Pfizer

Tiredness; nausea; headache; chills; This is a spontaneous report from a contactable Other HCP, the patient. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Dec2020 at 13:30 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, montelukast, and vitamin D3, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 08:00, the patient experienced tiredness, nausea, headache, and chills. The patient did not receive any treatment for the events. The clinical outcome of the tiredness, nausea, headache, and chills was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

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.

Dizziness, Nausea Vomiting, Tachycardia, epigastric pain and off; Narrative: advised to see his doctor regarding the abnormal ECG[NONSPECIFIC ST-T CHANGES] in view of the epigastric pain;

The night of the vaccination I became ill with flu-like symptoms. I experienced muscle aches, chills, a fever, fatigue, and stomach cramping that lasted 3 days.

Severe Nausea experienced 8 hours after the IM injection Treated with Zofran, Omeprazole, Diphenhydramine and Pepto-Bismol

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

Lower abdominal pain consistent with colitis flair >7 days duration. Treated with ibuprofen and heating pad. Pain continues at 2-3/10.

1/19 2300- INJECTION SITE DISCOMFORT 1/20 0100- FEELING OF FEVER, BODY ACHES, SORE THROAT 0830- NAUSEA, FATIGUE 1050- TEMP 100.4. TOOK TYLENOL 1000MG @ 0100 AND @1030

Patient experienced fever 103 degrees, body and muscle aches, chills, ringing in the ears, headache, loss of appetite. Dr. suggested Tylenol and fluids for treatment. Spent 24 hours in bed as I had no energy.

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.

I had chills, 102.7 fever that lasted the evening of 27th until about noon on 28th, some loose stool but a lot better

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.

Diarrhea; body aches; chills; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown) via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination Yes). The patient's concomitant medications were not reported. The patient experienced diarrhea, body aches and chills on 29Jan2021. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021. No follow-up attempts needed. No further information expected.

Upset stomach, headache, severe entire body aches short of breath, diarrhea, chest pressure, chills, fever and body weakness. Talk to Dr. and she recommended to drink plenty of fluids, take Tylenol , and rest.

Phizer-BioNtech COVID-19 Vaccine EUA. Mild, sore throat for a 30 minute period; then dizziness; then nausea /vomiting, chills; T36.2-36.7 celsius. Lasted from 6:00 pm on 2/25/21 to 3:30 am on 2/26/21.

Pt received Pfizer vaccine at 2:30pm. At 2:35 patient began feeling chest heaviness and nausea. Pt vitals taken: BP 150/90, HR 87, O2 97, respirations 18. Pt sent to EMS and given 324mg aspirin, vitals: NP 172/108, HR 92, O2 97% RA, resp. 18. EMS gave 0.4mg nitrogycerin PO x1. Chest heaviness resolved with nitro. Pt recommended to go to hospital for ER evaluation. Pt agreed. Pt transported via ambulance to hospital.

12-14 HOURS AFTER RECEIVING THE VACCINE PATIENT REPORTS HE DEVELOPED HEADACHE, MUSCLE ACHES, CHILLS, SWEATS, LOSS OF APPETITE. HE ALSO NOTED A RASH ON HIS NECK, FIRST ON THE NECK AND NOW HAS SPREAD TO THE ENTIRE BODY. PATIENT ALSO REPORTS SHORTNESS OF BREATH WHEN LAYING FLAT ON HIS BACK THAT STARTED AT THE SAME TIME.

diarrhea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient, who was also 60-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on left arm from 15Jan2021 14:00 as dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient received second dose of BNT162B2 on 05Feb2021 at 02:00 PM on left arm. On 18Jan2021 10:00, patient experienced diarrhea with outcome of not recovered. Therapeutic measures were taken as a result of diarrhea which includes Imodium. Information regarding the lot/batch number has been requested.

Starting Monday March 1st approximately 25 hrs after my injection I started feeling slightly nauseous , and had a loose stool, diarrhea, The following morning I had 2 of the same bowel movements. That continued for a week, until March 9. I would only go in the morning, not all day. The nausea went away after the first day. On Thursday of the week, I took a 1/2 pill of Imodium, On Friday I took another half pill, On the Saturday I took a whole pill. On the Sunday I took 1 pill in the morning and one in early evening. I called my Doctor on Monday March 8th to discuss, he suggested I continue taking Imodium, no more than 2 a day for the next 3-4 days, and to call if I was still experiencing the diarrhea after then. I took 2 pills on the Tuesday, then Wednesday I didn't have a bowel movement , and finall on the Wednesday March 10th I was back to normal... I am not sure if this was caused by vaccine or not, but felt like I should report it.

Escalated temperature in a range of 99.9 to 100.7 over a 19 hour period of time. Extreme fatigue - During a 34 hour period beginning 6 hours after receiving vaccination, I slept approximately 30 hours Diarrhea lasting fewer than 4 hours

Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours. Significant loss of energy and headache began around 8:00 pm on 3/1/2021, and persisted with gradually decreasing intensity until 3/5/2021.

Patient received Pfizer vaccine on 3/5/21. On 3/13/21 patient had fever, headache, diarrhea and tested positive for COVID 19 on 3/15/21 in our office.

Loss of Balance - unsteady - stagger - dizzy. Is more severe with motion - head up, down, standing up, bending, walking. -- not severe when not in motion - sitting-lying. Nausea when symptoms started but have subsided since the first full day. Some blurry vision at times and ear ringing - not constant. Does pass but continues with motion. Does not have a time frame as it is continuous when in Up-Down-Bending-etc - motion

10 hours after vaccine administered. Started with cloudy vision and a headache. Went to bed. Awoke two hours later with a fever of 102 and severe chills. That lasted 6 hours. Body temp went down to normal. Ate a little breakfast. Tired and achy. Went back to bed. Awoke several hours later. Fever was back. Though not as high, 100. Entire body hurt. Joints, head, abdominal pain, pain in left armpit. Stayed for several hours. Went back to bed about 4:00PM woke up an hour later fever down to 99. Ate a little supper. Acid reflux uncontrollable. Went back to bed. Awoke at 8:00PM . Fever still at 99. Stayed awake until 10:30. Went to bed. Tossed and turned with body aches all night. Had to get up every two hours to urinate. Awoke at 7:30AM. No fever. Feeling somewhat better. Still pain in left armpit. Headache almost gone. Joint pain almost gone, abdominal pain still present. Worst is over.

Patient felt nausea and started dry heaving. He was sweating profusely and had tremors. BP 140/60, HR54, O2 sat 98. He stated that he had not had a meal today and it could be his sugar. His glucose was evaluated and was normal. Pt. was taken to NWMC and was accompanied by his wife.

Sweating When Veteran returned to receive his 2nd Pfizer COVID-19 vaccine on 3/15/21, he reported that he had a mild reaction on the day of his first vaccine (2/23/21). Approximately 15 minutes after the vaccine, he experienced sweating, nausea, and one episode of vomiting. After drinking some water, the symptoms self-resolved within 3-5 minutes.

Acute appendicitis; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EH9899), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient received the vaccine in a hospital. The patient's medical history and concomitant medications were not reported. On 22Dec2020, the patient experienced acute appendicitis which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had appendectomy as treatment. The patient had no other vaccine in four weeks, no Covid prior vaccination and was not Covid tested post vaccination. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event appendicitis is likely an intercurrent medical condition and unrelated to suspect drug 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 RAs, Ethics Committees, and Investigators, as appropriate.

"flu-like" started 03/20/21 in the afternoon. Has had nausea, tiredness, headache, bodyaches that continue through 03/22/21. Called his own PCP who told him to call the Health Department.

Arm pain first day. Lightheaded, feeling like fainting, dizziness, above stomach pain nausea, that happened parallel to erratic high blood pressure, 199/98. Chills, shakes, joints and muscle pain, headache, palpitations, night sweats, severe fatigue. From day 3 to day 17. Went to healthcare facility twice, and two doctor calls.

Runny nose, sensation of throat closing up, difficulty swallowing. I could continue breathing nasally and could also drink water. Event cleared up around 6:00 PM the same day (date of vaccination).

12 hours later belly cramps. 24 hours later shortness of breath. Still can't take more than a few steps without getting out of breath.

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.

At around 2:20 in the morning I started getting really bad chills and shakes, I got 103 temperature and within 30 minutes diarrhea and stomach cramps and bodyaches

Severe neck pain on left side on first day of reaction followed by painful swallowing on left side the next day. Both conditions persisted for about 4 days and then resolved itself. Same reaction just 4 days later after second dose with pain more severe and longer lasting. Currently on day 7 after second shot and pain still not resolved.

I felt fine going in to get the vaccine, that evening my stomach hurt a little. And I do recall after the first dose I received back on 03-01-21 I had a little stomach issue but it was gone the next day. That evening I went to bed and I began to get the worst stomach cramps I will call them and sick to my stomach feeling I had ever experienced. I did not ever get a fever. I went to the ER the next morning and had my gallbladder and Pancreas as well as the liver scanned and checked. I was told that my blood work was good only a small elevation in a part of the liver test. but it was nothing to worry about. I came hone where I laid vomiting, very lose stools, and unable to keep anything in for almost 6 days. I followed up with my regular dr and will follow up again at the end of this week. I was literally down for 6 days. My blood sugars were over the chart because I was unable to eat or drink. The cramping or pains were awful. I am still sore in my stomach but now beginning to eat and feel better.

Started being cold around 11:00 on 3/29 - less energy throughout day - goose bumps from being cold around 9:45PM. Woke up throughout night with lower back/neck pain and headache. Now (7:18AM) experiencing headache, nausea, neck ache, chills and lower back pain. Feels like a hangover.

Difficulty and painful swallowing on left side of throat + severe neck pain on left side. All symptoms are left side only.

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.

Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.

Arm pain at injection site started 24hours later lasted 72 hours, Drowsiness started with in hours of injection lasted 48 hours,Sweating,Vomiting ,Dizziness,chills and Rapid heart beat started 48 hours later,sweating and vomiting lasted and hour.Rapid heart beat lasted about 15 min. Took anti nausea medicine for the vomiting and Tylenol & Motrin for arm pain.

Very bad stomach cramping, nausea and vomiting. Started when I woke up this morning around 7am. Also, I go from being hot to being cold.

Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitations

Burning stomach pain, feeling of fullness/bloating, feeling of fullness specifically on lower right side of abdomen. Day 1 - Milk of Mylanta, limit diet to less spicy, lower fat food. No alcohol, caffeine, carbonated beverages, chocolate. Day 3 - Stopped taking all OTC meds. A week later, fullness persists.

4/3/2021, Initial Stinging pain at time of injection 4/3/2021 - 4/5/2021, Pain on the left arm (injection site) extending into my shoulder and down to my wrist. 4/5//2021 - Current, Pain Reduced, but will be setting up an provider appointment. 4/3/2021 - 4/5/2021, Nauseas 4/3/2021 - 4/5/2021, Severe Headache, used Tylenol medication to reduce the pain. 4/5//2021 - Current, Light headache, Using Tylenol for relief

lightheaded; stomach pain; feeling like fainting; that happened parallel to erratic high blood pressure 199/98.; nausea; Arm pain first day.; fatigue; palpitations; shakes; joints and muscle pain; joints and muscle pain; headache; Chills; night sweats; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 10:30 (Batch/Lot Number: EN6199) as SINGLE DOSE (at the age of 60 years) for covid-19 immunisation . Medical history included immune thrombocytopenia from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , covid-19 from Mar2020 to Sep2020, (COVID 19 Long-Hauler from Mar-Sep2020). Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL); simvastatin (SIMVASTATIN). The patient previously took aspirin [acetylsalicylic acid] and experienced anaphylactic reaction, zantac and experienced rash and experienced peripheral swelling. The patient experienced feeling like fainting (medically significant) on 13Mar2021 14:30 with outcome of recovering , that happened parallel to erratic high blood pressure 199/98 on 13Mar2021 14:30 with outcome of recovering , palpitations on Mar2021 with outcome of recovering , lightheaded on 13Mar2021 14:30 with outcome of recovering , stomach pain on 13Mar2021 14:30 with outcome of recovering , shakes on Mar2021 with outcome of recovering , joints and muscle pain, headache on Mar2021 with outcome of recovering , chills on Mar2021 with outcome of recovering , night sweats on Mar2021 with outcome of recovering , nausea on 13Mar2021 14:30 with outcome of recovering , arm pain first day on 09Mar2021 with outcome of recovering , fatigue on Mar2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 120's-30's/70's, blood pressure measurement: 199/98 on 13Mar2021, platelet count: 99, sars-cov-2 test: Several negative tests on unspecified date. The patient went to Urgent Care twice. The patient took no other vaccine in four weeks and the patient was not COVID tested post vaccination.

SOB, nausea, headache. Felt chest heaviness. Vital signs wnl, O2 sat 97%. Given albuterol 2 puffs. Went to ED.

Extreme body aches. Slight Fever (101). Excessive unproductive coughing. Loss of appetite. Vomiting. Diarrhea. All symptoms continuing on 4/9/2021 except fever is gone.

weakness, nausea, vomiting, shortness of breath, diarrhea, muscle aches concern about antibody-dependent enhancement

12 hours later belly cramps; 24 hours currently shortness of breath; This is a spontaneous report received from a contactable consumer. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: er8732), via an unspecified route of administration, administered in Arm Right on Mar2021 12:00 PM at a SINGLE DOSE for covid-19 immunization. Patient had a history of gluten sensitivity from an unspecified date. The patient's concomitant medications were not reported. The patient experienced 12 hours later belly cramps (abdominal pain upper), shortness of breath (dyspnea) on 24Mar2021. The outcome of the events was not recovered. Information related to case additional information has been requested.

Burning upon injection. Numbness at injection site and entire left arm. 100.6 fever. Switch between chills and feverish and sweating. Intense pain under left breast radiating tru to left shoulder blade. 22 hours after injection, vomiting began and lasted the next 14 hours. Appetite is gone. 4th day post shot and all I've consumed is a banana and a yougurt. I has Covid 09/20 and the injection reaction was worse than Covid.

Symptoms began within 15 minutes of vaccination. C/o shortness of breath/chest tightness, "wheezing," had 1 episode of diarrhea. Sent to ED, given tylenol, zofran ODT, solumedrol, diphenhydramine injection. Diagnosed with allergic reaction and discharged to home with oral steroid.

Reaction to first dose was nil. Below is reaction to the second dose: Same evening: slight fever and chills Next day: Stomach upset, dizziness, mild headache, nausea. One fainting episode at 8PM followed by vomiting. Heartrate: 55-63. The day after: Another fainting episode at 11:AM, followed by vomiting. Heartrate: 55-60.

Body muscle aches. Cold sweats. Weak upset stomach. Raised body temperature 99.7 and dissyness and brain zaps.

This was the second shot. I didn't expect to get sick since I had been sick after the first one. Symptoms were for the first night uncontrollable shaking, vomiting & light fever (100). This is the second day and I feel tired although I slept about 20:00 hours yesterday and 12 today. Expect to recover tomorrow!

Immediately I lost my sense of taste - that lasted for four days. I had a little swollen in my arm- I felt nauseous but I wasn't sick. I had a fever but just slightly elevated. Two days after vaccine, my kidneys were in pain. It took a couple of days for it to go away and then it stopped. Called the doctor but he had said just to wait it out -and I kept taking my regular meds but no additional.

Arm pain; Tired; Abdominal swelling; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8730), via an unspecified route of administration, in left arm on 27Mar2021 at 12:00 (at the age of 60-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient hasn't been tested for COVID-19. The patient experienced arm pain, tired and abdominal swelling on 29Mar2021. The events were reported as non serious. The patient didn't receive any treatment for the events. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

sweating; loss of appetite; diarrhea; vomitting lasted for a day; chills; could hardly eat anything for 5 days; This is a follow up spontaneous received from a contactable Consumer (patient). This 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Unspecified) first dose on 11MAR2021 2 weeks ago (Lot: EN6207, NDC/UPC number: Unknown, Expiry Date: Unknown) at single dose for COVID-19 immunisation. Medical history included COPD, allergies, asthma, all from unspecified date to unspecified date and probably diagnosed from 10-15 years ago. Concomitant medications included Montelukast, Fluconazole, Trazodone for Muscle relaxant, tiotropium bromide (SPIRIVA), oxycodone hydrochloride (OXYCONTIN) for bad back and hip replacement and all of his pain medicine, Nebulizer at 2 times a day, all from unspecified date to unspecified date and other unspecified Concomitant Products. He took a sleeping pill at night so that he could sleep. He took 'Steopus' that was 2 times in the evening for his allergies. The patient previously took multivitamin at one dose every day for couple of months for low on some Vitamins. Received on 2021-03-30 19:21:32 UTC, Originating AE Request: REQ-219680. Submitted by Call Centre 1 Reference: W2021379399; PRIMA: 21-181755. Reporter was warm connected with agent with ID reportum number 542ANWOH. Reporter received the Pfizer covid vaccine, first dose 2 weeks ago and 3 days after that he had diarrhea, vomitting lasted for a day, chills, sweating, he could hardly eat anything for 5 days. The symptoms come and went but from yesterday he stated to feel better now. Probably about 13MAR2021 was when patient first had started with diarrhea and stuff and he vomited just for one day because he had quit eating so then giving up his appetite and from then it was like he would say, it had set off yesterday but he had had chills on and off possibly all day long and all night long, not really heavy heavy sweat but sweat and loss of appetite. Reported event seriousness was unspecified. When probed if the events are improved, worsened or persisting, the patient stated they were about gone now. He was scheduled for his second shot on the first of this month, not this month the coming month. He hoped his second won't be that bad, second shot was 01APR2021. The patient underwent lab tests and procedures, which included did a lab test month and they said he was low on some Vitamins. He was low in some vitamins, he thought. The outcomes of the events was Recovered. No follow-up attempts are needed. No further information is expected.

Joint pain, muscle aches, flatulence, hands (only) faded or appeared light brown, head ache (nail hammered into the skull pain), back pain, check tightness, and upset stomach.

Extreme diarrhea which lasted over two weeks. Finally settled down with significant doses of imodium. Also significantly elevated liver enzymes.

Injection site soreness, tiredness on 4/27/21. At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough. About 8 a.m took 1 Tylenol. About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up. Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one). Heart rate better and breathing better. Went back to bed to go to sleep about 10:30 a.m.

Sharp pain in right side of abdomen near appendix; bloating; distended abdomen; flatulence. Discomfort began 3 hours post vaccine. Peak discomfort lasted for 10 hours. Subsided overnight. Almost gone 20 hours post vaccine. Alka Seltzer & Tums

diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.

THE PATIENT RECEIVED HIS SECOND DOSE OF COVID 19 VACCINE ON 04/29/21 AND TODAY HE HAS MODERATE TO SEVERE NAUSEA AND VOMITTING.

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.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA. Day one was fine. actually no events not even arm pain. Pretty much 24 hours later I felt like I had an upset stomach. Which turned into diarrhea and a good bit of dizziness. I slept for 2 hr but felt fine the next day.

Originally went to ER, they diagnosed it as torticollis. They sent me to my PCP who confirmed it. I had violent & severe neck pain and severe headaches. Also an extremely stiff neck where I couldn?t turn it 1/8th oh an inch to either side. It all got so severe that I didn?t eat for days at a time and was literally not with it. Couldn?t respond when spoken to, and became excessively weak where I couldn?t walk w/o help, and speech was slurred. It all lasted 5 days where it was so severe. With medication it slowly began to back off.

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

Morning after the 2nd vaccine, I felt nauseous after eating breakfast, went to the kitchen sink to puke, passed out, and woke up on the floor in a puddle of vomit and with 2 broken teeth.

Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered. No follow-up attempts are needed. No further information was expected.

Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering. Information about lot/batch number has been requested.

He fell after his first dose and Rite Aid called the paramedics who took his blood pressure and wanted to go to the hospital.; He had difficulty swallowing after the vaccine; black eye; This is spontaneous report from a non-contactable consumer. This consumer reported that a male patient (brother) in his 60's received the first dose of at single dose for COVID-19 immunization on 16Apr2021. Relevant history and concomitant drugs were unknown. The patient fell after his first dose and called the paramedics who took his blood pressure and wanted to go to the hospital. his brother felt was a psychosomatic. He had difficulty swallowing after the vaccine. The neighbor text me a picture of him with a black eye after he fell. Outcome of the events was unknown. No follow-up attempts are needed. Information on batch/lot number cannot be obtained.

Patient experienced flare of oral graft versus host disease symptoms manifesting as problems swallowing/mouth soreness and large patches of skin coming off tongue, lip sores not improving, Also developed rash on foreskin on penis which may have been manifestation of flare of skin GVHD. Patient was started on topical triamcinolone for rash (now resolved), and dexamethasone swish and spit for mouth, then ultimately treated with prednisone 1 mg/kg and then tapper off over a month.

Patient stated Left Arm was very sore after first Pfizer Covid-19 dose, extending up his neck on the left side. He stated arm was still sore at time for second shot (5/17/2021). Patient opted to have SECOND Covid-19 shot given in RIGHT ARM. He also experienced a couple of days having nausea, vomiting, and diarrhea, concurrently. Patient complained that his Psoriatic Arthritis became aggravated also after the first shot also. Pharmacist askedif he wanted the second Pfizer Covid-19 vaccination and patient stated he did. Pharmacist administered the second shot in the series in the other arm (right) from the first shot (left). Patient was asked to remain for 30 minutes, which he did, then left stating he felt fine.

Office Visit 3/12/2021 WellSpan Family Medicine - Crossroads DO Family Medicine COVID-19 virus infection +10 more Dx Fever Reason for Visit Progress Notes , DO (Physician) ? ? Family Medicine ? ? Encounter Date: 3/12/2021 ? ? Signed Expand AllCollapse All Office Visit Assessment/Plan Diagnoses and all orders for this visit: COVID-19 virus infection Suspected COVID-19 virus infection - POCT COVID-19 Antigen Mild intermittent asthma without complication Essential hypertension with goal blood pressure less than 130/80 Coronary artery disease involving native coronary artery of native heart without angina pectoris Paroxysmal atrial fibrillation (CMS/HCC);Gastroesophageal reflux disease without esophagitis;Irritable bowel syndrome with diarrhea;Hyperlipidemia with target LDL less than 70;Chronic anticoagulation;Close exposure to COVID-19 virus;covid Ag is positive;MAB tx Clinical Support 3/12/2021 WellSpan Infusion Center - Ephrata RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/12/2021 ? ? Signed arrived to the ambulatory infusion site with his wife via car. Reports intermittent fatigue, dizziness, diarrhea, nausea, dry nonproductive cough, and shortness of breath, stated he discussed Bamlanivimab infusion and associates risks with his doctor prior to this infusion. Reports all question were answered to his statisfaction. Denies any concerns or needs at this time.

May 13, 2021, at 10:30 pm I suffered from severe sinus drainage and phlegm clogging throat that caused severe nauseau and dry wretching in an attempt to vomit. Since that time I have endured sinus drainage, coughing and phlegm clogging in throat. Symtoms have been moderate to severe and nothing alleviates the symptoms. Symptoms are worse at night or when I am sitting.

severe muscle pain in back and legs; Chills; Fatigue; Headache; severe pains in abdomen; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (COMARNITY; Lot/batch no: UNKNOWN) via an unspecified route of administration on 12Mar2021 at 09:00 AM (at 60-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included many food and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included fluticasone propionate (FLONASE) and essential amino supplements (MANUFACTURER UNKNOWN), for unknown indications from unknown dates and unknown if ongoing. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 09:00 PM, twelve hours after the injection, the patient had severe pains in abdomen with severe muscle pain in back and legs. The patient experienced some chills, headache and fatigue which were mostly over in 24 hours. The patient did not receive any treatment for these adverse events. At the time of this report, the patient was recovering from the events abdominal pain, muscle pain, chills, headache and fatigue. No follow-up attempts are possible; information about lot number cannot be obtained.

High fever, Nausea, joint pain, body aches, fatigue, vomiting, red spots all over body. Injury to kidney and liver

Client admitted to Medical Center on 5/19/2021 due to fever, chills, and nausea. Covid plus admitted for further assessment.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild

Per triage notes on 4/21/21: Pt had his 2nd COVID vaccine today at 0800. At 0900 developed lip swelling. Took two doses of Benadryl and has now developed chest tightness and throat swelling. Per doctor's notes: Patient is a very pleasant 60-year-old gentleman who comes in for evaluation after a possible allergic reaction today, possibly related to a second dose of Pfizer Covid vaccine that he got at 8 AM this morning. About an hour later he started to feel flushed. He felt like his face was warm and his ears were warm. He started to feel like the inside of his mouth had filled with a rubber ball. His tongue felt full and he started noticed progressively that he felt like he was having difficulty swallowing. States that he never actually had any lip swelling, contrary to the triage note, just felt funny in the interior of his mouth. Did feel like his tongue was slightly swollen, both based on the fact that it felt "thick" when he was talking, and on direct inspection, as well. Took 50 mg of Benadryl around the time that his symptoms started, and lay down to nap for a little while. When he woke up he was still feeling like he was having more difficulty swallowing. He also felt like his face was a little bit puffy, prickly under each eye. He also felt like he had a blotchy rash on his chest and upper back, which his wife corroborates. He felt like his chest was a little bit tight and that something was heavy on his chest, though he was not wheezing or acutely short of breath, per se. Took another 50 mg of Benadryl at about 2:15 PM, and presented to the emergency department for further evaluation. Currently still has a little bit of chest tightness and throat tightness. He feels flushed. Symptoms have not worsened, but they have not completely resolved, either. He has had anaphylaxis in the past and has had to be admitted to the hospital. And this was in relation to taking doxycycline, it sounds like. Patient presented again to the ED on 4/22/21 with the same symptoms. He was admitted with anaphylaxis. Per ED notes, also diagnosed with Angioedema, improved. Likely related to second covid vaccine. Cant rule out secondary to Lisinopril.

Post vaccination at approximately 10:30 am client reported feeling numbness and tingling in hands, developing a cough and a subsequently developing a felling of throat "closure" or tightness. Client was evaluated by Emergency response team and relocated to the Emergency response tents. At 10:45 am client was noted to become hoarse and requiring neck extension to swallow water. Client at this point was reported to be unable to speak in full sentences. Epinephrine was administered by Emergency Response physician at 10:50 AM. EMS was on site, oxygen was administered and transport to a nearby hospital emergency room was initiated and completed. Note: In retrospect client stated that he had similar symptoms after his first intramuscular vaccine dose (Pfizer, three weeks prior) for three days and had self medicated with Benadryl but had subsequently felt better.

Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date. Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955), via an unspecified route of administration on the left arm on 15Mar2021 at 14:00 (at the age of 60-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. He has no allergies to medications, food or other products. Furthermore, he has not received any other vaccine four weeks prior to COVID-19 vaccine neither was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 18:45, he experienced diarrhea. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken to treat this event. The clinical outcome of the diarrhea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

HAD PHIZER VACCINE: HEADACHES, CHILLS, HOT FLASHES, NAUSEA, SLIGHT TEMPERATURE. STARTED AT 6:00PM DAY OF VACCINE AND TODAY IS FRIDAY THE 4TH AND I STLL HAVE HEADACHE

At approximately 1102 (15 min after vaccine admin) pt c/o generalized itching without rash, headache and fatigue. Denied any difficulty breathing or swallowing. BP 163/99, HR 65, O2 95%, RR 16 (pt notes baseline hypertension). Attending provider, Dr. (Name), notified of pt's symptoms, bedside assessment performed, 50mg Benadryl IM ordered and given at 1110. At approx. 1120 pt c/o intermittent chest pain, describes as stabbing, and mild difficulty swallowing. BP 186/100, O2 96%, HR 74, RR 16. Provider updated, continued to monitor. At approx. 1125 pt notes increased itching, BP 161/103, HR 59, 02 97%, HR 18. Pt assisted to supine position with HOB elevated. Continued to deny difficulty breathing. Approx 30 min admin of Benadryl pt noted initial improvement of itching, BP 173/93, HR 58, O2 96%, RR 18. After approx. 1 hr after vaccine admin pts states symptoms mostly resolved, bedside assessment performed by Dr. (Name), pt cleared for d/c home.

Both doses first 2 days no fever but feeling very cold and mild headache. Following 4 days nausea ,unsteadiness and headache . Gradually reducing after 9 days

AT 1605 PALE, DIAPHORETIC, NAUSEA TREATMENT- AMMONIA, ICE PACK, OUTCOME- WENT HOME WITH WIFE WITHOUT ANY ISSUES

Was much sicker when he was little and received small pox vaccine than with the Covid vaccine; Severe fever; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (patient). Communication: Report 2 of 2. A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: ER2613) via an unspecified route of administration in right arm on 23Mar2021 as single dose (age at vaccination 60-year-old )and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: RE8736) via an unspecified route of administration in right arm on 29Apr2021 as single dose (age at vaccination 61-year-old ) for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. At age of 8-year-old, patient took smallpox vaccine on an unspecified date in 1968 in left arm for immunization and experienced sickness. When reporting on wife to agent, caller mentioned that he was much sicker when he was little and received the smallpox vaccine than with the Covid vaccine. Patient was sick for only a few days after he had the smallpox vaccine. Patient had severe fever and was throwing up. The outcome of events was unknown.

Talking caused SOB & nauseous/vomiting; Talking caused SOB & nauseous/vomiting; Fatigue after vaccination; fatigue increases.; Passed out at end of trip (confirmed ventricular tachycardia); Passed out at end of trip (confirmed ventricular tachycardia); Unable to walk > 10 ft/During trip, difficultly walking uphill; By midMay tolerates walking but gets SOB on staris/talking caused SOB & nauseous/vomiting/By midMay tolerates walking but gets SOB on stairs; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias.; Admitted to hospital (6/4) in 100% A fib & significant ventricular arrhythmias; Continued to worsen; Right ventricle pumping inadequately; Cardiogenic shock; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 23May2021 (at the age of 60-years-old), as unknown dose, single dose for COVID-19 immunization and varicella zoster vaccine RGE (CHO) (SHINGRIX) on 27May2021 for immunization. Medical history was not reported. Concomitant medications included Furosemide (LASIX). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 after vaccination, the patient experienced fatigue and it was increased. By mid of the May the patient tolerates walking but got shortness of breath (SOB) on stairs. On 20May2021, the physician doubled Furosemide (LASIX) dose for unspecified trip. During the trip, the patient had difficulty walking uphill. It was reported that patient passed out at end of trip, it was confirmed with ventricular tachycardia. On an unknown date, the patient underwent echocardiogram, and the ejection fraction was 25%. On 04Jun2021, the patient admitted to hospital in 100% atrial fibrillation & significant ventricular arrhythmias. The patient was treated with Intravenous heparin and he was kept for 2 nights in the hospital. It continued to worsen. On 08Jun21, the patient was unable to walk more than 10 feet, while talking caused shortness of breath and nauseous/vomiting. The patient was admitted to another hospital. On an unknown date, in hospital the patient had an esophageal echo to rule out (R/o) any clots in heart or lungs. On 09Jun2021, a cardioversion and on 10Jun2021, an angiogram was performed, it did not show any blockage or valve problems but showed the right ventricle pumping inadequately. The patient was advised new medications which included amiodorone. The patient was currently diagnosed with cardiogenic shock and expected to remain in CCU (cardiac care unit) until end of week. It was also reported the patient was hospitalized for Life threatening illness (immediate risk of death from the event). Seriousness criteria was reported as life threatening and prolonged hospitalization. The outcome of all the events was unknown. Information on Lot/Batch number has been requested.

Chest pain in heart region at night progressing to pain radiating down left arm and up left side of neck and slight nausea. Symptoms similar to beginning of heart attack, so went to emergency room for observation. No signs of heart attack were detected and emergency room doctor suggested follow up with heart specialist. Follow up also showed no heart attack occurred. Pericarditis not detected with stethoscope but was suspected. Pain in heart region was not severe, ~level 2, but was persistent. Heart doctor said that was not consistent with heart attack which tends to be severe but episodic. Slight pain noticeable in heart region for weeks afterward and still evident but now very slight. Not acute, but joint pain seems slightly increased after the vaccine.

Patient presented to the ED with dizziness/lightheadedness and nausea, was diagnosed with TIA and elevated serum creatinine within 6 weeks of receiving COVID vaccination.

1st dose of vaccine administered on 03/25/21 at 1:30 pm. Side effects: 03/25/21-03/28/21 ? pain on the site of injection; nausea. 03/26/21-04/04/21 ? increased tone of facial muscles; tiredness. 04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region. 04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone. 04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice. 04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice. 04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL 04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain. Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small). Temperature is in the normal range since 05/09/21. 06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL Looking for suggestion to do or not to do second vaccine administration.

Vaccinated person reported pain in his hands, nausea and chest pain approximately 48 hours post second Pfizer vaccine. was diagnosed with a STEMI heart attack and then coded on April 26, 2021.

Extreme muscle pain, chills, headache over right eye, fatigue, nausea, arm soreness at injection x 24 hours

tachycardia; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; This is a spontaneous report from a contactable other hcp reporting for himself. A 60-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9262; Expiration date was not reported), intramuscular, administered in Deltoid Left on 12Feb2021 15:15 (at the age of 60-years-old) as single dose for COVID-19 immunization. Medical history included spinal stenosis, spinal laminectomy from Jun2003 and ongoing, intervertebral disc operation from Jun2003 and ongoing, intervertebral disc operation from an unknown date and unknown if ongoing Failed L3-4 LAMI Discectomy, seroma from 2003 to an unknown date, intervertebral disc protrusion, HNP L4-L5 Protrusions, back pain (Back spasms), reduced inflammation from an unknown date and unknown if ongoing. It was reported that the patient had laminectomy discectomy approximately from June 2003 and not fully remedied, ongoing; pertinent details: L3-L4 laminectomy/ discectomy in 2003 with infection with difficile large seroma. family history: copd. Concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for intervertebral disc operation, spinal laminectomy, intervertebral disc protrusion from 2021 and ongoing; diazepam (DIAZEPAM) taken for back pain; lidocaine (LIDOCAINE) taken for impaired work ability from 2013 and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for inflammation from 2020 and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247), via intramuscular route in left deltoid on 22Jan2021 at 15:15 for covid-19 immunization. The patient previously took penicillin and had known allergy. Other vaccine in four weeks, covid prior vaccination, prior vaccinations (within 4weeks) included none. Vaccine was administered at hospital and not administered at military facility. The patient experienced sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160/110 on 19May2021 11:30. Patient received treatment with portable B/P monitor and reduced duty in Radiology. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 22Apr2021 Nasal Swab test. Other Relevant tests included none. It was reported that patient experienced tachycardia on 22May2021 11:30. Reporter considered the event seriousness criteria as important medical event. AE required patient a visit to Physician Office and patient received no treatment for tachycardia. Outcome of tachycardia was not recovered, and other events were recovered with lasting effects on unspecified date in 2021. Reporter considered that the Pfizer product had a causal effect to the adverse events.

