Pfizer

DVT left calf; This is a spontaneous report from a contactable Physician (patient). A 60-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 20Dec2020 08:00 at single dose on right arm for COVID-19 immunization. Medical history included Gastric reflux. The patient had no known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included omeprazole (PRILOSEC) and ergocalciferol (VIT D). The patient had not received other vaccine in four weeks. The patient experienced deep vein thrombosis (DVT) left calf on 27Dec2020 09:00 which resulted emergency room visit. Treatment received for the event included Xarelto. The outcome of the event was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.

Myocardial Infarction: patient began to complain of severe chest pain 3 hours after the vaccine was given .. Vaccine NDC # 59267-1000-1. 0.3 ml given by RN. Patient called his PCP: "... I had very bad chest and shoulder pains, neck pains and slight fever from 9 pm until early this morning (Jan 8). My blood pressure was 155/95 mmHg. Should I see you today? Still feel sore all upper body. Above message received at 0720 am (Jan 8) and the patient was called back at 0757 am (Jan 8): patient was told that many of the side effects above were related to the vaccine but the chest pain was worrisome and the provider requested the patient go to the emergency room. Patient understood the importance to seek medical attention..... Emergency Room notes: seen by MD on Jan 9. Note at 0749: patient complained of chest pain on/off since received COVID vaccine on Jan 7. Pain was substernal and radiated to the left shoulder, assoc with some SOB. EKG obtained and revealed ST segment elevation and a "cardiac alert" was called.

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;

Some time after vaccination noticed trouble breathing and shortness of breath. 2 days later ( Tuesday, 1-18-2021) still have difficulty breathing and heart beat is faster. Woke up in the middle of the night on Sunday with a rapid heartbeat.

3h after receiving the first shot, I developed symmetric flank pain in the mid-thoracic area that persisted about 28 hours. No CVA tenderness; elevated BP of 132/85; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on his left arm on 07Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID]) and naproxen. Three hours after receiving the first shot (07Jan2021 at 22:00), patient developed symmetric flank pain in the mid-thoracic area that persisted about 28 hours. No CVA tenderness. The following morning, he had an elevated BP of 132/85 that persisted this morning (120/98). His normal BP is 110/70. Checked a creatinine and metabolic panel on 07Jan2021, all normal. There was no treatment received for the adverse events. The outcome of the events was recovering.

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.

Elevated blood sugar, unable to get it under control. Right side of skull and face extremely painful, including tongue lips, teeth eye, skin. Some soreness continued after 2 days.

Second shot vaccine was end of Jan 2021 chills that lasted 48 hours, I lost appetite the next day for 24 hours, I continued working, I started getting headaches and ringing in ears I perceived this as hypertension and it lasted 2-3 weeks, losartan 12mg per day, I checked it and it was high it?s never been that high so I took 24mg instead. I took 50mg total of losartan and it?s taken until now to get down to 25mg daily. I may have been exposed in Jan of 2020.

4.5 days after vaccination he woke from a sound sleep with extremely fast heart, unable to breath, Apple Watch said "Afib". went to ER and cardioverted on his own and was discharged after 5 hours. MD later increased his HCTZ.

First ever episode of atrial fibrillation with rapid ventricular response (160 bpm). Acute onset while at rest with palpitations. Patient documented atrial fibrillation with consumer grade ECG (Kardia). (Patient is a cardiologist). Arrhythmia resolved 10 min after taking 6.25mg of Coreg. No recurrence.

1 day post second Covid 19 vaccine patient experienced severe headache that progressively intensified and loss of vision out of the right eye. Subsequently, he presented to the ED and was found to have a left occipital lobe intraparenchyma hemorrhage & 1-acute subdural hemorrhage posterior left tentorial. He was air transport to another facility for treatment:/monitoring. He is currently still admitted . He remains without right eye vision.

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.

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

Soreness at Injection site Lasted one day. Soreness in both shoulders and both upper legs near groin area till 2:00am heart palpitations started one hour after injections and lasted for 2 1/2 hours.

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.

Chest heaviness, lightheaded. Evaluated by EMS-Transported to Emergency room/department or urgent care.

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

Pt began to feel lightheaded and dizzy. He did pass out while sitting in chair. Quickly came back, woke back up and was able to answer orientation questions. He did report that this always happens to him when he takes antihistamines. Observed for a period of 5-7 minutes and felt / looked better. Told him we would observe him for a period of 30 minutes. Within 5 minutes, he had the exact same reaction. Patient passed out, was pale and diaphoretic. Blood pressure was 65/39 with HR 45 (3/16 @ 1430). At that time, he was moved to a gurney and placed in Trendelenburg position. Patient observed. repeat blood pressure at 1435 was 104/64 with HR 68. Patient continued in Trendelenburg position. Patient observed until 1455. Repeat blood pressure at 1452 was 105/69 with HR 73. Patient looked and felt better. He refused to go to ED. Wife to stay with patient and observe this evening and afternoon.

pt. experiencing some lightheadedness. L. sided neck pain and metalic taste in mouth. Medics present. pt. denies any difficulty swallowing &/or other s/s. Resolved with calming / comfort measures. Advised pt. to go to ER via EMS/ have someone come pick him up d/t increased BP. Pt. refused. Pt. asymptomatic prior to leaving vaccination site. Pt. advised to pull over & call 911 if anything changed / symptoms return- pt. agreeable. Advised to f/u with PCP/ Cardo. pt. communicates understanding. BP 216/117 at 1337 HR: 73; SPo2: 93% - smoker- 0.5 PPD x 27yrs. BP: 206/122 at 1443 HR 1443, HR 71; BP 187/112 at 1448, HR :69; BP 180/109 at 1453 HR: 72; BP: 173/103 at 1458 HR: 72; BP: 176/105: HR 71 at 1503.

Upper left side chest discomfort. Pain persisted moderately for 3-4 days, and slowly began fading. By 10 days the pain had almost completely ended. About 19 days after shot I had an unusual bruise appear on my right foot, which was not due to any impact, and has just a little pain

Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.

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

4 days post vaccination began having "chest or heart pain", later started with painful rash. Diagnosed by provider with shingles on 03/22/2021

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.

Patient received the vaccine on Tuesday, and on Thursday morning he woke up and couldn't speak and was taken to the hospital and diagnosed with an ischemic stroke

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.

Saturday 313 am, chills, 400am extreme sweats ended by 630am - 718am unable to breathe, It felt like right lung collapsed. I was able to pull up breath, however light chest pain persists at this time, 12;12pm.

numbing of right hand side of face/mouth and right arm. symptoms subsided after about 10-15 minutes but continued to present every few days. I advised when i presented for my 2nd shot and they told me they had other reports of that and that is was fine/safe for me to take the 2nd shot, but to wait in a holding area for 30 minutes after the shot.

stroke of the 4th cranial nerve; Dizziness; double vision; This is a spontaneous report from a contactable nurse. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), intramuscular, in the left arm on 16Mar2021 at a single dose (at the age of 60-years-old) for Covid-19 Immunization; vaccinated in the hospital. Medical history included hypertension and allergies to sulfa. Concomitant medications were not reported. No other vaccine in four weeks. The patient had no COVID prior to the vaccination. On 16Mar2021, the patent experienced dizziness and double vision. He saw the eye doctor who stated that he had a stroke of the 4th cranial nerve. No treatment was given. The patient was not COVID tested post vaccination. The nurse assessed the events as non-serious. The patient was recovering from the events.; Sender's Comments: A contributory role of BNT162B2 to event a stroke of the 4th cranial nerve cannot be excluded based on limit information. Case will be reassessed when further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

loss of taste; possible allergic reaction to the drug; Can't pronounce words right; can't close right eye; eyes started to tear a lot; can't smile; right side of his face started drooping like that of a stroke; right side of his face started drooping like that of a stroke; headache at the back of his head; mouth started to feel numb; mouth started to feel numb; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 61 year old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) at the age of 60 years old, via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EL6205) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, mouth started to feel numb and allergies to tree pollen; and family history of diabetic and heart disease (father); all from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium (TEMISARTAN), gabapentin, escitalopram oxalate (LEXAPRO), furosemide, potassium, valproate semisodium (DIVALPROEX) and tizanidine; all taken for an unspecified indication from an unspecified start date and ongoing. The patient received the first dose of BNT162B2. The next day, he said his mouth started to feel numb, and he had a loss of taste. Then on Saturday, his eyes started to tear a lot, and the right side of his face started drooping like that of a stroke. He also said he had headache on the back of his head, and his eyes do not. The patient wanted to know if he should go to the emergency room or if this is a normal reaction to the vaccine. The patient did have a sensation starting on Thursday of numbness in his mouth. The patient describes it as a feeling like when he was younger and would use chloraseptic spray, it feels like same numbness. He states that on Saturday his eyes started tearing up, and he does have allergies to tree pollen. The right side of his face feels and looks like he had a stroke, it is droopy on right side. The patient can't pronounce words right, can't smile, and can't close his right eye. The patient was checked with heart rate and EKG with his little machine and his temperature, and they all seem fine. The patient was also getting headaches at the back of his head. The patient took Advil for headaches, but it is not improving. The patient ran out of the Advil and doesn't have the bottle anymore. The patient took allergy pills, a knock off Benadryl, because he thought his eye tearing was possibly from allergies to tree pollen allergy or possible allergic reaction to the drug. The patient underwent lab tests and procedures which included body temperature: fine, CAT: not reported, EKG: fine, complete blood work: not reported and heart rate: fine; all on 15Mar2021. The outcome of loss of taste was unknown. The outcome of the rest of the events was not recovered. Information on the lot/batch number has been requested.

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.

Pt got vaccine at pharmacy off site clinic - this is notes from clinic staff "summary - pt was unable to speak and became somewhat unresponsive 15 minutes after 2nd Pfizer covid dose. family informed clinic staff after he had returned to the car. history of hypertension/diabetes/kidney transplant. Insulin was administered this morning. 911 was immediately called, taken to er. current condition unknown. blood glucose was 500+ when paramedics checked"

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

after receiving my second pfizer vaccine, i blacked out, broke my nose, and had a concussion. I had maxillofacial surgery the next day. 5 weeks later, i developed DVT, and now have pulmonary embolisms.

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

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

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.

chest pain, intermittent for 2-3 weeks, did not call covid clinic until day after 2nd dose with chest pain complaints, chest pain was a new onset, evaluated for cardiac workup in EC and discharged home

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

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.

Left arm tingling and numbness from hand to shoulder. Aching. No injection site redness or swelling. No palsy or other symptoms. Symptoms began on Day 10 post injection and continue. Had brief, faint chest pains last night, 4/12, while walking to car after restaurant prepared sea bass meal. This morning my arm is tingling and aches like it has been slept on or is not receiving proper blood flow. Right arm is fine. BP normal. Breathing normal. No other issues.

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.

Blood clot in left leg; first noticed on March 17; swelling and pain bad by March 19, called advice nurse who told me it sounded like a blood clot and told me to go to emergency room.

After my 2nd dose, I could not sleep that night and since I have been experiencing high blood pressure of 165/95 (my normal is 140/80) and I am experiencing mild angina that rarely resolves (I have exercise induced angina that generally quickly resolves). I believe this is a reaction to the vaccine.

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.

Face and arms visibly flushed. HX hypertension. No difficulty breathing or tightness in throat. Vital Signs: BP 150/80 HR 72 O2Sat 97% Skin Signs: Warm and dry, Other - Very red and flushed warm to touch Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally No increased res. effort Initial treatment: Continue observation. Patient observed to be flushed prior to vaccination. HX of rosacea. Patient states HX of sun exposure prior to clinic. 11:13 AM Vital Signs: BP 138/74 HR 76 Resp. 16-18 O2Sat 95% Possible irregular HR noted while getting BP Skin Signs: Other - Flushed A/Ox4 Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally Follow up Treatment: Observation. No increased res. effort. Neg S/S anaphylaxis. 11:19 AM Vital Signs: BP 122/80 HR 78 Resp 14-16 O2Sat: 95% Skin Signs: Warm and dry, Other - Flushed A/Ox4 Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally Notes: Vitals at 11:32 AM BP 130/72 HR 81 O2Sat 94% Lung sounds clear bilaterally Resp 16 Patient states no dyspnea upon sitting. Cap refill <1sec No nausea Patient instructed to update son. Released home by self.

Several minutes after injection patient began feeling hot and fainted - Patient never lost consciousness, breathing remained regular, but complained of neck pain

Patient experienced strong heart palpitations, heart rate 156 and arrhythmias for 20 minutes, patient took a nitroglycerin sublingual tablet and reported to the local fire department.

Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough. Admitted to ICU with acute hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis. Reportedly received 2nd dose of COVID-19 vaccine 2 days prior. Shortly after admit, pt developed worsening respiratory status requiring intubation @1045. Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15. Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation. Repeat arrest with PEA@1135 with return of spontaneous circulation. Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.

Patient c/o feeling dizzy and lilting to the left. Unsteady on his feet. B/P 162/87, HR 92 SPO2 100%, starting feeling nasal passages becoming stuffy, used EpiPen at 1310 and repeated at 1315 when he c/o heaviness in chest. HR increased to 105, TEAM alert CALLED and patient taken to the emergency room.

Temporary: aches, chills, fatigue Ongoing: chest pain/discomfort with activity, short breath, headaches, fatigue

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

2 weeks after 1st dose of covid vaccine, some fatigue and sob. The next morning, sudden onset of sob, chest pain. To Emergency department, cath lab, stent. Home within 36 hrs.

blood clot on the left side of neck; This is a spontaneous report from a contactable HCP (patient). The patient was a Respiratory Therapist. A 60-year-old male patient received his secondo dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration on 03Apr2021 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number EN6199) on an unspecified date for COVID-19 immunisation. Medical history included high cholesterol and hypertension from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for hypertension, start and stop date were not reported; rosuvastatin taken for blood cholesterol increased, start and stop date were not reported. The patient experienced blood clot on the left side of on an unspecified date in Apr2021. The event was treated with blood thinner. Patient thought it was called Xarelto because they called him on 07Apr2021. He was not sure how to spell that. Treatment was started on 07Apr2021. Consumer stated he first started having symptoms on the night of the injection. On an unspecified date in Apr2021 the patient did the ultrasound and that's when they found blood clot and he just got the results back. Recently, may be 2 weeks before reporting, patient had routine blood work and It was normal. It was nothing abnormal. The outcome of event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Clot blood cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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

10:05: PT reported chest tightness, denies SOB. 96% o2sats. EMS called to evaluate 10:30: Pt stated he was feeling better and refused any further medical care 10:37 : pt walked to car with wife and drove off

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

DVT; This is a spontaneous report from a contactable physician (patient). This 60-year-old male patient received 2nd dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek4176) at single dose via an unknown route in left arm on 18Jan2021 for Covid-19 immunization. Medical history included factor 5 leiden and prior DVT. Patient did not have Covid prior vaccination. Patient had no known allergies. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) on 26Dec2020 for Covid-19 immunisation. On 08Mar2021, patient experienced DVT which resulted in doctor or other healthcare professional office/clinic visit. Treatment included blood thinner. Outcome of the event was unknown. Patient did not have Covid tested post vaccination.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely associated with the patient's underlying medical condition and was unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

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.

Immune Thrombocytopenia Purpura; blood blisters in mouth; petechia; platelets were zero; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 60 years old) for covid-19 immunisation. Medical history included Multiple myeloma status post (s/p) CAR T therapy (Apr2020), on Pomalyst starting from Apr2020 to an unknown date. Concomitant medications included pomalidomide (POMALYST) taken for an unspecified indication from Jan2021 to an unspecified stop date; acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported. On 20Mar2021, the patient experienced immune thrombocytopenia purpura, blood blisters in mouth, petechia. In Mar2021, the patient experienced platelets were zero. Clinical course was as follows Immune Thrombocytopenia Purpura- About 24 hours after receiving the 2nd dose of the vaccine, started noticing blood blisters in mouth and petechia in 20Mar2021. Patient went to doctor on 22Mar2021 after 19Mar2021 vaccine and platelets were zero in Mar2021 and prednisone was started. Platelets were still 0 on 24Mar2021, and then was admitted to the hospital and was given steroids, IVIG, and Nplate. Now improvement. Of note, platelets were checked on 18Mar2021 and were 26, and then received 1 bag of platelets and they were not rechecked after. The patient underwent lab tests and procedures which included platelet: zero in Mar2021, platelet: 26 on 18Mar2021, platelet: were still 0 on 24Mar2021, Covid test: negative on unknown. Therapeutic measures were taken as a result of immune thrombocytopenia purpura, blood blisters in mouth, petechia, platelets were zero. Outcome of the events was recovered. Information about Batch/Lot number has been requested.

Stroke from blood clot. .Surgical thrombectomy . After initial full paralysis on left side, not adverse effects.

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

Patient presented to the ED with severe dizziness on 3/14/21 and was hospitalized for 43 hours. It was also noted he had NSTEMI. This visit is within 6 weeks of receiving COVID vaccination.

Pt light headed & fainting while getting vaccination. Moved to w/c then to cot in observation area. BP136/74 BP 137/87 after sitting for 20 minutes. Husband came to take her home.

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.

Vaccine 4/21. Date of symptoms 4/26. Initially went to an urgent care where they suspected PE and pt was started on anticoagulation without imaging being performed. Pts symptoms worsened and pt later had CTA which showed Saddle Embolus with Right Heart Strain. Transferred to hospital for possible tPa-catheter-directed therapy. ECHO showed Significant RV dilation and moderate RV dysfunction. b/l l/e venous doppler showed LLE acute DVT and RLE chronic-appearing DVT.

chest pressure; shingles/rash; itch and rash and tenderness on his rib cage; itch and rash and tenderness on his rib cage; chest pain; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 10Apr2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing Cholesterol. Concomitant medication included ongoing atorvastatin taken for blood cholesterol. Patient investigation assessment was No. The patient developed a rash from 16Apr2021. They figured out in the hospital that it was probably shingles. It had developed even more. They want to give him Valacyclovir. He came down with an itch and rash and tenderness on his rib cage from 16Apr2021. He slept on his chest and had pressure on his chest from 18Apr2021 to 19Apr2021. He went to the hospital to rule out a heart attack. The patients father passed away a long time ago of the heart attack and thought it was that as well. He went to the emergency room and was brought in the hospital under observation status. He was diagnosed with shingles at the hospital from 19Apr2021. They were on the right side. The itching, tenderness and pain got worse on Sunday with chest pain from Apr2021. Patient has not received Valacyclovir yet. The hospital was waiting to give it until after caller speaks with Pfizer. The patient was currently waiting to get the antiviral medication for shingles. The outcome of the event chest pressure was recovered on 19Apr2021, of shingles/rash was not recovered, of other event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Fever; felt like trash and didn't feel good at all; both of his pinkies down to his wrist were numb; Got really winded; didn't have any oxygen; Got really winded; didn't have any oxygen; Uncontrolled Chills; he was shaking like crazy and he couldn't get warm enough; Sore Right Arm after Second Dose; he was shaking like crazy and he couldn't get warm enough; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (BNT162B2), dose 2, administered in arm right on 14Apr2021 09:50 (Batch/Lot Number: EW0158) as single dose at the age of 60-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. The patient received bnt162b2 (BNT162B2), dose 1, administered on 18Mar2021 09:50 (Batch/Lot Number: EN6208) as single dose at the age of 60-year-old for COVID-19 immunisation and experienced on 18Mar2021 17:10 left arm hurt and on 19Mar2021 felt really fatigued, recovered on 25Mar2021 and 20Mar2021 respectively. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 22:00 the patient experienced got really winded; did not have any oxygen, uncontrolled chills, sore right arm after second dose, he was shaking like crazy and he could not get warm enough, he was shaking like crazy and he could not get warm enough. On 15Apr2021 the patient experienced 102 degree fever fever, felt like trash and did not feel good at all, both of his pinkies down to his wrist were numb. The course of events was as follows: On 14Apr2021 after his second shot that evening around 10:00 P.M., he had uncontrollable chills. He could not hold a cup of water without spilling it. He fought that off and it calmed down and he fell asleep. The next morning on 15Apr2021 he felt like trash and did not feel good at all and he had a 102 degree fever. He took Advil as treatment and one hour later he sweated that out and his fever went away then. Both of his pinkies down to his wrist were numb for the rest of the day and the next morning, his left hand was already feeling back to normal, and his right hand took the rest of the day and it got back to normal. No event required a visit to Emergency Room or physician office, but he almost went to the ER with the second dose because he was shaking like crazy and he couldn't get warm enough, but finally it wore off. It got to a point where he did not have any oxygen, he was shaking that bad. When he went up the stairs, he got really winded and sat and down. It lasted at least an hour, during that time he was awake he was trembling bad and couldn't get warm. When he quit shaking, he fell asleep. Patient stated his wife mentioned something about they gave him some tests, like COVID Experimental Drugs, when he was in hospital for 12 days. He could not even tell the names of them. That was 15-27Oct2020. He did not know if that has anything to do with his reaction. The outcome of got really winded; did not have any oxygen, he was shaking like crazy and he could not get warm enough was recovered on 14Apr2021, of uncontrolled chills, fever, was recovered on 15Apr2021, of sore right arm after second dose, both of his pinkies down to his wrist were numb, felt like trash and did not feel good at all was recovered on 16Apr2021.

Fever, chills, sweats, rigors, cough, shortness of breath, right sided chest pain, pneumonia- confirmed on cxr and Ct chest, small pleural effusion, hypoxia, decreased BP.

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

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.

had a stroke that left him paralyzed; had a stroke that left him paralyzed; 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 on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel. No follow-up attempts are needed. No further information is expected.

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.

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

Saddle pulmonary embolus diagnosed 5/12/21 with unilateral leg swelling starting over one month prior.

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

Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8737, on 02Apr2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included myocardial infarction, hyperthyroidism, allergy to Contrast agent. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), clopidogrel bisulfate (PLAVIX), atorvastatin, pantoprazole sodium sesquihydrate (CONORAN), sertraline. The patient experienced Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000 on 13Apr2021. The outcome of the events was unknown.

On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bear weight on right leg. Reduced to crawling around house on hands and knees. Went to former Primary Care Physician on 4//14/21, where I was treated for Sciatic Nerve flare up. Returned to Dr on 4/19/21 in severe severe pain. Dr referred me to hospital where I was again treated for Sciatic related symptoms. Symptoms worsened daily. On April 28, 2021, I crawled into Hospital, was admitted. Received injection in spine. Symptoms worsened. Changed Primary Care Physicians to Dr on 4/11/21.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was orthostatic hypotension

Patient felt fine after shot, then started feeling weak, hot, lightheaded, then lost consciousness. Tapped patient, yelled his name, called 911, monitored breathing and blood pressure, provided him water, banana, oragne juice when he woke and waited for Ems. He left with ems but was feeling much better.

Pt was admitted on 5/10/21 c/o of rigor. Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F. EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded. Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath. He does use inhalers and nebulizers and also continues to smoke. He also has a history of melanoma who follows with provider. In the ER he was found to have hypotension and was given 2 L of IV fluids. He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed. Because of the hypotension and drop in hemoglobin he was admitted to the ICU. He was started on Protonix IV. Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process. He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out. He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued. Patient's troponin was elevated with an elevated delta. He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued. he did require albumin but not pressor support. As he was more stable he was transferred out of the ICU to the medical floor. He was started on midodrine. His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics. At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found

Outcome : patient died Cause : cardio respiratory arrest Had previously tested for any heart problem but his heart was in excellent conditions

On 5/18/21 AM, woke to pain in my right side under my shoulder blade. Went to ER. They performed many blood test, chest Xray, Chest CTA. Determined Pulmonary embolism and infarction. I was admitted, more blood tests, Echocardiogram, Venous Doppler study( No evidence of DVT). Released 5/20/21. Prescribed Eliquis to thin blood for easier natural clot dissolve. No Known cause of PE, yet. Follow up scheduled with my PCP.

He was administered Vaccination at 2:47pm. He stood up at about 3pm and collapsed to the floor and started to get unresponsive. I administered 1 dose of epipen 0.3mg and he started to get better. 911 arrived and patient was feeling better so he refused to go to hospital. He is in good spirits and said he was OK that day. He said he will follow up with his doctor . Tried to follow up but have not been able to reach patient but have left a couple of voice messages.

After about 4 days with a temperature of 37.7 centigrade: high blood pressure -- > systolic 190 diastolic 115 (despite Ramipril 5mg morning and evening) Vertigo Acufene General discomfort duration of symptoms: 5 days

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.

Pt developed fever, cough and production of yellow phlegm for 4-5 days prior to clinic visit. When Pt was examined and labs draw he was found to have blood and protein in his urine. labs from 5/21 BUN 16 Cr 1.77, 5/25 BUN 17 Cr 2.01. Labs prior to vaccine from 02/2020 wer BUN 15, Cr 1.07

had a respiratory or breathing episode; did go into cardiac arrest; complaining of pain; breathing issues; This is a spontaneous report from a contactable consumer (patient's caregiver). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1st dose, single (patient was 60 years old at the time of vaccination) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, Friday or Saturday, the patent was complaining about breathing issues all of a sudden, he had respiratory or breathing episodes. The reported stated that that they called 911 right away, and they came and picked the patient up. The patient had trouble breathing and was complaining of pain, and he did go into cardiac arrest, but they checked, and it was not a stroke or a heart attack, none of those things, they cannot figure it out. It was reported that nothing was wrong with the lungs, and the hospital was treating the patient by currently having him sedated and treating his pain. The outcome of the events was unknown.

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

Confirmed pulmonary embolism in 3 locations. Prescribed Xaralto. Symptoms include Chest pain, rapid heart rate, increased blood pressure, dizzy, light headed feeling

PT REPORTED OF MUSCLE PAIN THAT RADIATED FROM LEFT ARM (WHERE HE WAS GIVEN THE SHOT), TRAVELLING TO LEFT SHOULDER, THEN TO LEFT CHEST MUSCLE. INJECTION OCCURED AT AROUND 1140AM, PT REPORTED PAIN TO PHARMACIST AT 1151AM. WHEN I EXAMINED THE INJECTION SITE, THE AREA DIDN'T LOOK RED OR SWOLLEN. I CHECKED BP AT 1153AM AND IT WAS 152/81. I CHECKED BP AGAIN AT 12:10PM AND IT WAS 155/85. AT 12:10PM, PT WAS STILL REPORTING CHEST MUSCLE PAIN ON THE LEFT SIDE OF HIS TORSO. PT WAS ALERT AND WAS ABLE TO TALK TO ME.AND TELL ME HIS SYMPTOMS. EMT WAS CALLED AT 1214PM. 911 OPERATOR INSTRUCTED ME TO GIVE HIM 4 TABS OF 81MG CHEWABLE ASPIRIN (NDC 00904-4040-73) AT 1231PM. EMT ARRIVED SOON AFTER. PT WAS TAKEN TO HOSPITAL AT AROUND 1245PM.

Rapid heart rate; This is a spontaneous report from a contactable consumer, the patient. A 60 Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (Lot number: Er 2613) via an unspecified route of administration in left arm on 17Mar2021at 1600, as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patients past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE (Lot number: EN6198) via unspecified route of administration in left arm on 24Mar2021 at 1645, as a single dose for COVID 19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination had not been tested for COVID-19. On 17Mar2021at 1730, the patient experienced rapid heart rate with 100 bpm. The patient did not receive any treatment for the event. Clinical outcome of rapid heart rate was recovering at the time of reporting. No further information is expected.

TIA; Swollen lymph nodes in chest and abdomen; enlarged spleen; fever; night sweats; exhaustion; This is a spontaneous report from contactable consumer. This 60-years-old male consumer(patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: unknown) at single dose for COVID-19 immunization on 03Apr2021. Relevant history and concomitant drugs were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced TIA (Transient ischaemic attack), Swollen lymph nodes in chest and abdomen, enlarged spleen, fever, night sweats, and exhaustion. Emergency room/department or urgent care was need, the patient was hospitalized due to the events. Outcome of events was not resolved. The patient was very sick in the hospital per patient's wife. The patient had SARS-CoV-2 test (Nasal Swab) in Apr2021 (After post vaccination) with negative result. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

Developed shortness of breath and high blood pressure within 48 hours. Chest pain and back pain. Shortness of breath when working out slightly.

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

Sharp chest pain, neck pain, difficult/painful breathing, emergency room trip, diagnosis of Pericarditis

Burning sensation started on back of neck - intense sunburn feeling. Later on arms, hands, feet and back. Also pins and needle feeling. Started taking Advil and Benadryl. Helped a little. Moved to Advil and Zyrtec during the day. The intensity varies during the week. To a little sunburn feeling to more intense on other days. Been doing on for two months now.

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

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.

Started to have chest pains a few days after vaccine. I passed out and was unresponsive with no pulse and breathing. Received cpr from my partner who found me on the floor at approximately 2:00am on 5/16/21. I was taken to the emergency room of the hospital and underwent extensive tests of the brain: CT scan, MRI, Angiogram, and Spinal Puncture. All tests negative. I cannot walk without a walker and have other cognitive neurological symptoms. I was discharged from hospital on 6/2/21 to sub-acute rehabilitation facility. I was discharged from rehab on 6/12/21. Neurological and neuromuscular symptoms are still present.

Blood clot formed in leg then went to lungs. Bilateral PE is diagnosis. Almost died from the event. In hospital for 5 days, went into a fib and now has heart issues.

Pericardial effusion, requiring pericardial window 4/16/2021. Recurrent effusion with Constrictive/restrictive pericarditis, requiring pericardiectomy 6/22/21.

Severe chest pain on left side, relieved when leaning forward, diagnosed with pericarditis, unspecified chronicity, unspecified type. Relieved with Toradol and Colchicine. Currently on 90 day treatment of Colchicine, 1 tablet per day.

Shortness of breath, pain in chest, heart rate elevated for 2-3 weeks. 60-65 normal up to 92 after 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.

Patient had a Non-STEMI MI on 6/24/21 with new onset A-Fib also. Pt arrived to ER from clinic with c/o chest and Left shoulder pain for 2weeks. Arrived to ER with HR in 150s that converted with IV Diltiazem. Pt showed s/s of MI with elevated Troponin. IV Heparin drip and IV Heparin bolus was given. Pt was transported by helicopter to hospital for further treatment and studies.

Blood pressure dipped to 85/56; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6206) via an unspecified route of administration in left arm on 17Mar2021 at 13:15 (at the age of 60-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 19:30 (approximately 6 hours later), the patient blood pressure dipped to 85/5. No therapeutic measures were taken as a result of the event. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of event hypotension was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.

Experienced tightness in chest while running, passed out, taken to hospital, had stent installed in heart after a number of tests were performed.

Patient presented to ED with small blood blisters to tongue, arms, and face; severe thrombocytopenia.

Shortness of breath; Chest pain; rapid respiration; weakness; increased heart rate; 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 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:00 (at age of 60 years old) as single dose for COVID-19 immunization. Medical history included Kidney stone. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient had Chest pain, shortness of breath, rapid respiration, weakness, increased heart rate on 12Mar2021 12:00PM. The adverse event result in: Emergency room/department or urgent care. No treatment received. The outcome of the events was unknown. This case Serious reported as No.

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.

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.

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

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient briefly lost consciousness and came too once we were able to lie him down and elevate his feet. Ambulance was called and they took him for further evaluation. per patient the next morning they observed for and hour and a half and he was released. was fine the next day

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

Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.

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

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

Pain started at the left shoulder and kept like traveling through the elbow to the side left to little finger and pounding of heart

A few days after my second Covid vaccination I started experiencing fatigue, dizziness and shortness of breath. I also noticed the calf muscle in my lower right leg began to swell. The swelling continued to get worse and about a week later I noticed a significant amount of petechial hemorrhaging in my lower right leg. I started using an ice-pack in an attempt to reduce the swelling. I also sat/lay with my leg up (horizontal) as much as possible. On 6/28 I visited with my primary care doctor to seek help in addressing the swelling. My doctor sent me for an ultrasound which discovered a deep-vein thrombosis (DVT) and a CT scan which highlighted pulmonary embolisms in my lungs. I was admitted to hospital where I was treated with blood thinners; Note: I had my first shot on 4/13/21 and also experienced fatigue, dizziness and shortness of breath, but did not experience any swelling. As a result of feeling unwell I delayed getting my second shot.

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.

tingling from fingers thru body to toes, cold sweats, flushing, elevated BP/Pulse (170/110,130) Date of Onset: about 40 min after receiving vaccine. Patient went to ED and received Medrol, benadryl, and famotidine,

The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20. He had known cardiac disease.

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.

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

Pulmonary embolus developed 8 days after second injection. No previous history of vascular events. No known risk factors.

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

pulmonary embolism that presented with chest pain and inability to take a deep breath, admitted and started on Heparin drip. Patient transitioned to Apixiban.

Angina Narrative: Pt presented to the ED with persistent chest pain and shortness of breath for 6 days after receiving 2nd dose of covid vaccine. Symptoms began morning after receiving vaccine. Negative work up, however pt is high risk of cardiac events. Given ASA and nitro for ongoing chest pain that is possibly cardiac in nature. Pt admitted.

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.

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

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

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

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

On January 24, 2021, Sunday, I received my first Covid-19 Vaccine. I had a shoulder/arm for the afternoon. Next day, all fine. I do not have a heart condition. However on Monday, February 1st I had odd heart palpitation. It felt like my heart skipped a beat. This occurred off and on, not lasting no more than 2-5 seconds. I thought nothing of it since I experienced something like this when I was a grad student when I was under a lot of stress. So I called my insurance nurse line and explained my symptoms. Nurse recommended I stop drinking coffee and stop taking vitamin supplements. Nurse advised to reach out to my doctor. I tried to make an appointment none was available within a month. I showed up on at the doctor's on Monday, February 8th. They gave me an EKG, it seemed normal. But I have a several tests scheduled for Monday, February 22, 2021. It just seemed odd that I have this palpitation off and on for a few seconds anywhere from 5-10 times in 24 hours. I have not had this sensation since grad school back in 1984.

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

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

Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue, ems arrived and found him to be 50% on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-year-old male presents with EMS for evaluation of shortness of breath hypoxia. History is limited due to the patient's current clinical condition and so is primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5 days ago. He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath. On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department. Patient does admit to shortness of breath. He denies any chest pain. He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery. He denies any new pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia. At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate. Oxygenation improved following intubation, with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able. ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable. Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal. Inhaled epoprostenol started Considered for ECMO but not initiated due to not a candidate Vasopressors required at times Antihypertensive infusion required at times severe hypoxia with position changes switched from heparin drip to enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and had worsening respiratory status. He was intubated after arrival, and was on ventilator for the entire intervening time, until he was extubated on 2/20 at the time of transition to Comfort measures only. Prior to developing COVID 19, he had received his first dose of the Pfizer vaccine, as a member of the school system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in place at the time of admission. He received Tocilizumab on 1/31, and underwent several cycles of prone positioning, beginning on 2/2. He completed a course of Decadron, he received Ceftriaxone and azithromycin beginning on admission, and completed a course of these. Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19. Vasopressor support was required at times, as well as diuresis for fluid management. He required high levels of sedation to maintain ventilator synchrony, and high levels of ventilator support with high oxygen levels throughout his stay. Tracheostomy was being considered, but family decided that since he was not going to have good recovery, withdrawal of support, and allowing death was the appropriate choice for the patient and for them. He was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021. Children were at bedside.

