Pfizer

3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21

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

Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination

Patient remains hospitalized but respiratory symptoms are improving, AST/ALT are down-trending, & PT/INR returned to normal. Symptoms: Bleeding, Abnormal INR & ElevatedLiverEnzymes

Per EMS, the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife, that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED, the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI, 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am.

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

Administered COCID vaccine , pt felt lightheaded , wife said he always does this then he proceeded to slide out of the chair, unsure if he lost conscience, called for help and Pharmacist who responded, pt hypertensive do called EMS, Fire Dept responded as well as EMS and it was decided he needed to be transported for further evaluation

Burning sensation on upper right back which moved to shoulder and right front upper chest. Elevated blood pressure. Went ER on 01292021. Resolved on own by 01312021

HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or something. It eventually radiated over up into the left quadrant of his chest where he could not push down on it. It was extremely painful by Monday. He has a history of esophageal spasms and exacerbated them to where he thought he was having a heart attack. He called his Cardiologist and told him to go to the ER. He went to the hospital Monday evening, he had two EKG's, had blood drawn 3 times, did sonograms looking for blood clots. He did inform them that he had the vaccine on Friday and they told him it was due to that. He went to nuclear medicine to get his lung checked for blood clots as well. All tests were negative. He saw his PCP today who told him that the lymph nodes were affected due to the vaccine. He has improved greatly, still has some slight discomfort which his PCP said would go away in time.

Chest pain elevated Troponin 112 T EKG Cardio Cath No sign of damage Diagnosis Cardiovascular Spasms

on 1/25 patient experienced dizziness, nausea and vomiting, dizziness worsened the next day. Nausea improved within a day and dizziness resolved fully in one week. According to records reviewed "LINQ device and showed mild arrhythmia but no Afib" MRI brain 1/26/2021: Tiny acute lacunar infarct in the left posterior medulla.

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

Patient presented for second COVID vaccine (1st dose given 1/21/21). While in observation, patient started feeling chest & throat tightness. Nurse in observation reports pt looked anxious. EMS was called over. EMS assessed patient and advised transfer to emergency department. Patient was taken to ER. At the ER, patient was diagnosed with chest tightness and shortness of breath. He received 325 mg of aspirin. EKG showed rate 63, no ST-T changes, no ectopy, normal PR & QRS intervals with rhythm atrial fibrillation. No epinephrine was given in the field (at vaccination site) or while in the ER. Patient was in NSR at time of discharge with recommendation for close cardiac follow up.

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

0945 Client related he is having difficulty breathing and is showing signs of cyanosis within 2 minutes of receipt of 2nd dose Pfizer vaccine. Epinephrine 0.3mg administered per auto inject pen IM to left thigh. Ambulance called. Nursing staff and medics on site. SPO2 55 pulse 133 client has Ventolin inhaler 2 puff administered .0949 BP 76/52. 0952 Sp02 64 Pulse 104. Client relates improved breathing. Audible wheezes. 0956 ambulance arrived Pulse 103 SpO2 76. Client remained conscious and continued to communicate. Client taken by ambulance to Hospital. Wife is with client.

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

1st vaccine 2/10/21; developed chest pain 2/21/21; seen at ED and admitted to Hospital 2/22/21 for chest pain.

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

1st vaccine 1/26/21; 2nd vaccine 2/19/21; developed chest pain 2/22/21 and went to ED and admitted to hospital, DX: Chest pain, unspecified type R07.9 786.50

18-20 hours after receiving the injection he noticed that "his heart would beat "hard"/heart beating fast; about 18 to 20 hours later the next morning he was experiencing something like a palpitation; arm hurt that night and the next morning/sore arm of course; This is a spontaneous report from a contactable consumer (patients wife). A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261) , via an unspecified route of administration on 21Jan2021 at 14:30 (at the age of 76-years-old) in the left arm as SINGLE DOSE for covid-19 vaccination. Medical history included cardiac murmur and Type 2 Diabetic. There were no concomitant medications. On 21Jan2021 the patient experienced arm hurt that night and the next morning/sore arm, and On 22Jan2021, 18-20 hours after receiving the injection he noticed that 'his heart would beat hard' /heart beating fast/he was experiencing something like a palpitation. Report described that it is like when you get scared. This Happens 2-3 times a day and it is not constant. The patient went to his primary care physician on Friday for a 'routinely scheduled annual check up' and mentioned this to her at his appointment. His provider encouraged him to call Pfizer and report these symptoms. His doctor is going to continue to follow up with him and if the problem persists do further tests. Lab data included heart rate on 22Jan2021 18-20 hours after injection his heart would beat hard /would be fast/something like a palpitation. The clinical outcome of heart beating fast was not recovered while palpitations and arm pain were unknown.

Rapid heart rate (140bpm-160bpm) @ 7:00 PM on day of vaccination. Heart rate was normal (60-66bpm) the morning of Friday, 02/26/21. Double vision was experienced the morning of Saturday, 02/27/21, 2 days after vaccination. Double vision continues at this time (12:15 PM).

blood sugar is higher; This is a spontaneous report from a contactable consumer (patient's wife). This 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration on 25Jan2021 (at the age of 76 years-old) for COVID-19 vaccination. There was no relevant medical history reported. Concomitant medications were not reported. On an unknown date, his blood sugar was higher. Sometimes he received testosterone injections and it stays high for a couple of days. The clinical outcome of blood sugar was higher was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

DEATH Narrative: patient's wife reported he had gone in an outside hospital, had held his brilinta as advised anticipating shoulder surgery "and he threw a big clot and died."

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

history cancer on chemo, DM2 non insulin dependent 10 min s/p vaccine adminstered pt developed Chest pain associated with shortness of breath. chest pain resolved after nitro SL and asa. pt was evaluated by cardiologist and discharged home. Denies cardiac history similar reaction with 1st COVID vaccine dose

Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF

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

24 Hours after receiving my second dose of the Pfizer Covid-19 vaccine, I fainted. I was only unconscious for s few seconds, and seemed OK upon regaining consciousness. So far, it has not recurred.

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

Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.

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

intraparenchymal hemorrhage, right occiput; This is a spontaneous report from a contactable nurse (patient). This nurse reported that a 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 76-years, via an unspecified route of administration on 04Feb2021 17:30 at single dose for COVID-19 immunisation, in hospital. Medical history included MGUS; thyroid nodule; hyperlipidemia; single episode A fib. Patient had no known allergies, no COVID-19 prior vaccination, no other vaccine in four weeks. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin; colecalciferol (VIT D3); cyanocobalamin (VIT B12); rivaroxaban (XARELTO). The patient historically received first single dose of BNT162B2 (lot number: EL3247) at the age of 76-years on 14Jan2021 05:45 PM for COVID-19 immunisation. On 09Mar2021, the patient experienced intraparenchymal hemorrhage, right occiput. This adverse event resulted in emergency room/department or urgent care, 5 days of hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient received XARELTO reversal and osmotic fluids to reduce brain s as treatments. The patient underwent lab tests and procedures, which included on 11Mar2021, COVID-19 test (Nasal Swab) was negative. Outcome of the event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event 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.

Minor Stroke affecting the right side (hand and leg). Went to emergency room Monday and Tuesday (3/1/21)

He had his Vivid shot and awoke blind in left eye 4 hours later. Went to ER and then on Friday went to eye Dr. at clinic.

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

chest pain Narrative: 6yo man received first dose Pfizer Covid vaccine on 3/1/21. Patient subsequently presented to the ED on 3/13/21 with a one day history of atypical chest pain and shortness of breath with walking and lying down. It is very unlikely that the vaccine is related to the patient's episode of chest pain. From a vaccination standpoint, it is safe for the patient to receive his second COVID vaccine as scheduled.

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

Patient complained of chest pain 20 min after receiving the vaccine. Patient placed on the stretcher and called 911. Vitals good but he was brought to the hospital for further workup.

Patient complained of chest tightness about 7 mins after receiving vaccine. Nurse assessed the patient.

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

12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k

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

blood pressure dropped really low; pulse went really high; heart rate went up; atrial fibrillation; his blood pressure and pulse have remained erratic; his blood pressure and pulse have remained erratic; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 10:30 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), at the age of 76-years at vaccination, as SINGLE DOSE for COVID-19 immunisation . Medical history included congestive heart failure, aortic valve replacement couple of years ago. Concomitant medication includes aspirin 325mg once per day by mouth. On 05Mar2021, the patient went into Afib, his heart rate went up and the next day on 06Mar2021, his blood pressure dropped really low but his pulse went really high and carried it that way for a few days and then he went pretty much back to normal. On 05Mar2021, the patient experienced atrial fibrillation for 22 hours and since that time his blood pressure and pulse have remained erratic. The reporter stated that the patient has returned to normal and his pulse is still a little high and his pulse used to run in the 70's and maybe 80 but today (15Mar2021), the pulse was still 95; on 06Mar2021, the patient took his blood pressure twice and is not sure at what time he checked it but one time it was 98/65 and the pulse was 114 at that time and the other time the blood pressure was 88/59 and the pulse was 115. States the patient's blood pressure pretty much turned back to normal on 10Mar2021 and the blood pressure started being normal on 10Mar2021. On 15Mar20021, the patient's blood pressure was 140/76 and the pulse is still real high at 95 today and he weighs himself, takes his blood sugar and blood pressure every day. Regarding the treatment, the reporter and the patient saw the patient's cardiologist this past Friday 12Mar2021 and put the patient on Metoprolol and the blood thinner Eliquis; states the patient was just taking a whole Aspirin and had previously had aortic valve replacement a couple of years ago and the HCP reduced his aspirin dose down to a low dose of Aspirin and then put him on the Eliquis at the HCP appointment. The reporter stated, for the Metoprolol and Eliquis she does not know the dosages or frequency of how the patient takes them at this time; states she has no lot numbers for the Metoprolol, Eliquis or Aspirin to provide as they are not with her at this time. The outcome of the event his blood pressure and pulse have remained erratic was not recovered; while the other events was recovered. Treatment has been given for the events.

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

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

Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.

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

DVT L leg, possible PE; DVT L leg, possible PE; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 09Mar2021 (at the age of 76 years old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took NSAIDS. The patient experienced DVT L leg, possible PE on 12Mar2021. Treatment given included Eliquis. 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 been tested for COVID-19. The outcome of the events was recovering. Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events deep vein thrombosis and possible pulmonary embolism occurred in a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Client c/o tightness to the chest. Client seen and assessed by EMT. No signs or symptoms of distress noted. Client observed talking without difficulty. V.S. are: BP 122/79, HR 64, O2Sat 100%. Client denies any other symptoms and cleared to go by EMT. Client also advised to seek medical attention if symptom worsen.

During my annual physical scheduled on 03/10/2021 at approx 11:00AM, my Primary Care Physician, listened to my heart and commented that it was irregular. He had his nurse take an ECG and after his review he said that I had new onset Atrial Fibrillation. He prescribed the blood thinner, Eliquis 5mg twice daily, and recommended that I schedule an appointment with my Cardiologist. I had an appointment with cardiologist on 03/17/2021 and he confirmed my Atrial Fibrillation. He scheduled me for a Transthoracic Echo (TTE) Complete with PRN definity on 04/08/2021 which was completed. It must be noted that annual visits to my three doctors over a past period of 5 years, never showed that I had an irregular heartbeat or Atrial Fibrillation prior to its first discovery by PCP on 03/10/2021, exactly one week after my second Pfizer Covid 19 vaccination.

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

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

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

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

Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive functioning

After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain was so bad that my dad went to ER and had a Pulmonary Embolism . He was hospitalized two nights. After the second vaccine: right leg pain, weakness in both legs. Three days after the second dose, my dad had a stroke.

Feb 3, 2021. Five days after first vaccination, had severe dizziness upon awakening. Could barely stand up. Dizziness and lightheadedness has persisted on and off for almost two months. Felt much better for about 3 weeks and then it re-occurred and continues to this day (5/3/21). On the evening of 4/29/21, actually passed out and hit the floor incurring head laceration. Epley procedures have had no effect. Doctors have not found cause. Cardiologist has me starting on a monitor, but I'm sure that's not the issue. Dizziness comes and goes and is not always present. Have never experienced these symptoms before. No history of vestibular problems. Very distressing.

Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful.

The day after my second shot I went into Atrial Fibrillation. This lasted for 6 days. I have never been diagnosed with this, but have had infrequent bouts with PVC's. Diagnosis was made at Hospital ER a few days after onset of symptoms. Visited my Cardiologist about a week after that, but by then my symptoms had disappeared. It is now about 3 months after this episode and I have had no irregular heartbeats since.

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

severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Nose bleed; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261 and expiration date was not reported), via an unspecified route of administration in arm right on 28Jan2021 at 12:10 as single dose for covid-19 immunization. He had already set appointment for second dose. No further details provided. Medical history included diabetes mellitus from Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced nose bleed on 28Jan2021 13:00 with outcome of recovered. Patient just received the Covid-19 vaccine today about 10 minutes after 12. About 1pm today he started to get a nose bleed and it continued bleeding for about 40-50 minutes, but it has subsided and stopped. Thought he should call to inform Pfizer of this. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. Pertinent Details was none and no Family history. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are swollen; burning pain in left lung, and it goes up to the breast and lymph nodes/ discomfort on left side Lung; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; has tenderness near the wrist and elbow, clarifying the inside of the elbow; felt numbness in the left arm; hot flashes; This is a spontaneous report from a contactable consumer (patient) and physician. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart conditions, he has had 2 heart attacks in the past, the first one was 21 years ago, and the second was 2 years ago. Concomitant medications included all his regular medications, nothing new; (also reported as No other products). Patient previously received BNT162B2 first dose on 13Feb2021 administered in left arm for COVID-19 immunization. Patient developed varicose veins a month after he received both his shots for Pfizer's COVID vaccine. Caller stated veins are swollen. It's coming down some, but patient need to know what medications could take or not take. On the left arm right inside of his elbow, he started getting some pattern of varicose veins. It was tender to some degree and people told him to massage it and put a warm pad on it. Seems like the veins were going to pop out. Patient stated he received his vaccine at a hospital. On 03May2021, reported patient was calling in regards to a covid vaccine. He developed a thrombosis on the left arm, it was varicose veins on the arm and the whole arm is swollen, it was still swollen but it was coming down. He had been using a heat pad. Initially after 2 weeks from when he got the shot he wasn't concerned, he went to the doctor and they gave him Cat scan, Ultra sound, and blood test and did not find a blood clot. He added that he had discomfort on left side Lung, but he had discomfort several years ago, an MRI in the past that showed he has a spot in the lungs, but they didn't think it was progressing. With this thing in the past 3-5 weeks he has burning pain in left lung, and it went up to the breast and lymph nodes, it is sensitive there, he has no idea what it is. Caller was asked to clarify since he stated that he had a thrombosis but all tests show no blood clot. Caller stated that he thought Thrombosis meant when the veins are popping out and gives impression of varicose veins. He had tenderness near the wrist and elbow, clarifying the inside of the elbow. If looking at the arm from the elbow up little, it looked like worms coming out, it was veins or arteries showing. The varicose veins appearance was more pronounced close to surface initially but is now minimizing. First dose date on 13Feb2021. He was not concerned after the first dose, he was fine, he thought it was a good product and it still is. Second dose date on 10Mar2021. After the second dose he felt numbness in the left arm and hot flashes, he looked down and saw the varicose veins. He did go see the primary care doctor. He also saw his heart doctor but that was an already scheduled appointment, he did not schedule it because of this situation. the heart doctor said to put a warm pad on the arm and lift the arm up over the head every so often. Caller did not have his covid vaccine card, caller stated that he has miss placed it. He found some paper but it only has his ID number and "LHDSER" on it. He received the vaccine in the left arm both times. All symptoms occurred on the left side. He recieved the vaccine in a hospital. Patient asked to refer to his primary care doctor as he has all the results for the tests. Investigation included CAT scan normal; Ultrasound normal; Blood test normal and MRI abnormal which showed spots in the lungs on unspecified date. The event outcome for all events was unknown. Information for batch/ lot number has been requested.

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

ED to Hosp-Admission Discharged 5/4/2021 - 5/10/2021 (6 days) Treatment team COVID-19 Principal problem Hospital Course HPI: Please see H&P for details Hospital Course: 76-year-old gentleman was admitted to hospital because of COVID-19 pneumonia and respiratory failure with hypoxemia secondary to it. He was placed on oxygen which was titrated. He was started on remdesivir and finished the course. Initially his condition got worsened and ID was consulted and he was given Tocilizumab. He also was started on dexamethasone from day 1. His condition has improved significantly. He is requiring 2 L of nasal cannula. At this point he is going to finish his course of dexamethasone as outpatient and he will be discharged home with oxygen. He was also educated about proning and he is very good at this. He also had remote patient monitoring arranged. He is going to follow-up with his PCP. Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Depressive disorder Yes Type 2 diabetes mellitus (CMS/HCC) Yes Chronic lymphoid leukemia in remission (CMS/HCC) Yes Pneumonia Unknown Acute respiratory failure with hypoxia (CMS/HCC) Yes

03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED BREIFLY IN THE MORNING 05/03/2021 AT NIGHT, SLUGISH SPEACH, DIZZY, HIGH BLOOD PRESSURE 05/04/2021 WENT TO EMERGENCY ROOM AND HOSPITAIZED (STROKE)

Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; high blood pressure; This is a spontaneous report from a non-contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration, administered in left arm on 20Jan2021 at 15:30 (at the age of 76-years-old) as an unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks prior vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 07:00 (next day after vaccination), patient experienced slight dizziness when tying shoes getting out of bed for four days though alpine skiing each of those days then fifth day dizzy almost staggering all day and high blood pressure. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.

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

AFIB incident . Dr. sent me to ER for cardizem and EKG. Have been on Metoprolol 25mg twice a day along with Eliquis 5mg twice a day. Prior to the vaccination had no heart condition.

Patient wanted the Shingles shot but unfortunately got the Covid shot. The Immunization Alert system checked before administration showed no records of a previous Covid shot. But after the shot patient presented us with his CDC card showing the Covid series completed in March 2021. He was ok. We informed his doctor on June 10th and upon follow up with patient he said his body temperature was very low and he had pain in his joints.

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

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

Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labored breathing and triggering of bowels.

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

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is a spontaneous report from contactable consumer via Medical Information Team. A 76-year-old male patient (Husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 17Feb2021 09:00 (at the age of 76-year-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced tingling pins and needles all over his body, pins and needles all over his skin. On an unspecified date, the patient experienced chest pain. Reporter stated that this morning it was only on his left arm where he got his vaccine. February 2021. She explained her husband had "pins and needles all over his skin", and in the morning it was limited to his left arm, where he received the vaccine. She added she experienced "chest pain" the Friday following the injection, which lasted for 4 days. She had a phone consultation with her cardiologist who said it was "fine and muscle pain". She mentioned their second dose was scheduled on 10Mar2021 and asked if they should receive it. She also reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained: one died after the vaccine; the second, in her sixties, died of a heart after the vaccine; and the third, in her fifties, died after experiencing chest pain for 2 weeks post vaccination. She explained she had no additional details on these adverse events. Her husband had pins and needles all over his skin the day after, and it was just in left arm where he had the COVAX. She said he tried to ask the HCP about it, but the HCP would not answer them and told them to call. She had chest pain 4 days after receiving the COVAX and her cardiologist told her it was just muscle pain. She did not have it. Patient was not visited to Emergency Room and physician Office. No vaccine was administered Prior Vaccinations (within 4 weeks). No treatment was given for the events. Outcome of the event chest pain was recovered on an unspecified date, and tingling pins and needles all over his body and pins and needles all over his skin was recovering. Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.

The day after getting the vaccine I went into atrial fibrillation and I have never been diagnosed with that before, so I went to the ER in hospital and got that diagnosis. They did a blood panel, and everything was ok, and an EKG which they used to diagnosed A fib. About a week after I saw my cardiologist and the atrial fibrillation had resolved itself, I was in A fib for about 5 or 6 days. I was in sinus rhythm now. The cardiologist increased my Metoprolol a little bit, I was taking amount twice a day and we increased that to other amount twice a day. I have not been in A fib ever since; I have been in sinus rhythm almost for 6 months now.

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

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

TIA - Transcient Ischemic attach; Both vaccines was administered on same day; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (at the age of 76-year-old) (Batch/Lot Number: E200187) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included glaucoma and cardiac disorder. Concomitant medication included acetylsalicylic acid (ASPIRINA); carvedilol (CARVEDILOL) and furosemide taken for an unspecified indication, start and stop date were not reported. On 04Jun2021 13:00 the patient was hospitalized for tia - transcient ischemic attach for 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Patient do not have any allergies. Patient tested positive post vaccination. Patient received treatment for adverse event as Physical Therapy. Post vaccination the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jun2021. The outcome of event was recovered and unknown for both vaccines was administered on same day. Follow-up actions are needed. Further information has been requested.

Patient states that he had vaccine on 1/13/21. He presented to the clinic 4 days later on 1/17/21 with light headedness, nausea and elevated BP 160/88 and upon recheck 175/100. There is H/O HTN but on medication he has not been this elevated in years.

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

The patient reported a history of syncope episodes with injections in the past. He reported that he vomited and passed out with his last four vaccines- flu and pneumonia. This time he was given his vaccine at 9:45 am and was sent to "high risk" observation and was monitored for 30 minutes. He experienced hypotension and tachycardia but did not faint. He was evaluated by the EMS at 10:10 and transported to the ED at 10:39 am. Upon arrival, his systolic BP was 90 mmHg with normal heart rate. He was monitored and discharged home with the final diagnosis of vasovagal syncopal response.

Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest

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

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

Pt receive his 1st dose of COVID-19 vaccine today at approximately 0915. At 0930, pt reported feeling "a rapid heart rate, like I have my A-fib again." Pt was non-ill appearing upon complaint, spoke clearly and was a good historian. Denied shortness of breath. Denied N/V Denied dizziness Denied Blurry vision Denied Chest discomfort or chest pain --"I just have the palpitation feeling, but not any pain." Pt reports a history of A-fib and needing Cardioversion in his past ("about 6 years ago I think." Pt offered to be seen in ED and states, "yes, I think that would be a good idea. This is what I felt like in the past when I had A-fib. I feel it right above my heart." Pt was moved via wheelchair safely to observation; vitals taken (see flow sheet). Charge RN called to give report; Charge RN arrived quickly to transport patient to ED.

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

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

Started getting dark urine and continued getting darker. Went to Hospital emergency dept. and was admitted on 1/31/2021. Tested for Covid negative. Blood test revealed low red blood cells. Urine tests and blood tests were inconclusive on 1/31.

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

Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.

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

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

He felt like he was having an asthma attack; Blood pressure became elevated; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1283), via an unspecified route of administration at right arm on an unspecified date at 77 years old at 09:30 AM at single dose for covid-19 immunization. Medical history included diabetes, sarcoidosis, hypertension, asthma, Idiopathic thrombocytopenic purpura, sleep apnea, arthritis. Known allergies included X-ray dye and statin medications. Concomitant medication included insulin, amlodipine, folic acid, nebivolol hydrochloride (BYSTOLIC), eicosapentaenoic acid ethyl ester (VASCEPA). No other vaccine in four weeks. No covid prior vaccination and Covid tested was not post vaccination. He felt like he was having an asthma attack and his blood pressure became elevated. He had to wait in the ER until they gave him his blood pressure medicine (Norvasc), a diuretic and an antacid (Pepcid). Adverse event start date was 22Jan2021 10:00 AM. The events resulted in: Emergency room/department or urgent care. Outcome of the events was recovering.

Patient was put into Irregular Heart rhythm 3 hours post vaccine; This is a spontaneous report from a contactable other healthcare professional (HCP). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el8982) Intramuscular on 29Jan2021 03:15 PM at single dose for covid-19 immunisation. Medical history included atrial fibrillation, prostate CA and dyslipidemia. No known allergies. No COVID prior vaccination. Concomitant medications were not reported. no other vaccine in four weeks. Patient was put into irregular heart rhythm 3 hours post vaccine on 29Jan2021 06: 15 PM, resulted in Life threatening illness (immediate risk of death from the event). Treatment included medication. No COVID tested post vaccination. Patient was recovered from the event on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of arrhythmia due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient with medical history included atrial fibrillation and 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 and during subject drug therapy, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, 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.

This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke.

I am 77 yrs old, male , , 150# and 5ft 6inches...Within 24 hours of receiving the shot, my body thru-up clots in my left leg. and I spent 4 days in the hospital ( 3 days in surgical ICU), breaking up the clots to save the leg. This is too much of a coincidence to ignore and I will not receive the 2nd shot.

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

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

Shortness of Breath causes by multiple large blood clots, put on blood thinners, seems to be fine, but has follow up appointment in March

2-3 weeks after COVID vaccination, patient presented to hospital with anemia and thrombocytopenia and intracranial hemorrhage. L axillary mass (same side as Pfizer vaccine admin site) found on exam. Bone marrow biopsy demonstrated Burkitt's Lymphoma. He is undergoing treatment at hospital

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

Patient had vasovagal reaction that required nurse to lay on floor and elevate feet. Patient's head slumped and nurse immediately noticed and placed in lying position with feet elevated. patient regained awareness and was A&Ox3, but required O2. patient was monitored and left under own power with out assistance. Patient given ER precautions and states understanding.

Pulmonary Embolism right lung and blood clot in right leg. No travel or other events or activities are known that might have contributed to blood clots in leg and lung. Symtoms of embolism first appeared about 10 days following 2nd dose of Pfizer vaccine.

1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.

Moderate pain in chest behind sternum when breathing. Admitted to Hospital on 1 February 2021. Diagnosed as pericarditis. Treatment: Ibuprofen 600 mg 3x/day for 2 weeks, and Colchicine 0.6 mg 2x/day for 3 months.

syncopal episode 40 min after vaccine. Nurse on floor took vitals 80/62 pulse 55, pulse ox 82% temp 96.9, FS 120, put on oxygen 2 liters pulse ox up to 98%. Called 911, transported to hospital

Patient complains of shortness of breath, difficulty breathing, decreased o2, chest congestion 3 days after receiving vaccine

Two days after receiving the vaccine the patient began experiencing shortness of breath. One week after onset of symptoms he presented to the hospital and was diagnosed with submassive pulmonary embolism. He underwent IR suction thrombectomy which removed 30% of the PE burden and spent two days in the ICU. He has now been transferred to the floor.

During post vaccination observation period complaint of dizzy, warm, clammy and hypertensive BP 180/96. While being observed complaint of chest pain, transferred to ED. EKG and lab work within normal limits, Observed an additional hour with symptom relief and discharged to home.

The patient is a 77-year-old male with T2DM (not on medications), gout, and HTN who received the first dose of the Pfizer COVID-19 vaccine on 2/14. On 2/17 (three days after vaccination), he sought care in the emergency department for chest pain that worsened when he was supine and shortness of breath. EKG in the emergency room showed STEMI and troponin levels were normal. He was transferred to a different facility for cardiac catheterization. Cath showed mild circumflex disease and a stent was placed. He was diagnosed with pericarditis at that time (elevated inflammatory markers ESR/CRP). He was discharged home post cath on Plavix/ASA. He had an echocardiogram at his PCP?s office on 2/25, results still pending (as of 3/10). 2/25 ? televist with cardiologist who concurred with pericarditis, maybe mild coronary artery disease (follow-up scheduled 3/11). 3/3 chest pain symptom improved further, no cough, improved shortness of breath. Medications at home: statin, previously colchine for gout, likely BP medication (PCP will send records) Allergies: None known. Vaccine Indication: Age >75

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

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

Patient went in to atypical rhythm junctions rhythm and atrial flutter and fib which was difficult to control. Our cardiologist says she?s been seeing a number of these post vaccine

3 days after 1st shot, I suffered a stroke; This is a spontaneous report from a contactable consumer (patient himself). This 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 02Feb2021 at 09:30 AM (at the age of 77-year old) at single dose for COVID-19 immunization. Relevant medical history included type 2 diabetes, kidney disease, heart failure, cutaneous T-cell lymphoma (CTCL) and allergy to lisinopril. Concomitant medications included atorvastatin (LIPITOR), metformin, losartan, potassium and acetylsalicylic acid (ASPIRIN). On 05Feb2021 at 01:30 PM, after 3 days from the first dose of vaccine, the patient experienced a stroke that resulted in hospitalization for 4 days. Treatment included CAT scan, MRI (with unknown results) and intravenous blood thinner. The outcome of the event was recovering. The event was serious due to hospitalization and life threatening illness (immediate risk of death from the event). Information on the lot/batch number has been requested.