Seen in the Emergency room on 4/29/21 for chest pain and nausea, vomiting, numbness and tingling in feet and hands. Various tests were performed to rule out a heart attack. We were told they felt the symptoms were due to side effects of the COVID-19 vaccination. Told we could go home, if symptoms worsened or persisted to check with our primary or return to the ER if needed. We returned home, symptoms did worsen, returned to the ER on 4/30/21. PT was admitted to the hospital and eventually diagnosed with Guillain-Barre Syndrome, type AIDP (acute inflammatory demyelinating polyneuropathy), elevated troponin levels, low vitamin B12, and hypertension. He was hospitalized through 5/11/21 receiving IVIG treatments and then referred to an acute rehabilitation facility through 6/24/2021. Released to home and receiving in home therapy services currently.

Fatigue; Headache; Muscle pain; Nausea; Feeling unwell in general; This is a spontaneous report from a 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 24Mar2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to CEFTIN. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within the 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:00, the patient experienced fatigue, headache, muscle pain, nausea and feeling unwell in general. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the fatigue, headache, muscle pain, nausea and feeling unwell in general were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Dizziness; not able to stand; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er2613) via an unspecified route of administration in the left arm on 27MAr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient previously had pollen allergy. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: en6205) via an unspecified route of administration in the left arm on 06Mar2021 at 04:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, the patient experienced dizziness, vomiting, and difficulty in standing 6 hours after vaccination (at 22:00). The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events dizziness, vomiting, and difficulty in standing was recovered on an unknown date at the time of report. No follow-up attempts are needed. No further information is expected.

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.

Death 7/25/21 N17.9 - AKI (acute kidney injury) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type

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.

I don't have a gallbladder so I follow a strict diet to prevent abdominal distress. About 4 hours after receiving the vaccine I experienced moderate abdominal gas that required otc medicine to alleviate. The issue was resolved in a few hours.

Headache; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-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 30Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, diarrhea and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, diarrhea and fatigue. The clinical outcome of the events headache, diarrhea and fatigue were recovered on an unknown date. No follow-up attempts are needed. No further information is expected.

Headache; Fatigue; Nausea; Chills; 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: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 10:30 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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, the patient experienced headache, fatigue, nausea and chills. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, nausea and chills were not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

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.

Myalgia & Diarrhea Narrative: Per employee, 14 hours after vaccination, felt abdominal cramps followed by watery diarrhea and sore left arm (vaccine site). No hx of changes in food prep nor diet 1/1/2021. Denied fever, some sniffles (chronic) diarrhea improving bowel movement mid morning following day

Got dizzy after vaccine and was told to sit down for 15 min after 15 I still felt dizzy so I stayed seated for an extra 10 min, still felt not ok but enough to go. Went home and still felt dizzy and then I felt like I need to pee but I was very cold , urinated 3 more times thinking it was because it was due to being cold but doctor explained it was due to me drinking lost of water. Went to bathroom and bassed out and woke up about an hour later, but during the fall I injured the neck by heating your head on the sink, back and broke my nose, when I woke up I was still very dizzy. Also felt a fast heart rate, chest pain, very nauseas and started sweating a lot.

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!

High fever; Vomiting; Severe fatigue; Weakness; This is a spontaneous report from a contactable physician (patient himself). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1442), via intramuscular, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 61-year-old. Vaccine location was deltoid left. The subject did not have a relevant medical history and concomitant medications. On 06Jan2021, the patient developed high fever, vomiting, severe fatigue and weakness. He did not experience anaphylaxis. The events were considered serious as medically significant. The patient stated that side effects mentioned lasted 3 hours and he felt much better now. However, the final clinical outcome was unknown. The patient is not sure if he should get the shot again in 3 weeks since he was really sick. The reporting physician considered the events 'high fever', 'vomiting', 'severe fatigue' and 'weakness' related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, vomiting, fatigue and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

fever of 101; Chills; loose watery stool; stomach problems; threw up a couple of times; headache; Nausea; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), via an unspecified route of administration on 05Jan2021 at a single dose (with a syringe left shoulder once; as reported) for Covid protection. Medical history was reported as none. There were no concomitant medications. It was reported that the patient experienced side effects on first Pfizer Covid injection that he had. He got it on Tuesday, 05Jan2021, and got a headache and nausea which started Tuesday evening. His temperature is 99.6. On Thursday, 07Jan2021, he had a fever of 101, nausea, chills, loose watery stool, stomach problems and threw up a couple times. He was under a blanket for the chills all day. His lasting effects was that he still has watery loose stool and went to the bathroom an hour ago. He took Tylenol for fever. He took Immodium yesterday three tablets and woke up at 3-3:30 am and took a couple (also reported as started taking it at 11am then took some at 4am and then two this morning) then some Tylenol. He was still feverish and has loose stools. The patient underwent lab tests and procedures which included body temperature: 99.6 on an unspecified date and 101 on 07Jan2021. The outcome of the events headache, nausea and loose watery stool was not recovered; the events fever of 101 and chills was recovering; and the event threw up a couple of times was resolved on 07Jan2021; while the outcome of all other events was unknown.

Some injection site soreness; Joint pain; Muscle aches; A little temporary nausea; This is a spontaneous report from a non-contactable consumer. A 61-years-old male patient started to receive received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number FL1284, via an unspecified route of administration on14Jan2021 09:00 at SINGLE DOSE for COVID-19 immunization. Vaccine location: Left arm Medical history included cardiovascular disorder, colitis ulcerative and depression. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), colecalciferol (D3), fluoxetine (FLUOXETINE), mesalamine (MESALAMINE), rosuvastatin calcium (ROSUVASTIN), ubidecarenone (COQ10 [UBIDECARENONE]). On 14Jan2021 19:00, patient experienced injection site soreness with outcome of recovered, joint pain with outcome of recovered, muscle aches with outcome of recovered and a little temporary nausea with outcome of recovered. The action taken was not applicable. No follow up attempts are possible. No further information is expected.

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

I was asked to sit down for 15 mins in the observation chair. I started to feel a warm feeling in the arm went back to work.The next day arm was sore at the injection site went away that night. On Friday night started vomiting and diarrhea at the same time.After 3 days following Monday I went to ER stayed 2 wks 12 days with blockage small intestine.

This is spontaneous report from a contactable consumer (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included Blood pressure high, Cancer (Two or less years ago; In remission, Taking medication to follow through with remission period), Allergies and sinus issues, covid virus (in July). The patient reported soreness in the arm (15Jan2021), fatigue (15Jan2021) and palpitations (16Jan2021) that he felt below the mouth and above the heart, calling it the esophagus area. He wanted to know if others had reported this same palpitation. The reporter further reported that he has a little bit of concern. He felt fine, had sore arm and fatigue that has gone away. Noticed lately, somewhere in his esophagus between his heart and mouth that he is feeling palpitations. Doesn't know if it's more indigestion. Stated it could be gas. Sometimes comes and goes, feels different than what he's already experienced. Wanted to double check if this has been heard of or anything similar to it. Clarified product as first dose of COVID-19 Vaccine. Received last Thursday. Received COVID-19 Vaccine in left arm on 14Jan2021 between 15:00 and 16:00. Both arms are sore, but only because other arm is injured. Pain level in injection arm was around 5-6 and he wasn't able to sleep on that side. Within the second day, 16Jan2021 in late afternoon soreness and fatigue was gone. Indigestion or Palpitations, feeling was happening again. They wanted to know if that is something he is experiencing from the COVID-19 Vaccine. Stated it doesn't appear to be related. It is around the esophagus. Stated it affects breathing. Stated maybe that has something to do with it. For the dose, they noticed it was a small amount of fluid in the tube that was injected into him. The outcome of the events soreness in the arm/sore arm and fatigue was recovered on 16Jan2021, while for other events was unknown. Information on the batch number/lot number has been requested.

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.

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

the swelling and extreme tenderness of the site of injection; the swelling and extreme tenderness of the site of injection; headache; I couldn't sleep last night because I have headache, thrombing headache and back pain; Nausea; I had like metallic taste; Dizziness; The initial case was missing the following minimum criteria: suspect drug. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician. A 61-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685, expiration date Mar2021) on his left arm, intramuscular on 18Dec2020 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertensive, 2 stents in heart in 2016, Hyperlipidemia, hypothyroidism, coronary artery disease in 2016 and Allergic (Allergic rhinitis + Chronic sinusitis). Concomitant medication included acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX). It was reported that the patient had swelling and severe tenderness left his arm. He couldn't sleep last night because he had throbbing headache and back pain on 18Dec2020. Initially, he had nausea. Patient stated further stated that Headache and swelling and extreme tenderness of the site of injection, that is the swelling, no redness but the swelling and tender and painful. Initially, he had till now the mild back pain. He patient said she took Tylenol. She also mentioned that initially she had like metallic taste and then disappear. The patient also had dizziness a little bit. The outcome of the event vaccination site swelling, dysgeusia and tenderness was recovered on unspecified dates, headache and back pain was not recovered, recovering for nausea while unknown for the remaining events.

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.

Extreme exacerbation of patient's longstanding Crohns Disease. Intractable liquid diarrhea for 5 days beginning approximately 48 hours after first shot; almost constant Fever; Body Aches; Strong lower back and hip pain; Bilateral pedal edema; dehydration; inability to absorb fluids for 5 days; arm, ankle, hip, back, shoulder, and wrist joint pain; difficulty getting out of bed in the morning, or getting up from the stationary position. Symptoms finally resolved day 7 just before I anticipated going to ED in local hospital, and were gone for two days. Symptoms returned on day 9 following vaccination and lasted 5 additional days, with symptoms resolving for good only on the 15th day after the initial injection.

sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.

This came on gradually over a period of about 5 hours: headache, aching in the joints, abdominal cramping, lethargy.

Slight light headiness - mid morning, early afternoon. Went away late afternoon. I did not take any medications Slight Nausea - late morning, all afternoon. Would eat and it would subside some. Went away late afternoon. Early evening.

significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; significant swelling and redness at the injection site with minimal pain; weakness; Nausea; mild myalgia; general muscle pain and aches; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), via an unspecified route of administration, on 28Jan2021 09:00 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. He did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. The patient had no relevant medical history and concomitant medications to report.The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported, NDC number: 59267-1000-1), on 09Jan2021 09:30 AM on the left arm for COVID-19 immunization, at the age of 61-year-old. He experienced myalgia at the injection site/pain at inject site after the first dose on 09Jan2021 and resolved on 12Jan2021. The first and second doses of bnt162b2 had the same lot number. On 28Jan2021, the patient received the second dose of bnt162b2. 24 hours later, on 29Jan2021, he experienced mild aches/pain, nausea/malaise. Three days (42-72hours) after 2nd dose, on 31Jan2021, he experienced "significant redness" and swelling at injection site with minimal pain. He described it as "Out of proportion to what should be expected". The redness and swelling were improving at the time of the report (01Feb2021). He asked if this should be of concern. He also asked if it was possible that the vaccine was given subcutaneously instead of intramuscularly. He developed a good amount of swelling and redness at the injection site. It seemed fine the first day. It took two or more days to develop the swelling. He added that he only had mild myalgia, weakness, and nausea initially on 29Jan2021 after the second dose of the vaccine. Then 48 hours later, he got the large amount of swelling and redness at the injection site. He later clarified he received the first dose of the Pfizer COVID 19 vaccine on 9Jan2021 at 09:30 AM in the left arm. He had some myalgia at the injection site on 09Jan2021 that went away on 12Jan2021. Then he received the second dose of the Pfizer COVID 19 vaccine on 28Jan2021 at 09:00 AM in the left arm. Initially he had no pain. 24 hours later, on 29Jan2021, he had myalgia referring to general muscle pain and aches and nausea that only lasted about two hours. He is mostly concerned now about the significant swelling and redness at the injection site with minimal pain which he noticed 48 to 72 hours after the second dose of the vaccine. He took some Aleve which gave some relief (for significant swelling and redness at the injection site with minimal pain). He asked if this is an expected side effect as it seem out of proportion to him. Outcome of events general muscle pain and aches and weakness was recovered on 30Jan2021. Outcome of event nausea was recovered on 29Jan2021. Outcome of events significant swelling and redness at the injection site with minimal pain was recovering. The reporting physician (patient) assessed the causality between the suspect vaccine and all events as related. He assessed the events "swelling and redness at the injection site with minimal pain" as medically significant (serious), while he assessed the other events as non-serious.; Sender's Comments: Based on temporal association and known product safety profile of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, expiry date: not reported), the contributory role of the product cannot be totally excluded. The events are known adverse event of the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

patient developed erythema at the injection site. he became nauseous and near syncopal. he then complained of chest tightness and DIB. Benadryl and two doses of epi given with no relief of symptoms. No facial swelling, wheezing, drooling, or hypotension. he was talking in sentences.

Cold sweat at 2am Achy all over and especially upper joints Injection site sore Cannot get warm Slight intestinal discomfort

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

Started 03/18 Headaches - stabbing/ache/pressure/burning/tingling Started 03/14 Tired Started 03/14 Dizzy Started 03/14 High Blood pressure Started 03/14 Slight nausea

Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00 AM

Patient received first dose of Pfizer COVID vaccine on 3/17/21. Around 3/19 or 3/20, patient started to feel fatigued with nausea, vomiting and diarrhea. He also developed fever, cough, and shortness of breath. He presented to the ER on 3/22 and was admitted to the hospital for supportive care and monitoring. Agency service was conuslted, and patient was started on COVID treatment with remdesivir and dexamethasone, and well as enoxaparin for VTE prophylaxis on 3/24.

I have vertigo and nausea that comes and goes throughout the day staring from 3/30. If I move my head I can feel the vertigo and nausea.

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.

Slight migraine headache, slight nausea, slight soreness on upper arm at injection site. Ibuprofen Lasted 2 days

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

Tinnitus in left ear. Soft high-frequency crickets when my throat gets stressed, including hiccups, burping, stretching, sometimes yawning, muscle tensing, sometimes swallowing, stretching to wake up in the morning. Last for the duration of the stress, a few seconds. Left eustachian tube slightly sore, slight earache. Has gone on for almost a week now. Best guess is nerve is pressured or damaged? Will try hydroxide in ear next, in hope it kills whatever's going on. Whether this will go away or not is unknown at present.

Patient said that soon after receiving his first COVID shot, he experienced extreme arthralgias and new onset arthritis in his knees, shoulders and arms. He said he never had this in his life and now struggles to ambulate distances > 100 feet and struggles to lift boxes at work. Today he received the second shot and that evening he experienced nausea, vomiting. and then passed out and was brought to the ED.

Began with left upper quadrant abdominal pain at approximately 1:30pm on 4/1/21, pain migrated to right side of abdomen by evening. Pain localized to right abdomen throughout night and into the next day with increase in pain. 4/2/21 approximately 6:30PM right lower abdominal quadrant very tender to touch. Individual taken to the hospital ER on 4/2/21.

The day after the shot, I was real tired. My arm was sore. I had the chills. My stomach was quezy . I had a slight headache . The day after that I woke up with a slight headache but by the afternoon all symptoms had disappeared.

Tiredness headache muscle pain chills joint pain fever nausea difficulty breathing swelling in the face a fast heartbeat dizziness and weakness stomach pain

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.

atrial fib; Short of breath; fatigue; Nausea; Dizziness; Unable to function; discolored; This is a spontaneous report from a contactable consumer(patient himself). A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration, at Right Arm on 24Mar2021 12:30 (at age of 61 years old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Short of breath, atrial fib, fatigue, nausea, discolored, dizziness, unable to function, all on 24Mar2021 14:00. Adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

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.

Chills and mild's fever for 5.5 hours. Then threw up a couple of times. I felt 95% better after throwing up. Now 5 days later my digestion system is still not back to normal with mild abdominal paisa.

The next day I was very sick. It felt like someone had beaten me up. I spent most of the day lying down and drinking water. I tried to eat something and slept more. When I awoke, it felt like four huge needles piercing my lungs. I had to use my albuterol inhaler it was so bad. My symptoms are normally completely arrested by the use of Advair and Spiriva. The albuterol caused a dry heaving fit during which I expelled quite a bit of phlegm from my lungs. I felt better and the pain went away after that. Since then I've been suffering higher levels of chest congestion than is normal for me.

Bleeding in stool; 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 26Mar2021 10:30 am (Batch/Lot Number: Er8733) as single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications within 2 weeks included amlodipine; cetirizine hydrochloride (CETRIZINE); carvedilol; oxymetazoline hydrochloride (AFRIN); diclofenac; and diclofeafrin, diclofe. Patient previously received first dose of bnt162b2 on 03Mar2021 10:00 AM at age of 61-year-old for covid-19 immunisation. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced bleeding in stool on 26Mar2021 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient didn't receive treatment for the event. The report was considered as non-serious.

Patient came to see me in the office on 4/12/21 and reported an adverse event that had happened after he got home from the drive thru vaccine clinic on 3/17/21. He had the vaccine around 11 am and later that evening, he is not positive of the time but between 7-9 pm, he developed severe swelling of his face and lips and tongue, he also felt nauseated. He called EMS and they found his bp to be low. He was not given EPI. His symptoms resolved on their own but reoccured the following evening; he went to ER and was monitored there; he was not given EPI at the ER. He was not admitted to the hospital. Symptoms have not reoccured and he is asymptomatic at this time. He was not sure if this was releated to the vaccine, but could not identify any new environmental or food items that would have triggered the reaction.

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.

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.

This patient came in to the community center to receive his 2nd dose of his Pfizer vaccine at approx 10:06am. At approx 10 minutes after sitting in the observation area, the patient started to fee hot, dizzy, some tunneled vision and nausea. This attendee did not have any sort of reaction to his first dose. This was brought to the attention of one of the observing staff members. This nurse, was called over to the patient. The attendee was asked to lay down on the cot provided and we elevated his legs. RN, measured his vital signs: bp 110/70, HR: 60, Resp 16, O2 97%. This patient denied any shortness of breath. Lung sounds were clear, and no wheezing or rhonchi were observed. This patient stated he has a history of Asthma and took his asthma medications this morning as normally directed. This patient was directed to lay down for approx 10 minutes, then stated he felt much better and wanted to sit up and take a sip of water. The attendee tolerated the water well. This nurse, advised for this attendee to stay for another 10 minutes until he had no symptoms present. The patient quickly felt better and stated that his wife was out in the car and would be driving him home. This nurse advised for him to go to the Emergency Room if he felt any of these symptoms again.

Fever or chills Cough Shortness of breath or difficulty breathing Fatigue Muscle or body aches Nausea or vomiting Diarrhea

Severe chills (2am 20 Apr thru 5am 20 Apr), fever to 103 (3am 20 Apr thru 3pm 20 Apr), mild fever (intermittent, 9pm 20 Apr to present), severe fatigue, diarrhea, dizziness, periodic nausea (all thru current)

Henoch Schonlein Purpura/IgA Vasculitis, with purpuric rash, abdominal pain, diarrhea 1 week post vaccination IV solumedrol followed by 8 week prednisone taper, rapid improvement with steroids after colonoscopy

Tongue swelling; could not process his breath; Could not swallow his saliva; headache; Nausea; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASL2021053617), license party for etanercept (ENBREL). This non-serious solicited report (USASL2021053617) was reported on 07/APR/2021 by a consumer from a commercial program (PSP00046b) and involves a 61 year old male patient who had headache [PT: headache], nausea [PT: nausea], tongue swelling [PT: swollen tongue], could not process his breath [PT: dyspnoea] and could not swallow his saliva [PT: dysphagia] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis. The patient's concomitant medications included methotrexate. The patient's co-suspect medication included covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. It was reported that the patient was using Enbrel for about five to six years. On an unknown date in MAR/2021, the patient received a recent injection of Enbrel. On 27/MAR/2021 at 10:00 AM, the patient received covid-19 vaccine. On the same day, the patient had nausea and headache but then it went away. On the same day at 05:30 PM, the patient had tongue swelling. The patient could not swallow his saliva and could not process his breath. Subsequently, the patient went to ER (Emergency room) and was started on Benadryl (diphenhydramine hydrochloride), prednisone and ranitidine. The patient was instructed by the physician not to receive a second dose of covid vaccine. The outcome of the events headache and nausea was reported as recovered/resolved. The outcome of the events swollen tongue, dyspnoea and dysphagia was reported as unknown. The events headache, nausea were resolved on 27/MAR/2021. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events headache, nausea, swollen tongue, dyspnoea and dysphagia. The causal relationship between the events headache, nausea, swollen tongue, dyspnoea, dysphagia and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up has been requested for lot number. Causality Assessment: Events Swallowing difficult, Breathing difficult, Swelling of tongue and Nausea were assessed to be not related to etanercept.; Sender's Comments: Based on a temporal association and the known safety profile, the reported events are considered possibly related to BNT162B2. The events were unrelated to etanercept. 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.

Starting 3-4 days after injection, began to have increasing pain in buttocks. Pain became more severe, spread to hips, then to knees/quadriceps over next 3 days - during this time, pain was relieved with Tylenol for 2-3 hours, then the pain would "break through" the Tylenol. Three days after onset pain was unbearable and consistent for 2-3 days. The pain slowly subsided over next 3 days without intervention. Morphine and Valium was required to manage pain in ER.

Severe Headache; Muscle ache; Abdominal pain; lost his appetite; had a horrible feeling in his stomach, almost like the stomach flu; cold and had trouble maintaining his body heat; significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week; nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick; Sore Arm; Runny Nose with Mucous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Batch/Lot Number: EN6206) (at age of 61-year-old) as single dose for COVID-19 immunisation. Medical history included Slightly Diabetic from 2009 to an unknown date. The patient stated he doesn't smoke or do drugs, or drink and he tried to eat good healthy food. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 10Mar2021 (at age of 61-year-old) (Lot number: EN6200) and experienced sore arm and runny nose with mucous. The patient experienced sore arm on 01Apr2021, runny nose with mucous on 01Apr2021, nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick on 02Apr2021 , severe headache on 07Apr2021, muscle ache on 05Apr2021, abdominal pain on 02Apr2021, lost his appetite on 02Apr2021, had a horrible feeling in his stomach, almost like the stomach flu on 02Apr2021, cold and had trouble maintaining his body heat on 02Apr2021, significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week on 02Apr2021.Clinical course: The patient had his second shot last Wednesday, 31MAR2021, and he was calling to report his adverse side effects. The patient stated he had a sore arm which was okay and runny nose with mucous, which was similar to his experience with his first shot, but then things went downhill. The patient stated with the first vaccine, he had arm pain that evening and it really wasn't bad. Stated there was an hour where it was really intense like he got shot up with something pretty powerful, he had a yucky feeling like when you catch the flu and get the first kick and then it went away. Stated he had a runny nose that first came on and lasted pretty much until he got the second vaccine, stated it got not so severe and heavy and decreased until the second shot and then went up again. Stated with the second vaccine he lost his appetite and he developed nausea in his stomach to the point where he couldn't eat and every time he did try to eat, it made him really sick. Clarified he did not have vomiting or diarrhea. Stated he just had a horrible feeling in his stomach, almost like the stomach flu. The patient stated yesterday (07Apr2021) was bad and he spent the last 2 days in bed. Stated while he was sick, her ate half a sandwich, that was all he could stomach and could eat. Stated he had significant weight loss, he went from 218 lbs. to 210 lbs. so he lost 8 lbs. over a week. Stated looking at his waist line he can tell he has lost weight. Clarified most of the pain was in his lower abdominal pelvis region, large intestine area. Stated he had a severe headache yesterday (07Apr2021). Clarified that it has significantly improved. Stated he still felt tension in his head but nothing compared to yesterday (07Apr2021) with the pounding migraine type of headache. Stated he was cold and had trouble maintaining his body heat. The patient clarified the phases of his events mimic the flu but unlike the flu, he wasn't coughing, but he was having the physical pain of the flu but not the normal symptoms you would expect like heavy mucous, coughing, sneezing, like if he had the flu or a cold, but he felt like he was going through the flu. Stated he had muscle aches. States his back is normally okay but he injured it in the past and it started to hurt especially at the points that were injured. The patient stated just before he called, his husband brought him some soup and he just finished that and he didn't feel immediately sick after eating something so it seems to have significantly improved. Caller states yesterday (07Apr2021) was the worst. Stated he has isolated, he didn't have to go out and lives in the mountains, he only goes out for groceries and they bring it out to him. Stated he did go to the hospital where he received the vaccine, he could have picked up something at the hospital. Stated he hasn't exposed himself to anything, no bars, gym, church, he is not hanging out with anyone, he maintained as restrictive environment as one could have and he wears a mask when they are putting the groceries in his vehicle. Restated that yesterday (07Apr2021) and last night were the worst and everything has significantly improved. Treatment: Been in bed for the last 36 hours, today (08Apr2021) he is actually up enjoying a beautiful day. The events did not result in emergency room visit or physician office visit. AE(s) following prior vaccinations: Every time got flu shot, and he didn't get them anymore, he got sick as a dog for a couple of weeks, with yellow phlegm. Stated he thought it was supposed to protect him, why is he so sick and hacking up phlegm? Stated maybe he is one of those people that doesn't do well with vaccines. Stated this is a new type of vaccine MRNA and it could just be him. Stated not all vaccines, it seems like flu vaccine kicks him in the keister but has had other vaccines like the MMR and no issues with that, no pain no nothing. The outcome of events Sore Arm was resolved on 03Apr2021 and Runny Nose with Mucous was resolved on 06Apr2021 and of the rest of events was Resolving. No follow-up attempts are possible; No further information is expected.

On Friday, April 23/ 2021 @4PM I began to feel pressure built up on my chest. @ 4:15 the pressure also built up on my neck. I was short of breath and I can feel the heartbeat way too high. I recall the person that gave me the first Pfizer shot to get ready for side effects after the second shot. @ 4:30pm the pressure was all over the back, the chest and the neck. Making things worse the jaw and lower teeth were also in extreme pain. I laid down on the sofa and must have passed out. 20 minutes later I began to come around but I was way weak and the heart beat was beginning to relax. The body pressure was present till 6pm I did not know what to do at that time other than take a nap. I was not able to eat any food until Saturday 6PM.

Aches, profuse sweating, fever, chills, no appetite. No resolution after 4 days. Ambulance called after 3 days w/ recommendation to be taken, but refused.

Nausea started a few days after my second dose. I contacted my PCP . He recommended doing COVID test, which I did at the Hospital - results were negative. I have ruled out diet as a source of nausea by fasting (significantly lower food intake than usual). Stopped drinking tea, which aggravated nausea symptoms. The symptoms persist after 3 weeks! Nausea is strong in the morning, and little better as day goes buy. I never had this problem in past decade or so, therefore I believe its the vaccine that's doing this.

Symptom: Very sharp pain at top of stomach followed by very low heart rate and brief loss of consciousness after 1 hour Diagnosis: Partial thombus (blood clot) of celiac axis which extended into the common hepatic artery and splenic artery Treatment: Blood thinners Timeline: Stabilized farily quickly and then pain subsided after 2 days Course of treatment: Monitor for any additional symptoms through additional CT scans

heart attack; severe diarrhea; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration on 11Mar2021 01:15 PM in the left arm at 61-year-old at single dose for COVID-19 immunization. Patient had known allergies to CT scan dye. And other medical history included heart. Patient had no covid prior vaccination. There is no other vaccine in four weeks. Concomitant medications in two weeks included: atorvastatin, metoprolol, clopidogrel bisulfate (PLAVIX), amlodipine. Patient got severe diarrhea within 4 hours that was so sever and it was every 10 minutes in frequency first day on 11Mar2021 04:45 PM. He still had diarrhea now 6 weeks after the 1st dose of Pfizer COVID vaccine on 11Mar2021. Also, he had a heart attack 39 hours later on 13Mar2021 which he was hospitalized for 5 days at the hospital. The adverse events resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received treatment for events included heart emergency drugs, catherization for the heart. Patient received covid tested post vaccination, Nasal Swab (PCR) negative. Blood test (covid antigen test): negative. Patient was not recovered. Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) on 01Apr2021 01:30 PM in the right arm at single dose for COVID-19 immunization.

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

Bloody diarrhea; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 15Apr2021 13:00 (Batch/Lot Number: ER8731) as a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included ibuprofen. 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. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. The patient experienced bloody diarrhea on 17Apr2021 10:00 with outcome of recovering.

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.

The second dose of the vaccine triggered a moderately severe RA flare lasting from 28 April to 29 April. Significant flu-like full-body joint pain, moderate fever (100.5 F against a normal base of 97.3), and light nausea. Joint pain continues as is usual for such flares, since some light damage likely occurred in my joints. I was unable to take NSAID or Prednisone (as I normally would for a flare) due to the vaccine. Acetaminophen taken but ineffective. NOTE: My RA is being treated with Rituximab, two doses every 4 months. Next dose scheduled 11 May 2021. Prior dose completed 12 January 2021.

Day 1 headache and sore arm. Day 2 intermittent weakness in both legs and cramps in the calves. Day 3 gradual withdrawal of reactions. Early am Day 4 , while sleeping stabbing pain in liver and gallbladder area (under right rib). Pain came on 5-10 minute intervals for 4 hours. Day 4 was at a hotel in another city. Pain was gone by Day 5. Neck was sore throughout the 5 days post vaccine.

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.

Nausea and dizziness started around 11:00 AM and ran for 4-6 hours. Mild fever and coughing started around 3:00 PM got up to 99.8 and ran till bed at 8:00 PM. Took Acetaminophen PM at bed time and was over majority of symptoms by morning, 5:00. Felt like prelude to when I got Covid in April of 2020. Have heard 2nd shot is usual side affects and worse so not looking forward to second shot. (but will be getting on 5-28-2021)

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.

body aches to "back, legs, knees and ankles," loss of appetite, fatigue and mild cough. Hypoxia Pneumonia due to COVID-19 virus Nausea & vomiting COVID-19 virus infection

2 hours after receiving his first vaccine the patient was presenting with light headedness, sweaty, pale, and stomach pain. I took his BP and it was 80/60 with a pulse of 60. I called 911 because he had a history of CHF and I didn't want his pulse to drop and not have other trained personnel on hand if CPR was required. I gave him water to try to raise his BP and rechecked his BP after 5 minutes and it raised to 127/83 with a pulse of 64. He stopped sweating and his color came back in his face at that time. The EMT's rechecked vitals and ended up taking him to the ED to run tests.

Called patient for a follow up and patient states has been sick for 3 days. Asked patient what sick meant and patient states has been vomiting and had cold chills every since he received the vaccine. Asked the patient if he would like an anti-nausea medication and patient stated that it wouldn't hurt. Sent in prescription for Zofran 4 mg po q8 hours as needed for nausea and vomiting x 5 days to patient's pharmacy. Told patient to watch for s/s of dehydration and to go to ER if these occur. Told patient to increase non-caffeinated fluids. Told patient that a report would be made.

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 .

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.

AS SOON AS WE COMPLETED VACCINE , HE START FELLING HOT AND NAUSE AND HE SAID HE FEEL LIKES HE WILL PASSOUT , WE GAVE HIM 1 TABLET OF BENADRYL 25 MG AND CALL 911 ,AFTER 5 MINUTES HE START FEELING GOOD AND EMS ARRIVED IN 10 TO 15 MINUTES CHECCK HIS BLOOD PRESSURE AND PULSE AND HE FELT GOOD AFTER 15 MINUTES AND WALKED TO HIS CAR.

He had extreme fatigue for 2 days after the vaccine. About 2 days after the vaccine, he developed watery diarrhea that has persisted for 2 weeks.

tiredness; headache; chills; Achy; threw up; nausea; This is a spontaneous report from a contactable consumer (patient wife) reported for her husband (patient). This is the report 2 of 2. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm right on 05May2021 at 15:45(at the age of 61-years-old) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included high cholesterol, ongoing from an unspecified date, high blood pressure, ongoing from an unspecified date and acid reflux, ongoing from an unspecified date. It was reported that, the patient takes medications for these, but the reporter does not feel these medications are relevant. The patient's concomitant medications were not reported. Patient took Covid-19 vaccine to prevent Covid-19 virus. No other vaccinations within four weeks prior to the vaccination. The history of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Adverse events following prior vaccinations were reported as none. The caller stated that, 14 days after receiving the first Covid-19 vaccine, the patient experienced tiredness, chills, headache, achy, nausea and he threw up when he got to work on 19May2021. Stated that, she does not have her husband's Covid-19 vaccine record card with her at the time of the call. It was reported that, no adverse events required a visit to emergency room or physician office. The relevant lab tests and procedures included were none and no investigation assessment was reported. The outcome of the events was recovering. Follow up (25May2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer(patient wife) reported for her husband (patient) included RMH, Patient details, outcome details, suspect product details, event details. Information about batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021599251 same report/drug/AE, different patient

Reports nausea, myalgias, lightheadedness, headaches, chills, diaphoresis, fatigue, chest pain, cough, dyspnea on exertion and shortness of breath at rest, most symptoms are chronic but reports worsening with second Covid vaccine.