At 8:30pm last night, 3/3/21, I developed dizziness and problems with my equilibrium. I went to bed around 11:30pm still experience the issue. This morning I seem fine, but it was not a good feeling. I also experienced an abnormal spike in my blood sugar levels yesterday morning. My sugar level was 65 points higher than normal.

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

While in the observation area for his 15 minute post-vaccine observation period, participant developed left sided chest pain. He has a history of myocardial infarction, diabetes, and pacemaker. A 12 lead EKG demonstrated ST elevation. He was hemodynamically stable. He was transported to local hospital for definitive care. Please note, the age and birthday reported in previous screen were approximate.

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

Patient reported dizziness, headache, racing heart and mild chest tightness. Was evaluated by NP. HR in 80's. Lung sounds clear. Moved to private area for rest, water, snack. Encouraged to use his personal albuterol inhaler for his asthma. Repeat HR at his baseline 52bpm. Lungs sounds remained stable. Final pulse ox 99%. Observed for another 30 minutes. All symptoms resolved.

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

Patient was driving into holding/observation post vaccination and complained of dizziness and then had a brief syncopal episode losing consciousness for a few seconds as reported by his wife.

Frequent nose bleeding (even after blowing nose, sneezing, bowl movement, significantly more frequent than before the vaccine), even after treatment by the ENT doctor.

Syncopal episode post vaccine (approximately 30 minutes post vaccine) patient had no recall of episode Vital signs and & B/P WNL Cardiac strip - Inverted T-waves(by paramedics) local Squad notified - client transported to hospital

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.

Patient in observation reports feeling as if his heart was "fluttering" and his pulse "is too high." Patient denied chest pain and pressure. EMS attended to patient. BP=148/68 and 132/80, HR=65, O2 sat=98% on RA. Patient refused further assessment and transportation with EMS. Refusal form signed with EMS. Patient to be driven home by family member.

cardiac arrhythmia tachycardia 220 BPM, an operation to install An implantable cardioverter-defibrillator (ICD)

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.

Low fever 0.5 F above the normal, heart rate increased from 75/min to 110/min. Blood pressure 15 above the normal daily reading. coughs 3 to 4 times. Then, after 30 hours of the shot of vaccine, felt headaches. At that time, heart rate was closed to the normal. But had a couple of coughs. Just felt having a light flu at the beginning and tired. Pain on the shot area in the arm was not a concern. After 60 hours of the shot, feel good. Just report what I had.

I discovered bleeding like bruise; I discovered bleeding like bruise; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient reported "I discovered bleeding like bruise in about 1 X 1 inches on my right fore arm" on 04Mar2021 at 14:30. Outcome of the events was unknown. Information about lot/batch number has been requested.

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

Massive heart attack, yelled for help to wife, 10 seconds later no pulse, called EMT, could not revive, DOA at hospital

Pfizer COVID-19 Vaccine EUA Pt received Dose 1 of Pfizer vaccine series 3/10/21. 3/21/21: A 61-year-old gentleman presented to the emergency room with increasing shortness of breath for 2 days. Patient reports mild nonproductive cough. Reports shortness of breath, worse with activities. He had his first dose of Pfizer COVID-19 vaccine 10 days ago. In the emergency room is noted to be hypoxic at 87% on room air, and now he is comfortable on 2 L of oxygen via nasal cannula, at about 94%. Chest x-ray suggestive of bilateral pneumonia. He is now testing positive for COVID-19. 3/26: The patient was diagnosed with moderate severity COVID-19 pneumonia and received Convalescent plasma and Remdesivir on March 21st and completed 3/25. He was on dexamethasone, doxycycline and pantoprazole. Initially D-dimer significantly elevated then trended down and the inflammatory markers trended down. The patient initially required 2-4 L of oxygen then improved and till he did not require any oxygenation today. His liver enzyme mildly elevated without disturbance in the liver function or kidney function. The patient will be discharged home on taper dexamethasone PO with pantoprazole for GI prophylaxis and follow-up with his PCP.

Deep Vein Thrombosis/he have numbness , tingling on his left foot. It was also swollen; CT scan shows he have PE; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Feb2021 10:15 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included back pains, acid reflux and chest pain; all from an unknown date. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported. The patient reported that after several days of getting his first shot, he have numbness , tingling on his left foot. It was also swollen, he went to the Emergency and they found out he have deep vein thrombosis and CT scan shows he have PE on 27Feb2021. The reported events resulted in emergency room/department or urgent care. The patient received treatment for the events which was a blood thinner, Eliquis. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Due to hx of allergy pt request to stay 30minutes post vaccination. During that time he c/o persistent chest tightness. Denies SOB. Vitals obtained @ 1104 BP 185/106 HR 72 SpO2 98%, @ 11:11 BP 181/108 HR 69 SpO2 99% , @ 1118 175/117 HR 72 SpO2 96%, and @ 1122 BP 183/112 HR 70 SpO2 98%. HOB elevated . BP remains elevated RRT called at 1120 they arrived 1125. Patient relaeased to RRT at 1125 to ER. Last BP 180/ 113 HR 76 SpO2 100%.

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.

Patient suffered acute STEMI . Was being escorted to medical when he became unresponsive , CPR was initiated immediately; AED was placed and "shocke advised". Patient recieved shock and became alert within 15 seconds. ASA Nitro and NS given. EKG showed 5 elevation infanct. Patient transported to hospital. STENT placed.

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

Pt presented to the ER on 3/26/2021 with c/o 3 days of chest pain 10/10. diagnosed with bilateral descending pulmonary artery pulmonary emboli on CT scan and admitted for further work up and treatment from 3/26-3/28/2021 for b/l PE and hypoxia. Discharged on eliquis with hypoxia resolved.

1307- I heard a car horn, located the patient in the driver's seat, put the car in park. Pt was completely passed out. He regained conciousness after approximately one minute after contact. Pulse weak at 68, I laid the seat back. Paramedics took over care. Unknown disposition by nurse, to her knowledge ambulance was not called. - RN

While sleeping had heart attack, seizure, went into cardiac arrest. No warning signs and did not have a previous heart condition. CPR was performed, shocked four times at home once in ER and placed on a ventilator. Catheterization procedure performed, full blockage of the right coronary artery received two stents. After surgery was in ICU on a ventilator for three days then went to step down unit for two days. Now being treated by cardiologist, pulmonologist, neurologist and primary care physcian.

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.

Patient fell while on the job on Friday March 26th, slurred talking. Later slumped over in the car while driving and had to be taken to the Emergency room where he later passed away. Cause of death on the death certificate per the coroner is Pulmonary Embolus. Patient was just seen my his family physician in January and was in good health no medications taken other than eye drops.

1505: RN x 2 responded to vehicle 2 to pt c/o increase in HR pulse checked and is 82, Denies SOB or any other sx. Monitored in lot X 15 minutes. at above average HR. Feeling better left at lot @ 1520 in no acute distress. Spoke to pt by phone @ 1626. Is home and doing well. No further complaints

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

The patient reported that he had a witnessed syncopal event - he was leaning against a wall and slid down the wall without head or other trauma. He recovered consciousness immediately thereafter. He did no check any vitals or blood sugar afterwards, and did not report the event until two days later, therefore no testing was done at the time of the event. There are no known sequelae.

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.

Afib symptoms; short breath just walking doing simplest little things; Rapid heartbeat again; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:30 (Batch/Lot Number: EN6208), at the age of 61-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included Ankylosing spondylitis/psoriasis, cardiac ablation from Jan2017. The patient received dose 1 of vaccination on 28-FEB-2021 12:30 PM and was feeling small symptoms sometimes. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient started feeling small symptoms after the second dose, the next day, 22-MAR-2021 15:00, the patient definitely was having the Afib symptoms again, short breath just walking doing simplest little things and having rapid heartbeat again. The patient stated he had no problems before Pfizer vaccination. The outcome of the events was unknown. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19.

61 yo male w/ history of DM, HTN, CKD IV and sleep apnea presents on 4/9/2021 with dsypnea that started while sleeping last night around 10PM. Also c/o cough , fatigue, diffuse wheezing. Had temp 99.9, chills. Does not use home oxygen and never smoked. Does not use a CPAP machine for his sleep apnea. He denies any recent ill contacts or new illness. diagnosed with sepsis and severe b/l pneumonia and significant hypoxia and admitted to the hospital on ivf, abx, oxygen. Currently follows with wound care for a right foot ulcer and is taking ciprofloxacin. For his diabetes he requires U-500 insulin. Today in ED he is on 5L oxy mask due to hypoxia. Noted to have leukocytosis. Normal lactate. CXR suggestive of pneumonia with bilateral diffuse consolidations.

About 30 minutes after getting the vaccine his developed a headache. Shortly after that he developed left leg weakness and inability to use left leg. The next morning his symptoms somewhat improved. Friday morning, 2 days later, his left leg weakness returned. He was directed to the ER where stroke was confirmed.

Bilateral arm and hand pain, numbness in fingers. Arms go completely numb when driving or holding grandson. Only time they are not numb is when he is standing up. It started the same time he got his COVID vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic three days after vaccination reporting pain and swelling in left lower leg starting shortly after receiving vaccine. Vital signs all within normal ranges. Physical exam shows asymetrical left lower leg edema with pitting edema 2+ to the level of knee. Both knees have decreased range of motion and effusion (during visit underwent bilateral knee arthrocentesis). Normal pulmonary effort and no respiratory distress. Patient diagnosed with deep vein thrombosis (DVT) and started on anticoagulation.

Stroke twice Acute idiopathic spontaneous intraparenchymal intracerebral hemorrhage (CMS-HCC) Loss of vision in lower left quadrant

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.

Morning of 4/8 at 0615, patient was in shower, started feeling pressure on top of head, was struggling to use arms, trouble using legs, unable to stand well. Wife noticed slurred speech, drooping left side of face. Called 911. Was taken ED and transferred to another Hospital. Was found to be having ischemic Stroke.

pt woke up with an ischemic CVA due to occlusion of the proximal posterior M2 branch of the R MCA the day following the vaccine

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.

Patient told the vaccinating pharmacist he had a history of fainting after receiving vaccinations. Patient was feeling okay after vaccination and went into waiting area. Pharmacist was called over because patient fainted. By the time we got to the patient he was awake, alert and sitting upright. He knew who he was, where he was, and that he just received a covid vaccine. The patient said he felt light headed. We offered water and an ice pack as the patient was sweating but he did not say he was hot. The patient was able to get up after a few minutes of sitting and sat in a chair. After another few minutes, the patients head went backwards and he was making a snoring sound. I tried to talk to the patient but he didn't respond. We called 911. We placed the patient on the floor and turned him on his side. After about 1 minute he was with it again. He knew where he was and thought he fainted again. Upon speaking with the patient we received details about his history of seizures due to alcohol withdrawal. He also confirmed the last time he drank was that morning and he had "a few shots and was cutting back." Patient told us he was not on any medications but did take 50 mg of benadryl around 12:00pm that day. The paramedics arrived and took him to the hospital.

4/3 to 4/5: Fever over 101. General malaise. Extreme chest congestion and productive cough. 4/5 to 4/9: Difficulty breathing, congestion and sever productive cough continued. Chocking on chest mucus. O2 levels 89-91. 4/7: visited urgent care. EKG was irregular. Chest x-ray indicated needed further CT scan. Rapid Covid-19 test was negative. 4/8: Outpatient CT Scan. Indicated Interstitial Lung Disease. 4/10 to 4/12: Coughing and congestion started to clear. Extreme fatigue with any activity. O2 level starting to rise: 91-93. 4/13 to 4/15: Cough and congestion much better. Still some production. O2 level at 93 to 94 (95 - 96 with breathing exercises)

Patient received vaccine was sitting for 15 minutes and got up in the middle of his 15 minutes to approach the pharmacist and the pharmacist sat him down again and he passed out onto the floor hitting his head with a cut on his eyebrow and nosebleed. Ems arrived and got patient back into chair and he again passed out and began seizing. He again regained consciousness and was taken away in a stretcher.

found a deep blood clot.; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 61-years of age), dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 12:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included blood clot after a back fusion about 16 years ago (2005), and had a knee replacement 3 months before the vaccine (Dec2020). The patient's concomitant medications were not reported. The patient previously took ANCEF [cefazolin sodium] and had allergies; and oxacillin which the patient had allergies and hepatitis. The patient was not diagnosed with Covid prior to vaccination nor was he tested for covid since vaccination. The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. It was reported that the day the patient received the first vaccine his calf, foot, and knee swelled up by evening. It stayed swollen for a week and he went to see his doctor. He did an ultrasound on his calf and found a deep blood clot. He was now on blood thinners. He mentioned that he had a knee replacement 3 months before the vaccine but it was progressing fine. Usually blood clots occur after surgery within a 2 week period. He had a blood clot after a back fusion about 16 years ago. He was reporting this because his doctor was not sure why he got the blood clot and it coincided with the vaccine. The patient underwent lab tests and procedures which included ultrasound scan: found a deep blood clot in Mar2021. The events started on 17Mar2021 18:30 with outcome of recovering. The events resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events with LOVANOX and PRADAXA. Follow-up attempts are completed. No further information is expected.

POST VACCINE PT BECAME DIZZY, DIAPHORETIC, HOT. TRANSFERRED TO OBS VIA W.C. PT REPORTS FEELING BETTER ONCE PLACED IN TRENDELENBERG ON STRETCHER. VS MONITORED THROUGHOUT OBSERVATION. HX OF HTN, TAKES BP MEDS QHS. ONCE SYMPTOMS RESOLVED, PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1200, INSTRUCTED TO MONITOR BP AND SEEK FURTHER EVAL/TREATMENT IF UNRESOLVED OR WORSENS. PER ON-SITE MD, PT EXPERIENCED CLASSIC NON SYNCOPAL VASOVAGAL REACTION-RESOLVED. 1120 INITIAL BP 193/100 HR 70 SATS 99% RA 1125 BP 185/94 HR 75 SATS 100% RA 1135 BP 186/105 HR 65 SATS 99% 1155 STANDING BP 175/98 HR 59 SATS 98%

PALPITATIONS, SWEATING AND MILD LIGHTHEADEDNESS POST VACCINE ADMIN REPORTED BY PATIENT, BROUGHT TO OBS VIA WC. PLACED IN TRENDELENBERG ON STRETCHER IN OBS, PATIENT STATES S/S RESOLVED SOON AFTER. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1415.1408 BP 128/80 HR 72 RR 16 SATS 96% RA.

Hematuria. Severely thickened urinary bladder with blood clots in organ and urine . Please note 1st Doze of Covid-19 vaccine was on 03/25/2021 and 2nd doze was on 04/15/2021.

Angina-like chest pain and frontal headaches off and on for three weeks from date of 1st injection. I believed it to be vaccine side effects and continued normal daily exercise routine, which is quite rigorous in some instances. Exercise seemed to alleviate problem temporarily. I never considered angina or heart issues as a problem since I've had great exam stats, including low cholesterol, low triglycerids, normal EKG, not overweight, never smoke, exercise regularly, maintain healthy diet. Day of second dose, chest pain and headaches increased significantly. EKG performed by PCP and Emergency Room confirmed abnormal. Diagnosed with acute myocardial infarction, emergency angiosplasty performed on right coronary artery. I felt this all to coincidental given timing and duration of side effect with 1st and 2nd shot. All EKGs in past, including one in August 2020, normal, and then abnormal six months later.

Pt presented for 2nd dose of Pfizer Covid vaccine on 4/5. for second Pfizer COVID vaccine, and reported to have Left facial droop, and slurred speech same night after first dose. He reports as soon as he made it home he "felt sleepy and went to bed, and woke up around 8:00 pm with my tongue swollen and Left facial droop, and unable to speak." States he did not follow up with PCP or ER.Uon assessment by LVN and MD facial droop swollen tongue still present 2nd COVID vaccine not give and instructed on EC visit. Pt diagnosed with CVA in EC. Pfizer noted as an allergy.

Client c/o chest pain since this morning, that is intermittent and started again while in observation. Fire Rescue onsite to evaluate client. Vitals are below, client stated he does not always take his blood pressure meds regularly. Fire Rescue called and client transported to ER for further evaluation.

Heart arrhythmia; shortness of breath; slight swelling of face and neck; slight swelling of face and neck; This is a 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: EP7534) via an unspecified route of administration into left arm on 21Mar2021 12:30 as single dose for COVID-19 immunisation. Medical history included heart disease, food and environmental allergies and diabetes. The patient's concomitant medications were not reported. On 23Mar2021 01:30, patient experienced heart arrhythmia, shortness of breath and slight swelling of face and neck. No treatment was given to the patient. Outcome of events recovered on an unspecified date.

Atrial flutter; Fatigue; Dizziness; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID-19 vaccine), dose 2 intramuscular, administered in Deltoid Right on 09Mar2021 (Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included Bladder issue, Elevated cholesterol, Elevated BP. Received BNT162B2 dose 1 on 16Feb2021 for COVID-19 immunization when he was 61 years old. Concomitant medications included rosuvastatin taken for Elevated cholesterol; losartan potassium taken for Elevated BP; oxybutynin taken for Bladder issue; tamsulosin taken for Bladder issue. The patient experienced fatigue on 12Mar2021, dizziness on 12Mar2021, shortness of breath on 12Mar2021, atrial flutter on an unspecified date. The patient underwent lab tests and procedures which included echocardiogram with atrial flutter on 05Apr2021, electrocardiogram with atrial flutter on 01Apr2021. After he saw the cardiologist, he was prescribed a betablocker and a blood thinner in the interim. He clarifies he was prescribed Metoprolol tartrate 25mg, twice a day. He was also prescribed Eliquis 5mg, twice a day. There were no additional vaccines administered on same date of the Pfizer. Events require a visit to physician office. prior vaccinations within 4 weeks was none. The outcome was unknown. No follow-up attempts are needed. No further information is expected.

he had a stroke; felt pressure on his head; He had slurred speech; he fell as well; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; At approximately 10:00 pm (patient) started having a fever and flu symptoms that lasted into the first day after taking the second covid shot; This is a spontaneous report from a contactable consumer (patient). This 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737) in left arm on 06Apr2021 10:30 am at single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy, chronic heart failure, pace maker/dif, diabetes, high blood pressure. Concomitant medications in two weeks included aspirin, carvedilol, valproate semisodium (DIVALPROEX), furosemide, and other medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) on 16Mar2021 10:30 AM at 61-year-old in left arm at single dose for COVID-19 immunisation, received levofloxacin (LOVENOX) and experienced allergies. No other vaccine in four weeks. At approximately 10:00 pm on 07Apr2021, patient started having a fever and flu symptoms that lasted into the first day after taking the second covid shot. By the second day, on 08Apr2021 at 6:15 am, patient took a shower felt pressure on his head and his arms would not work. He had slurred speech, and he fell as well, his lip was curled up on one side and patient sated he thought he was in trouble. He was transferred to ER, and they said he had a stroke. He then went to the Neurological ICU where he stayed until his discharge three days later. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalization for 3 days. Treatment received for all the events in patient hospitalization. No COVID prior vaccination, no COVID tested post vaccination. Outcome of the events was not recovered.

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

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.

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

I began having frequent tachycardia events two days after the first shot. They continued daily through the month and continued after the second shot.

Pain in my chest ,swollen throat, light headed, dizzy, shortness of breath. sick for a week steroids, fluids

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.

His platelets has falling and was hospitalized; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 16Mar2021 08:30 (Lot Number: En6199), at the age of 61-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included Cancer immune compromised. The patient did not have COVID-19 prior vaccination. Historical vaccine includes first dose of BNT162B2 on 23Feb2021. Concomitant medications included aspirin; ticagrelor (BRILINTA); amlodipine besilate, ramipril (COREYRA); cetirizine hydrochloride (ZYRTEC); sacubitril valsartan sodium hydrate (ENTRESTO), all were taken for unspecified indication, start and stop date were not reported. His platelet count on 05Feb2021 was 182. First shot on 23Feb2021. His platelet count on 05Mar2021 was 113. His 2nd shot was on 16Mar2021. His platelet count on 04Apr2021 was 47. His platelets was falling on 23Mar2021 (reported event onset) and was hospitalized for 8 days. Received platelets and waiting bone marrow biopsy results. Event required ER and physician office visit. The patient was tested for COVID post vaccination, with unknown results. The outcome of the event was unknown.

Arrhythmia lasting about 5 - 7 minutes. Unpleasant and got light-headed. Resolved itself instantaneously.

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

He is complaining of rhinorrhea, nasal congestion and a dry cough. He denies any fevers or chills. Patient said that he felt off yesterday. Since getting up today patient has felt more short of breath on exertion. He feels like he is breathing heavy. He is denying any chest pain or pressure. Patient did feel some pain behind his left knee over the last week, but has none at this time. He is also felt some mild right ankle discomfort, but that has resolved as well. He denies any recent COVID-19 exposures. Treated with heparin and catheter directed alteplase

Patient received first Pfizer COVID-19 vaccine. About 10 minutes after vaccine was given, patient passed out. He was diaphoretic and unconscious. At one point, he respiration rate stopped, patient had very diminished, weak carotid pulse. Epi was about to be given and patient started spontaneously breathing. Patient did not fall. Patient became conscious a few minutes later. He said he felt lightheaded and dizzy then he was out. Patient's wife said he has no allergies and not diabetic. He ate breakfast this morning. Medical response was called to bedside. Vitals were taken. Medical response transported patient to ER. As patient was getting transported, he started to go in and out of consciousness again. Patient in ER at this time.

after pt received 1st dose of covid vaccine, pt started having increased shortness of breath. he went to see his PCP and his PCP prescribed inhaler for him since his PCP thought it was due to his asthma exacerbation. but the inhaler didn't help. Shortness of breath worsened and pt started to have yellow/white phlegm. he came to ED for further evaluation. he was very hypoxic and tachycardic. per chart, he was noted to be mottled from his lower extremity up to his abdomen. BNP and troponin elevated.

Swelling, cramping, redness, pain, and warmth in left leg. He went to Urgent Care. The ultra sound lady said she saw a small clot. The PA he saw reported the radiologist did not diagnose a clot. The PA cautioned from prescribing any blood thinners for fear of interacting with DM medications (metformin and lisinopril).

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.

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.

Chest pains, chest exray, Pulminary Embolism, admitted to hospital early morning of 4-30-21, put on blood thinners, released 5-2-21 afternoon

diabetes/high glucose levels; Patient says he is feeling very weak; has fallen twice; This is a spontaneous report from a contactable consumer (patient's stepbrother). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Arm Right on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for covid-19 immunisation. The patient was feeling very weak and has fallen twice and no fever or flu like symptoms. He ended up going to the hospital where they did a blood test which came back showing he had very high glucose levels and he was now convinced that the vaccine has given him diabetes. The patient experienced Patient says he is feeling very weak and has fallen twice but no fever or flu like symptoms on 24Feb2021, high glucose levels and diabetes on an unspecified date. The patient underwent lab tests and procedures which included blood glucose increased: high glucose levels on an unspecified date.The patient was not tested for COVID-19 since the vaccination. Outcome of the events patient says he is feeling very weak and has fallen twice was not recovered and unknown for other events. Follow-up attempts are completed. 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

Pt experienced a syncopal episode within 5 minutes of vaccine administration. Pt was placed in supine position and regained normal vitals within 5 minutes. Pt symptoms of light headedness and palor resolved prior to discharge. Pt was monitored for 20 minutes w/o any other ASE.

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.

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.

RASH ON BIL UPPER EXTREMITIES, SOB, CHEST TIGHTNESS, NUMBNESS ONLIPS, 10 MG ZYRTEC GIVEN PO, BENADRYL CREAM APPLIED TOPICALLY TO RASH ON UPPER EXTREMITIES AT 1:10 PM. EXTENDED MONITORING FOR 1 HR WITHI SYMPTOMS LESSENING. VITALS STABLEAT 137/87 BP, HR 76, RR 18, 97% OXYGEN ON ROOM AIR AT 1:50 PM. PATIENT ADVISED TO SEEK ADDITIONAL MEDICAL EVALUATION.

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

swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.

Dizziness within 15 minutes, heart pounding a few hours later, gone by next day. Tolerated next dose with no symptoms.

He got his vaccine, he had a very, very bad headache. About 3 weeks later his neck stiffened. He developed a pain in his chest, stabbing in nature, down his neck, left arm, arm pit, down his side and through to his back and down his spine. He also has had numbness in his hands. He went to the ER because he thought he was having a heart attack, and they did a bunch of tests on him including a COVID test which was negative . They did a chest x-ray, EKG, blood work and possibly some others, and everything seemed to be OK, and could be a neuromuscular thing. He then went to see his PCP the next day who reviewed the ER results, and he sent him to a cardiologist and he is in the process of having tests done with him. He also has an APT set up with a neurologist and an Orthopedist as it has been 5 weeks since this started, and the pain is fairly severe. He has an overall feeling of weakness, light headedness and nothing really relieves the pain and has been using Advil. They told him to take Advil. The cardiologist has not given him any results yet. He did ask his PCP and his cardiologist if they felt that it was due to the vaccine, perhaps a delayed reaction and they told him that they would not rule that out.

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.

swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; swelling and numbness in my face and lips; Racing heartbeat; I have degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared; This is a spontaneous report from a contactable consumer, reporting for himself. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in left arm on 01Mar2021 11:15AM (at the age of 61-year-old) at single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. Relevant medical history included asthma, arthritis, degenerative disc disease and type 2 diabetes. The patient had latex allergy. He did not have COVID prior to vaccination. Concomitant medications were not reported. About 30 minutes after injection, the patient started to get some swelling and numbness in face and lips, racing heartbeat. Breathing was normal. As of 05Mar2021 he was still having these symptoms. On a positive note the patient had degenerative disc disease and arthritis. After 1 day those symptoms have almost disappeared. No treatment was received. The patient was not tested for COVID after vaccination. The events were non-serious and not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient had racing heart and chest pain following vaccination. Pain resolved within 30 minutes. Patient wanted to note this as he has a history of heart disease.

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

Congestive heart failure; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 24Apr2021 10:00 at age of 61years old as a single dose for COVID-19 immunisation. Medical history included congestive heart failure from Mar2013 to an unknown date, Chronic Kidney Disease Stage 2, cured Type 2 Diabetes from Dec2019 to an unknown date. Concomitant medication included losartan. The patient experienced congestive heart failure on 04May2021 12:00 with outcome of recovering. Therapeutic measures were taken as a result of congestive heart failure. The adverse event result in following: Emergency room/department or urgent care. Treatment for the adverse event included LASIK Intravenous (IV). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 15May2021 09:30 at age of 61years old as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

7 days after first vaccine, started to experience palpitations, and what appeared to me feeling my pulse on my arm as missed heart beats. They were very slow. We have a Blood Pressure Machine at the hose, and I took my pressure. It was normal but my heart rate was 44, did it several times and the highest it went was 49, also the Blood pressure machine indicated I was having an irregular heartbeat. I called my family doctor that morning and they had me come into the office, and they did an EKG , and got the same results . I was sent to a heart doctor two days later, and I was still experiencing these issues. I had a stress test done which showed everything was normal. But last week June 7th, had these palpitations again. The heart doctor only said maybe it's your inhaler. I saw my family doctor today and she indicated that this is not from an inhaler. I did mention the time line of the Covid vaccine and the heart issues, and she did not rule that out either.

Heart arrhythmia, skipped beats (usually every fourth beat), and palpitations starting about 2 days after vaccination, and lasting about 4 weeks. Eventually resolved on its own before date of doctor's appointment with cardiologist was reached. In addition, fatigue, flu-like symptoms

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.

30 minutes after vaccination he did not feel good, has droopy eyes , slurred speech, numbness of left arm. high blood pressure, headach, shortness of breath 2 days after vaccination he feels better but still has mild headache , pressure behind eye, Rt eyelid ptosis, numbness of left upper arm and slight shortness of breath

Patient had a stroke several years ago and is dependent on wife for mobility and caregiving needs. Patient experienced syncopal episode 20 minutes after receiving second dose of Pfizer shot. First shot was uneventful as per patient's wife. His wife also stated that he took his lisinopril about 40 minutes prior to coming in to receive vaccination. He did not take his blood pressure prior to coming. Patient was transported to local emergency department by EMS. I attempted to call patient's wife, no answer. Outcome currently unknown.

His stroke started on 07Jun; This is a spontaneous report from a Pfizer sponsored program. consumer (patient) reported for himself that a 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 07May2021 (Age at Vaccination was 61 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), at single dose for COVID-19 im-munisation on 16Apr2021 and did not feel any symptoms with her first dose (Age at Vaccination was 61 years). Patient experienced stroke (medically significant) started on 07Jun2021 and is 99% sure due to the COVID vaccine. He mentions that he was an athlete and a pilot. He states that he was in excellent condition and have no family history of stroke. He also said that doctors did not know about anything. Caller wants to know if it can recur again in the future. Outcome of the event was unknown.

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

I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the fourth day around 1:30 in the morning I woke up in a cold sweat and I felt my heart racing and also uneven heart beat. My blood pressure was up to 150/100. Over the next 20 hours this condition subsided and finally went away completely after 20 hours or so.

I ended up having a brain hemorrhage ! Terrible headache in the hospital for seven days in the intensive care unit !

Presented to ED on 6/21 w/ left knee pain. Doppler demonstrated DVT in left gastrocnemius veins. Discharged from ED on apixaban and to f/u with PCP.

Mild soreness at injection site then tired and achy that night. Fine next morning. Traveled to Dr's appointment and went shopping. Upon returning home, as I carried items up 3 steps to porch, I felt my heart begin to race. Thought I was just winded in cool temp. Parked and walked to house, up flight of stairs, drank water and set down. Still my heart was racing. My Watch beeped that I might be in possible A-Fib. Daughter-in-law, an LPN, stopped to pickup our grandchild. Took my pulse, said it was rapid and irregular. Told me to take 4 baby aspirins and get to ER. EKG showed I was in A-Fib , Blood work, tests etc. Admitted to Hospital for 1 1/2 days. Given Diltiszen and shots for blood thinner, IV's. Sent home, Converted to Normal Rhythm in couple of days. Saw Dr. He switched me to Cardeilol and Xarelto. Scheduled Echo of my Heart. Results were clean and fine. Now in Lymes (PLDS) Flareup.

Then on 19Mar2021 the number was 176 and checked the morning of 21Mar2021 the number was 184.; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Solution for injection, Lot number: EN6208 and Expiration date: unknown) via an unknown route of administration, in left arm on 18Mar2021 11:45 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. Medical history included diabetes, HPB and high cholerterol from an unknown date. Concomitant medications included insulin glargine (LANTUS, losartan, amlodipine besilate, fenofibrate and glibenclamide taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 18Mar2021 in the morning, my diabetic number was 129 and lower, then I got the vaccine, then on 19Mar2021 at 10:00, the number was 176 and on 20Mar2021 was 162. So, he increased insulin in the night of 20Mar2021 and checked the morning of 21Mar2021, the number was 184. He increased insulin dosage again in the night of 21Mar2021 and checked the morning of 22Mar2021 and the number was 176. This may not be correlated to the vaccine, but he wanted to report these events. No treatment was received for the event. The outcome of the event was not recovered.

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

Dec 7, 2020 felt chest pain on deep inspiration with fatigue, malaise over 7 days. No cough, no fever, no headache, no smell or taste alteration. On Dec 31 developed aching pain right shoulder scapular area, on Jan 5 developed weakness in the right arm and hand with intrinsic hand muscles weak and wrist flexion extension weak. Transient numb feelings in the right little finger. Diagnosed by myself as a Neurologist as an immune mediated motor brachial plexopathy affecting C6,7,8 and T1 myotomes. Prednisone 60 mg/ day for 5 days followed by a tapering dose completed. Complete recovery in 8 weeks.

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

Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified Thrombocytopenia, unspecified

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

Stroke; Blood pressure high; Vision peripheral decreased; Joint stiffness; Numbness on left side of body; This is a solicited report from non-Pfizer sponsored marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3921608-00). A contactable consumer reported that a 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at age of 61 years old (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from 2016 (Batch/Lot number was not reported) and ongoing, at unspecified dose for moderate to severe adult crohns disease. Medical history included alcohol use started from 1976, rarely use beer and red wine; tobacco use from 1976 to 2021, a pack of cigarettes a day; and moderate to severe adult crohns disease. Concomitant medications included clopidogrel bisulfate (PLAVIX) and acetylsalicylic acid (BABY ASPIRIN); both taken for prevent another episode of stroke. The patient previously received the first dose of bnt162b2 intramuscularly in Mar2021 at age of 61 years old for COVID-19 immunisation. The patient experienced stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body on 14May2021. Event stroke was serious per hospitalization, other events were reported as non-serious. Event details: On 14May2021, the patient experienced numbness on left side of body and peripheral vision on left side was affected. On the same day, he had stroke and was hospitalized due to that. He had physical occupational therapy after within two weeks when he returned home from the hospital. His blood pressure was high but could not remember the exact number. His joints got stiff with colder weather. He had unspecified high blood pressure pill as part of his concomitant medications. The action taken in response to the events for adalimumab was dose not changed. The outcome of event stroke was resolving, outcome of event blood pressure high was resolved, outcome of event joint stiffness was not resolved, outcome of other events was unknown. Causality for adalimumab: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with adalimumab was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with adalimumab was not provided. AbbVie's opinion was that there was no reasonable possibility that the events of stroke, blood pressure high, vision peripheral decreased, joint stiffness were related to adalimumab. Causality for bnt162b2: The reporter's causality for the events of stroke, blood pressure high and vision peripheral decreased with bnt162b2 was not related. The reporter's causality for the events of joint stiffness and numbness on left side of body with bnt162b2 was not provided. The reporter's assessment of the causal relationship of the events joint stiffness and numbness on left side of body with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. Information on the lot number cannot be obtained.; Sender's Comments: The events stroke, blood pressure high, vision peripheral decreased, joint stiffness, numbness on left side of body were considered as unrelated tot he use of bnt162b2. Patient received 2nd dose of bnt162b2 in Mar2021 and the events occurred on 14May2021. The temporal relationship between the events and bnt162b2 is weak.

started feeling small symptoms of AFib sometimes/that on the next day he was definitely having the A fib symptoms; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 at 12:30 (at the age of 61-year-old) as dose 1 single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, psoriasis and atrial fibrillation, corrected by ablation surgery in Jan2017 with no problem. The patient did not have allergies to medications, food, or other products. Concomitant medications (within 2 weeks of vaccination) included metoprolol 25 mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19 and since the vaccination, the patient had not been tested positive for Covid-19. It was reported that on 28Feb2021 the patient received first dose of vaccine and stated that on an unspecified date he started feeling small symptoms of atrial fibrillation sometimes. He stated that he received second dose on 21Mar2021 and after that on the next day he was definitely having the A fib symptoms again short breath just walking doing simplest little things and had rapid heartbeat again and mentioned that he had no problems before when took first dose of Pfizer vaccination. The patient did not receive treatment received for the event. The reporter provided seriousness of the event as non-serious. The patient was not recovered from the event. Follow-up attempts are possible. Further information is expected.