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

Blood pressure increase to 160/80 from 120/70. Previously treated with Lisinopril 10 mg. Had to increase to 20 mg to control BP on advice of doctor. Have spoken to others with same problem, all being treated with Lisinopril.

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

A fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Left Arm on 06Feb2021 03:45 am as SINGLE DOSE for covid-19 immunisation. facility type vaccine: Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Medical history included 3Rd stage kidney disease. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced a fast heartbeat (non-serious) on 06Feb2021 20:45. If treatment ae: No. The patient underwent lab tests and procedures which included heart rate: fast heart beat on 06Feb2021. The outcome of event was unknown

left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/first one on 02Mar, second one 13Mar and the third one yesterday; he had the Pfizer vaccine on 15Feb and 26Feb; he had the Pfizer vaccine on 15Feb and 26Feb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation; tafamidis (VYNDAMAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient took the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at age of 77 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient taking Vyndamax medication who stated that he had experienced blood clot in his left leg. Clarified that he had the Pfizer vaccine on 15Feb2021 and 26Feb2021. Clarified that on 02Mar2021 that he had blood clots in his left leg. Stated that he had three. Stated that he had the first one on 02Mar2021, second one 13Mar2021 and the third one yesterday (15Mar2021). Stated that he was told left leg was cold. Stated that he took his temperature with a thermometer and his left foot was 79-82 degrees Celsius. Stated that the right foot is 95-96 degrees Celsius. Stated that he filled it out for the Covid vaccination. Stated that he reported Vyndalink when it asked what other medications that he took. The action taken in response to the events for tafamidis was unknown. The outcome of events was unknown.

Two blood clots in left leg; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. Medical history included back disorder, ATTR amyloidosis, and allergies: caffeine from an unknown date. Concomitant medication included allopurinol (ELAVIL); meloxicam; tizanidine; tafamidis (VYNDAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), on 05Feb2021, administration time: 06:00 PM, vaccine location: Left arm for COVID-19 immunisation. The patient experienced two blood clots in left leg on 03Mar2021 23:00. Treatment for the event includes Aspirin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The outcome of the event was resolved on an unspecified date.

Chronic Nosebleed R nostril beginning 3/20 early morning while shaving; no history of any NB. ENT cauterized R nostril area on 3 different times & packed it on 3/30; cardiologist discontinued Plavix for 7 days. No NB since then, rechecking on 4/8, resumed Plavix on 4/5/21. No other symptoms during that 10 day period.

Passed out approximately 6 hours after receive COVID-19 injection; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 09:30 (lot number: ENU204) at the age of 77 years old, as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies. No other vaccines received four weeks prior to COVID vaccination. The patient took other unspecified medications two weeks prior to COVID vaccination. The patient passed out approximately 6 hours after receipt of COVID-19 injection on 18Mar2021 16:00. There was no warning, dizziness nor weakness of the knees, prior to passing out. The patient landed on his forehead (out less than a minute). There was no reoccurrence. His wife had shot same time, no effects. No treatment was received for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event on an unspecified date.

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

PT devolved occulsive DVT to left femoral vein; This is a spontaneous report received from a contactable physician. A 77-year-old male patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 24Mar2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included azithromycin (Z-PAK) taken for an unspecified indication, start and stop date were not reported. The patient experienced "devolved occulsive DVT to left femoral vein" on 24Mar2021 with outcome of unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of occulsive dvt to left femoral vein which included apixaban (ELIQUIS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event "occlusive DVT to left femoral pain" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

The use of telehealth was discussed with the patient who understands that telehealth services are provided by an Emergency provider at a distant site, not in the same room with the patient. The patient understands that his/her medical information will be discussed during the telehealth service. The patient consents to any additional persons on the patient?s end of the service hearing this information and is aware that he/she may exclude persons on their end of the communication if they so wish. The patient understands that at times the information and assessment gathered during a telehealth service may be insufficent given the nature of being remote from the patient, and that there could be equipment failures or security failures leading to a breach in privacy. A written consent was not obtained due to the nature of this telehealth visit as screening for COVID-19. Patient Location: ED Waiting Verbal consent obtained: Yes Patient Location: ED Waiting HPI and Screening Patient is a 77 y.o. male who presents asthma, pneumonia, sarcoid, on home oxygen, dm, htn, ttp, ulcer, presents after going to receive a Covid vaccine. After taking the Covid check he began to have central chest pain. He describes the pain primarily as discomfort or burning. This is his first Covid shot. Felt like when he had contrast dye in the past. He does have a documented contrast allergy. He states that his breathing in general is better today. But that was prior to vaccine administration. No itching hives difficulty swallowing. His speech is normal. No fevers chills sweats cough or cold no loss of taste or smell. Nausea vomiting or diarrhea.

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

Significant drop in blood pressure, couldn't walk more than 1/2 block, shortness of breath. This happened about 5 weeks after the 2nd dose of the vaccine. Had blood work, showed very low blood counts to the point of maybe needing a transfusion. Had GI work up today, no bleeding. Could this be an autoimmune reaction to the vaccine. His blood counts were fine prior to the vaccine.

Patient went to physical therapy on that day. Then when he came home I could barely get him out of the car. patient could barely walk and talking made little sense. He could not stand on his own. He was taken to emergency room by rescue squad. I thought he was having a stroke.

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

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely 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.

The night after receiving the vaccine he developed hematuria. This continued until his second dose of vaccine. After the second dose of vaccine, the hematuria worsened so much so that he was just leaking blood from the urethra even without urination. With urination he was passing frank blood and clots. He stopped clopidogrel and aspirin and it totally resolved. He underwent cystoscopy and there were no lesions identified. He resumed clopidogrel and aspirin and has not had any more bleeding.

The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.

4/14/21: onset of right leg swelling from the knee down that was painless. Calf circumference of the right leg had increased to 2cm greater than the left. No fever, chest pain, or difficulty breathing.

c/o palpitation. Client stated did not eat or take his blood pressure medication prior to taking COVID-19 vaccine today. B/P 192/118, HR 74. 11:25am Patient stated that he was feeling much better when he gets home will have something to eat+take his medication. Patient was informed by EMS if still has symptom to call or contact his doctor. Understanding verbalized.

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

Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into chest, down arm and down scapula. Sought treatment Thursday morning around 8:30am at ER in. Patient was admitted. Discharged Tuesday 5-4. Hospital tried pain medications and muscle relaxants (chewable baby aspirin, morphine, benadryl (after reaction to morhphine) norco, dilaudid, toradol, valium, oxycodone and flexeril. Sent home with diclofenac gel, and hydrocodone/apap.

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

I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial weakness I63.81 - Left sided lacunar stroke

77-year-old male with past medical history of stroke, hyperlipidemia, diastolic heart failure, diabetes mellitus, and hypertension presents ED for evaluation of sudden onset of dizziness. Reports his dizziness started today early in the morning while he was outside taken to trash. He later went to his house and sat down but his dizziness did not go away. His dizziness only resolved after arriving to the ED. Denies loss of consciousness. Did not fall. Has only eaten tangerines today

Blood clot in leg - first dose; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: CR2613), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunization. Medical history included broke femur of right leg on 09Nov2020 and hospitalized from 09Nov2020 until 15Nov2020 or 16Nov2020, surgery to repair broken right femur on 12Nov2020, rehabilitation following hospital discharge and got out of the rehab facility on 14Dec2020, been in either a walker or a wheelchair and still not fully recovered (ongoing); chronic obstructive pulmonary disease (COPD), asthma diagnosed at least 13-14 years ago, bronchitis, all ongoing from an unspecified date diagnosed at least 13-14 years ago. Concomitant medications were not reported. There were no other vaccinations within 4 weeks of the vaccine. On an unspecified date, the patient experienced a blood clot in the leg. The clinical course was follows: After he was discharged from rehab, the patient went to his own family doctor on 30Mar2021 because his ankle and leg were still swollen. The physician sent him to have a vascular done, on an unspecified date after 30Mar2021, with unknown results. The patient reported that the physician determined that he had blood clots in his leg. The patient was sent to the emergency room and started "that stuff" for about a week until he went to a regular vascular doctor and the physician determined what the patient should be doing. The patient reported that he was diagnosed with the blood clots after he got out of rehab. The patient received apixaban (ELIQUIS) from Apr2021 for blood clot in leg. The clinical outcome of blood clot in leg was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021478767 same patient, different dose/event

Severe clots on right thigh rushed to urgent care and urgent care referred me to emergency Hospital. Was hospitalized for 5 nights with severe swelling on right thigh. The swelling has since abated but has still not subsided. Feel still very heavy on right thigh.

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

Patient presents to the ED on 4/23 with complaints of dizziness described as presyncopal episodes happening twice that day. Felt lightheaded early in the day. Patient noticed his stool was dark black colored the last 2 days, no prior history of GI bleed. Patient is not on anticoagulation therapy currently, is taking fish oil and acetaminophen. INR is at 1.2 upon admission. Patient diagnosed with severe diverticulitis, patient was operated on to remove polyps, no source located for GI bleed. Patient was treated for anemia and discharged after 6 days.

vaccine failure -- despite 2 weeks having elapsed since 2nd vaccine, he was hospitalized for COVID pneumonia with hypoxemia 4/24/21 through 5/4/21, treated with oxygen, remdesivir, dexamethasone

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

Immediate memory loss. MRI has been taken with no abnormalities noted. Sugar count went from 116, 120 to 299 and continued through April and May with memory loss that he cannot remember anything within 2 minutes. He has been very confused and repeats the same questions over and over. His blood sugar has been the same for years until the vaccine

Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.

Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626

A-fib; renal dysfunction; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration in Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included carbidopa and levodopa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Mar2021, the patient experienced onset of A-fib and resultant renal dysfunction shortly after injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Cardioversion and medical management for the event A-fib. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Atrial Fibrillation and Renal Impairment and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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.

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

Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.

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

Patient received Pfizer COVID-19 vaccine on 1/24/21 (first dose) and 2/5/21 (second dose). Patient tested positive for COVID on 5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and passed away on 5/29/21: Preliminary cause of death: Respiratory failure with hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19 vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on methotrexate Anemia Hypertension Obesity

Patient presented to the ED on 6/7/21 with worsening redness and swelling of his legs. He had presented to the ED with the same complaints on 5/29/21 but was discharged back to his group home. On the 5/29 visit, he was tested for COVID as part of standard protocol, and was found to be COVID positive (asymptomatic) despite receiving 2 doses of Pfizer vaccine (1/15 and 2/5). On the 6/7 ED visit, pt was initially found to be hypoxic (89% on room air) in the ED, but once he was admitted and transferred to the COVID floor, he was found to be 95% on room air and supplemental O2 was discontinued. Patient has remained asymptomatic for COVID during his hospitalization, and has not required COVID treatment.

I had the vaccine on 01/16/2021 and my heart stopped. I had a long period of Atrial fibrillation, my heart will stop for 8 seconds and then it will start again. I had like 3 or 4 fainting episodes. Since then, I have had a heart pacer implanted. They put a Halter monitor to check my heart behavior. I was already under treatment for the fibrillation but this was an exaggeration of this problem. My cardiologist told me to come in because I had the monitor and they saw that my heart was stopping so I went in since it was an emergency. They kept me in the hospital for 3 days because they wanted to keep me in observation before they put the pace maker in.

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

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

around 05/30/2021 started experiencing numbness and pain on left arm, along with chest pain. patient was hospitalized at local medical center for 1 week.

spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

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

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

Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.

Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication. Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel. Follow-up attempts are completed. No further information was expected.

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

Pfizer COVID Vaccine EUA Pfizer Vaccine Dose 1 2/5/2021 (lot # not in state registry) Pfizer Vaccine Dose 2 3/6/2021 (lot # not in state registry) COVID Positive 3/27/2021 Hospitalized 3/27-4/2/21 Hospitalized 5/19-5/24/21 6/15/21: Presented to ED. This is a 77 years old gentleman with a history of COPD presents to the emergency department because of shortness of breath and chest pain. Patient states that he was in his usual state of health and suddenly developed shortness of breath and chest tightness. By the time of my evaluation he no longer has chest tightness. He was recently in the hospital and treated with antibiotics for Pseudomonas pneumonia. He is reportedly compliant with his COPD medications at home. He normally wears 2 L nasal cannula at home. Currently he is on the BiPAP and reports feeling better after treatment in the emergency department. He was given IV steroids, bronchodilator therapy. He was also given IV antibiotics given recent history of Pseudomonas pneumonia. Of note patient states that for the past week his bilateral ankle appears to be more swollen and he is on Lasix started by Dr. from pulmonology for this. 6/21/21: This patient with a history of COPD, atrial fibrillation on anticoagulation and chronic dementia, was again admitted 6/16 with increasing shortness of breath and chest pain. It was noted that his COVID 19 test was positive. He was started on IV Remdesivir, but since his COVID 19 test has been positive since March of this year was felt that he did not require additional treatment. We are treating him for an exacerbation of COPD. His chest x-ray was actually normal with COPD but no signs of infiltrate, heart failure or effusions. He is on apixaban for atrial fibrillation and should not have a pulmonary emboli. He was getting IV Lasix, but the BUN and creatinine were rising. We have obtained an echocardiogram to see if there is a degree of systolic heart failure. We will continue the IV antibiotics and steroid therapy. The patient seems comfortable at rest but is on 5 L nasal cannula. The patient reports that he is on 3 L of oxygen at home all the time. I called to talk to the good friend who is listed as the 1st contact and reviewed the situation. He does live by himself but has 24 hour a day care. We discussed that our goal was to get him back down to 2-3 L of oxygen. There seems to be some improvement but if still requires 5-6 L of oxygen, we will ask for a pulmonary consultation. I have talked to the pulmonary team several times unofficially for advice and they seem to have nothing else to offer at this time. Again today the patient seems comfortable and is warning why he can go home.Admitted and treated with bronchodilators, steroids, BiPAP and levaquin. Echocardiogram repeated. By the time of admission, chest pain resolved. Oxygen requirement stay high at 5 liters. Today improved to baseline 2 L. Discharged home.

The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting. After three attempts to walk, I could no longer continue. I was the beginning of a myocardial infarction. It was four hours before a rescue team could get me to the hospital.

Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. 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 did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM BICARBONATE 50 ML ONCE

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

Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall. Pt denies any LOC, but states he is currently on Xarelto. Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: "Dizziness, near-syncope: Onset following injection of COVID-19 vaccination.

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

New onset atrial fibrillation that resolved in 1-2 hours after treatment in ER with Amlodipine and Metaprolol. Observed overnight. No symptoms since.

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

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

Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure

Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he "grumbled" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.

1042 wife enters building to report pt lost consciousness. RNs responded and found pt awake and alert. RNs dialing 911 and pt and wife refused ambulance or trip to ED. Pt and wife states this happens to him if he walks too far when it is cold outside. Pt states he has heart rhythm issues and sees PCP. Pt was nauseated. Again refused transport to ED. BP @ 1049 144/82, HR 89 and regular. Pt and wife insist he is fine and desire to leave. Pt in drivers seat of car. RNs encourage wife to drive if they are to leave. Pt and wife refuse, and they left with husband driving.

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

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

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

Pt received vaccine on 1 Feb and presented to the ED on 3 Feb with Abdominal pain, epigastric; Acute pancreatitis without infection or necrosis, unspecified pancreatitis type; Hypertension, unspecified type; SOB (shortness of breath). He was discharged on 6 Feb 2021

Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.

myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement

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

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

Dizziness; Hypoglycemia; Hypotension; Generalized rash; This is a spontaneous report from a non-contactable healthcare professional. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; dose 1) intramuscularly on 25Jan2021 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Jan2021 during the 15 minute waiting period after the vaccine, the patient experienced dizziness. He denied difficulty breathing and swallowing. A differential diagnosis of systemic reaction (hypoglycemia, hypotension, generalized rash) was provided. The patient was given unspecified treatment and follow-up response was good. The patient denied dizziness when standing up and walking to leave the medical evaluation bay and clinical outcome of dizziness was completely resolved prior to discharge. No follow-up attempts are possible. No further information is expected.

11 Hours later ambulance called Taken to hospital C/O of left shoulder arm chest pain ,significant dizziness, unable to stand without falling over

within 10 minutes of second dose of vaccine pt reported new onset chest pain, rated pain 7/10, vitals signs obtained, EMS called, EKG obtained, received dose of aspirin and transported to ER for further evaluation.

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

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

Heart racing throughout the night; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), via an unspecified route of administration, in the left arm on 29Jan2021 at 11:00 AM (at the age of 78-years) as a single dose for COVID-19 immunization. Medical history included atrial fibrillation. Prior to the 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 four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on 07-JAN-2021for COVID-19 immunization. On 31Jan2021 at 11:00 PM the patient experienced heart racing throughout the night. The patient did not receive treatment for the event. The clinical outcome of the event heart racing throughout the night was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information requested on lot number.

Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab

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

possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve." Lab data included a nasal swab SARS-COV 2 test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.

PER MEDICAL RECORDS PATIENT PRESENTED TO ER VIA EMS REPORTING INTERMITTENT CHEST PAIN, FEELING LIKE HIS HEART WAS STOPPING.

patient began to have left sided chest pain which radiated to left arm. stated sharp pain but also belt like pressure. does not have history of similar chest pain. he also described dizziness and SOB, but additional questioning suggests this is his baseline. 12 lead showed a fib. patient denies history of similar. patient given ASA and transported to ED for additional work-up for his chest pain

The next day got a nose bleed that lasted for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at 10:00 (at the age of 78 years) in right arm at single dose for covid-19 immunisation. No other vaccine given in four weeks. No covid prior vaccination and no covid tested post vaccination. Not Known allergies. Medical history included Heart trouble, cancer (cancer survivor), high blood pressure, Alzheimer, bleeding ulcer, chronic obstructive pulmonary disease. Concomitant medication included lisinopril, isosorbide mononitrate, metoprolol tartrate. On 06Feb2021 at 16:00 the patient experienced a nose bleed that lasted for 2 days. No treatment was given. The event was non-serious with outcome of resolved. Information on the lot/batch number has been requested.

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

During my earlier years working in an industrial area I had inhaled asbestos which caused me to have plural thickening in my lungs. Every year since that diagnosis I have been required to annual Pulmanary (lung and heart) testing. On February 11th I had my 30th annual Pulmonary exam consisting of EKG, Stress Test, and Chest X-ray. As in the past, results were all good. On March 3rd I had my 1st Pfizer vaccination. Five days later on March 8th I collapsed, was taken to the hospital by ambulance having suffered a massive Pulmonary Embolism affecting my heart and right lung. During my 2 hour operation, Surgeons used a flexible suction tube inserted thru my groan to remove a large blood clot (embolectomy). Pieces totaling about 14cm long, 2cm wide and 1/2 cm thick. I was discharged 3 days later and instructed to take blood thinning medication probably for the rest of my life. I am now 78 years old.

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

Patient passed away unrelated to covid vaccine Narrative: The patient had new onset of CHF,A.fib and hx f COPD. Patient was admitted to hospital on 1/21 and Patient discharge against medical advise on 1/22. Patient aware of risk including early death and increased morbidity but patient still wanted to leave. Patient received the first dose of Pfizer vaccine on 1/19 and no adverse reaction was reported. Patient presented to ER for shortness of breath and chest pain and was admitted on 1/29. Patient passed away on 1/31. No indication that death was related to COVID 19 vaccination.

Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.

H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods, 9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities

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

Patient died in his sleep the night of getting dose 1 COVID -19 he had a massive heart attack and died

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

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

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

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

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

PATIENT REPORTED HAVING A BLACK OUT AFTER HE LEFT THE CLINIC AROUND 1400 ON 4/14. HE WOKE UP AT 0200 IN A TOWN 50 MILES AWAY IN A MUD FIELD WITH NO RECOLLECTION OF HOW HE GOT THERE. DENIES ANY OTHER SYMPTOMS. HE SLEPT IN HIS BACKSEAT AFTER AND CALLED 911. STATE POLICE AND EMT EVALUATED HIM AND A TROOPER FOLLOWED HIM HOME. HE CONTINUES TO SEEM ALTERED TODAY PER OUR TELEPHONE CONVERSATION ABOUT THE EVENT, AND CONSIDERING THE SEVERITY OF THE EVENT I ADVISED HIM TO GO TO THE ER FOR EVAL OF SELQUEA OTHER THAN SAE OF VACCINE, AND HE AGREED. HE IS ON THE WAY THERE NOW.

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

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

Pt presented with SOB and leg swelling and found to have RLE DVT. He was admitted and started on anticoagulation

his heart rate was 131. States he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 10Apr2021 15:30 (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFib) on 10Mar2021 (had A-Fib while hospitalized from 10Mar2021 to 22Mar2021. Did a cardioversion) and Guillain Barre syndrome on an unspecified date. Concomitant medication included metoprolol taken for heart (disorder). It was reported that on 10Apr2021 15:30, the patient got his first vaccine. The next morning (11Apr2021 08:30) when he did his vital check, that he does every morning, his heart rate was 131. Stated that he took some additional medication and it went back down to 82, then up to 128, down to 48, up to 115. Stated he was reading where fast heart rate can be one of the side effects. Stated today (12Apr2021) the highest his heart rate has been is 109 and lowest at 42. The patient stated that his heart rate goes from high to low. The patient stated that he normally takes Metoprolol 25 mg a day but he upped it to 100 mg on 11Apr2021 because that's what they did when he had AFib. The outcome of the event was recovering.

Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.

My father suffered a heart attack due to blood clots clogging the artery to his heart. He coded and was resuscitated and had four stents installed after the blockage was cleared. He had a second heart attack several days later when the stents clogged and had to be cleared. He was hospitalized for several days for each heart attack.

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

Pt had covid19 in 11/2020, now with immediate onset of sepsis of unclear source after 1 dose Pfizer vaccine as well as rapid atrial fibrillation and heart failure

A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barré syndrome, a debilitating condition where the body?s auto immune system attacks the nervous system resulting in peripheral numbness in one?s hands, feet and legs. This condition was diagnosed by a neurologist. Following his diagnosis, I spent 8 days in the Hospital and was treated for 5 days with a daily dose of 400ml of immune globulin (IVIG) to rebuild the damage to my nervous system. On April 10, I began to feel the onset of Guillain Barré syndrome as the bottoms of my feet suddenly began to tingle and feel numb. The next day I tripped while returning our waste management garbage cans to our garage. Fell face forward onto the driveway and was bruised pretty bad. The next day my BP zoomed to 224/160. 911 was called and I was taken to our local hospital fearing and thinking that I was having a heart attack. I spent 4 days in the hospital being checked for a possible heart attack and all the while my Guillain Barré syndrome was progressing undiagnosed. I was discharged and instructed to see a neurologist for the tingling and numbness in my hands, legs and feet. Within 15 minutes of the neurologist consult, a few days following my discharge, I was told I had Guillain Barré syndrome and get to a hospital. I left his office and went straight to the emergency room and I spent the next 8 days there and was discharged Tuesday, 4 May 2021. Several hospital neurologists treating me believed the vaccination triggered the syndrome as do I. It's not being widely reported even though there have been several Facebook postings of people saying the same thing as me.

Severe tightness in chest. Taken to Inspira Medical Center. Tested and kept overnight for observation. Hospital cardiologist diagnosed Pericarditis and this assessment was agreed to by my own cardiologist. Hospital Course: EKG, Cardiac Enzymes (negative), No arrhythmia on telemetry, Hemodynamically stable.

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

DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. 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.; Reported Cause(s) of Death: death/natural process

Patient presented to the ED and was subsequently hospitalized for left-sided nontraumatic intracerebral hemorrhage. He is currently admitted for rehab.

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

PT WENT TO ER AFTER INJECTION AFTER 2 DAYS DUE TO SHORTNESS OF BREATH. HOSPITAL FOUND INFLAMATION AROUND THE HEART (SIMILAR TO CONGESTIVE HEART FAILURE), CLOTTING, ARRYTHMIA.

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

Starting day of first shot on March 6 (and in the three weeks between first and second shot on March 27), I began having atrial fibrillation/flutter episodes twice a week for about four hours per episode. After second shot, episodes averaged four per week for six weeks. I went to the ER April 4 and was referred to electrophysiologist. I saw electrophysiologist on April 15, he immediately scheduled me for double cardiac ablation. I had this procedure on May 7, whereupon my episodes ceased.

Worsening heart function; increased sx PVC burden and runs of VT. Drop in LVEF from 40% to 15%. Worsening CHF sx. Occured after the second COVID 19 Pfizer vaccine dose

Pulmonary embolism; DVT; This is a spontaneous report from a contactable nurse (patient's wife). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included diabetes mellitus, Liver cirrhosis, thrombocytopenia, kidney stone, sarcoidosis, blood pressure (unspecified condition) and high cholesterol and a pacemaker (cardiac pacemaker insertion). Concomitant medications included insulin (manufacturer unknown), simvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), carvedilol (COREG) taken for blood pressure, and omeprazole (PROTONIX). On 12Mar2021, the patient developed pulmonary embolism and DVT (deep vein thrombosis) that requiring a hospitalization on 12Mar2021. The nurse reported, "He went into the hospital 12Mar2021 that's when they find out he had pulmonary embolism and DVT. They putted the IVC filter for blood clot." On 12Mar2021, the patient was hospitalized for pulmonary embolism and DVT. Therapeutic measures were taken as a result of pulmonary embolism and DVT. The clinical outcome of the events pulmonary embolism and DVT was unknown. Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported pulmonary embolism and DVT (deep vein thrombosis) were causally related to BNT162b2 . These are intercurrent medical conditions. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021528357 same patient/reporter, different vaccine dose with different events separated by time gap.

78y.o. male with a past medical history of COPD, DM II, and HTN who presented to the hospital's emergency department from an extended care facility. Patient was recently hospitalized and treated with IV antibiotics for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for ischemic signs but patient had an elevated troponin. CXR showed right pleural effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory failure. Patient's oxygenation continued to deteriorate despite Remdesivir, decadron and lovenox. Patient went into respiratory failure and expired from progressive respiratory failure.