This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EN6203) via an unspecified route of administration in left arm on 12Mar2021 at 10.00AM as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number; EL3247) via an unspecified route of administration in left arm on 19FEB2021 10:00 AM as a single dose for COVID-19 immunization. Medical history and concomitant medication was not reported. Patient was allergic to Iodine. Prior to vaccination, patient was not diagnosed with COVID-19, since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 12Mar2021 at 23:00 hours. the patient experienced body temperature (101 degrees), headache, diarrhea, nausea, chills, fatigue and body aches. The clinical outcome of the reported events was recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

2 days after vaccine developed diarrhea & body aches, then loss of smell and appetite. ED visit 4/8/2021, lymphopenia noted, COVID PCR positive. Returned to ED 4/11/2021 with SOB, oximetry low 70s, cyanotic, respiratory distress, elevated D dimer, CXR: COVID pneumonitis. "Deteriorated quickly despite maximal medical management" per Discharge Summary. Died 4/24/2021 from hypoxic respiratory failure and multiorgan failure, shock. Had also developed heparin induced thrombocytopenia during treatment for DVT Right lower and upper extremities.

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

some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report freceived rom a contactable other health care professional. A 61-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration and administered in left arm on 05Feb2021 10:00 (at age of 61 years) as dose 1, single for COVID-19 immunization. The patient didnot had covid-19 and was not tested for covid-19 prior vaccination. The patient was not tested covid post vaccination. The patient had no other vaccines in 4 weeks. The reporter was not aware of known allergies. The patient medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE), vitamin D NOS (VITAMIN D NOS). The patient experienced arm Soreness, some diarrhea issues the first 2 days with some stomach cramps, he have a bit of dizziness that he awoke to this morning. The patient didnt received any treatment for events. The outcome of events was recovering. Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.

Severe abdominal pain located right hand side below navel toward hip; This is a spontaneous report received from a contactable patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in the left arm on 18Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure but under control with medication. The patient was allergic to nuts, some fish, melons. Concomitant medications received (unspecified medication). Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 01: 00, the patient experienced severe abdominal pain located right hand side below navel toward hip. The patient did not receive treatment for the event. Adverse event not resulted in doctor health care visit. The clinical outcome of severe abdominal pain located right hand side below navel toward hip was not recovered. No follow-up attempts are possible. No further information is expected.

Chest pains, almost passing out. profuse sweating,throwing up, EMT ride to Hospital, full series of heart and arty tests. Cat scan EKG,ultra sound, blood tests, All came back negative no known cause for episode. Only thing different in life style was the vaccine

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

Patient admitted to MCH-BG on 7/12/21 with complaint of chest pain starting 2 days prior and worsening. No radiation quality of chest pain. Also complaint of diarrhea x2 days and sweating. Diagnosed with community acquired pneumonia on admission. Possible exposure to COVID at residential facility, so COVID testing was ordered which resulted as positive.

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.

Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all my bones, vomiting, feverish , extremely tired and in bad mood. Chills and numbness on the left side of my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood. Light bother me a lot, feel nauseas. I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength. Everything hurts, especially when I walk, I feel very weak.

low grade fever; body aches; fatigue; some nausea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 31Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included gout. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) 300 mg daily from an unknown date and for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6199) via an unspecified route of administration in the right arm on 10Mar2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 01Apr2021 at 04:00, the patient experienced low grade fever for 2 days, body aches, fatigue and some nausea. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events low grade fever was resolved on 03Apr2021, while that of body aches, fatigue and nausea was resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

Body ache; upset stomach; Headache; Chills; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 13:00(at the age of 61-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 00:30, the patient experienced body ache, upset stomach, headache, chills and tiredness. The patient did not receive any treatment for the event. The clinical outcome of the event body ache, upset stomach, headache, chills, tiredness was not resolved. No follow-up attempts are needed. No further information is expected.

Kind of tired after first shot; Stomach was kind of irritated; Back hurts a little bit more; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 12May2021 (age at vaccination: 61 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pain pump which was removed on an unknown date in 2015 at hospital. It was 16.5mg per day plus outside medicine. They were supposed to remove pain pump, but they let it run dry, he was regurgitating for 5 days, every 30 minutes. They got the pump out because he started getting tremors, and that's what gave him the memory loss. It was helping the pain quite a bit that's the only thing it was doing in the back. When they took the pump out, they left a piece of the catheter in one of the discs, he could feel that more than ever. They had him in like an outpatient for people that abuse drugs, he was just there to get the pump out. The patient had dementia, but he was surprised that he can remember his address and driver's license; that his memory is coming back quite a bit. Surgery on shoulder, fell right on that shoulder a week after surgery on shoulder, allergic to about 15 different medicines mostly the heavier ones like the muscle relaxants, 100 percent disabled, had 8 ulcers, stomach sometimes flares and back pain. Some of the shots he had from pain management were like epidural. The patient's concomitant medications were not reported. On an unknown date in May2021, the patient experienced kind of tired after first shot, stomach was kind of irritated and back hurts a little bit more. He didn't have blood work. He said he would have to terminate pain management if he was not comfortable with this. The patient said that he was unsure if this was related to the shot. It might not have been the shot. The kind of tiredness was more the issue because he already has back problems before, has a compression, broke. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Stomach has pains. Drank lots of water and got lots of walking at work. Symptoms slowly lessened throughout the day but still feeling them at 10:30 pm.

Stomach gas pains. Drank lots of water and got lots of did a lot ofwalking at work. Pain slowly subsided throughout the day but was still somewhat present at 11:00 pm.

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

On Jan 12th developed sever left upper abdominal pain or left lower rib pain. After Ct scans left lower lung atelectisis and splenomeglia . Also enlarged Lymphnodes in the Mesentergic areas.

Right arm numbness that radiated to right side of the neck. Weakness headache and shortness of breath, difficulty swallowing.

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.

The fist day I started feeling dizzy and stomach didn't feel good. On the second day I started having problems with my vision in my left eye, I went blind for 20minutes. When I did get my Vision back I got and slight headache. About 3am in the morning, I woke up like someone hit me in the head with a hammer. After that every second or third day the pain would come back and it would be worse, it brought tears to my eyes. I started taking Tylenol but then it stopped working. it kept kept getting worse and I went to see my Dr. and she put me on some medication, but they did work and she sent me to a Neurologist and he put two medications. They seem to be working, I'm not having them as much. I'm calling tomorrow to see when my appointment is scheduled.

Dizziness and feeling of difficulty swallowing . Pt symptoms resolve and vitals sign were stable upon evaluation by EMS. PT refused Treatment or transport

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.

fever at 100.4; Headache; Nausea; Sniffles; Chills; he was beated down with sweat; body aches; does not have an appetite; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EH9899, intramuscular in the left arm, on 08Jan2021 16:30 at 0.3 mL, single for COVID-19 immunization. Medical history included ongoing high blood pressure and spinal surgery in Jan2019. Patient's eyesight was not the greatest. Patient previously received flu vaccine on an unspecified date (the last couple of years). Concomitant medication included amlodipine besilate for blood pressure. He was scheduled to get second dose on 29Jan2021. The Saturday before he was scheduled to get the second dose (23Jan2021), he started feeling sniffles and stuff. He went to urgent care and he was tested for covid and the test came back negative. He then kept feeling bad. He clarified that on 24Jan2021, he had headache and nausea. He had chills and he was beated down with sweat; body aches which are constant and he would try to blame it on the position he was laying in while on the couch and it was not that; and does not have an appetite on an unspecified day in Jan2021. He has been in really bad shape for the last 9 or 10 days. When he went to go get his second shot, they would not give it to him due to his symptoms that he was experiencing since she had a fever at 100.4 the night before (28Jan2021). They scheduled him to get his second dose the following which was this Friday. He was asking if his side effects are totally normal. He cannot even sleep, reported that he will sleep an hour and then up for two or three hours. It really has him, and he feels miserable. The outcome of events Chills, nausea and fever at 100.4 was not recovered. Outcome of sniffles was recovered in Jan 2021 while the outcome of the remaining events was unknown. Therapeutic measures were taken as a result of sniffles; he went to urgent care and they gave him something like zyrtec, states it was an allergy medication and it wiped out the sniffles for fever, he will take Tylenol and it will break the fever for a few hours and then his fever comes right back. Follow-up attempts are completed. The information on the batch/lot number has been obtained.

Patient developed nausea, vomiting, and abdominal pain within 8 hours of first dose of COVID-19 vaccination on 3/5/2021. Patient continued to have symptoms overnight, but is reporting mild improvement in symptoms on 3/6/2021 in the morning.

Severe pain in lower right back, will last 1-2 hours as pain subsides, dry heaves begin. This has happened on 3/8, 3/9 and 3/10.

Sudden nausea getting out of shower and vomited. Stretched out on sofa with two hard ginger candies to help with queasy feeling.

Diarrhea that came on quickly (though I had taken some Gas-X the hour before as I was feeling unusually gaseous), the diarrhea lasted 30 minutes, and emptied a lot of my digestive tract. I drank plenty of fluids after this, slept OK, and ate well in the morning. So it was a short, but significant event. No noticeable fever or other symptoms.

62 yo M with no known medical history awoke 12:15 am on 3/11/2021 and told his wife he had "pain all over". When she asked if it was chest pain, he said he didn't know. He went downstairs, vomited, slumped over against the wall behind the couch, and became unresponsive. Wife called 911 and was instructed to begin CPR. EMS crew arrived shortly after that and performed prolonged resuscitation efforts as per ACLS protocol. Pt pronounced at 3:15 am. Patient had not seen a physician in many years, had not had any vaccines in over 20 years, took no medications, and had no known medical history. He did have a strong family history of heart disease and had told his wife the week prior to his death that he had suffered a several-hour bout of chest pain that resolved spontaneously 2-3 days prior to his telling her about it. He refused to seek medical evaluation despite her urging.

Day 1 (evening): soreness in arm radiating to back and neck, accompanied by waves of light nausea, resolved itself after about two hours. Low-grade headache continued to bedtime w/no appetite. Day 2: Low grade headache and lightheadedness. Light nausea only after eating. Resolved by dinner. Day 3: Some lingering fatigue, but symptoms mostly resolved.

I've been running a fever for almost 4 weeks now. I have to continually take Advil. My liver enzymes are high. Tiredness and fatigue. At times I have an upset stomach. I have been checked for Covid 3 times and each time is negative. I went to the emergency room on March 15. I was given fluids and an antibiotic through the IV. I have been to the Dr. multiple times. They have checked me from head to toe and are puzzled. This all started the day after I got the first shot.

Left side of face pain and swelling, under jaw and ear pain, tongue pain. Difficulty swallowing and speaking. This continues after four days!

Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain

Second COVID vaccine received 01/06/21. Within 24 hours developed fever, chills, malaise, myalgia, nausea, vomiting, diarrhea. Duration 8 hours, clinical dehydration, missed one night ED shift(HCP). 5 days post vaccine, 01/11/21 developed neck and chest pain, progressed requiring ED visit 01/12/21. Cardiology consult, negative cardiac evaluation. Persistent intermittent chest pains, usually exertional and post-exertional. 02/05/21 developed atrial fibrillation with rapid ventricular response with unsuccessful cardioversions, small pericardial effusion by echo. 03/11/21 readmission for enlarged pericardial effusion and pericardiocentesis. Continue high dose aspirin, colchicine, metoprolol, flecanide. Have not returned to work.

Cold sweats 64.5 hours later, causing fainting, followed by vomiting 6 times and diarrhea once. Recovered after 1 hour.

15 hours after vaccination had chills, fever 0f 100 F. 16 hours post vac. had nausea and vomiting (dry heaving) for 6 hours.

Chills and fever started approximately 12 hours after injection, at 3:00 a.m. on morning of 3/30, followed by a very bad headache and body aches. At around 1:00 a.m. on 3/31, nausea and vomiting began, and continued throughout the day into the evening, anytime food or liquids were injested. Headache and body aches continued.

Shortly after receiving vaccine, participant's wife summoned nurse, found him sitting in car with eyes open, but unresponsive. After approx. 30 sec. he was responding to questions; c/o feeling light headed, nauseated and had 'limited' vision. B/P 110/74, O2 sat 87%, HR 51. EMS arrived and assessed participant. Repeat B/P160/102 and BG 118. Due to cardiac hx., participant agreed to be transported to E.D. On 4/1/21 made a f/u phone call to participant and he stated that lab work in the E.D. indicated that he was anemic.

Considerable pain developed at injection site 6 hours after injection, then extended to pain in neck and lower back. All persisting 10 hours later, but possibly starting to fade. About 10 hours after injection, faint nausea noted for about 2 hours. No treatment sought or administered. Patient is doing physical activity and excercise, and symptoms seem to be fading.

Patient received the Pfizer Covid vaccine 1st dose. After the 15 minutes of observation, his wife notified staff he was feeling "dizzy and light headed". Patient stated he was having trouble breathing in his chest and thought he was having a little difficulty swallowing. EMS was called. Rph checked patient's BP which was 142/127. EMS arrived shortly after and took patient to ED.

Headache first day, headache & fatigue second day, headache, severe fatigue, muscle aches, nausea and diarrhea third day, fatigue and slight headaches Fourth day, mild fatigue fifth day.

8 hours after vaccine terrible chills, and cold, stomach ache 12 hours after vaccine had 104.7 temp. 24 hours still was dealing with 104.7 temp - showers and cold compress with tylenol would bring it down, but would spike back up 36 hours temp of 101

can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him. He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. On ~ 4/9/21, patient developed nausea, vomiting, diarrhea, and abdominal pain. He presented to the ER on 4/11/21 and was admitted for observation due to severe nausea and inability to take PO. He tested positive for COVID on 4/11 in the ED. COVID treatment was not started on admission due to lack of respiratory symptoms.

Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. He developed lower abdominal pain, diarrhea, nausea, chills and vomiting on ~ 4/9/21 . Patient presented to the ER on 4/11/21 and tested positive for COVID. Patient was admitted to the hospital for observation due to severe nausea and inability to take PO. COVID treatment was not started upon admission due to lack of respiratory symptoms.

Played tennis on Sun 4/11 (entire left leg felt numb; didn't fully support my weight) Played tennis on Tue 4/13 (had diarrhea beforehand; left calf throbbed and then "popped"; had to stop immediately) Overnight Tue/Wed upset stomach

Client reports feeling chest pressure, nausea and shortness of breath. Fire Rescue on scene to evaluate client. No resolution, Fire Rescue arrived for transport the patient to Medical Center for further evaluation at 10:00am.

My Dad was healthy no symptoms on first shot . On Second shoot just slight pain in arm , he felt sick on Sunday the 4 of April at around 7pm he had a upset stomach. He got worse at night. in the morning Monday the 5 April we decided it was time to take him to the hospital. Due to the covid 19 restriction we were not able to go in with him He was stable until 1 pm when he suffered 4 heart attacks . He Died . He was healthy he exercise and was active every day . We were told to report this because it was close to dates of vaccination.

Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15. Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.

Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient started C/O SOB, Abominal Pain, and Weakness. Patient states that the SOB and abdominal pain were experienced prior to vaccinations but got worse. Patient shared medical history of CHF, DM and Hypertension. Patient requested to be transported to the nearest ER. 911 Called by writer. Pulse Ox 98%, RR 20, BP 130/80. Temp WNL. Patient alert and responsive oriented x3. Patient Transported to ER.

Ringing in ears started about 30 hrs after 2nd dose Pfizer Covid-19 vaccine. Also had slight fever, chills, nausea but they stopped by next day. Ringing in ears subsided for a few days but has now gotten pronounced all the time.

Approximately, 1 minute after receiving his first dose of the Pfizer Vaccine the patient was noted to be slipping out of his chair. One of the staff members tried to help the patient to the floor but did not make in enough time to break the fall. The patient lost all consciousness and hit the back of his head on the floor. He awoke after about 5-10 seconds and was A&O x 4. EMS arrived at about that time. The patient continued to c/o dizziness and was notably pale. After a few minutes he was able to sit up. But then began to feel like he would pass out again. Patient was laid back and feet propped up on floor and then placed on heart monitor. VS were WNL. Rate and rhythm were also WNL. Patient was still pale, diaphoretic, and dizzy. He was then placed on gurney and brought to EMS station for further eval. When he was transferred the patient then began to vomit. EMS Continued care and then transffered to local hospital. Please see their notes.

Pain in lower abdomen closest to penis. Extreme urgency and frequency (every 15 minutes) in urination. No actual pain during the act of urination. It's almost like there was a blockage. Flow was very weak with lots of dripping. Only lasted for 24 hours (thankfully). Not that this is germane probably but I am Type O+. I did have Covid with 11 days of symptoms March 17-28 2020. Lastly, in this episode I did also experience fever, chills, fatigue, and body aches, and I know those are known AE's

Chills began at 11:00 pm, followed by fever, headache and body aches. this continued for over 48 hours. I could not eat and it was difficult to drink anything.

Fever, chills and nausea 12 hours; fever and chills for an additional 20 hours. Immediately following the subsiding of fever and chills, I had extreme pain in my left hand (same arm as the shot was given). No swelling in my hand but my hand aches all over. I have very little strength in and use of my hand. I feel like my hand is broken. I have been experiencing the left-hand pain from the wrist down for approximately 12 hours now with no relief as of yet.

Low grade fever (~100), chills, headache, nausea, muscle aches, feeling of fatigue and sore arm. Symptoms lasted about 24 hours.

Client received second dose of COVID vaccine. Post vaccine proceeded straight to bathroom and stated that he then vomited in bathroom. Client stated he was not feeling well prior to arrival to vaccine pod. Patient placed in observation room with EMS, symptoms persisted. vs's revealed that client was hypotensive and bradycardic, client transferred to hospital via ambulance.

Profusely sweating, rapid heartbeat, dizziness, fatigue, seeing spots, passing dark red/black stool for three days

Fever (101.2), chills, malaise, muscle ache, headache lasting over 24 hours no appetite swollen lymph glands in armpits lasting 48 hours +

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

PATIENT'S WIFE, CALLED ON SATURDAY EVENING 5/8/21 @ 6:57PM. STARTED TO EXPERIENCE DIZZINESS AND NAUSEA AT HOME APPROXIMATELY 60-90 MINUTES AFTER VACCINE WAS ADMINISTERED, THE DIZZINESS RESULTED IN A FALL WHICH PRODUCED A HEAD INJURY. i ADVISED PATIENT TO CALL 911 IF SHE THOUGHT HE NEEDED IMMEDIATER AND EMERGENCY MEDICAL ATTENTION. fOLLOW-UP CARE CALL ON SUNDAY MORNING 10:28AM, i SPOKE TO HIS WIFE AGAIN, STATED HE WAS RECOVERING AND DID NOT REQUIRE EMERGENCY MEDICAL ATTENTION. i ADVISED HER TO OBTAIN HIS DOCTOR'S ADVICE AND CONSENT TO RECEIVE HIS SECOND PFIZER COVID-19 DOSE.

I recieved the 1st shot at about 5:30 pm and by 10:00 am the following morning is when the symptoms started: head aches, nauseous (that lasted for 4 days), body aches. Hot and cold flashes followed by upset stomach and throwing up. Dizziness chills and trembling of the hands and then diarrhea (that lasted for about 8hrs or so); Sleep was internment for about 3 days and then the symptoms slowly started to fade. Taste for food and nauseousness (after I ate) last for about 5 days after the shot.

Fever; Real bad sweat; throwing up and it lasted for 9 hours; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, Expiry date: unknown) intramuscular, administered in left arm on 22Apr2021 at 11:00 am (age at vaccination was 62 years) at a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, heart disease, kidney disease and COPD for which the patient had taken lot of medication (Further clarification unknown). Concomitant medication was not reported. The consumer stated that he had his first Pfizer shot on the 22 which was last Thursday at 11 clock in the morning and at 6 'o' clock that night he started running the fever, having real bad sweats and throwing up and it lasted for 9 hours and but the next morning he was okay and his concern was, whether he should take the next shot or not. The consumer stated that he didn't have any computer, so he didn't have smartphone so he didn't have any email, they could text message him at the phone number he had given them. Reporter seriousness for events was unspecified. The consumer stated that the scheduled date of second shot was 13May2021. The patient did not receive any treatment for the events. The outcome of all the events was unknown. No follow-up attempts are needed. No further information is expected.

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.

He has been having diarrhea for the past 2 weeks ever since he received a second Covid vaccination he has been increasingly weak and could barely make it into the pulmonary function lab. At the pulmonary function lab, he was found to have new onset atrial fibrillation and worsening hypoxemia from baseline. Taken to ED from the lab on 5/12, found to have right middle lobe and right lower lobe consolidation and ground glass changes. Admitted. Conditioned worsened, respiratory acidosis and shock, started on biped and pressors. Taken to ICU. Found to have RV failure. Today he was intubated.

Patient was not feeling well with diarrhea and fatigue past 24 hours. After vaccination, patient went to observation area where they felt fatigue, sweating, and clammy. Patient alerted nurse they were not feeling well, and nurse noted patient was breathing fine. No rapid response was called, however patient was sent over to ED with wheelchair. Patient appears stable, but is being worked up in ED now.

The day after the second dose of the Pfizer vaccine, my father started to experience lethargy, headaches, nausea and vomiting. These are all advertised as common symptoms of the second dose so he did not seek medical treatment until 5/11/21, five days after. He went to the emergency room, his systolic blood pressure was over 200. A CT scan showed bleeding going from his basal ganglia to the right ventricle of his brain. His blood pressure had gotten so high that he had a hemorrhagic stroke. He has since been in the ICU. He had to undergo a ventriculostomy, was put onto a ventilator, and has now had a tracheostomy. He still has not regained full motor function and will have a long road to recovery after the stroke.

throwing up every 10 minutes; diarrhea; This is a spontaneous report from a contactable consumer (patient wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported), as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that patient took the Pfizer Covid vaccine. Reporter stated that her husband had not stopped throwing up since three o'clock this morning (28May2021) and had diarrhea on an unspecified date in May2021. She wanted to know how to get him to stop throwing up, that patient was throwing up every 10 minutes. Seriousness of the event was not reported. Outcome of the events was unknown. Communication: Caller was encouraged to reach out to her husbands healthcare provider, urgent care or emergency room for medical advice. Caller declines to provide further information and disconnects the call. No further information provided or obtained. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

I've had Covid (01/2021) and Monoclonal Antibodies (01/2021). Was told to wait 90 days before vaccination (04/29/2021 and 05/20/2021). After Covid I began experiencing severe tiredness, headache, brain fog and muscle pain. No issues after 1st vaccination. About 10 days after 2nd vaccination, the muscle pain started becoming severe. Getting up in the morning, muscle pain in legs (mostly things) started mildly, then became so severe it was impossible to put my full weight on my legs. Am able to "walk it off" after an hour or so. NSAIDS are somewhat effective. Other symptoms include tiredness, headache, muscle pain, generally feeling unwell, joint pain, diarrhea.

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.

31March2021 rec'd the 2nd Pfizer shot. Next morning 1April, multiple stripes of severe muscle pain from both ears, extending down the rear corners of neck across top of both shoulders to the shoulder joints. The 2nd set of severe pain was thin stripes of pain on the left & right sides of the spinal column from the neck to waist. The pain strips along spine disappeared in 3 days. The neck pain has continued to this day with varying intensity, sometimes random increases in pain. 7th of April 2021: Sudden onset of Covid like symptoms: extreme fatigue, extreme nausea, wild swings in perception of body temp from freezing cold which nothing warms me, to internal heat like a very high temp but not exhibiting any outward signs of fever. Felt like internal organs were heating up and nothing else like forehead or limbs etc. The symptoms of 7April2021 kept up for at least 2 weeks. No symptoms occurred together, each symptom came for varying lengths of time before subsiding and the next symptom surfaced. Towards the end of April the intensity of the symptoms was easing and eruptions were getting fewer with more time between. By end of May only the neck pain remained. BUT.... then the other symptoms reappeared in stronger form and still ongoing.

Hemorrhagic stroke/bleeding in his brain; He was feeling nauseous and had a very bad headache; He was feeling nauseous and had a very bad headache; Vomitting; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. Concomitant medication included unspecified blood pressure medications. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (Batch/lot number: EW0161) as COVID-19 immunization. Then, the 2nd dose on 06May2021. On that same day of 06May2021, he was feeling nauseous and had a very bad headache. He brushed it off as a side effect of the vaccine because that was listed as a common side effect of the vaccine on the CDC website. So, he did not seek medical attention for 5 days. It was later reported that the he suffered a hemorrhagic stroke that day after the COVID-19 vaccine administration. The patient was in the ICU after waiting 5 days to seek medical attention because the supposed to cause headaches, nausea and vomiting. But the nausea and vomiting was from his stroke, not from the normal side effect of the vaccine. They were suspecting that the bleeding in his brain started on the 07May2021. The patient had bunch of blood work (unknown results) done since the past two weeks. Outcome of the events were unknown

It felt like his intestines were twisting in knots; diarrhea; joint pain; chills; muscle pain; tiredness/exhausted; dizziness; weakness/lost strength; Arm pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in left arm on 20May2021 10:00 (at 62-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing HIV positive from an unspecified date (reported as 5-6 years ago), ongoing immunocompromised due to being HIV positive. History: Patient has been taking BIKTARVY daily ever since he became HIV positive which was years ago. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV positive. He did have vaccinations but he had them way longer than the 4 weeks prior to receiving his first dose of the COVID vaccine. No events following prior vaccinations. The patient stated he received his first dose of the Pfizer COVID-19 vaccine on 20May2021 and this weekend 29May2021 into 30May2021 he developed diarrhea, joint pain, chills, muscle pain, tiredness, dizziness and weakness. He's not sure if he had food poisoning over the weekend or what, but he has been suffering. He received his first dose on 20May2021, and the next dose wasn't due until 10Jun2021. He was reading through the literature and he sees that there are issues with immunocompromised people and all the medications that make a person immunocompromised which he is on. He has been reading the side effects and he has experienced diarrhea from hell, joint pain, he had chills, muscle pain and tiredness. He mentioned he did have some arm pain. He mentioned he didn't have anything soon, it was a little over a week. He also experienced dizziness and weakness, he felt like he lost strength or something like that. It may be coincidental and he could have gotten food poisoning or something over the weekend. Patient clarified his symptoms began on Saturday night, 29May2021 into Sunday, 30May2021. On 31May2021, his symptoms were a little milder, but then towards afternoon, his symptoms started back up. It felt like his intestines were twisting in knots and his diarrhea was back. He mentioned he had been taking Pepto Bismol and Alka-Seltzer. He confirmed the arm pain and diarrhea were still ongoing, however, the rest of his symptoms had pretty much improved. He clarified if he does too much too quick, his tiredness comes back. He felt like he was just zapped, he felt exhausted. The events did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included weight: 157-158 lbs on an unspecified date. The outcome of events arm pain and diarrhea was not recovered, outcome of the other events was recovering.

painful left arm/shoulder where shot was administered; painful left arm/shoulder where shot was administered; Hard to lift up arm, nothing noticeable on arm; bloodshot eyes; muscle aches; unable to take full breathes/shortness of breath; minor cough; migraine headache; chills; exhausted; aches; nausea; covid like symptoms; body aches; low energy; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 15:30 (Batch/Lot Number: EW0173) as single dose for covid-19 immunisation. The patient medical history was reported as none. Patient had not any known allergies. Patient had not received any other vaccine in four weeks nor received any other medications in two weeks. The patient did not received concomitant. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 07:30 PM, as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 2nd shot administered on 03May2021 and on 08May2021 09:00 PM six days later developed migraine headache, chills, exhausted, aches, nausea. Chills, migraine, lasted 1 day, night of 08May2021- 09May2021. It was reported that due to lifting weights, vaccine was trapped in the arm/shoulder muscle, released slowly where he developed covid like symptoms 6 days after shot followed by week of covid like symptoms, shortness of breath, body aches, exhausted, low energy. Week of 10May2021 exhausted, bloodshot eyes, muscle aches, unable to take full breathes, developed a minor cough. On 15May2021- 16May2021, painful left arm/shoulder where shot was administered. Hard to lift up arm, nothing noticeable on arm. No treatment was received for the events. The seriousness of events was reported as non serious by the reporter. The outcome of the events chills, migraine were recovered on 09May2021; events painful left arm/shoulder where shot was administered and hard to lift up arm were recovered on 16May2021 and recovering for other events.

Severe vertigo or dizziness and nausea that lasted around 4 hours. After the 1st two hours, I took a couple of aspirins which had me sweating initially and seemed to help a little. I was finally able to leave work around 10 am, at which time I went to bed for several hours. When I got up, the severeness was gone but mildly lingering. As of today, there is a small hint of dizziness in the background, but I feel much better.

Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination. Information about lot/batch number cannot be obtained. No further information is expected.

left leg and foot have tingled; semi-dizzy after the injection; involuntary bowel movement after injection.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 17Mar2021 at 12:00, (at the age of 62-years) as single dose for COVID-19 immunisation. Medical history included C5, C6 quadriplegia and spinal cord injury in 1977. The patient did not have allergies to medications, food, or other products. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other unspecified medications within two weeks. The patient experienced left leg and foot have tingled, felt semi-dizzy after the injection, and I had an involuntary bowel movement moments after injection on 17Mar2021.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of left leg and food had tingled, felt semi-dizzy and had an involuntary bowel movement was unknown. No follow-up attempts are needed. No further information is expected.

Nausea, vomiting, pasted out twice at the pharmacy, Dizziness, Muscle Weakness, Shortness of breath, chest pain and tightness.

INJECTION SITE PAIN & REDNESS, ARM PAIN. TIREDNESS, HEADACHES, MUSCLE + JOINT PAIN. CHILLS, FEVOR, NAUSEA, VOMITING, FEELING OFF/UNWELL.

2nd vaccine- 01-04-2021; initially started to feel loss of appetite, a lot of weakness and just feeling sick. I got to the point where I could not sit in my wheelchair, literally had no core strength in me. I went to the ER and they gave me a rapid swab for covid. They decided to do blood cultures, were getting ready to plasma when an infectious disease doctor came in and said to that I did not have covid but rather a UTI and my UTI went into sepsis. I was hospitalized, 2 ½ months. I believe that this started with the Pfizer vaccine. I also went to a rehab place to regain my strength. I continue to have today with weakness to my body and struggle with core strength. I do not have lot# to provide.

Shortness of breath; Body aches; Pain; Headache; Nausea; Muscle pain; injection site pain; fever; feeling unwell; swelling of throat; weakness.; This is a spontaneous report from a contactable consumer. A male patient of 62 years age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE LOT number UNKNOWN) On 21Mar2021 16:30 via an unspecified route of administration, on the left arm as a single first dose (at the age of 62 years) for Covid-19 immunization. Patients medical history reports bronchitis, COPD, asthma and oral cancer from 8/01 and operation/recovery/radiation till 11/01. The patient reports allergy to penicillin, nuts. Prior to vaccination patient has was not diagnosed with COVID-19. Since vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received doxycycline(UNKNOWN MANUFACTURER), metronidazole(UNKNOWN MANUFACTURER), guaifenesin(UNKNOWN MANUFACTURER), aspirin(UNKNOWN MANUFACTURER) within 2 weeks of vaccination. On 22Mar2021 patient reports to have shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The patient also reports to have a compromised immune system due to oral cancer. No treatment was taken as a result of the events shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of shortness of breath, body aches & pain, headache, nausea/threw-up, muscle pain, injection site pain, fever, feeling unwell, swelling of throat, weakness was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.

Dizzy; diarrhea; nausea; fever; tired; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unspecified indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced dizzy, diarrhea, nausea, fever and tired. 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 reported events. The clinical outcome of the dizzy, diarrhea, nausea, fever and tired was recovering at the time of report. No follow-up attempts are needed. No further information expected.

Came with a moderateheadache; Repeated nausea; vomiting from 7 am to 4 pm, could not hold anything down; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ep7534) and expiry date included 31Jun2021, via an unspecified route of administration to left arm on 17Mar2021 at 16:00 (at the age of 62-year-old), as single dose for COVID-19 immunisation. Medical history includes paroxysmal atrial fibrillation (episodic) and unknown if ongoing. Concomitant medications include pravastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN) and flecainide (MANUFACTURER UNKNOWN) for an unspecified indication since an unknown date. The patient had no known allergies to foods, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 07:00 (as reported 08: 00), the patient experienced repeated nausea and vomiting from 7 am to 4 pm, could not hold anything down and came with a moderate headache at 08:00. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 20Mar2021 (since the vaccination) which included nasal swab test (SARS-COV-2) and the test result was negative. Therapeutic measures were not taken as a result of the events nausea, vomiting and headache. The clinical outcomes of events nausea, vomiting and headache were recovered in 20Mar2021 at 16:00 and on an unknown date in Mar2021 respectively. No follow-up attempts are possible. No further information is expected.