Had a seizure that lasted an hour and 15 minutes. My blood pressure and heart rate have been unstable since the seizure.

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.

Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; This is a spontaneous report from a contactable consumer. This 61-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 16Mar2021 at 15:00 hours on left arm (at 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included cardiac failure. The allergies were reported as none. Concomitant medications included sacubitril valsartan sodium hydrate (Entresto) taken for an unspecified indication, carvedilol taken for an unspecified indication and spironolactone taken for an unspecified indication. On 18Mar2021 at 10:00 PM the patient experienced loss of vision, cerebrovascular accident and hemorrhagic stroke. The patient required emergency room visit and was hospitalized for 3 days. Therapeutic measures were taken with nir angiogram cerebral. The event outcome was unknown. It was mentioned that no other vaccine was received in four weeks, patient had no covid prior vaccination and was not tested for covid post vaccination. The device date was 03Jul2021.

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

Heart problems. Irregular heart beat resulting is plaque dislodge from right coronary artery. Doctors placed stint. Irregular heartbeat and mild angina still persist.

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

Fainting spell; blood clot; low heart rate for extended period of time; This is a spontaneous report from 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 09Apr2021 09:30 (Batch/Lot Number: EW0162) as dose 2, single for Covid-19 immunization. The patient received the 1st dose of Comirnaty (Lot number: ER8727) on 19Mar2021 09:30 AM (at the age of 61years) in left arm for Covid-19 Immunization (no reaction). Medical history included femoral artery aneurysm from Jan2020 to an unknown date. Concomitant medications included atorvastatin calcium (ATORVASTATIN CALCIUM) taken for an unspecified indication, start and stop date were not reported; and acetylsalicylic acid (ASAPRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 28May2021 16:00, the patient experienced fainting spell, blood clot, and low heart rate for extended period of time. The patient was hospitalized for the events for 6 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The treatment received for the adverse events included Stent inserted and heart rate monitor implanted. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovered with sequel on an unspecified date. Seriousness criteria was reported as hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage].

7/12/2021: Patient tested positive for COVID on 7/7/21 and was admitted on 7/12/21 by the transplant team after being hypoxic requiring additional oxygenation. diagnosed with widespread bilateral airspace disease typical for COVID-19 pneumonia. completed remdesivir regimen on 7/16. receiving Baricitinib. 7.26.21: patient is still admitted as of the date of this report submission.

death E87.1 - Hyponatremia J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified

Angina Upper lip swelling/tickling and tongue tingling Narrative: 61 year old female with HTN and asthma with multiple allergies to meds and prior angioedema in past. Presented for her first dose of COVID19 vaccine; after the injection she felt her upper lip tingling and tongue. NO SOB, no throat symptoms, no change in voice, no rash, no hives. NO N/V. She did have some chest tightness. Diphenhydramine IV, famotidine IV, and methylprednisolone IV one-time doses given in ED with surveillance. Patient recovered, denied previous sxs, and was discharged from ED with a family member. ED physician note documents patient "will take" following medications at home (however no outpatient prescriptions found): Benadryl 50 mg po Q8H x 5 days, prednisone 40 mg po daily x 4 days, and famotidine 20 mg po BID x 5 days

Syncope Hx of syncopal episodes during any procedures, per ED note. Narrative: c/o of feeling flushed and pt. asked to lay down @11 am in the observation area. Staff able to get pt. to cart before she "passed out." She immediately responded but RRT was called to assess the patient. BP low, per RRT (84/54 P 53, 108 /65 P 51) and pt. was taken to the ED at 1112. No SOB, nausea noted. Per ED and final report was that the reaction was not an allergic reaction nor a side effect of the injection.

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

New onset atrial fibrillation occurred 56 hours after receiving the vaccine. No prior history. Seen in emergency department on 1/13/2021 and underwent pharmacologic/medical cardioversion and cardiology consultation.

Have a cut in my leg which is very unusual; Saw a big cut in my feet; I was bleeding from somewhere; It was quite a lot of blood drawing out of my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient started to receive single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 23Dec2020 09:00 for COVID-19 immunization; and adalimumab (HUMIRA), via an unspecified route of administration from an unspecified date at unspecified dose (injection every other month) for arthritis. Medical history included arthritis, blood pressure (abnormal), and blood cholesterol (abnormal). Concomitant medication included rosuvastatin for blood cholesterol, olmesartan medoxomil, metoprolol succinate (TOPROL XL), and vitamins: ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride. Patient stated, "The reason I am calling, I have just a concern that something happened to me. I did not pay much attention but now I have read the news one doctor died after getting this COVID Vaccine (Further details were not available over the call) I have a small incident happened to me the day after I received my first dose of the COVID Vaccine. I just wanted to get some information. You know what happened the next day night, in the evening I was taking a shower and all of sudden I was bleeding from somewhere. Lot of blood was coming out while I was toweling my body out. I couldn't find out where the blood is coming from. I checked, it's not from my urine, not from my rectum but it was quite a lot of blood drawing out of my body. Immediately, I called my wife into bathroom, then I squeezed my body then the bleeding stops. It was on 24Dec2020. You know my kids were at home. I don't want them to find it. The bleeding stopped and everything went away. Then I thought maybe it is something related to my GI. I went to my GI doctor yesterday to have a checkup, they don't know anything either but I am due for my second dose for next week Wednesday. Now I had this news about thrombocytopenia on this doctor died (Clarification unknown). So I am just afraid if there is anything related this. Do you have any explanation on how I bleed and where it bleed? It was lot of bleeding even my towel was full of blood." Patient wanted to see if anybody else had similar experience or if he get the second dose and he get the complication again. Patient was a medical technologist. He was doing ultrasounds. He was working in a pediatric hospital. Patient was not prescribed/recommended vaccination. "Nobody recommended it. During my hospital. I am healthcare professional. So everybody in my hospital. I just went there and get it. I didn't ask my doctor." Patient added, "You know everything I read about this case and then you know, I have a cut in my leg which is very unusual. I have never seen that. I don't know how it happened. You know all of sudden oneday I wake up and I saw a big cut in my feet also. So, I am just afraid (onset date not reported)." The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown. Information about Lot/Batch number is requested.

Narrative: Patient was found to be short of breath with heart rate in the 140s. Initially he was thought to possibly be having an allergic reaction to the vaccine. For this, he received prednisone, Benadryl and famotidine. These medications did not improve his symptoms. He was then discovered to be in atrial flutter. He was admitted to the ICU for close monitoring. There he remained hemodynamically stable. He was treated with beta blockade that improved his heart rate and his symptoms. He was discharged to home the following day.

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

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

Pt admitted with a STEMI three days after vaccination with pzifer COVID-19 vaccine. Short time (<2hr) between symptoms onset and medical care. PCI on 1/14. Acute subtotal occlusion of proximal LAD and severe diffuse disease extending to distal LAD. Two DES to LAD (99% occluded) but RCA 50% and OMI1 60-65% also stenosed. Echo cardiogram 1/15. Pt noted to have severe wall motion abnormalities (severe hypokinesis of anterolateral and anteroseptal wall; akinesis of mid to distal anterior wall extending to the apex and distal inferior wall ) on echo. EF 30-35%. Received life vest on discharge.

On January 18, 2021, I experienced extreme weakness of both legs to the extent that I was unable to stand. I experienced an exacerbation of baseline numbness over many areas of my body. I had an elevated resting heart rate of over 108 bpm. I was transported by ambulance to that afternoon. I was admitted in the early morning hours of January 19, 2021. I was diagnosed with, "Exacerbation of multiple sclerosis; SIRS (systematic inflammatory response syndrome). I was given multiple intravenous antibiotics. I had a CAT scan. I had a chest x-ray. I had many blood tests. The adverse event resolved on its own. I was discharged January 16, 2021.

1/25/2021- Presented to ED with chest pain which radiated up his right shoulder, right armpit and across his chest. The EKG showed a STEMI [acute inferior]. He was transferred to other Hospital.

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

patient states the night after the vaccine he had a nosebleed and it stopped on its own. Then he complained of a sore, raw tongue and that it burned when he drinks juice and taste bad. Patient states he had not been exposed to a positive COVID case that he was aware of.

I had an increase in heart rate about 5 minutes after receiving the shot which lasted for a couple of minutes only. I have never had a reaction to any vaccination shot.

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

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

About 30 minutes or so after injection, patient had reaction. The patient had really bad tremors, blood pressure was ok but pulse was fluctuating. Nurse was at bedside providing oxygen through mask. He was given aspirin and didn't need EpiPen. 911 was called and patient was transported

Bleeding down his arm afterward; He received a dose in his left arm, and noticed he was bleeding down his arm afterward/He had another dose given in his right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), first in the left arm and second dose in the right arm, both via an unspecified route of administration on 02Feb2021 at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received his first round of Pfizer-Biontech Covid19 vaccine yesterday 02Feb2021. He received a dose in his left arm, and noticed he was bleeding down his arm afterward, which was out of character for him. When he alerted his nurse who had administered the vaccine, she discussed it with a colleague who said "go ahead and give him another one". He had another dose (second dose) given in his right arm on 02Feb2021. Patient stated he's "feeling fine". He wanted to know if he still needs to get the second dose in the series. It was also further reported as they gave him the shot in the left arm and he started to bleed. He got a 2nd one in the right arm. He was feeling fine. The nurse asked another nurs- and she said, "go ahead and give him another one". The outcome of the event bleeding down his arm afterward was unknown. Information on the Batch/Lot number has been requested.

I do not know if this is related to the vaccination, however, since the vaccination my blood pressure has increased to a much higher level. I was running in the 120/80 - 130/90 range. I am now running in the 170/90 -190/100 range. My doctor has increased my blood pressure medication to address this increase but I thought it best to report it.

Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever. Patient's condition progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am

Dizziness upon standing, hypotension. Did not take his daily hydrocortisone or lisinopril, did not eat prior to coming. Transported to ED where he was given his usual medications and monitored, discharged.

Patient experience sudden cardiac arrest approximately 2 minutes after vaccine was administered. Paramedics on scene provided CPR and defibrillation and pulse was restored. Patient was regained consciousness prior to transport to the hospital.

Patient received the vaccine and was observed in the post vaccination area for 30 minutes. He then went upstairs to his apartment and returned approximately one hour later. He sat in the lobby and looked somewhat ill. He was questioned by house staff and said that he was ok. He then lost consciousness and slumped in his chair. Medical staff was notified and he was still unresponsive. He was lowered to the floor and upon assessment, he had no pulse or respirations. CPR was begun with bag mouth ventilation and subsequently chest compressions. He received 50mg of IM Benadryl and 40mg of Solu Medrol IM. He still had no pulse and he an AED pads were applied. AED analysis indicated a shockable rhythm and one shock was administered with return of pulse. He remained unconscious and ventilation was continued until EMS arrived.

3:57PM 'FEELS LIKE PASSING OUT'. PALE, DIAPHORETIC. STATES HE HAD RT HIP SURGERY 3 DAYS AGO. PLACED IN W/C, MOVED TO TENT (UNABLE TO LIE ON COT). COOL CLOTH APPLIED TO NECK. 4:06PM 'FEELING BETTER NOW'. COLOR IMPROVED. NO SOB, DYSPNEA OR DECREASED LOC. PINK, W/D. 4:15PM WIFE TO DRIVE PT HOME. NO ACUT/OBVIOUS DISTRESS. 3-5-214:10PM TC - STATES 'ALL S/S RESOLVED LAST NIGHT - FEELS GOOD TODAY'.

64-year-old male with a history of hypertension, melanoma, vasovagal events from previous needles presenting to the emergency department today for vasovagal episode. Patient was across the street receiving his first dose of Covid vaccine. At that time patient had a syncopal episode. According to EMS they indicate that nursing there was unable to feel pulse and began CPR. They did multiple rounds of compressions and patient woke up. They are bringing patient in today for further evaluation of syncope versus cardiac arrest. Patient does endorse that he has chest wall pain from where they were doing compressions.

Within 1 minute of vaccine being injected. I started to feel dizzy. I was wheeled in wheelchair to observation area. I kept feeling more dizzy and started to feel tingly in my fingers and legs (both sides equally) After 15 minute observation time was over, I tried to stand up and immediately sat down again as a wave of dizziness hit me. Doctor in observation area saw me and came over. I told him how I felt. He put his fingers to my wrist and felt my pulse. It was initially between 40 and 90, then steadied off around 90-100. He called for EMTs on duty to come over with a stretcher because he thought I should be laid flat. The EMT took my blood pressure and it was 155/94. The doctor said at one point my pulse was thready. By this point the dizziness was stronger and I felt tingly in my teeth as well as other areas. I was asked about my breathing and I said that it was okay. An ambulance was called for and arrived. I don't remember the exact time. The moved me from the wheelchair to a stretcher. I could not stand up on my own and lurched toward the stretcher. I am grateful strong people were there to get me on stretcher and strapped in. All throughout this my normally barely noticeable Atrial Fibrillation was quite apparent and more erratic. This was a major reason for ambulance call. Some of the stroke protocol was done including gripping EMT's fingers equally and following his finger with my eyes. I was very cold throughout. I was brought to the waiting ambulance outside and driven to Medical Center. The EMT took an EKG which showed atrial fibrillation and a line was put into my arm. When we got to the hospital, I was brought into the triage area and had all my vitals taken. Blood pressure was high, so was pulse then for a half hour, I was very hot and sweated a lot after being cold.

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.

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

Severe Vasovagal reaction with syncope. He has a past history of the same but assumed he had outgrown it based on recent experiences.

03/07/21: Onset of dyspnea upon exertion 03/09/21: Worsening dyspnea and non-productive cough 03/11/21: Primary care visit for diagnosis/tests 03/12/21: Elevated BNP levels noted; chest X-ray 03/13/21: Further worsening of dyspnea 03/15/21: D Dimer test elevated (positive) 03/15/21: ED visit; CTA scan indicates pulmonary emboli (lots of clots); admitted to hospital; Heparin IV drip 03/16/21: (evening) Discharge on Eliquis 03/17/21: Moderately severe dyspnea upon exertion and non-productive cough continues Event: Pulmonary emboli

pulmonary embolism Narrative: Patient received first COVID-19 vaccine (Pfizer) on 3/2/21.Within 24-48 hrs patient had SOB. Patient went to ER & was Dx with unprovoked bilateral PE on 3/5/21. Patient has family history of VTE (father died of PE, mother had DVTs and was on warfarin). Patient was admitted from 3/6-3/7, discharged on apixaban. ID consult placed, ID physician recommended patient receive 2nd dose of COVID-19 vaccine in 21 days as scheduled.

Employee received his first dose of the Pfizer Vaccine and approximately 5-10 minutes after receiving his dose he began to feel very light-headed and faint. Vitals were taken. BP "higher than his usual" but within acceptable paramaters. Vaccine clinic staff continued to monitor, but he continued to report not feeling well. He was transported non-emergently to the ED for further evaluation. In ED: highest BP charted was 178/90. Patient monitored in ED for 1 hour then discharged. No chest pain, headache, n/v/d, or rash. No antihypertensives administered.

Yesterday evening he was lifting some boxes and moving them to the right and started to experience left-sided upper chest pain. It is described as "tightness" and is constant, radiating to the shoulder with movement. He denies cough, fever or shortness of breath. Ibuprofen taken this AM has helped and over the past couple hours the pain has resolved completely. No recent prolonged travel

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.

Patient received first dose of Pfizer. A couple minutes later patient felt dizzy and fainted. EMS responded and took vital signs HR 60, BP 144/87 O2 sats were 96%. Patient was offered to be transported if he felt like he needed it. Patient declined transport.

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

Per report from patient's daughter: Patient received 1st dose of Pfizer around 4:30 pm on 2/7/21. Around 4 am the next morning, 2/8/21, he woke up and didn't feel good. Around 12 pm on 2/8/21 he reported feeling "weak" especially on one side of his body. His daughter said she took him to the hospital around 9:30 pm that night, after he continued to feel unwell throughout the day. At Hospital he was diagnosed as having had a stroke. He was admitted to the hospital and kept for observation for 2 days. When his daughter reached out to the patient's PCP to ask if he should get the 2nd Pfizer dose, she was told he should wait at least 3 months and advised to report his stroke to the public health department.

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

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

Patient reported feeling a "prickly" feeling on his chest and left arm. Patient said "it feels like I fell into a cactus." Patient also reports his face itching. Denies any other symptoms. No bumps or redness observed. After 10 minutes, the symptoms subsided. Instructed patient to call PCP for new or worsening symptoms.

Pt developed high fever and rigors 45 minutes after receiving 1st dose of Pfizer COVID vaccine. Presented to ED where he was found to have fever to 101.3, tachycardia, tachypnea, leukocytosis to 25, and lactate 6, meeting SIRS criteria. Pt was admitted and started on Zosyn, but infectious w/u completely unremarkable (neg BCx, unremarkable CXR, normal UA, normal abdominal imaging, no elevated LFTs given h/o cholangitis). He was observed for 24h off of Zosyn and did not develop any further hemodynamic instability or recurrent fevers and rigors. His WBC improved daily 25 -- > 11.5 -- > 7.1 and lactate cleared on night of admission with fluid resuscitation.

Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; Superficial blood clot on left calf at the lower end of some varicose veins two days after injection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6207), via an unspecified route of administration in right arm on 10Mar2021 14:30 (at the age of 62-years-old) as single dose for covid-19 immunisation. The vaccine facility type was a pharmacy or drug store. The patient had no other vaccine in four weeks. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Medical history included macular. Concomitant medication included amitriptyline. The patient previously took erythromycin and statins and experienced drug allergies from these. The reported adverse events were superficial blood clot on left calf at the lower end of some varicose veins two days after injection (on 12Mar2021 at 10:00). It may be unrelated, but the patient wanted to let know. The events resulted in emergency room/department or urgent care. AE treatment included hot compress, support stockings and ibuprofen (MOTRIN). The outcome of the events was recovering.; Sender's Comments: Varicose veins most probably was a preexisting condition, unrelated to BNT162B2 vaccine. The reported superficial blood clots are considered a complication of varicose vein and unlikely related to BNT162B2.

Patient developed chest pain at about 3:30AM the following morning. Ultimately diagnosed with anterior STEMI requiring stent placement.

Bell's Palsy; stroke; Minor injection site soreness; Extreme sleepiness (2 days); This is a spontaneous report received from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6206), first dose via an unspecified route of administration, administered in right arm on 05Mar2021 07:30 as single dose for covid-19 immunisation. Medical history included high blood pressure (HBP) hypertension, Transient ischaemic attack (TIA) twice, pre-diabetic. Known allergies was none. Concomitant medications received within 2 weeks of vaccination included metformin, atorvastatin, losartan, amlodipine, Aspirin (acetylsalicylic acid). The most recent COVID-19 vaccine was administered at work location. 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 bell's palsy (17 days after vaccination - confirmed via ER visit vice stroke) and stroke (seriousness crietria was medically significant), minor injection site soreness (2days) and extreme sleepiness (2 days); all events on 22Mar2021 17:30. The adverse event result in emergency room/department or urgent care. Treatment was received for all adverse events including Steroid/anti-viral medication 7 days by neurologist. The event outcome for all events was not recovered. Follow-up attempts are needed. Information on batch/lot number was available.

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

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.

episodic chest pain that began this morning (4/5). Pain described as a severe, sudden, fleeting "lightening bolt" that resolved after roughly one second. Associated SOA after episode that has resolved. No radiation. Residual chest tightness after episode. No diaphoresis, N/V, calf tenderness or edema. Potential improvement after taking antihypertensive medication and aspirin.

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

Patient seen at the Vaccination Center on 4/9/2021. He had just received his first dose of COVID-19 vaccine. He was feeling dizzy and felt like he was going to pass out. He was transported by EMT to the Adverse Reaction Area and then moved. Representative served as sign language interpreter via tablet. His wife was also present and is deaf. Patient stated that his heart rate was very slow, and he felt dizzy, hot, and sweating. He also fel very weak and it appeared that was going to pass out. He was also shaking. Ambulance was called due to the above symptoms. Patient also stated that he thought he may need to go to the ER. Vital signs: 9:53 am: Blood pressure was 143/71, heart rate was 71. Patient was given an ice pack. He also took sips of water. He then noted that he felt better, after laying down. Ambulance crew arrived and he declined to go the ER. He got up and walked around stated the he felt better. He notes that his head feels like it's slightly buzzing, so he lay down again. Vitals signs: 10:25 am: Blood pressure 138/63, heart rate is 64, temperature is 98.1 Patient felt better and noted no more buzzing in his head. He also walked around and felt normal. Patient notes that he blacked out as a child whenever he got shots/injections. He was not surprised that this happened to him today. He wanted to know whether he should get the second vaccine injection. It is recommended that he get his second vaccine injection and we also discussed that he may have the same reaction as today. He should allow for extra time and be well-hydrated. He felt safe to go home and his wife would be driving him home. Should he feel worse, then he should go to the ER. The patient and his wife understand this. All questions were answered.

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.

A day after covid vacine shot 7:00 am 4/9/21 ,I developed shortness of breath and fatigue. Then I developed a fever of 99.1 at 3:00pm that afternoon and O2 saturation was at 92 percent on 4/9/21. Saturday evening at 5:30pm I developed a fever of 99.4 and sereve fatigue and 89 O2 saturation level. Later that night at 9:00 pm on 4/9/21 my fever rose to 100.7 and O2 dropped to 85 when I tried to fall asleep. I took two puffs of an inhaler, two extra strength Tylenol and one Allegra D 12 hour tablet at 10pm. My fever broke at 1am on 4/10/21 and at 2am 4/10/21 my O2 stabilized at 92 percent saturation.

62-year-old male with number of medical problems that include history of hepatitis-C, history of cirrhosis, history of alcohol abuse, cocaine abuse, history of diabetes hypertension who has initially presented to EMS with increasing shortness of breath. Patient suffered cardiac arrest during his transportation to the emergency room. A CPR was initiated and was given 3 rounds of epinephrine. Most of the history is taken from the ER physician chart review. ACUTE RESPIRATORY FAILURE SECONDARY TO HYPOXEMIA, COVID-19 , cardiac arrest, possible anoxic brain damage : Patient is 62-year-old male with complicated history with history of hepatitis-C, cirrhosis, alcohol use, cocaine abuse diabetes who presented after having cardiac arrest and possible anoxic brain damage. Patient was intubated after the arrest. Patient stayed in the hospital for number of days. Patient was found to have COVID-19 positive. Patient was found to have diffuse bilateral infiltrate. Patient was started on broad-spectrum antibiotics including cefepime Flagyl and Decadron. Due to patient's cardiac arrest patient was started on hypothermia protocol. Patient was rewarming after that. There was no purposeful movement or neurological recovery. After long discussion with the family, patient has been made comfort care. Patient was extubated. Patient expired promptly after that. Family is notified.

Pt presented with substernal chest pain and diaphoresis which started last night. Past medical history of previous MI with stents in place. Allergies - Penicillin. He was placed on stretcher and taken to EMS room for further evaluation. PT states the pressure is a 4/10 non-radiating and made worse when he moves around. PT also stated he started a new blood pressure medication three days ago. First set of vitals were at 13:15hours - HR 84 SPO2 95% BP 192/109 12-lead obtained - normal sinus rhythm Vitals reassessed at 13:20 hours - HR 89 SPO2 94% BP 154/124 Pt states he is still having the substernal chest pain. Upon evaluation pt is hypertensive and given past medical cardiac history 911 was activated for chest pain transport 20G IV was established in left AC Rescue arrived and pt care was transferred over to Rescue Personnel Pt received second dose of Pfizer today.

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.

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.

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.

Stroke symptoms (numbness on left hand, then developed into loss of control of left hand and left leg, and also drooping of left side of face) showed up about three weeks after 1st dose of Pfizer COVID19 vaccine, and stroke occurred on 04/12/21 which is two days after the 2nd dose of Pfizer COVID19 vaccine.

I took my first shot on March 24th, 2021, and I had a heart attack on April 3rd, 2021 from a blockage in LAD with a 99% blockage. I was to my PCP on March 10th, 2021 for a routine check-up and there were no issues. I wanted to report it so if anything has to be done can be done or at least the matter can be looked into.

My husband developed severe COVID symptoms, despite testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23. He was hospitalized on 3/28 due to low blood oxygen levels. Was diagnosed with COVID and pneumonia. Treated with remdesivir and a steroid, then monoclonal antibodies. Despite making progress to the extent doctors were cautiously optimistic on 4/9/21 he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21, placed on a ventilator on 4/11/21 and died on 4/15/21.

Got vaccine 4/10/2021 4 days later started having left lower extremity swelling, on 4/22/2021 was diagnosed with DVT

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.

The patient passed out while sitting in the waiting area about 15 minutes after the vaccine was given. They were pale but became responsive very quickly after the fall. After about 20 more minutes the patient was able to stand up and felt "all better". The paramedics were called and assessed the patient before the patient left.

March 15th COVID shot. March 16th started to get severe dizziness and fatigue. Went to bed early. March 17th speech was impaired and difficulty with gait and balance. Admitted to MAMC ER, which confirmed a stroke and released. March 18th early AM admitted again to ER due to unable to move/walk. Due to lacking proper equipment and space was transferred via ambulance to hospital in March 18th until March 24 Obeservations Inpatient at Hospital. March 24 to April 16th Inpatient rehab.

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

while I was driving I blacked out and was in a accident in my car; while I was driving I blacked out and was in a accident in my car; dizzy; very sick; soreness in my joints; headache; bodyaches; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; First dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00; This is a spontaneous report from a contactable other health professional (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 31Mar2021 13:00 (at the age of 62-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly administered into the right arm on 16Feb2021 12:00 PM (at the age of 62-years-old) for COVID-19 immunization. It was reported that the first dose of BNT162B2 was administered on 16Feb2021 12:00 PM and the second dose was on 31Mar2021 13:00. On 01Apr2021, patient experienced soreness in his joints, headache and body aches. On 06Apr2021 07:00, while driving patient blacked out and was in an accident in his car, he was also dizzy and very sick. The patient received treatment for the events "while i was driving i blacked out and was in a accident in my car" and did not receive treatment for all other events reported. Outcome of events recovered on an unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer 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.

Heart palpitations, ponding of heart, change in heart rhythm. Symptoms were frequent the first day and improved over the course of the week. I seem to be back to normal now.

Heart racing; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9261) via an unspecified route of administration at left arm on 31Mar2021 at 17:00 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing atrial fibrillation (afib) and allergies to phenothyazines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021, the patient experienced heart racing. Patient stated since he has afib, caused a problem for a day. Scared to get second dose. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

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.

felt funny in his chest, like a really weird, really warm and heavy feeling; Sore Arm; This is a spontaneous report from a contactable nurse. The nurse reported similar events for herself and her husband. This is the second of two cases. A 62-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 10Mar2021 at 16:00 as a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril (manufacturer unknown) taken for high blood pressure, start and stop date were not reported (reported as for over 5 years). The patient did not have prior vaccinations within 4 weeks from the the COVID vaccine. On 10Mar2021, the patient felt funny in his chest, like a really weird, really warm and heavy feeling. The patient did not freak out and didn't want to appear weak. It lasted 5 minutes and then it went away. It was a warm feeling in the chest and not being able to breathe. The patient also had a sore arm on 10Mar2021. The outcome of the event felt funny in his chest, like a really weird, really warm and heavy feeling was recovered on 10Mar2021 and the outcome of the event sore arm was recovered on 11Mar2021. The event felt funny in his chest, like a really weird, really warm and heavy feeling was reported as medically significant. The patient received the second dose of the vaccine on 31Mar2021. Relatedness of the suspect drug with the reaction 'felt funny in his chest, like a really weird, really warm and heavy feeling' from the Primary Source Reporter (method of assessment) is unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Chest discomfort and BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021408430 same reporter and drug, similar events, different patient

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

Severe Leg pain (especially calves. Both legs equally) Major Leg swelling Elevated D-Dimer Low platelets Elevated Liver enzymes General Body Aches. Shortness of breath Fever Rash Fatigue / Malaise

Muscle weakness, Hypertension that is not controlled with his regular antihypertensive meds, and light headedness (comes and goes). States that he has an appt with his doctor on the 5th. Recommended: he needs to be evaluated by a health care provider today. Can not wait for the 5th. 4/27-4/28 unable to reach

Pulmonary embolism, pea, heart arrest x2. 0100 4/14, some up with difficulty breathing. O2 sats low 80's and tachycardia low 100's. 4/15, says in mid 90's yacht at mid 120' s. 4/15 increased diffficulty breathing. Went to ed. Troponin in 800's. Saddle pe discovered on ct. Clots in rt leg found also. 4/16 is removed pe, ir decided to let clots in let reabsorb. 4/17, ready to d/c, when acute onset of respiratory distress occured. Went into PEA x 's 2. Back to ir to remove pe and place filter.

Stroke 3 weeks after receiving first dose; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 09Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stroke 3 weeks after receiving first dose(on 01Apr2021). The patient was hospitalized for 15 days. The patient underwent lab tests and procedures on 03Apr2021 which included nasal swab (for sars-cov-2) test with negative results. The outcome of event was reported as not recovered. The patient did not receive any treatment for the event. The event was considered as serious, resulting to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and disability or permanent damage. Information on about lot/batch number has been requested.

couldn't breath, gasping, inability to get up or get out of bed. lasted approximately 12 minutes then the gasping and labored breathing diminished and became easier to breath. after several more minutes, I was able to breath normally and could get up out of bed but couldn't walk without holding on to something. After a week my breathing is still shallow and my chest still feels "tight" at times.

At 0947, patient reported headache rated 5/10 on the pain scale and chest pain radiating to left shoulder (patient received vaccine on left arm). EMT assessed patient vitals: blood pressure 158/90 mmHg, heart rate regular 69 beats/minute, and SpO2 96%. Patient denied difficulty breathing, difficulty swallowing, itchiness, hives and rashes. Patient reported history of atrial fibrillation, pulmonary embolism, and surgeries on elbows, ankles and esophagus. Patient denied taking current medications. Patient offered 911. Patient declined 911. Patient given water and advised to wait for further observation. Patient reassessed at 1005. Patient vitals were blood pressure 149/90 mmHg, heart rate 67 beats/minute, and SpO2 97%. Patient reported headache decreased to 2/10 on the pain scale. Patient reassessed at 1015. Patient vitals were blood pressure 144/88 mmHg, heart rate 65 beats/minute, and SpO2 97%. Patient stated his headache was gone and he felt fine. Lead nurse educated patient on communicating with primary care provider about his reactions to the vaccine and seeking emergency care if symptoms worsen or has difficulty swallowing/breathing. At 1018, patient left facility to self with steady gait and unlabored breathing.

Atrial fibrillation, dizziness, difficulty breathing, profuse sweating, pulse 110, very high blood pressure starting approximately 10 minutes after injection. Transferred to emergency room.

A non-patient, community member, received 1st COVID vaccine at dialysis clinic on 4/2/2021. A clinic teammate reached out to schedule the second dose and was informed, by the wife, that he suffered a stroke the day after the first vaccine and was currently hospitalized and stable.

I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R47.81 - Slurred speech R29.810 - Facial droop Z86.69 - History of Bell's palsy R51.9 - Headache"

Left arm is in a lot of pain.; It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep.; The pain runs to my chest and behind to the back of my ribs.; The pain runs to my chest and behind to the back of my ribs.; This is a spontaneous report from a contactable consumer (patient). This 62-year-old male patient received 2nd dose of BNT162B2 (lot_number EP6955) on 25Mar2021 at single dose on Left Arm for COVID-19 immunisation. Medical history was heart attack and was hospitalized to rule anything out, Hugh blood pressure, Cholesterol. Historical Vaccine was 1st dose of BNT162B2 (Lot number=EN6199) on 04Mar2021 on Left arm for COVID-19 immunisation. No other vaccine in four weeks. Left arm is in a lot of pain. It falls asleep and I feel my circulation stopping. I feel numb and it causes my arm to fall asleep. The pain runs to my chest and behind to the back of my ribs. I have a history of heart attack and was hospitalized to rule anything out. Events started from 08Apr2021. Events results in healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (3 days), disability or permanent damage. Treatment was Pain meds. Outcome of the event was Not Recovered. No covid prior vaccination. No covid tested post vaccination. No Known allergies. No follow-up attempts needed. No further information expected.

After the vaccination in the morning, Sa-04-17-2021, have been in Urgent Care in the afternoon for an ongoing kidney stones issue that had occurred earlier this week. Felt tightness and pain in both lower legs which continued the next day, and it became worse. Mentioned this issue to the primary physician the following Monday 04-19-2021, but predominance had been given to the Kidney stones issue. On 04-26-2021 mentioned again the pain predominantly in the left calf to the primary physician. The same day, blood clots were found in both lower legs by Urgent Care. Had received information for Deep Vein Thrombosis by physician who prescribed Lovenox (enoxaparin) injections and advised to report the findings to V-safe. Continued narrative: Being informed by Urgent Care on 04-30-2021 that blood clots were not only in both lower legs, but also in both upper legs, now, after complaining about more pain. Ultrasound checks. Being advised to move and rest moderately. Received again information about Deep Vein Thrombosis. Advised to consider to skip the second Pfizer vaccination. Being on sick leave since 04-13-2021. Had switched from Lovenox to Pradaxa per prescription starting from Sa-05-01-2021. Urgent Care, 05-03-2021 conducted another ultrasound check. Another blood clot had developed. Again advised to consider to skip the second Pfizer vaccination, on SA-05-08-2021, to avoid more complications and risks. Under continued observation. Being alerted that this condition can lead to permanent damage and can turn life-threatening. Continued sick leave, considering medical leave. Concerned about the decision to take the second Pfizer vaccination, on Sa-05-08-2021.

Very sore arm, fatigue, headache, then about 30 hours afterwards, extreme pain on right side under ribs, hard to breathe, went to ER, after several test performed, finding is PE in right lung and DVT behind right knee. I had signs of these weeks to months prior, have no underlying conditions before this happen, now I on Eliquis for blood clots! Also due to the blood clots have pneumonia!