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

Vaccination series completed 3/6/21 and 3/27/21. Tested positive for COVID-19 incidentally on 5/27/21 during a previous admission at this hospital. Was discharged from that admission on 5/28/21 to a nursing facility. Presented to ED from nursing facility on 6/3/21 with hypotension and hyperglycemia, BG 823. Found to be in DKA.-- arterial pH 7.32, lactate 5.2. BP 104/57, HR 75, on 2L NC O2 with sat 100%. Unclear if COVID infection contributing to current presentation No specific treatment for COVID currently, supportive care for now.

started seeing strange things- saw things that weren't there. The yellow wall in his bedroom came up but had all kinds of art work on it, the ceiling and doors too; couldn't remember things; Weird things happened in my brain; lost his vision while driving; CT scan it did show hardening of the arteries in his brain ,was told had a TIA (Transient Ischemic Attack) or some kind of a stroke; had issues with confusion as well; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 as 2nd dose, single dose (at the age of 78-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 as 1st dose for COVID-19 immunization. On 02May2021 (26 days later), patient lost his vision while driving and it came back good enough to drive within a half hour (medically significant) and when it recovered on 02May2021, patient started seeing strange things, saw things that were not there. The yellow wall in his bedroom came up but had all kinds of artwork on it, the ceiling and doors too (medically significant), patient couldn't remember things, had weird things happened in his brain. Patient stated that it didn't go away entirely until about 10 days later. Patient also had issues with confusion as well. Patient stated that he thinks he was back to normal now. A computed tomography (CT) scan was completed a week or so earlier and it did show hardening of the arteries in his brain. Patient saw his primary care physician and was referred to a neurologist. On unspecified date of May-2021, patient was told he had a transient ischemic attack (TIA) or some kind of a stroke (medically significant). Patient had a Magnetic resonance elastography (MRE) (like a Magnetic resonance imaging (MRI) of the brain) yesterday (27May2021), but it had not been read yet. Patient asked if he was the only one that had done this or had other people had this problem, even two or three people or he was an isolated case and in response it was stated that, unable to find information about his symptoms in resources and the Product Information (PI) for the vaccine does not contain information reporting his symptoms (vision loss, memory loss, confusion, hallucinations) as side effects of the vaccine. The outcome of had a TIA (Transient Ischemic Attack) or some kind of a stroke was unknown, for lost his vision while driving was recovered on 02May2021 while recovered for rest of the events on May2021. Information about lot/batch number is requested.

He was living independently in a retirement home. They administered the vaccine. Since the jab he has been diagnosed with Parkinson's, Parkinson's dementia, Suffered two strokes and we were recently told he now suffers from seizures and will require medication for the rest of his life AND 24 hr. Care.

During his 30 minute waiting period after the injection, the patient began to experience itching; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for a patient. A 78-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206) via an unknown route of administration on an unknown date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, during his 30 minute waiting period after the injection, the patient began to experience itching and the differential diagnosis was systemic reaction (hypoglycemia, hypotension, generalized rash). Patient complained of itching of skin (chronic vs new itching). It was reported that patient denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizz. Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, dizziness and headache facial swelling, lip swelling and tongue swelling. Patient was discharge as stable to go home and follow up with PCP. Patient reported immediately upon getting back to the bay that he doesn't think it's anything but his chronic itching that he gets. Patient declines feeling like this is an allergic response like he had in the past. Benadryl given as requested. The outcome of the events was unknown. No follow-up attempts were possible. No further information was expected.

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

Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.

PATIENT WANTED BLOOD PRESSURE CHECKED. STATED 1 PFIZER DOSE CAUSED ELEVATED BP. PER PATIENT "FELT TWINGE LIKE BEFORE IN MY CHEST" NOT CHEST PAIN. STATED HE WOULD TAKE PRN BP MEDS AT HOME OBSERVED

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

Patient stated after receiving his second covid vaccine on 06/15 he started having visual changes, which was confirmed a stroke on 06/25 by MRI. Patient stated he noticed his stroke symptoms after receiving his second vaccine.

Chest pressure left of sternum. Reported to family primary care doctor nurse told him and was dismissed as it only occurred twice. It never happened before and has not occurred again since the beginning of April. Second symptom which was not reported was a raw feeling in the center of the chest between the lungs. This had never occurred before and started April time frame and as of late June has disappeared. Third symptom is getting out of breath with what I would consider minor exertion. Discussed with primary care and heart doctor both considered it to be age-related. But walking 200 yards and being out of breath for someone that is not overweight seems unlikely.

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

Legs and feet swelled suddenly and dramatically. Cardiologist described it as possible myocarditis and congestive heart failure.

This is a patient who presented to the ED with a cc of dyspnea and was found to have left central main pulm artery/left upper lobe/left lower lobe PE's and also has a large clot in transient in his RV. There is no provoking risk factor that I can clearly identify (no recent surgeries, trauma, immobilization, or active cancer). He does have a remote cancer hx of bladder cancer in 2015. He is a former smoker 20+ years ago. However, he is at risk for VTE events by being a ERSD patient and also there's increased risk for VTE for pts >70yo. His COVID vaccination a few months ago is a potential contributing risk factor, will report to VAERS

Pt. states after receiving the 2nd dose of Phizer 02/25/2021, started experiencing racing and pounding heart rate, hospital visit 03/22/2021 EKG preformed. Still experiencing mid-night heart palpations and shortness of breath.

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

first signs of were in last week of February and first week of march. approximately 5 times between Feb 21 and April 15 I had what I thought to be indigestion, constant belching with a little pain in center of stomach area, these symptoms disapeared after a few hours and tums. All started in early morning around 630 am. On April 15 it happened again but continued all day, went to urgent care at around 330n they did egg which was fine but advised going to emergency room for better tests,

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

shingles left chest painful maculopapular labs with elevated igg and igm vzv still painful lesions still present no crusting or weeping no past hx of shingles vaccine

Systemic: SOB, difficulty breathing, chest pain, Error: Wrong Patient (documentation in EMR); symptoms lasted 0 days

head rush Narrative: Patient provided juice/water, cleared by monitoring staff to leave vaccination clinic

Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.

nose bleed; This is a spontaneous report from a contactable consumer (patient's daughter). An elderly 79 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 17Jan2021 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications includes Aspirin. The reporter informed that her father (patient) received the first dose of the COVID-19 vaccine yesterday (17Jan2021) and today (18Jan2021), he experienced nose bleed. The patient had a nose bleed which lasted for a pretty long time. The patient just tried to stop it in a regular way. Just pinching the nose and stuff like that. The reporter did not know if there is any other medication that he takes only the Aspirin. The reporter just wanted to know if this was normal side effect. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up (18Jan2021): New information received from a contactable consumer (patient's daughter) included: concomitant drug, event details. Information on the lot/batch number has been requested.

Dizziness, nausea, irregular HR. EKC revealed AF. Drank full glass of red wine at 2 AM on the day of the vaccine. Went to the ED

sugar was elevated a whole lot/went real high; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunization (wanted to get because of the virus). The patient's medical history included hard of hearing and diabetes (reported as "diabetes and stuff). Concomitant medications included empagliflozin (JARDIANCE), dulaglutide (TRULICITY), and other medications (as reported " I take stuff for blood pressure all kind of stuff"). The patient reported that he got the vaccine on Tuesday (12Jan2021), he stated that he has diabetes and stuff and he noticed on Wednesday, Thursday, Friday his sugar was elevated a whole lot and he thought that would be possibly from the vaccine or it might be stressed because the Covid (unspecified). He stated that he doesn't know but it's unusual, he means it went real high. He wanted to know if there are any reports of like affects it might cause on hi sugar to go high. The patient checked this morning (unspecified date) it was high and just checked about 20 minutes ago and it has come down again so (further not clarified)." The patient mentioned that he takes Jardiance and Trulicity, once a week; he took Trulicity this morning (unspecified date) and stated, "so that probably helped". He had an unspecified laboratory test about 3 months ago, and there was no problem." The outcome of event was unknown. Information on the lot/batch number has been requested.

On 1/29/21, patient started to feel soreness of left side of toro. On 2/4/21, patient started to see rash of painful area. On 2/7/21, pt came to Urgent Care for evaluation, diagnosed with shingles, and prescribed valacyclovir 1g, one tablet by mouth every 8 hr for 7 days. Patient has history of shingles in 1984. Patient has never have COVID19 illness.

STOMACH CRAMPS LOWER BACK AROUND KIDNEY AREA ( NO KIDNEY MALFUNCTION) DIFFICULT TAKING A FULL BREATH FEELS LIKE A BALL BAT TO MY CHEST PAIN STARTED ON 02-05-2021. TODAYS DATE IS 02-08-2021. BLOOD PRESSURE IS 124/68 HEART RATE IS 51. OXEG IS 99.1 RIDE MY ROAD BIKE 30 MILES EVERY OTHER DAY.

At just after 5 o'clock, pt received his 1st dose of the COVID-19 vaccine and about 10 minutes later he began to feel flushed in his face. This was associated with some chest tightness as well. He was referred to the emergency department. He had no difficulty breathing and did not feel like his throat is closing. He had no rash anywhere else on his body but does feel like his face is redder than usual. His symptoms have not been associated with shortness of breath and has no abdominal pain. Upon presentation to emergency department, the patient was hypertensive to the 220s but his vital signs were otherwise within normal limits. Physical exam was fairly unremarkable with exception of some mild redness of the bilateral cheeks. He had no rash there is no evidence of airway compromise or wheezing. Low concern for acute anaphylactoid reaction. Patient was given diphenhydramine. Symptoms resolved and patient was discharged home.

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

1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hospital DX: 1. Right-sided nontraumatic intracerebral hemorrhage, unspecified cerebral location (CMS/HCC) I61.9 431 2. Long term (current) use of anticoagulants Z79.01 V58.61 3. Sensory neglect (left sided) R41.4 781.8 currently still admitted to hospital at the time of this report

Severe thrombocytopenia; This is a spontaneous report from a contactable Nurse. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had known allergies: methotrexate. There were no concomitant medications. No other vaccine in four weeks. The patient experienced severe thrombocytopenia on 17Feb2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for severe thrombocytopenia for 2 days. Patient was referred to hematology proactive for severe thrombocytopenia, likely ITP. Platelet (Plts) 5 and then 1. He was sent to the Emergency room (ED) and received plt transfusion w/ minimal effect. He was started on Intravenous Immune Globulin (IVIG) as well as high dose steroids. Plts currently w/i normal range after above treatment. The outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association, the Company assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported event Severe thrombocytopenia. 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.

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

gradually increasing pain in upper chest, which became severe; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received BNT162B2 (BNT162B2; Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 25Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications included acarbose (ACARBOSE), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), metformin (METFORMIN) and losartan (LOSARTAN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took denoral [risperidone] and darvon [betahistine mesilate] and experienced allergies. The patient experienced gradually increasing pain in upper chest, which became severe on 26Feb2021 at 20:00. It was reported that beginning in evening of day following vaccination: gradually increasing pain in upper chest, which became severe. Went to ER; tests there ruled out heart Involvement; referred to regular physician for follow-up (appointment booked for 03Mar2021). Pain slightly better when patient left ER, gradually subsided overnight and following day; pain gone on second following day. The patient underwent lab tests and procedures which included investigation: Test for heart involvement on an unspecified date (Tests there ruled out heart involvement). The outcome of the event was recovered. Information about lot/batch number has been requested.

Narrative: 79 yo patient with history of stroke, hypertension, prostate cancer. Hospitalized for acute CVA on 3/2 after receiving first dose of Pfizer vaccine on 2/27.

3-7-21 spouse first noticed red spots on face by spouse; also bloody nose later; pt stated that two weeks prior (2-21-21) patient noticed spots on L leg (calf) and assumed it was a rash. Saw PCP on 3-8-21 at health clinic who dx petechiae and ordered a blood draw. Repeated blood draw 3-9-21. Transported via car to ER 3-10-21 and later tranferred where he was treated by hematologist. Patient dropped to 0 platelets

As patient was leaving Observation area he complained of chest pains. He took nitro which he had from home and as instructed by his provider. BP 151/102 EMS arrived and patient still complaining of chest pains BP 82/58 patient transported to hospital by EMS

diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.

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

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

Patient developed substernal chest pressure and lightheadedness prompting visit to the ER where he was found to have a STEMI and developed Vfib arrest and had cardioversion x 2. Patient was found to have an inferior wall MI. Mechanical thrombectomy was performed for a thrombotic occlusion of the mid-distal RCA and DES X 1 placed. Significant CAD was present in the proximal-mid LAD and proximal-mid left circumflex.

Patient received first covid vaccination today, at around 1140 Volunteer monitoring patients noted that individual scooted down in his chair. She asked if he was okay and stated he was feeling dizzy. Vaccination clinic staff responded. Patient was able to assist to floor. Feet were elevated. He was provided water and ice pack. Patient did not appear to lose responsiveness at any point. He was able to state he was at the hospital as well as his name, DOB and where he was from, but patient was slow with answers. Patient then stated he was starting to feel better. He denies SOB or chest pain. As staff continued to interact with him, he was slower to respond again. He shared he had nobody in attendance with him and no family in the area. A code medical was called. BP cuff arrived BP was 164/110. ER nurse began assessment. Patient was able to get to standing position with staff assistance. He was taken to ER via stretcher for evaluation.

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

Received the vaacine on 2/3/2021 I felt fine that whole day. The following day as I was showering I got lightheaded and fell in the bathroom . I went to the ER and the sent me home because I had no injuries. My blood pressure was high . For a few days I got lightheaded off and on. Then on 2/24/2021 I went for the second dose again i felt fine the whole day. On 2/25/2021 as I was showering I got lightheaded and fainted. My family called the ambulance and I was hospitalized from 2/25/2021 to 2/27/2021. I had facial fractures, fractured septum (nose) and cut upper lip received 10 stitches and teesth and gums were numb and still are a little numb.

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

PCP notes in progress notes upon the patient return on 1/12/2021 Hospital course CT head/CTA neck/CT perfusion studies concern for possible right ICA and MCA thrombus, transferred to neuro ICU. TPA ( s/p alteplase). CTA shows >90% R ICA stenosis. Vascular consulted. Started on AC (heparin, plavix and loaded with brillanta). Pt underwent R TCAR (Transcarotid Artery Revascularization) on 1/11. No post-op complication. pt stable/neurologically intact. Pt offers no acute concerns. pleasant, pain is controlled. No CP, sob, palpitation. neck incision CDI. HR and BP controlled. He is happy to back to the rehab. CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF RIGHT CAROTID ARTERIES

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

* 4/9/2021: Father in law went to get blood drawn for his INR (before 10am) * 4/9/2021: He started seeing some spots develop on his back. he did not tell anyone * 4/12/2021: Spots spread on his back. He told my mother in law. My sister in law took him to an urgent care. They ran blood and said results would take 3-4 days *4/16/2021: Urgent care said results could take two weeks. My sister in law took him to the medical center. They diagnosed shingles but also said his heart rate was low. My father in law was talking in circles/not making sense/acting confused so they ran the EKG to check pacemaker * 4/16/2021: Heart rate stabilised and they discharged with topical treatment for his shingles

Nose bleeds/ worsened; Nose bleeds/ worsened; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old male patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 24Feb2021 (lot number EN6198) in the right arm, and on 20Mar2021 (lot number EP7534) (unsure which arm), respectively, both via an unspecified route of administration (at the age of 79-years-old), as a single dose for COVID-19 immunization; and apixaban (ELIQUIS) film-coated tablet, oral from an unspecified date (lot number 1743875, expiration date Feb2023), at 5 mg, twice a day as blood thinner. The patient's medical history included: chronic lymphoma leukemia from 2006- he is presently MRD negative, cardiomyopathy, alcohol ablation- where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart. There were no concomitant medications. In Feb2021, after the first dose, the patient experienced nose bleeds. The patient never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine causes nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. The nose bleeds were reported as worsened. The nose bleeds did not require an emergency room or physician office visit. The action taken in response to nose bleeds/ worsened for apixaban was unknown. The outcome of nose bleeds/ worsened was not recovered. Follow-up (26Mar2021): This is a follow up spontaneous report from a contactable consumer based on information received by Pfizer from US-BRISTOL-MYERS SQUIBB (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-031555), license party for apixaban (ELIQUIS). This case was received via Pfizer Inc (Reference number: 2021339514) on 26-Mar-2021 and was forwarded to BMS on 30-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleeds) in 79-year-old male patient who received apixaban (Eliquis) film-coated tablet (batch no. 1743875) for an unknown indication. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 immunisation. The patient's past medical history included Chronic lymphoid leukemia (He is presently MRD negative) in 2006, Cardiomyopathy and Alcohol septal ablation (where they go in through the groin and shoot alcohol to shrink the size of the heart to kill the fat around the heart). On an unknown date, the patient started Eliquis (batch no. 1743875) (Oral), 5 milligram twice a day. On 24-Feb-2021, the patient started Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced EPISTAXIS (Nose Bleeds). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS did not resolve. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he never had nose bleeds before until after getting the first dose and was having more since getting the second dose. He has had two in one day. He was asking if the vaccine caused nose bleeds with taking a blood thinner. The nose bleeds have been more frequent. He received he first dose on 24-Feb-2021 and the second dose on 20-Mar-2021. Event nose bleeds did not require a visit to emergency room or physician office. Relevant Tests: none.

Initially was thought to have developed pneumonia but without much in the way of clinical signs - little improvement and moved from local MD to Hospital for further work up. Developed Rapidly Progressive Glomerulonephritis and vasculitis. The subsequent acute kidney failure necessitated renal dialysis - which remains ongoing.

he fell in the bathroom and passed out; he fell in the bathroom and passed out; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's son). This consumer reported similar event for two patients (father and mother). This is the first (father) of the two reports. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 26Mar2021 (batch/lot number: ER8727) at 79 years old as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing AFib (atrial fibrillation) diagnosed between 1 and 2 years ago. Patient also has a pacemaker from an unknown date. Patient was exposed to COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS) oral from an unspecified start date and ongoing at 5 mg twice a day taken for AFib (atrial fibrillation). On 07Apr2021, the patient was admitted to the hospital due to a fall; he fell in the bathroom and passed out. The patient is on Eliquis, so they were worried about bleeding. He tested positive for COVID on 07Apr2021, this was the same day he was admitted to the hospital. He was discharged on 10Apr2021 and was improving. It was reported that the reporter (patient's son) tested positive for COVID on 27Mar2021, so it was likely his parents were exposed or infected prior to their first dose of the vaccine. The reporter confirmed he has not been vaccinated. The patient was due to get the second shot today, but the reporter cancelled the appointment since his dad was still in quarantine. The reporter heard different things about when to get the second dose, everyone says to wait 90 days, they're getting mixed information, then he has heard 3 weeks is long enough to wait. The reporter wanted to know when his dad can get the second dose of the vaccine after having the COVID-19 infection. The patient is recovering from "he fell in the bathroom and passed out." Outcome of the event "tested positive for Covid" was unknown. This case involves a Product Complaint: Consumer reported that his father and mother tested positive for Covid infection on 07Apr2021 after receiving the first dose of the Pfizer COVID vaccine on 26Mar2021. It was not provided if a sample of the product was available to be returned, if requested and if packaging was sealed and intact.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443810 same reporter, same drug, same event, different patient

Woke up in the middle of the night dizzy on the evening of 3/11/21,started vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with an abdominal clot size of a grapefruit

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

23 Feb 2021: event: fainting spell, nausea, no prior warning 26 Feb 2021: doctor visit, fitted with heart monitor 1 March 2021: Doctor visit, readout of heart monitor showed no anomaly. 16 Mar 2021: event: fainting spell, nausea, no prior warning 30 Mar 2021: event: passed out in shower, EMT called, rushed to Medical Center, admitted to ICU 31 Mar 2021: treatment: pacemaker installed circa 1000 AM, 2 Apr 2021: released from Hospital xxx

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

Chest pain; Pleurisy; discomfort in his chest (not in the lung) in the bone muscle around the lung, it feels like he has been punched right in the cardiac plexus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 79-years, on 07Apr2021 10:20 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included ongoing moderate to mild asthma that sometimes bothered him when he tried to sleep and maybe wheezed a bit and he had to use inhalers during the day as he cannot go to sleep if he got a wheeze; diabetes 8 or 10 years ago and he took Insulin for it; he was allergic to aspirin. Family History included that his mother had rheumatoid arthritis. The patient's concomitant medications were not reported. No additional vaccines administered on the same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021, next day (08Apr2021) he started to have discomfort across his chest like a hernia starting on the left (he started to have chest discomfort, like a hurting across the chest starting on the left and now on the right), after being checked on a medical place he was informed that he has Pleurisy, they did a chest X-ray and then they sent the information to the hospital to have a doctor look at it so he had to wait a half hour. Mentioned they wanted to put him on pain medication but he declined because he was allergic to aspirin and he only took Tylenol. He described the sensation as: a discomfort in his chest (not in the lung) in the bone muscle around the lung, it felt like he has been punched right in the cardiac plexus, now was a minor discomfort that won't go away. He cancelled his appointment to receive the second dose of the vaccine (due tomorrow) and wanted to know if he should receive the second dose at all. The patient also experienced Chest pain that started on 08May2021, but now it had shifted, and it was more on the right side. First he noticed it on the left then it moved under his sternum and now almost all of it is on the right side. The pain got up to a certain point and then it had stayed the same. Sitting he isn't feeling it but when he got up out of the chair it was worse. Seemed to be worse when he moved from a relaxed position like getting out of bed. Events of Chest discomfort and Pleurisy resulted in "Physician Office Visit". Events outcome was not recovered.

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

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

Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were: Severe sepsis (HCC) due to pneumonia causing acute on chronic hypoxic respiratory failure and hypotension that resolved with fluids. He also presented to the ED on 5/13/21 and was subsequently hospitalized for sepsis secondary to UTI.

heart inflammation, heart went into atrial fibrillation again, suspected myocarditis (symptoms within short time of second shot) Observation of EKG on Apple watch showed atrial fibrillation (after four years of normal readings)

Non traumatic insidious stroke right brain leaving left side paralysis; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 13:45 (lot number: EL9262) at 2nd dose, single for COVID-19 immunization. Medical history included coronary artery bypass grafting (CABG). Concomitant medications included metoprolol, atorvastatin (reported as 'atorvasten'), tamsulosin, and clopidogrel (reported as 'clopidigrol'), all taken for unspecified indications, start and stop dates were not reported, these medications were received by the patient within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in arm left on 07Jan2021 13:30 (lot number: EL3246) at 1st dose, single for COVID-19 immunization. The patient experienced non traumatic insidious stroke right brain leaving left side paralysis on 15Feb2021 12:30. The event reported assessed as serious which required hospitalization and resulted to disability. Hospitalization: 28 days. The event resulted to emergency room/department or urgent care. Treatment received included intensive care unit (ICU) care (1 week) and rehab hospital (3 weeks). The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination (unknown result on an unspecified date). The patient also underwent nasal swab on 22Feb2021 with negative result. The outcome of the event was recovering. Follow-up information has been requested.

embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left sided weakness on his leg; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history included transient ischaemic attack (TIA) from 2019 to an unknown date, mild hypertension, idiopathic neuropathy: in the left leg, started in the beginning of the year from 2019, melanoma removed in the 1970s, enlarged prostate, neuropathy, cholesterol and fluid retention. Ongoing concomitant medications included tamsulosin taken for enlarged prostate; gabapentin taken for neuropathy; candesartan taken for hypertension; pravastatin taken for cholesterol; acetylsalicylic acid (BABY ASPIRIN); and furosemide (LASIX [FUROSEMIDE]) taken for fluid retention. The patient has been taking all of his meds for quite some time, over 5 years. The patient did not have prior vaccinations within 4 weeks. The patient received the first dose of BNT162B2 on 09Mar2021 10:30 for COVID-19 immunization. The patient completed the Pfizer COVID vaccine series, the second shot was on 30Mar2021. On 09Apr2021, the patient had an embolic stroke. The patient's daughter stated that the patient has a history of TIA in 2019 and was concerned. She does not know if it was related. She added it might be that if people have previous risk, there may be some precautions, like to take a full dose of aspirin before, a week before. She sent an e-mail last 05May2021 and hasn't gotten a response back. The patient went to the ER due to embolic stroke and was in the hospital Friday (09Apr2021) through Wednesday. The patient went to the stroke rehab center for 3 weeks. The daughter clarified that the patient was in the hospital until 14 or 15Apr2021 before being transferred (also reported as 5 or 6 days and in rehab for three weeks). Then was discharged last 06May2021. The patient's condition seemed to be getting better. His major issue was speech and wasn't able to formulate any words. He was able to speak now. His rehab would be a lot of neurological rehab and speech therapy. The patient previously had left sided weakness on his leg from some random thing that happened. It didn't seem to get worse. It really affected his speech and cognition. The patient's daughter thought that the embolic stroke was related to the Pfizer Covid vaccine and added that thought was in some way but cannot say in what way. She thought that it exacerbated some type of blood clotting. She stated that he never had blood clotting issues before and was the type of person that would take a baby aspirin and get a nose bleed, he was the opposite of a clotter. An MRI in the hospital showed blood clot and stroke. He had blood work but does not know what it showed and presumed he was fine (unknown results). He has never really had any kind of blood work issues and does not know why he was on cholesterol medication. The patient required emergency room visit for embolic stroke. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported "embolic stroke" cannot be excluded. Previous medical history and Old age is a risk factor for the onset of stroke. 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.

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

Reported by wife; Husband (client) had chest pressure two weeks after Covid-19 Vaccine around June 2nd and has not experienced that pressure before, wife says. Wife explained it was so severe the husband was taken via ambulance to hospital.

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

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

Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling like they are burning, experiencing shortness of air when walking thirty to forty feet, and elevated blood pressure at times of episode. Wife reported she has called primary care provider to let doctor know. Doctor referred client to see his lung doctor as soon as possible. Wife reports they are in another state working on their farm and is having trouble getting client to cooperate to go to doctor. Clients wife reported primary care provider recommended going to ER as soon as client experiences any of those symptoms again. Educated wife the importance of listening to providers recommendations. Clients wife reported client using his own CPAP machine when episode occurs and it does bring some relief to symptoms.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

Being winded; Heart rate has dramatically increased during any type of exercise (125 plus); Rapid breathing; This is a spontaneous report received from a contactable consumer, the patient. A 79 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6200] via an unspecified route of administration in left arm on 19Feb2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. The patient medical history included allergy to Zocin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. No concomitant medication was reported. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: El9262] via an unspecified route of administration in left arm on 29Jan2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. On 28Feb2021, the patient noticed that his heart rate had dramatically increased during any type of exercise. The patients resting pulse was 74 and he was exercising on a treadmill for weeks before the second shot. The patient experienced being winded after a very short time on the treadmill with his heart rate reaching 125 plus after a very short time. This was out of patient target range and he stopped before getting to that heart rate that patient knew that something was definitely wrong. The patient also got rapid breathing when the heart rate increased. The clinical outcome of events heart rate increased, being winded and rapid breathing was not recovered. No follow up attempts are needed. No further information is expected.

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

Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines (replaced 4 pints of blood), shortness of breath.

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

AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 19:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 79 years old. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing emphysema, ongoing high blood pressure (he couldn't say, it has to have been a good 15 years he has had it), ongoing high cholesterol (he had it for over 10 years), ongoing Low red blood cell count (depending on his blood count, they give him either a Vitamin B shot or Procrit), ongoing idiopathic pulmonary fibrosis. Both of his parents had type 2 diabetes, and he had type 2 diabetes. Historical vaccine included 1st dose of BNT162B2 (Lot no: EL9263) on 25Jan2021 at 19:00 in left arm for COVID-19 Immunization and flu shot back on October for immunization. Concomitant medications included prednisone (It was for his lungs (unspecific). It was prescribed by his lung doctor. It affected the immune system. He took 10mg. He was taking 5mg then they changed it to 10mg about a month ago. He had taken it for maybe 1 and a half to 2 years); epoetin alfa (PROCRIT) taken for red blood cell count decreased, he only took it as needed when his count was below 10. He had not taken it in 6 months; losartan taken for high blood pressure, from May2021 and ongoing (It was new, he started it about a month ago); amlodipine taken for high blood pressure from May2021 and ongoing (He had been taking it for about a month); atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing (He had taken it for a couple years); nintedanib esilate (OFEV) taken for idiopathic pulmonary fibrosis from an unspecified start date and ongoing (He had been on it for about a year). The patient experienced AFib on an unspecified date with outcome of recovered. His voice was hoarse today (21Jun2021) with outcome of unknown. He stated he spent 4 days in the hospital and got his rhythm back to normal after 2 days. They put him on apixaban (ELIQUIS), which was a blood thinner. The AFib has resolved, he had no problem with it anymore. The patient underwent lab tests which included COVID-19 antibody test: negative on both 09Jun2021 and 16Jun2021. His HCP told him it was due to prednisone that lowers his immune system.

