provided. He was upset to know that he has shrunk a 1.5 inches over the years. He has been taking 2 Aleve a day since Saturday, this morning was his 4th pill. He said that it is really odd when he stands equally on both feet his lower back hurts. He has to sleep on his right side and that it hurts more when he sleeps on his back and on his left side. He was fearful doing eye exams next to his patient and how the lower back pain would affect him. Reporter considered seriousness for Lower back pain was Medically significant. The outcome of event lower back pain was not recovered; of event arm pain was recovered on 23Jan2021; of other events was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect vaccine BNT162B2 to the event low back pain cannot be excluded. The ongoing gout and concomitant drug torsemide may also play contributory roles to the event. 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.

Severe abdominal pain and sore abdomen; Fever at 100.2; Nausea; Fatigue; Anorexia; Foggy head; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262, Expiration Date: May2021), via an unspecified route of administration in left arm, on 21Jan2021 at 16:15 (04:15 PM), at a single dose, for COVID-19 immunization. The patient's medical history included coronary artery disease, hypertension (HTN), diabetes, and iron supplement. The patient's concomitant medications included cilostazol and chondroitin sulfate/ collagen (INTEGRA) as iron supplement. The patient previously took sulfamethoxazole/ trimethoprim (BACTRIM) and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 22Jan2021 at 04:00 PM (around 24 hours after shot), the patient experienced severe abdominal pain and sore abdomen for 12 hours; fever at 100.2; nausea for 24 hours; and fatigue, anorexia, and foggy head for 48 hours. OTC treatment was received for the events including calcium carbonate/ famotidine/ magnesium hydroxide (PEPCID COMPLETE), calcium carbonate (TUMS), and simeticone (PHAZYME). The patient had not been tested for COVID-19 post-vaccination. The patient recovered from "Severe abdominal pain and sore abdomen" on 23Jan2021 at 04:00 AM; "Fever at 100.2" in Jan2021; from "Nausea" on 23Jan2021 at 04:00 PM (16:00); and from the remaining events on 24Jan2021 at 04:00 PM (16:00).

fever; felt terrible; His rash ran up and down his torso, arms and hips/rash got worse; His rash ran up and down his torso, arms and hips; It was red and angry and itchy; It was red and angry and itchy; This is a spontaneous report from a contactable consumer reporting for husband. A 71-year-old male patient received first dose of bnt162b2 (BNT162B2, batch/lot number EL0142), via an unspecified route of administration on 14Jan2021 at single dose on right arm for COVID-19 immunisation. Medical history included slight rash on his stomach, ongoing allergy to pain relievers and fever reducers. The patient's concomitant medications were not reported. The patient previously took ibuprofen (ADVIL), Tylenol, aspirin (acetylsalicylic acid) and was allergic. The patient had a slight rash on his stomach before he received his dose. However, on 16Jan2021 he had a fever of about 100F. On 16Jan2021, his rash ran up and down his torso, arms and hips. It was red and angry and itchy. He applied Benadryl, hydrocortisone cream and aloe. He had a regularly scheduled (Institution name) appt and was prescribed prednisone, but it caused nausea and night terrors, so he stopped it. His rash is getting better. His 2nd dose is scheduled for 04Feb2021. The fever stayed just under 100.0 but he kept it all day long and felt terrible on 16Jan2021. He has had a horrible rash on his upper torso and top of his legs. It was getting bad and they were putting everything they could on it. Cortisone 10 was used and they seem to have it in check. He had a (Institution name) appointment and his doctor gave him prednisone to help but this made him sick to stomach at day 2 or 3 and so he stopped that product. Now the rash is coming back and they are wondering if is this part of the vaccine side effects. Caller remarks they didn't know what caused the rash to get worse, the vaccine or something else. The first dose was on 14Jan2021. The caller confirmed the fever started on day 2 all day long but broke that night and the next day he felt much better. On day 2 the rash got worse and itching like crazy, he remarked he felt like he fell in fire ants. At this point the rash is ok but is starting to itch again, they are applying everything they can think of to treat it. When her husband say his physician assistant at the (Institution name) she gave him the prednisone but he was nauseous and said he can't deal with that. He wasn't sure if he would rather itch or throw up so he did not complete the prednisone. Caller clarified the product is actually called Methylprednisone by Greenstone LLC. Therapeutic measures were taken as a result of it was red and angry and itchy (erythema), it was red and angry and itchy (pruritus) , his rash ran up and down his torso, arms and hips (rash). The outcome of fever, felt terrible was resolved on 16Jan2021, of other events was not resolved.