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

Began noticing rapid heart rate and dizziness approximately one hour after getting first dose of COVID vaccine. Symptoms continued and worsened over next two weeks. Went to ER on April 11th, 2021, due to immense head pressure, BP over 200, and ringing in ears. My blood pressure and heart rate were checked at ER and were high, but came down after laying down for a while. I was given blood pressure medication, Amlodipine, 10 mg tablets. Medication had minor positive effects but symptoms continued to get worse. Returned to ER on April 14th, 2021. Same diagnostic testing was performed. I was given more BP medication and recommendations were made for how to lower blood pressure with diet and exercise.

Patient fainted for several seconds, minutes after receiving vaccine. Patient became conscious again and sat with his legs up for some time before leaving. He was checked out by EMT and did not want to go with the ambulance.

Unclear if event is related to vaccination but occurred 5 days after the 2nd dose of vaccine Pt admitted on 5/12/2021 with refractory cardiac arrest. (PMH unknown). Patient reportedly went for a walk with his wife. Upon returning home, he went to take the garbage out. The patient was found down approximately 15 minutes later in his garage. The patient's wife called 911 immediately?it is unclear if bystander CPR was initiated. EMS was on scene within several minutes and initiated CPR. The patient 3 shocks, and epinephrine. ROSC was achieved at approximately 14:41. At approximately 14:50, the patient again went into VF. He received an additional 5 shocks, 1 mg of epinephrine, and 300 mg of amiodarone. He went into asystole at approximately 1510. ACLS was continued and the patient was given an additional 1 mg of epinephrine. Upon arrival to the University of Minnesota cardiac Cath Lab, the patient remained in asystole with Lucas on. He was cannulated on VA ECMO. In the cardiac cath lab, he was found to have OM disease and diffuse CAD involving LAD Received intervention to his OM. Initial LA was 14.3. ABG 6.94/54/44/12.

After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.

Hospitalization, on ECMO, deteriorating lung function - now on lung transplant list, hx. sarcoidosis. Question of whether vaccination caused worsening of lung function / sarcoidosis. Still currently hospitalized. Transferred to our organization for ECMO. Hospital Course: Patient is 62y.o. male with PMH of Sarcoidosis who presented to the hospital with worsening shortness of breath. Over the past 2 weeks, patient has had worsening shortness of breath on exertion and also while talking. On 4/23, patient noted intermittent fever, TMax 102F. Patient was seen by his PCP on 4/25 and started on a zpack, and was also seen in our ED on 4/25. He was discharged home with OP pulm follow up. Since then, patient has been feeling progressively worse, He noted 4/27, that his pulse ox was in the 70s with ambulation and that the cough and shortness of breath were worsening. In ER, patient has been placed on 6 L of oxygen via nasal cannula. He was also febrile with TMax of 101.5 F. POC COVID-19 testing was negative. WBC was slightly elevated at 10.7, Na level was noted to be 129. PCT was negative. CTA PE protocol was negative for PE, there was significant interval progression of nodular and consolidative opacities throughout both lungs when compared to 2017, compatible with interval progression of sarcoidosis. Patient was admitted for further workup and management. Patient's oxygen requirements gradually increased. He was initially treated with IV antibiotics and antifungals. He underwent extensive testing, including urine histoplasma, cryptococcal, respiratory viral panel which will negative. TB QuantiFERON was indeterminate, along with elevated IgM mycoplasma for which he received azithromycin. Patient was also placed on IV Solu-Medrol initially, transitioned to IV Decadron. Inflammatory markers were elevated. D-dimer was noted to be greater than 10,000, he was placed on therapeutic Lovenox dosing. Patient did have Covid testing which was negative, he was also vaccinated. His oxygen requirements continue to increase, he was eventually placed on BiPAP, although due to lethargy and increased work of breathing patient was eventually intubated and sedated. He was also started on paralytics. Patient was transferred to another hospital for possible need of ECMO or lung transplantation.

body aches; chest pain; pressure on chest; low fever; cold; tested positive for covid 19; This is a spontaneous report from a contactable consumer report for self from a Pfizer sponsored program Covax US Support. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 10Apr2021 16:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within 4 weeks. Medical history included ongoing high blood pressure started 8-9 years ago. Concomitant medications included lisinopril (LISINOPRIL) taken for high blood pressure about few years; acetylsalicylic acid (BAYER ASPIRIN) taken to keep the blood thin and blood pressure; Carvedilol taken for heart valve, something to do with his heart since couple years ago. Patient received his first vaccine dose on 10Apr2021 and on 11Apr2021 tested positive for covid 19. He was at Emergency Department on an unspecified date. He went because he had body aches, chest pain, pressure on chest, once in a while had low fever, cold, and achy body. He was given a treatment, but doesn't know the name of what was given. It was through the Intravenous site. Patient no longer has symptoms and has completed his required isolation. He is due to get his second vaccine dose on 01May and asked do he get second dose or should wait. The outcome of 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.

Acute trouble breathing followed by fainting/loss of consciousness. Chest compressions were started as paramedics were on the way. Paramedics worked on my dad for over 30 minutes but were unable to revive him. They stated he went into cardiac arrest.

We do not have immunization info for dose 1 New onset stroke symptoms/Stroke Alert 5.18.21 @ 1244pm following second dose of vaccine administered 5.17.2021. MRI + acute stroke, emergent TPA administered. Currently remains inpatient on ICU level of care.

Anemia, Elevated Ferritin, Inflammatory markers, Transaminitis, Splenomegaly, Lymphadenopathy, HLH syndrome

Stroke; Left ventricular thrombus in his heart; This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: EW0153) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included coronary artery disease (several years ago) and had a bypass (several years ago; not ongoing). The patient's concomitant medications were not reported. It was reported that the patient had a stroke on 17Apr2021 after he formed a left ventricular thrombus in his heart in Apr2021. The patient was hospitalized for the events from 17Apr2021 to 23Apr2021 and was treated with Coumadin. The outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely for BNT162B2 vaccine since there is no plausible mechanism implicating the subject drug to the events. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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

Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown. Information on the lot/batch number has been requested.

past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19. Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell. He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results. On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough. The patient then developed complaints of chest pain and rib discomfort. He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9. Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia. At time of admission he was given IV Lasix and started on Rocephin and Azithromycin. The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.

Pfizer-BioNTech COVID-10 Vaccine EUA. Possible Atrial Fibrillation detected using Kardia EKG application. Event started at 11:30 pm. First EKG taken at 12:00 am and measured 156BPM. I took one baby aspirin (81mg), drank cold water and did controlled deep breathing technique .

The day after 2nd shot I was tired and was feeling chest pressure. Pressure lasted about 10 days and continues on and off. BP went up to 180/101 and remained high. went to urgent care, then primary physician. he heard heart murmur (never had before) and sent me to cardiologist. Prescribed BP meds.

3/22, admitted for NSTEMI 2 days after Covid vaccine. Patient was shoveling snow on the morning of March 22, 2021. Shortly after doing that, he developed chest pain. He did not immediately seek medical attention, however. Rather, he had a preexisting appointment with his primary care provider, which he went to later that morning. The PCP did an EKG and found him to be having an acute inferior ST elevation MI. The patient was subsequently transferred by EMS to the emergency room at the hospital and then was taken immediately for emergency cardiac catheterization. The catheterization revealed 100% acute occlusions of both the proximal LAD and the distal RCA. These were both opened and stented. There was 1 drug-eluting stent placed in the proximal LAD, and 2 overlapping drug-eluting stents were placed extending from the distal RCA into the proximal PDA. Postprocedure, the patient did well with resolution of his chest pain. His peak troponin was 38.6. An echocardiogram was done on March 22, 2021, and showed inferior akinesis and septal hypokinesis with an estimated ejection fraction of 45% to 50%. The patient was started on the usual medications post MI and PCI. On the morning of discharge, March 24, 2021, he is feeling well and is medically stable for discharge.

4/11-4/17 Stiff neck and shoulders. Could hear whooshing sounds of my blood circulating at times squeaking sounds 3 different occasions. Thought I might have an ear infection and called Teladoc was prescribed Oxi Clav 825 mg . 2x day. 4/25-4/26 significant temporary loss of control of left arm and left leg felt wobbly but intensity subsided to minor loss of mobile control.4/27 Left leg went totally numb from the knee down with no control couldn't wiggle toes , Left should went numb 2x left face went numb 1x Stroke, total blockage of left corroded artery

Pt reports dizziness started and increasing blood sugars after receiving second dose. Pt had ER visit related to dizziness

Fatigue, unspecified type Dizziness Fever, unspecified fever cause Weakness COVID-19 virus infection Office Visit 5/12/20Family Practice PA Family Medicine COVID-19 virus infection +4 more Dx Cough Reason for Visit Progress Notes (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/12/2021 Cosign Needed Expand AllCollapse All Assessment/Plan TENT. 1. covid positive - symptoms and diagnosis occurred x15 days ago. He was improving but starting yesterday he has developed R sided chest pain and has been slightly SOB. Cough has worsened as well. He has not been taking ASA, will rule out PE at this time. STAT chest CTA ordered, CBC, and CMP. Possibility of secondary pneumonia but will hold off on abx for now, review after chest CTA results. Continue Acetominaphen and hydrating. If any symptoms worsen or the following occurs go directly to ED; fever/chills, chest pain, SOB. Patient understands and agrees. If chest CTA rules out PE and shows pneumonia would cover w/ azithromycin/ceftin/prednisone. Diagnoses and all orders for this visit: COVID-19 virus infection - CBC; Future - Comprehensive metabolic panel; Future - CT angiogram chest pulmonary embolism with and without contrast; Future Fatigue, unspecified type - CT angiogram chest pulmonary embolism with and without contrast; Future Other chest pain - CT angiogram chest pulmonary embolism with and without contrast; Future Tachycardia - CT angiogram chest pulmonary embolism with and without contrast; Future

Patient presented to the ED on 4/4/21 and was admitted to another facility for intestinal obstruction. Patient presented to the ED on 5/6/21 and was admitted for hypotension due to hypovolemia.

Patient reported to have a sudden heart attack on 05/04/2021. Patient was hospitalized, released to rehab and released from rehab on 05/24/2021. Patient thinks that the heart attack is related to his covid vaccine 2 weeks prior. Patient denies having any health conditions previously leading up to the heart attack.

Day after 2nd dose, discomfort stayed in bed. 2nd day after dose shoulder pain radiating to chest, during night intense chest pain with extremely shallow breathing. By morning chest pain so bad I went to E.R. I was admitted with normal EKG and oxygen levels. Elevated test that indicates blood clot in lung. CT scan done. Diagnosis Pulmonary Embolism. Was admitted to hospital for 2 days while undergoing heparin and warfarin therapy and pain relief. Prescribed blood thinners for 6 mos. After release severe fatigue and low HGB levels limited walking of more than 50' without losing consciousness. It has been 1 month and still can only walk 100' without lightheadedness.

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.

Afib; came down with symptoms on the following weekend/had every Covid symptom except smell and taste/still has a lingering fever, body aches and cough tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 62-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW0171; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in the left arm on 27Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, was exposed during over the weekend then began having COVID symptoms. The patient came down with symptoms on the following weekend and is still suffering from symptoms. The patient clarified that he had every Covid symptom except smell and taste and that he still has a lingering fever, body aches and cough since 01May2021. The patient tested positive for COVID-19 on an unspecified date. The patient is due to get a second dose on 18May2021 and wanted to know if he should get the second dose. He also wanted to know if when he holds off for several weeks before getting second dose, would it affect the efficacy. The patient also reported that after the first dose he went into Afib and he had to be on a blood thinner. He knows that it mentioned something about blood thinners in the paper that he got after the first dose. He wanted to know if he should get the second dose since he had to be on a blood thinner recently. The outcome of the event Afib was unknown while the outcome of the event came down with symptoms on the following weekend/had every covid symptom except smell and taste/still has a lingering fever, body aches and cough tested positive for covid-19 was not recovered.

Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved. Information on Lot/Batch number was available. Additional information has been requested.

He got his vaccine, within 15 minutes he was staring, and was offered something to drink and some graham crackers and his wife said and the nurse came over to see what was going on, and said that he had an absent seizure, he was not responding to anything. His oxygen was 93, his BP dropped. The nurse was watching his eyes to see if there was any reaction, but there was not. They kept talking to him until he responded and he had no idea of what happened. He has not had any more seizures. He has never had any seizures in the past. He came out of it and they did not take him to the ER. He is fine now. He currently has cellulitis around his eye.

Eyes open in fixed stare for approximately 30 seconds. Would not respond verbally. Was pale and skin clammy. Cool cloth to base of neck. Waiting in personal van with passengers seat partially reclined. Back to normal state by end of 15 minutes wait. VS were BP 97/66, pulse 57, pulse ox 97% Held for additional 15 minutes to further monitor. Was able to lay down for first Covid vaccination and had no adverse reaction(s). States his mother also reacts porky to any injection.

Minor intermitting chest pains started about 10 days after 2nd shot and continued to increase in duration

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.

Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

About 3 weeks after my second Pfizer shot my blood pressure has spiked from a normal of 130/70 (medication controlled) to 150+/80, and has not responded to an increase in my Losartan as directed by my physician. My hypertension has been very stable for years, the only change is receiving the COVID vaccine. As recently as March of this year I had my annual physical and my BP was under control.

AT about 11 pm I got up to go to bed, and all of the sudden I felt like I was freezing and shaking violently. I couldn't even hold my phone to call 911. I passed out. I woke up about 3AM on the floor. I was shivering. I got to bed, called my girlfriend, then fell asleep. The next morning it felt like I had COVID again, I had COVID back in December. I called the doctor, and they if I experienced it as bad as the night before then I should go to the ER, otherwise stay in bed, rest, and drink fluids.

I experienced a distorted vision problem covering the upper left corner of my visual field. I assumed it was fatigue. When it didn?t get better by 4/1/21, I went to Patient First be checked out. They sent me to Advanced Eye Care to follow-up with an ophthalmologist. She confirmed that the vision loss was being caused by something in my brain, at which time she sent me to the ER. At the hospital, an MRI revealed that I had suffered a stroke in the lower right rear side of my brain that was affecting my site in the upper left part of my visual field.

sometimes get pain in the area of the heart, which was short in duration; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8792), via an unspecified route of administration, administered in left arm on 13Apr2021 13:00 (at the age of 62-year-old), as 2nd dose, single dose for COVID-19 immunisation in pharmacy. The patient had no have other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) administered in left arm on 23Mar2021 14:00 as single dose for COVID-19 immunisation. After the second dose on 14May2021, the patient sometimes got pain in the area of the heart, which was short in duration. The patient had it for a couple days about a month after the second dose, but it went away. Now (at the time of report), again patient had it for the past two days. It seems to go away if the patient did not exercise (exercise routine is very mild). The patient did not receive treatment for the event. The outcome of the event was resolving. Information on Lot/Batch number was available. Additional information has been requested.

After my vaccine on 03/17/21 I started experiencing a rapid heart beat and at time my heart would skip! I reported this to the Covid 19 hotline immediately and also notified my doctor! My doctor scheduled a visit and did an EKG and also ordered a heart monitor which I wore for two weeks. The report from that went to Dr, a cardiologist at clinic where I was diagnosed as having Afib. I was shocked since my heart has always been healthy and heart disease does not run in my family! I was put on a beta blocker because of the concern of having a stroke! A follow-up visit to discuss a procedure that will fix my Afib in scheduled for 06/22/21.

Possible blood clot in left leg; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 22Mar2021 14:00 (Lot Number: EP7534) as 2nd dose single dose at the age of 62-year-old for covid-19 immunisation. Historic vaccine included bnt162b2 dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 14:00 (Lot Number: EN6203) as 1st dose single dose at the age of 62-year-old for covid-19 immunisation. Medical history included heart, diabetes, gastrooesophageal reflux disease(gerd), arthritis, high blood pressure (HBP) from an unknown date. Past drug event included diltiazem (CARDIZEM) and experienced known allergies to diltiazem. Concomitant medications included clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), metformin, metoprolol, and semaglutide (OZEMPIC), all taken for an unspecified indication, within 2 weeks of vaccination. The patient experienced possible blood clot in left leg on 19May2021 05:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No other vaccine in four weeks. The outcome of event was not recovered.

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

Pt states month after 2nd dose chest tightness, sweating, fatigued. Since then no breath, low energy. Feels like his heart is pounding out of his chest. Doctors ordered stress test, Ekg 04/28/2021. Extreme mental state stress.

chest heaviness/discomfort/ dull pain next to left arm till today no treatment usually constant discomfort till today

On the left side of the callers face down to his chest, pain and itching and burning and a rash. The caller went to the ER and the doctors gave benadryl and cream and said it was an allergic reaction. there is still a rash, and it is burning and painful.

Blood pressure spike above normal. Took multiple reads via an automated BP cuff/machine: 137/73 and 133/75 and 2 or 3 similar readings over ~ 2 hours. Friday, 6/26 I checked BP and readings returned to normal range : 114/67, 117/75, 107/61. Heart rate normal ~ 57 bpm.

2 months later I had two insect bites and the second day I had a severe case of hives (I have never had hives before). This lead to anaphylactic shock resulting in low blood pressure and passing out. EMTs administered saline/epinephrine/steroid. Currently Doing follow up for allergies. Stopped taking lisinopril.

Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine; Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine; This is a spontaneous report from a contactable nurse reporting for her husband. The report was not related to a study or programme. A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 5:45pm (at the age of 62-year-old) as single for covid-19 immunisation. Medical history included ongoing High blood pressure, BPH (benign prostatic hyperplasia) from an unknown date and unknown if ongoing and hip replacement for osteoarthritis. It was reported that within the last two years, her husband was not taking medications for this diagnosis. The patient had no family medical history relevant to adverse events. Concomitant medications included Amlodipine taken for high blood pressure; VITAMIN D3, started may be a year ago taken to support strong bones and immune health, curcuma longa rhizome (CURCUMIN TURMERIC), started maybe about a year and a half ago taken for antioxidant benefits, Paracetamol (TYLENOL), started few years ago for sleep and Melatonin, started from two years (sometimes it was a tablet and sometimes it was a sublingual lozengier) taken for sleep; all started on an unspecified date and ongoing. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 5:45pm (at the age of 62-year-old) as single for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not have any events prior vaccinations. She stated that she was not aware that her husband has had any vaccinations as an adult. On 5May2021 at 3 pm, the patient experienced right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine. The clinical course of the events as follows: She stated that his symptoms began on 05May2021. She reported that on 5May2021, her husband went through the emergency room, and had a stroke alert, called, and then was admitted to the hospital. On 6 May 2021, the patient was hospitalized for Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine. The patient admission diagnosis was left arm ataxia with neglect. The patient had some emotional issues and was not sure if it was from the stroke or from anxiety because of the event. She stated that her husband had a small CVA (cerebrovascular accident), cardiovascular accident, within 3.5 weeks of his second dose of vaccine. She stated that the doctors called his CVA as cryptogenic. On 6May2021, the patient lab tests included: CT scan (Computerized tomogram head) Scan of brain, two: Result: right parietal lobe acute cryptogenic small vessel CVA. MRI (Magnetic resonance imaging head) of the brain shows acute to subacute completed infarct involving the right parietal high convexity, CTA (CT angiography) of the head and neck shows no large vessel occlusion. The patient was discharged on 07May2021, with some lingering problems of his left arm, and spatial concerns. The patient discharge diagnosis was right parietal lobe acute cryptogenic small vessel CVA. Reporter seriousness for Right parietal lobe acute cryptogenic small vessel CVA: with left arm involvement and spatial concerns, and emotional issues, after the second vaccine was hospitalization. She reported that her husband had no underlying reasons to have the CVA. She reported that from a physical perspective, he was recovered completely. His left arm symptoms, cleared up, by 12May2021. She mentioned that her husband felt his symptoms went away, maybe about 12May2021. The patient was resolved from left arm symptoms on 12May2021, and the other events were resolved on an unspecified date in 2021. She stated that she was not sure if anyone else had reported this, but she would know, that some of the other vaccines had problems. Further follow-up is needed. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Early that morning I woke up seeing pink out of my left eye. I went to eye doctor and they found I had a mini stroke behind my left eye.

faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.

63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and intolerance to exertion that has become steadily worse despite supportive therapies. He reportedly completed outpatient ABX from PCP within the past 2 weeks and suffers ongoing deterioration of his breathing accompanied by night-sweats, chills and fever. 1st Vaccine on 5/27/21, 2nd 6/17/21. hypoxemia secondary to large left sided pneumonia.large left sided effusion with compressive atelectasis and question of infectious vs malignant origin.acute hypoxemic respiratory failure requiring HFNC. Patient admitted to the ICU on our service for ongoing care.Hospital Course:Mildly elevated BNP and non-diagnostic EKG.Findings consistent with bilateral pneumonia, large left complex parapneumonic effusion versus empyema with compression of left lung and evidence of external impingement on LV. Systolic blood pressures ranging in the 80s to 90s with MAPs ranging from mid 60s to mid 80s with heart rates in the 90s, which may be attributed to diminished LV filling. Transferred 6/26/21.

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

After I got my first Pfizer vaccine my heart became out of rhythm and I was later diagnosed with afib by a cardiologist. This does not run in my family! My hear was perfectly fine before the vaccine!!

Started with rash around belly and spread so went to ER. They gave him steroid shot, Benadryl, and one other thing he could t remember. things got worse. Blood pressure got very low, dizzy, nurse couldn?t get a pulse ox reading, fingers turning blue. They thought he was having allergic reaction to shot. Gave him Epipen. He said things got better then

Mild heart attack, with elevated cardiac enzymes, after second vaccine; Mild heart attack, with elevated cardiac enzymes, after second vaccine/ his heart enzymes, were elevated; High Blood pressure, after second vaccine/ Caller states his blood pressure was very high; Elevated heart rate, after second vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm (did not specify side) on 17Apr2021 at 12:00 noon (at the age of 62-years-old) () as dose 2, single for covid-19 immunization. Vaccination facility type was Pharmacy/ Drug store. Vaccine was not administered at military facility. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 20Mar2021 at 12:00 noon (at the age of 62-years-old) (Batch/Lot Number: EN6204) as dose 1, single for covid-19 immunization. Vaccination facility type was Pharmacy/ Drug store. Additional vaccines administered on same date of the Pfizer suspect was reported as no. Second dose of vaccine given 28 days after the first dose, on 17Apr2021. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as no. AE following prior vaccinations was no. Family Medical History Relevant to AE: Patient stated his mother had high blood pressure. Patient stated he was calling about the Pfizer vaccine, Covid, he just came from the doctor's office. Patient reported that after the second vaccine, he had a mild heart attack, and his blood pressure was elevated, he was not sure, it was from the vaccine, but his doctor recommended that he call, to report the event. About mild heart attack, stated in the afternoon, while he was at work, he was admitted to the hospital, he did not think the doctor saw the heart attack, on the EKG, also his blood pressure was very high, and reclarified, his heart enzymes, were elevated. Dates of hospitalization was unknown. Patient stated he was admitted to the hospital, and the next day, they went through his heart, with a camera to see if he needed a heart stent and said he did not need a stent. He just had a cardiac stress test, and was still recovering, he was scheduled for Cardiac Rehabilitation and was put on some blood pressure medications. About high blood pressure, patient stated the doctor thought his high blood pressure, caused his heart attack and it was the high blood pressure, that may have caused the enzymes, to elevate, it happened in the afternoon, while he was at work, his heart rate and blood pressure were elevated today, for his test, and the doctor recommended, that he call Pfizer. About elevated heart rate, stated in the afternoon, while at work, the doctor wanted him to continue to monitor his heart rate, because it is still somewhat elevated. Patient added that on 01Jul2021, he would begin a cardiac Rehabilitation program. The events mild heart attack, heart enzymes elevated, elevated blood pressure and elevated heart rate started on an unknown date in Apr2021. The events mild heart attack, heart enzymes elevated, elevated blood pressure and elevated heart rate resulted in emergency room and physician office visit. The events mild heart attack and heart enzymes elevated resulted in hospitalization. The events assessed as serious. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on Apr2021, cardiac stress test: unknown results on 23Jun2021, electrocardiogram: unknown results on Apr2021, heart rate: elevated on Apr2021 blood pressure heart enzymes: elevated on Apr2021. Therapeutic measures were taken were taken for the events. The clinical outcome of heart attack and heart enzymes elevated was recovering, whereas for high blood pressure and elevated heart rate was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Extremely high sugar levels; Shortness of Breath (am COPD to begin with); flu-like symptoms; Malaise; Chills with no fever; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EN6198, expiration date not provided) via an unspecified route of administration (age at vaccination 62-year) in Left Arm on 02Mar2021 at 08:00 AM as DOSE 2, SINGLE for COVID-19 immunization. The medical history included chronic obstructive pulmonary disease, diabetes mellitus, coronary artery disease, and reaction to preservatives (known allergy: Food sulfites (MSG)) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9269) administered in Right arm on 12Feb2021 at 08:00 AM for COVID-19 immunization. There was no COVID prior vaccination reported. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. On 03Mar2021 at 03:30 AM the patient experienced extremely high sugar levels, shortness of breath, flu-like symptoms, chills with no fever and malaise. It was reported that extreme onset of flu-like symptoms almost 20 hours after shoot. Chills with no fever. Shortness of Breath (am COPD to begin with). That relaxed after about 12 hours, but SOB continued. General malaise continued for a few days. Extremely high sugar levels persisted for a few days, readings over 500 and once even over 600 which is rare for me (diabetic). The patient underwent lab tests and procedures which included blood glucose increased: 500 (over 500) and blood glucose increased: 600 (over 600) on 03Mar2021. No treatment was received for the adverse events. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; Congestive Heart FailureFluid Buildup in lungsEnlarged HeartPalpitation in beating of heart; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8734, expiry date not reported), via an unspecified route of administration, administered in right arm on 30Mar2021 09:30 (at the age of 62 years old) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The most recent COVID-19 vaccine was administered in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (lot number EN6206) as Covid-19 immunization on 09Mar2021 9:30 am (at the age of 62 years old) administered in the right arm. On 19Apr2021 21:00, the patient experienced congestive heart failure, fluid buildup in lungs, enlarged heart, and palpitation in beating of heart. The events were reported as serious, hospitalization on unknown dates for 4 days, disability, and were life threatening. Adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken in response to the events which included unspecified medicines. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events reported was not recovered.

About 2 weeks after vaccination received, patient states he began to have more fluctuations in his glucose levels as well as heart palpitations. Reports that his glucose levels do not generally go above 180. As glucose levels kept increasing, patient began exercising more. In early July, started to have levels in the 400s. Started to feel more dizzy & weak and had polydipsia and increased frequency of urination. He went to the Emergency Room on 7/8/2021; glucose level was 373. He was given IV fluids and 6 units of regular insulin. Glucose level came down to 252 prior to being sent home and instructed to follow up with his Doctor. Patient had follow-up labs on 7/12/2021, which show hemoglobin A1c of 10.0% and glucose level of 272. Prior to vaccination, patient's hemoglobin A1c was 6.5% and glucose level 135 on 1/29/2021. Historically, this patient's A1c has been between 5.3 and 6.5 since 2014. His BMI is 28, actively exercises and has been adherent to his diabetes regimen of metformin 500mg twice daily.

Patient calls with report of irregular heart rate, shortness of breath, chest congestion, sinus congestion, loss of smell. There have been three positive COVID cases at his work. He is full vaccinated. Reports hx of afib.

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

COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "COVID-19 PCR test/he was positive per the PCR test" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded

Severe shoulder ache followed by muscle tightness in neck, lasting several hours. On subsequent days muscle pain continued sporadically in neck, mid-back , and chest. Hot/ fLushed feeling accompanied back and chest pain but no elevated temperature was observed. On day 5 the left shoulder pain returned with a vengeance for about 4 hours, centered at the injection site.

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

First shot was 1/22/21, light headedness afterwords but no other. On Jan 27th blood pressure dropped so stopped high blood pressure meds. on 1/29 noticed blood pressure going up. Began meds with no effect. Has been going up to 198/112 during the week. Went into Hospital on 2/1. BP high, did blood work, ecg, released when BP dropped to 156/90. On 2/2 possible atrial fib and blood pressure up to 180/106, drove 280 miles to Clinic where they kept me overnight and did blood work, ecg, echocardio, xray and released me on 2/3 with double dosage of linisipril to 40 mg. Blood pressure did not go down and seemed to go up when I took the linisipril. 2/6 Drove back to clinic again and went into ED. BP 175/103, ecg switched bp meds to 50 mg Losartan and discharged. Drove home on 2/7. 2/8 blood pressure back up to 173/108 bpm 62 at 1:15 pm.

Recurrence of Atrial fibrillation; Recurrence of Atrial fibrillation; This is a spontaneous report from a contactable physician (patient himself). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on the right arm on 25Jan2021 13:00 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD (gastrooesophageal reflux disease), and atrial fibrillation, all from an unknown date and unknown if ongoing. The patient had prior ablations for Afib. The patient had no allergies to medications, food, or other products. On 04Jan2021, 18:00, the patient took the first dose of BNT162B2 (lot number and expiry date unknown) via an unspecified route of administration on the right arm at a single dose for COVID-19 immunization. Concomitant medications included dofetilide, diltiazem, loratadine, rosuvastatin calcium (CRESTOR), and omeprazole (OMEPRA); the patient received these medications within 2 weeks of vaccination. The 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. The patient has not been tested for COVID-19 since the vaccination. On 28Jan2021 02:00, the patient experienced recurrence of atrial fibrillation after 6 months, the last episode was within a month after an ablation. No treatment was received in response tot eh event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The reported recurrence of atrial fibrillation was more likely due to natural recurrence of underlying atrial fibrillation, and unlikely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

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

Shortness of breath - Initial ED Comments: Patient is a 63 y.o. male patient presenting to the ED via EMS with c/o shortness of breathin which began this morning. EMS reports that the pt had a bilateral lung transplant 1 year ago and has been on cyclosporine and cellcept. EMS also reports that the pt recently received his COVID vaccine. Pt denies fever, chills, chest pain, abdominal pain, back pain, nausea, vomiting, or lower extremity edema. EMS reports that the pt does not normally require supplemental O2 but states that his O2 sat was 75% on 3 L NC home O2. EMS reports that they gave 2 albuterol, 1 Atrovent, and solumedrol. EMS also reports that they placed the pt on 10-15 L NRB and states that his O2 sat was stable at 100%. Pt denies any aggravating factors for his symptoms

Heart palpitations, they lasted from 3 hours after vaccine until the following afternoon, around 26 hours.

Client stated feeling warmth and flushed face after receiving Pfizer Covid-19 vaccine, dose. Client was sitting in post vaccine waiting area. At 1023 EMT noticed client appeared uncomfortable in chair and asked how we was feeling. Client stated feeling warm and EMT saw face was flushed. PHN was alerted. When PHN arrived, client was sitting near doorway, face flushed, and was speaking with EMTs. Client alert and oriented, stated feeling warm and sweaty. EMT assisted client to remove jacket to take vitals. 1027 vitals:blood pressure 145/90, pulse 66, o2 97, respirations 16. Client denied shortness of breath, chest pain, dizziness, headache. Flushed face, did not radiate past face, no swelling noted or rash. Allergy to penicillin and client was already aware to wait 30min after vaccine. Per client did not take blood pressure medication this morning. List of medications: allopurinol, toprol, pantoprazole, colchicine, lasix, potassium, crestor, vitamin D, praluent, eliquis, spironalactone, nitroglycerin and hydrocodone. Client given water and instructed to take small sips at a time. Client informed he would be observed for 30 minutes. Vitals 1034: blood pressure 150/70, pulse 60. Flushed face same, not improving. PHN offered client if he would like benadryl, client denied. Vitals 1040: blood pressure:130/90, pulse 61, o2 95 , respiration 16. Client stated symptoms improving. Last set of vitals at 1053: blood pressure 120/80, pulse 60, o2 95, respiration 18. Client alert and oriented, stated warmth feeling improved, face still flushed, not worsening. Client advised to speak with provider prior to receiving second dose. ER precautions given, wife driving client home. Client left facility with steady gait.

One week to the day after my second shot, overnight I came down with a sore throat which turned into chest congestion, coughing, sinus discharge (green) tightness of my chest. This came on extremely fast. I had to take 2 days off work. I saw my family physician, who sent me for chest X-rays. Came back negative for COVID, but showed signs of Bronchitis. I have been subject to sinus infections, but have not had any issues in over 5 years. I have never had issues with Bronchitis. My Family doctor prescribed Prednisone & Levaquin. One round did not take of the issue. I received a second round of both. It has not cleared up my coughing/congestion. I still have a sinus discharge (green) infection to date.

Pt presented for second vaccine and stated after his first vaccine he experienced severe chest tightness. He was watched by the EMS but the symptoms never progressed. Prior to receiving his second dose the patient was given 50 mg Benadryl, waiting 15 minutes and then given his vaccine. The patient felt well and did not experience any symptoms. The patients wife was the driver.

I have intermittent A-Fib and didn't have an episode of A-Fib for 3 weeks. In fact I came out of A-Fib immediately after the first dose of the vaccine on February 15, 2021. After the second dose of the vaccine at 10:00 A.M. on March 8th I went into A-Fib at approximately 2:00 A.M. on March 9th. I was out of A-Fib and back into a normal sinus rhythm at approximately 2:00 P.M. on March 9th.

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

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

Two (2) days after receiving the 1st vaccine shot I began having pulse irregularities being detected when taking my blood pressure. The detection has occurred 4 times in the last 2 weeks. I have never received this detection previously.

Neck, shoulder, arm, trunk pain. chills. neck and axilla adenopathy. possibly related to using NSAIDS around vaccination

Approximately 5-10 minutes after first covid vaccine, patient was witnessed to become pale, eyes roll in the back of head, become stiff, and fell backwards in chair and onto floor. Patient hit back of head after fall. Patient was laying supine on floor and lost consciousness for approximately 30-60 seconds. He did not respond to name or place when asked. He had a strong pulse and was diaphoretic. After approximately one minute, patient opened eyes and stated his name and where he was. During this event, Code Medic was called by another staff member. Patient continued to talk to writer while waiting for code team to arrive. He stated that he had no pain and was starting to feel better. Report given to code team and care transferred. Patient taken to ED for further evaluation.

Decedent began noticing symptoms on 3/17/2021. He c/o worsening back pain, joint pain, headache and stiffness last Sunday (3/21/2021). Today (3/25/2021), he c/o chest pain. The decedent received his COVID-19 vaccine on 3/16/2021.