Violently Sick; Throwing up/ Violent vomiting to Biel for 6 hours straight; cannot drink fluids or foods for 12 hours plus.; Chills; Joint pain; barely able to move or walk; Fever/Fevor 101; barely able to move or walk; Muscle pain; Nausea; Feeling unwell; Injection site pain; Tiredness; arm pain; Headache; injection site redness; injection site redness & swelling; He has minor discomfort; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 02Jul2021 at 10:30 AM (at the age of 62-year-old) as dose 2, single for COVID-19 immunization. Medical history included valtrex for infection in right eye, known allergies: mold, mildew, blue grass, dust, mites, cockroaches (start - 10 to 15 years). The patient concomitant medication included valaciclovir hydrochloride (VALTREX), allergy shots taken for allergy (patient stated it changes based on vials). Patient did not receive any other vaccine within 4 weeks prior vaccinations. Patient was not diagnosed with COVID prior vaccination. Patient was not tested COVID post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in arm right on 02Jul2021 at 05:45 PM (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient experienced he has minor discomfort, diarrhea on an unspecified date in 2021; injection site pain (the date patient received the vaccine), tiredness, arm pain, feeling unwell (subsided from feeling violently sick yesterday), headache, injection site redness, injection site redness & swelling on 02Jul2021; nausea on 04Jul2021; violently sick (It started at 5am (67 to 68 hours after vaccination). It has mostly subsided, gone away. Patient stated he has recovered with lasting effects because he was so beat up from throwing up) on 05Jul2021 at 05:00 AM, throwing up/ violent vomiting to biel for 6 hours straight (at 5 or 6 am yesterday. It lasted around 6 hours until noon), cannot drink fluids or foods for 12 hours plus, chills (around 5 or 6 am), joint pain (5 to 6 am), barely able to move or walk, fever/fever 101 (5 to 6 am, patient temperatures are normal now), muscle pain (around 5 or 6 am) on 05Jul2021. Adverse events did not result in emergency room, physician office visit. Adverse event: 12 of the 17 listed side effects on fact sheet revised 10May2021. injection site redness and swelling, arm pain. Feeling unwell, off. Joint and muscle pain, barely able to move or walk. Chills & Fevor 101. Violent vomiting to bile for 6 hours straight. cannot drink fluids or foods for 12 hours plus. Patient is calling about the vaccine, stated covid 19. He got the vaccine, his second shot and had a reaction that is on the paperwork. The patient underwent lab tests and procedures which included fever was 101 on 05Jul2021. The patient received tylenol, advil and pepto-bismol as treatment medication for the events joint pain, nausea, headache, fever/fever 101, muscle pain. Outcome of the events violently sick, feeling unwell, he has minor discomfort, diarrhea was unknown; tiredness, arm pain, cannot drink fluids or foods for 12 hours plus, joint pain, headache, injection site redness, muscle pain was recovering; injection site pain, throwing up/ violent vomiting to bile for 6 hours straight was recovered on 05Jul2021; chills, barely able to move or walk, nausea, injection site redness & swelling, fever/fever 101 was recovered on 06Jul2021. Follow-up (PRD/SRD 08Jul2021): Follow-up attempts are completed. No further information is expected.

I was eating dinner and swallowed a steak and it got stuck at the top of my stomach. It was the next day to get the food free. I had an endoscopy.

Have had Covid symptoms for 4 days.; Vomiting bile; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and covid-19 in Jan2021. The patient had no known allergies. Concomitant medications included metformin hydrochloride (METFORMIN) used for unknown indication from unspecified dates. 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 01May2021 at 12:00 the patient experienced covid symptoms for 4 days, vomiting bile and loss of appetite. The clinical outcome of the events covid symptoms, vomiting bile and loss of appetite was not recovered at the time of this report. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

About an hour later, slight headache. Around 2am on 1/12, woke up with hip joint pain. On 1/13 slight injection site pain and continued hip pain, and around 11am had slight nausea that went away. 1/14 still have hip pain.

Progressive symptoms of mild itchyness of skin all over body on first day to painful pin and needles sensation with continued itching over entire body only occuring at night by day 7 . Symptoms are temporarily relieved with zyrtec and famotidine. Symptoms are ongoing and getting progressively worse each night. No rashes are observed so far. Headache and severe dizziness with nausea were experienced on day 4 but only lasting 4 hrs.

pt developed a partial small bowel obstruction which required surgical intervention. He was found to have an adhesive band compressing the small intestine. There was no other signs of pathology in the abdomen. The pts only other surgical procedure was a right inguinal hernia repair which was distant from the site of the band. The pt began with persistent nausea, crampy pain and vomiting 5 days after his first dose of the Pfizer vaccine.

Shortness of breath started 1/16 in the AM, worse when lying down. .Also had diarrhea and a rash on right lower extremity. Discharged from ED to home. No significant findings found on work up.

strong shaking; teeth chattering; temperature went up to 101; consumed very little food in 48 hours; This is a spontaneous report from a contactable other-HCP, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3249), via an unspecified route of administration on 16Jan2021 at 08:45 (at the age of 63-years-old) as a single dose, in the left arm for COVID-19 immunization. The patient has no relevant medical history, no known allergies and no prior vaccine reactions. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen at an unknown dose, for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jan2021 at 10:45, the patient experienced strong shaking, teeth chattering. On 16Jan2021 the patient experienced fever up to 101 and on an unknown date in Jan2021 the patient experienced consuming very little food. The patient did not receive therapeutic interventions for the events. The patient described the clinical course as follows: two hours after vaccine administration the patient experienced strong shaking and teeth chattering as would be normal for influenza or Noro Virus per patient. The patient's temperature went up to 101 and the patient was in bed with fever for 40 hours, the patient consumed very little food in 48 hours, and maintained fluid intake. The patient reported he had no nausea, no diarrhea. The patient stated it was unpleasant to the point of not being to do anything but lay in bed. Then, at about 40-48 hours temp was gone, and the patient felt very close to normal and the patient resumed eating. The clinical outcomes of the strong shaking, teeth chattering, temp went up to 101 and consumed little food were recovered on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

severe headache; dizziness; nausea; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration (left arm) on 16Jan2021 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) on 26Dec2020 for Covid-19 immunization. The patient's medical history included sleep apnea and increased blood pressure (managed); no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, dizziness, nausea on 16Jan2021. There was no treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination

Dizzy, nausea/vomiting within 5 minutes or receiving vaccine. BP - 169/89; O2 sat 100%. Pulse 53. Received small bottle of water and felt better, with pulse of 68. Vomiting stopped.

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

Lower abdominal pain; ringing in ears; aching joints, frontal headache, very tired/Felt like the worst flu ever; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 and expiry date unknown), via an unspecified route of administration on 13Jan2021 10:30 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma and allergies: sulfa drugs. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did fine until 23Jan2021 09:00 through 25Jan2021 as the patient experienced lower abdominal pain, aching joints, frontal headache, ringing in ears, and very tired. The patient stated that it felt like the worst flu ever. He also stated that his concern was will it be worse on the second injection. He may not take it. Events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. Outcome of the events was recovering.

New onset dizziness with hypotension, tachycardia, and vomiting blood. Sent to ER - told he went into cardiac arrest and died.

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.

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

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

On date on second dose, 2/27/2021, the pt began have fatigue and diarrhea at around 10:30 am. This continued to the following day. On 2/28/2021, the patient was last seen around 4:20 pm by his wife in their residence. She found him unresponsive at 5:30 pm in their bedroom. EMS was called and the decedent was declared deceased. The pt had his first dose on 2/9/2021. Both doses were given at the hospital. Per family, the pt had no adverse affects following the first dose.

Headache--2 days Diarrhea--6 days Fever--1 day Weakness--4 days Fatigue--4 days Arm pain--2 days

Nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unspecified route of administration in the left arm on 06Feb2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient had no medical history, had not been diagnosed with COVID prior to vaccination, and had no known allergies. Concomitant medications included cetirizine hydrochloride (ALLERTEC) from an unknown date for an unknown indication; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) from an unknown date for an unknown indication; and ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iron, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenite, thiamine mononitrate, zinc oxide (ONE A DAY MEN'S 50+ HEALTHY ADVANTAGE) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to administration. On 07Feb2021 at 10:00 the patient experienced nausea and vomiting. No treatment was provided for the events. The clinical outcomes of nausea and vomiting were recovering. It was also reported that the patient had not been tested for COVID since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

I started to develop a headache and became a little nauseous right after. After two days, my fingers started swelling and hurting. I couldn't make a fist. It caused my immune system to go crazy. That lasted about 5 days. After taking Aleve and Tylenol, it helped reduce the pain. My kidney doctor told me to stop taking Aleve because it was interacting with my BP meds. The doctor from Northwest Arthritis prescribed Tramadol to help with pain. I still have pain, but it's tolerable.

I had an unusual reaction, my lips swelled up after I received the vaccination. I received the shot about 9:30 am. It started about 5:00 pm to the next morning and subsided. I also had more common symptoms as well headache aches and pains and diarrhea.

Bad itchy rash and severe indigestion. Cardiac surgeon recommended 40 mg Pepcid AC. This reduced the acid build up and I was left with the rash

Headache, NauseaVomiting, Contracted COVID 19 virus. Tested positive 03/11/21 at facility. He was admitted to hospital. Narrative: Patient who completed the Pfizer vaccination on 01/26/21 with his second dose. Tested positive for COVID 19 at Medical Center on 03/11/21. He was admitted to hospital and spent two days in house. First dose was on 1/5/21, second dose 1/26/21

I fully understand that this is outside the side effect window. However, on Sunday, March 14 I started to experience a fever (100.4), fairly significant fatigue,, tireness, loss of appetite and a slight headache. The reason I am writing is that in addition to getting the vaccine, at which time I was triple-masked, I only left my home one other time to drop off mail at a post office (again, triple masked). Neither myself nor my wife (the only other person I live with) left the house (other than she left once to pick up our grocery order, outside). On Sunday, after the symptoms started, I went to a local clinic and took a PCR Covid test. The results came back negative six hours later. The symptoms lessened on Monday (the fever ranging from 99.4-100.4----my usual body temp is 97.6) and by Monday night the fever was gone. By Tuesday morning not only was the fever gone, but so also were all the symptoms. Again, I know this is outside the usual timeframe for side effects, other than maybe a skin rash, but I wanted to let you know because I think it is unlikely I contracted another virus because I go virtually nowhere, and am tripled masked whenever I go anywhere.

First: Site swelling & pain (about a week - 03/04 to about 03/10/21) Second: Headache, muscle pain, joint pain, tired (started day after - 03/05 to 03/06/21 - about 1-2 days) Third: Serious pain in left arm (mid-upper arm & lower arm down to the hand). Bones hurt, muscles hurt, and joints hurt. Rash on upper and lower left arm. Sensitive to touch and slightly red. Serious diarrhea just after arm started to hurt. (started 03/17/21). Still on-going.

numbness and tingling in left hand diarrhea , fever chills nausea vertigo malaise increased heart rate decreased 02 stat

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.

Got my second shot Tuesday around 12:15. Everything was fine, no symptoms until Wednesday night. I went to bed around 11. I had diarrhea all night, at least six times. Headache, fatigue, and I stayed in bed until Friday morning.

Vasovagal, vitals normal after oral fluids but patient felt weak, flushed nauseated. Drove himself and did not feel comfortable driving home. Asked that we call ambulance

About 18 hours after my 2nd Covid vaccine I had trouble swallowing, The liquid would come out the left side of my mouth and I couldn't control it. The next day my left eye hurt and would not stop watering. Yesterday it was worse, I had a crooked smile and more severe eye pain and watering, Went to Urgent Care and after ruling out a stroke I was diagnosed with Bell's palsey. I have not been diagnosed with Bell's in the past.

Abdominal bloating and distention beginning on March 19 and persisting to present day (Mar 25, 2021). Seeing doctor about it today.

mucsle aches, nausua, night sweats, chills, cough, major fatigue had 2 telehealth conversations with 2 drs through primary care In the meantime doctors encouraged and strongly supported receiving second vaccine - symptoms continues and primary care presecribed antibiotic (arithomiziathan) or possible pneumonia, tylenol PRN for bilaterl lowert extremity pain follow up call a week later -f/u call-with another general practicioner - rx antibiotic (levofloxacine750mg x 7 daye) ) CC- same syptoms, dr said to "follow the course", eventually sent ED at local hospitalwent to Hemotologist = Blood cultures, stool cultures, and on the verge of bone marrow biopsy

10 minutes after received shot, left arm went numb, then both arms turned blood red. Two hours later had H/A, fever, chills, increased heart rate, 102.8, nauseous, caused UTI. Wife had to help him get into the car due to feeling of illness. No shortness of breath or difficulty breathing

Injection site pain, fatigue, headache, chills, nausea, upset stomach, feeling unwell, inability to eat Took 2 Tylenol

Stood up after receiving the vaccine and immediately got dizzy and felt like I could faint. As the morning the dizziness got worse and had nausea, this continued for 4-5 days before it seemed to get a little better. It has now been 7 days and although it is better I still have some dizziness. For the last 4 days I have been taking 2 meclizine.

Awaken around 5 am with a head ache and as morning progressed I had mild nausea on and off. With lunch at noon I took 2 acetaminophen.Head ache and nausea went away.

Pt c/o unable to eat, vomiting and weakness starting after vaccine. Patient admitted for Diabetic ketoacidosis without coma associated with other specified diabetes mellitus (Primary Dx); Weakness. DM Type I/DKA - POA. Patient with a blood sugar of 351. He was admitted to the ICU for insulin gtt and closer monitoring. The next day patient was switched to high dose sliding scale, standing AC insulin with long acting insulin at night. The patient was transferred to the medicine floor later that evening.

1. Peripheral neuropathy in arms and legs, no treatment, perceived same day as getting the vaccine, symptoms continue. 2. Arthritis in neck, shoulders and hips, no treatment other than ibuprofen , perceived same day as getting vaccine, symptoms continue. 3. Metallic taste on tongue and tingling of tongue, no treatment, perceived same day as getting vaccine, symptoms seemed to have subsided. 4. Stomach muscle fatigue, no treatment, perceived same day as getting vaccine, symptoms including burning sensation continue. 5. Itchy head, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 6. Stuffy head - unable to clear ears, no treatment, perceived same day as getting vaccine, symptoms have lessened over time. 7. Generalized sore muscles, no treatment, perceived on same day as getting vaccine, symptoms continue. 8. Generalized aching joints, no treatment, perceived on same day as getting vaccine, symptoms continue. 9. Enlarged or swollen lymph nodes, no treatment, perceived a few days after getting vaccine, symptoms have lessened over time. 10. Testicular pain, ice pack as needed, perceived a few days after getting vaccine, symptoms continue.

Day 1 Diarrhea, Fatigue, Dizziness Day 2 3 4 5 Add Nausea, Headache, Fever to me but not thermometer, Sweating, Body Achs, no appetite. mild cough first time, worse 2nd injection.

Pfizer-BioNTech covid-19 Vaccine EUA: Sore arm 1st day after about 4 hours - better by next morning, no other symptoms until 3 days after the shot then I had Chills, Fever (101.8) Nausea, Fatigue, Headache. These went away within 24 hours but a bout of Diverticulitis had started up right when the symptoms started and made everything feel worse than it would have. Went to doctor and was put on antibiotics the following Wednesday.

Triggered Minere's Disease flare up the following day, after each shot (dizziness, nausea, headache), treated successfully with typical doses of Valium.

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

Resident passed on 3/23/2021. Resident continues to decline medically. 2/22 He was admitted to nursing home with worsening pressure injury.

Chills for 3-4 hours 12 hours after receiving shot. Than sweats for a few hours until morning. Slight headache, as well as slight nausea. Slept on and off until 2:00 PM next day, then felt better and able to eat.

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

Nausea and dizziness 4/14 - 4/17. Sudden hearing loss and tinnitus in right ear on 4/17 (no prior tinnitus and previously only mild hearing loss in both ears).

Abdominal pain, Portal Vein Thrombosis (Blood clots in veins to the Liver, Spleen and Large Intestine) Treatment - Heparin drip and then converted over to the blood thinner Xarelto Recommended that I follow up with my primary care physician and seek the advice of a Hematologist

Patient is a Certified Nursing Assistant in the hospital. COVID-19 testing was as the direction of Employee Health for COVID-19 symptoms on two days since vaccination: symptom onset date of 3/30/2021 (symptoms = diarrhea and headache) on 4/16/2021 (symptoms = chills, cough, nasal congestion, runny nose and sore throat).

Blood in stool; PFIZER-BIONTECH COVID-19 VACCINE First dose on 30Mar2021 08:00 and Second dose on 30Mar2021 12:00; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 30Mar2021 08:00 (Batch/Lot number was not reported) and 2nd dose on 30Mar2021 12:00 (Batch/Lot number was not reported) both given via an unspecified route of administration administered on Arm Left as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history was not reported. Concomitant medication included phentermine (PHENTERMINE) taken for an unspecified indication and therapy dates. On 05Apr2021 03:00, the patient had blood in stool and not yet recovered. The patient did not receive any treatment for the event of blood in stool . The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. Information on lot and batch numbers cannot be obtained.

Severe vertigo, moderate nausea, minor soreness at injection site the next morning. By 2 pm, down to minor vertigo and moderate headache.

The first day after the vaccine I felt a total lack of energy as well as muscle soreness and general aches. By the second I was pretty good. On the 11th day It all came back and more. Dry and soar throat, headache , total loss of energy, no apatite, muscle aches. This has gone on now for 5 days. On the 2nd day I had a covid test- came back negative. On the 4th day I had another at a different facility, came back negative. Could this still be a reaction to the first vaccine and should I have the second?

he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; 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), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently. He does not know if it just the progression of the pain or if it is coming from the injection. The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe. He added that he has had nausea with the cancer, so this nausea would be very light. But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works. The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this. He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice. He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.

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.

On my first vaccine shot done in 03/26/2021, only minor fever was experienced (expected, no complaint on this one). On my second vaccine shot done in 04/23/2021, I experienced: 1). slight fever (temp "normal" around 96-F) on the first and second day after the shot was given at 1:10pm (I took 800mg Ibuprofen before sleep at first night around 3am, and took 400mg Ibuprofen at the second night around 2am), AND 2). rather heavy diarrhea on 04/24/2021 twice (at around 4pm), and heavier diarrhea on 04/25/2021 twice (at around 6pm); in both days, I took Imodium to treat my stomach upsets.

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.

Sinus symptoms and also reflux symptoms. I had these for two days. I took Benadryl; a day off from work and then I had the weekend off to recover. - I had a doctor visit - telephone consult

stroke; he could not speak; diarrhea; vomiting; This is a spontaneous report from a contactable physician. A 63-years-old male patient received bnt162b2 (BNT162B2), intramuscular on 12Mar2021 as single dose for COVID-19 immunization at a workplace clinic. Medical history was reported as none. There was no known allergies. There was no vaccine administered in four weeks. There were no concomitant medications. On 13Mar2021, the patient experienced diarrhea and vomiting for 8 hours and 2 days later on 15Mar2021, he could not speak so patient went to the hospital and was told he had a stroke. The patient underwent lab tests and procedures which included SARS-COV-2 test, pcr swab test: negative on 14Mar2021. Therapeutic measures were taken as a result of the events which included aspirin, clopidogrel (PLAVIX), atorvastatin calcium (LIPITOR), evolocumab (RAPATHA). The events caused hospitalization. The patient recovered from the events on an unknown date. Information on batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the reported events of diarrhea, vomiting, could not speak and stroke cannot be excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient received first COVID vaccine Pfizer on 4/14/21. Subsequently, he developed fever, dry cough, HA, chills/shakes, nausea with diarrhea. Patient presented to ED on 4/29/21 and found to be COVID-19 ( ) w/hypoxemia. File this incident for record keeping.

Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15 (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.

Three weeks after 2nd shot on May4 I stood up and got dizzy.Im still dizzy four days later.Vomited while awake four 48 hours off and on.Went to urgent care Thursday May 6 2021 received medicine for nausea.Cant drive or walk outside because I get dizzy when I move my head side to side Is this a known side effect and when will it go away? Was diagignosed with stomach virus. Dont know if thats correct.

Approximately 24 hours after second dose, dizziness, nausea, headache, fever. Duration of approximately 18 hours.

has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating/gas and acid reflux is worse; has reflux, gas and bloating; he is so tired; hard time breathing from gas/ had a hard time breathing last night; hives on his face on both sides of his cheeks; disturbance on his throat; felt like something was blocking his throat; This is the spontaneous report from a contactable consumer (patient wife). A 63-year-old male (patient) received BNT162B2 (lot number: EW0158) first dose on 14Apr2021 16 15 PM on left arm at single dose for COVID-19 immunisation. Medical history included allergic to milk and beef, gives him hives on his face. Concomitant medications included nasal spray (he doesn't take any other medication). No Prior Vaccinations (within 4 weeks). Consumer asked if her husband can take benadryl before the vaccine. Consumer stated her husband has no known allergies to medications. Caller stated that her husband had the first dose of the Pfizer covid 19 vaccine on 14Apr2021 at about 4:00 pm. Caller stated he ate dinner and then around 8;00 or 8:30 he felt like a disturbance on his throat. Caller stated he could swallow but felt like something was blocking his throat. Caller stated that 1/2 hour later it went away. Caller reported the next day (15Apr2021) he had hives on his face on both sides of his cheeks. He is so tired. Caller stated her husband has reflux, gas and bloating. Hard time breathing from gas. Caller stated her husband had a hard time breathing from gas last night (20Apr2021). Gas and acid reflux is worse on 20Apr2021. Vaccine Administered at Military Facility was no. No event require a visit to: Emergency Room or physician office. The outcome of event disturbance on his throat was recovered on 14Apr2021, hives on his face on both sides of his cheeks recovered on 15Apr2021, gas and acid reflux is worse recovered on 21Apr2021, hard time breathing from gas/ had a hard time breathing last night was recovered on 21Apr2021. The outcome of other event was unknown. No follow-up attempts are needed. No further information is expected.

Received shot on 5/8/21 at 11:00am. States nauseated, dizzy and light-headed at 5:00pm on 5/8/21. Also c/o headache. Headache will go away with tylenol. States nausea, dizzy, and light-headedness symptoms have been continuous since receiving second dose.

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.

dvt; diarrhea; okay for him to get the second dose outside of the recommended 3 weeks ( 6 weeks and 2 days ).; This is a spontaneous report from a contactable consumer. This male consumer reported for himself. A 63-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced side effects such as diarrhea and DVT on their left leg. As second dose scheduled on 06May2021 wanted to know if it is okay for him to get the second dose outside of the recommended 3 weeks (6 weeks and 2 days). He would like to know if Diarrhea and Blood Clots are side effects of the vaccine as he is currently experiencing these adverse events. The Outcome of the events were unknown. Follow-up (05May2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. This contactable male consumer reported side effect from the first dose, second dose scheduled on 06May2021. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: Yes: Customer and/or medical inquiry forwarded or referred to MI. Information about lot/ batch number has been requested.

testicles swelling; experienced a rash three hours after the vaccine; fever; chills; diarrhea; Malaise; they gave him a quick test that said he had covid; 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: unknown) via an unspecified route of administration in left arm on 15Apr2021 at 10:30 (at the age of 63 years old) as single dose for COVID-19 immunization. Patient's medical history included asthma and it was diagnosed years ago. Concomitant medications were not reported. On 15Apr2021, the patient experienced fairly, fever, chills, testicles swelling, and diarrhea, malaise, COVID-19 and rash three hours after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported symptoms went on for several days and began on 15Apr2021 about three hours after he was administered the 1st dose of the Pfizer COVID vaccine and the symptoms resolved probably 7 days later. Patient do not have prior vaccine side effects. Patient did not require treatment but for one thing he did call to HCP and was sent for a COVID test and it came back negative, and it was the one that takes three days, states patient still did not feel good so that same day patient first COVID test on 23Apr2021 patient went to another COVID test at and they gave him a quick test in that result patient had COVID. Outcome of the events fever, chills, diarrhea, malaise was recovered and testicular swelling, rash, COVID-19 was unknown. Information on the lot/batch number has been requested.

Vomiting; Headache; This is a spontaneous report from a contactable consumer. A 63-years-old male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 at 09:30 in left arm as a single dose for covid-19 immunization. Medical history included hypothyroidism, restless leg, high blood pressure and stroke all from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin, clopidogrel and tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); all start and stop date were not reported and used for unspecified indication. The patient experienced headache, vomiting on 28Jan2021 at 15:00. The events were reported as non serious. The outcome of both events was recovering/resolving. Information on the lot/batch number has been requested. Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected

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.

Mild soreness and fever two days . followed by persistent extremr fatigue nausea headache itching, easy bruiising and bleedind Sick for 6 weeks. No improvement

Shortness of Breath, cough, no taste, symptoms started Sunday afternoon, had send out covid on Monday was neg, (rapid was positive) pt has had both covid shots ? Nausea ? Fever ? Fatigue ? Headache ? Diarrhea Patient is on Rituximab and received doses on 5/12 and 5/29. which was 5 weeks after finishing vaccine.

Left arm was very swollen from shoulder to his neck; Stiff arm and stiff neck; headache; dizziness; muscle and joint aches; muscle and joint aches; Everything hurt; Thought he had the Flu/ flu symptoms; Couldn't lift left arm; Chills; Temperature got up to 99.2; Bed sweats; Nauseous; This is a spontaneous report from a contactable consumer. A 63-year-old male consumer (patient) received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the left arm on 28Feb2021 16:30 (at the age of 63-year-old) as single dose for COVID-19 immunisation. The patient medical history included type 2 diabetic. Concomitant medications were not reported. The patient reported that he was calling to report a reaction to his first vaccine dose. He had no medical questions at this time and requested to be transferred to safety. 30 calls ahead, caller was agreeable to holding for the safety department. Got COVID-19 vaccine on Sunday afternoon 28Feb2021. Was okay after the fifteen-minute waiting period. Got home and took a nap. On 28Feb2021, the patient woke up at around 6:30 PM, he was feeling a bit nauseous. He drank ginger ale and went back to bed. On 01Mar2021 at around 01:30, he reported of everything hurt and thought he had the flu/ flu symptoms, could not lift left arm, chills, temperature got up to 99.2 and bed sweats where he had to change his bed and t-shirt twice. Never had a fever, but his temperature got up to 99.2. Last time he had the flu was 10 years ago, which was why he thought he must have the flu. Thought it was a coincidence he received his COVID-19 Vaccine and then got the flu. That morning, 02Mar2021, he felt great. On an unspecified date, he reported that his left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness, muscle and joint aches. Did not know what that was, but glad it was gone. His left arm was the injection arm. Arm was very swollen from his shoulder to neck. He felt his armpit and did not feel like his lymph nodes were swollen. Felt like a stiff neck and stiff arm. Did not have any trouble breathing. Did not have heart palpitations. No prior vaccinations within four weeks. He tested positive for COVID-19 Virus on 01Feb2021 around 4:30PM. Believes it was a PCR COVID-19 test. End of his isolation was 11Feb2021 and he tested negative. Was getting tested for a procedure that was scheduled for 03Feb2021. However, the procedure is now moved to 15Mar2021. No further details provided. Last vaccination was a Tdap and he did not have any problems with that. Tdap was forever ago and has no NDC/Lot/Exp to provide. Would like to speak to a consulting Nurse. Had first dose of covid vaccine and had bad reaction. Has surgery scheduled very close to second dose appointment of vaccine. Clarified surgery was scheduled before first dose of vaccine. Wants to know with having reaction to first dose and being close to surgery, should he get second dose. No unaddressed medical questions referred or forwarded to Medical Information. He was having surgery (hip replacement) on 29Mar2021 and was scheduled for his second Pfizer vaccine on 30Mar2021. Since he had several side effects with the first vaccine dose, he enquired that should he not get the second vaccine dose the day before his scheduled surgery. He was having a heck of a time getting scheduled for his second dose, window was supposed to be 20-25 and he was able to get it scheduled on the 28th, he had a severe reaction to the first dose, night sweats, no fever, but classic flu symptoms, lasted about 24 hours, started on 1:30am Monday morning is when he started having the symptoms. Had shot Sunday afternoon 28Feb2021. He was having a hip replacement on 29Mar2021, will it be a problem if he has another reaction, cannot cancel surgery. First surgery was cancelled because he tested positive for Covid on 01Feb2021, prior to vaccine, tested negative for covid on 11Feb2021, hip issues and surgery were scheduled prior to vaccine. Was it okay for him to get his hip surgery the day after his second dose of the vaccine. Investigation assessment was unknown. Outcome for the events left arm was very swollen from shoulder to his neck, stiff arm and stiff neck, headache, dizziness and muscle and joint aches were unknown. Outcome for rest of the events was resolved. Follow up (02Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics, relevant medical history and concurrent conditions, vaccine details, case narrative information. Follow-up (11Mar2021): This is a follow up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported which included verbatim and event description, medical information. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included patient characteristics. Follow up (11Mar2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) reported which included event details (no new events). No follow-up attempts are possible. No further information is expected.

light headed; Chills; Nausea; Pain/Soreness at injection site; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6206,) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included heart disease. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Atorvastatin (MANUFACTURER: UNKNOWN) for an unknown indication, Metoprolol (MANUFACTURER: UNKNOWN) for an unknown indication, Lisinopril (MANUFACTURER: UNKNOWN) for an unknown indication and Tamsulosin (FLOMAX) for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Mar2021, the patient experienced chills, nausea, pain/soreness at injection site, tiredness and light headed. The clinical outcome of the chills, nausea, pain/soreness at injection site, tiredness and light headed were recovering at the time of report. No follow-up attempts are needed. No further information is expected.

Experienced lightheadness about 1/2 hour after shot. Then days later, symptoms come and go. Naseua and shortness of breath continue for months. Bloodwork done, EKG showed irregular rythm, referred to cardiologist. Feeling better at time of visit, all additional tests ok. Weeks of extreme fatigue and lightheadness occur for periords lasting 6-24 hours at average. Any major activity would cause debilitating weakeness the next day. Felt so badly one night, thought he was dying, didn't go to ER (was affraid of expense). Another day again we drove to ER, but started feeling better during wait time and decided not to stay. Was going to return if not feeling good, but felt better for 3 days, longest period to date.

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.

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.

After being fully vaccinated I contracted the COVID virus with in two months. My symptoms was fatigue, nausea, shortness of breathe, and light headedness.

Abdominal cramps and diarrhea 8 to 14 times a day since April 27; June average 8.4 times/day though now stool is all pencil-like

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.

Chron's disease flare up; Discolored stools; Inflammation; diarrhea; This is a spontaneous report received from a contactable physician. A 63-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 07Apr2021 (at the age of 63-year old) at single dose for COVID-19 immunization and adalimumab (HUMIRA) solution for injection in pre-filled pen, subcutaneous on an unknown date at an unspecified dosage for Moderate to severe adult Crohn's disease and moderate to severe ulcerative colitis. relevant medical history and concomitant medications were not reported. On an unknown date the patient experienced dark stools, inflammation, diarrhea and Crohn's disease flare up. The action taken with adalimumab was unknown. The outcome of the events diarrhea and Crohn's disease aggravated was recovered while the outcome of the other events was unknown. The causality assessment with adalimumab was No reasonable possibility for events diarrhea and Crohn's disease aggravated and not reported for the other events. The causality assessment with BNT162B2 was not reported for all events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.

Fever; chills; pain at injection site; headaches; muscle pains; joint pains; nausea; vomiting; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration on the right arm on 20Mar2021 at 15:00 (at the age of 63-year-old), as an unknown single dose for COVID-19 immunisation. Medical history included hypertension and colon cancer. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 1300, the patient experienced fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell. The patient received other medication within two weeks of vaccination. Tylenol and Motrin was taken as therapeutic measures as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, pain at injection site, headaches, muscle pains, joint pains, nausea, vomiting and feeling unwell was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

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.

Had headache on June 30(day after 2nd Pfizer vaccine injection). Headache became persistent migraine after day 4 and only started to subside after taking 2 advil tablets per day for about 5 days in a row. In addition to migraine headache, general dizziness(lasted almost two weeks now) loss of appetite(lasted week and a half) intermittent pains in stomach active bowels(going to bathroom 4 or 5 times a day rather than once) SEVERE PAIN in left leg which could best be describe as a general Neuropathy(no pain in muscles or bones) - had to take two advil tables on separate nights to relieve pain. After fourth day of this leg pain and having taken the advil, the pain subsided and seems to be mostly cleared up. NOTE: This leg pain started on July 2(4 days after injection) and lasted 4 days. NOTES: I rarely get even mild headaches and never get any of the other symptoms.

Extreme vomiting; stomach pain; back pain; Loss of appetite; fatigue; chest pain; This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose via an unspecified route of administration in her right arm on 20Mar2021 at 16:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included kidney stones. The patient had no allergies to medications, food or other products. The patient received hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 21:00, the patient experienced extreme vomiting later same day of vaccination, chest pain, stomach pain, back pain, loss of appetite and fatigue. The patient did not receive treatment for the reported events. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events vomiting, chest pain, stomach pain, back pain, loss of appetite and fatigue were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Travelled a day after vaccine, gradual GI inflammation, went to bleeding, after 6 weeks returned home and got colonoscopy. Since treatment has returned to normal. Given steroids for about a month

Immediately - I just had moderate fatigue the day after the vaccine - and it was gone after the following day. No treatment. I started having chronic hoarseness in March. I had a visit with the doctor's partner and she came in on that same visit - on May 17th. I had a laryngoscopy that day and that is where they found the vocal chord nodule. I had surgery on the 26th of May to have the nodule removed. They did a pathology and a culture and it was HPV related and found that it was cancerous. I am still getting monthly surveillance as I had vocal chord cancer - monthly scopes. I have developed scarring and some inflammation. The voice is better but it's not where it needs to be. New med: Omeprazole - 20 mg twice a day -to make sure they can keep from getting acids on the vocal chords so they can heal (I had a diagnosis of reflux.) I was also diagnosed with Melanoma in February on my left arm. I had an incision of that and that was done on February 1st - Melanoma In situ. I will start speech on August 10th. April 20th - I had a physical with my primary care doctor and that was fine.

This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date: not reported), via an unspecified route of administration in left arm, on 03Mar2021 at 14:30 (at the age of 63 years old) as dose 1, single for COVID-19 immunization in a facility reported as other. Medical history included chronic fatigue syndrome. The patient was allergic to amoxicillin, clavulanate (AUGMENTIN) and amoxicillin. Concomitant medications included diltiazem. The patient didn't receive any other vaccines in 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient didn't had COVID-19 and post vaccination, the patient was not tested for COVID-19. Two days after the vaccination, the patient experienced diarrhea on 05Mar2021. It was continued for the past 14 days, and still persists. The patient was treated with loperamide hydrochloride 2 mg for this event. The event led to doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Pt is 63 yo male employee at this institution. He is s/p full COVID-19 Pfizer vaccination: first dose 1/21, second dose 2/11. Reports symptoms: fever, chills, new onset cough, headache, sore throat, diarrhea, and congestion/runny nose. He denies any known exposure to COVID-19. On 7/21 undergoes testing which results back positive for COVID-19.

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.