On Monday night, after the vaccination on Friday, about 10:00 I began to feel pain in my neck, both shoulders, and across my chest. Sleep was fitful and finally impossible, with every breath being painful. We went to ER about 6:00 A.M., thinking it was either a heart attack or COVID. I was checked very well, with good results. EKG was fine, Oxygen at 97%, chest x-ray looked good, white blood count was good, but platelets were low. A subsequent flu test and COVID test both came back negative. My symptoms were constant for several hours then diminished, increased, and diminished until Friday when I felt largely symptom free.

his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy; Pain at the injection site; This is a spontaneous report from a contactable consumer (patient's wife). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), via an unspecified route of administration on 24Jan2021 12:30 at single dose in right arm for COVID-19 immunization. Medical history included Diabetes, Blood pressure high, High cholesterol, Enlarged prostate. Concomitant medications taken within two weeks before the event onset included irbesartan, verapamil, metformin, topiramate, omeprazole, tamsulosin, clonazepam, simvastatin, acetylsalicylic acid (BABY ASPIRIN), all were ongoing. Vaccination facility type was Hospital. The patient received the Pfizer covid vaccine first dose on Sunday 24Jan2021, On Monday (25Jan2021) afternoon, his face was feeling funny, by the time he got home, his face was paralyzed on the left side. The injection site was on his right arm. The reporter called paramedics and he went to the Emergency Room, and was diagnosed with Bell's Palsy. No history prior to vaccination. All his tests were negative in the hospital, EKG, CT, all tests negative in Jan2021. wasn't a stroke or anything like that. One doctor said it could be related to the vaccine and the other said he didn't know. The reporter wanted to know if he could go back for the second dose, if one dose could provide any protection. Consumer calling about the Pfizer COVID-19 vaccine (later referred to as just shot or COVID shot by caller) for her husband, and says the reason why she called was her husband got Bell's Palsy from it, and she didn't know if he should still go for a second shot. She said his face was all paralyzed right now, he got the COVID-19 shot on Sunday, then Monday night he went to the ER and was diagnosed with Bell's Palsy, all tests were clear that it was not a stroke and had to be from the shot. The patient's face was feeling funny, and when he got home his face was paralyzed and she called 911. She said he was admitted from the ER overnight on Monday night (25Jan2021), then she picked him up on Tuesday night. She said he was diagnosed with Bell's Palsy, and they gave him medication, which was Prednisone and patches to keep his eye closed, and another med called Valacyclovir, which was an antiviral medication, and some eyedrops. She said his vaccine card just says first dose, patient number, (City and State name), and has a date on the back for his second shot which was scheduled for 14Feb2021. Treatment Valacyclovir: Caller says that this was in a (Pharmacy name) bottle and that label told instructions to take it and said no refills, discard after 26Jan2022, it was a week's worth of pills. Prednisone 10mg. Caller said this was also in a pharmacy bottle that said take 5, then 4, then 3, then 2, then 1. The label said discard after 26Jan2022. She said that the eyedrops were over the counter lubricant eye drops for his left eye. Caller said the patient took a medication for electrical activity in the brain, so they did a MRI and a CAT scan and they all came back negative on the tests, and his heart tests came back negative (Jan2021). No further details provided about electrical brain activity medication or test results. Caller said that the doctors sent her husband home and said it was Bell's Palsy, likely a result of the vaccine, that there was nothing wrong with him, they can't say for sure, they said it could be coincidental. She said they probably can't say it was the vaccine that gave it to him, some doctors said yes during the stay at the hospital and some said they couldn't say. She said that there were quite a few doctors there, it is a big hospital, that worked in the stroke unit. Caller said that she would like to know if there were any product recommendations about whether her husband should get the second dose. It further reported that on 25Jan2021 at Lunch time his face felt funny and by 17:00 left side of face was paralyzed. He was treated in the ER of (Hospital name and Address). as if he had signs of stroke. Reporter seriousness for Bell's palsy was Hospitalization. The dates when patient was in hospital for Bell's palsy was from 25Jan2021 to Unspecified date. Reporter stated patient also experienced pain at the injection site in Jan2021. MRI, EEG, EKG and Sonogram, all clear and All negative in Jan2021. The outcome of the event "his face was feeling funny/his face was paralyzed on the left side/ Bell's Palsy" was not recovered, of the other event was unknown.

Progressively getting dizzier and out of sorts every day since the vaccine. Getting worse every day. No brain function. Cant drive. Cant work. Feeling weak, shakey and like shit. Blood oxygen levels dropped to 93. Deep breathing brings it up to 98 but drops again as soon as deep breathing stops. All other vitals normal.