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

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

I was doing light yard work and felt discomfort in my chest. Went in the house to get hydrated and test my blood pressure and pulse. Rapid heart rate of 143. Monitored for 3 hours and was consistently 140-142. Called cardiologist who referred me to the Emergency Room at the hospital ER Administered Cardizen IV and returned to normal heart rate within 45 minutes. I have been experiencing foggy brain since the incident. I consider myself to be in perfect health and am very active.

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

Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug 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.

Chronic Orthostatic Hypotension; Chronic Pain in the Arm that got the shot still; Dizziness; Cannot walk without support and fall to my knees to prevent falling; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 12:00 (at the age of 79-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included seizure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included midodrine; levetiracetam; doxazosin; finasteride, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right in Feb2021 at 12.00 (at the age of 79-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Since 15Apr2021, 12:00 PM, the patient experienced chronic orthostatic hypotension, chronic pain in the arm that got the shot still, dizziness, cannot walk without support and fall to my knees to prevent falling. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hosp, Disability or permanent damage. The patient was hospitalized for 10 days. The patient received treatment for AE, adjusted medications. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. Information on lot/batch number has been requested.

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

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

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

80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE "Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain." "Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative

Drop in blood pressure. Patient was monitored for 15 minutes and after, the patient was not at base. Patient was moved from chair to bed and was monitored constantly for 1 hour

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

We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.

Tested blood sugar on 01-22 in the AM. Normal sugar test is in the 150's. The blood sugar was in the high 180's. Tested the blood sugar on 01-23 in the AM and it is still in the high 180's.

Acute Gastrointestinal Bleeding per rectum with massive bloody diarrhea, transfer to Emergency room by EMS with IV placement and fluid resuscitation, vital signs unstable, emergency assessment and massive transfusion over next 4 hours of 4 units of PRBC and 2 units platelets, dual 16 gauge IV's, intrarterial line. ER Summary available and can be scanned and sent. Low HgB, Low platelets in 60 k range and multiple consultants and diagnositcs

HYPOXIA Narrative: Patient received dose one of COVID vaccine and at the time was COVID negative (documented shortly before and after the vaccine). COVID test turned positive 14 days after first injection. He then received his second vaccine 4 days after positive test. 12 days after the second vaccine he was admitted to our facility and is currently in critical condition in the ICU with COVID pneumonia. It is unclear what role, if any the second vaccination had related to critical condition.

heart attack; chest pressure; hardly slept; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient (reported also as 81-years-old, to be clarified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3246), via an unspecified route of administration, on 13Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 80-years-old. Medical history included ongoing emphysema and ongoing diabetes (caller has been diagnosed for 35 years for both conditions), heart was damaged because of the diabetes, and a history of bypass 4 years ago however he hasn't had any issues with chest pressure since before the bypass. Concomitant medications were none. On 15Jan2021 at 1:am he developed pressure in the chest which ultimately resolved. This trouble last night, lasted over 1 hour. He couldn't get back to bed. He had to sleep sitting up on the sofa. That was the only way he was comfortable. Her husband has hardly slept. She was seeing how he was doing. He said he was okay sitting. The pressure on his chest would go away while he was sitting, but laying down it would come back. This morning (15Jan2021) she made him check when he woke up at 8 o'clock. She made him lay down, and he said it was gone after sitting the whole night. He is well now. He is feeling fine. He didn't even ask for help getting on his clothes. He got the vaccine because of his age and because of underlying conditions. Her husband has done very well this year. He even has underlying conditions. He has had Emphysema for 35 years, but it hasn't been bothering him. He has also had diabetes for 35 years. The reporter spoke to her husband's hcp (nurse) who said it could have a heart attack and for him to go to hospital if it reoccurs. She did speak with a nurse with his primary doctor, and she said the pressure in his chest for 1 hour could have been a heart attack. That if it occurs again to give him the nitroglycerin. She told the nurse it wasn't pain. The reporter stated chest pressure could have been a heart attack. He is scheduled to get the 2nd dose on 21Jan2021. The reporter was wondering if her husband can have the second dose given it has potassium in it (given he has bypass history). The reporter is afraid the vaccine is not safe, and they may not go for the second vaccine. She wants more information if it is safe. The events recovered on 15Jan2021.

Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30.

Felt dizzy after the shot with resultant spike in blood pressure to 190/80. Blood pressure receded to 156/76 before7:00 pm to allow drive home. Please provide information with medications taken and results for safety.

irregular hearbeat; Belching; Gas; Stomach cramps; felt antsy; his blood pressure went up the day he hook the vaccine to 200/93; He was anxious feeling; sharp pains in his right eye; Ears Felt Funny; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiry date not reported), via an unspecified route of administration on 19Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included high cholesterol and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included propranolol hcl for blood pressure and an unspecified cholesterol pill. The patient previously received influenza (Flu shot) on an unspecified date (years) ago for immunization and experienced light headed. The patient reported that his blood pressure went up the day he hook the vaccine to 200/93 and he was real concerned about that. He took a blood pressure pill and was having some sharp pains in his right eye (he had 3-4 at different times). He was anxious feeling and could hear it blowing in his ears (which happens when his blood pressure is high). He stated he has never had his blood pressure that high and has never had any heart problems. The patient asked, whether he was in the danger zone, the danger zone of having a stroke and if they should take their second dose. The patient wondered if they could just take the first dose only. It was further reported that he took the vaccine yesterday or the day before (19Jan2021) at 11'o clock. He didn't have any problems, he just got home. Then 11'o clock at night he had fallen asleep during the day and woke up at that time, 11'o clock and he felt Antsy, his blood pressure was up, his ears puffed real high, he's on Blood Pressure medication. He Clarified further that his First Dose was on 19Jan2021 at 11 o clock during the day. Then 12 hours later that same day, he woke up, and that's when he felt antsy and the blood pressure being up. Normally he takes his Blood Pressure 2-3 times a week but that day it was like 190/80 something. When he saw it, he sat down, and thought if he relaxed it would go down. He went back over in 45 minutes or an hour later and it was 200/93, he thought he had sharp pain in the right eye during that time as well. He Never had that before, he had pain in eye before, but not like this. He then told himself maybe he should take a blood pressure pill, because he was concerned he didn't want to stroke out. He took a Blood pressure pill and then relaxed for an hour later he checked it was 189/82. He waited some more, and it kept coming down. He stayed in the recliner all night. Then on 20Jan2021 he checked and it slipped to 140/55 at about 5 o clock. The Blood pressure kept coming down 10 to 15 points every hour. The last one he took later that day was 118/65. He explains that his Blood pressure normally runs 120/65 to 140/70 normally. His blood pressure medication is only 10mg, its a low dose, he is a Healthy Person, he walks every day, his weight is good. The blood pressures provided were from 11AM to 11PM at night of 19Jan2021. It was the same day when he felt the ears feeling funny, and the sharp pain in the right eye, he has never had that before. He also forgot to mention that the next day he had a lot of stomach irregularities , he had cramping, it was uncomfortable, this was on 20Jan2021, he was also belching, and had gas. It went away that evening lasting 4-5 hours, it started in the morning 10 o clock went till 3 or 4PM. The BP value of 140/65 was from today, before lunch. The right eye sharp pain went away during the night, after he took his blood pressure pill, he didnt notice it anymore after. He doesn't know if the vaccine caused this. He couldn't tell any difference even with the pain. The ears feeling funny, he took his blood pressure a couple times a day. The monitor is showing an irregular heart beat, he didn't notice that before. He has had no positive COVID test or Antibody Test prior to the vaccine. The patient recovered from sharp pains in his right eye, ears felt funny on 19Jan2021, stomach cramps, belching, gas on 20Jan2021 while the outcome of the rest of the events was unknown.

Patient scheduled, arrived and consented to receive the first dose of the Pfizer Covid vaccine on Thursday Feb 4,2021 around noon. Patient received his vaccine and was directed to an observation seating area, accompanied by his wife and completed at least 15 minutes of observation prior to being released home. When patient stood up from his chair to exit the clinic , he fell and hit his head on the floor which caused substantial bleeding. He was immediately attended to and transported to the Emergency Dept on the campus of this vaccination site for treatment.

At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.

Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before. Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.

Patient became dizzy and hypotensive 70's systolic after receiving his 1st PFIZER COVID-19 MRNA VACCINATION. Patient was taken to the ER.

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

Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post vaccination. Reported feeling nervous, anxious, cold sweats. Pt with hx of HTN, on cardizem. Denied hx of afib. Denied other past medical hx. Pt with elevated BP 160s with labile pulse, ranging from 30-80s. O2sat 99%. Pt escorted to ED.

Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient found unresponsive sitting in recliner and breathing. Vitals normal. After 5min sternum rub patient became conscious and stated he could hear being spoken to but could not respond. Felt weak rest of the day. Although this occurred several days later there were 3 patients at same facility experiencing similar issues on same day

1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and seen in ED and admitted to hospital 2/22/21 Dx on admission: 1. Hypoxia 2. Elevated troponin 3. Elevated brain natriuretic peptide (BNP) level 4. Generalized weakness 5. Closed head injury, initial encounter

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

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

Resident with acute onset of SOA this AM with Sao2 of 65%. Transfered to ER with diagnosis of bilateral pulmonary embolism

Severe thrombocytopenia. Administration of dexamethasone and IVIG immune globulin. Petechiae over bilateral lower extremities and feet. Ecchymosis.

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

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

pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia, high blood pressure, COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM), anastrozole (ARIMIDEX), simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema, low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine, morphine, nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed. information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema, low heart rate, and chest pain, all reported as fatal, are deemed unrelated to BNT162B2 vaccine, being rather accidental occurrences, likely favored by the patient's age and by the mentioned high blood pressure, known risk factor for cardiovascular diseases. 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.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain

patient presented to ED with chest pain, gone upon arrival to ED, dyspnea on exertion, shortness of breath. no congestion, no cough. Nausea present. patient tested for covid and found to be positive. Received 2nd covid vaccine on 2/3/21

Patient had sudden cardiac arrest; currently on a ventilator with very poor prognosis 3/11/21; 1st COVID vaccine given 3/2/21

the night after receiving this 2nd COVID vaccination, I returned to active Afib and started in active Afib status for 9 1/2 days. Since then I have had 2-4 days where no Afib (irregular heartbeat) was recorded, but the past week irregular heartbeat has been recorded each time I took my blood pressure (using an Omron series BP monitor).I can feel my heart flutter often and I am very short of breath, where I cannot walk over a block without getting out of breath.

until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown. This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.

Received vac. on 2/10/2021 and on 2/15/2021 had a stroke with no warning. Hospital and Rehab ever since.

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

STEMI; This is a spontaneous report from a contactable healthcare professional. An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscularly, administered in the left arm on 29Mar2021 13:30 (at the age of 80 years old) at a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, asthma, chronic kidney disease (CKD) 3, all from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin, amlodipine, doxazosin mesilate (CARDURA), albuterol [salbutamol], umeclidinium bromide (INCRUSE ELLIPTA) atorvastatin (LIPITOR) and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient previously took enalapril and augmentin [amoxicillin; clavulanic acid] and experienced allergies with both. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), intramuscularly, administered in the left arm on 05Mar2021 13:00 (at the age of 80 years old) at a single dose for COVID-19 immunization. The patient experienced ST-elevation myocardial infarction (STEMI) on 31Mar2021. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (also reported as number of days hospitalization: 0; pending clarification) and was reported as life threatening. Treatment included cardiac catheterization. There was no other vaccine in four weeks. It was unknown if the patient had COVID prior vaccination and was not COVID tested post vaccination. The outcome of the event was recovering. Information on the batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event 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.

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

passing out; really bad reaction; This is a spontaneous report received from contactable female consumer (wife) on behalf of her husband 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 29Mar2021, the reporter stated that patient had a really bad reaction last night and had to go to the emergency room, she stated that overnight her husband kept passing out and states that when he would come to, he would say it's the medicine, the medicine. The reporter thought he was talking about his blood pressure medication because she states she checked and he hadn't taken it yet, but when she asked if what medicine he was talking about, her husband would say the one in my arm. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

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

My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same. In the evening he collapsed falling out of his wheelchair. He tried for an hour to sit down back in his wheelchair with my help, but he couldn't. He agreed that I call 911. Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him. In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am.

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

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

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

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild

Patient presneted to the ED and was subsequently hospitalized for NSTEMI on 3/24/21 as well as 4/12/21.

Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.

First dose covid vaccine given 1/28/21, second dose given 2/18/21. Admitted for bilateral pulmonary emboli to hospital on 4/25/21. From H&P "He reports that he woke up this morning and then subsequently started developing left-sided chest discomfort, it was pleuritic in nature. It is sometimes worse with position. He traveled to the Emergency Room where he was found to be mildly hypoxemic. He underwent workup to include a CT angiogram, which revealed multiple predominantly small peripheral bilateral pulmonary emboli with borderline dilation of the main pulmonary artery and slightly greater than 1:1 right to left ratio. He subsequently was felt to be appropriate for admission because of his underlying hypoxemia. He denies any unilateral weakness or stroke symptoms. He does have a patent foramen ovale. He also reports no history of calf discomfort. With the exception of being sedentary because of the pandemic, he has not traveled anywhere in a car or in a plane in the last 6-12 weeks." treatment: enoxaparin 1mg/kg SQ Q12h starting 4/25 @1659, changed to apixaban 10 mg PO Q12h 4/26 at 1756.

His blood pressure was up just a bit; This is a spontaneous report from a contactable consumer (patient). This 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6023) via an unspecified route of administration in the top part of the left arm on 27Feb2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD from an unknown date and unknown if ongoing, reported as diagnosed 3 to 4 years ago and the patient was not taking any medication for it; and blood pressure from an unknown date and unknown if ongoing. The patient reported no family medical history and no adverse events following prior vaccinations. Concomitant medications included atenolol from an unknown date for blood pressure. The patient reported he received his second dose of BNT162B2 on 20Mar2021 for COVID-19 immunisation. The patient reported he did not have any trouble with the first vaccine and that one other thing had happened, and he was unsure if it had anything to do with it or not. He reported he went back to his doctor and had been taking atenolol for blood pressure at a dose of 50/25; his blood pressure went up just a bit and he could not verify who the girl was that changed it to 100/25; also reporting he didn't like the way he felt and eliminated it and went back to the previous dose taking two over a period of 2 to 3 days. The atenolol was in a pharmacy vial and he didn't have the lot or expiration date. The date his blood pressure was up was for the past couple times; further stating it usually was 120/60-70 and then it jumped up to 150/60-70 and that was why it needed to be changed. The patient reported it was filled on 18Mar2021 which was after the first vaccine but before the second dose. The clinical outcome of his blood pressure was up just a bit was unknown. No follow-up attempts are needed. No further information is expected.

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

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

4/30/21 Patient presents to the ED w/complaint of SOB x 2 days. He had rales on exam and RA pulse ox was 88-90%. Troponin was elevated and EKG showed lateral ST-T wave changes. Pt was admitted for COVID and NSTEMI. NSTEMI Hx of CAD sp CABG Presented with dyspnea, Trop of 382, trended up to 859, now trending down CXR with findings of pulmonary edema Started on lovenox, aspirin, coreg, statin Cardiology consulted TTE showed EF 50 %, normal diastolic dysfunction, moderate AV stenosis S/P Cardiac cath 5/3 with severe disease of SVG to Diag with successful PCI Continue aspirin, plavix, statin, coreg Follow up with cardiac rehab once he has completed quarantine 10 days after 4/29 Pulmonary Edema Acute HFpEF CXR with findings of mild/early bilateral pulmonary edema. NT ProBNP of 3081 Started on IV lasix and improved Lasix stopped 5/3 due to improvement in symptoms and worsening Na TTE as above Monitor intake and output COVID 19 infection Symptoms of exertional SOB of 2 days Diagnosed on 4/29 Has received two doses of Pfizer Vaccine, last dose 1 month ago per patient CXR Low lung volume examination with findings suggestive of mild/early bilateral pulmonary edema. Was on 2L oxygen, now on RA after diuresis Doubt symptoms are due to COVID-19 and suspect more likely cardiac in origin given rapid improvement of oxygen status with dose of lasix Inflammatory markers also not elevated held off on decadron and remdesivir due to patient not requiring oxygen Complete 10 days of quarantine Patient was discharged home on 5/5/21

Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69. Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.

headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown. Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

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

Heart rate was about 10 points higher than normal; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Feb2021 at 03:30 AM (Lot Number: En9810), as single dose, for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food or other products. Concomitant medications included lisinopril (unknown manufacturer) and allopurinol (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced heart rate was about 10 points higher than normal (non-serious) on unknown date with outcome of recovered in Feb2021 after 1 week. The patient underwent lab tests and procedures which included heart rate: about 10 points higher than normal on unknown date. The patient has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient presented to the ED on 5/5 after being sent by his PCP after an ultrasound in the office showed a DVT along with patient's complaint of shortness of breath. Patient denied history of DVT/PE. In the ED, CTA-PE showed bilateral pulmonary embolic disease and Ultrasound confirmed acute right lower extremity DVT. Patient was started on a heparin drip and then switched to enoxaparin 1 mg/kg every 12 hours per pulmonary. Hematology/Oncology was consulted and determined that acute bilateral PE likely provoked by recent vaccination with the second dose of the Pfizer vaccine. Patient was switched to rivaroxaban 20 mg daily prior to discharge for planned duration of 3 months.

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

Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later.

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

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

vaccinated 1/27/2021. Tested (+) COVID 5/22/2021. Admitted for 3 days into hospital for decreasing oxygen levels. Case completed initial case investigation but was unable to reach afterwards. Family disconnected my call 3x in attempts for follow up. Person was not found in local obituaries.

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

Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack.

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

shortness of breath; The shortness of breath has continued and has gotten a little worse; Nasal congestion; Coughing; heaviness in chest; It was like lumps; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 12:10 (at the age of 80 years old) (Batch/Lot Number: EL9269; Expiration Date: 31May2021) as single dose for COVID-19 immunisation. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (at the age of 80 years old) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as single dose for COVID-19 immunisation. Medical history included Heart bypass, it was 18 years ago. It was a aortic valve replacement, ongoing lymphoma cancer, and it is gone at this point, had shingles on the right side in 2015, skin cancer in both ears in 2016. Concomitant medications included ongoing warfarin sodium (COUMADIN), ongoing warfarin deanol, ongoing carvedilol, ongoing atorvastatin calcium (LIPITOR ORIFARM), ongoing atorvastatin, ongoing hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), ongoing gabapentin (GABAPENTIN) taken for restless legs syndrome, ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing turmeric and bromelain, ongoing ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) taken for macular hole, ongoing loperamide hydrochloride (IMODIUM) taken for diarrhoea, ongoing bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10), ongoing potassium, ongoing Calcium citrate magnesium zinc all in one pill 80mg Magnesium, 500mg Calcium, 10mg Zinc, 20mg B6 taken for restless legs syndrome. Has been on his normal medications for years and nothing has changed. Has been on all of these medications at least 15 years, or more than that, maybe 18 years. The patient experienced shortness of breath since Feb2021 (at the age of 80 years and 6 monthes). He received both doses of the Pfizer Covid-19 Vaccine and received his second dose 13Feb2021. He has been to his doctor and has been treated with antibiotics and Prednisone. He wanted to know what he should do about it. Caller's shortness of breath began a couple of weeks after his second dose in Mar2021, where it became noticeable, and it continues. The patient would like to know if others have reported shortness of breath after receiving the Pfizer Covid-19 Vaccine. He has been experiencing shortness of breath since Feb2021. Maybe it is a side effect of the Covid vaccine, he does not know. First stated that it was around 15Feb2021 or earlier, when he first went to the doctor. He stated that he did start experiencing it before then. He wouldn't of went to the doctor if he didn't have that. Wife was brought on the phone to describe the event further. Stated that 01Mar2021 is when he first went to the doctor. They went on vacation on an unspecified date in Mar2021 and his wife had to take him to a clinic there that it was around 09Mar2021. He has had 4 series of antibiotics and prednisone since that first visit in Mar2021. When he got home, he went to the doctor again and they gave him more antibiotics and Prednisone. Then again in May, he had another round of it, and is still experiencing shortness of breath. He had also had other symptoms at that time. He had a lot of congestion. It did not stop but that has kind of subsided. The shortness of breath has remained. He had heard a news report stating shortness of breath symptoms have been reported regarding the COVID vaccine. He had his last shot 13Feb2021, he thinks it was. Soon after, he started having the shortness of breath. At first, he didn't relate it to the Covid shot. He does have heart problems. The first antibiotic was Azithromycin, it was with the Prednisone, It was the ZPack. He took it for 6 days and then tapered one every day. In Mar 2021 he took Medrol pack, which was 4mg tablets. They were different Prednisones and different antibiotics each time. The last one he took was Doxycycline, which was 40mg and he took it for 4 days. Can't remember what the other one was. Caller states that he had the Zpack from the clinic and his doctor gave him Doxycycline after he came home. It was a different amount of Prednisone each time. He had a lot of allergy like symptoms with nasal congestion and coughing. States that it was clear congestion and was probably 3 times as thick as with normal nasal problems. It was like lumps, was clear and was coughing it up. The congestion started when he was coughing up stuff. The last time his doctor gave him nasal spray, Azelastine HCI, which was in a spray bottle with 30ml. He stopped it after a period of time. He still has some congestion every day, but it is not near what it was before. The Prednisone and antibiotic lessened the problem along with the nasal spray and really helped. The shortness of breath has continued and has gotten a little worse. He used to be able to walk 3 quarters of a mile every day but now he probably can't walk 4 blocks. Sometimes, just sitting on the couch, watching TV, he gets heaviness in his chest. He has to breathe really deep to get it fixed. When he had his oxygen level tested, at the doctor's office, it is always 98, 99 or 100 percent. The doctor listens to his lungs and he doesn't see or hear anything that is going on. He had an X-ray for his lungs they didn't see anything there either. Had a chest X-ray, blood tests by his primary care physician and heart doctor. Had blood tests by his oncology doctor. All of those came out normal, with no problems. Feel free to ask for those results. No other additional vaccines were administered on Same Date of the Pfizer Suspect. The patient has not received any other vaccines within 4 weeks prior vaccinations. The adverse event shortness of breath resulted in visit to urgent care and physician office. The patient underwent lab tests and procedures which included chest x-ray: normal on an unspecified date. Therapeutic measures were taken as a result of the adverse events. The outcome of the events was unknown.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events "Dyspnoea, Nasal congestion ,Cough, Chest discomfort " and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in re-sponse, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Heart rate slowed significantly down to 32bpm Tightness in chest, trouble breathing Elevated blood pressure

Chest pain; LBBB (left bundle branch block); NSTEMI (non-ST elevated myocardial infarction); angioplasty & bypass done 1/11/21; discharged home 1/12/21 with referral to radiation oncology and f/u with interventional cardiology.

Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.

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

My heart began to skip beats on Friday, the day after the shot, at around 8:20 am. The skips continued for 3 days , Fri., Sat., & Sun. And finally on Monday they ceased. I could feel my heart beat skipping, and by taking my pulse, it would beat 1-2-skip 1-2-skip 1-2-3-4-skip at times it would beat Consecutively for 27-28 beats then revert back to 1-2-skip - 1-2-skip etc. I did not go to my heart doctor during this time, as I have experienced Skipped heartbeats previously , but not for several years, and not as long as they continued for the 3 days after my shot.

Syncope. Patient presented to ED due to syncope in the shower. Patient received 2nd dose of Covid vaccination this afternoon. Patient also received dialysis today. EKG sinus rhythm with 1st degree AV block. BP WNL, BG 132. Admitted. It is possible that patient had mild hypovolemia following dialysis or vasovagal event, and less likely by Covid vaccine thus got discharged. Patient had a ground level fall on next day at ALF. No acute findings noted

hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.

Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x 5 days, Augmentin 875mg 1 tab po bid x 10 days.

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

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

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

Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected.

I have a scheduled appointment with my doctor the day of the vaccine at 3PM for my annual physical. When I got my doctor's my blood pressure was high, the top number was 210 I do not remember the bottom now. He said I needed to get over to the ER clinic as soon as possible which is joined to my doctor's hospital. When I made it to the ER the blood pressure was 240 now. They to put on blood pressure monitoring, EKG. They gave my a chest x-ray. Cat-scan , blood work and gave me something in my IV. I went home that about 9:30 PM that night. My blood pressure was 213/99 and started my new medicine Nifedipine 30 MG . The ER Doctor told me to schedule an appointment with my doctor ASAP. The appointment was scheduled for today but was canceled as my doctor's office still has no power and was rescheduled for Monday the 22nd. Prior to receiving the vaccine I have no had high blood pressure. I was feeling anxious once I was informed that my blood pressure was dangerous high.

Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors in his hands. Had a syncopal episode and chest pressure. Went to ER on 2/20/21

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

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

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

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

Patient developed significant nose bleed after receiving vaccine. Required emergency department visits x2 and hospitalization.

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

COVID hospitalization 2/19/21, patient arrived at hospital. Tested positive for COVID, reported had symptoms for 3 days prior with exposure to his son also positive for COVID

81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.

4 days after receiving the second injection on Feb20, 2021, I experienced significant weakness in my legs which caused me to be unable to stand upright for any extended period of time and prevented me from taking care of my self. This condition has persisted since then and has not improved significantly.

Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.

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

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

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

Sudden onset of Atrial Fibrillation within 2 minutes; This is a spontaneous report from a contactable physician (patient). This 81-years-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6206, on 05Mar2021 10:45 in right arm as a single dose (at the age of 81 years) for COVID-19 immunization. The patient had dose 1 of BNT162B2 for COVID-19 immunization, Lot number EL9261, on 05Feb2021 10:45, in Left arm. Relevant medical history included GERD (gastrooesophageal reflux disease). There were no allergies reported. Concomitant medication included Omeprazole, Ursodiol, fexofenadine hydrochloride (Allegra), diphenhydramine hydrochloride (Benadryl). The patient had no other vaccine in four weeks. The patient experienced sudden onset of Atrial Fibrillation within approximately 2 minutes on 05Mar2021 reported as 10:45. The patient was seen at the physician's office. Treatment included EKG; Xeralto anticoagulant. The patient did not have COVID prior to vaccination and was not tested post vaccination. The outcome of sudden onset of Atrial Fibrillation was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Tachycardia >100 bpm; This is a spontaneous report from a contactable consumer, who reported for himself. A 81-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 22Feb2021 09:00 AM (at the age of 81-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant medical history and concomitant medications were not reported. On 24Feb2021, the patient had Tachycardia >100 bpm. The patient went to see a doctor or other healthcare professional office/clinic visit. Treatment was not received.The clinical outcome of the events Tachycardia >100 bpm was recovered Feb2021. It was reported that since the vaccination, the patient had not been tested for COVID-19.

Patient waited the 15 minutes in front of the pharmacy and then started shopping in the store and passed out on one aisle in the store. I was called to look at patient and they had already placed him in a chair and he was alert but weak and was able to answer questions coherently. His son that was with him call EMS to come. I called the son later in the day to see how everything was going and the son said that EMS told him all vitals were normal and he did not go with them. He then told me that his dad and him were having dinner at the time I called and that he felt fine. He also said his dad did not have breakfast that morning which could have contributed to it since he had T2DM.