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

Patient received his 1st dose of PFizer vaccine and about 10 minutes after the injection he got pale, diaphoretic , and lighteaded and dizzy. He was removed from the cell and taken to medical observation. he stated that he had this before when he got a shot for yellow fever . he stated that he also did not have breakfast, patient blood pressure on arrival was 119/82 HR 65 and oxygen on room air was 93%. He was observed for an additional He denied nausea, follow up blood pressure was 123/80 laying, sitting on the edge of the bed he was 105/78 HR, 72.. he then stood for 1 minute and follow up blood pressure was 133/68 HR 77. Patient reported that his symptoms have resolved . His color had returned as well and was reporting feeling better.

Pt developed left facial numbness and sensation of heat and numbness in the left arm and numbness into the leg and foot. Symptoms started at 1:36 pm while walking to catch train. Pt noted numbness and felt light headed. Pt had mild headache that he associated with not eating much. Pt returned back to urgent care because of symptoms and RR team called. Pt had given blood for tests (12 vials) and abdominal ultrasound earlier in the morning as work up for his chronic renal insufficiency. Pt drank several cups of water before the ultrasound. Symptoms initially improved but did not resolve, so he was sent to ER for stroke. Pt had 3 more episodes of worsening left sided numbness and lost consciousness on 2 of those occasions per the patient. Neurology evaluated patient and said that they were likely thalamic strokes. Pt was unable to have an MRI because of metal in his eye.

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.

The patient stated he felt fine the day he received the vaccine. However, starting the day after, he developed dizziness, achiness and a headache. These symptoms progressively worsened over the course of several days. On day 6 after receiving the vaccine, the patient stated his right leg started dragging and he had a difficult time functioning. The patient drove himself to the ER where he collapsed. A bleed in the brain was subsequently discovered and the patient underwent surgery, where he spent 3 days in the ICU. The patient was later discharged. As of today, the patient states he has resumed normal function

Patient suffered a stroke 6 days after receiving the 1st dose of his Pfizer vaccine. He initially developed left arm numbness and tingling which prompted admission to ER. Later that same day, he had significant worsening with left hemiparesis. MRI demonstrated right hemispheric ischemic stroke and focal right carotid ruptured plaque. Somewhat unusual given his overall good health and lack of risk factors. Has never smoked, exercises regularly and carotid duplex performed in 2017 demonstrated less than 50% right internal carotid artery stenosis. Takes aspirin daily. Currently remains hospitalized with significant left upper extremity paresis. Minimal left leg function. Did require carotid endarterectomy. The plaque rupture was focal and hemorrhagic with no significant evidence atherosclerotic plaque beyond the focal ruptured plaque.

Patient presents with history of noticing some tachycardia. Symptoms started 5 to 7 minutes after he got the first Covid vaccine. He has a history of A. fib. He denies any chest pain. Has also had TIA in the past. EKG completed and no a-fib. HR 62 and BP 130/92. Patient offered further evaluation at ER and refused.

After about 6 or 7 days of receiving dose #1 of Pfizer vaccine in my left arm, I experienced sharp/severe left-chest and upper left-back pain for a few days and the pain gradually decreased until it was finally gone as on 04-07-2021.

After mandatory waiting time of 15 minutes I left the facility, during driving to home I started feeling some sort of dizziness and palpitations. I completed night duty at work, had my last meal at 5 am , I went to bed at 8 am, wake up at 1 pm to go for vaccination, just had water but no food. I turn back to facility and reported, they ask me to sit for some more time, I took water and was feeling better.

Died from cardiac arrest; 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, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 24Mar2021 as single dose for COVID-19 immunization. Medical history included heart disease, kidney issues, and physical disability from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin; spironolactone; lisinopril; and ubidecarenone, vitamin e NOS (COQ10 COMPLEX) taken for an unspecified indication. The patient previously received the first dose of BNT162B2 on 03Mar2021 11:00 AM, on Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was reported to have died from cardiac arrest on 26Mar2021. The reporter did not know if it was related to vaccine. The patient died on 26Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: It appears he died from cardiac arrest.

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

After patient took the first shot for 2 weeks, he suddenly could not breathe and hold his hist very tight in the morning while he was sleeping. My mom tried to wake him up, and he woke up and thought he was dreaming. He was fine during that time and we did not realize it might be caused by the vaccine. However, after patient took the second shot of the vaccine for 2 days, he suddenly could not breathe again and hold his fist very tight and bite his teeth very tight while he was sleeping. We try to do the CRP for him right away and called the ambulance at the same time. We try to wake him up, but he had no consciousness. And we realized that it might be the vaccine's problem.

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

Family member reported to this Nursing Supervisor patient suffered stroke 04/13/2021 at the patients home. Family discovered patient 04/14/2021 and taken to Hospital then life flighted to another hospital. Family reports he has left sided paralysis, slurred speech, nasogastric tube placement and currently in neuro ICU.

Patient was complaining of being really hot & dizzy. His eyes rolled and he lost consciousness for a few seconds. He was pale and diaphoretic. Made some chocking sounds. Denied any swelling of the throat or tongue. He was lowered to the ground and ice packs applied under his arms. 911 was dispatched and the medics came to attend.

CTA showed extensive bilateral PE involving R and L-pulmonary arteries with extension into lobar, segmental and subsegmental branches with questionable heart strain. LE US showed L-DVT in L-femoral vein, popliteal vein, posterior tibial veins, gastrocnemius vein. He denies any prior COVID diagnosis and reports 2nd dose of Pfizer vaccine on 3/31. Patient treated with heparin infusion and subsequently discharged on xarelto. No urgent mechanical thrombectomy or catheter thrombolysis was done.

dizziness and loss of coordination in left leg; diagnosed TIA at hospital per symptoms; MRI and echocardiogram were normal

Acute right lower lobe subsegmental pulmonary embolism. Patient presented with right-sided, intercostal chest pain and shortness of breath. CT angiogram revealed a PE with small infarct, no heart strain. Patient started on pain medication and anticoagulation. Anticipate full recover and discharge the day after hospital admission. This is hospital day 1.

patient is 63-year-old male, active smoker with no history of hypercoagulability or malignancy is admitted in hospital for DVT in left popliteal vein. He received first dose of Pfizer vaccine for COVID about 1 week ago. Patient's PTT was high on presentation even before being started on heparin. Due to sudden drop in hemoglobin patient's heparin drip was suspended since 4/12. Mixing studies showed partial correction consistent with acquired factor inhibitor. Factor VIII levels less than 1 consistent with factor VIII inhibitor. Patient was started on FEIBA at 100 units/kg every 12 hours, tolerated very well, In order to eliminate the inhibitor immunosuppressive therapy was initiated: Will continue Solu-Medrol 80 mg daily and Cytoxan 2 mg/kg daily. This treatment will continue until his clinical stability is achieved, at which point taper will be initiated. Patient required 2 transfusion over the course of the hospitalization. Currently, he is stable but still hospitalized and receiving treatments. No signs of new bleeds.

multi focal pneumonia; atrial fibrillation/the second worst feeling he has ever had since he had his first heart surgery; arm started hurting real bad/a severe pain that radiated down to elbow, arm, chest; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021(Lot Number: EN6204; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included acute diabetes, acute thyroid disease, covid like in 2021 (10 weeks before), 3 heart surgeries with 12 stents, ongoing chronic obstructive pulmonary disease (COPD)slight case diagnosed in 2016-2017, bad thyroid from 2006 and ongoing and told he had full blown Hashimotos in 2017, bad diabetic from 2015 and ongoing and went into diabetic type coma on 18Dec2015 (sugar when got him out of the parking lot cause he had to drive there was 738 or 768 put him in ICU from 18Dec2015-25Dec2015. Had to give him shots like every 2 hours. Started giving him insulin there but insurance wouldn't approve it so kept him on Metformin. Like 5th or 6th day got it under control), bad heart from 2007 and ongoing (In 2017 he had a heart attack they call 'widowmaker', he was told he hemochromatosis like his brother and sister. Caller stated they got it from his parents, but the doctors can't find it now. He had 3 different heart surgeries and has 12 stents in him. 9 weeks before (2021), he went to the hospital because of his heart, got a real bad heart, been put on a heart transplant list, they told him his blood tries to flow backwards and all of it's going over to the right chamber; after 2 hours after he had been admitted to the hospital they told him he had had a heart attack, level 3-they knew from blood tests they'd done. About 1 hour later said test was positive for COVID. He had no symptoms. While in hospital they gave him Zinc, Vitamin D3, Vitamin B1 and that was it. They kept him 5 days at the hospital. Also reported that went to the hospital for triple bypass heart surgery when he got in said somethings wrong, watch everything on the monitors wouldn't tell him nothing; said your widow maker is completely blocked up 99% had to go in and unblock that up so they can't do any kind of bypass on him again. The only thing they can do was heart transplant or heart graft where they take part of the left chamber and he din't have but like 18% of that left, take it come over whatever they're talking about, he doesn't know it's a heart graft whatever they're talking about there), 2 hernia operations, hemochromatosis (little sister and older brother has hemochromatosis-patient got hemochromatosis (too much iron in the blood) from 1 gene from his mother and 1 gene from his father. Brother doesn't have it anymore; but patient's and his sisters mutated); ongoing blood pressure abnormal; anxiety; ongoing wheezing; ongoing chronic Atrial fibrillation. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken to help blood to be thin from 2007 and ongoing; levothyroxine taken for Bad thyroid from 2006 and ongoing; metoprolol succinate taken for blood pressure from 2015 and ongoing; clonazepam taken for anxiety from 2012 to an unspecified stop date; fluticasone propionate taken for sinuses from 2015 and ongoing; insulin glargine (LANTUS) taken for diabetes from 2019 and ongoing; insulin aspart (NOVOLOG) taken for diabetes from 2019 and ongoing; salbutamol (ALBUTEROL HFA) taken for wheezing from 2018 and ongoing; budesonide, formoterol fumarate (SYMBICORT) taken for COPD from 2018 and ongoing; amiodarone (AMIODARONE) taken for atrial fibrillation from 22Mar2021 and ongoing; amoxicillin, clavulanate potassium (AUGMENTIN) taken for an unspecified indication from 22Mar2021 to 29Mar2021; apixaban taken for prevent blood clots and chronic Atrial fibrillation from 22Mar2021 and ongoing. The patient had pneumonia shot and flu shot took that in Sep2020. The was no vaccinations within 4 weeks prior to the BNT162B2.The patient previously received Xanax for anxiety from unknown date to 2012; received Humalog , Glipizide and Metformin for Diabetes. The patient got his first Pfizer COVID-19 Vaccine shot on Monday 15Mar2021 at sometime between 15:30-16:00. Not even an hour after he got the Pfizer COVID-19 Vaccine shot his arm started hurting real bad, felt like a hot ice pick was in his arm-described as it started locally just in one spot, then started getting worse going down to his elbow. About 30-45 minutes after got out of there, he was sick, didn't know what was wrong with him. Also reported as by 16:30 he felt bad and pulled up to a friends house. He would say it was an allergic reaction; starting in his arm, a severe pain that radiated down to elbow, arm, chest, it was hard to breathe since 18Mar2021. He went to a friends house after getting the shot, and by the time he got to the friend's house, he felt sick and laid down for about two hours and just kept feeling worse and worse. After that he went home and went to bed. He stayed in bed Tuesday, 16Mar2021, Wednesday, 17Mar2021 and was able to drag himself out of bed to at least go to the bathroom on Thursday morning, 18Mar2021. When he got out of bed, he couldn't breathe. When he got up Thursday morning he couldn't even move his whole left side, had to grab nightstand and pull himself up to stand up out of the bed; stumbled to the bathroom about 3 feet away.He made his way to the phone and called his sister to tell her to call an ambulance because he couldn't breathe. When he got to the emergency room he was told he was in atrial fibrillation. He stayed in the hospital with primary diagnosis as multifocal pneumonia with atrial fibrillation. Feeling like heart beating out of his chest, machine going off every 2-3 minutes. It took about 9-10 hours to get the atrial fibrillation under control. He stayed in Hospital for 4 days-admitted 18Mar2021-discharged 22Mar2021. He spoke to his heart doctor who said it was hard to breathe due to the Atrial fibrillation and all his doctors say they did not know whether it was a reaction to the covid vaccine.He heard the doctors talking and they were saying they didn't think he was going to make it. His heart rate was going between 80 and 200. He had 3 different IV's going in each arm shooting different heart medications in him and the doctor explained that the medications didn't mix well, could not go in the same IV at the same time. The patient shared that this was the second worst feeling he has ever had since he had his first heart surgery. He meant they thought he was dead or dying he lost feeling of everything. His arm felt better, but every now and again felt like a little knot or something was in there. He was breathing better, they gave him inhalers, albuterol. He thought that his heart doctor was going to start him on oxygen. He went to his Cardiologist on 01Mar2021 on Monday, 2 weeks before getting his first Pfizer COVID-19 Vaccine: cardiologist told him his triglycerides raised up about 15 was about 268. All his Cardiologist did was change his blood pressure medicine. Went to his Endocrinologist on 08Mar2021 Monday, 1 week before he took the Pfizer COVID-19 Vaccine: Endocrinologist raised his Lantus SoloStar U-100 insulin 100 units/mL (3mL) from 60 units nightly to 64 units nightly then. All his other blood tests were good, they just said keep doing what you're doing.The outcome of all the events was resolving. Follow-up attempts are completed. No further information is expected.

Patient had a stroke that began the morning of 3/14/21 around 10 AM. He was in the bathroom at the time by himself and fell as he became disoriented as a result of the stroke. His diagnosis on 3/15 was "intraparenchymal cerebellar hemorrhage with intraventricular extension". Right-sided 7.0 French triple lumen IJ central venous catheter placement under ultrasound guidance was completed on 3/15 as well.

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

Took my last shot of Pfizer on 4/10/2021 at 10:00 AM and on4/12/2021 started having shortness of breath,tiredness, and chest pains this continue on until 4/15/2021 while I was at work at 6:15 PM my wife had to be called to come pick me and take me to the hospital where they did a Cat scan and discovered that I had Blood Clots In both Lungs and had to remove them at that time in order to save my life

patient stated his daughter found him ?unconscious and he was rushed to the hospital, he stated he still has facial paralysis and is experiencing difficulty eating?. I attempted to contact patient and voicemail was full. Alternate number was given and wife answered the phone. interpreter use during call. Wife reported her experience with vaccine and reported husbands as well. States, her husband is at work and cannot talk on the phone, he may be home late?. Wife states her husband received Pfizer vaccine on a Friday 4/9 and then woke the following Monday with a ?crooked mouth, migraine headaches, very sleepy and heavy arm?. Wife states he did not loss consciousness but was take the Hospital on Monday 4/12/21 and was not given an answer to what was wrong with him. Advised wife I cannot share any medical information about her husband with her, that he could return my call.

Within 6 hours of getting my shot, I went into A-Fib; 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), via an unknown route of administration at 63-years, at single dose in right arm on 17Mar2021 at 09:30 (Lot Number: ER2613) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, within 6 hours of getting his shot, he went into A-Fib (on 17Mar2021). He was in it for 18 hours before going back into the clinic. They took him to ER where he was electro-cardioverted. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". And the patient received treatment of electro-cardioverted for the event. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was recovered.

allergic reaction; body rash; Blood pressure has gone up; Ears ring a little bit; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EP4534) via an intramuscular route of administration in left arm on 28Mar2021 at 10:15 AM (at the age of 63-year-old) as single dose for COVID-19 immunization. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 at 10:15 AM, the patient experienced body rash, blood pressure has gone up and ears ring a little bit, on an unspecified date patient experienced allergic reaction. The events were considered as a non-serious. Therapeutic measures were taken as a result of body rash and treatment included diphenhydramine hydrochloride (BENADRYL). The outcome of the event body rash was reported as not recovered and other events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Patient (per family member) received 1st dose of Pfizer COVID vaccine on 4/24/2021. On 4/26/2021 at 6 AM patient presented to hospital with chest pain for 2 hours. EKG showed inferior ST segment elevation myocardial infarction (a "heart attack") and the patient was brought emergently for cardiac catheterization. Catheterization showed an occluded right coronary artery, and angioplasty/stenting was performed. Following brief restoration of blood flow to the heart, the artery re-occluded and the patient arrested. After 90 minutes of CPR, the patient expired.

Acute pericarditis, severe chest pain, colchicine 0.6 mg tablet 2 times per day for 10 days, asprin 81 mg

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.

I've had both shots. Issue started after 2nd shot received on 4/20/21 at 11:00 am. I felt great all that day until I woke up at 1:00 am next day with pain and fatigue of about a 7 on 10 point scale. That lasted all day and I stayed in bed. There was less pain and fatigue the following day but instead my heart was racing. In days since the pain has stopped and fatigue is gone, but I have periods of my heart racing. Today is 6 days after the second shot almost to the hour. I feel good at the moment, but did have a short lived episode of heart racing in middle of the night. Hopefully this is all getting better, but I thought best to report it because everything I've read on Internet suggests that the after affects would only be a day or two.

Developed shortness of breath and exertional chest pain within 24 hours of vaccine. Ended up having NSTEMI and 3 vessel CABG a week later. Will attend cardiac rehab

Brain Bleed.; Pain in back of neck; BNT162B2 in right leg; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiration date not provided), via an unspecified route of administration, in right leg, on 26Mar2021 17:45 (at the age of 63-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure. Patient had no known allergies. No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV6206, expiration date not provided), via an unspecified route of administration, in right arm, on 03Mar2021 17:45 (at the age of 63-year-old), at single dose, for COVID-19 immunization. On 27Mar2021 03:30, the patient experienced pain in back of neck and brain bleed. 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 was hospitalized for 19 days. The patient underwent lab tests and procedures, which included COVID test was negative in Apr2021. Therapeutic measures were taken as a result of events and included treatment with observation intensive care unit (ICU) 7 days, tube feed and medication. The outcome of the events "pain in back of neck and brain bleed" was not recovered.

Patent experienced seizure like activity. Unable to follow commands, LOC x2-3 minutes. EMS immediately summoned over. Fire rescue notified, responded. Patient refused transfer to hospital, signed liability waiver with fire rescue and departed

Presented to emergency department on 4/22/21 after having an unwitnessed syncope episode at home. Was found to be in atrial fibrillation with RVR. He denies any COVID-19 exposure, but was found to be positive upon screening for admission. No COVID-19 symptoms were reported during admission.

Less than 3 hours after 2nd Pfizer vaccination headache, chest pain, fatigue and ringing in the ears occurred. Headache went away after 1 hour. Fatigue and ringing of ears persist. GP doctor prescribed asteroids for ringing in ears and fatigue. as of 4/29/2021 currently taking MethyIPREDNISolone tablets.

4-3-21- received my first covid 19 shot 4-10-21 went to have foot blister examined- they admitted me and started an IV of Vancomycin which sent me into anaphylaxis and this stopped my heart. I required cpr, defibrillator to get things going again. I was on life support for the better part of 4 days and then finally come back

was sent to the hospital due to a stroke; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stroke and was sent to the hospital. The patient was not able to get the second dose tomorrow (as reported). His 2nd dose will be on 17Apr2021. Outcome of event was unknown. Information about lot/batch has been requested.

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.

Right after vaccination recipient became pale, cool, had narrowing vision, near syncopal episode, bradycardia, and increased BP. Recipient was stabilized by onsite EMS and transferred to the hospital.

Patient is a pleasant 63-year-old gentleman who came to the hospital originally on 4/10/2021, refer you to the H&P done at that time by Dr. Comes in with a diffuse rash over his torso and his legs. He did get COVID vaccine, his first one (4/1/21 at Imaginetics) about a week to a week and a half before admission. He said shortly thereafter is when his symptoms began. The rash is pruritic. He had no breathing troubles whatsoever. No throat closing or tongue swelling, etc. No mouth lesions and in fact the rash over his torso and his back is pretty minimal, looks more like a sunburn type appearance. In any case, also had a petechial type of purpuric rash on his legs and I did show this to Dermatology who felt that it did look like vasculitis. He was placed on steroids. He did SOLU-MEDROL while here and this was converted to prednisone on discharge for which he will continue with for the next few weeks. Slow taper. Rash had improved over his stay here. His LFTs were also up somewhat as well, but these did improve while he was here and multiple imaging studies were done including ultrasound, CAT scan and abdominal Doppler all were negative for any kind of pathology. Suspect probably these elevated LFTs could have been from vasculitis and that is also improving now with the steroids. He is tolerating diet well. He has no abdominal pain. Okay to be discharged today. We will continue with prednisone taper. Follow with PCP in 1 week. Also know, there is an ANA pending as further workup for vasculitis. We will defer to PCP on follow up for that. 4/21/21 Follow-up with PCP: 63-year-old male here for a hospital follow-up. He was hospitalized for rash suspected to be vasculitis and elevated LFTs-started 2-3 days after his COVID vaccine. Etiology of elevated LFTs unclear. Liver US and CT were negative. Hepatitis, viral testing, and ANA negative. Received his first COVID vaccine on 4/1. Still on prednisone taper for rash. He is feeling better, still somewhat tired. Rash is almost resolved. Current complaints sore on the left side of his tongue for the past 11 days. Initially hurt when he would eat, is better now. Is back at work. Denies abdominal pain nausea, vomiting, stool changes, dark or light stools, yellowing of skin, swelling in abdomen or legs. Does not use tobacco, alcohol, or drugs. No history of liver issues. Normal LFTs 7 months ago. Follow up appt at Allergy/Immunology on 4/29/21: Plan: Patient had a delayed reaction to his 1st dose of Pfizer vaccination that included symptoms of arthralgias, rash as well as elevated liver enzymes. His symptoms don't meet criteria for type 1 IgE mediated reaction so skin testing would not be beneficial. His symptoms required hospitalization and improved with tapered steroid course. His symptoms did not fit DRESS syndrome criteria as he did not have peripheral eosinophilia, fevers, sloughing of skin/oral mucosa or blistering. We discussed how there is not much data or case reports about how to proceed with completing vaccination for COVID. I would recommend he get Johnson & Johnson vaccination since it is a different class of vaccine and he may not have the same reaction but again this is not guaranteed. There is a small chance of clotting with Johnson & Johnson vaccine as well. He should pre-medicate with cetirizine 20 mg po qday for 1 week before vaccination and 2 weeks after. I would also suggest he get a steroid course to have on hand from his PCP in case rash starts again after vaccination. It may be beneficial to have him get lab work several days after vaccination as well (U/A, CBC, CMP) to evaluate for any inflammation.

-abnormal reaction to covid-19 vaccination, states having lip swelling, body swelling, red rash in upper extremities, itching, chest tightness that resolved at the end of the day. -had an adverse reaction to 1st covid vaccine, pfizer, had facial swelling, leg and arm swelling, resolved after 24 hours

The very next day after my second dose, Left hand pointing finger, primarily joint between distal and middle phalanx became swollen and very sore. Felt like I had sprained the finger. Then, on 05/03/2021 I had a blood test for my annual exam and my ESR and CRP levels are elevated, and my hemoglobin was low.

Pfizer-BioNTech COVID-19 Vaccine EUA NEW diagnosis and onset of Type II Diabetes Mellitus, symptoms started approximately 10-14 days after 2nd vaccination. Ongoing problem, started on Metformin.

Patient states that after 2nd vaccine on 4/29/21, he woke up with severe chest pain episode in the middle of the night. He went to the ER, where he was admitted overnight. He was discharged on 4/30/21.

Extreme flare up of gout. The worst gout I ever experienced. I can be prone to gout so am familiar with the issue. This began immediately the following morning after the first dose and is still a problem now 3 weeks later. My entire foot, ankle and lower calf were completely swollen and the foot turned blue. Finally now 3 weeks later the swelling has reduced to the big toe but I am still limping. I was schedule for the second dose yesterday and we cancelled. I am very concerned about taking the second dose, especially since we have a wedding trip planned in early June. I can not suffer with this again during that trip and not sure if a 10% increase in immunity from Covid is worth the risk of another major gout flare up like that. Naturally I am concerned about permanent joint damage also.

urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose

blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same patient/reporter, different AE/first dose

passed out; no energy; Tired/exhausted; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Lot Number: RW0150) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6207) dose 1 in the right arm on 24Mar2021 for COVID-19 immunization. Medical history included ongoing hormones are low. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hormone from an unspecified start date and ongoing; hydrocortisone taken for hormone from an unspecified start date and ongoing. The patient took the second dose of the COVID-19 vaccine, the next day he was tired on 15Apr2021. The patient had never been tired in his life like that. The patient was completely passed out. His wife wanted to call an ambulance and the caller told her no ambulance please. He knew the tiredness would eventually go away. The patient had no energy, zero, for 4 days or so. He has blurred vision for some reason on 15Apr2021. He thinks that the vaccine was no good. The patient has never had blurred vision before that that he is still experiencing some blurred vision. The blurred vision is what concerns him. His vision is not right and his side effects were severe. The tired disappeared, but the blurred vision is still there at time of call on 23Apr2021. The patient was wearing his reading glasses but that something has happened with his vision. He had 20/20 vision and now something is not right. The patient was exhausted, passing out, and not polite. The patient has to go to the doctor for the doctor to check his eyes. The outcome of tired was recovering. The outcome of the event blurred vision was not recovered and the outcome of the rest of the events was unknown.

While this first vaccine gave no side effects other than a slightly sore arm, 17 days later on 4-17-2021 I suffered a TIA (Transcient Ischemic Attack). That occurred at 5:15 pm and I immediately took 4-81 mg aspirin and headed for a nearby Emergency Room. They said it was a stroke (and it did show on an MRI the next day but sub-centimeter and I was told the size of a pinhead. AT the ER the double vision in my left eye and numbness in left lips, gum and tongue were already subsiding, but the DR there gave me a Plavix and within 5 minutes I was completely back to normal (or close). I am not sure IF that first dose of vaccine had anytrhing to do with this TIA, but it might have? I had also stopped taking my 81mg aspirin several days before this TIA as I had a Periodontal appointment for insertion of an implant post and wanted to control the possible bleeding. The thoughts of my Doctor at Hospital as well as the Neurologists was that the omission of the aspirin PROBABLY was the main cause of the temporary clotting that caused this event HOWEVER I did not tell them that I was 17 days post-Covid Pfizer vax #1 and so the possibility remains that the vaccine could have been partially the cause of this event? As listed previously, Dr at Hospital was my Doctor and might shed some light on this and her thoughts. I felt it was important enough to report as I have heard stories of all of the vaccines possibly causing some clotting and this might fit.

Severe arthritis pain in hands and back for about 2 weeks, Severe sinus paid over left eye that started day after shot and lost 6-7 days Tightness is chest that started say after shot and lasted 5 days Tinnitus that started on approx 5 days after shot and still exists as of today (May 9th)

hemoglobin had dropped 1.1 grams/now anemic; thrombocytopenia; This is a spontaneous report from a contactable physician. A 63-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunization. Medical history included autoimmune thyroiditis, psoriasis. Concomitant medications included levothyroxine. The patient experienced thrombocytopenia on 13Apr2021, one week later, platelets rebounded but his hemoglobin had dropped 1.1 grams, now anemic. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, patient was unknown diagnosed with COVID-19. The outcome was recovering. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events thrombocytopenia and hemoglobin decreased and the suspect drug. 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 agency, as appropriate.

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.

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.

Leg pain initially, diagnosed with blood clots may 17. receiving treatment currently 15mg xarelto twice daily.

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

Please refer to the H&P for full details. This is a 63 y.o. male with PMHx of HTN and HLD who presented to the ED with chest pain NSTEMI Type 2 Myocarditis Patient was seen by her PCP on 5/12 with c/o chest pain found to have elevated troponin 0.06 (0.03 upper limits of normal) otherwise EXG and CXR nl and was recommended to come to the ED. Patient reports the chest pain started ~1.5 weeks ago, initially resolved, however began to have discomfort again 4d PTA. She describes the sensation as a dull ache with radiation to the neck and her right shoulder. No history of heart disease. Risk factors for this pt include HTN, HLD and tobacco use. On admission HS-Tn elevated at 230 and EKG shows NSR, no ST/Twave changes. ECHO shows EF 60%. Received ASA and nitro in the ED. -monitor on telemetry -cardiology consulted, angio on 5/14 showed normal coronaries, cardiac MRI with evidence for myocarditis per discussion with cardiology - final read is pending at dc - colchicine started Moderate aortic stenosis Noted on ECHO, no significant change in the aortic valve pathology or aortic root dimension compared to prior in 2017 HTN Normotensive in the ED -continue amlodipine and lisinopril HLD Last lipid panel on 12/1/2020 with LDL 109 -continue statin - increased to high dose 80 mg Tobacco abuse Current everyday smoker of at least 1 ppd -cessation discussed Tremor: Continue home med Aortic root dilation - 4.0 cm. Monitor.

Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.

headache; dry hacking cough; running nose; repeated sneezing; Rapid heartbeat; body ache's; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient's medical history included HIV+, chronic bronchitis, asthma, and arrhythmia. It was unknown if the patient had known allergies. The patient received unspecified medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021 at 02:30 PM, approx 20 hrs later, she started with a headache and a dry hacking cough, developed a running nose then repeated sneezing. She also had rapid heartbeat and body ache's at about 24 hrs. Symptoms continued through Saturday and Sunday. She felt better today (Monday 01Mar2021) but body aches were returning around 3:30 pm still had a headache and it had never gone away. The patient did not receive any treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

First dose received on 4/18/2021, second dose received 5/9/2021. Admitted to Hospital on 5/21/2021 with large pulmonary embolus and bilateral DVT. Patient became short of breath 3 days prior to admission, and the day of admission developed left sided pleural pain. Physical exam revealed a friction rub in left posterior chest. Patient was initially heparinized, then switched to oral apixaban bid and is being followed up as an outpatient. As of this day 5/31/2021 patient is asymptomatic at rest but still has dyspnea on exertion.

Started with not being able to wake up but being aware of surroundings. He then got very dizzy and passed out. 911 was called and EMS was dispatched to his home. He experienced cardiac arrest and need to be resuscitated 7 times. He was flighted to hospital where he had surgery to place a pacemaker.

63 y.o. man with hx of prediabetes, diverticulosis, and family hx of CAD who presented on 4/12/21 with chest pain.(Pt had first dose of Pfizer Covid Vaccine on 3/25/21, with no causative factors for Pericarditis). He developed sternal CP radiating to both shoulders while working in the garden on 4/11. The pain improved with acetaminophen and sleeping overnight, but still was present in the morning, prompting him to go to the ED. EKG showed diffuse 1-mm ST segment elevations, prompting emergent cardiac catheterization + coronary angiography --- > no obstructive CAD. cTnI and CK-MB were normal. He had WBC 14.1 & CRP 9.3, which raised suspicion for acute pericarditis, although his symptoms were not typical. Overnight 4/12-4/13, he developed new-onset rapid atrial fibrillation which was treated with IV diltiazem and metoprolol tartrate. He is discharged with colchicine and metoprolol tartrate. The CP resolved postprocedurally and did not recur.

Patient stopped breathing at 6:15pm on 04/22/2021. Fire dept was called. He went into cardiac arrest and they took him to ICU. He died on 04/26/2021 in ICU.

Shortness of breath, gradually progressed over two weeks time to become more pronounced. Doctor visit on 6-5-21 and lab tests showed elevated D-Dimer results, indicating presence of a blood clot, where CT scan showed presence of "extensive" clotting, primarily in lower lobes. Was prescribed blood thinner medication (Xarelto). Remained in E.D. overnight under observation. Results over the past four days are that breathing is getting better.

Pt feeling light-headed, dizzy with mild headache. Pt states hx of similar symptoms 1.5 hours after first dose. Pt states marked improvement upon supination. Vital Signs: BP 124/92 HR 104 Resp ~14 O2Sat 99 After ~4 min HR dropped to 68 Skin Signs: Warm and dry, Skin normal Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally, No increased or abnormal Res effort Initial Treatment: Observation for 15 min. HR dropped to normal levels within a few min. 10:18 AM Vital Signs: BP 162/98 HR 73-77 Resp 14 O2Sat 96 Skin Signs: Warm and dry Circulation: Cap refill <2sec Follow up Treatment: Had pt sit up slowly. Immediately reassessed vitals. Vital Signs: BP 146/100 HR 73 O2Sat 97 Skin Signs: Warm and dry Circulation: Cap refill <2sec Notes: No local reaction/swelling, no tenderness. Pt stood for 3 min to see if light-headedness spiked. Pt notes having caffeine before vaccination. Pt advised to follow up with PCP about blood pressure. Home by self.

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.

Brain bleed; His platelets were only 9000; This is a spontaneous report from a contactable consumer reporting for her husband. A 63-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 14:00 (Batch/Lot Number: EW0172) as single dose for covid-19 immunisation (Age at vaccination 63 years) . The patient medical history was not reported. Concomitant medications included atenolol (ATENOLOL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. On 23Apr2021 the patient received the first dose of BNT162B2 vaccine Lot # EW0169. The patient experienced brain bleed on 30May2021 causing patient's death on an unknown date, and his platelets were only 9000 on 30May2021 with outcome of unknown. The patient underwent lab tests and procedures which included platelet count: 9000 on 30May2021 , sars-cov-2 test: negative on 29May2021 . The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter's comments: My husband was rushed to the ER one week after his 2nd vaccine. He had a brain bleed, they couldn't operate because his platelets were only 9000. He died! I believe it was from the vaccine Information about lot/batch number has been obtained. Additional information is requested.; Reported Cause(s) of Death: Brain bleed

mini stroke (TIA); small carotid dissection in neck artery; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 01May2021 10:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included lisinopril (LISINOPRIL), amlodipine besilate (AMLODIPINE BESILATE) and lactulose (LIS) all taken for an unspecified indications and therapy dates. On 21May2021 (also reported as 2 weeks after 1st vaccine), the patient went to the emergency room department with a mini stroke (TIA). CT of neck on that same day of 21May2021 showed a small carotid dissection in neck artery. The patient also had nasal swab COVID test on that day with unknown results. It was reported that TIA possibly caused by dissection being blocked for a short time. The patient went 3 days in hospital (since May2021) running test. It was stated that the events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had prescriptions (unspecified medications) and follow up care as treatment. The patient recovered from the events in May2021. The patient then received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 26May2021 16:45 ((Batch/Lot number was not reported) on the left arm. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

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

Sudden Onset AFIB. No personal history.No family history. Had shock and heart cath today. Shock has worked so far.

The day after I had fever, aches, sore arms, and chills for the first three days. On 03/26/2021 I was rushed to the hospital which resulted in a diagnosis of Atrial- Fib.

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.