Extreme dizziness; Nausea; Vomiting; Hot flash; Some congestion; Hoarseness; This is a spontaneous report from a contactable consumer, the patient. A 63-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 01Apr2021 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and penicillin allergy. Concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN), both on unknown dates and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021 same day after vaccination (also reported as, on evening of second injection - 02Apr2021), the patient experienced extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness for the first time. The patient had sudden recurrence daily of dizziness, nausea and sometimes vomiting. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event extreme dizziness. nausea, vomiting, hot flash, some congestion and hoarseness was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

dizziness (not true vertigo) started when I woke up to go to work 5:30AM accompanied by nausea. Mild headache came on about noon Dizziness subsided about 3PM and headache about 8PM Nausea lasted until 1/6/2021 about noontime No treatment done for any of the above

fever; chills; nausea; headache; fatigue; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn."; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on 19Dec2020 at a single dose for Covid-19 immunization. Medical history included pneumonia from 03Aug2020 to 08Aug2020. Concomitant medications were not reported. Patient had the first COVID-19 vaccine dose on 19Dec2020. Patient said he had a "pretty strong reaction" of fever, chills, nausea, headache, fatigue in Dec2020. Felt ill until day 2, started feeling better on day 3. Patient also had a local reaction of a "patch of inflammation, redness, burning sensation- similar to a 2nd degree burn" in Dec2020. Patient also mentioned he had his blood work last 30Dec2020 and confirmed he has IgG antibodies. Patient then asked "I want to get the second dose, is it okay to get the vaccine?" The outcome of the events 'fever, chills, nausea, headache, fatigue' was recovering while unknown for the other events. Information about Lot/Batch number has been requested.

Myalgia, Diarrhea, pain at injection site Narrative: Myalgia and inection site pain/myalgia and diarrhea by 9pm on date of injection 12/29/20. Myalgias continued for 2 days and resolved by day 3.

Headache, soreness of eyes, fever, chills, mild nausea, one episode of diarrhea, fatigue, slowing of cognitive function.

Severe diarrhea, followed by severe muscle cramps; Severe diarrhea, followed by severe muscle cramps; This is a spontaneous report from a contactable nurse reported for himself. A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EL1283), intramuscular in right arm on 05Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, ulcerative colitis, prediabetes, previous hypertension, hypothyroidism, partial heart block and known allergies: Sulfa. Concomitant medication included mesalazine (LIALDA), indometacin (INDOMETHACIN), levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), zolpidem tartrate (AMBIEN), metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced severe diarrhea, followed by severe muscle cramps on 05Jan2021 16:00 with outcome of recovered in Jan2021. The events were reported as non-serious.

From about 9:30pm Saturday 01/23/2021 till approximately 11am Sunday01/24/2021 I experienced serious diarrhea (8 times), accompanied by muscle pains and chills. Thirst. I had no difficulty in breathing.

upset stomach; diarrhea; temperature to 101.7; I was tired and sleepy; I was tired and sleepy; fever; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), second dose on 07Jan2021 07:00 (lot number: EJ1685) via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. Medical history included diabetes mellitus (DM), coronary artery disease (CAD), hypertension (HTN), HLD, glaucoma, retinal tears and overweight. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in the left arm, first dose on 31Dec2021. The patient previously received first dose of bnt162b2 on 18Dec2020 16:45 (lot number: EL3248) for covid-19 immunization. On 08Jan2021 07:00, the patient experienced upset stomach, diarrhea, temperature to 101.7, tired and sleepy and fever. The patient received Pepto-Bismol and Azithromycin as treatment for the events. The patient did not have covid prior vaccination and had not tested positive for covid post vaccination. Events fever ad temperature to 101.7 recovered on 09Jan2021; event diarrhea recovered on 11Jan2021; all other events resolved with sequel.

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.

The following day I woke up with bad body aches. then around 4 pm I started feeling nauseous and vomited intermittently for about 2 hours. I spent the rest of the day in bed. I was supposed to go to work the next day, but I had to call out, just not feeling up to it. the next day I managed to go to work and was fine.

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.

Patient presented to the ED with severe lower abdominal pain. Patient reports pain as severe, 10/10, in the mid-lower abdomen, constant with radiation to the right LQ. He reports N/V as well. Of note, patient is on chemotherapy (currently FOLFIRI/cetuximab) and follows with an oncologist for his colon cancer. His oncologist believes that the cause of his presentation is due to him taking Imodium for his chemo-induced diarrhea. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

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

About 21 hrs after shot I experienced significant dizziness and almost fainted. I have continued to experience slight dizziness from time to time but only severe when lying down, rolling over while lying down, looking straight up, and sometimes bending over. 5 days after shot I decided to check blood presure and it was repeatedly around 175/100. I went to local doctor and he prescribed additional BP meds. BP now good (126/80) but I still experience dizziness from time to time. Yesterday when BP high I also had constant headache and some nausea. Today(3/12), almost week after shot I still experience dizziness to a minor degree off and on, but still somewhat severe when lying down, looking up, and bending over

Stomach pain diarrhea unstable heart rate. Low blood pressure extreme body sweats loss of consciousness

Stomach Pain, Vomiting a lot, Diarrhea, chills....Once my body was cleared of fluids I was okay...It lasted about 3 to 4 hours. Shot was at 1400hrs and side effects began around 1800hrs and over by 2100hrs or so.

Terrible cramps diarrhea nausea vomiting constipation a high fever of a 103 or more Muscle aches sore skin joint ache Worse than the flu

About 15 minutes after receiving vaccine, patient became dizzy, diaphoretic and lost consciousness briefly. Client was transferred to an antigravity chair, and regained consciousness but continued with severe diaphoresis, nausea and dizziness. 911 was called and patient was transported at 2:25. HR42, BP 84/62

Patient states he had excessive fatigue to the point of not being able to get out of bed starting 3/12/21 Friday. and has had motor issues/dizziness since. Experienced puking and was not able to get out of bed until Monday 3/15/21. This is still occurring but improving since he has been able to move around since Monday.

Severe explosive diarrhea lasting 4 hours, then just continued diarrhea for 3 hours then it subsided. No fever, no chills or other symptoms.

Had minor pain at injection site beginning 4 hrs after ijection, resolved after 24 hrs. No other side effects until 7 days late (19 Mar). Moderate chills, moderate fatigue, moderate headache began 7 days after first injection, persisting with little change now 80 hrs after onset. One instance diarrhea 60 hrs after first injection. No fever. No joint pain or swelling. Have consulted PC nurse who advises I report this, and self-quarantine while await PCR results. I will report to ER if symptoms significantly worsen, otherwise will check back with PC physician Monday 22 Mar.

Spots in vision, dizziness, light headed, passed out multiple times, BP and sugar fluctuations on day of vaccine. approximate 5 days later developed a fever, vomiting and pneumonia. currently being treated at Hospital in by Dr.

Please include ?Pfizer-BioNTech COVID-19 Vaccine EUA? in the first line of box #18 of the report form. Mild pain around injection site (dose #1 & dose #2) and mild diarrhea approximately 14 hours after dose #2 injection only. Diarrhea persisted approximately 30 hours.

Flu-like symptoms, sweating, chills, nausea, passed out twice during the first few hours after the onset of symptoms. Upset stomach, vomiting in the night. Felt better the next day and by the third day after the onset of symptoms felt recovered.

Hard to swallow, but I can swallow liquids. Throat is swollen. Dizziness & chills. Not going to the ER unless it gets worse.

Fever of 104F, arthralgia, nausea and vomiting, extreme fatigue. N&V last ~24h and other symptoms lasted three days

Felt fine initially. About 4 hours later got very light-headed and fainted while walking to rest room - resulted in 7 stitches (head laceration) and 2 broken ribs from fall. A "vaccident". I was taken to the ER for treatment and spent 2 nights in the hospital. Over the next 8 or so hours I experienced fatigue, chills/shakes, nausea (threw up 3-4 times), and fainted a second time (while lying down).

lightheadedness, weakness, Pain Narrative: A 63yo male with history of tobacco use, Cocaine dependence in remission, PTSD, Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he received Covid-19 vaccine on January 11, 2021, per protocol, without complications and was advised to stay on site for 15 minutes. Instructions about side effects and ADR reporting were also provided. He called hospital advice line on January 12, 2021 to report ADR symptoms of having LT arm pain that radiates to his back and chest which started on his way home after he received the vaccine. Also reported he felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the call documenting nurse, to go the hospital ED, for evaluation. Per telephone note - Physician A/P documentation included that symptoms were discussed with the patient on January 12, 2021 @13:01 PM, patient was assured what he experienced was an expected reaction from the vaccine and it'd be safe to get his second scheduled shot On January 14 the patient called back to report feeling a little light headed, having muscle/ body ache and feeling weaker after the Covid-19 vaccine. Recommendation was made to go to the ER by the call taker Patient called on January 15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17, 2021 the patient presented to the ED with chief complaint of Chest pain, was hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained in MICU and passed away on February 4, 2021

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.

Anaphylaxis, dizziness, flush, itching, nausea, headache, heart racing, difficulty breathing. Gave me EpiPen. Was in ER for 4 hours after. Took antihistamine every 6 hours for 3 days.

COVID-19 Infection Narrative: Patient received dose of Pfizer COVID-19 vaccine on 2/23/21. On 3/5/21 the patient presented to the emergency department with fever of 102.4 F, chest pain, dyspnea on exertion, non-productive cough and diarrhea. Pt was tested and found to be positive for COVID-19 infection. Patient initiated on remdesivir and dexamethasone for treatment of COVID. Remdesivir discontinued due to new onset acute kidney injury. Patient completed course of dexamethasone. Patient discharged home on 3/9/21. Has not received second dose of vaccine.

Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.

Two weeks after vaccination I had severe constipation. It developed over several days and I had to seek treatment. No reoccurrence since that time.

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.

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.

sore arm; general muscle soreness; slight nausea; lethargy; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ER8732) via an unspecified route of administration, in Left arm on 26Mar2021 at 11:00 (at the age of 64-year-old) at a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6206), via an unspecified route of administration, in Left arm on 02Mar2021 at 15:00 at a single dose for COVID-19 immunization. The patient was vaccinated at hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient did not have allergies to medications, food or other products. The patient medical history was not reported. The patient received unspecified concomitant medications. The patient experienced sore arm, general muscle soreness, slight nausea and lethargy on 26Mar2021 at 21:00. The events were reported as non serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

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.

slight stomach spasm, racing heart, pins and needle pain in bottom of left foot and right foot, sore arm, nausea

no treatment. High fever and flat out in bed or 3+ days. excessive sweating, bad headache, no appetite, no energy

The day following receiving the vaccine I had no appetite whatsoever and was fatigued. The symptoms were similar to when I had Covid in November 2020 except I also had fever at that time. I did not treat the symptoms and they went away by the next morning.

Dizziness, difficulty breathing for 3 days, fever in excess of 101.6 for 2 days, loss of taste, loss of appetite, severe fatigue, body aches especially in neck and chest,

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.

4-1-21-headache, indigestion, 4-2-21 ER visit, with admission, R/O MI. 4-3-21 transferred via ambulance for pulmonary embolism almost occluding pulmonary artery with peripheral and additional pulmonary clots. Performed thrombectomy immediately on arrival to hospital. Then 48 hours heparin therapy, home on Eliquis

Symptoms began roughly 15 hours from the injection with severe headache and body aches. That continued to progress to include a 102 fever, aggressive chills, nausia, no appetite and muscle weakness. The symptoms continued, especially the muscle weakness, to the point that by the afternoon of the 12th, I was unable to get up from a chair or navigate stairs on my own. I was really unable to sleep. By the afternoon of the 13th, the muscle weakness subsided to the point that I could get out of a chair and navigate on my own, not well, but on my own. Symtoms continued to decline by the afternoon of the 14th. Symptoms continued to improve by the afternoon of the 14th that I could return to computer work.

I felt well for 1.5 months, then I started having colon clearing diarrhea almost every morning and a fever some of the nights. I was very concerned, but I drink plenty of fluids and lot of food supplements that I was able to endure it. This situation lasted for a little over a week and I decided to go to the ER, but first tried taking Zinc. The zinc was recommended by many of my customers at the pharmacy as a Covid reliver. It worked on the first DAY! I feel fine now and the diarrhea is gone. I may have had Covid again or a reaction to the vaccination. I had Covid last March that had the same explosive diarrhea, but it only lasted a day!

Tested Positive on January 6th, 2021 Bad headache, I hurt all over just like when I had the Covid Virus, Joints were the most painful, My body had hives on all places I was able to see, Eyes were very red with red rings around the outside of my eyes and eye lids, Nausea, my skin had a red look and there were red lines on my arms and legs, Every vein on my limbs were very pronounced, I had a "restless" arm and leg" vibrations and I had to get up and walk to make the feelings stop. I fought against the symptoms.

At about 10:30 on the evening of receiving the vaccine I started to get chills and became feverish. This ended at about 4 a.m. and did not return, but in the morning I had no appetite and had diarrhea. My appetite returned the following day but I also had an issue with my taste being off that lasted for 2 days after the vaccine. Basically with the second shot I got all of the symptoms I had when I got covid in November. After the first shot I only got about half of these symptoms.

nausea and vomiting after 5 minutes of vaccine administration. observed x45 minutes with recurrent Nausea and vomiting. Transported to ER

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.

Dizzy, muscle aches, joint pain, nausea, flu like symptoms for 3 1/2 days Rather severe Same problems on second shot but less so.

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

FEVER, CHILLS, BODY ACHES, NASUEA....DIDNT FEEL GOOD ENOUGH TO CHECK FEVER FRO SEVERAL HOURS . WHEN FINALLY CHECKED IT AROUND 2 AM IT WAS 100.9 UNSURE IF THIS WAS THE HIGH OR LOW OR WHAT.......ALSO VERY SORE ARM BUT THAT WAS SAME AS FIRST DOSE ( 04/06/2021........) ADVERSE REACTION WAS ONLY ON 2ND DOSE ( 04/27/2021)

5 days after the first shot-severe gastric pain (which went away after 1 hour) and then chills for 5 days & fever & weakness-- ater 5 days, I was 100% ok--- Exactly 5 days after teh 2nd dose, the same gastric pain arose in same spot--lower intestines--followed by onset of intestinal colitis & severe rectal wall inflammation-- I have no previous history of either--

Pt reported having a very sore throat on the left side, the side opposite of his injection. It lasted for nearly a week. It hurt to swallow anything. On 3/14, he went to Instacare & was give prednisone (unk dose) BID x5 days & a penicillin injection. Received 2nd shot on 3/31/2021. Didn't have the same problem after 2nd. Doing better now.

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

Pt received both doses of Pfizer COVID vaccine on 3/30/21 and 4/16/21. On 5/11/12, patient experienced right lower abdominal pain, nausea, and decreased appetite and presented to the ED on 5/12/21. Pt was found to have acute appendicitis and was tested for COVID in the ED as part of standard procedure. Despite receiving both doses of COVID vaccine, patient tested positive for COVID (rapid test). Pt did not have any respiratory symptoms and his chest X-ray showed no active disease. Pt was admitted to the hospital for treatment for his appendicitis.

On 4/21 patient was seen at urgent care with symptoms for several days: history of fever up to 101, abdominal pain, nausea, vomiting, diarrhea and body aches, 1 week post 2nd dose of vaccine. Patient admitted to ED on 4/30 with high fever up to 104, generalized body aches and a lack of energy. Patient was diagnosed with AKI on CKD, secondary to sepsis and polycystic kidney disease, patient was given fluids and ceftriaxone. discharged 5/3

ED Discharged 4/19/2021 (2 hours) Last attending ? Treatment team Cough with exposure to COVID-19 virus +1 more Patient presents with ? Fatigue HPI: Patient presents with a 3-day history of illness, started with a cough, generalized fatigue, some nauseousness and decreased energy. He is here today with wife, over the last 2 days has not really ate or drank much, only had 1 cup of chicken noodle soup, states he has not really ate or drink anything secondary to no appetite. Denies any diarrhea. Denies history of problems with his heart or lungs such as asthma COPD smoking heart failure or heart attack. Denies any new or different swelling in his lower extremities, denies hemoptysis. Patient had a COVID-19 test at pharmacy and was told the results may take 2 to 7 days. He has received one of his Covid vaccines but not the second, he was recently at an orthopedics appointment, otherwise denies any recent known exposures or other sick individuals to his knowledge. Wife was fully vaccinated for COVID-19. He does admit to feeling more short of breath. Patient is retired Clinical Support 4/23/2021 COVID-19 Dx Medication Infusion Reason for Visit Progress Notes (Registered Nurse) ? ? Encounter Date: 4/23/2021 ? ? Signed 12:30 pm: Patient arrived in clinic for MAB infusion, wheeled to the clinic on a wheelchair, reports generalized weakness and a cough, no SOB. VS acceptable . 12:52 pm - Commenced on MAB infusion 01:15 pm - Infusion ended successful with no adverse reactions. VS stable. Will observe for 1 hour before discharge. 02:15 pm - Patient stable post infusion. Given a pulse oximeter and shown how to use it, educated on when to seek help.Navigators to make home follow up calls.Discharged home. Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide ED Discharged 4/26/2021 (5 hours) DO Treatment team Bilateral pulmonary embolism (CMS/HCC) +6 more Patient presents with ? Shortness of Breath History of Present Illness: Patient is a 64-year-old male who presents for respiratory distress. Patient has recent history of Covid approximate 10 days ago who presents for shortness of breath. Patient says he woke up acutely short of breath with pain in the center of his chest. EMS arrived, they said patient was diaphoretic and they could not get a pulse ox. Patient's blood pressure was normotensive. Patient now continues to feel like he cannot breathe. Patient reports some mild pain in the center of his chest. Patient denies history of DVT or PE. Patient denies history of COPD or asthma but he is a former smoker. Patient said he was started to feel better from a Covid standpoint until this morning. Admission Discharged 4/26/2021 - 4/29/2021 (3 days) Last attending ? Treatment team Pulmonary embolism associated with COVID-19 (CMS/HCC) Principal problem Discharge Summary (Physician) ? ? Internal Medicine INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/29/2021 DOB: 10/28/1956 Admission Date: 4/26/2021 Length of stay: 3 Days Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pulmonary embolism associated with COVID-19 (CMS/HCC) Yes Essential hypertension Yes Other hyperlipidemia Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Graduation Infusion Date: 04/23/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

got cold, chilly, and freezing; diarrhea; throwing up; Fever; Sucking Breath, cant breathe and was out of air; This is a spontaneous report from a contactable consumer (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, administered in the left arm on 30Apr2021 at 08:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing hypertension (diagnosed 20 years ago, in 2001), ongoing diabetes mellitus(diagnosed 10 years ago, in 2011), ongoing high cholesterol (diagnosed last year, in 2020), ongoing triptococcus, ongoing myocardial infarction with stent placement (reported as on 16Sep), ongoing gastrooesophageal reflux disease ( GERD) (diagnosed 10 years ago, in 2011). Concomitant medications included valsartan for hypertension, start and stop date were not reported; glipizide (GLIPIZIDE XL) for diabetes mellitus, start and stop date were not reported; atorvastatin for blood cholesterol increased, start and stop date were not reported; ticagrelor (BRILINTA) for an unspecified indication, start and stop date were not reported; carvedilol for an unspecified indication, start and stop date were not reported; omeprazole for gastrooesophageal reflux disease, start and stop date were not reported; fluconazole for triptococcus, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on an unknown date in the beginning of Apr2021 in the right arm (Lot Number: unknown) for COVID-19 immunisation. The patient reported in was about four weeks between the two shots. On 30Apr2021, the patient experienced sucking breath, cant breathe and was out of air, got cold, chilly, and freezing, diarrhea, throwing up, and fever; all events for which the patient was hospitalized. The patient was hospitalized from 01May2021 to 06May2021. Clinical course: Two Fridays ago (on 30Apr2021), patient got second shot. He stated that he came home, he eventually went to the store, got back from the store. He stated that he walked the 20 steps from his car to his house and was sucking breath. He states he couldn't breathe and was out of air. He got really cold, chilly, and freezing. Had to lay on couch with comforter on. Started having diarrhea and throwing up. He had a fever. He states that he ended up in intensive care for 6 days. Patient stated he is on an inhaler but does not seem to work. He stated his breathing problem has improved, they had him on so many antibiotics, but it's still there. Caller did not provide products names regarding the antibiotics he was on. He states that when he had the chills his teeth were clattering. He stated that he still gets a little chilly but it is pretty much gone. He stated that the diarrhea has not stopped it is still real bad and he is having like black water coming out. He stated that the vomiting stopped on 09May2021. He stated that he has been unable to eat because he been so sick. He stated that he went to the hospital at about 9:30 am Saturday morning, on 01May2021. He said they were going to put him on a ventilator or a breathing tube, but he did not want that. He was on oxygen and 3 IV antibiotics at one time. He says on 06May2021 he left hospital. He stated that he told at least 20 people not to get their shot and they agree now. He states that there is something wrong with the vaccine somewhere. The patient recovered from the event, throwing up on 09May2021. The patient was recovering for the events, experienced sucking breath, cant breathe, and cold and chills. The patient had not recovered from the event, diarrhea. Outcome of the event, fever was unknown. Information about lot/batch number has been requested.

he's not doing well/ he felt so sick that he could not walk to go to work this morning/ Still can't function well; I can hardly move/ took him 20 minutes to get out of bed and get dressed; couldn't move and struggled to get through work; he felt so sick that he could not walk to go to work this morning/ Could hardly walk, it took over his whole body, back, legs, and speech; nausea; head, back pain/ Headache; head, back pain; stiffness in his legs; Fever; like the flu, worse than the flu; fatigued; fell asleep; This is a spontaneous report from a contactable consumer and other hcp from a Pfizer sponsored program Pfizer RxPathways. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 64 years, on 04May2021 14:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing single functional kidney. The patient's concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 on 13Apr2021 for COVID-19 immunization and experienced pain in arm. The patient received the 2nd dose of the covid vaccine yesterday and said he felt so sick that he could not walk to go to work this morning, fatigued, nausea, head/ back pain and stiffness in his legs which were categorized as severe on 05May2021. The patient's wife called and stated "My husband got the Pfizer vaccination, the second dose yesterday and he's not doing well." The patient than got on the phone and stated "I had an adverse reaction, I can hardly move." He also stated he could hardly walk, it took over his whole body, back, legs, and speech; still can't function well and been in bed since he got home. The patient was calling about the Pfizer Covid Vaccine and stated he received his second shot yesterday, 04May2021. He stated after he received the shot, he felt fatigued (04May2021) and fell asleep (May2021). He stated he works nights and when he got up at 02:00, it took him 20 minutes to get out of bed and get dressed. He stated he was home now, and he has a headache, fever, he still can't function well, and it is like the flu, worse than the flu. He stated at 02:00 a.m., he couldn't move and struggled to get through work and he still has a fever and is fatigued. The outcome of the events back pain, stiffness in his legs, fell asleep and nausea were unknown while other events were not recovered. No follow-up attempts are needed. No further information is expected.

vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 08May2021 (at the age of 64-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting on 08May2021. But because he takes other essential medication, he needed to be admitted to the hospital. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 09May2021. Therapeutic measures were taken as a result of vomiting. The event was assessed as serious, hospitalization. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.

One episode of vomiting; Leg spasms; Severe back pain; Chills; This is a spontaneous report received from a contactable consumer (reporting on himself) via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E087217 and Expiration Date was not reported) via intramuscular route of administration in Arm Left on 22Mar2021 10:00, as 2nd dose, single dose for COVID-19 immunization. Medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Incomplete Quadriplegic and in a wheelchair since 1972. Immune and respiratory system are probably compromised since 1972. He was ambulatory up until 15 years ago. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthralgia, myalgia from an unspecified start date to 2016. Previously patient took first dose of BNT162B2 Injected intramuscularly in left arm on 01Mar2021. Patient stated he has 8 separate reactions since the second dose. Reported leg spasms, Severe back pain, chills and one episode of vomiting. Stated he was two months out and still getting them every 2 weeks. Reported that he was an incomplete quadriplegic since 1972. The dates as 25Mar2021, 30Mar2021, 04Apr2021, 05Apr2021 noting had the leg spasms, 06Apr2021 reported vomiting, 15Apr2021 had the fourth reaction that continued for 3 days noting they usually last 24 hours, 21Apr2021, 2May2021, 19May2021 and 21May2021. Patient stated he thought the frequency was getting longer up until last week. Wanted to know what type of doctor if any should he be talking to and if any-thing could be done other than taking Tylenol and if there have been reports of reactions continu-ally happening before. She received their first vaccine 01Mar2021, and second dose 22Mar2021, but was having same side effects 2 months out every 1 -2 weeks. He was having leg spasms, severe back pain, and all kinds of side effects. He was trying to figure out who can he talk to and how to manage these symptoms. Celebrex was the only thing he heard of that may have interacted. He did not have a lot or expiration for that. NO ER or physician's office required. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Vomiting; no energy; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 11:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing and Patient had no known allergies. There were no concomitant medications. Patient had no other vaccine in four weeks and no other medications in two weeks. Patient had no covid prior vaccination and no covid tested post vaccination. On 27Feb2021 12:00 AM, the patient experienced vomiting and no energy. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

injection site was painful and uncomfortable; fatigue/feeling of tiredness; nausea; chills; hot; pain in his arm of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot:Unknown),via an unspecified route of administration on 11May2021 as second dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine was bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration as 1st Dose, Single Dose for COVID-19 immunization Within 6-7 hours, on 11May2021,the patient experienced fatigue, nausea, chills, hot, feeling of tiredness, pain in his arm of injection ,injection site was painful and uncomfortable. The events resolved within 48 to 72 hours except for the arm pain which was still persisting. The outcome for the event pain in extremity was not recovered/not resolved, vaccination site pain was unknown and rest of the events was recovered/resolved. No follow-up attempts are needed. No further information is expected.

Arm hurts where shot was administered. (Like muscle pain). Two days later, tiredness and occasional light stomach ache. Four days later, slight back pain on both sides like punched kidneys that continued for a week. Rash developed on ankles of both feet that has continued till present. (applying Hydrocortisone with slight success) Have an appointment with dermatologist 6/17. Joints started aching all over with 2 areas (left Ankle and right elbow) continues to have pain. These were areas that had old injuries but had no prior pain before the vaccine 2nd shot.

diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported). This 64-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via an unspecified route of administration on 23Mar2021(age at the time 64-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was not able to get the 2nd dose on time since he felt ill, mentioned he had "diarrhea" after the first dose. The patient had a word with nursing department. The patient wanted to know if he can still get the second dose given the timing. The outcome of the event was unknown. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

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.

one week after the 2nd shot of Pfizer vaccine, I developed stiff neck such that I cannot turn my head beyond my shoulder and have difficulty to turn my head when driving and changing lanes. two days later, my lower back pain re-occured after being pain free for more than a few years. I let the both pain to recover by itsself but the recovering process of the back pain is quite different from my past experience; the back pain last for more than 3-4 weeks until I feel freely to move around.

He had shortness of breath and chest pain. He had to go to the emergency room via his wife. When he arrived they performed an EKG and gave him oxygen. He was admitted for 3 days. While there they performed blood tests. They finally treated him on the second day, One doctor thought it was GERD. Another doctor, his cardiologist, thought it was Pericarditis. The first doctor prescribed pantoprazole. The cardiologist prescribed Colchicine. Then he was released from the hospital on June 2nd.

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.

I am suffering from extreme pain in all of my joints; I am suffering from extreme pain in muscles also; I am suffering from severe exhaustion; I am suffering from headaches; I am suffering from nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-years-old male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN] via an unspecified route of administration on an unspecified date, at the age of 64 years as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension and gastroesophageal reflux disease. 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 medications included gabapentin (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN), hydrocortisone (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN). The patient suffered from extreme pain in all of my joints (joint pain) and muscles (muscle pain). The patient also suffered from severe exhaustion (exhaustion), headaches and nausea on 12Mar2021 at 12:00. The patient cannot do any day to day activities. The patient did not receive any treatment for events. The clinical outcome of events joint pain, muscle pain, exhaustion, headache and nausea were not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/02/2021, pfizer,Lot# EN6205 2nd dose: Pfizer 03/23/2021, Pfizer lot# EN6208 Diagnosed covid positive:06/26/21 Exposure:Home Symptoms:Headache, cough,nasal congestion, rhinorrhea, diarrhea.

colon, causing lack of function, some pain; cannot have bowel movements; lower bowel regions became inflamed; Felt some normal symptoms of illness; Inflammation of colon; causing lack of function; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration in arm right on 01Apr2021 as dose number unknown, single at the age of 64 year for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Anti-inflammatories, stool softeners, laxatives were the other medications the patient received within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Apr2021, first 30 hours after vaccination it was reported that the patient felt some normal symptoms of illness. Then lower bowel regions became inflamed, had months of symptoms since. Inflammation of colon, causing lack of function, some pain, cannot have bowel movements, said this condition is very rare. My neighbour just one block from here also is reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softener etc. The clinical outcome of the events on an unspecified date 2021 was resolved with sequel. Information about lot/batch number has been requested.

07/01/21: cough, fever, runny nose, nasal congestion, shortness of breath, body aches, loss of taste and smell, loss of appetite

Patient recieved the first pfizer vaccine on 3/15 and tolerated without side effect. On 4/5/21 he recieved the 2nd vaccine and 72 hrs later he felt extremely weak sweaty had some nausea and then developed the swelling over the temples on 4/12 he had no visual loss he had no headaches he had no PMR type symptoms. He developed neck pain shoulder pain or hip girdle pain. He had no visual changes. he was referred to our office with a high sed rate and elevated glucose. Saw Dr 4/26/21 for initial evaluation. pt was started on prednisone, temporal swelling had already resolved.

I had an emergency appendectomy on May 18,2021 at the age of 65. I am questioning if the vaccine could be the antecedent for the appendicitis that resulted in the appendectomy. I am curious if other seniors have had the same issue also. Thank you.

Monday 22-Mar Rec'd 2nd vax shot Thurs 25-Mar 1st reaction, feeling cold & sore back Tue 30-Mar 2nd rxn milder effects Sun 4-Apr 3rd rxn, sore back & chills Mon 5-Apr spasums, 6pm to 4am Tues 6-Apr vomitting 7pm to 3am Thurs 15-Apr 4th rxn Fri 16-Apr cont'd 50% sore back Wed 21-Apr 5th rxn, noon started feeling minor effects` Sun 2-May 6th rxn. started feeling effects around 5pm (Just tired) - mild, & chills Mon 3-May just minor effects, feeling chills Wed 19-May 7th rxn woke up feeling chills / minor effects Fri 21-May 8th rxn, woke up started feeling minor effects` sore back & chills Tues 25-May 9th rxn, started after midnight started feeling chills, no back pain. 26-May lower back pain & chills Fri 4-Jun 10th rxn, started at 8pm chills Sat 5-Jun lower back pain & chills Wed 30-Jun 11th rxn, started at 12am-midnight chills Thurs 1-Jul lower back pain & chills Wed 7-Jul 12th rxn, started at 10.:30pm chills Thurs 8-Jul mild lower back pain & chills

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.

Pronounced change in taste/smell. These senses were not lost, but changed in pronounced ways. Foods commonly left bad (metallic) aftertaste in mouth, and highly spiced foods sometimes caused either immediate sneezing (as in allergies) or gut discomfort. During this period I noticed episodes of sinus and/or ear infections. The symptoms started around the time of first injection, although I did not recognize them as a pattern for some time. The strength of the symptoms fluctuate in time. 3.5 months after the 1st injection it seems that taste/smell is becoming more normal, although there may be some residual, fluctuating symptoms.

Patient states that 10 days later, patient stated he had nausea. Patient experienced this for 3 days, and telecommunicated with doctors and was prescribed meds to relieve nausea and meds somewhat worked.

woke up from sleep with stomachache, which spread and stayed inribs, both sides, front, in the middle ofthe rib cage.; woke up from sleep with stomachache, which spread and stayed in ribs, both sides, front, in the middle ofthe rib cage.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 02Apr2021 at 11:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), atorvastatin (LIPITOR), acyclovir (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and aspirin (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 04Apr2021 at 04:00, the following night (36 hours post shot), the patient woke up from sleep with stomach ache, which spread and stayed in ribs. Ache in both sides, front, in the middle of the rib cage. It got better in the morning and started up in the next night, but less severe. The pain was diffuse and strong. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events woke up from sleep with stomach ache, which spread and stayed in ribs, both sides, front, in the middle of the rib cage was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Abdominal cramping and diarrhea pretty much beginning on day 2 post vaccination and has lasted for 10 days so far. OTC treatment with Imodium was used.

Received the covid vaccine on 1/12/21 started having symptoms evening of 1/15 including stomach upset, chills, muscle and joint pains headache and overall feeling Blah........on Saturday afternoon started feeling much better. Over all symptoms lasted less than 24 hours slight headache after that but relieved with medication.

Jan 3 vaccine administered, jan 4 started headaches, vomiting, pain in the back of the neck, Headaches, chills, loss of speech,

He woke up with nausea, headache, very sore injection site, fever of 101. He couldn't move his left arm up higher than his waist. He took Ibuprofen OTC, rested, felt ok by evening. Next day, no side effects remained.

injection site pain, headache, muscle pain, chills, joint pain, and nausea. Started 0300 02 Feb 21, ended 1000 02 Feb 21.

Symptoms manifested approximately 12 hours after injection and lasted 30-36 hours. Started with rather severe chills, fever of 102 for next 24 hours, extreme fatigue, body aches, head ache, loss of appetite. NOTE that I was tested Covid positive on November 2, 2020. I was tested for Covid antibodies in December 2020.

Blood present in stools during bowel movement. Never before have I had this problem. And I've had a colonoscopy in the last five years with no problems at all. Never seen blood in stools before this vaccine!

Pt found by (paramedic) at 1027 leaning forward in chair in vaccine observation area. C/o nausea, dizziness. Pt ambulated self to recliner chair. Clt leaned back in chair, head to the side, then leaned forward feeling like was going to throw up, exhibiting vasovagal like symptoms. Vitals taken at 1032: BP 160/90, HR 110, RR 16, pupils sluggish, AxO x4. 9-1-1 activated at 1143, vitals recheck at 1145: BP 160/92, HR 90, RR 16, pupils sluggish, A x Ox4. Pt transported by ambulance, hospital unknown.