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

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

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

Admitted on 3/10/2021 with altered mental status, hypotension, persistent orthostatic hypotension requring medications at discharge

I am a moderate diabetic but after the injection I have had a considerable increase in fasting and postprandial blood glucose reaching 330.; This is a spontaneous report received from a contactable Health care Professional. A 81-year-old male Patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number and Expiration date: UNKNOWN ), via an unspecified route of administration in left arm on 27Mar2021 15:00 as a single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included Metformin 850mg, gliclazide 60 mg, detusitol. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 28-MAR-2021 at 08:00, the patient stated, I'm diabetic, moderate, but after the injection I've been presenting high fasting and postprandial blood sugar level, reaching to 330. Patient was treated with Glicazide (dose increased). Seriousness of the event was not reported. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

Multiple blood clots, bleeding, hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital.

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

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

history is a bit complex. I had had occassional r shoulder pain in the past without a diagnosis or specific Rx. 2 days before 2nd dose, i b raised upper L ulna. 2 days post 2nd dose, rather severe olecranon pain developed dwith expuisite tenderness and mild swelling, but no fever. Subsequently over a period of days and weeks, I developed worsening right and then left shoulder and some neck pain and some additional hip and other pain. Shoulder tyenderness was diffuse and mostly muscular, Siginficant limitations of ROM withinability to raise arms. Pain was worst at night and on awakening with some relief with acetaminophen (no NSAIDS as on Xarelto).

Got worse and the leg swelled and was also having foot swelling because blood flow wasn't there; sore arm; blood clot; pain behind left knee; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right shoulder on 23Feb2021 (Batch/Lot Number: EN6202) (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, stage 3 renal failure (was not bad, was in stage 5 couple of years ago, was a month or so away from full failure, was in the hospital and had dialysis, was able to get reversed with medication and diet), high blood pressure, and blood cholesterol increased/high cholesterol. The reporter stated that with regards to patient's height, he shrunk a little. Patient had no prior vaccinations within 4 weeks, didn't get flu shots. Concomitant medications include about 12 other unspecified drugs, takes statins, has high blood pressure and high cholesterol. Patient started experiencing pain behind his left knee about 6 or 7 days later in Mar2021 (also reported as 04 or 05Apr2021, pending clarification). By that Sunday, it had gotten worse. The leg swelled and was also having foot swelling because blood flow wasn't there. There was no TIA's no stroke, no heart racing, no sweating, was all pain. Got leg up and kept elevated until they could get to the doctor and get imaging. Patient went Monday 08Mar2021 to see the doctor. Patient was brought to the doctor and was then sent to the imaging place. Radiology read the imaging around 5:15pm on the Monday, 08Mar2021. The radiologist said there was 2.5" blood clot behind the left knee. He had never had a blood clot before. Patient was then sent to the Emergency Room at (Name) Hospital, in (Name) where they live. Was kept there several hours. Did a lot more blood tests. He was immediately put on 10mg ELIQUIS 10mg, once in the morning, and once at night. He is now taking 5mg Eliquis in the morning, and 5mg at night. He has not had any of these problems before the Pfizer shot. The reporter knew that not a lot had been reported. It seemed it should be safe. The correlation and timing having the shot on 23Feb2021 and all of a sudden a week and a half later this happened. It was 10 days later. There was nothing they can do about it. Just continuing with the ELIQUIS, trying to dissolve the blood clot, will be staying on it for 4 to 6 months. It was a pretty big blood clot and were worried about it breaking up and traveling. The patient had no other symptoms, had a sore arm, that was it. Patient going back to (Name) 01Jun2021 and he will have another CT scan or ultra sound when they get back. The reporter did not want to need to get the leg amputated. Patient was only in the ER, was not admitted to the hospital. Patient was concerned because of his age. If it doesn't dissolve, they know there will be a lot more trouble. The event of pain left knee, blood clot and sore arm required a visit to the emergency room and physician's office. The patient received the second dose of BNT162B2 on 01Apr2021 (lot number: ER8730) in the right arm. The outcome of events was unknown.

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

This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21.

This 81 year old white male received the Pfizer Covid shot on 2/20/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) unable to speak

This 81 year old male received the Pfizer Covid shot on 3/01/21 and went to the ED on 3/20/21 and was admitted on 3/20/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

Patient developed chest pain late March. Duration of 1-2 days. No medical follow-up. Patient developed chest pain and difficulty breathing 26 Apr. He reported to a facility like Urgent Care. HCP recommended CXR which revealed questionable findings. HCP recommended hospital visit but patient did not go that day. Instead patient called ambulance to home the next morning and was transferred to the local hospital. Chief complaint chest pain and difficulty breathing. Bloodwork ruled out myocardial infarction. Various other assessments done over the first three days of hospitalization, including a CT scan which purportedly showed about a pulmonary emboli. Most (if not all) of the emboli were in the right lung and were small and fixed/immobile. At least one was larger. Patient was started on heparin . Echocardiogram workup ruled out presence of DVT in the legs. Patient was discharged after 13-14 days in the hospital.

developed anemia and requiring blood transfusion following receiving the vaccine and having ankle repair

Patient received COVID vaccine #1 on 3/25/21 and #2 on 4/17/2021. He had CBC done on 3/3/21 which showed normal CBC with WBC 4.4 and platelet 172K. On 5/3/2021 with routine CBC, it showed WBC 2.3 and platelet 10K. On 5/7/2021, WBC 0.3 and platelet 16K. Methotrexate was D/C'd then. He was given dexamethasone 40mg daily for 4 days for presumed ITP, completed on 5/10/2021. On 5/12/2021, WBC 2.9 and platelet 122K. Methotrexate still on hold.

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

Patient got second dose of the vaccine on 2/4/2021. He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was hypoxic, developed changed in mental status. Died on 5/16/2021

Patient brought to ED due to what he described as indigestion not improving over time. Diagnosed with ST elevation MI on EKG. 4 stents were placed in the RCA, EF at 50%. Given Brilenta and admitted to ICU. Discharged and placed on atorvastatin and ticagrelor.

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

About 2 weeks after receiving the vaccine, the patient started developing progressive shortness of breath. He obtained a CT chest which showed bilateral pleural effusions and congestive heart failure. Patient was evaluated in emergency room at hospital and treated with IV lasix for acute on chronic heart failure. However, his symptoms were progressing. Currently, he is hospitalized with suspicion of myocarditis / cardiomyopathy.

Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia 2. acute respiratory distress syndrome due to COVID 19 3. Acute heart failure with reduced ejection fraction 4. aspergillus pneumonia 5. history of prostate cancer, history hypertension

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

Patient presented to the ER on 7/7/21 with hematuria and was found to have acute kidney injury. Patient was recently diagnosed with a PE and bilateral DVT 4 weeks PTA and was on Eliquis for these. Patient also has a history of lung cancer and COPD and is chronically on 4L O2 at home. A foley was placed by Urology in the ER and Eliquis was held due hematuria and changed to heparin drip upon admission. In the ER, patient was tested for COVID per policy, and was found to be positive on 7/7/21 despite being fully vaccinated (1/24/21 and 2/14/21). Patient was admitted for further work-up and has not been started on COVID treatment due to patient being asymptomatic for COVID. Pt's chest X-ray was negative for pneumonia.

Blood pressure went to 180/82/ another hour BP was 164/75/ remained up at 154/75 at bed time/ did drop to 135/70 the next morning; 1 hour after the vaccination lower left lip swelled for 15 minutes and slowly went down.; This is a spontaneous report received from a contactable consumer (patient). A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in arm left on 12Feb2021 14:30 (at the age of 81-year-old) as dose 1, single for covid-19 immunisation. Medical history included stroke-heart stents. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication and levothyroxine sodium (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took hydrochlorothiazide and experienced allergies. The patient did not have other vaccine in four weeks. The patient had amlodipine besilate and levothyroxine sodium medications in two weeks. The patient did not have covid prior vaccination and no covid tested post vaccination. On 12Feb2021 15:30, one hour after the vaccination lower left lip swelled for 15 minutes and slowly went down and blood pressure (BP) went to 180/82. After another hour BP was 164/75. Blood pressure remained up at 154/75 at bed time and did drop to 135/70 the next morning. The patient did not received treatment for events. The clinical outcome of the events was recovered on an unspecified date in Feb2021.

Pt had his Pfizer COVID vaccinations at Medical Center on 2/23/21 and 3/16/21. on 6/8/21 he presented to the office for an apt for Pulsatile tinnitus in right ear x 2 weeks. Pt was examined and Doctor ordered a CBC and MRI with constrast, ENT referral to be scheduled. Pt to start Fluticasone nasal spray. :Pt referred to Neuroradiology

Sever abdominal pain extending up center of chest to ears and down center of back. Sever pain if trying to lay flat. Initial occurrence March 31,2021 approximately two weeks after 2nd Pfizer vaccination, Released from hospital same day but unable to lay flat for four days. Same symptoms reoccurred on May 26, 2021 and was admitted to the hospital for three days and it was determined my condition was pericarditis.

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

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

Patient had fall x 2 with or without sycnope (conflicting documentation) with humeral fracture after recieving the vaccine. Workup demonstrated PE and DVT (appears PE was not submassive/massive, unlikely it directly precipitated fall/ syncope)

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

Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath)

increased heart rate; breathing difficulty; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2(lot number=EK5730), via an unspecified route of administration on 15Jan2021 13:45 at single dose, left arm for covid-19 immunization. Medical history included partial obstruction in coronary artery, arthritis, allergies to pregabalin (LYRICA), levofloxacin (LEVAQUIN). Concomitant medication included cortisone. The patient experienced increased heart rate and breathing difficulty on 15Jan2021 13:45 with outcome of recovered in Jan2021. The events were non-serious. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

fast heartbeat; This is a spontaneous report from a contactable consumer reporting for self. This 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at left upper arm at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medications included lisopnphill (as reported, spelling as provided by caller- as close as he can get) started it 3 years ago (in 2018) for blood pressure; pravastatin started about 3 years ago (in 2018) for cholesterol. On 07Jan2021, patient experienced a fast heartbeat for about a minute when was going to lay down to go to sleep. He had not had the other symptoms like dizziness or chills, and did not experience a rash, dizziness, or swelling all over face, that had not happened. He saw his primary guy 3 days after and all his counts were good, his blood pressure and everything, etc. so they didn't suspect anything at this time. He will go ahead with the second shot. He had an exam with his private doctor on 12Jan2021, and everything was fine. The outcome of event was recovered on 07Jan2021. Information on the lot/batch number has been requested.

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

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

Patient felt dizzy after Pfizer COVID-19 vaccine and was moved to recover room with EMS. Blood pressure was elevated as below: 11:10 - BP 154/107, Pulse 90 11:25 - BP 148/94, Pulse 86 Patient was observed for 30 minutes. After 30 minutes, patient was released with his companion back to his house.

Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine.

During the patient's 15 min observation period, he began to complain of "lightheadedness" and palpitations. No other symptoms. He was moved to a treatment room. Blood pressure checked, EKG performed, observed for 30 min. Ate small snack. Complete resolution of symptoms.

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

passed out; light headed; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 25Jan2021 09:50 at single dose for covid-19 immunization. Medical history included visual problem. The patient's concomitant medications were not reported. The patient experienced passed out on 02Feb2021 and light headed in 2021. Clinical course: Consumer was calling regarding her dad who got the Pfizer COVID-19 vaccine. She said her dad had an event and she took him to his cardiologist who checked him out and suggest they call about it. She said that her dad passed out a week and a day after getting the vaccine and had been light headed. She said she was concerned that the second dose of the vaccine was supposed to be worse for effects, and she knew he was supposed to get it, but she wasn't sure that he should. She said her dad would say to call his daughter, because he had a visual problem, which he had since before the first dose of the COVID-19 vaccine. Caller said that NDC/EXP were not provided on the handwritten card. She said it said he got his first dose 25Jan2021. She said that the report she filed online asked what time he got the vaccine dose, and she put 09:45AM since it would not let her put 09:50AM, it was really at 09:50AM. Outcome of events were unknown.

passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Severe stabbing heart pain. Called 911. In hospital 2/19 thru 2/22. Chest x-ray, EKG, and ultrasound indicated no heart attack and heart looked good. Doctor stated ordeal was result of 2nd dose of vaccine. Person had previously suffered with Covid and was hospitalized from 10/26/20 thru 11/5/2020

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

Diagnosed with CML few months ago and taking Dasatinib daily with great response and normalized WBCs. Had second dose of Pfizer vaccine 2/2. Blood work on 2-5 WBCs 150K and 2/6 bilateral blood clots in legs which then became pulmonary blood clots.

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

bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events "patient's WBC was 150,000" and "bilateral blood clots in legs that then went to lungs then went into BLAST crisis" was recovering. Information on the lot/ batch number has been requested.

Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021.

Patient received first dose of Pfizer/BionTech vaccine ~2:40p Patient experiencing palpitations and dizziness. patient took 1 nitro tablet, 3 minutes later patient told staff he was having chest pain and and nausea. He stated nitro was helping but he knew this was gonna be a bad one and 911 was called . 2 minutes later(2:56p) took 1 nitro tablet. still having chest pain, dizziness nausea. took third nitro tablet at 3:01p. BP 125/101 and 86 BPM. 5 minutes later BP was 138/78 mmHg. A and O x 3. ambulance transported him to hospital for further evaluation

pulmonary embolism; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted with pulmonary embolism and Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after the 1st dose of Pfizer vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the events. The reported events may likely represent intercurrent medical conditions. Pulmonary embolism is known to be a potential complication of COVID 19 infection, including COVID 19 associated pneumonia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan and coagulation panel, 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.

Patient presented to ED for on/off SOB the past few days. Required O2 60% FiO2. Acute on chronic CHF exacerbation. Treated with Lasix. Patient is currently improved and planned discharge.

started with a sore arm, Tuesday pain radiated to chest. Pain pressure in chest come and go. Wednesday pain got worse. Thursday I felt dizzy and I felt short of breath. Chest area felt like bruised pain

Severe shortness of breath, and decrease in oxygen saturation to 61%, 2 weeks after second Covid Vaccine dose. He was rushed to the hospital and was diagnosed with pulmonary embolism and received oxygen therapy. He also received Lovenox injections and then apixaban orally.

82-year-old male who presents after getting dizzy and weak just prior to arrival. Patient was receiving his first dose of COVID. Pt's blood pressure was checked and was found to be 78 systolic. On arrival patient's BP was 91. Patient states that when he gets up he can still dizzy however while in bed patient currently asymptomatic this time. According to the patient's failure member he has been dizzy and increasingly dizzy over the past few days.

D= decedent D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime. ************ also mentions that there were no adverse reactions following the first dose either. The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported.

Seizure followed by Acute encephalopathy a few hours after receiving 2nd dose of Pfizer COVId-19 vaccine. COPVID-19 PCR testing positive on admission. Ongoing encephalopathy and patient made Comfort care. EEG showed no overt siezures.

On Saturday patient woke up saying he was in extreme pain with his left arm. At 5 o'clock that night he lost his equilibran and I had to call 911. They came and after an initial examination took him to Hospital's emergency room. They did c-scans, MRI. and they said that a blood clog was showing in his brain and that he had atrium filibration of his heart. His vision has been affected, though the hospital thinks it will improve. The left side of his body is not function right and he needs a walker to walk. He has been in ICU since Sunday. This is late Tuesday.

patient experienced TMI approx 2 hours post vacc presneted with loss of balance and listed to right. diagnosed by MRI the next day.

seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling symptoms worsening each day per patient suspect rheumatoid arthritis even with negative rheumatoid factor will recheck labs today and refer patient to rheumatology for further work up patient to start prednisone 7.5 mg every day x 30 days used in the decision making process Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness pain since administration of Pfizer covid vaccine in January patient agrees to steroid injection to area patient reports improvement post injection used in the decision making process Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects will check lab today continue current treatment used in the decision making process Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process hyperlipidemia denies side effects continue current treatment used in the decision making process celiac disease denies worsening symptoms continue current treatment neoplasm of prostate followed by oncology--reviewed records congestive heart failure followed by cardiology--records reviewed overweight BMI 27.8 + hypertension, hyperlipidemia, CHF weight maintained since last visit continue current efforts--diet and exercise History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking established pt pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free

Atrial fibrillation; Cardiomyopathy; Mixed hyperlipidemia; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the first of three cases. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 04Mar2021 and first dose on 27Jan2021 (batch/lot numbers not reported); both via unspecified routes of administration as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not specified and reported that they were too many to list, also he has quite a list of prescription. The patient stated since he has gotten both COVID shots and it was found out after going to the doctor and to a cardiologist that he was the third person that has been diagnosed with atrial fibrillation from taking the COVID shots and since he was the third person that they had recently after both shots, he thought he should call the toll number and report side effects after taking the vaccine. Consumer confirmed the date for diagnosis of atrial fibrillation as 08Mar2021 and stated primary care doctor, he went for his quarterly visit and she gave him an EKG and it showed this the fibrillation and he was immediately sent to a cardiologist who confirmed it after a second EKG and echocardiogram had both of those. Consumer stated it said atrial fibrillation, cardiomyopathy and mixed hyperlipidemia whatever that was, he has a print out of the diagnosis from the cardiologist in his hand. Consumer stated date of test was yesterday, 08Mar2021. Consumer stated he was given a new medicine Eliquis 5 mg twice a day as treatment. Consumer stated he just wanted to report this, since the doctor yesterday told him that he was the third patient that had both shots and came back with this. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274387 Same reporter and drug, similar event, different patient;US-PFIZER INC-2021316269 Same reporter and drug, similar event, different patient

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

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

Systemic: Weakness-Severe, Additional Details: AFTER 20 MINUTES WAITING TIME THE PATIENT WAS LEAVING THE STORE WHEN FELT AND BECOME UNRESPONSIVE, 911 WAS CALLED AND PATIENT TRANSPORTED TO MEDICAL CENTER. NO MORE INFORMATION KNOW

I went to hospital on 04Feb2021 and was diagnosed with TIA.; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation (Afib), high blood pressure, pacemaker, type 2 diabetes and high cholesterol. Concomitant medications included apixaban (ELIQUIS), metformin (METFORMIN), levothyroxine sodium (SYNTHROID) and valsartan (VALSARTAN). The patient reported "I went to hospital on 04feb2021 and was diagnosed with tia. (transient ischaemic attack)" on 04Feb2021. The patient was hospitalized for the event from 04Feb2021 to an unknown date. The patient received first dose of BNT162B2 on 14Jan2021 First dose (lot number EL3248, vaccine location= Left arm). Therapeutic measures were taken which was reported as AE treatment Jardiance. Outcome of the event was recovered.

83 yo F presents to the ER on 1/30/21 with complaints of worsening SOB and weakness. She was diagnosed with COVID-19 in 1/22/21, 7 days after receiving the first dose of COVID-19 vaccine. She had a fall on 1/25/21 and was evaluated in the ER, where she was placed on steroids and oxygen at home. She was admitted on 1/30/21 for hypoxia, generalized weakness, and A-Fib with RVR. Patient required oxygen supplementation and was treated with IV dexamethasone and inhaled budesonide. She also received treatment for afib/RVR with improvement upon treatment. Patient was discharged on 2/1/21 with recommendations to transfer to skilled nursing facility.

Patient was admitted to hospital for chest pain and was found to have a NSTEMI. Upon screening for hospital admission, was found to be COVID-19 positive. He was asymptomatic and was not treated for infection.

DVT -- leg pain began the day after vaccination, patient was seen in the ER a week later and diagnosed with right leg DVT. Started treatment with Eliquis.

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

Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with complaints of acute mental status change. He was recently diagnosed with enterocoal/pseudomonas UTI four days prior to presenting to ED and was being treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on 2/7/2021 x3, developed three pressor shock, and required maximum ventilator settings. Patient subsequently expired.

Patient began to experience breathlessness after receiving vaccine. His SOB continued to worsen. On the 13th, the patient reported to the ER. The patient was discharged from the hospital with a diagnosis of CHF exacerbation

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was new onset atrial fibrillation.

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

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

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

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

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

This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included dementia and he shrunk he is 5'9" or 5'8". Concomitant medication(s) included warfarin sodium (COUMADIN), at 4 mg once daily in the evening 6 days per week, On Fridays he takes 6 mg once in the evening. Patient's wife says her husband had one vaccination, the Pfizer vaccine and a week later her ended up in the hospital. They had to postpone his second dose because he ended up in the hospital but they have the second one coming up on the 14May2021 and she is scared for him to get it, he is adamant he is going to take it. He was taking her to the doctor for a problem she had and he told her he could not go to the bathroom and she was like what, because he has a stoma bag and she looked and it was plugged with a blood clot, he couldn't open it and drain it so she told him to get in the shower and take it off and put a new one on and she was pulling it off, it was full of blood and there was a big huge, like real liver sized clot came out of his stoma bag. She went to get the stoma bag after the thing came off she grabbed it and got it in the bag and took it out. He was taken to the hospital by the paramedics and he spent 3 days in the hospital. He is 83 now but this happened the week before his birthday, he was 82 when they noticed the blood in his stoma bad, he was a week away from 83. She provides his height and says he shrunk he is 5'9" or 5'8". She does not remember the date of the first dose. She says his birthday was 18Apr2021. She thinks he was admitted to the hospital on 12Apr2021 and he got the first dose the week before that. She thinks it was 12Apr2021 that he was admitted because it was just before birthday first dose week prior to that. They never made the connection. She thinks he ended up in the hospital on a Tuesday and she is trying to count from his birthday 18Apr2021, she thinks he got to come home on Thursday, 15Apr2021. She believes he went in on 12Apr2021 and was discharged on 15Apr2021, he was there 3 days. No further information provided. Her husband is not there with her. She does not have his vaccine card to provide NDC lot expiration or dose amount. he may not even have his vaccine card because he has dementia. No further information provided. He hardly takes any mediation He takes Coumadin he takes 1 per day except Fridays he takes 2, she thinks it's 4 mg and he takes 2 at night everyday except Friday he takes 3. she was guessing. She has one there called Atorvastatin that says it is for Lipitor, so that is not it. She sees Glipizide. No further information provided. She says she found the Coumadin, they are 2mg tablets and he takes 2 at night. She says the dose is not written on there because they call him every 3 weeks because he has to have a blood draw. He takes 2 tablets at night 6 days per week. She clarifies he takes 4 mg once daily in the evening 6 days per week and on Friday he takes 6 mg once in the evening. They just got report for that and it was 1.8 which is a little bit low but he lost blood and had to have a transfusion while in the hospital. It is in a white plastic bottle they got it from (Name). NDC 0093-1713-01 she does not see anything else. She thinks the pharmacy label is wrapped almost all the way around the bottle but she does not see lot number expiration. She sees they ordered it 11Feb2021 and she has a quantity that is it. Treatment received and outcome was unknown. Information on the lot/batch number has been requested.

Breathing issues; COVID positive with mild infection; COVID positive with mild infection; Nosebleed; This is a solicited report from the marketing program, marketing program not available received from a contactable consumer (patient's wife). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose on 16Feb2021 (Lot number and expiration date was not reported) at single dose, via an unspecified route of administration first dose on 26Jan2021 (Lot number and expiration date was not reported) at single dose for COVID-19 immunization (age at vaccination 82 years old), treprostinil sodium (TYVASO, inhalation gas, strength: 0.6 mg/ml), resp inhalation from 07Aug2018 to an unspecified date, at unknown dose and frequency; then from an unspecified date (Lot Number: 2101911; Expiration Date: 31Oct2021) to an unspecified date, at 4x/day (18-54 mcg, qid) for pulmonary arterial hypertension and treprostinil, resp inhalation from 07Aug2018 to an unspecified date, at 0.6 mg/ml; then from an unspecified date (Lot Number: 2101911; Expiration Date: 31Oct2021) to an unspecified date, at 4x/day (18-54 mcg, qid) for pulmonary arterial hypertension. The patient's medical history included ongoing pulmonary arterial hypertension. The patient's concomitant medication included tadalafil. On 13Mar2021, the patient experienced COVID positive with mild infection, difficulty breathing, and nosebleed. On 31Mar2021, 2 years 7 months 25 days after initiating IH Tyvaso, the patient was readmitted to the hospital for breathing issues. The events COVID positive with mild infection, difficulty breathing was assessed as serious (medically significant and caused hospitalization). The events nosebleed and breathing issues was serious (caused hospitalization). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 13Mar2021. The action taken for the suspect drugs treprostinil sodium and treprostinil in response to the events was unknown. The outcome of the events was unknown. The reporter did not provided causality for events. Case Comment/Senders Comment: The company has assessed the serious adverse event of COVID-19, epistaxis and dyspnea as not related to IH treprostinil and TD-300/A device. COVID-19 was likely due to infection with SARS-CoV-2 virus infection during the ongoing COVID-19 pandemic and epistaxis and dyspnea was likely a clinical cascade from COVID infection in setting of underlying PAH in this elderly 82-year-old patient. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on the lot/batch number has been requested. Follow-up (07Apr2021): New information received by Pfizer via United Therapeutics (MFR report #: UNT-2021-004686) from the same contactable consumer (patient's wife) includes: suspect product details (new dosing regimen for treprostinil sodium (TYVASO)), new event (breathing issues) and clinical course details. Information on the lot/batch number has been requested. Follow-up (19May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Based on the available information, the Company cannot completely exclude the possible causality between the reported COVID- 19 positive with mild infection, which is considered failure of COVID-19 vaccine BNT162B2, and the administration of BNT162B2 vaccine. The Company considers the reported events Nosebleed and Breathing issues as unrelated to BNT162B2 vaccine, more likely being inter-current medical conditions.

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) (at age 82 years old) as single dose for covid-19 immunisation. There was no relevant medical history. The patient's concomitant medication was not reported. The reporter wanted to report a possible connection to an adverse event from the Pfizer COVID vaccine. The patient had the vaccine in either January or February and last week he had a heart attack. The reporter stated that he was okay. He was not completely "out of the woods" right now but he was extremely healthy and what had happened was kind of unusual. After this, the patient was given some kind of statin (unspecified). Since the heart attack, he had a lot of tests but the reporter didn't know. As for the treatment, the reporter responded that "Yes, they are having there. They are under the care of doctor now." Outcome of the event was unknown. Information about lot/batch number has been requested.

Death 4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week) 2) COVID Pneumonia (onset interval 1 week) Other: acute on chronic congestive heart failure

Rash: all over his body, like measles, on his back, arms, and legs/ terrible measle like rash all over my body except for my face; The itching was so bad that I scratched myself to the point of drawing blood; Itching, worse itching he ever experienced/ intense itching all over my body/worse itching/ itching was so bad; they called it, Dermatitis.; he thought he was having a stroke.; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. An 82-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6208; NDC/expiration: unknown) via an unspecified route of administration, administered at arm right on 22Mar2021 at 10:00 (at the age of 82-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed many years ago, ongoing high cholesterol which was diagnosed around the same that his high blood pressure, ongoing type 2 diabetes mellitus diagnosed when he was in his 20's and he does not take any medications for his type 2 diabetes. The patient did not receive other products. No investigation assessment was reported. He stated several family members had the Moderna Covid vaccine, and they had some negative reactions. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks prior to the COVID vaccine) and no adverse events were reported following prior vaccinations. Family medical history relevant to adverse event was not provided. His other family members had flu like symptoms, and they were all females. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR); losartan (LOSARTAN); propranolol; primidone (MYSOLINE) and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indication, start and stop date were not reported. He had been taking the same medications for years and never had any negative reactions. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EN6200; expiry date: unknown), via unspecified route of administration, administered on right arm on 01Mar2021 at 10:00 for COVID-19 immunization. The patient experienced terrible reaction 3 weeks after the second vaccine. He woke up in the morning, turned on light and saw that he had rash all over his body (except for face), like measles, on his back, arms, and legs, intense itching all over body, worse itching he ever experienced in his life on 11Apr2021. The itching was so bad that he scratched himself to the point of drawing blood. He thought he was having a stroke. When he went to urgent care, he was treated with 2 injections Benadryl and steroid (Lot or expiration date was unknown). He was also treated with Pepcid. The injections did not help his symptoms. In the urgent care they didn't knew what the rash was and later clarified that they called it dermatitis. He stated that the staff did not thought that it was not related to the vaccine. He reclarified that when he was at urgent care, the staff told him that he should feel better in the evening, but by midnight, he decided to go to the emergency room. In the emergency room, he was given Tagamet, Hydroxyzine, and Prednisone. The rash went away and reported that itching was present, but not as bad as it was before. He reported that he took Hydroxyzine as prescribed, and after about 20 minutes, his itching diminishes but then in the evening he started to itch again. Later in the report it was mentioned that for some days he only has to take it once a day and sometimes he can skip a day when he was not itching. He was treated and released from the emergency room. The patient went to dermatologist and neurologist and no one could tell him why he had itching, no one had come up with a treatment as he was still itching. The patient stated that he called because he was reading information about the side effects and learned that the vaccine may cause a rash. Relevant tests were reported as none. Device date was reported as 22Jun2021. The outcome of the rash was recovered completely in 2021, for scratch and pruritus was not resolved and for stroke and dermatitis was unknown.