Received second dose above on 1/8/21. Developed a blood clot in left leg early February, Went to doctor after a week or so on February 8. Bad Swelling in left calf

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

patient had a heart attack from 90% blockage of artery; patient had a heart attack from 90% blockage of artery; 10Mar2021 10:30 1st dose/31Mar2021 10:30 2nd dose/ COVID-19 sentinel type of nasal swab on 07Jun2021 result was positive; COVID-19 sentinel type of nasal swab result was positive; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 10Mar2021 10:30 (Lot Number: EN6199) (at the age of 63-year-old) as dose 1, single, via an unspecified route of administration, administered in Arm Right on 31Mar2021 10:30 (Lot Number: EP6955) (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC); mometasone furoate (FLONASE); naproxen; omeprazole (PROTONIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no known allergies. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient had a heart attack from 90% blockage of artery on 20Apr2021 21:00, with placement of 2 stents which resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days in 2021. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had COVID-19 sentinel type of nasal swab on 07Jun2021 result was positive. Outcome of 'patient had a heart attack from 90% blockage of artery' was resolved in 2021 while outcome of the other events was unknown.

postponed his second dose until they see what is going on and they improve his 02 sat; it will be 35 days this coming Monday since his first vaccine; Tachycardia; Sweating Profusely; Itching at the Injection Site; Very Tired; Low 02 Saturdationg; This is a spontaneous report from a contactable nurse. This contactable nurse reported for 63-year-old male patient (reporter's husband) A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EWO709), via an unspecified route of administration on 17May2021 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Historical vaccine included Hepatitis B vaccine. The patient's medical history included allergy, fatty liver, weight loss, Irritation of Nasopharynx, Granuloma (//2020). The caller stated that on May/2021, about less than 2 weeks after receiving the first dose, the patient started to feel very tired and his O2 saturation while resting was 90-93 on room air and with deep breathing he reached 95, but while he was laying down and sleeping it drops below 90. The reporter stated that the patient had no fever and no inflammation except a little itching at the injection site. The reporter also stated that the patient was excessively tired and sleeps every day. Stated that they didn't really pay attention to when tiredness started, but it was around the last week of May. The reporter stated that they had a weight trainer who comes to the house. The patient stated that her husband felt exhausted during the weight training and couldn't do his workout. Caller stated that she has tried to associate it with other things, the low 02 sat and said that it could be something else. It was reported that he has no coughing and no shortness of breath. It was stated that on 27May2021, her husband was really pooped. The reporter stated that she had him walked with the Pulse Ox and they went outside and had him run a little bit and do a little bit of cardio and his heart rate went up to. Caller stated that he was tachy and it stayed for a day after he ran and stated that it was after he ran in the evening and through the following day. Caller stated that he took some Raw Garlic because it helped when he was tachy before. Caller stated that her husband didn't directly complain of the arm side effects, it was more of her asking whether he was having any side effects, and he said just a little itch, no redness or swelling. The reporter stated that he was laughing about the shot, and had no body aches or tears, just itching on the deltoid area for just a few days and as time progressed, he started to feel more tired. Caller stated that the Low O2 Saturation has improved. Caller stated that she had him do the incentive spirometry and it was gradually starting to go up. Caller stated that they haven't checked his sleep tracking devices yet. Caller stated that on the same arm he wears a Garmin and a Fit Bit to make sure he was not going crazy. Caller stated that at night his O2 saturation level dropped to 88 for long periods of time. Caller stated that they ordered a Garmin night sleep tracking device from, towards the first of June. Caller stated that she was checking him with 2 pulse oximeters and then she ordered the Garmin on 01Jun2021. The reporter stated that low O2 saturation started towards the end of May, may be on 28-31 May. The patient had a physician office visit due to the events. Caller stated that they have postponed his second dose until they see what was going on and they wanted to improve his 02 saturation. Caller stated that the patient was able to walk 5 miles 2-3 times a week and did swimming. Caller stated that the patient was concerned about his low 02 saturation. Caller wanted to report this and the doctors did not know what to do with the second vaccine. Caller stated that it will be 35 days this coming (Monday) since his first vaccine. Caller was asking whether the low 02 Saturation can be a side effect of the vaccine. The patient underwent lab tests and procedures which included CT and pulmonary tests done with normal results. The patient o2 saturation level tests with unspecified results. The reporter assessed the events to be related with the suspect product. The outcome of the events was not resolved for fatigue, oxygen saturation decreased, unknown for 35 days this coming Monday since his first vaccine and resolved for other events. Follow-up (17Jun2021)- Follow-up information was received from the same contactable nurse included non-clinical information Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events 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.

It started to ache on April 3 in arm and shoulder and progressed, and on the 4th I went to ER because I could get comfortable and it raised my blood pressure. ER doctors gave me ibuprofen and Percocet.

When I got the shot, nothing happened. My blood pressure was normal. The next day when I woke up, my heart problems had worsened and my blood pressure was high. Through out the day my blood pressure stayed high. Days later I spoke with a doctor and decided to go to urgent care. They triaged me there. They did vital signs and got me into a clinic examination room. They noticed my heart rate was fluctuating from 93 to 49 BPM. My heart rate had been dipping into the 40s. I didn't take the medicine I was given because of my already low heart rate. I was concerned that the medicine was going to make my heart rate drop even more. When I spoke to my cardiologist he said it may of been the vaccine that caused inflammation and problems with my heart rate. June 14th I went to the ER because my heart beats were severe. At the ER they agreed that it could've been the vaccine that caused the problems. The doctor said it may be inflammation that would resolve in time. It was an unusual heart beat pattern. The ER doctor told me to request an echocardiogram. The echocardiogram said I had atrial premature complex and left ventricular hypertrophy. After the 1st dose my high blood pressure went up but intensified after the 2nd dose.

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

Heart attack June 5, 2021. No prior symptoms of heart disease. Per cardiologist he saw no other evidence of significant plaque buildup in other heart arteries, just in hte one that caused the heart attack.

Missing Heart Beat. Often 1/4 beats were missed and at times 1/2 the beats were missing. Heart Rate slowed to 38 beats per min per my home BP monitor. These events were sudden, lasting hours and repeated daily.

My adverse was more a lung Covid-19. My doctor called it Covid-19 induced asthma. I had low oxygen levels. I had tightness in my chest and hard to breath.

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.

Bp spike; Heart rate increase; Head rushes (lightheaded feeling); This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP8727), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 63-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included Thyroid- cloestoral. Allergies to medications, food, or other products was reported as none. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) (125mcg), atorvastatin (ATORVASTATIN) (20mg) taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021The patient experienced bp spike, heart rate increase, head rushes. Therapeutic measures were taken as a result of bp spike, heart rate increase, head rushes (lightheaded feeling). Events resulted in Emergency room/department or urgent care. Events were considered as serious (medically significant). Patient received treatment with IV solution. The outcome of events were recovering. No follow-up attempts are needed. No further information is expected.

Pt.'s girlfriend states after receiving the 1st dose of Phizer 03/31/2021, 24hrs after vaccination experienced a massive heart attack, emergency stent surgery preformed 04/01/2021. Has recovered from heart attack.

Shortness of breath is primary complaint, BP = 219/91 on arrival. Cardiology consult. Patient admitted to critical care unit, pacemaker placed. Patient to go home with furosemide, spironolactone, adjustments in antihypertensive meds with follow up with cardiology.

Pt developed Immune Thrombocytopenia (ITP) after his 1st dose of COVID vaccination, requiring hospitalization and treatment.

Spike in BP; Spike in heart rate; Lighted; This is a spontaneous report received from a contactable consumer (patient). A 63-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP8727), via an unspecified route on 19Mar2021 at 10:15 (at age of 63-years old) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included thyroid, high cholesterol. The patient had no known allergies. The patient concomitant medications included levothyroxine with dose 125mcg and Atorvastatin with dose 20mg from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route on 26Feb2021 (at age of 63-years old) as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 12:00, the patient experienced spike in BP, spike in heart rate and lighted. The patient received treatment IV fluids for events. The event resulted in emergency room visit The reporter assessed the case as non-serious. The outcome of the events was recovering.

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

Thursday night going into Friday, 4/9/2021, I had some issue with my heart. Fluctuations ? 3 to 4 rapid beats that felt like they were from the top of my heart followed by a very slow booming 2 beats that felt like they came from the bottom left side of my heart. I tried coughing to get back into rhythm without success. Felt light headed but no nausea. Went and laid on the sofa and put my feet above my head. Couldn?t stay in that position due to size of the love seat. This started around 10 PM Thursday and lasted until about 6 AM on Friday. I finally fell asleep around 6 AM and stayed in bed until around 9 AM. Got up and putted around the house cleaning, coffee, dressing. She came home around 10:30 AM and called clinic for an appointment to get an EKG. We went to clinic at 11:00 AM and were able to get an EKG around 12:30 PM. All was normal with the EKG. She brought a double cheese burger for a snack when she picked me up. No blood pressure was taken, so I purchased a BP machine at store after eating. When I took my BP around 1:30 PM, it was very low - 90/52. Later that evening, we made a beef taco dinner (slightly salty). When I took my BP after dinner settled, it was more normal ? 118/70.

Pt states his blood pressure has been uncontrolled since receiving 1st Covid vaccine. Pt states he has been on 3 different blood pressure medications since vaccines received and BP still not controlled. Pt instructed by PCP -, NP to call HD and report condition.

He had Covid 19 on Thanksgiving 2020 and recovered fully. Even though he now had natural antibodies, his Doctor convinced him that he needed the so called Covid 19 vaccine "mRNA gene therapy". On 04/29/2021, he was injected with the so called vaccine and that was the beginning of the end. On 05/10/2021, he was admitted to the Hospital with irregular heartbeat and trouble breathing. The Hospital could not get him stabilized so they transported him to another Hospital. He was there a couple of weeks or so and was now having issues with his kidneys and liver. It appeared the spike proteins had started to battle the rest of his viable organs. The hospital had to transport him to a nursing home facility because his number of days in the hospital per insurance had run out. Then on the evening of 06/13 or 14/ 2021, he became violently ill. He was taken to hospital again and was subsequently transferred back to another Hospital. The Spike proteins had now gone into overdrive attacking all his major organs. His liver, kidneys, lungs and heart were being attacked by the spike proteins created by this deadly vaccine. He was put on 24 hour dialysis and then had to be put on a ventilator. He died 06/24/2021.

shortness of breath for two days, came in to the er and found to have bilateral pulmonary embolus, heparin gtt and hospitalization

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.

The first symptoms were a headache and then breathing problems. I was having more intense headaches that they were becoming more frequent. About 4 weeks ago I had a 10-day period of headaches, but I needed to seek medical attention. The doctor diagnosed me with cluster headaches. I also had elevated blood pressure which I had never had an issue with before. The doctor also wants me to have an MRI schedule to make sure there are no underlying physical issues causing the headaches. The medication i was prescribed is helping the pain but I am still getting the headaches.

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

I had a stroke. My headaches were only on the left side of my temple. I've been getting a lot of nerve pain all on the left side on my body, back and leg. This pain has been occurring for over two months.

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

Nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 12:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was not aware of any allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) ROVUSTATIN and MULT-VITAMIN from an unknown date, for an unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03Apr2021, at 14:30 the patient experienced nose bleeds. It was reported that the patient experienced nose bleeds (heavy) started on 04Apr2021 and have recurred on subsequent days, no particular changes in activities or exercise habits. On 15Mar2021, the patient underwent blood test and the result was negative. The patient did not receive any treatment for the reported adverse event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nose bleeds was unknown at the time of report. No follow-up attempts are needed. No further information is expected.

Vasovagal- Lightheaded, weakness with standing- patient said he was not dizzy. Stood up/ sat down 3x. Outcome: Rest, recovered.

Pleuritic chest pain in left parasternal area upon inhalation starting 1/12/2021 at ;7:30 am. I went to ER. Given chest x-ray, EKG and blood. All negative; to have cardiac treadmill morning of 1/13/2021. Pelvic pain started 19:00 1/12/2021 when I returned from ER.

Myocardial Infarction; This is a spontaneous report from a contactable Other healthcare professional (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 20201216-1), via an unspecified route of administration on 16Dec2020 08:15 at single dose for COVID-19 immunization, vaccine location provided as Left arm. Medical history included arthritis and sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced myocardial infarction on 19Dec2020 23:00. The patient was hospitalized for myocardial infarction for 3 days. The patient underwent lab test which included Covid test via Nasal Swab post vaccination on 20Dec2020 with test result Negative. Therapeutic measure Cardiac cath procedure was taken as a result of myocardial infarction. The outcome of the event was recovering. This case was reported as Serious with seriousness criteria hospitalization.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myocardial infarction and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. However, more information is required, such as the complete medical history, clinical course, for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

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

Patient was was brought to the ED from facility which he received the vaccine via ambulance with BiPAP, hypoxia, and one dose of Epi of 0.3 mg. He then required intubation, and had struggled with hypoxia, even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details), and he came in and out of the code 5 times. After 95 minutes, with the wife at the bedside, and family conference by phone, the code was called, and he was pronounced at 18:20. He received in total 8 me of Epi, 3 shots of Atropine, 3 amps bicarb. He got lasix 40 mg, lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular, and levophed was started, then Epinephrine drip was started. Prior to the code he got steroids (solumedrol 125 mg, then later decadron 6 mg iv), benadryl iv, antibiotics (ceftraixone / zithromax), and lasix 40 mg. All this time while in the ED, the Rt was at the bedside, and lots of secretions from the lungs were aspirated, bloody color. Code was the result of PEA secondary to hypoxia (</= 85%), despite being on the vent, with PEEP 12, FiO2 of 100%, with acidosis. After 95 minutes of active resuscitation, the patient was found not responsive to painful stimuli. There was no palpable pulse. No spontaneous respirations. No heart or breath sounds by auscultation. Absence of pupillary light reflex.

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

Patient received his 1st Pfizer dose on 12/17 and 2nd dose on 1/6. He gets tested for Covid-19 weekly at the nursing home and was negative 1/4 but tested positive on 1/8. On 1/15, he was admitted to the hospital with hypoxia and fever 102. O2 sat 88% on room air, 90% on 4L O2. No cough. BP dropped to systolic 90s. He was admitted for 10 days. Did not require ICU care.

Note Text: Resident oxygen was going down to 74% during change of shift 3-11, oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified, ordered Prednisone 20mg stat, Rocephin 1gram IM stat administered, Per NP statement if pt's condition worsening sent him to ER, continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor, 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60, temp. 98.3,m pulse 109, res 22, 02. 82%. Resident father notified.

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

Body aches, fever, chills, joint swelling gradually worsened until had to miss work on 2/9/21. Symptoms persisting. Sudden onset dermatomal type skin rash 2/12/21. As of 2/16/21, starting to resolve. Diagnosed as atypical shingles because other than rash, no pain or itching associated with this.

Report minor chest pain after receiving both first and second dose x 1 week later. Treatment: Visit to Cardiologist with stress test and EKG being unchanged from previous. Outcome: Continue to monitor. Employee continues to work

Worsening pneumonitis, hypoxemia, hypotension requiring hospital admission. Had had mild hypoxemia without other symptoms starting 1/25/2021, shortly before first dose of COVID19 Pfizer on 1/27/2021 and after he had been considered clinically recovered from acute COVID19 illness on 1/14/2021.

Elevated blood pressure. Brother picked him up after it went down a bit. He felt hot after the vaccine and has a past history of heart problems. Heart rate and pulse were normal.

Slight increased heartbeat for about one hour; Headache for the rest of the day; This is a spontaneous report from a contactable consumer (patient) reported that a 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: En-6201, expiry date unknown) in the hopsital via an unspecified route of administration on 11Feb2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight increased heartbeat for about one hour at 12:30 then a headache for the rest of the day both on 11Feb2021. The outcome of the event slight increased heartbeat for about one hour was recovered on 11Feb2021 at 13:30 and the outcome of the event headache for the rest of the day was recovered on Feb2021. The patient did not receive treatment for the events. The events was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.

Shortness of breath and, pressure and or tightness in chest. Symptoms began to subside 1:15 after injection

Within 5 minutes felt flushed , high blood pressure and heart rate, body trembling, red skin rashes.

Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 31Jan2021 08:30 (at 64-year-old) at single dose for COVID-19 immunization. Medical history included Type 2 diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient received Diabetes medication within 2 weeks of vaccination. The patient previously took Percocet and Bactrim, and experienced drug allergy for both. The patient experienced higher than normal blood sugar on 31Jan2021 10:30. Therapeutic measures were taken as a result of higher than normal blood sugar, patient took extra insulin. The outcome of the event was recovering. Event was reported as non-serious.

Chest pain and pain shooting down my arms before going to bed. Sweats/fever. Went away after sleeping in chair each night. Felt tired next day. This went on four nights and subsided. No tightness now.

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

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

Symptoms: Patient states that he has HX of COPD and has noted an increase in SOB on Sunday. He states he is taking his ProAIr inhaler every hour and it helps for the hour, but after that his breathing gets worse. Patient states he gets SOB with lying down and walking. Patient was speaking in full sentences and states it was because he just took his inhaler medication. Patient states he is positive for chills onset Sunday. Patient did have his first dose of COVID vaccine on Thursday. Denies difficulty breathing on Thursday, and per patient could have started Saturday night. DIAGNOSIS at time of disposition: 1. Chronic obstructive pulmonary disease with (acute) exacerbation (HCC) Patient is a 64-year-old gentleman with history of chronic obstructive pulmonary disease, on p.r.n. albuterol at home as well as nightly Spiriva, coming to the emergency department for evaluation of worsening shortness of breath over the last 3 days with associated tightness with his breathing. On arrival to the emergency department, patient is sitting forward, tachypneic, prolonged expiratory phase with diffuse expiratory wheezing. He is saturating low 90s on room air. He is placed on 2 L nasal cannula for comfort. He received 2 DuoNeb treatments with EMS as well as Solu-Medrol. I am going to treated with a continuous nebulizer treatment and obtained laboratory workup as well as chest x-ray. Vital sign show tachycardia which is likely from his albuterol treatment, he is mildly tachypneic, otherwise stable. Patient's laboratory workup is reassuring, troponin is negative. Chest x-ray does not show any consolidation. Patient does have some improvement in his symptoms after his continuous nebulizer treatment. His VBG is repeated after treatment and shows that his pCO2 is going down however he is still slightly acidotic with the pH of 7.28. Patient reports that he still tight in his chest, improved however uncomfortable going home. He is still significantly wheezing on my exam, given this I did discuss this case with emergency department observation who agreed to accept for admission. COVID testing is negative. Patient is admitted in stable condition. Pulmonary: Comments: Patient is sitting forward in the stretcher, he is tachypneic, prolonged expiratory phase with expiratory wheezing in all lung fields.

Pt presented to the ER on 1/4 2021 with worsening sob, found to have acute ST elevation MI and new rapid atrial fib with RVR. He tested positive for covid 19 requiring new oxygen and received his first pfizer vaccine on 12/31. He was acutely transferred to rochester general hospital. He progressed to multiorgan failure, sepsis, mrsa bacteremia and died on 1/14/2021

No treatment. I had a cardiac ablation in the fall because of chronic atrial fibrillation. It appeared to have worked. One day after receiving the vaccination I took a walk with some hills and had what I believe was a mild episode of atrial fibrillation. I verified as best I could, using a pulse oximeter. I feel fine for the most part, but a little bit tired and dizzy. I do not plan to call the doctor unless things get worse.

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

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.

c/o chest tightiness (midline) w/ h/o asthma & 4 CABG. HR 68-80 Reg Resp 16/unlabored; SpO2 97% 152/95 h/o HTN; self medicated with own ventolin 2 puffs & NTG 0.4ml SL with increase in symptoms. Asymptomatic after additional 15 mins.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: initial dizziness, loss of consiousness for roughly 30-60 seconds, body rigidity before waking up-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: 4-5 minutes after vaccinating patient he reported feeling dizzy, when accessing patient he became unresponsive and breathing became louder, he became pale and lost consciousness. 911 was called. His face began turning red and with the help of 2 individuals we lowered him to the floor, his arms became rigid for abotu 5 seconds, and upon trying to wake him/checking for vital signs, he came to and was aware of where he was and that he had just got a vaccine. he did not recall the event post dizzine

day after vacc #1 Pt. developed Atrial flutter, hx Afib for 20 years, over last1-2 years no problems after ablation, only one episode of Atrial flutter during suspected Covid +in Aug, 2020 Current Atrial flutter event required conversion, 4 days later develped slight rash around pelvic area, very local read article it is nano partilcles of polyethelene glycol causing issue. not questioning taking second vacc.

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.

PT WAS AT CHCKOUT. PT LEANED OVER GRASPING HIS CHEST. PT PLACED INTO OBSERVATION CHAIR AND IMMEDIATELY BROUGHT TO OBSERVATION ROOM WHERE HE WAS ASSESED BY STAFF NURSES, MEDICAL PROVIDER, EMT'S. . PT MASK REMOVED UPPER LUP SWOLLEN. AIRWAY PATENT, NO S/S OF RESPIRATORY DISTRESS NOTED. PT GRASPING CHEST, MOANING IN PAIN. 12 LEAD EKG PERFORMED SINUS TACH. 18 GUAGE SL PLACED TO RT HAND, ATTEMPT X 1 PT TOLERATED WELL. BENADRYL 50MG IM X 1 DETHAMEXASONE 10MG IMX 1 CHEWABLE ASPIRIN 324MG PO X1 12:45 PT HR TACHY AT 132, RR20, B/P136/82 12:49 PT HR 125, RR20, B/P 138/88 12:54 PT HR 119, RR 19, BP 159/83 1300: RESCUE ARRIVED, CARE TAKEN OVER FROM THERE. PT REMAINS STATUS REMAINS FAIR AND STABLE UPN D/C

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

Chest pain, flushing of face. No sob, no edema, BP and HR stable, ASA 325mg given po and 911 called

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.

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.

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.

his pulse shoot up to 118; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, on 12Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, blood cholesterol abnormal, Chronic cough spread on by allergy to oak. He got oak pollen allergy that's pretty bad it causes him to cough a lot, during the allergy season, he got the chronic cough, it's been looked at, they are trying to figure it out. Prior to vaccination (unspecified date), the patient was diagnosed with COVID-19. Patient was taking other medication, for high blood pressure, type 2 diabetes and cholesterol (all unspecified "don't have the exact names"). On 12Feb2021, the patient experienced his pulse shoot up to 118; it has gotten back into the 100, it does goes up into the 90's which is high for him. Patient had lab test and procedures on an unspecified date and stated "everything was good in the blood work"The outcome of event was recovering. patient did not receive treatment for the event but he went to the hospital on Saturday to get it checked out and they told him it was likely a reaction to the shot and they said it might have been too quick and that's what they told him at the hospital, so yeah they send me home and told me to rest. Follow-up attempts are completed. The information on the batch/lot number has been obtained.

PATIENT HAD AN EPISODE OF SYNCOPY. PATIENT HAS HAD SYNCOPY REACTION IN THE PAST TO NEEDLES. EMT ON SITE MONITORED BLOOD PRESSURE AND PULSE. THE PULSE REMAINED LOW (40'S) AND SO THE EMT'S TOOK PATIENT TO THE HOSPITAL.

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

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

Died 4 days after shot from blood clots in my lungs. No history of clotting before this. Did have Covid asyptomatic back in January. So not sure whether having had Covid caused the clotting. Having the vaccine or being out of work with torn meniscus. They think clots started in my legs and ended up in my lungs. I was brought back after coding for 6 minutes. They seem to think Covid caused it. Not sure if vaccine contributed or not. But it did happen 4 days after the shot.

Patient with severe COPD and respiratory failure on home O2, currently undergoing evaluation for potential lung transplantation. Patient reports feeling "fine" and got his vaccine 4/1. On 4/2 in the evening he developed feeling of malaise and fatigue, fever, and by 4/3 he noted cough productive of brown sputum, and dyspnea which became progressively severe. Presented then to the ED 4/3 where he appeared to be in respiratory distress and was treated with BiPAP, albuterol/atrovent nebs, solumedrol, then prednisone, antibiotics (levaquin in ED, then doxycycline after admission), hypertonic saline . Remains admitted, still on higher O2 requirements than baseline.

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

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.

Heart rate dropped to below 50 ppm; finger tips heavily tingled the morning after the injection.; This is a spontaneous report received from a contactable consumer (patient). A 64-years-old male patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 64-years-old ,via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (Lot Number: ER8730) as single dose for Covid-19 immunisation. Medical history included cardiac failure, diabetes 2, obese. No Allergies to medications, food, or other products The patient's concomitant medications were not reported. The patient experienced heart rate dropped to below 50 ppm on 30Mar2021 10:00 with outcome of recovered, finger tips heavily tingled the morning after the injection on 30Mar2021 10:00 with outcome of recovered. No treatment received for adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Pt received vaccine and was sitting in observation area. Observation nurse observed pt sliding onto floor. Pt was unconscious for 10-15 sec. On-site EMTs came to pt, placed him on his side. He resumed consciousness, was able to respond appropriately to questions. Pt did not hit head per both observation nurses. Pt denied hip pain, head pain. pt was hooked up to VS monitor. All VS were WNL (BP 100/63, HR 64, PSO2 98% on room air, RR 16). Blood glucose was also checked = 86. When pt was assisted into seated position, BP dropped. After sitting up, pt then stated he felt nauseous and vomited. Pt was advised d/t nausea and BP instability he should be transported to ED for assessment. Pt stated understanding and agreed w/ plan of care.

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

Heart races. Noticed it as soon as I received the injection.; This is a spontaneous report from a contactable consumer(patient). A 64-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jan2021 09:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included High blood pressure. Concomitant medication(s) included amlodipine besylate (AMLODIPINE BESYLATE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Allergies to medications, food, or other products was none. On 25Jan2021 09:30 AM, the patient experienced Heart races. Noticed it as soon as he received the injection. Did not seem to be all the time but periodically he would notice. The patient just wanting to confirm how long this side effect would last and should he take the second dose. The event was assessed as non serious. No treatment received for the adverse event. Outcome of the event was not recovered. Information on the lot/batch number has been requested.

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

Patient received first dose of pfizer (lot # ER8729 )at 11:17AM. Individual complained of sick feeling. EMT found no abnormalities, EMT assessment: BP-110/60, RR-16, HR-66, A&Ox4, PERRLA, skin warm and dry, lung sounds clear to auscultate. EMT notified RN of Individual complaints. When RN first arrived on scene individual was sitting in chair erect. Client appeared sweaty having labored breathing. Client state "I am feeling tightness on my chest. EMT took individuals vitals (BP 110/80, HR 90, RR 16, SPO2 98). Individual was found to have a history of high blood pressure and diabetes. Currently taking metformin and medication for high blood pressure but denies taking the diabetes medication this morning. Additionally individual was alert and oriented times three and had clear lung fields as assessed by the EMT. Despite no change in vitals, 911 was called at 11:35 by lead ancillary. During which time the individual stated "I'm starting to feel drowsy and sleepy." Paramedics arrived on scene at 11:40 at which time the EMT and RN transferred care. The individual refused ambulance transportation and signed waiver. Individual was asked if symptoms had improved or if they were the same and he stated "I feel the same." Upon giving this answer, the signed the AMA, the last assessment: client breath sounds were assessed to be clear to auscultate, speaking in full sentences without shortness of breath, was A&OX4, skin was warm and dry and not showing signs of anaphylaxis. At 11:40AM and upon completion of the last assessment, the individual departed the facility without any assistance with a steady gait.

Minutes after vaccination patient became syncopal, clinical team was nearby, patient difficult to rouse. EMS responded. HR was 36, BP 60/30, patient was responsive but within a few minutes had an additional syncopal episode. Patient was responsive again, bp was 85/40, Blood sugar was normal, EMS set up IV line and monitored patient briefly. HR recovered to 80, and BP e179/50. 12 lead administered, but unclear. Patient was transported by EMS to Emergency Room for further assessment.

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.

4/5/21 Patient presented to ED w/fever, weakness, cough and SOB. Initial temp was 103 and RA pulse ox 87%. Signs of AKI with cr up from baseline of 0.9 to 1.49 and he was hyponatremic (Na 130). Pt was admitted on O2 per NC, IVF, Decadron and Remdesivir. He completed a 5 day course of Remdesivir. AKI and hyponatremia resolved. he was not able to be weaned off oxygen. H was discharged on 4/13 on oxygen 2L per NC and Decadron to complete a 10 day course.

Pain in left arm (injection site), right upper arm muscle (less pain than left arm), left and right upper chest between collar bone and shoulders, chills all night with headache and tossing and turning, swollen lymph nodes behind both ears with an ear ache in right ear, profuse sweating, fever and temperature but not checked until 16 April around 9:00 AM. Read 100.4; 10:30 AM Read 100.6; continued going down from there. 17 April 7:00AM temperature read 97.1.

pt says he had numbness in his right side. this includes his arm from finger to shoulder and leg from knee to toe. these symptoms would come and go and he would have to lay down when this happened. His hands and feet were shaking like he had low sugar. this happened for 2 days. the 3rd day he could hardly walk saying his right leg was feeling paralyzed. the left side of his lips were burning like he had been given anesthesia. Every day about 5pm he would have these symptoms. He went to Medical Center ER on 3/26/21. they did EKG, Blood Work, X-RAY, MRI, nuclear medicine heart test. He was admitted and stayed overnight. Discharged to FU w/ PCP and Neurologist. Pt went to see neurologist on 4/6/21. On 4/7/2021 They did another EEG with normal results. On April 8th patient says he still has numbness in the right hand only but the numbness has moved to the left side of this body and everything is numb. He bites his tongue while he is sleeping and it is sore when he wakes up. He still has these symptoms today.

Stroke that lead to loss of speech and use of right arm and leg. Patient currently in rehab facility.

This is a pleasant 64yo male that presents to Hospital with acute SOB. He states that yesterday morning he received his covid-19 vaccine and then went home. Later in the afternoon he developed acute SOB, not made worse by exertion or lying down. He has chronic COPD and checks his pulse ox multiple times per day. He typically runs 85-92% and states that he was running around 87%. Due to his SOB he sought medical care and was found to be hypoxic with an O2 saturation of 78% in the ER. He had a CTA of the chest which showed a chronic left lobe PE and an acute PE to the left subsegmental branch of the inferior lingula artery, small bilateral pleural effusions and cardiomegaly. There was no evidence of right heart strain on the CT readout. His first two troponins are WNL. He admits to being sedentary at home over the last year since he lost his job. He was also found to be in a-fib with RVR and intermittent a-flutter, both of which are new per patient report. He has been started on Cardizem and Heparin drips. Currently, he is up ad lib and comfortable. He denies overt shortness of breath and is able to carry on a full conversation. He denies chest pain, abdominal pain, m/s pain, bowel/bladder issues, n/v/d or diaphoresis. He is alert and oriented. He has a PMH of copd, chroinc hypoxia, tobacco use, ble pitting edema, htn, and hld.

Per family, patient received 2nd vaccination and began experiencing swelling and shortness of breath the following day. This progressed over the course of 2 weeks until this today when he suffered a cardiopulmonary arrest and could not be resuscitated. Death resulted on April 24th 2021.

Flushing of face, chest, feeling of warmth internally Vital Signs: BP 152/92 HR 85 Resp 16 O2Sat 98% Skin Signs: Warm and dry, Other - Flush feeling in chest and face Circulation: Cap Refill <2sec Respiratory: Breath sound clear bilaterally Initial Treatment: Vitals taken at 1:29 PM. No sign of anaphylaxis noted. 1:49 PM Vital Signs: BP 142/90 HR 78 Resp 16 O2Sat 98% Skin Signs: Warm and dry, Other - Flush Circulation: Cap Refill <1sec Respiratory: Breath sound clear bilaterally Follow up Treatment: 'Warm feeling internal chest'. Warm feeling in throat upon exhale. 2:08 PM VItal Signs: BP 144/90 HR 85 Resp 12 O2Sat 97% Respiratory: Breath sound clear bilaterally Disposition: Home by self. Advised to drive into town with wife to see primary care doctor.

Patient developed cough and fever post 2nd covid shot. Patient was seen at MD office 2 weeks after shot and was sent to hospital for worsening Transaminasemia and newly developed Thrombocytopenia (CMS/HCC).

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

No reaction to 1st dose. Since my 2nd dose, I started to have headaches every day since the 2nd vaccine shot, the headaches continue as of today. I called my primary care and found out that my blood pressure was higher than normal. Readings from a low of 146/97 to a high of 184/98. Primary care has started me on 10mg of lisinopril, once per day. Prior to vaccine my blood pressure never exceeded 150/100 to my knowldege. Primary care suggested I report this back to pharmacy, however, pharmcy web site suggested filling out this form.

Dose #1 EN 6199 3/10/2021 Dose #2 ER 8132 3/31/2021 Acute PE/DVT on 4/6/2021 Hospitalized with leg swelling shortness of breath Diagnosed with submassive PE, right lower extremity extensive DVT Anticoagulation started subsequently discharged home

Heart fluttering and pulsing several times a day. Seemed to be getting better but still happening 1 or 2 times a day. On 4-21-21 had aches, shaking, and felt flu like symptoms plus the heart fluttering and pulsing. After 24 hours everything but the heart issues subsided. It happens sporadically. I held off notifying my doctor because I seemed to be getting better. It just happened again and it is becoming a concern.

2021-01-28 Received the 1st shot of COVID-19 vaccine Pfizer and noticed on or about February 1, my farsighted vision began to change for the better in that I was able to read fine print and view the computer screen without wearing prescription glasses. 2021-02-19 Receive the 2nd shot of COVID-19 vaccine Pfizer and subsequently my vision changed where my nearsightedness became worst and I began to see halos when looking at lighted objects, especially at night. **Later I researched and found the Pfizer vaccine can cause symptoms of illness that can lead to high glucose levels.