Pt got up after 15 minutes and felt sick-reported nausea and feeling hot. Gave water and called rapid response, no other intervention.

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.

Records review utilized to obtain information: Pt recieved his first dose of the Pfizer COVID-19 vaccine on 1/27/2021, unable to determine location that administered vaccine. Pt called to his PCP and indicated he was experiencing "intense, but intermittent stomach pain in the LUQ since the day after receiving vaccine. He stated he was not eating due to the pain, and that nausea and vomiting would occur when eating. His wife and son both tested positive for COVID-19 per PCR on 1/29 (unknown what type of test). He was tested on 1/25 prior to vaccination and was negative at that time. He ended up going to the ER later that day and is recorded as having a fever and cough at that time, in addition to the pain as described above. Pt tested positive at this time on admission testing (2/5/2021). He is still currently inpatient at our facility.

severe shaking convulsive; chills; nausea; leg cramps; difficulty breathing; vomitting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received single dose of BNT162B2 (PFIZER, Solution for injection, batch/lot number and exp date not reported ), via an unspecified route of administration (vaccine location: left arm) on 22Jan2021 10:45 for COVID-19 immunization. Medical history included diabetes and high cholesterol. The patient did not have Covid prior vaccination. The patient had no known allergies. Concomitant medication/other medications within two weeks included rosuvastatin calcium (CRESTOR), telmisartan, empagliflozin, metformin hydrochloride (SYNJARDY), and atenolol. There was no other vaccine within four weeks. On 24Jan2021 02:00, the patient experienced severe shaking convulsive, chills, nausea, leg cramps, difficulty breathing, and vomiting. No treatment was received for the events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Jan2021. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.

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.

02/07/2021- AM have abundance of floaters in right eye, not had previously. Later in day had some nausea, headaches and extreme soreness at swelling site but those 3 issues went away after a few hours. That evening I started getting what I will call "Lightening Bolts" flashing along the outer right edge of my right eye when I moved my head side to side. 02/08 & 09/2021- "Lightening Bolts were constant and I went to hospital.

At midnight I started coming down with a fever which peaked at 101.3. Severe chills. Body aches. Headache. Nausea. Temp is still at 100.0 as of 8:51a on 2-13-2021. Yes, I'm drinking water and taking Tylenol.

My throat started closing within 30 minutes. I had difficulty swallowing. It was similar to an anaphylactic reaction I get to nuts. It lasted about three hours.

Blood in stools the next day after getting vaccine.; This is spontaneous case from a contactable consumer reported for himself. A 65-year-old male patient received 1st dose of BNT162B2 (lot# EN5318) on 04Feb2021 00:00 (reported as 03Feb2021 12:00 PM) at single dose on Right arm for covid-19 immunization. Medical history was diabetes from Aug2018. Concomitant drug was Insulin lispro (HUMALOG) for Diabetic. Patient experienced Blood in stools the next day after getting vaccine (04Feb2021 08:15 PM). Never had this problem before. Have had colonoscopy in last 5 years with no diagnosed problems. No treatment received. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. No follow-up attempts are possible. No further information expected.

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.

Day one was low-grade fever and fatigue. Day two was vomiting. Day three through five was vomiting and continuous diarrhea. Hospital admission on day five for dehydration. Diarrhea continued through day eight post vaccination.

Nausea/feel like vomiting-riding bike in esophagus; indigestion; diarrhea; Slight headache on injection day; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 30Jan2021 08:30 AM at single dose for COVID-19 immunization in a hospital. Medical history included hypertension, anxiety and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications received within two weeks of vaccination. The patient experienced slight headache on injection day. The patient experienced nausea and indigestion leading to diarrhea and feel like vomiting - riding bike in esophagus on 31Jan2021 at 01:00 AM. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

Patient received his first Pfizer COVID vaccine on 3/3/21. Patient was conscious with no apparent issues after administration. Patient was asked to sit down for 15-minute observation afterwards. A few minutes later patient was swaying back and forth in his chair and saying he was feeling faint. I repeatedly addressed patient by his first name and asked if he could hear me and repeatedly asked if he was okay. Patient began slumping down in his chair but was still conscious. Patient was not responsive but made eye contact with me. Patient requested water. After giving patient water and observing him drink he began looking nauseous and threw up. Patient then passed out in his chair. I supported the patient upright in his chair and made sure he did not fall down or injure his head. I then immediately tapped him on both shoulders and repeatedly called his name. Patient then became responsive and 911 was called. While waiting patient said he was starting to feel better and was able to support himself in his chair. I did not observe any injuries due to fainting. When the ambulance came patient agreed to be taken to the hospital.

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.

Tachycardia, joint soreness on March 5th. Low grade fever (100.5), severe headache, nausea, whole body ache on March 6th. Severe shaking on the evening of March 6th, duration over 60 minutes. Night sweats, nausea, headache that night.

Headache that lasted 24 hours, nausea that lasted 24 hours, vomiting that lasted 12 hours, and body aches and pains that continue at this time , 36 hours later. The headaches have mostly subsided, vomiting has ceased, nausea has mostly ceased, although it may continue at bedtime much like last evening.

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.

Upset stomach / nausea started just a few minutes after the vaccination then upon waking the next day headache, muscle aches, fever came on in addition to nausea.

For the first time in my life, I had blood in my stool. At 10 pm on the same day of my injection. 03/09/2021.

Slight soreness in left arm around and just below the point of injection. This went away around 6PM on Tuesday, the day after the injection. For about 2 hours around 10PM until I went to sleep on Monday night (the night of the injection), I had a slight fever but it was only slight. I had a more intense fever (though for only 30 minutes) the evening that I had my flu shot last October when I visited my doctor for a check up, so I would definitely categorize the fever from the COVID-19 shot as very slight. It was gone when I woke up in the morning. After I woke up, I was a bit nauseous, but it was so slight (and I have not been nauseous for well over a year) that it took me awhile to actually recognize it as being nauseous. This lasted for 15-20 minutes and then it disappeared. On Wednesday morning, my heart went into an irregular heartbeat that felt different than what I feel when it goes into an irregular heartbeat. I have no idea if there is any relation between receiving the vaccine and getting an irregular heartbeat but I thought I should report it. I have recovered from all symptoms from the vaccination except the irregular heartbeat. I put down as "unknown" if I have recovered from the adverse events as I don't know if going into an irregular heartbeat was in any way related to the vaccination.

Oral thrush with plaques in the back of throat and uvula. Difficult/painful swallowing. I have been treating myself empirically with Mylanta, Rolaids, gargling salty water alternating with diluted listerine, honey, and basically a soft diet. I experienced headaches, general fatigue, and diarrhea as well, no fever, cough,not even pain or swelling at site of injection. I must said that I am feeling better, but still have soreness when swallowing, and I have lost 4 lbs. I do not know if this is a common side effect,so I decided to report it, I am on Humira due to my AS.

c/o dizziness and nausea when at registrar desk, sat down wheeled to recovery cot to lie down feet elevated Assess: AAO, no SOB, + nausea, no vomitting VS 164/86, HR 44, Resp 16 regular non labored CO2 sat 97%. continued to monitor Heart rate continued to be 40's to low 50's. Dr. called to evaluate. Recommended to be sent to hospital. 911 called transported via ambulance left 10:15 am. Called 3/7/21 to get an update of condition - spoke to wife - Pt released to home from hospital same day. Feeling better today BP 129/47, heart rate 64 Going to follow up with his cardiologist within 3 days.

Called over to patient's car after vaccination where patient reported feeling nauseated and unwell. Reports sudden onset of nausea and dizziness. Denied chest pain/pressure, palpitations, SOB, HA, abdominal pain, or any other complaints. Reports feeling well prior to vaccination. HR initially low 40s regular with thready radial pulse. Quite diaphoretic. Patient reclined in driver's seat as far as possible. EMS on site notified and responded. PMH significant for HTN and HLD. No DM, neurologic, or cardiac history. Medications Losartan and Lovastatin NKDA Initial HR 42, sinus on monitor without ectopy. BP 92/56 RR 16 SpO2 97% RA Alert and oriented, Pale cool diaphoretic Regular bradycardia with normal S1 and S2 Lungs CTAB Abdomen soft, NT/ND Likely vasovagal, with increasing HR and BP after 15 minutes, however patient still reports feeling dizzy and nauseated with borderline hypotension. Strongly recommended transport to the Emergency Department for further evaluation and monitoring. Briefly discussed that as patient was alone in the care, I felt extremely uncomfortable allowing the patient to drive. Transported in care of EMT. Returned within 2 hours and picked up his car.

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.

Explosive Diarrhea; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received first dose BNT162B2 (PFIZER, Formulation: Solution for injection, Lot: Number: EN5318) via an unspecified route of administration on 06Feb2021 08:30 AM at single dose for covid-19 immunization. Vaccine location was left arm; facility where the most recent COVID-19 vaccine was administered was other; did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's medical history included inflammatory bowel disease (IBS) (being treated with unspecified treatment) and hypertension. Allergies to medications, food, or other products: No. Concomitant medications included ciprofloxacin and lisinopril. On 10Feb2021 evening 08:30 PM, the patient experienced explosive diarrhea which may be due to being treated for colitis, but doctor said to report it. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient received a round of FLAGIL and CIPRO prescribed and no soli. Prior to vaccination, was the patient diagnosed with COVID-19?: No; Since the vaccination, has the patient been tested for COVID-19?: No. Outcome of the event was recovering. Vaccine Facility information, ethnicity information and race information was available.

Evan began to feel ill, loss of appetite, feverish, tired. Napped several hours, took a dose of acetaminophen around 4 pm. Symptoms subsided after about 6 hours with no recurrence.

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.

Nausea, fever , body aches , chills loss of appetite fever from 99 to 100 degrees F for over one week

Extreme heat of head flushed , itching of chest and arms, rapid heart beat,, extreme nausea, coughing

Headache, stomach ache, slight nausea. Some fatigue. Started late evening 3/23, lasted til late afternoon 3/24. No treatment.

Significant diarrehri; vomiting; severe dehydration; kidney damage; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm at 14:15 on 27Feb2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included Crohn's disease. On 28Feb2021, the patient experienced significant diarrehri (diarrhoea) and vomiting resulting in hospitalization for 3 days for severe dehydration and kidney damage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received over the counter medications within 2 weeks of vaccination. The adverse event resulted Emergency room/department or urgent care and admitted for 3 days. Treatment (IV of fluids and pain medications and anti-nausea) received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The outcome of events was recovering. Information on the lot/batch number has been requested.

For my second dose, I experienced fever, nausea, explosive diarrhea and headaches that lasted two to three hours. I had no adverse reaction to my first dose Pfizer vaccine. (lot#: EL0140)

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.

24 HOURS AFTER VACCINE INJECTION, EXPERIENCED DIARREA, RUNNY NOSE AND CHILLS - NONE WERE MAJOR ISSUES

PATIENT STATES HAS NAUSEA AND FLUSH FEELING. PATIENT DENIES SHORTNESS OF BREATH, DIZZINESS OR WEAKNESS. BP IS 143/79, HEART RATE IS 61, O2 SAT IS 99 %. PATIENTS SYMPTOMS RESOLVED AND PATIENT RELEASED.

Very nauseous; dizzy can't stand; Feeling very sick; head feels heavy; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9264/expiration date: not provided), via an unspecified route of administration, on 20Feb2021 at 13:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Feb2021, the patient was very nauseous, dizzy can't stand, feeling very sick, and head feels heavy. The patient did not require hospitalization and did not receive any treatment for these events. At the time of the report, it had been 5 days since the second dose and the outcome of the events nauseous, dizzy can' stand, feeling very sick, and head feels heavy was not recovered. Since the vaccination, the patient had not been tested for COVID-19.

day 7 queasy stomach after eating breakfast, lasted all day. Day 10 intense itching all over skin, continued for duration. Day 12 Diarrhea 10-20 minutes apart for 5 days. GI tract slowed or stopped for 48 hrs, continued eating, Vomited @ 48 hours and diarrhea again for 2 days, GI tract slowed for 2 days, Vomited and Diarrhea for 8 hours, GI tract slowed, when the full feeling was there this time I fasted and exercised until there was pressure relieved by constipated bowel movement. My GI tract seems to be flipping from purging and slow down. The itchy skin subsided more or less as the GI tract stopped purging. as of April 5 my GI tract seems to have settled into a mild constipated state, not it?s normal.

Fever, chills, muscle contractions in lower back and stomach for two days. Loss of appetite, lower back pain. My urine was deep orange in color and bowel movements were very loose (not formed). Extreme fatigue for almost 8 full days before I felt any sense of feeling normal.

bodychills; headache; heavy sweats; low fever; no appetite; losing weight; lethargic; heavy head; tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (Lot number: En6205), via an unspecified route of administration, administered in left arm on 08Mar2021 11:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. No Covid prior vaccination. Concomitant medications included amlodipine besilate; benazepril; and gemfibrozil. No other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced body chills, headache, heavy sweats, low fever, no appetite, losing weight, lethargic, heavy head and tired. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized due to the events on unspecified date. There was no treatment given for the events. The outcome of the events was not recovered.

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.

diarrhea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 12:00 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included High BP. Concomitant medication(s) included metoprolol 50mg; valsartan 325mg. No Known allergies reported. The patient had diarrhea several times each day beginning the evening after the shot. It's worse at night but it's been 10 straight days of continuous going. Patient had not experienced any other side effects. No fever, pain, swelling, fatigue or anything. The patient experienced diarrhea on 09Feb2021 20:00. No COVID prior vaccination and no COVID tested post vaccination were reported. No treatment was received. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

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.

slight fever 99.7 early evening 07Feb; lower abdomen pain thru to back; lower abdomen pain thru to back; then woke to cold and shivering lasting 2hours that night; then woke to cold and shivering lasting 2hours that night; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 06Feb2021 at 03:45 AM as single dose for COVID-19 immunization. Medical history included hypertension, chronic obstructive pulmonary disease. Allergies included shellfish allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 07Feb2021 at 19:00, the patient experienced slight fever 99.7 early evening, lower abdomen pain thru to back, woke to cold and shivering lasting 2hours that night. The clinical outcome of the events slight fever 99.7 early evening, lower abdomen pain thru to back was unknown and the event woke to cold and shivering lasting 2hours was recovered. The patient underwent lab tests and procedures which included body temperature: 99.7 on 07Feb2021. No follow-up attempts are possible and no further information is required.

After second vaccine felt nauseous for 2 hours; vomit two times; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (brand: PFIZER), dose 2 via an unspecified route of administration, administered in left arm on 08Feb2021 (lot number: EM9808) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received 1st dose of bnt162b2 (brand: PFIZER, lot number: EL3247) on 18Jan2021 04:30 PM for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. After second vaccine felt nauseous for 2 hours and vomit two times on 13Feb2021 23:30. Outcome of events was recovering. No treatment was given for the events. The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.

I was pretty sick for 2-1/2 days after my second shot. then felt pretty normal for two weeks. about 17 days after my last shot I began to get head aches, body aches, mild stomach ache and fatigue. I have a steady temperature of 98.0 I do not have a sore throat or a runny nose. although that is because of the Allegra. sorry I forgot to include that in my meds list. there has been no change or improvement so far. I am in great physical and mental health prior to this. very fit. need motrin pills to cope and sleep. what is most likely going on??

NOTE: I ALSO ATTMPTED TO FILED ONLINE BUT SITE CRASHED ON LAST PAGE , site got stuck on Military info - would not validate input or allow 'submit'. -----symptoms---- Same day (4/7): malaise, no fever, started 10PM Next day (4/8): Awakened to severe shaking (no fever or chills) 1AM, no fever (<99F), took 2x Tylenol at 3AM, shaking subsided Awakened to 103F fever (ear thermometer), no shaking 7AM 104F fever at 11AM, accompanied by vertigo/nausea when upright Took 2x Tylenol 1PM, fever reduced to 101F Fever at 101F until 10PM, then dropped to 99F with 15 min cold sweat 2nd day (4/9): Awoke with no fever or further symptoms, 8AM. Never got a sore arm.

Admitted for abdominal pain and weakness. Subsequently found to be COVID-19 positive, >14 post vaccination series

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

History of hypertension and COPD presents to the ED 4/23/21 with complaints of fever, nausea, dizziness, muscle aches, diarrhea, urinary urgency, and shortness of breath that started 4/20/21. SARS-CoV-2 COVID-19 resulted positive 04/22/21 23:40 on PT admitted 4/23/21. PT received dose 1 Pfizer vaccines on 2/25/21 LOT EN6200. Pfizer dose 2 received 3/18/21 LOT EN6207. PT discharged 4/25/21.

Pt received his 2nd covid 19 vaccination on 3/31. Presents on 4/26 with 3 days of nausea, vomiting, diarrhea, fever, chills. admitted with severe sepsis and gram negative bacteremia of unknown etiology. being treated with ivf , zosyn and supportive care

3 days of Diarrhea, Severe Headache, Dizziness, Nauseous, Very Sore Arm for 5+ Days, Fever, and extreme tiredness. Most of these symptoms lasted about a week. Had second vaccination on April 14 at 10:00 am and experienced symptoms. Those included Headache, Severe Dizziness, Fever, Tiredness. For the past 2 weeks have had Coughing, Dizziness, Sneezing, Phleum discharge in the throat and nose.

Tired; Low energy; Chills; Headache; Nausea; Feel unwell; This is a spontaneous report from a contactable healthcare professional (other HCP; patient himself). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration in the left arm on an unspecified date (at the age of 65-years-old) at a single dose for COVID-19 immunization at a hospital. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN), ciprofloxacin (CIPRO) and amikacin sulfate (BIOCIN) and experienced allergies (drug hypersensitivity). No other vaccine was given in four weeks. The patient has not been tested positive for Covid prior vaccination. The patient has not been tested for Covid post vaccination. On 23Jan2021 09:45AM, the patient was tired and experienced low energy, chills, headache, nausea and felt unwell. No treatment was given for the events. The outcome of the events was not recovered. No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.

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.

Sweating, nausea, paralysis from neck down sensation of loss of bowel lasting 60-minutes Residual effects sore left arm bicep to wrist into middle finger (currently)

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.

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.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient came to pharmacy and stated that his doctor looked at his medical history and said he can get a COVID vaccine. Answered questionnaire and stated no allergies to anything. Gave pt the vaccine, and then patient told us that he had history of Guillain-Barre Syndrome. Gave patient cold water. Patient requested some table salts and 2 tabs of 25mg diphenhydramine. Patient refused Epipen and calling 911. He sat for at 45 minutes to an hour before leaving. He said he was feeling okay when leavin

Chill, headache, dizziness, sore muscles, nauseated, tired. for 2 days. Milder headache & dizziness for 2 more days so far

Patient reports light headedness, mild dizziness and nausea. Vitals 98% and heart rate 79. Patient asked to lay down. Cold water offered. Observed patient for 15 minutes. He became fine and was able to drive home.

Nausea come and go.; Running 100+ fever; Bad head ache; This is a spontaneous report received from a non-contactable consumer, the patient. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6208, dose number: 2) via an unspecified route of administration in the right arm on 16Mar2021 at 15:30 as single dose for COVID-19 immunisation (at the age of 65). The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no; EN6198; dose number:1) via an unspecified route of administration in the right arm on 22Feb2021 at 13:00 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. Medical history included allergic to statins. Concomitant medications included Levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. On 16Mar2021 at 16:00, the patient experienced nausea which was come and go, running 100+ (units unspecified) fever and bad headache. No therapeutic measures were taken for the event. The clinical outcome of the events fever, headache and nausea were not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

flu-like symptoms; joint and muscle pain in hips and back of thighs; joint and muscle pain in hips and back of thighs; headache; bodyaches; fever; lack of appetite; fatigue; weakness; light headedness; 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: EN5318), via an unspecified route of administration on 09Feb2021 (at the age of 65-years) as 1ST DOSE, SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: known allergies: Minor Adverse reaction to Yellow Fever Vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. Prior to the vaccination the patient was not diagnosed with COVID-19. On 09Feb2021, the patient experienced 5-7 days of flu-like symptoms: headache, bodyaches, fever, lack of appetite, fatigue, weakness, light headedness. Additionally, the patient had 5-7 days of joint and muscle pain in hips and back of thighs interfering with sleep at night. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 12Feb2021, post vaccination the patient had nasal swab test (SARS-CoV-2 test) and the result was negative. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Headache; nausea; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:30 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient stated that in Mar2020, his wife was tested positive for covid. The patient's concomitant medications included Vyvanse, Duloxetine, Divalproex, Tamsulosin, Levotab. The patient did not have covid prior to the vaccination nor been tested post vaccination. The patient had no Known allergies. On 04Mar2021 at 18:30, the patient experienced Headache, nausea and tiredness. All symptoms were mild and lasted. The patient did not receive any treatment for the events. On an unknown date in Mar2021, patient had recovered from all events. No follow-up attempts are needed. No further information is expected.

Since March 2021, I am experiencing discomfort in the upper abdomen area, just under the rib cage. At times the pain is in the rib area. On a scale of one to ten and ten the worst, it is about a one. I have undergone several tests, a stress test, and two ultrasounds, one with contrast. Still, the discomfort persists. The only change in my routine was the administration of the vacation.

He had flu like symptoms; Severe diarrhea; Low grade fever; Nauseous; He got dizzy and his hands fell asleep; He got dizzy and his hands fell asleep; 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: ER8736), first dose via an unspecified route of administration, administered in left arm on 03May2021 (at the age of 65-year-old,) as a single dose for Covid-19 immunisation. The patient's medical history, family history and concomitant medications were reported as none. The patient did not experience any adverse event prior Covid vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 03May2021, it was reported that 5 min after the vaccine dose around 13:30 to 14:00 in the afternoon the patient's hands fell asleep, and the fire department had to walk him around for a bit. Six or seven days later after Covid vaccination on 09May2021, the patient was dizzy (time unknown), and, in the afternoon, he felt nauseous and experienced diarrhea and flu like symptoms, on the same day in the evening he also had low grade fever. The patient did not visit emergency room for events. The patient did not received treatment for dizzy and flu like symptoms. Therapeutic measures were taken, because of diarrhea he took Imodium (a week before he visited physician office) and Tylenol for low grade fever. Treatment for nauseous was not reported. No investigation assessment was reported. No relevant tests were performed. The patient underwent lab tests and procedures which included Sars-Cov-2 antibody test: result was negative. The reporter did not specify event seriousness. No product quality complaint was reported. The patient visited the physician office after it was over to get doctors opinion. Everything went away and the patient did not know if it was a reaction or food poisoning and the doctor said it was a reaction to Covid vaccine. The patient reported that he was supposed to get second dose of vaccine and he would like to know that if he should get second dose or not because he recorded an Adverse event with DSU on 24May2021. The reporter also mentioned that since his second dose was on 24May2021 (reported as today), would it screw things up if he did not get the second dose on the date of report 24May2021 (today). The patient states that his provider says that his side effects are from vaccine and he would be putting him on medication for side effects. The patient also queried that would it screw things up if he waits for a week or so before going back to get the second dose. The patient dug through when he got back on 24May2021 (today), he was curious if it is advisable to go back after the reactions. Attempted was made to explain to the patient that ‘we' would not be able to tell him whether or not to go back for his second dose and that we suggest he reach out to primary care provider for more information. The patient wanted to know if it is advisable to get the second dose or hold off and that's his biggest worry. The has a second question, the second dose date is supposed to be on 24May2021 (today) will it screw things up if he waits a week or so before going back to get the second dose. The outcome of the event hands fell asleep was reported as recovered on 03May2021, events diarrhea and low-grade fever was recovered on 10May2021, events flu like symptoms and nauseous was recovered on 11May2021 and event dizzy was recovered on 12May2021. No follow-up attempts are needed. No further information is expected.

Swollen lymph in right neck throat; painful and difficult to swallow.; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6205), via unspecified route of administration in the right arm, on 05Mar2021 at 09:00 AM, as a single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications included Ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol and vitamin B not otherwise specified (MULTIPLE VITAMINS), Saw Palmetto 320,NSK-SD™ 100 mg. The patient was allergic to Shell fish. On 06Mar2021 at 10:00 AM, the patient experienced Swollen lymph in right neck throat making it painful and difficult to swallow. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Pt received his second dose of Pfizer COVID vaccine on 5/19. That same day he developed diarrhea and shortness of breath. He presented to hospital emergency department on 5/23. They recommended COVID test, but patient refused and he was discharged home. He re-presented to ED on 5/26 and was admitted and treated for bacterial pneumonia with CTX/Azithromycin. During that admit he was newly diagnosed with Atrial fibrillation. Discharged on Eliquis. He then re-presented on 6/2 and tested positive for COVID. Pt got upset with the diagnosis, refused care, and left hospital. His daughter lives in the northwest suburbs, so she brought him to Hospital, where patient also tested positive for COVID on 6/4 and was admitted for COVID treatment (noted to be hypoxic (89% O2 sat) on room air).

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.

On the evening of March 6, I developed sharp pain in my upper right quadrant. I had a history of similar episodes over the previous decade, but this one required emergency room treatment. I was given pain medication and sent home. Twenty four hours I returned to the emergency room. I was diagnosed with acute cholecystitis and admitted to the surgical service at the hospital. The next day, my gallbladder was removed by laparoscopic surgery. The pathology report confirmed cholecystitis with cholelithiasis. I was discharged on March 9, 2021.

Inability to swallow food to my stomach/ Inability to drink over 1/2 cup; Inability to swallow food to my stomach. Much discomfort. Inability to drink over 1/2 cup. Much discomfort; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ew0171, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 29Apr2021 at 12:15 (at the age of 65 years old) as second dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. The patient has no other medical history. The patient has no known allergies and prior to vaccine the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: er8737), via an unspecified route of administration administered in left arm on 08Apr2021 at 12:15 (at the age of 65 years old) as single dose for COVID-19 immunisation. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no list of any other medications the patient received within 2 weeks of vaccination. On 02May2021, the patient experienced inability to swallow food to his stomach with much discomfort and inability to drink over 1/2 cup with much discomfort. At the time of report, it was the second week the patient experienced the events. The patient stated that he needed to eat. The patient was able to eat only ice cream slowly. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.

diarrhea; Severe joint pain in knees; lower back pain kidney area; kidney pain; pain in his thigh muscles and buttocks; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6205) via an unspecified route of administration on 10Mar2021 at 02:00 pm on the left arm as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications patient received within 2 weeks of vaccination included : Lisinipril, coreg hydrocodone, Cialis and sertraline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 10Mar2021, at 09 30 pm, the patient experienced severe joint pain in knees, lower back pain and kidney area. The caller also stated that he experienced severe pain in his thigh muscles and buttocks. He had terrible pain in his knees. He also had pain in his kidneys for 4 days. The patient took Meloxicam for inflammation, Hydrocodone for pain and Flexeril for a muscle relaxer. The caller stated that he can deal with his muscle and joint pain but is concern was about the kidney pain and he didnot want kidney failure. The caller stated that he also had diarrhea on the 5th and 6th days. The caller stated that he was scheduled to get the second shot tomorrow. caller has read that the second dose was worst than the first. The caller stated that he doesn't know whether he should get the second dose and his doctor advised him to speak with Pfizer or where he received the first vaccine or to go to the emergency room. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

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.

Pt. is a 65 yrs. male with h/o renal transplant on immunosuppressive therapy, presenting with worsening productive cough of white sputum for the past couple of days. There is associated fever, chest pain while coughing, shortness of breath, sore throat, painful swallowing, chills, and generalized body aches. Had one episode of non-bloody emesis and watery stool. Denies change in urinary habits, no dysuria. He went to minute clinic at store pharmacy and an X-Ray showed RRL pneumonia per radiology report he is holding, got one dose of azithromycin, came her for worsening symptom. Portable X-Ray in ED was negative for infiltrate, he was febrile and tachycardiac. He is fully vaccinated for covid 19. Hospital medicine was asked to admit the patient for further evaluation and management.

My problems began with a bad case of diarrhea, fever and high blood pressure of 170. I could not walk and unfold my hands. I lost strength in my legs , arms, and hands. My most severe problems lasted for two weeks. I laid in bed and took aspirin. After about two weeks , the most severe problems subsided. I currently fill weak and stiffness., and tightness in my chest.. My doctor has taken me off the blood pressure medication because pressure is down. My doctor has advised me to report problem to VAERS. I'm waiting your response.

Headache; Body ache; Fever/chills; Fatigue; Upset stomach; This is a spontaneous report received from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no. EP6955) via an unspecified route of administration in left arm, on 23Mar2021 at 13:45 hours (at the age of 65-years), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure and paroxysmal atrial fibrillation (parox afib). The patient had no allergies to food, medications or other products. The Concomitant medication included chlorthalidone (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) 81 milligram (mg). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no. EN6198) via an unspecified route of administration in left arm, on 02Mar2021 at 09:30 hours, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 24Mar2021 at 02:30 hours, the patient experienced headache, body ache, fever chills, fatigue and stomach upset. 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 headache, body ache, fever chills, fatigue and stomach upset were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Headache; fever ranging from 99 - 101; Shortness of breath; Fatigue; Body ache; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 04Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), obesity, type 2 diabetes, asthma and COVID-19 in Mar2020 and Apr2020. It was reported that the patient was on unspecified concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 02:30, the patient experienced, headache, fever ranging from 99 - 101, shortness of breath, fatigue, body aches, nausea, vomiting, and diarrhea. The symptoms lasted for about forty hours after they began. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included tylenol (MANUFACTURER UNKNOWN) for fever and ondansetron (MANUFACTURER UNKNOWN) for nausea. The clinical outcome of the events headache, fever, shortness of breath, fatigue, body ache, nausea, vomiting and diarrhea were resolved on 07Mar2021. No follow-up attempts are needed. No further information is expected.

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.

Six weeks ago, I was at work and I lost control of my bowels for no reason at all. I came home and called Urgent Care. I went there and took different tests. I was recommended to see a specialist. Later I had a colonoscopy and I was diagnosed with diverticulosis. I had to make dietary changes.

consistent diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 08:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 10:00, about 1 hour after the vaccination, the patient began having consistent diarrhoea that lasted approximately 12 hours, otherwise, the patient had no other adverse effects. No therapeutic measures were taken as a result of the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the event diarrhoea was recovered on 01Apr2021. No follow-up attempts are needed; information about the lot number cannot be obtained.

Fall/ The second fall put him back in the hospital; He had a fever of 104; Endocarditis; got sick; sepsis; stroke; fell and broke his hip; weak; get a partial hip replacement; enlarged heart; know which bacteria caused it; his blood sugar was in the 600s; sleeping all of the time; lost his appetite; could not get out of bed; Patient was not eating or drinking; This is a spontaneous report received from a Pfizer sponsored program. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0169) via an unspecified route of administration, administered in Arm on 14Apr2021 around 15:00 to 15:30 as dose 1, single for covid-19 immunisation. The patient's medical history included atrial fibrillation, patient was diagnosed years ago, before his stroke in 2015, a long time ago, cardiac failure congestive, aortic valve disease, cerebrovascular accident, diabetes mellitus, hypertension, last year patient had a blood infection, so he had to take four antibiotics. The patient's concomitant medications included rivaroxaban (XARELTO) taken for atrial fibrillation. It was reported that patient received the first dose of the vaccine in mid-April and got sick 2 days later(18Apr2021). Patient had a fever of 104. Caller took him to the doctor and patient was diagnosed sepsis. Patient was in the hospital and was then tested for and diagnosed with Endocarditis due to the sepsis. Patient was currently in a rehab facility and was weak. The rehab facility wanted to give patient the second dose of the covid vaccine. But the rehab facility was not sure if they will get the Pfizer covid vaccine. Reporter was worried about patient getting a second dose of anything. This was not the first-time patient has had endocarditis. Patient has been diagnosed with it before. Patient has a history of congestive heart failure, a bad aortic value, past stroke, and diabetes. They do not know if patient still had endocarditis, but patient has completed the antibiotics. They are unable to test patient again for endocarditis because he is in such bad shape. Patient had one side that was weak, and then he fell and broke his hip. Patient was not a candidate for open heart surgery because of his enlarged heart. Before patient received the first dose of the covid vaccine, patient was sleeping all the time and reporter thought it was due to the sepsis. The doctor told reporter that the sepsis was there before patient got the first dose of the covid vaccine. Patient has A-Fib and takes Eliquis. It was reported that patient had a stroke while he was in the hospital. Patient fell because of the weakness from his stroke. The second fall put him back in the hospital. Patient was in poor shape; his blood sugar was in the 600s. Before patient went to the hospital, he was sleeping all of the time, and he lost his appetite. They did not know if patient still has endocarditis because he could not have the follow up procedure done because he was in bad shape. Patient had weakness and fell and broke his hip. Patient was currently in rehab for physical therapy. Reporter clarifies that she took patient to the emergency room, and then he was admitted to the hospital. Patient's fever did not start out at 100 degrees, it gradually went up to 104 degrees. By the second or third day, patient's fever got up to 104 degrees. Reporter is back to square one for help. Reporter is asking if there is anyone who would know what to do. Patient's cardiologist said for patient to get the second dose of the covid vaccine. Reporter knows that no one had that in the clinical trial. Before the covid vaccine, patient was having a crown done in his mouth. Last year patient had a blood infection, so he had to take four antibiotics. Reporter thinks they were called amoxicillin, and they were 500mg each. Patient had to take them all at once as a preventive. Patient is on a lot of things, that reporter does not even know. Patient has had a lot of things done to his heart. Patient has had to have ablations. Patient has a very bad heart. Patient has a question about herself. She had the covid vaccine and had no reactions. She is on Celebrex 200mg. Reporter stopped taking a day and a half before the covid vaccine. Reporter is asking if she could have messed herself up by taking an anti-inflammatory, and if taking Celebrex could have prevented her from getting the full effect. Prior to taking Covid vaccine her husband has had Endocarditis, congestive heart failure, bad heart valve and a stroke. 1st dose of vaccine mid-April. 2 days later had a fever of 104 and was admitted to the hospital with sepsis. The sepsis caused endocarditis again. Husband is in rehab facility, and they want him to take a second dose. Should he be getting 2nd dose of Pfizer or a different Covid vaccine. Wife wondering if husband should get 2nd dose at all. Reporter does not think that this has anything to do with the covid vaccine, since they know which bacteria caused it. Reporter thinks that maybe patient getting the first dose of the covid vaccine put patient over the edge. This is the second time that patient has had vegetation, the first time was last year. Reporter thinks that all of patient's doctors are panicking over the covid vaccine. Reporter knows that patient is in bad shape. In the clinical trial, there was nothing in there about congestive heart failure, or nothing about endocarditis. Patient may still have endocarditis. Reporter does not know what will happen to patient if he gets the second dose of the covid vaccine. Reporter states that unfortunately patient does not go to the best cardiologist. Reporter thinks that patient is so bad off, that he could be on palliative care. The only reason reporter waited so long to call Pfizer is because patient is in rehab now, and they might be getting in the Pfizer covid vaccine. They asked reporter if she wanted patient to get the second dose of the Pfizer covid vaccine. They should get them in on 16Jul2021. Reporter said yes, about a week ago, but it has been on her mind to call and ask the source. Reporter took patient to the hospital, and the doctors diagnosed him with sepsis: Patient was not willing to go to the hospital at first. Patient could not get out of bed. Patient was not eating or drinking. Reporter was trying to give him stuff. Reporter is not a scientist. An infectious disease doctor told reporter that patient already had sepsis before the covid vaccine. Patient was in terrible shape. Patient had a stroke while he was in the hospital. They figured out he had a stroke about five days after being in the hospital. After the stroke, patient had two weeks of physical therapy there. Dates of Hospitalization: He was in the hospital for a few weeks. Patient was home for two days he fell because of the weakness from his stroke. The second fall put him back in the hospital. Patient had to get a partial hip replacement. For about a week now, patient has been in rehab. Patient has A-Fib, since the stroke, he is not on Eliquis. Patient was not on Eliquis before. Patient also has hypertension, but it is under control. Therapeutic measures were taken as a result of endocarditis and fell and broke his hip. The outcome of the events was unknown.