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

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

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

APPROXIMATELY 30 MINUTES AFTER VACCINATION, DEVELOPED DIZZINESS AND PRESSURE IN CHEST THAT LASTED UNTIL THE FOLLOWING MORNING.

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

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

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

On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy. Resident sent to ER via 911. He was sent home that same day. On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness. Resident had also fallen the previous night and on the morning of 1/27/2021. Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of TIA; rule out stroke.

Day 1-1-1/2 Slight soreness at vaccine site; Days 2-3 Soreness throughout chest (as with the flu); Days 4-5 Soreness in left side of chest; Day 6 - present Soreness concentrated in one area of left chest/side; more intense and "takes my breath away," at times, with certain movement and total inflation or deflation of lungs.

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

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

Urinary tract infection; high blood pressure; Fall; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. An 83-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: 31Mau2021), via an unspecified route of administration on 02Feb2021 13:12 at SINGLE DOSE for Covid-19 immunisation. Medical history included heart surgery (Between 6-9 years before), Congestive heart failure, blood pressure (problems with blood pressure) and fall (history of falls). Concomitant medication included ongoing carvedilol for Congestive heart failure. The reporter stated that her husband has high blood pressure (occurred on an unspecified date) and was having problems falling. He fell the night of 03Feb2021. She called the paramedics to come help get him up. He was taken to the emergency room on the morning of 04Feb2021. He was found to have a urinary tract infection (on 04Feb2021) and was admitted. The patient was hospitalized for the event urinary tract infection on an unspecified date for 2 days. He is now in rehab and will have to learn to walk again. She is calling to ask what needs to be done about her husband getting the second dose. The patient underwent lab tests and procedures which included blood pressure: 150/90, CT scan, labs, urine test and X-rays: unknown, weight: 175-180 lbs on an unspecified date. Outcome of the event urinary tract infection was recovered with sequelae on 06Feb2021. Outcome of the event fall was recovered with sequelae on 03Feb2021 while outcome of the event blood pressure increased was recovering.

Pulmonary Embolism suffered on 2/13/2021. Hospitalized at Medical Center. Discharged on 2/20/2021. Still recovering.

Patient w/ L sided heart palpitations after COVID-19 vaccine 2/8/21. First episode lasted 4-5 hours: BP=113/78, HR=78, O2=96. Happened a few hours after second dose of vaccine as well (3/1/21). He visited PCP and was stable.

my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.

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

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

Deceased Narrative: Patient was a 82 yo male with multiple co-morbidities consisting of AF (on warfarin), prio PE, HFrEF, CAD, HTN, mixed CSA/OSA, hypothyroidism, COPD and GERD. Patient was admitted to facility on 7/12/20 after he was found down in his home for 3 days, dx with right MCA ischemic stroke with hemorrhagic conversion. Etiology of CVA was presumed to be secondary to AF/warfarin failure. No treatment with tPA or thrombectomy was initiated as he was outside the window for intervention. Patient was also found to have bilateral DVTs. Patient was then admitted to facility 08/14/20 for end of life care.

Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.

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

cardiac arrhythmia; Atrial fibrillation; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EL8932), via an unspecified route of administration, administered in the left arm on 21Jan2021 as a single dose for covid-19 immunization. The patient's medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing , Defibrillator/pacemaker insertion from 2015 to an unknown date. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The next day after 1st dose the patient experienced a 7hr period of atrial fibrillation (all recorded on a cardiac monitor), he stated he was dizzy, light headedness and periods of shortness of breath. He just became aware of this cardiac arrhythmia from his Cardiologist. He has an internal heart monitor and the Doctor was able to see this report. He was now taking medication for A-FIB. It was reported that patient never had it until the night he got the shot. The outcome of the events was unknown.

Pt developed dyspnea and decompensated due to underlying metastatic adenocarcinoma of lung and large pericardial effusion which caused cardiac tamponade ultimately causing him to succumb.

Patient's immune thrombocytopenia was quiescent 15 months but relapsed 2 weeks after receiving first and only dose of Pfizer Covid vaccine. Non-critical GI bleed. Also neutropenia. Treated with IVIG and high dose prednisone with response.

TWO WEEKS AFTER SECOND PFISER COVID SHOT RECEIVED VERY URGENT CALL FROM EMERCENCY ROOM STATING MY PLATLETS HAD DROPED BELOW 5. RUSHED TO EMERCENCY, ADMITTED TO HOSPITAL AND STARTED INFUSIONNS STAT. STAYED IN HOSPITAL FOR 3-4 DAYS AND RELEASED TO SEEK FURTHER MEDICAL HELP.

Immune thrombocytopenic purpura; ITP; acute bleeding and thrombocytopenia; uncontrollable bleeding that did not stop; This is a spontaneous report from a Pfizer-sponsored. A contactable physician (anesthesiologist) reported that an 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 25Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient developed immune thrombocytopenic purpura (ITP) after getting or receiving the COVID-19 vaccine. The physician would like to know the protocol of that. The patient got his vaccination, on Thursday before the reporting (25Mar2021). And the patient was admitted to the hospital 48 hours later on Saturday (27Mar2021) with acute bleeding and thrombocytopenia. The patient went to the hospital with uncontrollable bleeding that did not stop. The physician was interested if the company had any internal protocol for treatment of ITP occurring acute onset after the Pfizer COVID-19 vaccine. The physician was trying to get some information to help some rheumatologist who can't seem to be finding things on the information on treating this. The physician was not here to blame anybody for it and from what he/she read, there are like 150 cases around the world with thrombocytopenia after the COVID-19 vaccine from totally different manufacturers (further clarification unknown). The physician had read a many couple case reports of different individual, people have tried for that but he/she was just interested if the company had any inhouse information for the treatment protocols for acute thrombocytopenia after the Pfizer COVID-19 vaccination. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information provided and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Immune thrombocytopenic purpura. 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.

A FIb kicked in/A Fib again; Meniere's attack/light headed and get winded very easily; This is a spontaneous report from a contactable consumer (patient and his spouse). An 83-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2), intramuscular administered on arm left on 08Feb2021 08:00 (Batch/Lot Number: EL9269; Expiration Date: 02Feb2021) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing atrial fibrillation (AFib) and he had maybe once or twice a week but never felt it (before Pfizer shot), ongoing hypertension, and Meniere's disease which had attacks several times a year and since he lost his hearing in his right ear the attacks were minor (he felt a little nauseous, similar to having a minor hang over and with a louder than normal ringing in his right ear -tinnitus). Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 2016 (reported as 5 years ago) and ongoing; and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2011 (reported as 10 years ago) and ongoing. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Before the shots, he had an AFib attack maybe once or twice a week never felt it. He mentioned that the only way he knew he had it was using his fitness watch and take his pulse before several times a day (unknown results) and before he exercise (he will not exercise if he was in Afib but it always went away overnight). His doctor recommends staying hydrated and will see a cardiologist if it does not stabilize. After his first vaccine shot on 21Jan2021 06:45 (Batch/Lot Number: EK9231) intramuscular administered on arm left and while he was at his car, the was in Afib which lasted for 5 days (26Jan2021) which was unprecedented. After about five days, his pulse stabilized and was back to normal having AFib again maybe only once a week (AER 2021194945). Then, the patient received the 2nd dose on 08Feb2021. By 08:45, the patient was in AFib again for five days (13Feb2021) when it cleared but then it came back almost immediately for another two days and he was not back to normal even after 7 days. The patient also had Meniere's attack the same time (08Feb2021 08:45) with the Afib he had. He was little lightheaded and get winded very easily during that time and recovered by 13Feb2021 (same time with the Afib). The event of Afib noted on 08Feb2021 was persistent/Significant disability/Incapacity and did not received any treatment. No follow up attempts are needed. No further information is expected.

Got first pfizer vaccine 4/7. Started to feel pain in right calf 4/9. Went to emergency room Hospital, 4/14 where after an ultrasound was diagnosed with blood clot in saphenous vein. Repeated ultrasound per primary care recommendation 4/21, no changes in size were noticed. Currently taking Advil.

Patient presented to the ED and was subsequently admitted for TIA on 2/21/2021. He also had an ED visit on 3/10/21 for peripheral edema.

This 83 year old black male received the Covid shot on 03/22/2021 and went to the ED on 4/5/21 and was admitted on 4/8/21 with CHF, bilateral lower extremity edema, chronic kidney disease and died on 5/1/21 . 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.

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

BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021 Active Hospital Problems Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment. In the emergency department the patient's vital signs were stable. Labs revealed a potassium of 3.3. AST was 52 and ALT 61. White blood cell count was 11.13. Troponin was negative and BNP was within normal limits. Lactic acid was 1.5. UA showed trace blood. EKG showed normal sinus rhythm with PACs. CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes. There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl. Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available. He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months. He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months. He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day. His daughter was updated over the phone.

Awoke with extreme dizziness. Over next few days, blacked out 3 times. Vomited 3 times. Remained in bed much of the time for a week. Constant tinnitus (still present). Current working diagnosis: Vestibular Neuritis and Labyrinthitis. Still have significant problem with balance (current date - 05/10/2021)

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

Patient presented to the ED with acute coronary syndrome and was subsequently hospitalized, diagnosed with NSTEMI. This was within 6 weeks of receiving COVID vaccination.

83 yo c/o dizziness and blurred vision 15 minutes after receiving his 2nd dose of the Pfizer vaccine. Patient stated to staff member that after he stood up he felt like passing out. Patient was escorted to the triage area where he was evaluated by on-site EMS and NP. Vital signs and EKG initiated . BP elevated. Patient states he has not taken morning BP meds which may be causing the elevation. Patient has a PMH of HTN. Allergic to Pollens and Perfumes. After about 15 minutes, BP decreases and patient states he's feeling better. Patient agreed to leave and have daughter drive him home.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were weakness, elevated CPK, anemia, non-traumatic rhabdomyolysis.

Admitted to hospital on 5/2/2021 due to hypoxia and ultimately intubated. Family moved to comfort care and he died on 5/2/2021 at 10am.

This is a spontaneous report from a contactable consumer (patient). A 83-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an unspecified route on 19Jan2021 at 11:15 (at the age of 83-years) as 1st dose, single dose in the right arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 23Jan2021, the patient experienced chest pains and problems breathing and went to Emergency room and diagnosed has pleurisy. The patient received treatment for events with steroids, pain meds and muscle relaxers. The patient underwent lab tests and procedures which included nasal swab, COVID test was negative on 19Feb2021. The outcome of the events was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Patient hospitalized for atrial fibrillation with RVR and underwent a cardioversion within 6 weeks of receiving COVID vaccination.

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

83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath. Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress. The patient had recent angiogram with 2 stents placement. The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention. Critical Care, Cardiology, and Infectious Disease were consulted. Urology was consulted for the patient for urinary retention. The patient went to the OR for urinary retention and urethral stricture. The patient had transurethral incision of the vesical neck contracture. Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection. Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids. The patient was seen and examined on June 15. At that time, Neurology was consulted for patient's seizure. Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation. Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%. The patient was on aspirin and Plavix. The patient had a recent stent placement. The patient was seen and examined on June 22, 2021. At that time, the patient was successfully extubated to nasal cannula. The patient was improving. The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia. Infectious Disease was following the patient. The patient was seen and examined on June 28. At that time, IR was consulted per Pulmonary request for thoracentesis. IR requested to hold Plavix for the procedure. The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021. At that time, the patient was lying down in the bed, no acute distress noted. The patient denied any chest pain or shortness of breath. The patient was status post thoracentesis. Infectious Disease was following the patient and IV antibiotics recommended. The patient was status post pneumococcal pneumonia with septicemia, bronchitis. At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days. The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.

Lethargy/Fatigue, fever/chills, acute chest pain or pressure, Exertional chest gas and pressure occurring in the last week or so Pericardila effusion was present in echo May be alternative cause/etiology for diagnosis--but not identified in report Complex medical history in 83 yr old male including Paroxysmal Atrial Fibrilation, HTN, dilated aorta, s/p prostate cancer, recent hernia surgery (1 week prior) with new signs of inflammation of pericardium after vaccination. Was also treated for possible UTI due to hematuria and fever

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.

Paroxysmal atrial fibrillation 4 hrs after vaccine administration. Symptoms: palpitations, dyspnea, throat tightness, fatigue

CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit "like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm.

~2 weeks after 1st dose, patient suffered cerebral hemorrhage. Was also on Eliquis. Received KCentra.

admitted 21 Jan 21for Chest pain; Elevated troponin; Hypokalemia; SOB (shortness of breath); Shortness of breath; Volume depletion Dishcarged on 23 Jan 21

Excessively tired during the week after the first vaccine. One week after an undiagnosed episodic atrial fibrillation was discovered when treating a stroke. Causation not researched.

Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase. Diagnosis Left MCA stroke. Reporting event given was just over 24 hours after first COVID vaccine dose.

Shortness of Breath, Continuous Coughing with blood tinged spit, Blood Pressure 200/100, Oxygen level 84 began around 5:00 am with paramedics arriving and transporting to the hospital around 7:00 am.

Admitted to Medical Center with syncopal event that occurred at home. Cause of syncope unclear at discharge

Severe attack of shivering, followed by increased pulse rate - 70 to 120, loss of stability, stiffness in joints, tiredness, loss of apatite. Treated with extended sleep. Stiffness lasted 20 hr and was treated with Ibuprofen

At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.

Development of chest pain and dyspnea. Large pleural and pericardial effusions requiring drainage. No evidence of CHF by echo or BNP. Fluid was found to be exudative rather than transudative. No growth of infectious agents found to be causal. ESR and CPR extremely elevated. All self resolving after thoracentesis and pericardiocentesis.

Pt. recieved COVID vaccine on 6 Feb @0730 and presented to the hospital with chest pain & quesionable stroke. + CT and transferred to another hospital @ 1430, appears CVA (cerebral vascular accident); Cardioembolic stroke; Cerebrovascular accident (CVA), unspecified mechanism; TIA (transient ischemic attack). He was discharged on 10 Feb. Home course unknown

Patient went into rapid afib at around 8 pm (6 hours after vaccination) Rate up to 180-190. Became hypotensive with BP as low as 76/56. Went to ER. Hospitalized overnight for observation

Patient presented to the ED reporting that he was feeling "real weak". In the ED, he was found to be hypoxic, tachycardic, and hypothermic with a temperature of 93.2. Pt has history of COPD (on chronic oxygen), HTN, CAD, atrial fibrillation, spinal stenosis, bilateral pleural effusions requiring thoracentesis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Injection in left arm at 4:15 pm. on Friday 3/5/2021. At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room. He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021. He found non responsive at home shortly thereafter.

Severe weakness 3 days after vaccine (3/5), to the point I which patient could not stand. Presented to hospital 6 days after vaccine (3/8). Hospital workup notable for CPK 45,720 U/L with CRP 109 (3/8) and low-grade fever (3/9). Negative infectious workup so far (BCx, Biofire, COVID PCR, UA without WBCs, no leukocytosis). He also had new thrombocytopenia to 84 (3/8), but possibly due to rifampin for LTBI. He remains admitted at this time, receiving fluids for rhabdo, undergoing further infectious and rheumatologic workup.

On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.

The patient presented to the ED on 3/11/2021 with fatigue for a few weeks, and recent abdomen pain. The patient was found to be hyponatremic and there was also evidence of a CVA on MRI findings.

03/16/2021: Presented to the emergency department with substernal chest pain/pressure. Patient was admitted for non-ST elevation MI, and currently awaiting cardiac catheterization.

03/14/2021: Presented to the emergency department due to fall which occurred prior to arrival. Patient states he climbed up his attic, lost balance came down rolling the stairs and hit the back of his head. He did not lose consciousness, but is taking a blood thinner. The patient is currently still admitted with subarachnoid hemorrhage and pelvic hematoma.

Received 2nd dose of covid19 vaccine on Wednesday 3-24-2021, felt fine Thursday, Friday loss of appetite tired, Saturday lethargic could barely function on his own. Sunday morning lethargic, weak, could not walk very well, complained of shortness of breath. Called 911 and took to emergency room. White blood count off, platelet level low, 14,000

Patient had unexplained asystolic cardiac arrest 3 days after second Pfizer shot was administered. No recent illnesses or complaints, no fevers.

Patient presented to the emergency department of Hospital on 1/16/21 with severe hypoxia to 70s% on room air and was found to have COVID-19 infection with pneumonitis. Patient is a resident where received Covid Vaccination on 1/15/21

Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.

heart attack; This is a spontaneous report from a contactable consumer. A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE (at age of 84 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart attack on an unspecified date within 15 minutes after taking the Pfizer COVID-19 vaccine. Outcome of the event heart attack was unknown.

Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics

He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12). Both shots were given into the left arm. He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees. Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees. Some soft tissue swelling was noted around the hand. Simvastatin was discontinued with no improvement in symptoms. Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L. Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare. He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms. Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.

3 hours after receiving 2nd COVID shot, while at cardiology clinic appointment patient experienced syncopal episode and was taken to ED by ambulance

The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21. His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks.

WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.

3/30- Resident was sent to ER was found to have acute CVA, R vertebral occlusion, carotid stenosis, 17mm lung mass suspicious for malignancy, family opted for palliative and or Hospice. 4/03-re-admitted to the facility. 4/14 Admitted to Hopsice. Resident deceased on 4/16.

Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures.

went on Saturday afternoon to the Arena where the 2nd dose was given. On Sunday afternoon he was not feeling well, achy, and by evening slightly light headed. Monday morning he had worsened, and tried to stand, and collapses, the home health nurse called for an ambulance. By mid afternoon on Monday March 1st he was blue around the lips and skin, doctor worked to try and stabilize him throughout the evening, until his heart stopped at 1:30am on March 2nd.

Patient presented to the ED and was subsequently hospitalized with a pulmonary embolism within 6 weeks of receiving COVID vaccination. Patient also hospitalized on 3/12/21.

Nose bleeds began the week after the first vaccine dose and continue at one or two per week when bending over, picking up broken branches, yard waste, etc. My husband has so far refused to see a doctor. Does not have a regular physician. Did not tell me initially. Claims to not have had any for past ten days. Symptoms did not seem to be worse after second dose, but I can't be sure.

stroke; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient has no known allergies and no covid prior vaccination. Concomitant medications included clopidogrel bisulfate, amlodipine, vitamin d [vitamin d nos] and "levoth" (as reported). The patient has no other vaccine in four weeks. On 21Feb2021 at 12 AM, the patient had a bad stroke "14 days" after he's first shot. They think it's the vaccine. The event resulted in hospitalization for 25 days and disability or permanent damage. The patient was covid tested post vaccination via nasal swab on 17Mar2021 which was negative. The outcome of the event was not recovered. Information on the Lot/batch number has been requested.

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

Patient developed shortness of breath and "barky cough" 5 days after first COVID 19 vaccination. Chest imaging revealed pulmonary embolism. Patient was hospitalized for 4 days and discharged on anticoagulation.

Hospital admission on 03/22/2021, dx COVID+ with acute respiratory failure, acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity.

after his first dose he had one day where his blood pressure went "very low"/Low blood pressure; This is a spontaneous report from a contactable consumer (who is the patient, reported for self). This 84-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9262, Expiration date: UNKNOWN), via an unspecified route of administration in the left arm on 23Jan2021 (at the age of 84-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure and that he was taking pills, it was under control. Patient says occasionally he develops rapid heartbeat, for which he has medication and mainly these are things taking medications for. No further details provided about these medications; Cholesterol and open heart surgery nine years ago and macular degeneration in each eye and puts eyedrops in and occasionally they give him injections. The patient received his second dose on 13Feb2021 (Batch/Lot number: EL9266). Concomitant medications included that he takes Lipitor 10mg every day for his cholesterol. Estrogen 10mg every day for his open-heart surgery. No further details provided about these medications. The patient initially stated that he has practically had no symptoms with either shot. He said he basically had no symptoms other than after his first shot. The patient then stated that after his first dose he had one day where his blood pressure went "very low" but by the time he talked to his cardiologist it had "gone back to normal" on 25Jan2021 in the morning, that was the only side effect he experienced. He did not have any other recent vaccinations nor started any new medications. Investigation assessment was not provided. Outcome for the event was resolved on 25Jan2021. Follow-up (02Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (patient) reported which included clinical course of events. No follow-up attempts are possible. No further information is expected.

Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021

Patient presented to the ED with shortness of breath and was subsequently hospitalized for elevated troponin, pneumonia and palpitations. She was in the ICU for 9 hours before being transferred to the cardiology floor.

L sided heart palpitations; This is a spontaneous report from a non-contactable pharmacist. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via intramuscular on 08Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. It was unknown, whether the patient had other vaccine within four weeks; prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. The patient medical history was not reported. Concomitant medication(s) included rivaroxaban (XARELTO); tamsulosin hydrochloride (FLOMAX); metoprolol tartrate; docusate sodium (STOOL SOFTENER); levothyroxine; furosemide; omeprazole; potassium. On 24Feb2021, the patient experienced L sided palpitations after COVID-19 vaccine 08Feb2021. First episode lasted 4-5 hours: Blood pressure -113/78 mmhg, Heart rate- 78, O2 consumption - 96 and oxygen saturation: 96 %. Happened a few hours after second dose of vaccine as well (01MAR2021). The patient visited to doctor or other healthcare professional office/clinic visit for adverse event. He visited PCP and was stable. It was unknown, whether patient recevied any treatment. Outcome of the event was resolved on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Patient presented to the ED on 4/13/2021 for syncope. Patient presented to the ED and was subsequently hospitalized on 4/23/2021 for bradycardia, AV block. These visits are within 6 weeks of receiving COVID vaccination.

84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week. He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS. Decision to dc to hospice

The next day after the vaccine, I could not stand, no balance and drooping on right side of face. My spouse called 911 and thought I was having a stroke. I was admitted to the hospital. I had numerous blood work done and tests done and was diagnosed with TIA transient ischaemic attack and to follow up with a neurologist. I was in the hospital 3 days. I am being followed by the neurologist. I still have balance issues and the facial drooping is gone.

Patient presented to emergency department with complaints of worsened shortness of breath and lower extremity edema on 6/22/2021. He was admitted for further management of CHF exacerbation. During screening for placement to post acute rehab facility, patient was found to be COVID-19 positive on 6/29/2021. He was treated for COVID-19 infection in April of 2021. He is still admitted at time of writing.

N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of COVID-19 illness on 06/13/2021

This is a spontaneous report from two contactable consumer (Patient and patient's wife). A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 at 09:30 as dose 2, single (at the age of 84 years) for COVID-19 immunisation. Medical history included ongoing hypertension About 20 years, ongoing biliary obstruction started about 20 years ago (Bile ducts prone to being clogged), Sees a doctor every 3 months and has blood tests every 3 months, ongoing prostatomegaly about 10 years (prostate enlargement that has been for about 10 years.), ongoing pressure in eyes about 15 years and was on medicine for all of that. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiry Date: unknown), dose 1 via an unspecified route of administration in right arm on 26Jan2021 as dose 1, single (at the age of 84 years) for COVID-19 immunisation. On an unspecified date in 2021, reporter stated that patient had his blood pressure taken and it seems to be up. Patient has been on a high blood pressure medicine, and it just shot up. Reporter doesn't know when it first started. Patient went to the dentist and they took it there on 03May2021 and the dentist said it was a little bit high. Patient went to the doctor again this past Monday and it was up to 170. His appointment at the dentist was at 10:30, and the appointment at the doctor's office was at 14:30. They have also been taking his blood pressure several times a day. They increased his blood pressure medicine. When asked if it is ongoing, reporter said his blood pressure has been running between 140/79 and 164/89. Patient has some different medications, but nothing has changed. Patient mom had diabetes and passed away, and his dad had throat cancer. The patient underwent lab tests and procedures which included blood pressure measurement: between 140/79 and 164/89 on 03May2021, blood test: unknown on an unspecified date. He has had it for quite a long time, about 20 years. The outcome of event was unknown. Follow-up attempts are needed. Further information is expected.

Hemoglobin has dropped; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored program. An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 28May2021 (at the age of 84-years-old) (Batch/Lot Number: EW0172) as DOSE 2, SINGLE; and dose 1 via an unspecified route of administration, administered in arm left on 07May2021 (at the age of 84-years-old) (Batch/Lot Number: EW0172) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included cardiac congestive heart failure from Feb2020 and ongoing; quadruple bypass surgery 35 years ago, had low hemoglobin that was stabilized after receiving RETACRIT infusions, internal haemorrhage and anaemia. There were no concomitant medications. The patient previously took Retacrit Epoetin Alfa [epoetin alfa epbx] since Mar2021 for low hemoglobin, internal haemorrhage and anaemia. The patient had no prior vaccinations within 4 weeks prior covid-19 vaccine. It was reported that the vaccine doses were given on 07May2021 and 28May2021. It was mentioned that prior to vaccination the patient had low hemoglobin that had stabilized after receiving RETACRIT infusions. After vaccination, his hemoglobin has dropped and he needed RETACRIT infusions again. The reporter wanted to know if this happened to anyone else. The patient has had a problem with his hemoglobin levels ever since he got both COVID-19 Vaccine doses. The patient was getting infusions (RETACRIT) prior to the COVID-19 vaccine doses. It was mentioned that he did not have any infusions for 8 weeks prior to the COVID-19 vaccine doses. The patient's hemoglobin dropped after getting both COVID-19 vaccine doses in Jun2021. The reporter (patient's wife) asked if her husband's hemoglobin dropping was a side effect of the COVID-19 vaccine. Her husband received his first COVID-19 Vaccine dose on 07May2021 and his second COVID-19 vaccine dose on 28May2021. The reporter mentioned that she and her husband (patient) was originally not going to get the COVID-19 vaccine because they both react to so many things. Their doctor told them if they got the COVID-19 virus, they wouldn't survive, so she and her husband got the COVID-19 vaccine. It was clarified that the patient had been getting a clear liquid injected (called Retacrit Epoetin Alfa) into his arm every week since Mar2021. The patient was taking the Retacrit Epoetin Alfa for some internal bleeding, and anemia. After 8 weeks of taking the Retacrit Epoetin Alfa, her husband's hemoglobin was at a safe level. When her husband received both COVID-19 Vaccine doses, his hemoglobin dropped afterwards. Her husband had to go back to getting weekly Retacrit Epoetin Alfa shots. Therapeutic measures were taken as a result of hemoglobin has dropped wherein patient restarted weekly Retacrit Epoetin Alfa shots in Jun2021, providing treatment dates: 07Jun2021, 14Jun2021, 21Jun2021, 28Jun2021, and 12Jul2021. The patient's hemoglobin level was 11.8 when quit getting his Retacrit Epoetin Alfa shots (in Apr2021). His hemoglobin level then dropped to 10.5 in Jun2021. It was clarified that his recent hemoglobin levels were 10.7 on 14Jun2021 and 10.5 on 21Jun2021. The event resulted to physician office visit. The outcome of the "Hemoglobin has dropped" was not recovered. Follow-up attempts are completed. No further information is expected.

nose bleed; Atrial Fibrillation; hypertension; This is spontaneous report from a contactable consumer or other non HCP. The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Jul2021, this case now contains all required information to be considered valid. A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: unknown), via unspecified route of administration in the right Arm, on 28Jan2021 at 12:00 PM, (at the age of 84-year-old) as dose 1, single for COVID-19 Immunisation. Medical history included blood too thin to coagulate. Concomitant medications included warfarin taken for Blood too thin to coagulate start and stop date was not reported, acetylsalicylic acid (ASPIRIN 81) taken for unspecified indication start and stop date was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via unspecified route of administration in the left shoulder, on 19Mar2021 at 11:00 AM, as dose 2, single for COVID-19 Immunisation. On 10Feb2021 at 07:15 PM, the patient experienced nosebleed. On an unknown date, the patient experienced hypertension and atrial Fibrillation. The patient visited 3 times to emergency room for bleeding and received two transfusions to stop bleeding and kept in hospital until 19Feb2021. On an unknown date, the patient transferred to ENT physician. It was reported that he was hospitalized and couldn't make it to appointment for second dose on 26Feb2021. Prior vaccinations within 4 weeks were none. The patient was visiting her primary care physician and cardiologist regularly. The outcome of the events were not recovered. Information about lot/batch number has been requested. Follow-up (19Jul2021): The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (19Jul2021), this case now contains all required information to be considered valid. new information added which included suspect product detail, event detail, Patient age at time of vaccination, patient medical history was updated. Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.

vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.

Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: PATIETN HAD HIGH BLOOD PRESSURE. PATIENT MISSED HIS LISINOPRIL DOSE. HE FELT ALITTLE DIZZY AFTER THE SHOT AND BLOOD PRESSURE WAS CHECKED AND IT WAS FOUND TO BE HIGH 180/90 PATIETN WAS MONITIERED

Had fallen early morning the day after the injection. At approx 12 noon, was eating lunch and became nauseous, diaphoretic, vomiting and ashen. Complained of chest pain. EMS activated and sent to ER for further evaluation. Cardiac work up completed and within normal limits. returned to facility. ER note: ?Very likely musculoskeletal in nature (maybe from recent Covid vaccination?

Passed out; massive diarrhea; fell and hit his face; fell and hit his face; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing (Caller says her father in law hasn't had seizure in years, it was diagnosed when he was a kid, 60-70 years ago). There were no concomitant medications. The reporter is calling on behalf of her father in law. She said he had his first dose of the COVID vaccine recently, she pulled this number off of the paperwork today. She says that she believes he had a side effect for it, and also he was rescheduled for his second dose. She says his second dose was supposed to be in 21 days but they rescheduled him for it at 18 days instead. She says he got the first dose on 11Jan, and they rescheduled his next for the 29th. She says she wanted to know if this was correct or ok. The reporter says that the following day he ended up having massive diarrhea, that it caused him while he was on the commode to pass out and he fell and hit his face, the best she can tell he was alone at the time. She says he did not go to the hospital for that, he got up and cleaned himself off and took a nap, and the nurse next door checked on him later on. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID19 dose #1 given IM LD at 10:30AM 1/27/21. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting. While seated, vital signs were taken- BP 148/76, HR 73, O2 98%. No falls or medication administered. EMS arrived around 11:10am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on EMS assessment, recommenedation was to go to the ER. Patient brought to Sharp Memorial Hospital by EMS staff at 11:20am, spouse was present and in agreement.

Trouble swallowing: 30 hours after shot, continuing though current time of 70 hours Nausea, vomiting, dizzy, fainting 65 hours after shot. 2 episodes Fever - 72 hours after shot

Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates ("had flu shots before with no reactions and everything, nothing before"). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; "which was a normal thing for him, it was not that low for him." Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was "perfect three weeks ago." The patient had just gone to the doctor the other day and his blood pressure was "fine and everything." The patient's wife stated that other than his diabetes, "which he had for (sentence incomplete)." Regarding lab tests, the patient's wife stated, "No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good" (as reported). Regarding causality, the patient's wife stated, "I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died." The patient's wife further added, "I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine." The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to "heart stopped." An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped

1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.

Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment.

unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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 morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; feel light headed and it's been coming on and off/feeling dizzy and light headed; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EK4176, via an unspecified route of administration in his left upper arm, on 22Jan2021 at single dose for COVID-19 immunization. Medical history included surgery on aorta to put a stent in Nov2020. There were no concomitant medications. On 26Jan2021 at mid day the patient started to feel dizzy and light headed and this feeling has been coming on and off, so he decided to take his blood pressure. He didn't have his values from 26Jan2021. In the morning of 27Jan2021 at 6 am his blood pressure was 156/74, with 65 beats, then, at 7am, it was 167/76, with 65 beats and at 8:40 am, his blood pressure was 137/64, with 65 beats, so it was fluctuating. At the time of the report the events had not resolved yet.

No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.

ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.

Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)

Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.

DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing

Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation, elevated lactate, anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom. Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM.

Pt fell within 24 hours after vaccine. was sent to hospital. pt was found to be hypoxic with multifocal opacities on CT scan

Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.

DEATH Narrative: Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21

Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22. Again admitted and had further rheumatological and infectious work up with negative results He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and thought to have viral pericarditis. Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION. He was started on celebrex in addition to the the colchicine as an anti-inflammatory. After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased. He was monitored for another days and was feeling better. He is therefore being discharged home. In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.

While seated in post vaccine observation area, slumped in chair, losing consciousness.Lifted to stretcher and regained consciousnee. 911 called and responded transporting patient to hospital.

Patient received dose around 9 AM on 3/16/2021 and felt fine the rest of the day. On 3/17/2021, patient was so weak he fell at home and could not get himself back up. A friend was called who was able to help the patient up off the ground and got him a walker to use. Patient was able to get around using the walker, but then fell again around 20:00 on 3/17/21. He called 911 because he could not get himself up off the ground and EMS brought him to the hospital. Patient denied other symptoms other than new onset BLE weakness. Patient worked with PT/OT next morning and was able to walk 400 feet on level terrain and safely ascend/descend 4 steps with rails.

TIA- mini stroke; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 PM (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril. On 27Feb2021 14:00, the patient experienced TIA- mini stroke. The AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of tia- mini stroke. The outcome of the event was recovered.

UNKNOWN. PT'S WIFE CALLED US TODAY 3/30/2021 TO INFORM US THAT PATIENT PASSED AWAY ON 3/29/2021 DUE TO MASSIVE HEART ATTACKED

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

Pt fainted 10 min after receiving vaccine.He was talking to his friend who brought him in to the clinic when event happened.Pt fell from the chair, did not remember what happened.Initial BP is elevated,HR elevated,pt was pale and clammy and diaphoretic,O2 100%.Pt monitored for 30 min BP and HR stabilized. Pt was comfortable going home.

Systemic: Fainting / Unresponsive-Severe, Additional Details: according to daughter patient crashed about 1 hour after receiving vaccine, taken to hospital in diabetic coma with glucosse level of 20..hospital trying to rule out TIA

Pt presented to ED at the recommendation of the PCP for low hemoglobin where he reported having increased generalized weakness for the past month, dyspnea on exertion, occasional lightheadedness. On arrival to ED was found to be hypotensive, with elevated WBC count, mildly elevated lactic acid level, and anemic at Hgb 7.5. An incidental finding of a positive COVID-19 nasal swab was found despite receiving Pfizer COVID vaccinations on 1/30/21 and 2/20/21. Pt admitted for additional management of sepsis, hypotension potentially secondary to COVID-19 infection and/or RLL developing pneumonia. Pt currently still hospitalized with worsening acute respiratory failure due to COVID and acute pulmonary embolism.

Father received 2nd vaccine and died two days later of heart failure. Was not in critical condition prior to the vaccine.

4/1/2021 routine lab work done for follow up Dr. visit, 4/2/2021 Dr.office called stated platelet count is 14,000 go to ER. Patient was admitted to the hospital and as of this entry still a pt. because the Drs can not get his platelet count up or to stay up ( range has been from approx. 7,000 to 30,000) Patient is in declining health. As I understand it labs from Jan /2021 the platelets were 77,000. He has been treated with IVIG, prednisone, NPlate, platelet infusions-please contact Drs. and the hospital Patient displayed NO outward bleeding of any kind. He had only1 small bruise about the size of a dime on the base/web of his left index finger

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. 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.

Thrombocytopenia 14000 on admission. Was at the dentist day before and had cleaning No bleeding at that time. Most recent platelet count in computer in 2017 was 144,000. patient had BMB showing Amegaryocyte no schistocytes Was treated with steroids IVIG no improvement. Had Nplate 4/14/2021 and 4/21/2021 no improvement.. Had also HLA match platelet transfusion for platelet < 10,000. Today 04/22/2021 platelet count 4,000

Patient presented to the ED on 4/20 after near syncopal episode. Found to have submassive saddle PE with bilateral DVTs. No prior hx of coagulopathys.

new onset of Pericardial effusion and tamponade of unknown etiology extensive infectious disease evaluation was negative. after second vaccine; severe fever chills and hypotension.

This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810 and expiration date not provided), via an unspecified route of administration, in right arm, on 05Mar2021 12:30 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, atrial fibrillation (AFib), congestive heart failure (CHF), blood pressure high (HBP) and obesity. Patient had no known allergies. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medications included rivaroxaban (XARELTO), lisinopril, metoprolol, metformin, and atorvastatin calcium (ATORVASTIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265 and expiration date not provided), via an unspecified route of administration, in right arm, on 12Feb2021 11:30 (at the age of 85-year-old), at single dose, for COVID-19 immunization. On 01Apr2021, the patient experienced "platelet count of 14,000/ low as 7,000 and high as 30,000". On 01Apr2021, patient had routine 3 month blood work done for follow up doctor visit. On 02Apr2021, results revealed platelet count of 14,000, doctor called and said to go to ER (platelet count was 77,000 in Jan2021). Patient was still in hospital as of 20Apr2021 in declining condition despite multiple doses of immunoglobulins (IVIG), prednisone, romiplostim (NPLATE), and platelet infusions. Patient's platelet had been as low as 7,000 and high as 30,000 during his time in the hospital. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 18 days. No COVID tested post vaccination. Other medications reported as glipizide, ergocalciferol (VIT D), furosemide, potassium chloride ER. The outcome of the event was not recovered.

he developed "a nosebleed yesterday and today.; This is a spontaneous report received from a contactable consumer (patient's wife). A 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, in left arm, on 18Feb2021, as single dose for COVID-19 immunisation. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that on 20Feb2021, the patient developed a nosebleed. It lasted about 10 min to maybe 30 min with pressure and gauze applied. He might have just blown his nose too hard, or it could be the cold weather. Patient's wife was not sure that it was from the vaccine. Outcome of the event was unknown. Follow-up attempts are completed. Information about Lot/batch requested.

bent over to look up and almost blacked out; swimmy headedness was really more noticeable after second shot; sensation in equilibrium or vision or whatever; weakness; felt different/really knew something was wrong/something is not right; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 09Feb2021 (Lot Number: EM9810) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 85-year-old, via an unspecified route of administration, administered in Left arm on 20Jan2021 (lot number: EL3302) as single dose for covid-19 immunization and experienced Vertigo, felt peculiar, nausea, dizziness/swimmy headed. The patient previously received the flu shot for immunization and experienced Sore arm. He is 85 and not familiar with all the goings on today but heard a report the other day and did not know there was such a thing as Vertigo. He thought that was just a movie. When he took the shot at (place name) in (county name) on 20Jan2021, soon thereafter, not that day but maybe next, he felt peculiar. It was just uneasiness and he did not feel right. That went on and on 09Feb2021, he got second shot and he got swimmy headed, but it has continued on since then and probably gotten worse, especially when he gets up in the morning. He has to hold on until he gets balanced or coordinated. It just doesn't seem right After he gets up and gets going, it is not as prevalent. But then sometimes it strikes him and he is just completely out of it. He later stated the peculiar feeling and swimmy headedness started the same day as the first injection, but he just did not really pay attention to it and thought it was just one of those things that you accept with getting older. Wife and he both went and he thought his feelings were merely from excitement or depletion or exhaustion. He felt like he had weakness and he just felt different. He got it at noon and waited for 15 minutes. Because of the events around him at the time, it did not register with him because it was the stress of driving 30 miles through expressway. Old people aren't used to driving that far. It got worse after the second shot and then he really knew something was wrong. When you are old, you have these feelings and pains and aches and all that stuff, and you just accept it as being old. It did not register with him until a couple of weeks ago when he heard it on TV about Vertigo and he said that is what he has. The swimmy headedness was really more noticeable after second shot, it brought it on stronger. He does not complain about things and thought it may just be getting old. He said it just kept on and getting a little worse and worse. Then he said something is not right and one day he bent over to look up and almost blacked out because of sensation in equilibrium or vision or whatever. He got scared and that was a couple of weeks ago. (name) was not cognizant of what was going on until he heard on television about Vertigo. One of the news channel mentioned or somebody mentioned it. It was just general things. He confirmed it was regarding someone who had gotten Vertigo after getting the vaccine but did not have a particular person to report on. NO ER or physician's office required. The outcome of the event dizziness aggravated and Weakness was not recovered, other events was unknown.

after 1st vaccine he noted slowed heart rate and irregular heart rate. Also developed dizziness/lightheadedness. These symptoms worsened after 2nd vaccine (received on 2/3/21.) PCP in community did Holter that confirmed heart block. He presented to clinic today.

Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever. COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.

Bleed; Hemoglobin and it had dropped to 6.1; 2nd dose- He was extremely exhausted/weariness/tired feeling; This is a spontaneous report from a contactable consumer (patient's wife). An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 85-years-old via an unspecified route of administration, administered in arm left on 15Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus, cancer removed from his buttocks (It was either a basal or a squamous and they did not feel it was bad and they had removed it all) on an unspecified date, he has had a stent put in on an unknown date, Had surgery for a valve replacement on an unknown date, heart disorder (He is on a lot of medications) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 85-years-old on 24Feb2021 and experienced he was tired a little bit. After the second dose on 15Mar2021 her husband and her were extremely exhausted, not sleepy, just tired. They were told to expect that though. He was extremely exhausted and this began soon after the COVID vaccine fairly early in the day. Her and her husband came home soon afterwards and looked at each other and said that they were tired and it was not sleepiness, it was not like they needed a nap. It was profound tiredness and exhaustion. Her husband had it more so but they were both in bed for a couple hours. Neither had pain in the injection site though. This lasted for several hours into the evening. Adds that for her husband 1st dose he did not have any effects basically but for his 2nd dose he did have the weariness, not sleepiness, just a tired feeling for several hours. He was just resting and he was also in the hospital but it was for another event not because of the COVID vaccine. She says that it was frightening, he went to the doctor for a routine check up he has had a stent put in and had surgery for a valve replacement at the beginning of the year and also he has had a cancer removed from his buttocks at the beginning of the year. But during his regular check in they did his hemoglobin and it had dropped to 6.1 on 20May2021, and the doctor said that they were going to call an ambulance and her husband said he was going to drive to the hospital since he was only 2 to 3 minutes from there. They admitted him and he was in for 3 days. They can not find the bleed site and they did an endoscopy and they are waiting for him to have an outpatient colonoscopy. They can not figure out the bleed and where it is coming from. He is currently been resting but it is frightening because it was out of the blue. Caller confirms that the stent, cancer and the valve replacement were all prior to the COVID vaccine. The patient was hospitalized for hemoglobin and it had dropped to 6.1 (haemoglobin decreased) and bleed from 20May2021 to 22May2021. The patient underwent lab tests and procedures which included endoscopy: unknown results on May2021, haemoglobin: 6.1 on 20May2021. The patient recovered from fatigue on 15Mar2021 while the outcome of the other events was unknown. Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595342 same patient, and vaccine, similar event, first dose

Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.

Severe cough, shortness of breath, exhaustion leading to emergency room visit followed by hospitalization wherein it was discovered Pt was diagnosed with acute congestive heart failure. Prior to this vaccine he was living alone, preparing meals, driving to errands, etc. Over the following few weeks after release he became unable to live at home so he was moved to an assisted living facility where he rapidly declined and was put on hospice less than 2 weeks after his second Covid shot on 3/2/21 (Lot EN9581) (which he only took because his doctor pressured him). He died on 6/2/21 of heart failure.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45.

Shortness of breath, low blood oxygen which gotten increasingly worse the days following first vaccine. Went to ER two days after vaccine as symptoms continued to get worse and was placed on oxygen full time. Had a portable oxygen machine. Was also placed on hospice care March 18, 2021; 3 days after 1st vaccine. He had a stable bill of health on Feb 4,2021. Dizziness, fainting and falling down days after second vaccine on March 8 2021. Was in and out of urgent care, ER and assisted care as symptoms and health rapidly deteriorated. He died May 1, 2021

Irregular heart beat developed few hours after injection of the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 85-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8730) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, type 2 diabetes, gout and glaucoma. Concomitant medication included High blood pressure medicines and Diabetic medicine. The patient previously took quinidine and diamox for unknown indication and experienced an drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient experienced Irregular heart beat developed few hours after injection of the vaccine. The patient did not receive any treatment for the adverse events. The clinical outcome of the event Irregular heart beat was recovering. No follow-up attempts are needed. No further information is expected.

Chills; Fever / temperature; Elevated blood pressure; a little bit of redness or pain; a little bit of redness or pain; This is a spontaneous report from a contactable consumer (the patient). A 85-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in right arm on 15Apr2021 (at the age of 85-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included metoprolol taken for blood pressure, start and stop date were not reported (been taking it close to a year every morning). Additional Information for Concomitant Products metoprolol: He thinks it 100mg Extended Release. He was taking 250mg a day then they went to extended release. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) intramuscularly in right arm on 25Mar2021 as a single dose for COVID-19 immunization. Prior vaccinations (within 4 weeks) not provided. On 29Apr2021 11:00, the patient experienced chills, fever / temperature, elevated blood pressure. On an unspecified date in Apr2021, the patient experienced a little bit of redness or pain. It was reported that "Caller stated that he had both Pfizer COVID vaccine shots, second one was two weeks ago today. Caller stated that he sailed along without a single symptom, maybe a little bit of redness or pain. Caller would like to know if there is a likely effect within or after 2 weeks of getting the Pfizer COVID vaccine. Caller stated that he has been isolating for almost a year, that he waited until things have eased up to get the Pfizer COVID vaccine and here he is seeing possible symptoms. Caller asks how long after the second Pfizer COVID vaccine do you hear of any adverse reactions. Caller states that his wife passed away about 2 months ago and the provider's office was very hard to get access to during that time. He experienced Chill, fever, and a temperature. His symptoms occurred a couple hours after he got up today at about 11AM. It happened all the sudden. Caller states that he has an infrared thermometer and has been taking his temperature and blood pressure on a regular basis along with an oxygen reading. Caller stated that his temperature was up over 102F and is down to about a 100F now. Caller stated that the temperature may still read high but he does not feel bad and is not having chills. Caller states that 97.6 is his usual temperature so it is up more than caller is accustomed to. Caller states that his blood pressure is normally 110/72 or 73 and that he is on metoprolol and has been taking it close to a year every morning. Caller stated that his blood pressure is back to normal. Caller states that he received both Pfizer COVID vaccines in his right arm because he is left handed and had no issue whatsoever in terms of use or limitations. Caller stated that the symptoms today are the first sign that the shot may have something to do with it. Caller stated that he hasn't done anything unusual in the last 2 weeks other than to get the Pfizer COVID vaccine. He asks if he needs to get any medical tests or if this is normal." On 29Apr2021, the patient underwent lab tests and procedures which included body temperature: 100F (over 102F and is down to about a 100F now), blood pressure measurement: normal and on unspecified date, body temperature: 97.6 (his usual temperature), blood pressure measurement: 110/72 (normally (110/72 or 73). Therapeutic measures were taken as a result of elevated blood pressure. The outcome of events chills, elevated blood pressure was recovered on 29Apr2021. Outcome of fever / temperature was recovering. The outcome event a little bit of redness or pain was unknown. No follow-up attempts are needed. No further information is expected.

he was 6 feet but had shrunk a little; fever of 100.9; chills; pain around pacemaker in chest; lower back pain; had a sore arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: 3L3246) on right arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included 3 heart attacks in the past and pacemaker from an unspecified date. Concomitant medications were not reported. The patient had a reaction to the Covid vaccine he received on 05Jan2021, stated he had a sore arm the next day 06Jan2021 that had resolved. Stated last night on 07Jan2021, he had a fever of 100.9 and chills and mild pain around pacemaker area in his chest and lower back pain. Stated he treated the fever and chills and pain with Tylenol and stated it had improved. The patient stated he was 6 feet but had shrunk a little on an unspecified date. The outcome of the event had a sore arm was recovered on 07Jan2021, for the event he was 6 feet but had shrunk a little was unknown, while other events were recovering.

8:33 am, 1/17/2021, 10 min after being vaccinated, patient began complaining of chest pain. Patient has extensive cardiac history but did not have acute pain until after vaccination. Client was released by EMS with wife, to home.

RN received a phone call from patient. Patient was found by home health physical therapy assistant to be extremely short of breath, dizzy, hypotensive and tachycardic at home following 1st dose of covid vaccine today. Blood pressure on initial check was 58/46 and 66/52 on recheck. Heart rate (on pulse oximeter) was initially at 130-142 but came down to 72, irregular. After resting and hydrating, patient denies shortness of breath, but is still dizzy. RN advised 911

RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/03/21. REPORTED ER FALLING ON ICE WITH RIGHT HIP PAIN. ALSO HIT HEAD. IS ON BLOOD THINNER. IN ER O2 SAT DROPPED AND WAS PLACED ON 4L OXYGEN. ADMITTED INPATIENT AFTER BEING DIAGNOSED WITH HYPOXIA, CHF, AND PELVIC FRACTURE

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

During the 15 minute respite the patient appeared to have a primary cardiac event and rolled forward off their chair onto the floor. Hitting their nose causing significant bleeding. 911 was immediately called Found to be pulseless, CPR was initiated within 30 seconds of event. Patient received 2 rounds of CPR, 1 AED shock, 1 mg Epi, Oral airway placed, High flow O2 with Bag Mask. ROSC returning in approximately 3+ minutes. Patient was able to talk appropriately after ROSC minus some coughing due to postnasal blood. Patient was transferred via EMS to local ED for cardiac workup. Code was run by Cardiac Surgeon, National Guard EMTs, Redmond Fire Paramedics

DATE: 02/20/21 12:00AM - AWOKE WITH SEVERE ITCHING ON WRIST OF BOTH ARMS 12:00 - 12:45AM - STAYED AWAKE WHILE IN BED ITCHING BOTH ARMS 12:45AM - WENT TO BATHROOM TO A VISUAL VIEW OF ITCHING ARM. BOTH ARMS, WRIST TO ELBOWL, WERE EXTREMLY RED "RED" DOTS OVER WHOLE BODY FROM THE THROAT DOWN; NO SPOTS OR REDNESS ON THE HEAD OR FACE. SLIGHT PRESSURE ON CHEST. APPLIED CERAVE LOTION ON MULTIPLE AREAS OF THE BODY, WHICH PROVIDED INSTANT RELIEF. DRANK A CUP OF BIGELOW MATCHA GREEN TEA WITH TURMERIC. WEN TO BED AT 02:00AM UNTIL 07:30AM. ALL PROMBLES ABOVE WERE GONE. SKIN LOOKED THE SAME AS LAST EVENING AT BEDTIME 10:30PM.

Patient passed away from chronic respiratory failure with cardiogenic shock 24 hours from 2nd dose of vaccine. Patient with longstanding history of pulmonary HTN and heart failure with desire for comfort care only. Entering into VAERS out of abundance of caution.

Two nosebleeds; Heart skipped all day long; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EU9231, unknown expiration), via an unspecified route of administration in left arm on 22Jan2021 at a single dose for prevention; apixaban (ELIQUIS), oral from an unspecified date at 2.5 mg twice daily for thromboembolism prophylaxis; and ranolazine (RANEXA), oral from an unspecified date at 500 mg twice daily for an unspecified indication. Medical history included bypass surgery in 2007, stent placement (5 stents), and 3 blocked arteries, diagnosed several years ago, he guesses he is living on half of them. There were no concomitant medications. The patient received his first shot of COVID vaccine on 22Jan2021. The patient then experienced two nosebleeds, they did not ask if he had been on a blood thinner, he takes Eliquis, 2.5mg and Ranexa, so his question is a couple days, his heart skips beats anyway, but on the 13th day, it skipped all day long, so he was concerned about the other shot, he was supposed to get it today, he was concerned because he had bypass surgery, had 5 stents, 3 blocked arteries now that they can't do anything about. He was calling about COVID vaccine. He took it 3 weeks ago today and was supposed to get second shot. Concerned as to whether or not he should take it. He was supposed to get the second shot today (12Feb2021), doesn't know, but was really concerned about whether he should take or not. Nosebleeds were the 13th day after the shot (on 04Feb2021). He has recovered completely from nosebleeds. He stated he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot (on 04Feb2021), states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart. The patient recovered from the event two nosebleeds on unspecified date, while unknown outcome for the remaining event. The action taken in response to the events for apixaban and ranolazine was unknown. Additional information was also received by Pfizer from Bristol-Myers Squibb Company (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016064), license party for Apixaban. This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long) in 86-year-old male patient who received apixaban (Eliquis) tablet for Thromboembolism prophylaxis. CO-SUSPECT PRODUCTS included ranolazine (Ranexa) tablet for an unknown indication and Covid-19 Vaccine injection for Prevention. The patient's past medical history included Bypass surgery in 2007, Stent placement and Arterial occlusion. On an unknown date, the patient started Eliquis (Oral), 2.5 milligram twice a day and Ranexa (Oral), 500 milligram twice a day. On 22-Jan-2021, the patient started Covid-19 Vaccine (unknown route) by injection once to left shoulder. On 04-Feb-2021, an unknown time after starting Eliquis, the patient experienced EPISTAXIS (Two nosebleeds) and EXTRASYSTOLES (Heart skipped all day long). The action taken with Eliquis(Oral) was unknown. At the time of the report, EPISTAXIS resolved and EXTRASYSTOLES outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments. Nosebleeds were the 13th day after the shot. He took shot on 22Jan2021. Has recovered completely from nosebleeds. States he only bled for a couple seconds. Heart skipped all day long the 13th day after taking the shot, states it is doing fine at this time, comes and goes, may skip one day, next day maybe 3 times and skip, then 4 times and skip, he guesses he has a crazy heart.

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying.

Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital . Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.