IgM and IgG (antibodies not detected) and stated that it does not preclude acute sars-cov 2 infection; he experienced a little bit of soreness,runny nose, coughing up phlegm,Around 09Apr2021 he lost his taste and smell; His doctor told him his D dimer was elevated.; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 11:30 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included history of COPD treated by CPAP, high blood pressure, Cancerous tumors removed from bladder- He is cancer free, atrial fibrillation (From: 28Feb2021 To: Ongoing), In Feb2021, prior to receiving his first dose of the Covid 19 vaccine he had some heart problems. He had gone into atrial fibrillation. His doctor prescribed Eliquis and put him on a heart monitor. He took a nuclear stress test and that was ok and now he's wearing a heart monitor. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for an unspecified indication from an unspecified start date and ongoing; apixaban (ELIQUIS) taken for atrial fibrillation from Feb2021 and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional Administered Vaccines on same date with the Pfizer vaccine considered as suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. The patient received the 1st dose of the Pfizer covid vaccine on 17Mar2021, he experienced a little bit of soreness, no complaints, no issues. He was scheduled for the 2nd shot on 09Apr2021 or somewhere. However, on 04Apr2021, he started having a runny nose, coughing up phlegm. He has a history of COPD treated by CPAP. He lost his sense of smell and taste. On 7 or 8Apr2021, he took a covid test. He did not get 2nd shot. Covid test results were negative: IgM and IgG (antibodies not detected) and stated that it does not preclude acute sars-cov 2 infection. The D-dimer part of the blood work came back as 0.44 (reference says it should be less than 0.5). A t the end of Feb 2021, he had A-Fib treated by Eliquis. The doctor said it should be 0 if on Eliquis, but attributes that result to him taking the Pfizer vaccine and explaine dit as a higher blood clot risk. His 2nd shot is scheduled for tomorrow. He was told by the doctor to wait until mid May and start all over again with the [Redacted]. Caller would like to know whether increased blood risk has been reported as related to the covid vaccine. Referenced EUA Fact sheet for HCPs under section 6 OVERALL SAFETY SUMMARY, Unsolicited Adverse Events: There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. The patient wanted to know it is normal to test negative for antibodies after his initial dose. Caller requesting assistance interpreting his blood work results. Provided basic information and referred caller to his HCP for interpretation of his results. The patient had his first Covid 19 vaccine on 17Mar2021. He had no issues with the first vaccine. About 2 weeks after he received his first Covid 19 vaccine maybe around 01Apr2021 he started sneezing, having some phlegm, and coughing stuff up. He does use a CPAP machine at night. Around 09Apr2021 he lost his taste and he lost his smell. He was scheduled for his second Covid 19 vaccine on 10Apr2021 but thought his symptoms were worse than he originally thought. He went to his doctor on 09Apr2021. His doctor did the nasal swab for the Covid 19 virus. He never had a fever or chills. His doctor gave him some erythromycin. He also did some blood tests. His Covid 19 virus test came back negative. On the results of his blood tests on the first page, the first thing it says are that his Covid 19 results are negative. His doctor told him that his body showed no response to the Covid 19 vaccine. He doesn't see that this blood test is testing for antibodies. Later in his blood test paperwork he sees that it says "antibodies not detected, does not preclude acute Sars-Cov-2 infection". His paperwork says IgG and IgM were negative. He provides the following in a historical context. In Feb2021, prior to receiving his first dose of the Covid 19 vaccine he had some heart problems. He had gone into atrial fibrillation. His doctor prescribed Eliquis and put him on a heart monitor. He took a nuclear stress test and that was ok and now he's wearing a heart monitor. He's reading from his blood test results. His D-dimer result was 0.44. In the reference range it says anything less than 0.50 is a normal range. But he is taking Eliquis and his doctor told him his D-dimer should be zero. His doctor told him his D dimer was elevated. His doctor believes the first Covid 19 vaccine has something to do with his D-dimer result. The caller reports that he has heard about the [Redacted] and [Redacted] vaccine and blood clots but he hasn't heard anything about Pfizer having problems with blood clots or anything of that nature. His doctor told him that his body showed no response to the Covid 19 vaccine. Later in his blood test paperwork he sees that it says "antibodies not detected, does not preclude acute Sars-Cov-2 infection". His paperwork says IgG and IgM were negative. AE(s) did not require a visit to Emergency Room/Physician Office. The primary infection site was Unknown. There were no predisposing factors. A culture was not performed. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Loss of Breath after 5 days after both Vaccines Urgent Care concerned about Blood Clot Hospitalize 3 days - New diagnosis - Congestive Heart Failure

Less than 15 mins after having the shot, I had passed out. This was Wednesday. On Sunday morning I got the worst headache I have ever had. Acetaminophen didn't do anything to alleviate the pain. It was debilitating. Took Motrin, 2-200 mgs. finally got some relief. The pain lasted the rest of the day. Monday it came back just after lunch. Pooped more Motrin, better. Tuesday just before dinner it came back. More Motrin. That was the last of that headache, just very worn out, tired the rest of the week.

Feverish; Headache; Lethargic; achiness/feels achy; sore arm; Not feeling well; Cold; he (her husband) could have died; Blood pressure at 78/45/blood pressure dropped to 75/48; pulse in the 40s/heart rate was in the 40's; warm sensation in his upper torso; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient's wife) reported that a 64-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: OER8731), via an unspecified route of administration, administered in Left arm on 18Apr2021 (at the age of 64-year-old, Time the Vaccination Was Given also reported as 15550 18Apr2021) at single dose for Covid-19 Virus. The patient medical history was not reported. No family medical history relevant to events. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EO6955, Expiry date: Jun2021), intramuscularly administered in Left arm on 28Mar2021 (at the age of 64-year-old) at single dose for Covid-19 Vaccination and had no problems. No other prior vaccinations within 4 weeks and no events following prior vaccinations. Patient received second dose on 18Apr2021. He sat down in his chair stayed for 15 mins after his vaccine like they asked to. All of a sudden, he had a warm sensation in his upper torso on 18Apr2021. Blood pressure at 78/45 and pulse in the 40s on 18Apr2021. They called the ambulance and he was taken to the hospital. His blood pressure had since recovered but he's not feeling well on 18Apr2021. 19Apr2021 he had achiness and a sore arm, reporter asked could he take Tylenol. They were told by the nurse to try to delay medication as much as possible. Reporter also reported that he (her husband) could have died, they felt like they should have been warned about the adverse event her husband went through. Patient was not feeling well today 19Apr2021 and had not contacted his physician yet. Patient felt a warm sensation over his upper torso and felt like getting a CT/CAT scan with contrast on 18Apr2021. His blood pressure dropped to 75/48 (also reported as dropped to 75 over 48) and heart rate was in the 40's on 18Apr2021. The nurse who gave him the injection came, laid him down, called an ambulance for him and he had to go to the hospital. When the ambulance got there, the EMS tried to stand him up and his blood pressure kept dropping and so they took him to the hospital. Patient started not feeling well within minutes after getting the vaccine on 18Apr2021. He felt better than yesterday (18Apr2021) though. She said that 19Apr2021 he just felt achy and feverish, he had a headache and is lethargic today 19Apr2021. Patient experienced the warm sensation in his torso a few minutes after getting the injection and it lasted about 3 minutes. Yesterday (18Apr2021) evening he stabilized and when his blood pressure went back to normal the emergency room let him go home. He was kept in the ER for observation and was not admitted. Events blood pressure dropped to 75/48 and Heart rate in the 40's required a visit to Emergency Room, no physician office visit. Reporter further reported that after 15 minutes of vaccine on 18Apr2021, patient's blood pressure went down to 78/48 and he was cold. The outcome of the events blood pressure decreased and heart rate decreased was recovered on 18Apr2021, warm sensation was recovered on 18Apr2021 for about 3 minutes, not feeling well was recovering, outcome of events could have died and cold was unknown, outcome of the other events was not recovered.

felt pain at injection site; dry mouth; feeling cold; dry eyes; rapid pulse; his breathing changed'; states it was hard to breathe; felt like he had fever; This is a spontaneous report from a contactable consumer (patient). This 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 04Apr2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient stated after injection, felt pain at injection site and felt like he had fever; fever lasted 2 days (as reported). Patient also added immediately after receiving the shot, he had a 'rapid pulse and his breathing changed' on 04Apr2021; stated it was hard to breathe. Patient stated he calmed himself and he was ok. Patient reported 2 weeks later after the first dose, he reported shortness of breath, dry mouth, feeling cold and dry eyes (unclear timing/onset). Patient stated these were ongoing currently. Patient was asking if these could be side effects. Patient also reported that he cannot take medications; he had allergies to medication (did not specify). Patient asked should he delay second dose given he had ongoing side effects from the first dose. The outcome of events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

fever 100.8 severe pain head ,neck, back, shoulders ,back arms hands hot cold sweats, lungs , weakness

MI, symptoms started 2 hours after immunization; This is a spontaneous report from a contactable physician. A 64-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the right arm on 14Apr2021 (Batch/Lot Number: EW0161) as a single dose for COVID-19 immunization. The vaccination facility type was reported. Relevant medical history included obstructive sleep apnea on CPAP; hypogonadism on bioTE; depression; history of (h/o) pneumonia; colon polyps; recurrent sinusitis; erectile dysfunction; MTHFR Mutation C677T Heterozygous; low high density lipoprotein (HDL); dyslipidemia; lumbar disc disease; and sciatica; all from an unknown date and unknown if ongoing. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL); anastrozole; celecoxib (CELEBREX); levothyroxine, liothyronine (NP THYROID); and escitalopram oxalate (LEXAPRO); all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), from which the patient had known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced myocardial infarction (MI), symptoms started 2 hours after immunization on 14Apr2021. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and an emergency room/department or urgent care, and hospitalization. The patient was hospitalized for the event "MI, symptoms started 2 hours after immunization" for 3 days. Therapeutic measures were taken as a result of the event, which included cardiac stent. The patient was recovering from the event.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of myocardial infarction. The reported event likely represent intercurrent medical condition in this patient with history of dyslipidemia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline, counteractive treatment measures and concomitant medications This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

This 64 year old male received the Covid shot on 3/29/21 and went to the ED on 3/29/21 and was admitted for left-sided nontraumatic intracerebral hemorrhage and died on 5/4/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Patient presented to nurse A&O x3, with calm affect. No history of reactions to vaccines. After prescreening patient the vaccine was given. Immediately, the patients eyes rolled back and he went limp. RN supported patient in chair until paramedic took over quickly..

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

My husband who is 64 years old, was a previously in good health. Only history was mild cardiomyopathy diagnosed 12 years ago. And elevated blood pressure, which was normal with medications. He was very active, maintained a demanding full time job and was a great husband of 2 children. He received his 2nd dose of Pfizer on approximately 4/1/21. He didn?t complain of any side effect. However, on the morning of 4/27/21 he woke me up saying that he could not breath. We started driving to the hospital, however he got worse and we stopped at the fire station. They gave his oxygen and rushed him to the hospital. We came to hospital and when the fire truck was pulling in, I was told that my husband went into pulseless electrical activity. CPR was started and after approximately 5 minutes he regained pulse. He was taken to the ICU and therapeutic hypothetic protocol was completed. Since then, he is still requiring mechanical ventilation. He opens his eyes spontaneously, at times appears to obey small commands and is bedridden.

36 hours following injection of my second Pfizer COVID vaccine on 3/21/21, I suffered an afib episode lasting 15 hours starting in the early morning hours of 3/23/21. I then experienced another episode of afib lasting 19.5 hours on 4/10/21. On 4/16/21, I suffered my third afib episode following my second injection, which lasted three hours. As I was converting to a normal sinus rhythm on that day, I went into sudden cardiac arrest for 10-20 minutes and was transported to the local hospital emergency room via ambulance where I was held for approximately 24 hours for observation and testing. Since that sudden cardiac arrest event, I have experienced two more afib episodes to date, one on 4/26/21 lasting 8 hours and one on May 5, 2021 lasting 6.5 hours. While I have experienced afib in the past due to a virus attacking my heart in 2018, I had not had any afib episodes for 14 months and had built my ejection fraction back up to 60-65% over a three-year period. I have never experienced afib episodes with such frequency since my initial conversion to sinus rhythm three years ago following the virus attacking my heart until I received the second dose of the Pfizer COVID vaccine along with never, ever experiencing sudden cardiac arrest following the second dose of the Pfizer COVID vaccine.

1st dose in series on 03-18-2021; 2nd dose in series on 04-08-2021 2 days after 2nd dose, he developed severe pain in both legs. He was taken to the hospital where clots were diagnosed in both legs and groin area. A previously undiagnosed lung nodule was found and he was given a cancer diagnosis. He was discharged home on apixaban (Eliquis) and comfort measures 2 days after admission. Over the following weeks, he had a permanent lung drain placed. He died on May 5th or 6th at home. No autopsy performed.

Reported per patient via message to clinic: "Sometime in June, I will undergo a left knee replacement. My blood tests showed a lower than normal hemoglobin level. I told (my PCP) that I had an unusual reaction to my second COVID (Pfizer) vaccine which was administered on Sunday, March 21. I was pretty sick for two days and then for four weeks, every time I had a bowel movement, my hemorrhoid bled. During the first week, it was pretty bad, and gradually bleeding got less and less and as of three days ago, I am back to normal. In the past, I had problems with inflammation of external tissue that caused bleeding but it was nothing like this and I have not had a problem for the last few years. First, I got scared but then when I talked to a cousin who had the same problem following her second vaccination for COVID. I thought there might be a connection. "

pt with 1- of dry cough followed by fever to 102 on 5/7/21. Pt was not hypoxic on home but on arrival to ER had hypoxia, requiring high flow NC. condition has not improved despite treatment for bacterial infection, PE and atypical pathogens ( possible tick bite). Admitting inflammatory CRP > 15 , Ferretin > 1100, IL6 > 50 and D dimer > 5. Pt with mild thrombbocytopenia COVID IG G pending

his pulse shoot up to 125; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in left arm on 05Mar2021 21:30 (Lot Number: EN6206) as single dose for covid-19 immunization. Medical history included covid-19 from 26Jan2021 to 10Feb2021. There were no concomitant medications. The patient received dose 1 intramuscular left arm on 12Feb2021 07:30 (Lot: EL9266) for covid-19 immunization. The patient experienced his pulse shoot up to 125 on day after 2nd Vaccine. None received prior vaccinations (within 4 weeks). None family medical history relevant to AE. The outcome was unknown. Follow-up attempts are completed. No further information is expected.

pt developed generalized papular/drug rush 2 days after vaccine on all extremities and trunk. this eventually started to resolve after about 3 weeks and a course of prednisone. on 5/6 he developed shortness of breath/chest pressure worse on exertion. he was hospitalized with a negative cardiac workup (telemetry, trops, nuclear stress test) negative chest XR and negative CTA chest for PE. VS remained stable throughout. some improvement now with prednisone. unclear if related to his vaccine but pt feels it was.

found out COVID-19 the 30th by the COVID; I was trembling; could not walk/with my legs, my feet's, can't hardy walk, use walker to walk around, it's causing my foot to not work properly. I cannot move my toes; It was standing low when I was in the hospital/I came home I don't know it's my neither or what I was 169 and 117 at the bottom; they give me down it was high couple of time and one time all I have my heartbeat was beating 131; they thought what patient had is a stroke; feeling chills; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 23Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. Patient had got diabetes, hypertension and he got everything. Concomitant medications included insulin taken for an unspecified indication, start and stop date were not reported and unspecified drugs, concomitant Medications: Consumer stated he was taking 2 different insulin. Patient was taking a fast release insulin at the hospital and he did not know it will take but he got told to his primary doctor as he was first he was taking (medication name not clear and not confirmed) he was taking that's the insulin. he did not know what it was. Diagnosis date for diabetes and hypertension: Consumer stated they give he down it was high couple of time and one time all patient had his heartbeat was beating 131 so he called 911. So, patient did not know what caused it but they got everything under control and patient called 911 (Further clarification unknown hence not captured as event), they kept he in hospital for 11 days but patient know something was going on when he first got the Covid shot, he felt after his first injection 2 or 3 days later he was feeling chills and then that was it but by the time and patient took that on 23Mar2021 by the time, all of a sudden patient did not know the day it was it to be in the March because he went for testing and then later on 30Mar2021 the caller found out that he had Covid after getting the vaccine. Patient had the first shot on 23Mar2021 and patient was trembling, he could not walk, he was crazy. It took about 4 or 5 days he went to get out of the bed and he cannot walk at out. he came what at all his wife look and then shut down because patient had not experienced that before and they thought what patient had is a stroke and patient had in my eyes, in so it was not a stroke, that major (Further clarification unknown) but they never told he what it could have been or what it was. Patient stayed in hospital for 11 days after he got that first shot. Patient had CAT (computerized tomography) scan and had MRI (Magnetic resonance imaging) and some other skin they did it with machines in your leg but before it could be they did all that and patient did not know what they did like what they did like he was about in Emergency room. Patient was still experiencing the events with his legs, his feet's, he could not hardy walk, he used walker to walk around because his equilibrity was going off and patient had no problem with his equilibrity (as reported). Patient was still experiencing events they tried to do surgery on his legs but they get his had got his diabetes patient was back on the control he take medications for that, patient could not carry out medications because he didn't know about the number and then they got his high blood pressure, they got down to control it was 118 last time patient had seen like 118-75. It was standing low when patient was in the hospital (Further not clarified hence not captured as event) So, when he came home he did not know it's his neither or what patient was 169 and 117 at the bottom so patient did not know what they got, what's going on. It was causing his foot to not work properly. Patient could not move his toes forward. The outcome of event could not walk was not recovered, of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021493685 same patient, same product, different dose and events.

Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; 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; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out. Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19. Follow up needed, further information has been requested.

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

fainted; fell and hit his head; fell and hit his head; felt lightheaded/Dizziness; blood clots in his lungs; he has a spot on his lung that they are monitoring; hypoacusis and has a new hearing aid; This is a spontaneous report from a contactable consumer (patient's wife). A 64-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 02Apr2021 (at the age of 64 years old) (Batch/Lot Number: ER8733) as 1st SINGLE DOSE for covid-19 immunisation. Medical history included severe sleep apnea from 18Mar2021 (received a machine not long after), gout (diagnosed about four years ago) , ex-tobacco user from an unknown date to an unknown date (two pack a day smoker over thirty years). Concomitant medication included colchicine (COLCHICINE) 0.6 mg, 1x/day taken for gout, start date was not reported to Apr2021. The patient experienced blood clots in his lungs (hospitalization, medically significant) on 02Apr2021 (also reported as 02May2021). , fainted, fell and hit his head, felt lightheaded/dizziness on 02Apr2021, The patient was hospitalized from 2Apr2021 to 4Apr202. It was reported the patient experienced hypoacusis and has a new hearing aid on an unspecified date. Caller says her husband has new hearing aids, which is why he is not doing the report himself. Patient has a spot on his lung that they are monitoring on an unspecified date. The patient underwent lab tests and procedures which included blood test: results unavailable on an unspecified date , 'they did a couple tests' (details not provided) results unavailable on 02Apr2021, urine analysis: results unavailable on an unspecified date. Therapeutic measures were taken as a result of blood clots in his lungs included Thrombectomy on 02Apr2021. The clinical course was reported as follows on April 2nd her husband received his first dose of the Pfizer COVID-19 vaccine. Approximately an hour later they went to the market and he felt lightheaded, so instead of getting out of the car they sat there 20 minutes. He started to get out again then halfway out the door he fainted and fell down on the ground. She says he was out for, 5-10 minutes, clarified to not even a minute. Since he hit his head she called an ambulance, and they took him to PRIVACY in PRIVACY. They did a couple tests and said since it was so soon after getting the vaccine that they did not think the vaccine had to do with his blood clots. Caller also stated he fainted because that was one of the side effects of the vaccine, but they were glad he got there since he had several blood clots in his lungs. On the same day (02Apr2021) he had a thrombectomy to remove the blood clots and put him on a blood thinner. Patient was admitted to the hospital April 2nd and was discharged April 4th. He is doing better, he is on a blood thinner now. She says there were a few doctors that had to weigh in on whether he should get the second dose, they decided it wouldn't affect it since the vaccine goes into his muscle. No other vaccinations on the same days as his Pfizer COVID-19 vaccinations or during the four weeks prior. Once they placed him on a blood thinner, they took him off Colchicine 0.6mg. He stopped taking Colchicine because they said the blood thinner doesn't work with that particular medication. It was also reported The patient is to schedule an appointment with a rheumatologist and a hematologist, they did blood work and a urine test and said he has a spot on his lung that they are monitoring. The clinical outcome of the event blood clots in his lungs was Recovered/Resolved with Sequel while the remaining events was unknown. The second dose bnt162b2 was administered on April 29th. LOT: ER8751, caller hopes that is a 5, the writing is very bad on there. The patient had no side effects from his second dose of the Pfizer COVID-19 vaccine.

shortness of breath which is been ongoing for the last several days. His symptoms have progressively worsened over that time. He was seen here in the ED 5 days ago and had a neb treatment for COPD, he had a positive D-dimer and negative CT angiogram of the chest for PE. He was discharged home on Azithromycin and prednisone for AECOPD. His symptoms unfortunately continued to worsen with increased cough and shortness of breath no fever, chills, sore throat, nausea, vomiting or diarrhea. He came back to the ED today for evaluation since he was feeling worse. Patient has a history of lung cancer on the right status post pneumonectomy in 2013. On initial eval in the ED he was noted to have bilateral rhonchi on the left greater than right and received neb treatments and Solu-Medrol 125 IV push. His symptoms did improve somewhat. ED staff checked a COVID 19, despite confirming his second Pfizer vaccine was received on 3/21/2021, and it came back positive. Procalcitonin was negative. He clearly has an exacerbation of his COPD but with the COVID 19 positivity, the ED staff was concerned with his comorbidities that his prognosis is poor in the face of progression of symptoms. I was contacted and agreed to admit him for Remdesivir therapy, supplemental O2, dexamethasone and supportive care.

Patient presented to the ED on 5/7/21 with CVA. He was hospitalized on 5/8/21 for 12 days, and died on 5/20/21.

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

passed out; dizzy; cannot raise my arms above my waist; neck is stiff; limited rotation of my head; tired; aches and pains and severe reduction in range of motion in all of my joints and muscles; aches and pains and severe reduction in range of motion in all of my joints and muscles; aches and pains and severe reduction in range of motion in all of my joints and muscles; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 64-year-old male patient received second dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 PM (Batch/Lot Number: ER8730) as 2nd dose, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer COVID 19), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:30 AM (Batch/Lot Number: EN6202) for covid-19 immunization. The patient experienced passed out (medically significant) on an unspecified date with outcome of unknown, aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , aches and pains and severe reduction in range of motion in all of my joints and muscles on 07Apr2021 with outcome of not recovered , dizzy on an unspecified date with outcome of not recovered , cannot raise my arms above my waist on an unspecified date with outcome of not recovered , neck is stiff on an unspecified date with outcome of not recovered , limited rotation of my head on an unspecified date with outcome of not recovered , tired on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on unknown date, electrocardiogram: unknown results on unknown date, sars-cov-2 test: negative on 21Apr2021. Therapeutic measures were taken as a result of the events. Facility where the most recent COVID-19 vaccine was administered was Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination. The clinical course was reported as follows: I have aches and pains and severe reduction in range of motion in all of my joints and muscles. I also got dizzy one day and passed out. I have been put on a 6 -day steroid pack twice already. The steroids help greatly but once the pill pack was complete the symptoms came back. I cannot raise my arms above my waist. My neck is stiff and I have limited rotation of my head. I'm tired most of the time. I have had many blood tests, (2) EKG tests and my blood pressure is being monitored. So far nothing. My doctor is going to send me to see a rheumatologist. I was very healthy before receiving my 2nd shot of the vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. The adverse event resulted in Emergency room/department or urgent care. Treatment was received for the adverse event included Put on a 6-day steroid pack twice so far. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Batch/Lot number has been obtained. Further information has been requested

bilateral subsegmental PTEs; right flank pain under ribs; This is a spontaneous report received from a contactable HCP. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route, on 30Apr2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. The patient was not diagnosed with COVID-19 before vaccination. Relevant medical history included hypertension (HTN), gout and osteochondritis dissecans (OCD). No relevant concomitant medications were provided. The patient did not have allergies. No other vaccine was received in four weeks. The patient presented to the emergency room (ER) with right flank pain under ribs. Found to have bilateral subsegmental pulmonary thromboembolisms (PTEs). The onset date of the events was provided as 20May2021. Both events were reported serious because requiring hospitalization for 3 days (admission date not provided) and as life-threatening conditions. The patient was treated with enoxaparin then apixaban. Nasal swab was done on 21May2021 and resulted negative. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0172) on 21May2021 for COVID-19 immunisation. The patient was treated with enoxaparin then apixaban. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of all reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Hospitalization same day as Pfizer COVID-19 Vaccine (4/8/21) post-syncopal episode, hypotensive, CHF exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 4/11 nephrostomy tube placed. 4/20 pt stable to disch to LTAC.

Pt became weak, dizzy, pale and very diaphoretic a few minutes after receiving the vaccine. When further evaluated it was found that he was hypotensive and bradycardic. His blood pressure was initially 77/42 with a pulse of 54 following the vaccine at 11:21. As patient rested and drank water he was continuously evaluated and his BP increased to 91/53 a few minutes later and then it was up to 111/40 with a pulse of 60 at 11:29. Due to his condition EMS was activated @ 11:27 and they arrived on scene at 11:36 for further evaluation and transport to a higher level of care.

The fourth night after my first Pfizer vaccination I awoke at 2:30 am with severe chest pain. It felt like my heart was being squeezed. I was worried I was having a heart attack. I sat up in bed and felt some reduction of pain. I decided to sit in a chair and see if I continued to get relief. After around 2 hours the pain reduced to the point I could fall asleep. The same thing happened for the next three nights. I concluded it was a side effect of the vaccination. I had an appointment scheduled with my cardiologist, the day before the second dose so I decided to ask him about this. Dr perform an EKG that he said was "Perfect". He said my pain was probably from acid reflux. I received the second dose the next day and the same chronology of symptoms occurred but the pain was a little less that with the first dose. I was now certain this was caused by the vaccination. My vaccinations were administered on a base. The lot numbers are hard to read on the vaccination card. The second dose lot number looks like ER9727.

Arm soreness; Headache; Extreme fatigue; Dizziness; Bleeding from both nostrils; 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 BIONTECH, Lot number: EN6204), via an unspecified route of administration in left arm on 03Mar2021 at 14:15 (at the age of 64-years-old), as a single dose for COVID-19 Immunisation. The patient's medical history included 2 ischemic strokes on May2018. The patient did not had any allergies to medications, food, or other products. Prior to vaccination, the patient was not been diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patients concomitant medications were not reported. The patient experienced dizziness, 10 minutes after first shot, arm soreness for 3 days, headache from day 1 to 3 and 6 to 7, extreme fatigue from day 1 to 2 and 6 to 7 on 03Mar2021 at 14:30. The patient experienced bleeding from both nostrils (two weeks after first injection) on an unknown date in Mar2021 from day 3 until present. Bleeding started as dark bloody crust inside nose, then turned to red blood every time the nose was blown, from both nostrils. No therapeutic measures were taken for the events. At the time of report, the outcome of the events bleeding from both nostrils, arm soreness, headache, dizziness and extreme fatigue was not recovered. No follow-up attempts are needed. No further information is expected.

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.

Within 24 hours, my right foot swelled, especially the middle of the sole, but also the toes and top of the foot. After a two-week delay due to a misdiagnosis by my PCP, I was seen at an urgent care center. An ultrasound of the right leg discovered a blood clot. I was placed on Eliquis 10 mg twice a day for the next 7 days followed by 5 mg twice a day. After 7 days, the swelling was reduced by 90%. The swelling has remained at that level since then. I changed my PCP on May 21 and was cleared for most activities. She advised me to continues with the Eliquis for three months from May 3, with no need for further testing.

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

Site: Redness at Injection Site-Mild, Additional Details: About 5 min. after immunization, pt fainted, pt had pulse and breathing but high BP 180/89; paramedic were called & pt was take to ER. Per pt wife, he had history of fainting with injwection & blood tests. Also he has cardiovaculary disease and pacemaker. I recieved all these info after pt. faining; if I was informed prior; I would have recommended pt to recieve vaccination at hospital location.

Had to postpone the second dose because of a medical issue, anemia; Red blood cell aplasia; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2), first dose intramuscularly, administered in arm left at 23Mar2021 07:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at age of 64-year-old. Medical history included Addison's disease from 1980 and ongoing, slightly hypothyroid from 1980 and ongoing, ongoing Good syndrome, cholesterol increased from 2018 and ongoing, adrenal insufficiency and IGG deficiency (diagnosed with it five to six years prior to this report). No family medical history relevant to event. Concomitant medications included hydrocortisone taken for Addison's disease from 1980 and ongoing; fludrocortisone taken for Addison's disease from 1980 and ongoing; atorvastatin (LIPITOR) taken for lowering cholesterol from 2018 and ongoing; levothyroxine taken for slightly hypothyroid from 1980 and ongoing; immunoglobulin human normal (HIZENTRA) taken for Good syndrome. History of all previous immunization with the Pfizer vaccine considered as suspect were none. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient got his first dose on 23Mar2021. He knew it is supposed to be within 42 days for the second dose, but his was scheduled about 60 days. He would like to get his second dose. His second dose was scheduled pretty far apart, about 60-70 days since his first dose. The patient had anemia and still had it. The patient had to postpone the second dose because of a medical issue, anemia. They decided to postpone. He was diagnosed with a red blood cell aplasia. He got blood transfusions. He was hospitalized three weeks after getting the first dose. The same day he was supposed to have the second vaccine they discovered the problem and he had to be hospitalized. He had blood transfusions. They are still trying to figure out why he had it. The treatment included blood transfusions, he got concentrated red blood cells. Four times, once in the hospital. Confirmed as he received four units. The third one he just had outpatient. He had one two weeks after, since the beginning of April. He just had one yesterday. He had them about every two weeks. He was about to start treatment for this anemia. The both events require a visit to emergency room and physician office. The patient had relevant tests and was diagnosed with red blood cell aplasia and then hospitalized, but unable to provide exact details. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Postsyncopal episode; Hypotensive; CHF exacerbation; Sepsis; pyelonephritis; E.coli bacteremia; This is a spontaneous report from a non-contactable pharmacist. A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 08Apr2021 at the age of 64-years-old (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, diabetes, coronary artery disease (CAD), heart failure with reduced ejection fraction all from an unknown date (HFrEF). Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 08Apr2021, the patient experienced post-syncopal episode, hypotensive, CHF (Congestive heart failure) exacerbation and sepsis. Diagnosed: pyelonephritis and E.coli bacteremia, given abx coverage. 11Apr nephrostomy tube placed. 20Apr patient stable to discharge to LTAC. The patient was hospitalized for the events from 08Apr2021 to 20Apr2021. Therapeutic measures were taken included antibiotics, fluid, cardizem, nephrostomy tube. The outcome of the events was resolved in 2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available clinical data, reported events were most likely intercurrent medical conditions not related to vaccination with BNT162B2. Patient's history of diabetes, atrial fibrillation and heart failure are known risk factors for the occurrence of events that patient experienced. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

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.

Acute respiratory failure with hypoxia; Acute respiratory failure with hypoxia; Couldn't breathe; Pneumonia due to MRSA/Ground glass pneumonia; weak; lost 20 pounds; fever; Cough; This is a spontaneous report from a contactable consumer (the patient himself). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208, Exp 30Jun2021) via an unspecified route of administration in arm left on 16Apr2021 11:00AM (at the age of 64-year-old) at single dose for COVID-19 immunisation. Relevant medical history included heart disease ongoing from 1997 (this happened in 1997 and the patient had been living with it for a little while), heart attack, pacemaker defibrillator because of cardiac arrest (in 2011), atrial fibrillation (diagnosed a little while, he was not sure and had been in and out of the hospital and to heart doctor quite a bit) and hypertension. The patient was administered with first shot of BNT162b2 (Lot number EW0153) in left shoulder on 16Mar2021 11:00AM (at the age of 64-year-old). Concomitant medications were not reported. On 16Apr2021 after the second dose, the patient was fine. There were no reactions after the first dose, but the second dose two days after he started developing a cough and fever. He thought it was a side effect but then ended up in the ER with pneumonia. They gave him antibiotics and sent him home. He went through the antibiotics and went back because he was still sick and not responding. They gave him more antibiotics and sent him home. He went through that batch and ended up really bad so he had to call an ambulance a few weeks later. He was diagnosed with MRSA Pneumonia and stayed in the hospital for 5 days. Then, he was discharged. He went back to the ER again a few days later because he did not seem to be improving. He was coughing and was weak. He was given another batch of antibiotics. He did not know if it was from the shot or what - he was healthy until then. The patient added that she lost 20 pounds and confirmed that it was following the vaccine. Two days after the vaccine, maybe it was 19Apr2021, he had a fever and it was now gone (exact dates were unknown). Cough happened at the same time of the fever but it was not as bad, and then progressively got worse. His lungs started filling up. They thought it was COVID. by the x-rays it looked like COVID lung but they took a sample and it was MRSA (exact dates were unknown). His admission was 18May2021 and was for acute respiratory failure with hypoxia. Discharge paperwork said acute chronic combined systolic diastolic congestive heart failure but he has had that for many years. It also stated primary hypertension but he has had that. The paperwork sayid pneumonia due to MRSA and pneumonia due to unspecified organism. He was hospitalized 18May2021 through 23May2021 with pneumonia and the reason he was hospitalized was because he could not breathe. Lost 20 pounds: after he started getting sick from the beginning of it all, he was coughing and losing weight and all that. It may not be quite 20 pounds, maybe 17, but he just knew that he was down quite a bit. He was 160s now, he was high 170s before (as reported). Treatment included Lasix and all kinds of different antibiotics. They were giving him, he did not know what it was, at first. Then, they narrowed it down and once they found out it was MRSA they gave him Clindamycin he believes. Investigations: they did CT scans, chest X-rays, and labs but he does not know any information. Each time they did a chest x-ray, when he went to get a chest x-ray, each one was worse all the way up to when he was admitted. When he went, they did a bronchial scope or whatever, he was not sure, and they saw lots of swelling and infiltrate. He did not know what this meant, stuff was infiltrating into the tissue and it was not just in the airways. He added it looked like ground glass pneumonia is what they said. The patient added that he was usually pretty active and cannot do anything anymore. He had three or four Covid tests, all negative, no additional details provided. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Patient stated that the day after vaccine (over 24 hours later) he experienced chest tightness and difficulty breathing. He is still having these issues. I did instruct him to go to the hospital, but he refused at this time.

Chest pain which started 6/17, improved 6/19 and 6/20. Chest pain worsened 6/21 and persisted through the week. Became acutely short of breath and passed away 6/25 at hospital

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

CT scan showing lungs FULL OF PE; product smell abnormal; top of feet cramping at night/leg cramps; aortic widending; after 2nd dose shortness of breath worsening each day; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in left arm on 05Apr2021 as dose 2, single (at the age of 64-years-old) for COVID-19 immunisation at other. Medical history included ongoing arthritis. Concomitant medication included paracetamol (TYLENOL) tablet at a dose of 500 mg taken for arthritis, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 13Mar2021 at 09:00 as dose 1, single (at the age of 64-years-old) for COVID-19 immunization and experienced shortness of breath, strange smell of burning plastic, top of feet cramping at night. On an unspecified date in Apr2021, the reporter stated that after 2nd dose shortness of breath worsening each day and reported to PCD on day 10. Series of blood tests ordered along with CT scan showing lungs FULL OF Pulmonary Embolism (PE) with no prior history. Other symptoms include strange smell of burning plastic, top of feet cramping at night, and shortness of breath continues. On Eliquis for PEs. Also found aortic widening in echocardiogram. The patient underwent lab tests and procedures which included computerized tomogram: lungs full of PE and echocardiogram: aortic widening and Series of blood tests on an unspecified date. Treatment Eliquis was received for the events. Patient visited doctor or other healthcare professional office/clinic visit and he visited Emergency room/department or urgent care. It was reported patient was not overweight, non-smoker, and highly active. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved with sequelae. Follow attempts needed. Further information is expected.

aortic widening; Strange smell of burning plastic; Top of feet cramping at night; showing lungs full of PE; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 64-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:00 (at the age of 64-years-old) as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0153), via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 64-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for arthritis. The patient previously took Tylenol. The patient was not overweight, non-smoker and highly active. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. On 14Mar2021, after first dose shortness of breath lasted 2 days and experienced top of feet cramping at night. After 2nd dose shortness of breath worsening each day and reported to PCD on day 10. Series of blood tests ordered along with CT scan showing lungs FULL OF PE with no prior history. On unspecified date, other symptoms include strange smell of burning plastic and shortness of breath continues. Also found aortic widening w/echo. Treatment Eliquis was received for pulmonary embolism (PE). Patient visited doctor or other healthcare professional office/clinic visit and he visited Emergency room/department or urgent care. On unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: showing lungs FULL OF PE, Echocardiogram showed aortic widening. The outcome of the event shortness of breath was reported as recovered with sequalae on an unspecified date in 2021 and while for other events was unknown. Follow-up attempts are needed. Further information can be expected.