This case meets vaccine breakthrough criteria review with +COVID test >14 days post vaccination series. Presented to ED with shortness of breath, myalgias, fatigue, nausea, abdominal pain, cough, vomiting, diarrhea

Headache; Fever; Stomachache; General malaise; Oxygen saturation decreased/ oxygen level was 96 then went down to 95, then 94, and then 93; feels real weak; This is a spontaneous report from a contactable consumers. A 65-year-old male patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm (at the age of 65-year-old) on 16Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart surgery from Apr2020 to an unknown date, hypertension from Apr2020 to an unknown date, Autonomic dysfunction from 1989 to an unknown date and COVID-19 from Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient did not had any other recent vaccinations or not started any new medications. The patient previously received first dose of bnt162b2, (PFIZER COVID-19 VACCINE, solution for injection, Lot Number: EN6203) via unspecified route of administration (at the age of 65-year-old) on 23Feb2021 as single dose for COVID-19 immunisation. The patient experienced headache, fever, stomachache, general malaise, oxygen saturation decreased and feels real weak on Mar2021. The second dose was given yesterday and this morning he is having adverse reactions, and she would like to know what they can do to help him. She says he had a high fever, a stomachache, and a headache. She says his oxygen level was 96 then went down to 95, then 94, and then 93 on Mar2021. Patient says that his headache, fever, and stomachache are getting a bit better, but he had general malaise and feels real weak. He says he feels very bad like when he had COVID-19 this past Jan2021. He says that it was diagnosed with a deep swab, not the shallow one, in both nostrils and was a 24 hour test that was positive, it was not a rapid test. He says he had recovered from COVID-19. The patient underwent lab tests and procedures which included oxygen saturation: 95, oxygen saturation: 94, oxygen saturation: 96, oxygen saturation: 93 on Mar2021 and sars-cov-2 test: positive on Jan2021. The outcome of the events headache, fever, and stomachache was recovering and other events was unknown. No follow-up attempts are possible. No further information is expected.

Client is a resident at the facility. Client had the first dose of Pfizer COVID vaccine (Lot #EW01071 expiration date 8/2021) on 6/28/2021. The Pfizer vaccine was given by RN in client?s left deltoid without incident. Client also received Hepatitis A vaccine (Lot #G99R2 expiration date 5/20/2022) and Hepislav-B (Lot # 934599 expiration date 2/22/2022) both in the right deltoid by RN. Client was observed for 15 minutes per protocol without any side effects/adverse reactions. Upon return to facility on 7/27/2021 for second dose of Pfizer vaccine, Client informed this nurse of his hospitalization post first dose of Pfizer vaccine. According to client the morning of 6/30/2021 he was dizzy, with diaphoresis and nausea/vomiting. Client reports he was taken to ED and was admitted to the hospital. According to client?s hospital records client was diagnosed with bradycardia, hypotension and near syncope. Client reports he had 2 stents placed in blocked arteries to the heart during his 6/30/21 stay at hospital. Client also reports he has a history of a previous heart attack. Client was discharged on 7/01/2021 to the care of his cardiologist. Client reports he is currently taking medications as prescribed by his cardiologist and client reports his cardiologist wants him (client) to follow up with his second dose of Pfizer COVID vaccine. Client reports he read in a journal it was best to wait 10 weeks for second dose of COVID vaccine (explained to client the CDC guidelines was 3 weeks apart). Encouraged client to get a Rx from his cardiologist for the second dose of Pfizer vaccine. Client reports he will get a Rx from his cardiologist for the second dose of Pfizer 10 weeks after the first dose. Client reports he will continue with his cardiologist for follow up and continue medications as prescribed. RN

Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; Nausea, flu like symptoms, headache, dizziness, fatigue, diarrhea; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EH9899) intramuscular at single dose on28Dec2020 18:00 for Covid-19 immunisation, administered at hospital. Medical history included Covid-19: he tested positive for COVID and received the monoclonal antibody, bamlanivimab on 13Dec2020; other unspecified health conditions which might make him high risk. The patient previously received monoclonal antibody 17-1a, bamlanivimab on 13Dec2020. For Covid-19. The patient received other unspecified medications in two weeks. On 28Dec2020 21:00, 3 hours after vaccination, he was feeling bad with flu-like symptoms, nausea, headache, dizziness, fatigue and diarrhea. No treatment received. Covid was not tested post vaccination. The outcome of events was not recovered. His colleague now knows he should have waited 90 days after the antibody but reporter was wondering if there was information. Since there probably is no information, this is a unique situation and reporter wondered if Pfizer wants him to run any particular tests or send in some blood to Pfizer for testing to further medical knowledge on giving the vaccine within 90 days of the antibodies.

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

Nausea Vomiting c/o nausea, no vomiting Narrative: Felt nauseated about 15-20 min. after immunization. vss. Given water and felt better and said he felt ok to return to work. D/C'd in stable condition to work.

Dizziness, NauseaVomiting, FELT HOT Narrative: PATIENT EXAMINED BY PHYSICIN AND NURSES. FOUND TO BE IN NSR AND SATTING IN THE 90'S WITH A BP OF 90/62. PATIENT STATED NORMAL VITAL SIGNS FOR HER. PATIENT HELD FOR ADDITIONAL 30 MIN AND RE-EXAMINED BY PHYSICIAN BEFORE BEING RELEASED FROM VACCINE CLINIC.

Immediately felt the vaccine ? pain in arm site, headache and nausea. Muscle aches and a slight tightness in chest about 12 hours later. Three days later (now) still have headache, muscle aches and an uncomfortable feeling in chest, although no chest pain.

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

Client states that 24 hours post vaccination he began experiencing nausea, vomitting, chills, lack of sleep, body aches. He states the felt like "he had the flu but it was on steroids and much more severe". He contacted his PCP and he instructed him to not take the second dose.

Nausea Narrative: 65 yo male reported nausea and headache during the minutes recover period. This was attributed to COVID PFIZER vaccine, which patient received on 2/3/2021. Vital signs were stable. Patient felt better within half hour and was able to leave (self-resolved). The patient denied any prior severe reaction to this vaccine or to any injectable therapy. Patient has been tested positive for covid 19.

Patient stated that 4 days after first dose he developed vomiting and appetite suppression Patient stated that 2 days after second dose he developed vomiting. around 4 am and it was improving but he still felt puney

Achy; Headache; Throwing up; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at single dose in left upper arm for COVID-19 immunisation at the age of 66-year-old. Lot number was EL3249. Medical history and Concomitant medications were none The patient woke up on 24Jan2021 morning and he felt like he was coming down with something. The achiness was first; it started early in the morning, then the headache was in the afternoon, and then at night he started throwing up. While the symptoms were developing, they were worsening, but since they started, they have stayed the same. On 24Jan2021, the patient experienced achy, headache, and threw up. The patient did not recover from the events.

Pt was concerned due to close contact with a covid + patient in the 14 days prior. 66 yr old male contacted and consented for telehealth visit for Covid-19 f/u. Pt started being symptomatic on 1/26/21 and tested (+) on 1/27/21. Pt states he has no appetite and is having fever/chills off/on and body aches. Pt states his temp was 100 deg F when checked.

Starting at 8:30 the morning after the injection, i got chilled to the bone and could not warm up, had a bad headache, no fever, and nauseous. Was ok the day after those symptoms occurred.

dizziness, nausea immediately after shot lasted 4 hours fatigue, headache later lasted 36 hours

For two days severe body aches, very tired, had to stay in bed most of the time. Nausea so didn?t eat much during this time. Headache too. Joins painfull.

Around 5:00 felt nauseated, runny nose and mild sore throat. He still has the sore throat, took his vitamin C with zinc, and is pretty much feeling better. Gargled with aspirin solution.

1) Fever (101.1 degrees) 2) Extreme Fatigue 3) Muscle pains 4) Shooting pains under left arm 5) Nausea

Had chest pain ("lung pain") the day after vaccination, then 2 days after the shot, he experienced some dizziness and nausea. Dizziness and nausea lasted for 3 days and 3 nights. Chest pain persisted and seems to be getting worse. Severity 3/10 - 7/10. + pain with movement, none at rest. No dyspnea, shortness of breath or fever.

Severe chills & trembling, fever (101.5), nausea, , achiness, feeling of malaise, severe fatigue. Started 7 hours after vaccine administration, and lasted 15-16 hours, with ongoing residual fatigue - it was bad.

Sudden onset 14 hrs after injection. Severe nausea (exact presentation as Covid) Fever 103 12 hour duration 2 day recovery

Minor skin rash on left upper arms and right leg 12 hours after the injection on 02/10/2021. Minor Diarrhea on 2021/02/11 and 2021/02/12. Mild Skin rash and itching on both upper arms (take Claritin for it) and mild Diarrhea on 2021/02/13. Minor Diarrhea and Stomach in a week after the vaccine.

Developed fatigue, myalgias, and loose stool on the evening of 3/1. On 3/2 developed hoarse voice and sore throat. Mild fatigue and myalgias persisted.

Sudden high blood pressure right after shot, followed by shaking, fever, and stomach ache. All symptoms where right after the vaccine at the location given. 911 was called and was told he had a reaction and blood pressure was high. Hypertension, and shaking lasted for a few minutes.. fever went away in couple hours. Stomach ache lasted couple days.. Was told by medics to see medical personnel for check up. Has appointment with medical doctor for 3/8/2021.

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.

bad stomach ache; severe chills; tired; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration in the left arm, on 02Feb2021 19:30, at single dose, for COVID-19 immunization, at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 04Feb2021 at 14:00, the patient had a bad stomachache, severe chills and was tired. No treatment was given for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.

I was monitored the recommended 15 minutes and was fine. I went to the car, was being driven home, and about 20 minutes after the vaccination I developed an odd sweet/metallic taste in my mouth, followed by increased saliva, some difficulty swallowing, nasal congestion, and some chest discomfort. They symptoms were already getting a little better by the time we got home (about 30 minutes after the shot), but I took a Benadryl and the symptoms resolved within 2 hours. After that I just had the expected arm pain and fatigue until the next morning. Since then I have been fine.

Violent shaking chills/rigors alternating with feeling feverish, muscle aches in all large muscle groups, headache, dizziness (mild compared to headache), anorexia, fatigue.

Allergic reaction; no energy; no appetite; he is not feeling good at all; has been in bed all day; fever; splitting headache; Pfizer COVID-19 vaccine made him sick as hell; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot: Number: EN5318, Expiration Date: May2021, NDC: Unknown) via an unspecified route of administration from 04Feb2021 14:24 at single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Historical vaccine included unspecified flu vaccine 2-3 months ago and patient received made him sick as hell, zero energy and losing weight. The reporter stated that Pfizer COVID-19 vaccine made him sick as hell: Consumer says he got his first dose of the COVID-19 vaccine yesterday at 02:24 PM and had an allergic reaction to it, he is not feeling good at all and he has never been allergic to anything before. COVID-19 vaccine NDC: Unknown, this was not provided on his handwritten vaccine card. Caller says he also had the flu vaccine 2-3 months ago and the flu vaccine also made him sick as hell, the same thing happened. unspecified flu vaccine NDC/LOT/EXP: Unknown. Caller says that his allergic reaction is that he has no energy and no appetite. He says after the flu vaccine he had zero energy and ended up losing weight. He says he has felt like this again since getting COVID-19 vaccine yesterday and has been in bed all day. He says he had a fever this morning and a splitting headache. He says his fever temperature was unknown, he had done no treatment for that, he laid in bed all day, and he has done no treatment for the headache either, though he is thinking about taking some Tylenol in a minute. He says he wants to get better and he might need to call his doctor for information about what to do to get better, he just wanted to see if Pfizer could provide any solutions for him. The clinical outcome of the events was reported as unknown.

severe vomiting starting 12 hours after vaccine for 8 hours. Nausea has continued for 11 days. Occasional vomiting. Loss of appetite continues. Also neck hurts from intensity of vomiting.

Headache, diarrhea ,sick at stomach ,body aches, balance problems, and low grade fever. Symptoms lasted 36 hours.

Presents to the ED 4 days after 1st covid vaccine with aches, flushing, abdominal cramps (currently undergoing chemo for prostate cancer), cough, nasal congestion, fever. Admitted for possible sepsis, low suspicion. Dischaged home next day in stable condition.

Pfizer vaccine injected 3:00 PM 3/10/21. The next day, 27 hours post-vaccine injection, while in a store, patient noted at 6:06 PM onset of numbness/tingling Right foot/leg with difficulty standing/lifting foot. He needed support of shopping cart to make it to car. Once in car, numbness/tingling, heaviness/clumsiness of right hand/arm noted. Then right side of lips/mouth affected with dysarthria. Wife witnessed evolution and drove directly to Hospital ER/stroke center by which time patient was vomiting and required wheelchair to enter ER. Stroke team evaluation neurologist concluded ischemic stroke and administered TPA. During TPA infusion, all symptoms resolved remarkably so that dysarthria cleared, numbness resolved and dysmetria/fine motor incoordination/right hand/arm/leg/foot symptoms were markedly improved. Patient admitted to ICU for one day and then neurocare floor for one day. MRI showed 8 mm linear diffusion weighted lesion in right centrum semiovale which was deemed c/w acute/subacute infarct. Attending neurologist in ICU and neurofloor noted that location laterality of MRI lesion did not correlate well with the right-sided patient symptoms, but could not identify other left brain lesions on review of scans. EKG, TEE and echo studies showed no cardiac lesions. Carotid studies were negative. CT and CT angio were uninformative; no hemorrhagic lesions or large vessel blockage. At discharge on 3/14/2021 around 6 PM, patient could walk, talk, and use hands essentially normally to outside observer although patient could relate intermittent brief episodes of possible numbness in lips or hands/fingers or slight heaviness of foot which is slight and decreasing. Patient discharged on atorvastatin, amlodipine, fluticasone, Loratadine, 81 mg aspirin, Ibuprofen (for headaches) for further post-stroke follow-up.

Excessive night perspiration since first dose, evening low grade temperatures 99.6-99.8 average, loss of appetite Some weight loss

Severe chills approx. 11 hours after injection. Did not check for fever but had chills, then sweats during Friday. No appetite, malaise, achy joints through Saturday. Began to feel normal by Sunday.

Fever above 101 degrees, severe chills, severe headaches and fatigue for 48 hours. Two days later when appetite returned, I realized I had completely lost my sense of taste and smell, which has not yet returned. Still experiencing fatigue, mild headaches, and nasal stuffiness.

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.

Sudden nausea with fever and mild diarrhea and weakness and also achy joints. After about thirty minutes, symptoms past but had a tired/sleepy. Rested for about three hours and felt better. Did not take any medications.

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.

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.

sick for 12 days but getting a little better, fever,chills sick to stomace head ach like they look like little boils under arm pit sore and being tired

No symptoms immediately, then 3/13 fever No bowel movements since 3/13 3/20 bowel obstruction - over 4 days: initiated enemas, colonoscopy prep gallon, bottles of magnesium citrate to no resolve 3/25 not a candidate for surgery, all solids and liquids d/c. Awaiting end of life

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.

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.

fever (100.5 F), fatigue, body ache, head ache, nausea, vomiting. Symptoms began in the evening of March 10 and were the most severe throughout the day on March 11. Symptoms were gone by the morning of March 12.

Pt's daughter called to report her father's reactions after dose 1 of pfizer vaccine. about 4 hours after receiving the vaccine, he started to experience a headace, facial swelling, puffy, watery eyes, and nausea. This morning his symptoms have worsened to severe headache, continued facial swelling and double vision. Daughter was advised to bring pt to the ed for evaluation. Allergy consult has been requested.

Exhaustion, starting when I get up in the morning, and lasting throughout the day, even if I take several naps a day. Stomach aches. No treatment has been prescribed yet.

Bleeding with stool; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in Left arm, on 15Mar2021 at 12:30 (at the age of 66 years old) as a single dose, for COVID-19 immunisation. Medical history included moderate high blood pressure. The patient did not have any known allergies. The patient did not experience COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included lisinopril, montelukast, vitamin C and vitamin D. The patient did not receive other vaccines in the four weeks prior to receiving the BNT162b2 vaccine. The patient experienced bleeding with stool on 18Mar2021 at 09:00am. The patient did not receive treatment for the event. The event resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the event bleeding with stool was unknown.

30 hours later, headache starts, arm ache at site, body aches, no fevet, virtigo, body chills, shaking, diarrhea, dizziness, discomfort, joint aches, runny nose, hearing got worse. Loss appetite, no eating. I drank water andtook one 300mg tylenol anout every 8 hours to reduce pains and aches. It helped some.

Vomiting; This is a spontaneous case received from a contactable Pharmacist. A 66-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), intramuscular, administered in left deltoid on 03Feb2021 at14:00 (the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included neoplasm malignant from an unknown date and unknown if ongoing and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 on 15Jan2021 at 13:28 in the left deltoid for COVID-19 immunisation. On 05Feb2021 at 04:00, after the second vaccination, the patient experienced vomiting. Patient thought the vomiting could be in part to chemotherapy he had; the last treatment was about 2 months before his first dose of the vaccine. No admission to the hospital was required due to the event. COVID-19 vaccine was accidently mixed with sterile water for injection instead of Sodium chloride 0.9% for injection. Error was made in part of education for diluent use. Clinical outcome of the event vomiting was recovered.

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.

20 hours after receiving the vaccine, I got out of bed (~ 6 AM) to use the bathroom and while in the bathroom and on my feet, I fainted and fell to the floor. I came to a few moments later when I heard my wife calling my name. For the next two minutes or so I was very nauseous, but I did not vomit. The nausea quickly passed and there were no further fainting episodes or dizziness. I was a bit achy over the next 24 hours, but no further or additional symptoms to report. ,

Second Dose: blood pressure went to high; Second Dose: started to black out, if his partner had not been there for him he might be dead right now; Second Dose: blood pressure dropped to 89/56; Second Dose: too weak to walk very far; Second Dose: diarrhea; Second Dose: Nausea; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 09:00 at single dose for COVID-19 immunisation at the age of 66-year-old. Lot number was EN6198. Medical history included ongoing hypertension (10-15 years), ongoing degenerative arthritis since 2010, ongoing Rheumatoid arthritis since 2015, pain, prostate infection (treated with antibiotic; stopped taking the antibiotic and all of his medications), pneumonia in Sep2020 (unrelated to the Covid 19 virus, hospitalization). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Feb2021 at single dose in left arm for COVID-19 immunisation at the age of 66-year-old and he experienced nausea, slight diarrhea, tiredness; lot number was EM9810. Concomitant medications included adalimumab (HUMIRA), methotrexate, hydrocodone. On 18Mar2021, the patient experienced nausea and diarrhea. The patient received ondansetron 4mg tablets, take 1 by mouth every 4 hours as needed for nausea. On 20Mar2021, the patient experienced black out, if his partner had not been there for him he might be dead right at the time of report, it was a bad, bad experience (life-threatening), blood pressure dropped to 89/56 and too weak to walk very far. The patient drank lots of fluids and they were able to get his blood pressure back up, the doctor almost sent him to the hospital to get fluids. Then his blood pressure went to high and he had to get it down. The patient had gone to pick up some groceries and he started to black out. He had to ride in the motorized cart around since he was too weak to walk very far. The patient has had to ride the motorized cart before because he has degenerative arthritis and rheumatoid arthritis. The patient got into his van to leave and he could not drive home. It was only 7 miles but he felt like he would have blacked out and it would have been dangerous; he called his partner and he came to get him. On 21Mar2021, the patient experienced blood pressure went to high. On unknown date, blood pressure resulted high, cystoscopy (urine came back positive for infection), Covid 19 virus test (negative). On 20Mar2021, blood pressure dropped to 89/56. On 22Mar2021, blood work was performed (unknown results). Doctor recommended that he should stop taking his arthritis medications and pain medication. The doctor told him those medications might interfere in getting the Covid 19 vaccine; the patient took immune depressors. The patient did not recover from weakness and nausea, the patient recovered from diarrhea; the outcome of other events was unknown.

Fever at onset of symptoms 100.5 F, rose to 102.4 F 12 hours later, remained above 100.0 F for more than 48 hours. Nausea and aches for first 24 hours, dizziness and exhaustion for more than 48 hours.

My husband had fever of 102.6 the morning after he received the vaccine. He continued to run high fever. He had gi symptoms with diarrhea. He was up all Saturday night with generalized body aching and diarrhea. On Sunday night he coded in the bathroom at home. CPR was started when EMS arrived he was in full cardiac arrest. He was coded for 1 hour without any return of heart function. I found my husband on the bathroom floor on that Sunday night about 1140pm performed CPR and activated 911.

Chills, nausea, vomiting , headaches, sweats, frequent urination, over all joint pain started at 0400 this morning.

I developed severe vertigo with nausea and vomiting, unable to stand or move around effectively. Cold and clammy. Symptoms lasted about 2 hours. No difficulty breathing and no headache. No fever or focal neurologic signs. Pulse was regular and blood sugar was 95.

appendicitis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 66-year-old via an unspecified route of administration, administered in Arm Right on 10Mar2021 15:15 (Lot Number: EN6199) as single dose for covid-19 immunisation. Medical history included High blood pressure, asthma. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. No known allergies. Concomitant medication included lisinopril received within 2 weeks of vaccination. The patient previous received first dose of BNT162B2 (Lot Number: EL9267) in Right arm on 17Feb2021 15:15 as single dose for covid-19 immunisation. The patient experienced appendicitis on 13Mar2021, resulted in Emergency room/department or urgent care. The patient was hospitalized for appendicitis for 2 days. The patient had an appendectomy. The patient underwent lab tests and procedures which included covid-19 (Nasal Swab): negative on 16Mar2021. The outcome was recovering.

03/07-27 Progressive left and right hip pain 03/13-03/14 and 03/20 Significant hip pain after yard work 03/07-03/27 Progressive left and right groin pain 03/13-03/14 and 03/20 Significant groin pain after yard work 03/07-03/27 Progressive outside lower right calf pain (sporadic) 03/13-03/14 and 03/20 Significant lower right calf pain after yard work 03/28 Unusual reaction at night following second vaccine - flushed 03/28 - 04/01 Progressively acutely severe both hip, groin, and lower outside calf pain 04/02-05 start of indigestion, heartburn, brain fog, fatigue, leg tremors - leg pain less with Tyleniol 04/05 Significant chest pain - went to ER - EKG, blood work, chest x-rays checked OK, given GI cocktail 04/05 - 04/18 Leg/hip/groin pain (joint and muscle) - not as severe as first 5 days after 2nd shot), some heart burn, indigestion , cotton mouth, periodic tremors, periodic fatigue, feeling of thickening throat, slight eye burn, easily chilled o Each episode is preceded with an allergic reaction type feel o Each episode is near end of 8 hr Tylenol duration although seems worse at night

back pain; abdominal pain; scrotum pain; dehydration of the kidneys; Fatigue; headaches; dehydration; Constipation; This is a spontaneous report received from a contactable health care professional. A report on behalf of her 66 years old husband who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at single dose at right arm for COVID-19 immunisation on 14Mar2021 at 14:00. Relevant history included high blood pressure, Atrial fibrillation and memory problems. No family history. Relevant concomitant drugs included ongoing Diltiazem at 120 mg once daily for high blood pressure and Atrial fibrillation, ongoing Losartan at 25mg once a day for high blood pressure and Atrial fibrillation, ongoing Aspirin at 81mg at night. The reporter stated her husband had severe side effects. Her husband was having low back pain, scrotum pain and abdominal pain and constipation. She did not know if this had anything to do with the vaccine. Her son was a doctor and thought that her husband may have been a passed kidney stone. She took him to the doctor and did an X-ray which showed dehydration of the kidneys. They were pumping him full of water. She stated that the dehydration and constipation could have been self induced. This started about last week and was home all week. It may have been around 29Mar2021, about 2 weeks after the vaccination. On day 3, her husband had headaches and fatigue on 17Mar2021. The patient was taking Tylenol pretty much every four hours for a week because he was in so much pain. The patient wear APAP machine at night. No history of all previously immunizations. No additional vaccines administered on same date. No prior vaccinations within 4 weeks. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The events was considered related to suspected vaccine BNT162B2 based on temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions 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.

Within 48 hours of receiving vaccine, patient developed intense swelling of left side of face and left neck with progressive dysphagia lasting more than 3 weeks

Patient with coughing and vomiting starting on 4/10/2021. Patient presents to ER for symptoms and found with elevated BUN/creat. During hospitalization he was dx with C-ANCA vasculitis. Patient with worsening symptoms leading to stroke and need for dialysis.

Sore arm day of vaccine only. Nausea and vomiting x7 starting at 9:00pm day 3 post vax and lasting until 5:00am on day 4.

Pt was hospitalized with severe sepsis and septic shock with hypotension, hypothermia, bradycardia, AKI, pancytopenia requiring pressors on 3/11/21. This was 14d after the initial vaccine. He received his second vaccine on 4/2 and was hospitalized with severe sepsis again on 4/27/21 with similar symptoms. First episode c/o diarrhea but no pathogen identified. Second episode with bilateral multifocal pneumonia but no pathogen identified.

pneumonia; temperature going up to 103 degrees/fever; tested positive for COVID19/COVID 19 positive; sore throat; cough; diarrhea; very bad headache; a little tired; high blood pressure; His Legs were a little wobbly from not using the muscles while in the hospital; get dehydrated; This is a spontaneous report from a contactable consumer(patient). A 66-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ERO727), via an unspecified route of administration at Arm Right on 31-MAR-2021 09:30 at the 66 years old at single dose for COVID-19 immunisation. The medical history was none. The concomitant medications were none. On 07Apr2021, he started to develop symptoms: sore throat and cough. On 08Apr2021, he got a PCR and rapid test, and he tested positive for COVID19. On the weekend of 10Apr2021 and 11Apr2021, it started getting more severe. He had a very bad headache on the left side of his head, right next to his left eyeball on 07-APR-2021. The patient stated that he could not get any relief, tried to take Tylenol but nothing helped. He also had diarrhea on 07-APR-2021, "couldn't hold anything in", and started to get dehydrated in APR2021. The reporter states that then that weekend on the 10Apr2021 at night getting a high temperature going up to 103 degrees/fever. On 13Apr2021, his son told him that he better get to the ER. At the ER, he did a chest X-ray and another PCR test to confirm the COVID19 diagnosis. On the chest X-ray they found something unusual in his chest so they did a "contrast cat scan" and found pneumonia on 13-APR-2021. He was admitted the hospital on 13Apr2021 and was discharged on 16Apr2021. He is now scheduled for his second dose of the vaccine one 21Apr2021. He went to a clinic yesterday for a PCR test and it came out positive. He's getting conflicting information as to what needs to be done, some people are telling him he has to wait for 3 months, other are telling him to notify his PCP. He's wondering if he can get his second dose as planned on 21Apr2021. The patient stated that while he was in the hospital, they did a CAT scan. Caller reports that first they did an X-ray of his lungs and found something in lungs. The patient stated that they scheduled a CAT scan with contrast and was told he had pneumonia on top of having the COVID virus. The patient stayed in the hospital and they pumped him with fluids because he was pretty dehydrated because he couldn't hold anything in. The patient stated that he had diarrhea and everything else. The patient stated he had high blood pressure in APR-2021 and he just didn't want to take a risk of any fatalities. The patient stated that they gave him some type of medication to fight the COVID virus, "Repar" or something like that. 16Apr2021 in the afternoon, they released caller back home. The patient stated that his temperature went down, his blood pressure went down and everything seemed to be ready for him to go home. The patient stated that yesterday on 18Apr2021 he decided to get another PCR test because he wanted to see if he still had the COVID virus. The patient stated that he didn't have a follow up PCR at the hospital because the hospital doesn't normally do it. PCR test still came out positive yesterday 18Apr2021. Caller states that his big question is that he is scheduled to get the 2nd Pfizer COVID vaccine on 21Apr2021 and since he is still testing positive for the COVID virus, is he still required to get the second Pfizer COVID vaccine or does caller have to wait. The patient stated that he is getting conflicting answers, some say you can't get the second shot for at least 3 months but the caller doesn't know how true that is. The patient stated that he tested positive for the COVID virus on 8Apr2021, caller went to a testing center. The patient stated that it was getting annoying, it was not the COVID symptoms. The patient stated that he thinks only thing is he was feeling was a little tired and tired from being in the hospital for so many days in APR-2021, In APR-2021 his Legs were a little wobbly from not using the muscles while in the hospital. The patient stated he was walking around in the apartment to help build up the leg muscles. The patient stated that he does have an appetite and is drinking liquids. The patient stated that he was diagnosed with pneumonia on 13Apr2021 and he is not sure if it is ongoing or not. He asked the hospital before discharge about if they were going to check again for the pneumonia the answer was we normally don't test and that caller needs to go to his PCP doctor to see if the PCP will order another test for the pneumonia. The patient stated that it would have been easier for them to check again while caller was still in the hospital already. The events sore throat, fever, cough require a visit to Emergency Room. If applicable, there was not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of event COVID-19 was Not recovered, the events Pneumonia, Dehydration, Tiredness , Muscle weakness was unknown, the events Sore throat, Cough, Diarrhea, Fever, Headache was recovered on 16-APR-2021, the event Blood pressure high was recovering.

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.

Feel like I want to throw up/ nausea; Feeling kind of dizzy/ dizziness; 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) via an unspecified route of administration, administered in right arm on 15Apr2021 (around 08:00 or 09:00) (Lot Number: EW0162) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (he was diagnosed with high blood pressure 2 years ago, or maybe 3 years); ongoing diabetes mellitus (type 2 diabetes, maybe 3-4 years ago, his father was diabetic); heart problems (he has had 17 strokes and 10 heart attacks so far, his father passed away of a heart attack), ongoing polycythaemia (diagnosed a few years ago, maybe 10 years, or 10-12 years, or maybe 15 years, he was in his late or early 40's when he was first diagnosed with polycythemia and the diagnosing physician said it was kind of odd that the patient had polycythemia because it's usually older people that get polycythemia); pain; heart burn. Patient mother had arthritis really bad. Concomitant medications included eicosapentaenoic acid ethyl ester (VASCEPA) for pain from awhile ago, maybe a year or two; metformin for blood pressure for at least 2-3 years; lisinopril for diabetes for a few years, maybe 3-4; omeprazole for heart burn for a few years, maybe 3-4; lovastatin from a few years ago, all ongoing. Patient had no prior vaccinations (within 4 weeks). The patient experienced felt like he wanted to throw up/ nausea on 15Apr2021, feeling kind of dizzy/ dizziness on 15Apr2021. Patient reported that his weight is between 170 and 180, and that the last time he weighed himself he weighed 176 pounds. Clinical course: Patient reported that he got the first dose of the Pfizer Covid-19 vaccine a couple of hours ago, 2-3 hours before time of call, on 15Apr2021. Patient reported that he felt like he wanted to throw up and he was feeling kind of dizzy. Patient inquired how long feeling like he wanted to throw up and feeling kind of dizzy was going to last. Patient inquired if he needed to go to the hospital or the doctor for the nausea and dizziness. Patient reported that he could deal with feeling like he wanted to throw up and feeling kind of dizzy, but that he wanted to know how long he should wait before he went to the hospital or the doctor. Patient inquired if he should go to the hospital or the doctor after so many hours or days. Patient reported that he wanted to puke but he couldn't puke. Patient reported that he was still feeling dizzy at time of call on 15Apr2021. Patient reported that he did not know if the dizziness has gotten any worse or not. Patient reported that he is a healthy person, and he is not sure why the Covid-19 vaccine is affecting him this way. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Mild itching on both upper arms; Minor Diarrhea/ mild Diarrhea; Minor skin rash on left upper arms and right leg/Mild Skin rash on both upper arms; 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), via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:15 (Batch/Lot Number: EL9267) at the age of 66-year-old; as single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced minor skin rash on left upper arms and right leg/mild skin rash on both upper arms (rash) (non-serious) on 10Feb2021 21:15 with outcome of recovering , minor diarrhea/ mild diarrhea (diarrhoea) (non-serious) on 11Feb2021 with outcome of recovering , mild itching on both upper arms (pruritus) (non-serious) on 13Feb2021 13:00 with outcome of recovering. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of minor skin rash on left upper arms and right leg/mild skin rash on both upper arms (rash), mild itching on both upper arms (pruritus). Follow-up attempts completed. No further information expected.