Absolute ZERO side effects from first dose, not even a sore spot on injection location. Migraine intensity headaches started 4 hours after injection of the second dose and lasted for approx. 40 hours. Went to sleep at 10:30 PM the night of the second dose and woke up in a startled state every half hour until I got out of bed at 5:30 AM. From 5:30 AM until approx. 10 PM the day after my second dose I experienced seizure-like symptoms where I would seem to fall asleep while in a sitting position and awake just a minute(s) later in a confused state of mind. This would happen frequently and stopped its frequency slowly and stopped entirely late that same night. I experienced eye pain to the point I had to apply ice bags to my face the entire day after the second dose. Body pain was so sever I cannot compare it to any other flu-like symptoms I've ever had. Totally recovered after 48 hours.

Pt had fever to 102, headache, weakness and needed help out of bed, fell once and even had some confusion. He had to be watched overnight in the hospital 2/11-2/12. By 48 hours after the vaccine, he felt improved and normal by 72 hours. Note that pt had similar but not as severe reaction the first vaccine(Pfizer EL9882) that I was not aware of til now. Also note that pt had covid infection about 3 months prior to this vaccine.

Slightly dizzy "spacey" b/p 148/78 pulse72 Respirations18 right after seeing vaccine. Client refused medical treatment.

11 Feb: second Pfizer Covid vaccine 18 Feb: headaches. Resolved with Tylenol 21 Feb: 8;30AM: neurological symptom onset with intermittent severity. Patient at lunch, went back to bed. Is hydrating. Disoriented Lightheaded Faint feeling Intense periods of ?spinning? feeling Dizzy General weakness

Five minutes after injection I began to feel agitated, experienced balance problems, had trouble mentally focusing, hands were shaking noticeably. These were the same symptoms that I experienced after my first injection of the Pfizer COVID-19 vaccine administered on February 2, 2021. I reported that event under VAERS temporary case number 279639 on 02/02/2021. As with the first event, the symptoms began in 5 minutes and lasted about 8 hours. However, the symptoms associated with event in this report (second injection) were more severe and peaked about 45 minutes after injection, as opposed to about 30 minutes after the first injection. I reported the first adverse event to the nurse before she gave me the second injection and she had me placed under observation for an extended period of time. The trouble mentally focusing, unsteadiness, and shaking were more pronounced this time and got worse after 45 minutes when I got up and walked to the car, but began to diminish rapidly that. I did not attempt to drive.

pt reported feeling dizzy after first dose so 2nd dose was administered while pt was laying down. After about 5 minutes pt reported feeling dizzy, was shaky and described difficulty focusing

I had chills and shaking at 2am Feb 19 for about 10 minutes. I had a normal temperature of 97.2F. After this I would not go back to sleep. I was awake until about 8:30am. I slept from 8:30am to 11:00am. I was tired all day. I napped again from 3:00pm to 5:00pm. I sleep my normal Feb 19 11:00 pm to 6:00am. I was back to normal after this.

About 8 hours after injection, I began having pain on right side of back just under ribs. Pain worsened through night, causing difficult sleep. On evening of second day, pain spread to right flank and right front of abdomen, causing entire right side of abdomen to experience significant pain. It is possible this is muscular pain, but after reading the Internet, I believe it is inflammation of the gallbladder. I have never before experienced gallbladder issues. The pain is much worse than the "muscle aches" described as a COVID vaccine side effect. There is no fever or other significant symptoms. Today (third day) I emailed my doctor. His nurse responded that it is hard to tell if it is vaccine related, and that if it begins to resolve not to be concerned about it, but if it gets worse I should be seen by the doctor. I am taking Tylenol and applying Voltarin topically, but neither helps much.

High fever 103-104, confusion, nausea, body aches, headache, chills, lasting about 2-3 days. Is feeling better since then, just has some hip aches.

Anxiety; tiredness; headache; chills; nausea; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on right arm on 26Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included chronic back pain. The patient has no allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and pain medications which he received within 2 weeks of vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 05Jan2021 at 2:00 PM at single dose for COVID-19 immunization and experienced headaches for a week. The patient received his most recent COVID-19 vaccine at a hospital. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced anxiety, tiredness, headache, chills, nausea, and feeling unwell. All these feelings come and go but made him very uncomfortable. He was told that it would dissipate in 48 hours. There was no treatment received in response to the events. The outcome of the events was not recovered. The events were assessed as non-serious.