The D-dimer part of the blood work came back as 0.44; runny nose; lost his taste; lost his smell; coughing stuff up; coughing up phlegm; sneezing; This is a spontaneous report received from a contactable consumer (reporting himself). A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207, Expiry 31Jul2021), via an unspecified route of administration in left arm on 17Mar2021 at 11:30 (age at the time of vaccination was 64-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COPD treated by CPAP (continuous positive airway pressure), high blood pressure, cancerous tumors removed from bladder, atrial fibrillation. The patient's history of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient had no additional administered vaccines on same date with the Pfizer vaccine. The patient did not required any visit to emergency room or physician office. The patient had no loss of taste and smell within 4 weeks of prior vaccinations. The patient had no adverse events following prior vaccinations. The patient had no predisposing factors. No culture test was performed. The patient's concomitant medications included Eliquis (apixaban) taken for cardiac disorder from Feb2021 to an unspecified stop date; lisinopril and metoprolol tartrate for an unspecified indication. The patient called about the COVID-19 vaccine. The patient had his first COVID-19 vaccine on 17Mar2021. The patient had no issues with the first vaccine. About 2 weeks after the first dose received maybe around 01Apr2021, the patient started sneezing, having some phlegm, and coughing stuff up. The patient used a CPAP (continuous positive airway pressure) machine at night. Around 09Apr2021, the patient lost his taste and smell. The patient was scheduled for his second COVID-19 vaccine on 10Apr2021 but thought his symptoms were worse than the patient originally thought. The patient went to his doctor on 09Apr2021. The patient's doctor did the nasal swab for the COVID-19 virus. The patient never had a fever or chills. The patient's doctor gave him some erythromycin. The patient also did some blood tests. The patient's COVID-19 virus test came back negative. On the results of his blood tests on the first page, the first thing it says are that the patient's COVID-19 results were negative. The patient's doctor told him that the patient's body showed no response to the COVID-19 vaccine. The patient did not see that this blood test was testing for antibodies. Later in blood test paperwork the patient saw that it said antibodies not detected, does not preclude acute Sars-Cov-2 infection. The patient's paperwork said IgG and IgM were negative. The patient provided the following in a historical context. On an unspecified date in Feb2021, prior to receiving his first dose of the COVID-19 vaccine the patient had some heart problems. The patient gone into atrial fibrillation. The doctor prescribed Eliquis and put him on a heart monitor. The patient took a nuclear stress test and that was ok and now the patient was wearing a heart monitor. The patient's reading from his blood test results. The patient's D-dimer result was 0.44. In the reference range it said anything less than 0.50 was a normal range. But the patient was taking Eliquis and his doctor told him his D-dimer should be zero. The patient's doctor told him his D dimer was elevated. The patient's doctor believed the first COVID-19 vaccine has something to do with his D-dimer result. The caller reports that the patient heard about the Johnson and Johnson vaccine and blood clots but he had not heard anything about Pfizer having problems with blood clots or anything of that nature. The patient now has his second COVID-19 vaccine scheduled for next day on 23Apr2021. The patient's follow up visit with his doctor was on 17Apr2021. The patient's doctor advised him to wait until mid May2021 and start all over with the COVID-19 vaccines but this time his doctor wants him to get the Moderna COVID-19 vaccine. The patient was not sure why his doctor was wanting him to stay away from Pfizer. Was there an indication that the patient was not aware of that the Pfizer COVID-19 vaccine would cause his D dimer to be elevated at 0.44. The patient was aware and there may be other factors that cause his D dimer to be elevated. The patient just wants to see if he can get his second COVID-19 vaccine. The patient just wants to get the vaccine and get on with his life. The patient would not get the vaccine if there was a known reason not to get it. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

June 26, shortness of breath and a heart palpitations. No indication that anything was coming on. Tests performed. Findings, blood clots in left leg and both lungs. Admitted to hospital on June 26. Discharge on June 28. Currently on blood thinners. Sonogram of both legs. Clots found in left leg. EKG, ECG of heart, CT scan found clots in both lungs. Numerous blood draws. Dr. advised I would not have made it to June 27 if I did not come in on June 26. States worst he?s ever seen for blood clots and lungs.

Heart palpitations and light-headedness. Bad EKG Diagnosed as electrical problem at right ventricle.

Arrhythmia (irregular heartbeat). Patient spent 24 hours with a Holter monitor showing 17% extra/irregular beats. After that, he took medication, then spent another 24 hours with a Holter monitor, showing the extra beats were gone.

I am an avid runner, averaging 8 mile runs 5-6 days per week at an 8 minute per mile pace. ri an 7 miles after my 2nd covid vaccine and felt fine. 3 days later I started my run, had difficulty breathing, and could not even run a quarter mile. I had my yearly Cardiac Dr appointment, which was done virtually, on 4/15/2021. I mentioned the difficulty breathing during exercise and he ordered Pulmonary CT and chest xray on 4/16/2021. The testing showed I had multiple blood clots in both lungs and was immediately admitted to the Emergency Room where I had a negative Covid test and started me on blood thinners. I was admitted to the hospital and discharged on 4/18/2021. I was placed on Xarelto for a minimum of 6 months, and to follow up with my Pulmonary Dr in 3 months.

Within 5 minutes feeling flushed; high rate beat; high rate beat and pressure; trembling; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection;Batch/Lot Number: EN6203) dose 1 via an unspecified route of administration, administered in Left arm on 02Mar2021 12:45 (At the age of 64-years -old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. No covid prior vaccination, and no covid tested post vaccination, Known allergies was none, no other vaccine in four weeks and concomitant medications were not reported. On 02Mar2021 12:45 the patient experienced Within 5 minutes feeling flushed, high rate beat and pressure, trembling. Patient received treatment with ekg, Benadryl, prednisone, pepcid. The patient underwent lab tests and procedures which included heart rate: high. Outcome of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

normal tiredness and head ache for two days. Extended irradic blood sugar readings 87 to 326 from vaccine to present. no apparent patern.

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.

Taste rubber/vanilla milk; Vertigo prone sleeping; High blood pressure; Left arm sore; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en 6206) via an unspecified route of administration in the left arm on 06Mar2021 at 15:00 (at the age of 64-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removed on 11Feb2021. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 07Mar2021 at 04:00, the patient experienced taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore 5 days. Therapeutic measure was taken as result of event vertigo and included treatment with meclizine (MANUFACTURER UNKNOWN). The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of taste rubber/vanilla milk, vertigo prone sleeping, high blood pressure and left arm sore were resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

One week after first Pfizer shot, had bad heart palpitations, thumping and very noticeable. After two weeks, immediately before second shot, got slightly better. Went forward with second shot. Still have mild heart palpitations ever since, but more like a flutter. But it has been continuous and it's now two months after. Also, extreme fatigue, shortness of breath and mild joint discomfort.

First dose on January 14, 2021 - No adverse events. Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening. I was in the waiting room for observation. Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction. She had to hold me under my arm to help me walk back to the nurses who gave the vaccines. When I arrived, my vision got black and I passed out. I passed out from the reaction to the vaccine. I have a history of Anaphylaxis, I carried episode pens for years. I forgot my episode pens that evening but I carried my own benadryl. I stopped the reaction by drinking liquid Benadryl. I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl. My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.

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

I normally have a resting heart of 65 bpm-30 mins after the vaccine it went up to 120 and there for about 4 hours, it dropped to about 80 and has stayed at about 80 bpm. Two weeks after I saw my regular dr and I mentioned it. At that time my BP was higher 160/90, Dr monitored, and I went back the following week and the BP went back down. The heart is still staying in the 80's range to this day. On 06/08/2021 went to ER per my dr office-with a bleeding ulcer. I was in there for about 3 days, had an Endoscope, they cauterized it, also I had to have to blood transfusions while there.

myocardial infarction; Fluid; Shortness of breath; Chest pain; This is a spontaneous report from a contactable nurse (patient's wife). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 11Jun2021 10:00 (64-year-old at time of vaccination) as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 21May2021 (64-year-old at time of vaccination) for COVID-19 immunization. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced chest pain on 17Jun2021, fluid and shortness of breath on 25Jun2021, and myocardial infarction on an unspecified date. Patient's wife (a registered nurse, recently retired) just wanted to report this. She can't say that it is the vaccine or anything. Her husband received the second COVID-19 Vaccine on 11Jun2021 and he died at the emergency room 2 weeks later of a cardiac event. She couldn't do the report online because it was making her the one she was reporting on. Chest pain: She took him to the emergency room on 25Jun2021. He had been having chest pain that he reported to her that Monday before. He told her that it actually started the Thursday before on 17Jun2021. He had some chest pain that felt a little better over the weekend, then Monday it was worse. He wasn't a complainer, but he was obviously having chest pain. He was very stubborn and so he just kind of let it progress and it got worse during the week. He wouldn't go to the doctor. She kept telling him she read about myocarditis mostly with adolescent males. She thought what if it is something like that. Time of Onset of Chest pain: He reported it on Monday that he had chest pain on Thursday. She became aware when he woke up at 06:30 on 21Jun2021 and she knew something was wrong when he went for the Ibuprofen. Fluid and shortness of breath: The day she took him to the emergency room the chest pain had worsened and he had fluid and shortness of breath. The fluid and shortness of breath started on 25Jun2021. Death: He died on 25Jun2021. The cause of death was a myocardial infarction. They didn't do an autopsy. The reason they gave for not being able to do an autopsy was they were overwhelmed with drug overdoses and homicides. Indication for COVID-19 Vaccine: He didn't want it, but he needed to go back to the office and didn't want to wear a mask. Adverse events required a visit to emergency room. Investigations: She doesn't have his medical records yet. Essentially they were recording him. She can't believe she got him in in a wheelchair. Immediately they were doing resuscitation efforts. Relevant Tests was reported as none. The outcome of myocardial infarction was fatal; outcome of other events was unknown. The patient died on 25Jun2021. No autopsy was performed. The cause of death was a myocardial infarction. Causality: the reporting nurse has no opinion. She just thinks that the patient didn't randomly die any of his other 64 years. It may be a coincidence.; Sender's Comments: The event myocardial infarction with fatal outcome is considered unrelated to suspect product (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0180). The compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity may explain as alternative cause.; Reported Cause(s) of Death: Myocardial infarction

Elevated fasting blood glucose levels; 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: EN 6205) in the left arm on 12Mar2021 at 12:15 (at the age of 64-year-old) as a single dose and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8735) in the left arm on 02Apr2021 at 12:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated blood glucose levels, but under control with diet and exercise, A1C was 5.6. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications or vaccines within four weeks prior to the vaccination. On 12Mar2021 at 17:30 hours, the patient experienced elevated fasting blood glucose levels. The patient had noticed elevated fasting blood glucose levels after the first shot. During the 3 weeks between shots, his fasting blood glucose (BG) readings were 100 or greater all but once. Many readings were well above 100 (as high as 115). He had been carefully regulating his carbs for the last year and he kept track of everything he eats, so these were unusual. After the 2nd shot, his blood glucose reading was unusually high after his first meal, but his fasting readings had been back to nearly normal (100 - 101). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event elevated fasting blood glucose levels was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Congestive Heart Failure; Blurred vision; The caller was concerned the brother may have had an emboli,; Dizziness; Flu like symptoms; He had difficulty breathing/couldn't breathe; Headache; Cardiac issues; Fatigue; The blood pressure keeps spiking; Unable to stand very well; muscle & joint pain; muscle & joint pain; This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in deltoid muscle in Jul2021 (Batch/Lot number was not reported, expiration date not provided) at age of 64 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced congestive heart failure on 10Jul2021, blurred vision (Life-threatening) on 10Jul2021 19:30, the caller was concerned the brother may have had an emboli, dizziness (Life-threatening), flu like symptoms (medically significant), he had difficulty breathing/couldn't breathe (medically significant), headache, cardiac issues, fatigue, the blood pressure keeps spiking, unable to stand very well, muscle & joint pain, all in Jul2021. The patient was hospitalized for congestive heart failure from 10Jul2021 to an unknown date. The patient underwent lab tests and procedures which included blood pressure: keeps spiking in Jul2021. The outcome of the events was unknown. Clinical course: The caller was a pharmacist calling in regards to her brother. The caller did not know if this has any correlation. The callers brother received the first dose Pfizer Covid Vaccine, a day later all the typical side effects of flu like symptoms occurred. Had to get up in the middle of the night to raise arms because couldnot breathe: The caller's brother had to get up in the middle of the night to raise his arms because he couldnot breathe. The caller states this occurred the second night after the caller received the first dose Pfizer Covid Vaccine. The caller did not know specifically what time this occurred. The caller told her brother to go to a hospital. The callers brother had every excuse not to go the hospital. Later that evening, the caller called her brother to check on him. The caller's brother was having more symptoms, the brother had dizziness. This was not just typical Pfizer Covid Vaccine symptoms. Ended up in the hospital with congestive heart failure: The patient ended up in the hospital with congestive heart failure. The hospital is still having trouble, this is the patient's second or third day in the hospital. The hospital is having trouble maintaining the patients blood pressure, the blood pressure keeps spiking. This could be coincidental. The caller is asking if anything different is presenting after receiving the Pfizer Covid Vaccine? The caller would like to present this information to the doctor if so. Is there any correlation at all? The caller states she knows there have been incidents of myocarditis, but the caller's brother is not a youngster, the patient is going to be 65 in less than a month. Received first dose vaccine, a day later all the typical side effects of flu like symptoms occurred: The caller states this occurred after the patient received the first dose Pfizer Covid Vaccine. The symptoms have gone away after the third day. The caller has not asked the specific question if the patient recovered with lasting effects or recovered completely and does not know. Had to get up in the middle of the night to raise arms because couldnot breathe: When asked when this began the caller states her brother must have had the first dose Pfizer Covid Vaccine on Friday, 09Jul2021, or it could have been Thursday, 08Jul2021. The caller called the patient on 10Jul2021. When asked if this was ongoing or went away, the caller replies the patient continued with other symptoms that happened. The caller was concerned the brother may have had an emboli, all sorts of things. The caller advised the brother to go to the hospital. Had dizziness: When asked when the patient's dizziness began, the caller states she can not answer that exactly. The caller clarifies the dizziness occurred after the patient received the first dose Pfizer Covid Vaccine. The patient had only received one dose of the Pfizer Covid Vaccine so far. The caller is not sure if the patient has been advised to receive the second dose Pfizer Covid Vaccine or whether this is something totally different. When the patient was having flu like symptoms he was also having dizziness. The dizziness became different the second day at night time at 1930 pacific time, the patient told the caller he went out to the car and got so dizzy and light headed and couldn't breathe. The patient was bringing groceries inside and got winded. It was not normal. Ended up in hospital with congestive heart failure: The caller states the patient was hospitalized yesterday 12Jul2021, the caller then clarifies, no it was Saturday night, 10Jul2021 the patient was admitted to the hospital. The patient is still hospitalized at this time. The caller states she asked the cardiac nurse at the hospital and the cardiac nurse says she thinks this has nothing to do with the Pfizer Covid Vaccine. The caller is not sure and has heard so many different reports. Causality: When asked causality for each symptom, the caller replies, she certainly thinks the flu like symptoms are related to the first dose Pfizer Covid Vaccine. The caller does believe something must have happened to cause his condition to spiral down hill. The patient had some symptoms prior to receiving the first dose Pfizer Covid Vaccine but these were all manageable and not a problem. The caller doesn't know if the patient having the flu like symptoms may have put extra stress on the patient's heart. Had to get up in the middle of the night to raise arms because couldn't breathe: The caller considers this life threatening. Had dizziness: The caller states when the patient had dizziness at night, the caller considered it life threatening. The patient had other dizziness and blurred vision and inability to breathe and it was clearly cardiac issues. blurred vision: The caller does not know when this began. The caller states when her brother called at 1930 on 10Jul2021, that is when he had the blurred vision, the caller does not know if the caller had the blurred vision before and can't answer that question. The caller does not know if the blurred vision is ongoing at the moment. The caller knows the blurred vision had mostly gone away, the caller does not know if any of the blurred vision has come back, she believes it is gone. The caller considers the blurred vision life threatening. Date of first dose: The caller is unable to provide the date the patient received the first dose Pfizer Covid Vaccine. The caller states she would have to be in touch with the patient. It was either 08Jul2021 or 09Jul2021. ~ Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event headache, fatigue, joint pain, muscle pain and the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient reported as breakthrough infection requiring hospitalization. Received dose #1 of Pfizer on 3/4/21 and dose #2 on 3/25/21. Patient hospitalized from 7/12-7/15. Below is copied from discharge summary: Pt is a 64 y/o M with pmHx of Afib on eliquis, HTN, chronic HFpEF, anxiety/depression, chronic pain who presented with c/o generalized weakness x 2 days after having an exposure to COVID-19 from a family member. He also reported fever and chills with reported temperature of 102F. He completed COVID vaccine back in March. He tried tylenol with mild improvement. He denied chest pain, cough, SOB, n/v/d, loss of smell, LE edema, orthopnea. He was found to be meeting sepsis criteria in the setting of COVID 19. CXR showed bilateral hazy pulmonary opacities and left sided pleural effusion. Initial vitals showed sinus bradycardia and home amiodarone and coreg were held. He was not requiring oxygen on admit. He was admitted for further management. Procalcitonin was elevated at 0.33 and pt was started on azithromycin and ceftriaxone for possible superimposed bacterial PNA. On 7/14, pt was found to be hypoxic and required 3L of oxygen and was started on Dexamethasone. An echo was done showing mild concentric LVH, EF 50-55%, moderately enlarged RV. He did receive a few doses of IV lasix while inpatient. His home coreg and amiodarone were resumed. He was seen by PT/OT who recommended HH services which was ordered. He was feeling well on 7/15 and back on room air. He passed a walking desaturation study. He had completed 4 days of azithromycin and ceftriaxone and was discharged with Augmentin to complete a 5 day course.

DEVELOPED INCREASED HYPERTENSION >20 POINTS HIGHER THAN NORMAL (185/115 ON 01.02.2021); GENERAL MALAISE, HEADACHE. TREATMENT NONE AS OF THIS DATE; OUTCOME; PENDING STILL ELEVATED BP AND HEADACHES

Resident became SOB, congested and hypoxic requiring oxygen, respiratory treatments and suctioning. Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s. On 1/3/2021 was found without pulse and respirations. Resident was a DNR on Hospice.

Angina Hx. of HTN, DM, pacemaker presented with CP that radiated to bilateral jaw/chin. VSS. Narrative: After covid19 vaccination, c/o CP with radiation to jaw/chin. denied SOB, nausea or diaphoresis. Monitored for 30 minutes with CP resolved but jaw/chin sensation remained. Brought to ED at 15:25 in stable condition. . In ED, stable vitals, a-paced rhythm w/o ST changes per ED note. Offered OBS admission for further cardiac workup but patient declined and was discharged in stable condition with no CP or jaw/chin sensations present.

Shortness of breath, pounding irregular heart beats, pressure in center of the chest, clumsiness. I had a symptom free case of Covid-19. I took 25 mg instant release Metoprolol beta blocker I keep around for a flutter. The symptoms I had after the vaccine were in no way related to the symptoms I have had with aA flutter. The worst of the symptoms after the covid vaccine lasted from 9:00 pm to 12:00 pm or so when I fell asleep. Diagnosed Positive with Covid-19 on 12/28/2020 by saliva test VAULT TESTING SITE. The day of this Covid-19 Vaccination was my first day off of quarantine.

After sleeping 2 hours at night I got up to use the restroom. After standing to wash my hands, I fainted and fell halfway into the bathtub and floor. My girlfriend came to help to find my eyes rolled to all white. After getting back to bed I was very hot, sweaty and tired. After a hour I was feeling better and slept until 10:00 AM. Being in this location for 6 months I really have no primary doctor and I went to the hospital. They?re tests listed below and all came back normal. Was given paperwork for Fainting (Syncope) and released. The Doctor stated that with all the causes of Fainting it seemed the only one that pertained to me was ?old age?.

i'm an ophthalmologist with paroxysmal afib. very fit, play tennis at the national level 2-3x/week. usually have 2-3 brief bouts of afib per year. since being vaccinated (got second shot on 1/9/2021) have had at least 5 bouts lasting minutes to hours, some apc's also. incidence decreased after the first shot, and seems to be occurring same way after the second shot.

Resident experienced chest pain the evening he received the vaccine and requested to go to the hospital as he stated his "chest is pounding".

At about 10 pm or approximately 5 hours after receiving my shot I noticed a slightly elevated heart rate. My resting heart rate is normally in the high 40's bpm to about 55 bpm. My heart rate remained elevated (between about 75 bpm to the low 90's bpm) until about 2 am the following morning when it returned to normal where it has since remained. I have had no other symptoms. (Pfizer-BioNTech Covid-19 Vaccine EAU) I should add that from about 6:30pm to 7:30 pm I had two glasses of white wine. I know that alcohol can be a cause of an afib occurrence.

Received Pfizer vaccine (dose 1) on 01/23/21 around 2pm. At 10:30pm on 01/23/21 he stated that his chest was heavy and felt like fluid was in his lungs. He coughed up some fluid and mucous. He stated that he had shortness of breath on 01/24/21 and 01/25/21, but has no difficulty breathing since 01/25/21.

Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed, patient reported difficulty breathing to his wife, then turned blue, and became unresponsive. Family report pt was without any symptoms prior to event. 911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib. Between EMS and Medical Center ER, pt had 9 rounds of epi, CPR w/ LUCAS machine, given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs, which did not show STEMI, but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's). Pt had return of spontaneous circulation. Pt intubated, and started on Levophed. Pt transferred to ICU, and had central line placed. Family decided to make patient DNR. Pt went into coarse VFib again, and as per wishes of family, code blue not called. Patient expired at 01:53 on 1/19/21.

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

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

Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. 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 stated he felt flush, lightheadedness, and heart palpitations after receiving the vaccine at 8:42 am. Vital signs were taken and within normal limits. EMT also called and checked patient. Patient declined to be transported to the hospital. Patient left the facility at 9:45 am on his own.

my blood sugar has been up; I was 197 before breakfast; my blood sugar has been up; I was 197 before breakfast; This is a spontaneous report from a contactable consumer reporting for self. A 65-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing insulin dependent diabetic, hypertension, and kidney disorder. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (LANTUS), acetylsalicylic acid (ASPIRIN), lisinopril to make his kidneys strong. The patient stated he had the first shot and he believe one of the side effects was it can cause your blood sugar to go up. So, he had to monitor his blood sugar more closely. He got the vaccine on Thursday (14Jan2021), since then his blood sugar had been up. He stated that he was taking his insulin aspart and insulin glargine. Like today (18Jan2021) he took 4 units of because he was 197 before breakfast. The outcome of event was unknown. Information on Lot/batch number has been requested.

1-7-21 - Posterior lumbar interbody fusion @ L3-4 (N/A spine lumbar) by Dr. 1-19-21 - 1st dose Pfizer Covid-19 vaccine given. 1-26-21 - Swelling of (R) calf (H/O peripheral edema) 1-29-21 - 1-31-21 - Hospitalized with DVT (R.leg) & PE (lungs bilaterally)

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.

Two hours post shot patient began experiencing chest pain, presented to ED and had a troponing of 0.7, started on heparin infusion and taken to cath lab where received complex PCI to prox LAD lesion as well as distal LAD lesion

Patient had vaccine on 1/29/21 and had STEMI on 2/4/21, started with back pain symptoms on 1/31/21 requiring hospitalization and MI occurred in the hospital

Immediately after finishing a lunch meal on 2-14-21, I blacked out, without warning, and fell from my chair to the floor. I remained unconscious for approximately 30 seconds. My blood pressure reading was 136/82 approximately 10 minutes after the incident. This apparent vagal syncope was the first I have experienced. Had I been operating a motor vehicle, I would have crashed the vehicle as the blackout was instantaneous. I visited my PCP on 2-17-21. He checked my blood pressure and performed an EKG and both were normal. He has requested appointments with a cardiologist and a neurologist.

Within one week of receiving vaccine, experienced shortness of breath and chest tightness on exertion, lightheadedness, tachycardia. Became increasing worse over next 5 days. Visit to ER on 1/18/21. Diagnosed with many bilateral pulmonary emboli with clots in both pulmonary arteries. Admitted to hospital and started on Eliquis. Had doppler on legs which showed DVT.

Patient hospitalized due to fevers, hypoxia to mid 70s, severe fatigue and lethargy which developed within hours of receiving vaccine.

Patient passed out in the immunization chair - Passed out 2 minutes after the vaccine, came-to a few seconds after, was fine after that

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.

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

Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death

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.

I check my blood glucose twice a day. I noticed after about 36 hours my glucose was running higher then normal, 150's, with the same diet and exercise routine. This evening, March 8, it is still a little high at 120, but better and closer to my normal. I had read online that the vaccine could cause glucose levels to rise so I have waited it out.

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

Chest Pain started on Feb 2, 2021. Comes and goes from light pain to excruciating pain. I was admitted into the hospital through the ER with chest pains on Thursday Feb 18, 2021. Stayed two days and one night and had 5 test done to fine the cause of the pain. The doctor on the floor told me all the test were good and they didn't believe it was my heart. So they released me the second day. I was have excruciating pain. They released me and still having chest pain. Told be to take benadryl. As of March 9, 2021 still have the pain.

Pt was visiting dr for routine checkup. Pt began to experience difficulty breathing, 911 called. I showed up to pt apneic, pulseless. CPR initiated. Return of spontaneous circulation in ambulance (without Rx). Pt intubated, ventilations continued throughout contact. Pt still had spontaneous pulse upon delivery ti ED, placed on vent in our presence. Pt later transported to Level 1 hospital on vent.

Patient stated he had right chest discomfort but denied pain; no ther symptoms; relieved after rest for 10 minutes

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.

About an 1 1/2 hours after getting my first shot I had what I can only describe as a RUSH/High energy feeling along with a soreness in my chest around my heart area. Lasted for about 2 hours and that was it no other symptoms that I noticed. Then after getting my second shot had the same thing only much more intense to the degree I was worried I may be having the start of a Heart Issue. This last for a couple days. And now I?m about 14 days after my second shot and my heart area feels much better but my whole back from my neck almost to my waist feels like sore and achy. Never had fever chills shortness of breath or anything really other than what I?m describing above. I?m starting to feel a little better each day. I just boy wanted to report this because I could not find anyone else who had felt like this after the shot. Thank you

The patient is a very pleasant 65 year old gentleman with a history of hypertension who presents to the hospital reporting a fever, cough, and chest pain starting two weeks ago. He states that he has had flu-like symptoms for the previous two weeks with a prominent nighttime fever and sweats. He states that he had a similar episode approximately one year ago. He reports that since Saturday he became short of breath. He states that when he goes and feeds the horses and walks back he is short of breath and needs to rest. He denies any myalgias, nausea, vomiting, diarrhea, or abdominal pain. He reports that he has chest heaviness. In the emergency department he was diagnosed with pulmonary emboli with large clot burden. He states that he has never had a blood clot. He has no family history of cancer, deep venous thrombosis, or pulmonary embolus. He denies any melena or hematochezia. He states he has not had a colonoscopy. He reports that over the past two weeks he has not been moving around much, saying that he has been largely confined to his chair due to his illness

Patient developed fevers the day after vaccine, arthralgias/myalgias. daily fevers persisted, and he was eventually admitted to the hospital for FUO workup. fevers finally stopped after prednisone initiated on 3/11 (3 weeks after vaccine) presumed Still's disease type phenomenon from vaccine (has high ferritin, high WBC, low albumin, mild LFTs abnl, persistent fevers), never had rash

My Sugar level have shot up very high. It is not going below 250 and goes to 390 after eating!; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered at the left arm on 17Feb2021 16:15 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus (diabetic). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, the patient's sugar level had shot up very high. It was not going below 250 and went to 390 after eating. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.

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.

Client reported L subcostal chest pain. History of 3X MI; B/P 200/100; no acute distress; chest pain occurred around 2 minutes post Pfizer vaccine. EMS called and arrived within 3 minutes. No SOB; lives in truck; n meds; unsure of meds; HTN. EKG normal. At 9AM B/P 200/100, HR 80. EMS took over care of client. Ambulance called and on site within 3 minutes. Client refused to be taken to the ER. Client expressed to drive himself to the hospital. Client left the building per client request.

Developed a DVT in right calf on 03/17/2021. Doctor told me it was a significant clot that had developed , after review of ultrasound exam

Hard to breath, very bad chest pain and the worst head ache I?ve ever had. All symptoms went away in about 15 minutes.

Pt presented SOB several days prior to receiving vaccine. His sister reported he had severe COPD and was getting progressively worse. On the day pt was vaccinated, his sister picked him up for the appointment and pt refused a wheelchair. Pt walked into the clinic on his own and recevied his vaccine. Sister reported pt walked to the car after his vaccine and was winded. She dropped him off at his house and called him later to check up on him. Pt stated he was feeling fine but his arm was sore. Pt's sister called the next morning and reported that he sounded terrible. He was strugging to breathe and was SOB. His sister went over to his house to check on him and wanted to take him to the doctor's office or the hospital. Pt refused at that time. Pt agreed to make a doctor appointment for later in the afternoon. Sister left at noon. She stated her brother had made a doctor appointment for 4:00 at Family Practice. Upon arriving, pt started walking towards the entrance and became SOB. His significant other asked the doctor's office for a wheelchair and was denied. Pt coded in parking lot of Doctor's Office and passed away at 4:31 p.m.

65 y.o. male who presents with chest pain. Patient reports he has been having intermittent chest pain since Friday. Patient reports the episodes last only a few minutes to maximum 2 hr. Patient states his episode of chest pain hit him this morning around 7:00 a.m. after he got up. Patient reports his pain is currently a 4/10. He describes it as a sharp pressure located in the center of his chest. He denies any radiation the pain. Patient denies any associated symptoms of shortness of breath, lightheadedness, dizziness, diaphoresis, nausea, or vomiting. Patient does have cardiac risk factors including hypertension, hyperlipidemia, diabetes, family history, obesity, and former smoker. Of note, patient states he was recently diagnosed with angina and placed on metoprolol and given sublingual nitro to take as needed. Patient reports he has not used his sublingual nitros. Patient sees HCP. Patient had exercise stress test with nuclear scan that was negative in January of 2021.

Patient had vaccination at an outpatient site 2 days prior to presenting to our hospital with severe bilateral pneumonia and hypoxia.

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

Awoke to rapid heart rate and dangerously high BP. He was sweaty and light-headed. Couldn?t reach cardiologist so called PCP. She told him to take another Metoprolol and Multaq. She called in an emergency prescription in case needed during winter freeze we were under. Then the Oncologist reduced his Inlyta dosage.

4 days after receiving vaccine I started getting palpitations. Like I was skipping a beat. It is still happening but has reduced by about 50%

AE: pt reported chest pain and tingling/ numbness of lips approximately 30 minutes post vaccination Tx: EMS eval and vitals Outcome: pt refused further treatment and transport

Passed put while walking in home. Hit head on stair railing. Gashed head. Lots of blood. Bleeding stopped after 1 hour (pressure applied)

Patient has substantial bilateral lung PE 12 days post vaccination; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 65 years) as single dose for covid-19 immunisation. Medical history included allergies: penicillin and testim. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date for covid-19 immunization. The patient had substantial bilateral lung PE (pulmonary embolism) 12 days post vaccination on 14Mar2021 (as reported, pending clarification). The event resulted in emergency room/department or urgent care and hospitalization in Mar2021. Treatment of heparin infusion with rivaroxaban (XARELTO) initiation planned was received for the event. The patient had no covid prior vaccination and had not tested post vaccination. Outcome of event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event pulmonary embolism 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.

Patient was in the observation area after his second Pfizer COVID-19 vaccine dose. Shortly after, patient was observed to be shaking and then fell out of his chair and hit his head on the ground. Patient sat up immediately afterwards. Patient was coherent and able to respond to questions when addressed by the healthcare team. Patient was diaphoretic and was bleeding slightly from injury on his head from falling.

Immunization 3/29/2021 COVID Vaccine Clinic Need for vaccination +1 more Dx Referred by MD Reason for Visit Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/30/2021 8:12 AM Expand AllCollapse All COVID VACCINE CLINIC 3/29/2021 Patient: (name) DOB: (date) Date: 3/29/2021 MRN: (number) Subjective Patient is a 65 y.o. male who was seen at the COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience shortness of breath as he was walking out to the front. He reports no issues with the vaccine as he was waiting. He denied rash, hives, welts, 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, rapid progression of symptoms and respiratory distress. Pmh: hx of iron deficient anemia. He just stopped taking his iron supplements on Saturday after being on it for 10 days. He also was taking Diflucan and had some "adverse reaction" of nausea and sleeping issues. Denies hx of heart or lung disease, not on any inhalers or medications for these. Past Medical History: Diagnosis Date ? Fatigue, unspecified type 2/7/2017 ? Impotence of organic origin Impotence, Organic; NG PMH ? Obstructive sleep apnea ? Osteoarthritis ? Unspecified essential hypertension Hypertension; NG PMH ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 03/29/21 1035 BP: 138/58 Pulse: (!) 102 SpO2: 92% 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: Regular rhythm. Tachycardia present. Heart sounds: Normal heart sounds. Comments: HR improved with rest down to 90 Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Comments: Speaking full sentences. 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 normal. 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: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash) Pt with improvement/resolution of sob with rest. I suspect sob related to iron deficiency. Recommend that he monitor breathing at home . If symptoms return or Worsen, seek care in ED. Certainly to follow up with pcp accordingly for management of his iron levels. Pt voiced appreciation and denies any other questions or concerns. (name), APRN Electronically Signed 3/29/2021 10:42 AM