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.

Fever, chills, myalgia, new loss of taste and smell Sore throat and Cough Shortness of Breath Fatigue Headache Diarrhea

Excessive stomach gas build up causing uncontrollable belching. This occurs numerous times throughout the day.

ED to Hosp-Admission Current 5/20/2021 - present (6 days) Last attending ? Treatment team Syncope and collapse Principal problem History of Present Illness a 66 y.o. yo male presenting to the ED with syncope. Patient is diagnosed with COVID-19. He has passed out twice today. He feels lightheaded and nauseous prior to passing out. He wakes up feeling diaphoretic. Denies chest pain. Admits to shortness of breath and the feeling of difficulty getting a deep breath in. Patient denies history of blood clots, recent unilateral leg swelling or edema, hemoptysis.

Adverse effects have made running so painful I can't do it anymore: Column 1 is the Date: 2 is location: 3 is distance in miles: 4 avg. time @ mile 3/1 Neighborhood 3.5 9:58 3/3 Neighborhood 6.43 11:01 3/5 1st Pfizer Vaccination 3/6 Neighborhood 3.4 11:27 3/8 8.02 11:35 3/11 Some neck pain 3/13 Run-Treadmil 6.26 12:19 3/19 Neighborhood 7.23 10:49 3/26 2nd Pfizer Vaccination 4/2 Neighborhood 3.5 10:06 4/6 Neighborhood 6.44 11:14 4/8 Run-Treadmil 3.19 11:23 4/12 Neighborhood 8 12:27 4/16 First Serious Symptoms 4/16 Run-Treadmil 6.28 11:20 4/20 Run-Treadmil 2.7 11.38 4/23 Run-Treadmil 5 11:53 4/26 Aborted Run Abdominal and Neck Pain 5/7 Doctor 5/14 CT Scan / X-Ray 5/25 Aborted Treadmil Jog

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.

Pancreatitis in tail of pancreas; fever (101.2F) for four days; left side abdominal pain; diverticulitis; headache; This is a spontaneous report from a contactable physician reporting on behalf of patient. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: EP7533) as 1st dose single for covid-19 immunisation. Medical history included ongoing high cholesterol which was diagnosed decades ago at least, kidney stone. Concomitant medication included simvastatin (strength: 20mg) from 2011 and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The reporting physician is the patient's primary care physician. The patient came to the physician's office on 16Apr2021 for the fever, left sided abdominal pain, and headache which had been going on for 4 days in Apr2021. Physician reported that the patient thought his left-sided abdominal pain was caused by a kidney stone. Because of the high fever of 101.2 and the persistence of 4 days of fever, the patient was admitted to the hospital. Patient had an elevated white blood cell count of 13000. The patient had a very high D-dimer test which kept rising. The patient's C-Reactive Protein was very high. white blood cell count was 12.6 on admission and went to 6.8 after IV antibiotics were administered. The patient's fever resolved within 24 hours of starting IV antibiotics and fluids. When queried for seriousness criteria, physician reported that the patient's headache was just nagging. Physician reported that he doesn't have the patient's chart, but he is guessing that the patient's headache resolved within 3 days of admission to hospital. Regarding pancreatitis in tail of pancreas, physician reported that there was a possibility that the patient's abdominal pain was diverticulitis, it was unclear if the inflammation was from diverticulitis or the pancreas. Physician reported that the patient had a GI consult. Physician reported that the GI provider did an MRI on the patient's abdomen and the final word was pancreatitis. Physician reported that since the patient was hospitalized, all of the inflammatory markers, D-dimer, sed rate, CRP, have come down. Physician stated something happened. The patient has no risk factors for pancreatitis. He doesn't drink, isn't on any medications that would cause pancreatitis, doesn't have high triglycerides, and doesn't have gallstones; the Pfizer Covid-19 vaccine was the only variable. Physician is thinking that the whole inflammatory process was part of a reaction to the Covid-19 vaccine. Patient is clinically recovered, he was hospitalized from 16Apr2021 to 22Apr2021. Physician reported that the patient hasn't been checked radiologically but the physician is hoping to repeat the patient's MRI in a couple of weeks. He eventually got better and went home. He is now wondering if he should get the second dose of the Covid-19 vaccine. Physician is a little hesitant to tell the patient whether or not the patient should get the second dose of the Covid-19 vaccine. Physician does not know if the patient's adverse events were related to the Covid-19 vaccine and stated that risking another pancreatitis episode is a big deal. The patient's lipase never went up unless it was high 4 days before admission. Physician reported that the patient didn't seek attention then. Patient underwent lab tests and procedures which included D-dimer: 416ng/mL (16Apr2021), 959 ng/mL (18Apr2021), 933 ng/mL (19Apr2021), 818 ng/mL (20Apr2021), 842 ng/mL (21Apr2021), 686 ng/mL (22Apr2021); White blood cell count: 12600 (16Apr2021), 6800 (22Apr2021); C-reactive Protein: 148 ng/mL (16Apr2021), 109 ng/mL (18Apr2021), 84 ng/mL (20Apr2021), 73 ng/mL (21Apr2021), 51 ng/mL (22Apr2021), less than 1 ng/mL (12May2021); CT abdomen (16Apr2021): Inflammation in tail of pancreas; Covid-19 test: negative on 16Apr2021 and 18Apr2021; Erythrocyte sedimentation rate: 68 mm/hour (19Apr2021), 20 mm/hour (12May2021); Blood cultures: negative on 16Apr2021; Alk phos: 123 IU/L (26Apr2021), 85 IU/L (12May2021); ALT: 46 IU/L (26Apr2021), 40 IU/L (12May2021); GGT (Normal range: Up to 65 IU/L): 92 IU/L (30Apr2021), 59 IU/L (12May2021); CT angiogram chest, abdomen, pelvis on Apr2021 and revealed negative, no thrombotic event (Apr2021). MRI Abdomen: Pancreatitis localized to tail of pancreas (Apr2021); CT head was Negative (Apr2021). Outcome of diverticulitis was unknown, outcome of other events was recovered in Apr2021. The reporting physician assessed fever as serious with seriousness criteria hospitalization, left sided abdominal pain is serious with seriousness criteria medically significant and pancreatitis is serious with seriousness criteria medically significant, disabling. Physician reported that the Covid-19 vaccine potentially yes caused the patient's abdominal pain, but he did not know if the headache and pancreatitis were related or not to the Pfizer Covid-19 vaccine. Physician reported that in the absence of anything else, he is suspecting that the patient's headache and pancreatitis were caused by the Covid-19 vaccine. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a contributory role of BNT162B2 to reported events cannot be fully excluded. 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.

Medications Prior to Admission Medication Sig Dispense Refill Last Dose ? aspirin 81 MG PO Chew Tab take 81 mg by mouth once every other day. 6/4/2021 at Unknown time ? docusate (COLACE) 100 MG PO Cap take 100 mg by mouth as needed for FOR CONSTIPATION. Past Month at Unknown time ? insulin 70/30 (NovoLOG) (70-30) 100 UNIT/ML SQ Suspension Sliding scale twice daily with meals 6/4/2021 at Unknown time ? latanoprost (XALATAN) 0.005 % OPHTH Solution place 1 Drop into both eyes once every night at bedtime. Past Week at Unknown time ? methocarbamol (ROBAXIN) 750 MG PO Tab take 750 mg by mouth every 8 hours as needed for FOR MUSCLE SPASM. Past Week at Unknown time ? Alirocumab (Praluent) 75 MG/ML SQ Solution Auto-injector inject 75 mg as directed every 14 days. 3 mL 3 5/31/2021 ? amLODIPine (NORVASC) 10 MG PO Tab TAKE 1 TABLET BY MOUTH EVERY DAY 90 Tab 1 Past Week at Unknown time ? Insulin Syringe 31G X 5/16" 0.5 ML XX Misc Twice daily for insulin injections. 100 Each 3

AS LISTED IN #17 , I RECEIVED A TEXT AND EMAIL FROM THE COUNTY ON THE 20TH TO REPORT FOR THE 2ND SHOT ON THE 21ST, WHICH I DID, WHICH WAS A WEEK TO SOON AND NOT 1 OF THE 4 PEOPLE WHO LOOKED AT MY VACCINE CARD TOLD ME I WAS THERE TO SOON. AND THEY PROCEEDED TO GIVE ME THE SHOT. I WAS ALSO UNAWARE THAT I WAS THERE TO SOON UNTIL THE ADVERSE AFFECTS STARTED THE NEXT DAY. THAT'S WHEN I LOOKED AT MY CARD AND NOTICED THE MISTAKE. THE ADVERSE AFFECTS WERE AS FOLLOWS: FIRST CAME SHARP STABING PAINS MOVING TO VARIOUS PARTS OF MY BODY THEN CAME COMPLETE FATIGUE WITH INTERMITTENT FEVER AND CHILLS THEN CAME STOMACH ISSUES WITH DIARREA THEN CAME SEVERE SHORTNESS OF BREATH AND SOME CHEST PAIN I AM RECOVERING SLOWLY BUT STILL FATI

Pt had first dose of Pfizer COVID vaccine on 3/9/2021 and second dose on 3/31/2021. Pt tested positive for COVID-19 on 5/18/2021 and did have symptoms, such as diarrhea, myalgia, and cough/chest congestion. He presented to the ED on 6/2/2021 and was admitted for COVID-Pneumonia and afib with RVR. Pt still inpatient.

when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Diarrhea; Severe Headache; Dizziness; Some Blood In Urine; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration in the right arm on Mar2021 at 23:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 06Mar2021, the patient experienced diarrhea, severe headache, dizziness, and some blood in the urine. The patient did not receive any treatment for the events. The clinical outcomes of the evente diarrhea, severe headache, dizziness, and some blood in urine were recovered. No follow-up attempts are needed. No further information is expected

Severe headaches never get headaches; Whole body aches; Fever; Diarrhea; This is a spontaneous report received from a contactable consumer or other non hcp(patient). A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO191) via an unspecified route of administration in Arm Left on 04Jun2021 at 10:30 AM (66-years-old age at vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Heart arithmia from an unknown date and unknown if ongoing, covid-19 from Jan2021 to an unknown date. Concomitant medications included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 04Jun2021 at 13:00, the patient experienced severe headaches never get headaches, whole body aches, fever and diarrhoea. I had covid in january and felt like I have it all over again. Treatment was received for the events. I called Dr and got advise on meds to take. The events was reported as non serious. The outcome of the events was reported as not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Pt was admitted to hospital from the ED with GI bleeding on 4/4/21 after receiving the 2nd dose of vaccine on 3/30/21. Per guidelines, all hospitalizations are reported.

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

chest pain, sweats, nausea, diaphoretci, tachypnea, possible V2 and V3 ST elevation, pancreatitis, gastroduodenitis, elevated lipase, leukocytosis, hyperlipidemia, myoclonus/twitching of face muscles

Waves of chills; Rapid heart beat; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in left arm on 21Mar2021 at 16:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. Medical history included coronary artery disease (CAD). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clopidogrel (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ASPIRIN (MANUFACTURER UNKNOWN) and C (as reported); all were taken for unknown indications from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 24Mar2021, at 09:30, the patient experienced waves of chills, rapid heartbeat, nausea and fatigue all intensely. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events waves of chills, rapid heartbeat, nausea and fatigue were resolving at the time of report. No follow-up attempts are needed. No further information is expected.

Fever; General achiness; Chills; Heavy night sweats; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included bladder cancer. The patient was on a regimen of Keytruda immunotherapy for bladder cancer. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206), via an unspecified route of administration in the left arm on 03Mar2021 at 14:00 (at the age of 66-years-old), as a single dose for COVID-19 immunisation. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 09:00, the patient had experienced fever and general achiness starting on the second day following the vaccination. Fever has persisted between 100.8F - 102.2F during this time. Also, he had experienced chills, heavy night sweats and loss of appetite. Therapeutic measures included Tylenol 650 mg for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, generalised aching, chills, night sweats and appetite lost was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

I loss 7 pounds due to my diarrhea; my food is not digested everything I eat is not digested; Diarrhea; Magnesium low; my heart skip beat like it was skipping one beat skip; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0150, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 66-year-old). Medical history included diabetes mellitus from an unknown date, and blood pressure high from an unknown date. Concomitant medications included metformin (METFORMIN) 1000 mg twice a day taken for diabetes mellitus, from an unknown start date; and lisinopril (LISINOPRIL) 10mg taken for hypertension, from an unknown start date. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00, as DOSE 1, SINGLE for covid-19 immunization (at the age of 66-year-old). On 15Apr2021, the patient experienced diarrhea like for two weeks, 2-3 times a day and then patient started on probiotic (Further clarification unknown), then patient was ok for like 4 weeks and now patient was having diarrhea everyday once or twice. And that caused patient's magnesium to go down, it was also reported he experienced heart skip beat like it was skipping one beat skip, skip and patient ended up in emergency, but patient's magnesium was low because of diarrhea they did stool test everything came back negative, DNA stool test the other test. The patient reported that he lost 7pounds of weight due to the diarrhea during the 3 months prior to this report (last 3months). The patient had lab test on an unknown date which included blood cholesterol results were less than 139, blood magnesium was low, full blood count results unknown, A1C (glycosylated haemoglobin) was 6.9, Stool analysis was also negative, patient had weight loss in 3months. On an unknown date, the patient also experienced that food was not digested every-thing he eat was not digested. The patient had to take therapeutic measures and the patient was on probiotic but it was not helping. The outcome of the events was unknown. Follow-up attempts were completed. No further information was expected.

Nausea; abdominal pain; rash purpura on lower legs; Leg sweling; low grade fever; severe headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disease and penicillin allergy. The patient had received other unspecified medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 11:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 the patient experienced severe headache. On 27Mar2021 the patient experienced low grade fever, purpuric rash on lower legs and leg swelling. On 28Mar2021 the patient experienced nausea and abdominal pain. On 29Mar2021, patient felt better and also the symptoms was resolved on 30Mar21. On 29Mar2021, the patient underwent lab tests which included covid virus test (nasal swab) and the result was negative. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of the reported event was unknown. The clinical outcome of the events severe headache, low grade fever, purpuric rash on lower legs, leg swelling, nausea and abdominal pain were recovered on 30Mar2021. No follow-up attempts are needed. No further information is expected.

Three to four days after, he started having diarrhea/he had diarrhea nonstop for two weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 66-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 on 10Apr2021 (age at vaccination was 66 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Apr2021 the patient experienced three to four days after, he started having diarrhea. The patient had diarrhea nonstop for two weeks and was taking probiotics. The patient was okay for four weeks. Now the patient was back to having diarrhea once a day daily. The patient had a stool test done, and it came back normal. The patient had a colonoscopy done to be on the safe side. The patient did not know if the diarrhea was a coincidence or related to the COVID vaccine. Right after the covid vaccine, the patient started having diarrhea. The patient received treatment for the event. The patient had a colonoscopy done to be on the safe side, stool analysis shown normal on an unspecified date in 2021. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

feeling a little hazy; Blurred vision; general weakness; minor aches; nausea; body aches; slight headache; soreness in injection site; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 08:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic type 2 controlled and Psoriasis. The patient was allergic to cucumbers. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), tiagabine (MANUFACTURER UNKNOWN) and meloxicam (MANUFACTURER UNKNOWN) and seven more medication, all for unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 09Mar2021 at 08:45 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 13:00, the patient experienced slight headache and soreness in injection site(vaccination site pain). On 31Mar2021 the patient experienced headache, nausea and body aches. On 01Apr2021 the patient experienced vision impaired(blurred vision), slight headache, slight nausea general weakness and minor aches. On 02Apr2021 the patient felt slight headache, slight nausea, slight weakness. On 03Apr2021 the patient felt little hazy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events slight headache, slight soreness in injection site, nausea, body aches, vision impaired(blurred vision), general weakness, minor aches and feeling a little hazy were recovered with sequelae. No follow-up attempts are needed. No further information is expected.

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.

Terrible reaction as far as taste/bad taste starts in far back of mouth; bad smell/ seems to hang in the nostrils and sinuses; feeling of heat traveling down nostrils; disgusting taste and smell forces to stop eating; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 03Mar2021 at 12:30 (at the age of 66-year-old) as a single dose and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 12:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included neuropathy peripheral since unknown date and penicillin allergy. Concomitant medications included pregabalin (LYRICA) 300 mg daily and doxazosin (MANUFACTURER UNKNOWN) 8 mg daily, all received within two weeks of vaccination for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, shortly after first dose, the patient started experiencing a terrible reaction as far as taste in the foods (never had a problem previously) bad taste starts in far back of mouth, then a bad smell became associated with it which seems to hang in the nostrils and sinuses. When the patient continues eating the bad taste and smell, intensify and a feel of heat travelled down to nostrils. The disgusting taste and smell forces patient to stop eating small quantities of food like peanut butter, peanuts and potato chips. After second dose the foods peanut, pretzels, popcorn and tostitos got added. The patient did not receive any treatment for the events. The clinical outcome of the event altered taste, altered smell, feeling of heat and stopped eating was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Patient received first dose on 12/29/20 with no complaints. Patient received second dose on Tues 1/19/21 and waited 15 minutes. He had no complaints. He returned to work and finished his shift. Patient went to gym, after work at 6 pm. As he started to workout he felt dizzy. He rested for a few minutes then made his way to dressing room. He started feeling nauseated and cramping in lower extremities. He reported having difficulty vomiting but after one episode he felt better. He called his wife who called attendant. They called EMS. He made his way out to the ambulance with help from the attendant. He continued to have cramping in legs and then stomach. EMS assessed him. His blood pressure was high. Patient and his wife decided to not go to ER. EMS released him and he went home. Patient continued feeling light headedness, dizzy and having nausea and vomiting till around 11 pm. Today, he reports feeling better but continuing to feel dizzy. He is following up with doctor today.

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.

Persistent dry cough, fever, nasal congestion, chills, and diarrhea beginning evening of vaccine dose. Wife with similar symptoms. Proceeded to outside facility ER, unclear if COVID test positive.

Patient received the vaccine, and was watched for 15 minutes. Patient was approximately 30 minutes away from clinic when he started feeling nauseous. Patient stated that he threw up three to four times while driving. Upon reaching his destination, the staff at his facility noticed that he looked pale. He began to complain of chest pain on the right side and EMS was called. Patient was transported to Hospital.

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

severe rigors; massive headache; extreme nausea; horrible arthralgia such that I could not get out of bed; This is a spontaneous report from a contactable physician (patient). A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 13:15 at single dose (Lot number= EL3246) on Left arm for covid-19 immunisation. Medical history included hypertension (HTN), covid prior vaccination. Known allergies: Yes. The patient previously took first dose of bnt162b2 (Lot number= EK9231) on 26Dec2020 01:15 PM Left arm for COVID-19 immunization. The patient experienced on 17Jan2021 02:00 AM reported as "14 hours after vaccine awakened with severe rigors, massive headache, extreme nausea and horrible arthralgia such that I could not get out of bed. Lasted several hours. Arthralgia then abated sufficiently enough to get medicines in bathroom". Treatment received included Anaprox, Nexium. Outcome of events was recovered. No covid tested post vaccination.

Fever (tmax reported per 100.0; temp at clinic 100.9); Rapid heartbeat; Chills, Fatigue, Dry mouth, loss of appetite, nausea

extreme exhaustion, low grade fever 98.2 to 99.5 (normal is in the 97 degree range), loss of appetite

Within 15-minutes of vaccination, the patient reported feeling dizzy and nauseous. EMS manages the patient's care on-site.

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.

On 2/11/2021, after about an hour the vaccine was administered to the patient and with about minutes left of his dialysis treatment. , the patient reported to staff that he was feeling nauseous and then spit out a 3/4 quarter sized blood clot. Pt was almost done with his dialysis treatment and his time was cut short by 3 minutes. Pt then verbalized that he felt "fine." The RN working with the patient notified the on-call nephrologist and 911 was called. Pt refused to go to the hospital. On following up with patient and RCM on 2/10/2021, patient reported he notified his nephrologist and CXR was scheduled. As of 2/11/2021, pt stated he is not feeling well and did not arrive for scheduled hemodialysis. RCM aware.

Severe vertigo hours 8-36 hours post injection. Telehealth RX for Zoltan. Chills, shaking and fever 102.3 degrees 30-40 hours post injection. Severe diarreha (explosive for 12 hours) day 2-3.

Severe abdominal cramps shortly after a meal. Started second day after injection, only once a day in the afternoon or evening shortly after a meal. Repeated for three days and have been fine for 36 hours now. No fever, nausea, diarrhea, or constipation. Cramps lasted about an hour each time and then I felt fine for the rest of the day. I did not see a pattern relating to what I had eaten.

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.

swollen lymph nodes, runny nose, nausea, jittery, chest and bronchia congestion, low energy NO headache, NO cough, NO fever took benadryl at 12 noon - relieved some symtoms slightly

Upon waking, some nausea, mild headache, sore arm, dizziness, inability to walk or stand without support, needed to look straight ahead. Subsided somewhat after a few hours and eating. Expect full recovery within day.

SUMMARY Two weeks after first vaccine: uncontrollable shaking throughout body, followed by chills, then entire body ache and fever. The first 12 hours were the worst, but after 36 hours all symptoms were gone. DETAIL The Feb 3, 2021 First vaccine - Phizer Feb 18, 2021 5:00 pm suddenly came down with shaking throughout my body and then chills. 6:00 pm shaking subsided 7:00 pm entire body aches from head to feet Later in evening - fever throughout body Feb 19, 2021 feeling better, but still muscle and joint pain throughout body. Some slight fever. No appetite, but can smell chicken broth. February 20, 2021 feeling better but tired 10:00 am COVID test at pharmacy. Noon ate peanut butter and crackers 2:00 pm sat outside for 30 minutes 6:30 pm ate full Mexican dinner February 21, 2021 feeling good with a good appetite. NO SYMPTOMS. 9:30 am breakfast 1:00 pm sat outside for 30 minutes 1:30 pm lunch REFLECTION: During entire time, no difficulty breathing or coughing. And the other symptoms came and went in 36 hours. The symptoms I did have are the same as a bad reaction to the 2nd vaccine. (my muscle aches are not a reaction to the vaccine). Yet, my reaction was not immediate, rather it was 2 weeks and 1 day after my first vaccine. Therefore, do I have COVID, or a bad reaction to my first vaccine? WAITING for COVID test results. Second vaccination is scheduled for upcoming Friday, February 26.

1st dose was 3-weeks prior and had sore upper arm for 2-days with no other problems. Second dose had much less soreness however on day 2 developed a slightly nauseating stomach which lasted a few hours.

Within 4 hours developed cephalgia, myalgias, fatigue, nausea, chills and fever that spiked to 102 deg. 24 hours later still fatigued, but afebrile.

Began having SOB and cough on 2/18/21, the day after his first vaccine. Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints. Presented to the hospital on 2/23, soon after required intubation. Admitted with severe pneumonia, diffuse colitis, and sepsis. Condition continued to worsen until patient passed away on 2/24/21 @ 1632.

Injection site pain, tiredness, headache, muscle pain, joint pain, nausea, feeling unwell, swollen lymph nodes.

rapid onset of intense Dizziness followed by Nausea lasting approximately 2 hours also had fatigue and had to sleep for several hours.

Swollen ulcerated tongue, bleeding out of tongue. After applying pressure and 24 hours, tongue stopped bleeding. Swelling ended after 48 hours. Nausea, 2/8 in morning, 2/9 in morning Headache, 2/9 in morning Crawling skin on chest, 2/10 afternoon

feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.

c/o nausea, sensation in left rib, dizziness. Paramedics attended to him. Upon reaching client, client was oriented to TPP. Communicative. Client was transferred to Medical Center for further review. Vitals by paramedics: O2 sat 99%, B/P 150/87, HR 80 BPM.

This was the second shot. Adverse effects included vomiting, diarrhea, chills, headache, sweating. Required ER visit for dehydration. Treatment included IV fluids, and Zofran for vomiting.

diarrhea; 12 hours after injection - fainted in bathroom/fainted 2nd time; woozieness when trying to walk/just felt woozy; headache; chills; This is a spontaneous report from contactable consumers (patient and wife). This 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) in right arm on 23Feb2021 05:00pm at single dose for COVID-19 immunisation. Medical history included high cholesterol, acid reflux (esophageal). The patient had no known allergies. Concomitant medications in two weeks included atorvastatin for high cholesterol, ongoing omeprazole for acid reflux (esophageal), and ongoing multivitamins (1 tablet a day for men over 50 by mouth as supplementation therapy). The patient did not receive other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810) at the age of 67-year on 02Feb2021 at 05:00PM in left arm at single dose for COVID-19 immunisation, had no reaction with the first dose, had no issues in the waiting period or while shopping afterwards; received influenza vaccine (FLU) and pneumonia shot for immunization on an unknown date a couple of months ago. The patient did not have COVID prior vaccination, COVID was not tested post vaccination. The patient received second dose of the Covid-19 Vaccine, then on 24Feb2021, fainted twice 12 hours after receiving the second dose, fainted in the morning of 24Feb2021 around 05:20, he got up because he had diarrhea and that was when he first fainted in the bathroom. He also had chills and a headache in the morning of 24Feb2021 at 05:15, but she reported that he did not have a fever. Temperature was normal on 24Feb2021. The patient reported that he just felt woozy, wooziness when trying to walk/just felt woozy in the morning of 24Feb2021 at 05:15. She said that he fainted for a second time just minutes after he fainted the first time when the reporter was helping the patient get back from the bathroom to the bedroom, the patient collapsed on the floor and reporter got him up. He developed the diarrhea around 05:30 in the morning of 24Feb2021. He took some ibuprofen to treat the headache. It was unknown if the treatment received for the other events. He has been resting since he had the diarrhea. Outcome of the events faint and diarrhea was unknown, wooziness when trying to walk/just felt woozy was recovering, while other events was recovered on 24Feb2021.

Wednesday 3-10-2021, mild dizziness, at about 5:15AM. For about 10 seconds. Thursday 3-11-2021, dizziness that made me hold on to counter and sit in chair for about 45 seconds, about 5:20AM. At work at 2:00PM, dizziness, weakness, upset stomach, breathing hard, could not stand for fear of falling. This lasted about 45 minutes. Felt better drove from work at 3:30PM. Got home another dizzy spell that lasted about 15 minutes, no other symptoms. Got to the bed about 4:30PM, stayed in bed for about 2 hours, got up ate a lite supper and went to bed about 8:30PM. Friday 3-12-2021, felt fine all day no problems.

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.

Progress Notes Expand AllCollapse All Patient: DOB: 1/5/1954 Date: 3/15/2021 MRN: Subjective Patient is a 67 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience slight nausea and heart racing sensation. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, collapse, rapid progression of symptoms, respiratory distress and skin changes. Past Medical History: Diagnosis Date ? Cancer (HCC) 2004 surgery ? Malignant neoplasm of colon, unspecified site (HCC) ? Peripheral neuropathy due to chemotherapy (HCC) 2004 ? Rheumatoid arthritis(714.0) Rheumatoid Arthritis; NG PMH ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, vomiting, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none to vaccines. Objective Vitals Vitals: 03/15/21 1433 03/15/21 1437 BP: (!) 168/62 (!) 152/68 Pulse: 62 SpO2: 98% Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood is anxious (slightly anxious affect.). Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Pt improved after monitoring in bay for 15 minutes. He denies any concerns and states symptoms have resolved. Pt able to ambulate out of the facility w/o assistance. He expresses appreciation of his care today.

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.

I cannot move out of my bed; My vision is also blurred; It am dropping rather rapidly because I am not able to eat; It am dropping rather rapidly because I am not able to eat; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6200 , on 17Feb2021 at single dose in arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number ELI283) on 27Jan2021 and had no adverse effect. The patient was wondering if he hold the current record for the number of days consecutive for a person to have adverse reaction to the second vaccine because it was over a week and he could not move out of his bed. That almost killed him. His vision was also blurred. His weight was dropping rather rapidly because he was not able to eat. The outcome of the events was unknown.

Slight fever and nausea at first. 4 days later severe chills for 8 hours. Two weeks later severe chills and dizziness feeling as though about to pass out like Vertigo. Since continue to experience dizziness when rising from prone position - daily.

Headache, nausea for next three days after vaccination. Treated with acetaminophen and cold compresses

dizziness; vertigo; mild headache; mild diarrhea; no appetite; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) via an unspecified route of administration, administered in left arm on 30Jan2021 at 09:00 (at the age of 67 years old) as a single dose, for COVID-19 immunization. The patient also received dose 2 of BNT162b2 (Lot number Unknown) via an unspecified route of administration, administered in left arm on 20Feb2021 at 09:00 (at the age of 67 years old) as a single dose. The patient was administered dose 2 of BNT162b2 at a Doctor's office/urgent care. Medical history included hernia from an unspecified date (Hernia surgery 22Feb2021). The patient did not have any known allergies to medications, food, or other products. The patient did not experience COVID-19 prior to vaccination. Concomitant medications received within 2 weeks of vaccination included levothyroxine and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to vaccination. On 19Feb2021, six days after vaccination (as reported), the patient woke up with dizziness, vertigo, mild headache and mild diarrhea. These continued throughout the day with no appetite. The vertigo was better if the patient sat still. The patient woke up on day 2 to vertigo again but easing. The events did not result in hospitalization/prolongation of hospitalization. The patient had a negative COVID-19 test (nasal swab) on 19Feb2021. The patient did not receive treatment for the events. The clinical outcome of the events dizziness, mild headache, mild diarrhea and no appetite was not recovered. The clinical outcome of the event vertigo was recovering. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.

All of the following symptoms lasted for a minimum of 4 days:extreme fatigue, headache, muscle pain, chills, joint pain, fever as high as 101.8, nausea, feeling very unwell, difficulty breathing off and on. I have also been experiencing dizziness and being very unsteady on my feet which is now into its 5th day.

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.

extreme heartburn in first and second dose (3/30/2021). Onset of heartburn is at bed time, lasting several days, each succeeding night was progressively better, over the counter meds were no help whatsoever

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.

Started with upset stomach that continued in intensity. Not feeling well then about 10 days later I woke up with Vertigo. The symptoms are slowly reducing.

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.

on 4/6/2021 around 5pm pt got a headache on the left side mainly, felt like throwing up and stomach ache.

Patient died of expected causes 5 days post-vaccine. Patient was known to have advanced colon cancer. Patient's COD was metastatic cecal cancer, admitted to hospital on 3/22/21 for palliative treatment, PEG tube placement for decompression, and pain control.

Vomiting and Severe Diarrhea! started at 6am 4/7/2021 and has not stopped yet at 5pm in the afternoon!!! and a temperature of 100.4

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.

feels like he might be getting the flu; pain in stomach; headache; anything he eats turns to acid; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in local center, via an unspecified route of administration, in left deltoid on 10Mar2021 at 09:30, at 67 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. Medical history included ongoing sarcoidosis he has had for at least 35 years, oozing leg from 2019 and "underlying health issues". He had bloodwork done 3 times and it came back negative for COVID-19: he had one done in Mar2020, one done in Jun2020, and one done three months before this report (Dec2020). Historical vaccine included flu shot in Sep2020 or Oct2020 with no problem and he gets it every year. Concomitant medications included olmesartan/hydrochlorothiazide 40 mg/25mg tablets from 2019 and ongoing for blood pressure; amlodipine from 2019 and ongoing for blood pressure abnormal; oxybutynin for incontinence ("to control his bladder so that he does not have to go"), from an unknown date, almost one year before this report (2020) and ongoing; colchicine (COLCRYS) (not actually taking it as he is out of it), from the middle of Feb2021 for gout; allopurinol from the middle of Feb2021 and ongoing for gout; calcium carbonate (ACID BREAKTHROUGH FORMULA) for antacid therapy, from an unknown date and ongoing ("has been taking it on and off for 20 years"); ibuprofen, taking on and off for the last 5 years (now ongoing) for pain, from an unknown date; ascorbic acid (VITAMIN C ACID) from an unknown date (has been on at least the last 4 years) for cold or flu prophylaxis; ongoing fish oil (has been on for the last 2 or 3 years) for blood cholesterol (he was told it was supposed to help cholesterol), from an unknown date and metformin for pre-diabetes ("his numbers are very low, but they told him to take it so that he does not get diabetes"), from an unknown date (has been on it for about a year and a half). Past drug history included oxycodone-acetaminophen, which was last filled on 03Oct2011. In Mar2021, two weeks after the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine he did not feel the best: he felt fine the first week, but then, on "Sunday" [21Mar2021] the patient felt like he might be getting the flu, he experienced pain in stomach, stating that the pain is there but it does not hurt that bad, headache, defined as "not that bad, just a mild headache; it is about the same, it is an annoying ache", and anything he eats turns to acid. The events didn't require ED or physician office visit. The patient added that there is a problem with his leg where it is oozing, started two years before this report, and they are going to give him antibiotics, cephalexin 500 mg capsule. His second vaccine dose is planned on 31Mar2021 and he is afraid that antibiotics could interfere with the vaccine efficacy. The patient didn't receive any treatment, as he thought that this would just go away in 2 to 3 days. At the time of the report the stomach pain was ongoing ("it goes and comes"), as well as the event "anything he eats turns to acid"; the outcome of the other events was unknown.

COVID Infection breakthrough in fully vaccinated individual. Patient was vaccinated on 1/30/2021 and 2/20/2021. He developed symptoms of COVID on 4/6/2021 (including fever, stomach ache, chills, nausea, cough, shortness of breath, lightheaded and chest tightness). He presented to the emergency department on 4/7/2021 and has been admitted since then on a medical surgical unit. His maximum oxygenation needs have been 3L.