At about 7 hours post vaccination, the patient experienced extreme fatigue, confusion and weakness. The patient's wife called their doctor who advised them to call 911 due to concern of stroke. Paramedics came to their home, but did not need to take the patient to the hospital. By the next morning, the patient was feeling better. At 4 days post vaccination, the patient's wife states that he is back to baseline.

neuropathy on feet, arms, and chest; chills; fatigue; lack of sleep for the last 12 days; This is a spontaneous report from a contactable consumer, reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an unspecified route of administration at the left arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Vaccination was administered at a military base. Medical history included hypertension (controlled with medication) from an unknown date and unknown if ongoing. There were no known allergies. There was no other vaccine in four weeks. Concomitant medication included lisinopril, felodipine and tamsulosin (reported as medications in two weeks). On 04Feb2021 at 17:00, the patient experienced chills, fatigue, neuropathy on feet, arms, and chest and lack of sleep for the last 12 days. The patient was advised to drink plenty of water and take Tylenol. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The events required a doctor office and emergency room visits. The patient underwent lab tests and procedures which included influenzas A: negative, influenzas B: negative, both on unspecified dates; and COVID-19 nasal swab: negative on 08Feb2021, 11Feb2021 and 12Feb2021. The outcome of the events was not recovered.

Spasm in the back of neck; difficult to sleep; This is a spontaneous report from a contactable consumer (reporting for himself). A 71-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on his left arm from 29Jan2021 11:40 to 29Jan2021 11:40 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included cholesterol, gout, vitamin supplementation, and hypothyroid. Concomitant medication included simvastatin for cholesterol, allopurinol for gout, cinacalcet for hypothyroid. On 30Jan2021, the patient has a spasm in the back of his neck that makes it difficult to sleep and if you turn your head in any direction, you get a crook in your neck and it feels like someone is grabbing you by the back of neck. Therapeutic measures were taken as a result of spasm in the back of neck which included Tylenol Arthritis pain. The outcome of the events was not recovered.

There were no immediate reactions during the 15 minute wait period. 45 minutes after my injection, while at a different Walgreens where my friend received a Moderna jab, I was hit with a rush of side effects. The first was a deep gripping pain in the diaphragm area, like a punch to the stomach with some dizziness. While seated, my left leg experienced increasing pain from foot to hip. In short order, my left foot grew completely numb and this extended up my calf to my knee. My foot became paralyzed. Rather than go through a lengthy emergency room procedure, we drove back and luckily, the numbness did not spread. The intense leg pain remained steady. Breathing labored. At my friend's house, the left foot & calf numbing and paralysis finally subsided 4.5 hours after injection. At home, some numbness returned but subsided. Sat. through Wednesday, 2-28 to 3-3-21: Weakness in left leg. Cramping of calf muscle. The chest cavity pain began to intensify. Chills arrive plus daily headaches. These start to resemble reported "normal" reactions minus the special situation of the left leg. Pain while deeply inhaling, exhaling or bending increasing. Fatigue - partly from poor sleep. Thur. 3-4-21 Day 7: Still with strong muscle or lung pain, especially upper back. Painful to pull back shoulders. Periodic sharp pain in upper left inner arm, not at injection site. Still pain with deep exhale or inhale. Tried a short walk: After 200 feet, left calf tightening up and pain increasing in both hips. A short rest would clear it but would return with exercise. Lower back pain as well but some of that is pre-existing. Basic circle of pain around rib cage. Skin (or deeper tissue?) on my upper back still very sensitive, resembling sunburn. Produces chills when touched. Sleep still nearly impossible. No sleep aids being used. Fatigue, some headache and chills remain. During this period, I have resorted to pain relievers only twice in order to learn the nature of the symptoms. Fri. 3-5-21 Day 8 During this reaction period: NO fever, nausea, diarrhea, loss of taste / smell, sore throat, congestion or runny nose. Headache, chills, joint & ribcage pain remain. Skin hypersensitive on my upper back. Symptoms today same as on 3-4-21. Moderate morning headache. On a 1.5 mile walk, slight improvement with the left calf muscle cramping. Occasional "clearing" cough, small amount of clear phlegm produced.

shingles; he started feeling strange; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 71 years, on 20Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included white blood cell count decreased from an unknown date and unknown if ongoing. The patient stated that his white blood cell count was usually on the low side and his doctor sends him to a hematologist to do whatever, then they say he was fine. Concomitant medication included an unspecified flu shot. The patient said that he had his first Pfizer COVID-19 shot 20Jan2021, and this coming Wednesday he was supposed to have his second shot, but unfortunately in the interim he found out he has shingles. He says he would like to know if he can get a second shot or would he need to hold off. He says that developed shingles 9 days later after getting first COVID-19 vaccine shot (31Jan2021), and he doesn't want to do something that will be a problem. He says that he was on an antiviral to treat the shingles. No further details provided about the antiviral. He says he didn't go see his doctor until last Wednesday, he thinks he has been suffering from shingles since 07Feb2021 or a little before that when he started feeling strange. The patient clarified he meant 31Jan2021 since he began dealing with this. The patient said when he was diagnosed with shingles they didn't do any tests, the doctor walked into the room and looked at him, though he didn't have a lot then, over the days it has gotten worse. Therapeutic measures were taken as a result of shingles (herpes zoster). The outcome of the events was unknown.

patient became syncopal/unresponsive for about 3-4 minutes, EMS called, wife performed chest compressions. He was evaluated by EMS but not transported. He felt "foggy" and tired the remainder of the day but back to normal the next day.

Burning during urination; Headache; body aches and pains; joint fatigue; Very restless and difficult sleep; Very restless and difficult sleep; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 04Feb2021 08:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma but no food or medicine allergies but seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin, losartan, and metoprolol ER (extended release). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 14Jan2021 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other vaccine on the same date as the COVID vaccine. On 04Feb2021 22:00, the patient experienced headache, body aches and pains, joint fatigue, very restless and difficult to sleep first night. The patient experienced burning during urination the next morning (05Feb2021). No treatment was received for the events. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information of lot number has been requested.

Temperature 99.4 and chills sustained for 14 hrs beginning @ 0430 on 03/06/2021 / Body aches, stiff neck, significant pain in left arm 7/10 sustained until 03/08/2021 / unable to complete usual daily activities until side effects subsided on 03/08/2021

Received 2nd dose of Pfizer COVID vaccine on 2/24/21. No reported adverse reaction at that time. On 3/10/21, developed worsening of chronic back pain. On day of event, took a dose of celecoxib and rivaroxaban (concurrently). He had been avoiding taken chronic celecoxib since at least the time of his last COVID-19 vaccination, and potentially took this fairly rarely due to concern for interaction with his DOAC. Beginning about 5 minutes after these medicaions were taken, patient felt weak/strange and asked his wife to take him to ED. In ED he was initially somnolent but arousable, but then developed hypotension and hypoxemia. Given IV benadryl initially, but then acutely worsened with development of facial, hand, and neck swelling. Reportedly had substantial "frothing at the mouth." Treated with SQ epinephrine, IV methylprednisolone, IV famotidine and was intubated with difficulty. Started on an epinephrine infusion due to persistent hypotension (dose up to 0.1 mcg/kg/min) and transferred to referral center ICU (reporting center). On arrival here, notable hand edema, some facial edema. Ventilator support rapidly weaned to minimal settings. Evaluation and hospitalization ongoing. Overall clinical assessment is anaphylactic reaction to celecoxib unrelated to COVID-19 vaccination.

Patient received the vaccine around 10 am on 3-10-21. He mentioned to the vaccinator that he had a large anxiety of needles. After receiving the vaccine the patient went to the recovery area for the required 15 minutes. About 10 minutes later his breathing rapidly increased - eventually turning to large gasps of air. The patient then briefly passed out but then quickly woke up. He then started vomiting for the next 10 minutes. Eventually he recovered enough to walk with the help of his wife. The wife stated that he has had episodes like this from other vaccines and blood draws. He has never vomited from the episodes, however.

MRN 2941254 -Loyola med ctr. racing heart around Jan 11/13 for week to 10 day. got immediate care and got Ablation done in Feb 4 2021...Not sure but heard of this side effects in news.. but could be related to my HEART ISSUES. but i was fine before ALL ECHO/STRESS/EKG all ok. !st shot might have hit nerve? slight pain even now and bother me to sleep on that side /radiate slight pain to shoulder/right chest? not sure?

30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/10/10 pain at night; rigidity; diffuse muscle weakness; Unable to get out of bed or up from chair without assistance; weakness; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation. Medical history included hyperlipidaemia. Concomitant medications included rosuvastatin; escitalopram; ubidecarenone (CO Q 10 [UBIDECARENONE]); colecalciferol (VIT D3); all taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentin and experiencedknown allergies. On 26Jan2021 19:00, 30 hours post vaccine developed diffuse symmetric muscle pain. Muscles became rock hard/rigidity. Over next week developed diffuse muscle weakness. Proximal worse than distal. Unable to get out of bed or up from chair without assistance. Persisted for over 6 weeks: 10/10 pain at night. Muscle pain, weakness, rigidity. The events were assessed as serious (hospitalization, and disability). Number of days in the hospital: 1. Therapeutic measures were taken as a result of the events. No covid prior vaccination, and no COVID tests post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.