During post vaccination observation pt complaint of weakness and was hypotensive. Transported to ED, blood sugar 39, given IV fluid and food. Other lab work within normal limits, symptoms resolved and discharged to home

Jittery, shaking hands, tight muscles in chest (confirmed that there were no palpitations). Going to take tylenol and call doctor in morning if not feeling better.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk. Discharged with 3 weeks physical therapy to regain his strength. First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever. Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion. He was taken by ambulance to the hospital on 2/26/2021. I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions. During this admission determined to have heart attack with cardiac cath and stent placement. Brain MRI showed new 1cm occipital left infarct and developing pneumonia. Started on anticoagulation with Plavix and ASA 81mg. Readmitted to the hospital on 3/8/2021 with suspected GI bleed. Had colonoscopy and endoscopy with gastric erosion cauterized.

your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-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 on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown. Information on the lot/batch number has been requested.

husband's blood count was very low, was bleeding in colon; husband's blood count was very low, was bleeding in colon; his platelet count became too low; This is a spontaneous report received from a contactable consumer (patient's wife) and from the Pfizer-sponsored program. An 86-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 86-years-old on 06Feb2021 (also reported as 13Feb2021, pending clarification, Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included heart condition. Concomitant medication included warfarin sodium (COUMADIN) taken for heart condition, start and stop date were not reported. The patient received the 1st dose on 06Feb2021 (also reported as 13Feb2021) but missed the 2nd dose on 06Mar2021 (lot reported as "EL9269") because he was hospitalized. She mentioned that he is taking Coumadin everyday for his heart condition and his platelet count became too low. Wife wanted to know timing of the second dose. Her husband's blood count was very low, was bleeding in colon. He was on Coumadin after the hospital he will be going to the rehab. The patient underwent lab tests and procedures which included blood count: very low and platelet count: too low on unspecified dates. Therapeutic measures were taken as a result of Colonic hemorrhage and Platelet count low. The outcome of the events was unknown. The case was assessed as serious due to hospitalization (husband's blood count was very low, was bleeding in colon). Information on the lot/batch number has been requested.

Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83). Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.

I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.

The first doze made him tired and got back pain. Went to his Primary Doctor to see if it is okay to get the second dose. He got his blood work done, echo Cardiogram and all the necessary test have been done and he is okay to proceed by his Doctor. On the fourth day after he get the second dose of Pfizer-BioNTEch, in the afternoon, he couldn't get up from his bed that he had lay down. He experienced slur, facial droop and left side hand weekness. We called the paramedics right away and they checked him and took him to the nearest Emergency Hospital. They ran tests, did CT scan and diagnosed him with Ischemic Stroke on his right side which has effect on the left side of his body for facial droop and weekness and not being able to get up. He was threated with Mechanical Thromboctomy to remove the blood clot. He stayed in the hospital for 8 days and is bed bound up until now and is transferred to a re-hab. He still can't stand. Today is the 27th day since the adverse reaction started. His left hand has improved a little bit.

blood pressure went much too high; blood glucose went high also; After the first shot, I experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 2/27/21 and condition worsened. Not only did I experience ter; This is a spontaneous report from a contactable consumer (patient). This 86-year-old male patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (Lot: EL3247) on 27Jan2021 06:30 PM at single dose on Left arm, second dose on 27FEB2021 at single dose on Left arm, both for COVID-19 immunization. Medical history included Diabetes mellitus. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. After the first shot, the patient experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 27FEB2021 and condition worsened. Not only did patient experience terrible GI problems, his blood pressure went much too high and blood glucose went high also. The events onset date was reported as 28JAN2021. The adverse event "GI problems" result in doctor or other healthcare professional office/clinic visit. There was treatment received for the adverse event, medications to lower blood pressure and blood glucose. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was Recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Stroke like symptom- babble; could not form words to communicate to wife or EMT; 24 hrs before he didn't feel well nothing in particular-no headache, no stomach issue, no fever, no tremors or motor skill issues.; This is a spontaneous report received from a contactable consumer (patient). An 86-year- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Feb2021 as a single dose and first dose on 28Jan2021 as a single dose and both the doses (at the age of 86-years-old) for COVID-19 immunisation. The patient medical history included Prior stroke, Kidney disease and inactive pituitary gland. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication within two weeks of vaccination (names not specified). The patient did not receive any vaccine within 4 weeks prior to the vaccine. On 09Mar2021, the patient had stroke like symptom- babble, could not form words to communicate to wife or EMT and he didn't feel well on an unknown date in Mar2021 (24 hrs before) (as reported). It was reported that patient had no headache, no stomach issue, no fever, no tremors or motor skill issues. The patient visited emergency room and was hospitalised on an unknown date in Mar2021 for the events Stroke like symptom- babble, could not form words to communicate to wife or EMT for 2 days. Therapeutic measures were taken as a result of events stroke like symptom- babble, could not form words to communicate to wife or EMT. The patient had undergone laboratory test and procedures on an unknown date in Mar2021 includes EKG, heart CT, monitored blood, a full MRI (next morning) and the results were not reported. The outcome of the events Stroke like symptom- babble, could not form words to communicate to wife or EMT was recovered on an unknown date in Mar2021 while for another event was unknown. Information about batch number and lot number is requested.

Suffered a stroke 1 to 1.5 hours after vaccination. He was driving when according to my grandmother he couldn't deccelerate and was having trouble communicating. Grandmother had to take control of the wheel and somehow stop the car by driving it off the road. Patient was combative with healthcare and had to be restrained and was confused about why he was there. he no longer remembers the events that lead to his hospitalization.

pt came into the office with symptoms of left lower extremity swelling/edema. Ultrasound was done that determined patient is Positive for acute deep vein thrombosis of the left femoral and left popliteal veins. Pt placed on Eliquis right away.

possible heart attack; High pain in left arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in left arm on 08Feb2021 13:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from 2010 to an unknown date, hypertension from 1971 to an unknown date, both knees replace from May2011 to an unknown date, left shoulder replaced from Nov2011 to an unknown date, left eye cataract removal from Jun2013 to an unknown date, right eye cataract removal from Oct2013 to an unknown date, L4 & L5 disc repair from Aug2014 to an unknown date, Gall bladder removed from Sep2014 to an unknown date, Right shoulder, Kidney disorder, cramps, Virus fighter, Heart disorder, eye disorder, General Health, Blood thinner, R. shoulder pain, sleep disorder, constipation, Clear vessels. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient experienced possible heart attack on 08Feb2021 with outcome of not recovered, high pain in left arm on 08Feb2021 with outcome of not recovered. High pain in left arm-possible heart attack on 08Feb2021. Reported it was not caused by shot, but result is possible pitched nerve- X-ray and CT scan Being done. AE required Scheduled X-Ray and then CT scan on neck. Treatment included the event did require the initiation of new medication/other treatment/procedure. Seriousness criteria reported as not serious. COVID-19 testing had not been conducted.; Sender's Comments: A contributory role of the vaccine BNT162B2 to the event possible heart attack cannot be fully excluded based on the temporal relationship. Patient's advanced age, underlying hypertension, atrial fibrillation, kidney disorder and other comorbidities provide alternate explanation for the event. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021277193 same patient, same product (second dose), similar events.

Patient complained of chest heaviness and fatigue at bedtime 6 days after receiving the first dose of the Pfizer COVID vaccine. Patient planned to go to the doctor in the morning, but died while sleeping.

Patient's wife noticed red blotches on his arm and suspected hives. Patient brought back to Med OBs at 2:55, he was alert and vital signs were: HR: 63, BP: 134/51, SPO2: 99. denied itchiness, SOB, throat tightening, palpitations. Scattered dry, red blotches on bilateral arms. Examined legs, back, and chest, no other blotches noted. Had patient wait with us for observation. At 1545 rechecked vitals: HR:65, BP:128/55, SPO2:98, patient had no further redness and continued to deny any symptoms. he felt he was ready to go home. discharged to home with wife. consulted patient and wife he could take Benadryl.

86y.o. male with history of hypertension, Diabetes mellitus type II, OSA (uses 2L of O2 at home), CAD, cardiomyopathy, CVA with right hemiparesis, gout, GERD, and depression who presents to the hospital on 4/27/2021 for shortness of breath that has been worsening over the past week. Patient positive for COVID on 4/26/21 when he presented to the ED with fever, cough, and chronic toe infection. Patient had no hypoxia or increased work of breathing and was discharged from ED with doxycyline for his toe infection. Patient reports that he returned to ED due to family concern over symptoms. In ED, patient became hypotensive and was given 30 mL/kg bolus by ideal body weight. Patient remained hypotensive and central line placed in ED for possible vasopressors. Patient is on his home oxygen of 2L and has no increased requirements. Patient in ICU for sepsis and hypotension that responded to IV fluids.

small blood clot in brain; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Type two diabetes b, covid prior vaccination in 2021, blood clot in lung. Concomitant medication included exenatide (BYETTA). The patient previously received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced small blood clot in brain on 09Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received the treatment Heparin for event. Covid test post vaccination (Blood test) was negative on 12Apr2021. The outcome of the event was not recovered. Information on Lot/Batch number has been requested.

I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)

shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough

This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

J18.9 - Left lower lobe pneumonia I48.91 - Atrial fibrillation with RVR (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) N30.01 - Acute cystitis with hematuria

Pfizer Dose 1 2/19/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6207) COVID Positive 4/29/21 5/3/21: A is a 6-year-old male past medical history significant for COPD with chronic bronchitis, AAA, pulmonary embolism chronic heart failure, OSA and previous smoker was referred from infusion center for hypoxia on room air of 88%. Patient endorses that since field note Will with some shortness of breath; contacted PMD and COVID test was done and was found to be positive. Patient was then referred to infusion center and was found to be hypoxic on room air 88% and referred to the emergency room. Patient endorses that progressively has been feeling short of breath with generalized malaise otherwise denies any fever chills or rigors. Patient had 2nd COVID-19 vaccine X2 doses in March. Patient was found to be hypoxic in the emergency room requiring 2 liter/minute to bring saturation to acceptable level. Chest x-ray shows mildly cardiomegaly with pulmonary vascular congestion and grossly scatter bilateral pleural plaques. CT angio of chest to rule out PE was done and was unremarkable for pulmonary embolism; however shows right lower lobe airspace disease that might represent pneumonia; intervals catheter bilateral calcified pleural plaques stable as prior. 5/11/21: Patient is an 86-year-old male was admitted with COVID-19 pneumonia with superimposed bacterial pneumonia. Patient had been vaccinated in March 2000 in 21 for COVID-19. Patient was started on remdesivir received Actemra as well. Patient was covered with IV Zosyn for possibility of superimposed bacterial pneumonia. Blood cultures x2 were negative for the patient. Pulmonology team was following the patient and we were able to successfully wean the patient down to room air. Pulmonology cleared the patient for discharge. Patient was discharged to skilled nursing facility with a prednisone taper as recommended by pulmonology. On 05/10/2021 patient had a sinus tachycardia and EKG revealed right bundle branch block which was discussed with Cardiology. Patient was asymptomatic and Cardiology did not recommend any further workup for right bundle branch block. Patient's electrolytes were in the normal range. Patient was in sinus rhythm upon discharge from the hospital on 05/10/2021. Patient was discharged to skilled nursing facility in a stable medical condition on 05/10/2021

While in observation he began to get clammy and sweaty. Vital signs were obtained which revealed elevated BP. After several minutes, BP was reassessed and was still elevated. Patient was AAOx3 and had no speech difficulties. Patient reports that his baseline BP is 140/65. BP noted as 206/89. ED notified and patient transferred via wheelchair to ED.

After taking the first dose of the vaccine, within 3 hours he could feel the skipped heart beat; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 86-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, on 13Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included skipped heart beat for which took medication Pacerone 4 years ago. Concomitant medications were not reported. The patient reported that he got the COVID-19 virus shot on the 13Jan2021, and about 14 days ago he started having skipped heart beats. He said he had a condition, and took a medication for skipped heart beat that he started taking 4 years ago that when they gave it to him it cured the problem of the skipped heart beat for 4 years. He said after he took the first dose of the vaccine, within 3 hours he could felt the skipped heart beat on 13Jan2021, and he didn't know if it had to do with it or not, but he was calling to see if anyone else had reported this since the only thing on the paperwork he was given that references the heart was a fast heart beat. The patient reported that the skipped heart beat happened from time to time, every 3-4 hours it might happen, though sometimes it didn't happen. He said last night it did not happen any and that it was not serious, it was more of an irritating thing. He took medication, Pacerone, cured him in three days, and he only skipped one day of taking it in those 4 years. He already called his doctor and was gonna see him soon, but he wanted to get the second vaccine because he was an attorney and he was in meetings face to face with people, so he wanted to take the second dose which was scheduled on 02Feb2021, The patient said something about 14 days, and he was thinking he would go and take the second dose anyway and see what happens, then thought that might be stupid, but he wanted to take it so bad, but if it caused these heart beats not a good idea possibly. There was product complaint. The patient was unwilling to complete the report. and declined to complete a report. No further details captured, reported, or documented at this time. Outcome of the event was unknown. Information on the lot/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

I began to have some skipped heart beats; This is a spontaneous report from a contactable consumer (patient). This is 1st of two reports. A 86-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248, expiry date not reported) via an unspecified route of administration on 13Jan2021 (at the age of 86-years-old) as a 1st dose, single for COVID 19 immunisation.The patient medical history included skipped heartbeats and was taking a medicine (Unspecified medication), that for 4 years and it had been working. Concomitant medication were not reported. On an unspecified date, the patient began to have some skipped heart beats. The patient was supposed to take the second dose on 02Feb2021. He did not have any skipped heart beats with the unspecified medication he used but after the vaccination, he began to have some skipped heart beats. The outcome of the event was unknown. Consumer was informed about Pfizer Medical information department and was unwilling to complete the report, hence further probing could not be done. Limited information was available over the call. Follow-up attempts are completed. No further information is expected.

On 3/20 this patient started exhibiting right sided facial droop and paralysis of right arm and leg, dysphagia. On 3/25 he was discharged from the hospital on hospice.

March 5th Ultrasound revealed Severe DVT in left leg. Emergency room March 5th prescribed Eliquis 10mg twice daily. May 24, 2021 blood work showed elevated Ddimer. Dr requested another Ultrasound, May 27, 2021 Severe DVT not responding to blood thinners. May 30, 2021 Dr. switched to Xerelto 20mg. June 3, 2021 Dr. determined that patient has developed Chronic DVT and will continue to follow up with Blood work and Blood thinners. Next appointment is June 11, 2021.

She has seen that sometimes he appears to be cold and he is tired.; She has seen that sometimes he appears to be cold and he is tired.; RBC 3.80/the counts were significantly low; blood count to be low; HgB 11.3; HCT 33.8; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm left on 28Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, coronary heart disease, intestinal polyp removed from 2014 she believes it was maybe a duodenal polyp. Concomitant medication included apixaban (ELIQUIS) took since 2018 or 2019 and ongoing. The patient historical medicine includes received first dose of BNT162B2 for COVID-19 Immunisation. It was reported that her husband received the first vaccination 28Jan2021 and approximately 3 weeks later received the second vaccination. They both got it at the same time. They were pleased and had no problems. It was reported that on 11Feb2021, they went to the primary care physician for a regular follow up and her husband's blood count was low. The doctor didn't tell them about her husband's low blood count in Feb2021. He did call attention to a seriously low count this past week. Also reported that Low blood count: Results from 11Feb2021, Red blood count: 3.80, Hemoglobin: 11.3, Hematocrit: 33.8, Does not have the paperwork from the results from last week, which indicated that the counts were significantly low. Treatment: None, he is scheduled to have an endoscopy and a colonoscopy 04Jun2021. Also reported he had Second dose and Unable to read the date, stated that it looked scratchy. Stated that is was something, 1, 2021. She is pretty sure she knows it was in a 3 week period. It was administered by the Fire Dept, LOT: EN620, thinks it is a zero, or 2 zeros mushed together. First dose was in the left arm and the second dose was in the right arm. Has read about anemia recently since Friday, She has seen that sometimes he appears to be cold and he is tired. Doesn't know what fatigue is but they are not 25 any longer and things change. He sleeps well during the night. He did have a surgical procedure 16Apr2021. They released an ulnar nerve in his wrist and elbow of his left hand. The patient underwent lab tests and procedures which included blood count: low on 11Feb2021, haematocrit: 33.8 on 11Feb2021, haemoglobin: 11.3 on 11Feb2021, red blood cell count: 3.80 on 11Feb2021. Th outcome of the events was unknown.

Developed dizziness. Had several episodes a week or so after the shot getting progressively worse. On April 10, 2021 three bad episodes - last one resulted in fainting and splitting head open. EMT's came took me to the hospital and on April 12th I had a pacemaker installed. Breathing problems improved after pacemaker.

His blood pressure went extremely low to 88/55; heart rate went to 160; was not a place on his body that did not hurt; charley horses in his legs; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot Number: EL9264) via intramuscularly on 02Feb2021 at 08:15 as SINGLE DOSE and first dose on 14Jan2021 (Lot number: EL3248) for covid-19 immunisation.The patient's medical history included myocardial infarction (from 2002 to an unknown date Verbatim: Heart attack), prostatic operation (from 2002 to an unknown date Verbatim: Prostate surgery), knee arthroplasty (from Jun2016 to an unknown date Verbatim: Knee replacement), cataract operation (from Feb2013 to an unknown date Cataract surgery), hypertension (ongoing), cardiac disorder Heart strengthener (ongoing), anticoagulant therapy (ongoing), sinus disorder (ongoing), lung disorder (ongoing), diuretic therapy (ongoing). Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; ubidecarenone (COQ-10) taken for cardiac disorder from an unspecified start date and ongoing; (ASPIRIN) taken for anticoagulant therapy from 2002 and ongoing; Ipratropium (IPRATROPIUM) taken for sinus disorder from 2019 and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for sinus disorder from 2019 and ongoing; (FLONASE) taken for sinus disorder from an unspecified start date and ongoing; (BREO) taken for lung disorder from an unspecified start date and ongoing; spironolactone (SPIRONOLACTONE) taken for diuretic therapy from Dec2020 and ongoing; guaifenesin (MUCINEX) taken for lung disorder from Jun2020 and ongoing; leuprorelin acetate (ELIGARD) taken for prostatic specific antigen, neoplasm malignant from an unspecified start date and ongoing; alirocumab (PRALUENT) taken for blood cholesterol from 2018 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2015 and ongoing. It was reported that, patient was feeling great all day on 02Feb2021. The patient went to bed around 22:00 and at midnight he woke up and there was not a place on his body that did not hurt. He spent the rest of the night hugging a heating pad and had Charlie horses in both of his legs and had to force himself to walk on them. He said that he felt like he played in the super bowl after he got up that morning. He was concerned because the next morning he started having blood pressure activity. His blood pressure went extremely low to 88/55 and heart rate was 160 beats per minute at around 08:30. He took it again at 10:00 and it was 112/75 and pulse was down to 109. It remained at that number pretty stable until around 16:00 and at that time it was like someone upstairs said he was done, he quit hurtling, his blood pressure went back to normal and he felt great again. Outcome of the events was resolved on 03Feb2021. Follow-up attempts are completed. No further information is expected.

Developed symptoms of SARS-CoV-2 infection including shortness of breath, cough and was tested due to persistence of symptoms despite antibiotic treatment. Antigen testing was positive. Approximately 1 week after symptom onset patient was noted to be lethargic and confused by family who contacted EMS. Patient was hypoxic in ER and required 8 L of O2. Was admitted with COVID-19. Subsequently did decompensate on the floor and required intubation. Currently intubated receiving remdesivir, dexamethasone, and antibiotics.

Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.

elevation in blood pressure/hypertension has persisted; This is a spontaneous report from a contactable Physician (patient himself). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266, expiry date: not reported) via unspecified route of administration in left deltoid, on 17Feb2021 13:00 (age at vaccination: 86-year-old) as DOSE 2, SINGLE for Covid-19 immunisation. Patient took first dose of vaccination (Lot: EN5318 or it could be ENS318, expiration date: not reported), via unspecified route of administration in left shoulder in the deltoid on 27Jan2021 13: 00 (age at vaccination: 86) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history t and concomitant medication were not reported. He was taking a very modest dose of Lisinopril 2.5mg daily, now taking 10mg lisinopril daily. Information was reported regarding Lisinopril 5mg, expiration was filled 25Nov2019 says discard 24Nov2020. It was reported that his blood pressure has gone up after receiving the second dose Pfizer Covid 19 Vaccine, he doesn't know if his blood pressuring going up is a coincidence or if this is being seen by other people. Blood pressure has gone up: states 29Apr2021 was when the caller first noticed the hypertension, the blood pressure going up is ongoing and it is the same, states he has increased his anti hypertensive medication so in a sense. Before 29Apr2021 the caller's blood pressure systolic was below 120, and now the caller is getting ratings like 135, was taking a very modest dose of Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. It was also reported that because this spike in protein reacts with the ACE2, the molecule on the surface of the cell spikes protein reactions, which has to do with blood pressure. Patient stated that on 29Apr2021 he noticed an elevation in blood pressure and this hypertension has persisted. He would like to know if this event is a coincidence or if this is a side effect that has been reported with the Pfizer COVID-19 vaccine. Patient was inquiring about the length of time the spike protein remains in the body and circulates after receiving the Pfizer COVID-19 vaccine. He escalated to secondline for further research. He asked if Pfizer would be interested in obtaining a blood sample from him to see if he still has spike proteins circulating in his system from the Pfizer COVID-19 vaccine after his second dose in Feb. Treatment was given for the adverse events includes Lisinopril 2.5mg daily and is now taking 10mg Lisinopril daily. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021651524 same reporter/SD, different patient/AE

he fallen split his head open and he thought he just would go to the ER; actually fell couple of times and he finally actually fell and hit his head and was taken to the ER; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; he became weaker and weaker and recently he been using walker now; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand/ he became weaker and weaker and recently he been using walker now; This is a spontaneous report from a contactable consumer. A 86-years-old male patient received bnt162b2 (BNT162B2, Lot number: EN6201 and Expiration date: unknown), via an unknown route of administration on 19Feb2021 (at the age of 86-years-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes and hypertension. The patients concomitant medications included 3 pills one was blood pressure, one for sugar, and one for Potassium correct, he took these 3. Patient previously took first dose of bnt162b2 (Lot number: EL8982) on 23Jan2021 and on an unknown date felt very weak and walking slow. Reported said he was just calling to report the side effects that happened to my uncle, after he get the Pfizer vaccine. Well, the first weakness was in January and February they did not think too much about it because it was not one of the side effects that were told to watch out for. So, they noticed, my aunt and my cousin noticed that he was having trouble in walking and he used to walking and drive and to the church on regular basis after his first vaccine he had trouble walking and he started moving very slowly that was unlike him and he became very weak. He always has been a walker and that was not normal for him, he was very healthy. So, that was the first injection and then he got the second injection then nobody realized about you know, weakness was none that, no side effects that we talk about, you know from you providers that you read about and what was on the news. So, he got the second injection, and he became weaker and weaker and recently he been using walker now. His weakness got worsen and he could not even move the walker because he could not grip it with his hand. He could not use his hands and it got worse and he has fallen a couple of times, but they did not take him to hospital as he did not want to go to the hospital it was not until 05Apr2021 that he fallen split his head open and he thought he just would go to the ER. He fell couple of times and he finally actually fell and hit his head and was taken to the ER. From the ER he was transferred to the hospital. He was hospitalized and then they could not find anything wrong with him. He first went to the ER on 10Apr2021 at 21:30. Patient was in the hospital for three days on 14Apr2021 they transferred him to a rehab and he was there for 6 weeks and he was sent home on 01Jun2021, but he still could not walk but they sent him home and he could not even move his hand, so, he got taken back to the hospital at the hospital request on 14Jun2021, and she said to keep him bed rested at home and 2 days to be rested here that he fell or might now fell until we find care for him but we need to go back so she called 911, took him back to the hospital, second rehab and she came back to the hospital and they still could not find anything wrong with him and he got transferred on week later on 21Jun2021. Patient did not receive any other vaccine prior or during the covid vaccine. It was reported that he has both Diabetes and Hypertension but doctor was absent because he has Diabetes for about 25 years and when my aunt told them that she thought that it was related to the vaccines then they just said they have no idea. They just said they had no idea they wished what they knew what was wrong with him, because everything was normal with exception of elevated blood pressure, elevated sugar and elevated potassium. At the time of reporting, he weighed about 139 pounds. Since he has been out of hospital, he has lost about 25 pounds. Reporter stated that, she has to pay out of her pocket for his rehab because they did not know what was wrong with him and her insurance only cover certain amount of days and she was trying to figure out how she can get some assistance in paying for that rehab visit because they paid certain number of days and then she ready to go but he was not ready to come home so she had to pay out of her pocket to keep him there and also trying to see if that is something that pfizer would reimburse for. Reporter stated that, her insurance would not cover all the kind of aiding there and then they sent him home and then he had to back to his status because nurse said he should not be home he is too fragile and that was dangerous for him to keep him in the hospital, if he falls, he falls. She was asking if can either reimburse my aunt for the extra days that insurance did not cover, she had to pay out of her pocket for those because insurance did not cover everything and the doctors, nobody know what is wrong, they just says I wish I knew what was wrong, they can see that he was weak, they can see that he can not walk, he can not feed himself, so he can not be home and yet none of this happened if he did not have these vaccine. Upon follow up, reporter stated that, all events were reported yesterday, first was an ER visit, the doctor said they had no explanation, what was causing this, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things and he fell a couple times, but he got the second shot, he got worse, and he went to ER because he fell and cracked his head on wall and cut it open, so he was taken to ER and admitted. Reporter did not know why the lady last night gave her a number that was not valid. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized for 2 weeks. Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus. Micro vascular ischemic changes. Critical test result of acute stroke.

Developed temp 101.2 on 12/30/2020. Treated with Tylenol. The following day, the patient complained of chest pain and was sent to ED for evaluation. He was transferred to Hospital and admitted with altered mental status. He returned to the Nursing Home on 01/01/2021 with no acute findings and has been stable since that time - Dx was lethargy and altered mental status.

- vomiting multiple times 2-3 hours after the vaccine - severe headache 2-3 hours after the vaccine- given tylenol - severe dizziness 2-3 hours after the vaccine - fainting 2-3 hours after the vaccine - extremely tired

Patient was leaving the 15 minute post-vaccine monitoring area approximately 40 minutes after vaccine administration (administration of second dose at 08:42, rapid response called at 09:21). He became pale, lethargic, diaphoretic, incontinent of urine, and collapsed onto his walker. A rapid response was called. Blood pressure on arrival by team was 50's/30's, and fluid resuscitation with 0.9% sodium chloride 500 mL was initiated while in transit to the ED. Approximately 20 minutes later the patient's had stabilized but remained appropriately alert.

Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1288 and expiry date: unknown), via an unspecified route of administration on the left shoulder, on 14Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing acid reflux, atrial fibrillation, and cholesterol. Concomitant medication included omeprazole, apixaban (ELIQUIS), and atorvastatin. Patient previously took pneumonia vaccine. On Jan2021, patient noticed an increased blood pressure (usually his BP is around 120, now has consistently been around 150). Prior to the shot, he has not been on blood pressure medication. His blood pressure usually runs high 120s to 130s on the top, and mid 50-60 on the bottom. His blood pressure prior to the vaccine that day was 132/56. Then a couple of days after the first shot, the top number of his blood pressure was in the high 150s, but the same on the bottom. Patient was wondering if he has a problem, or is this a side effect. He went in as a senior. He didn't have a prescribing doctor. The blood pressure difference started a couple of days after his first shot. He was scheduled for his second shot 4Feb2021. He has had no other side effects or anything. There was no swelling, no fever, no chills and he felt good. Just his blood pressure has been an issue. Outcome of the event was not recovered.

Nose bleed; Anemic; her husband's hemoglobin and hematocrit were low; her husband's hemoglobin and hematocrit were low; low on iron; This is a spontaneous report from a contactable consumer (wife of patient). An 87-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 at 16:00 at single dose in right arm for COVID-19 immunisation at the age of 87-year-old. Lot number was EL3249. Medical history included atrial fibrillation, by-pass surgery in 1999 then high blood pressure in 1999, gout (diagnosed before 1999, it was an on and off thing, he had flare ups, the last one was at Christmas time), High cholesterol (diagnosed in 2000 or 2001), diabetes, anemia. Concomitant medications included rivaroxaban (XARELTO) in 2014 for atrial fibrillation. Historical vaccine included flu vaccine in Sep2020 for immunization. On 20Jan2021, the patient was anemic. On 21Jan2021 at 02:30, nose bled. The patient just kept wiping his nose for thirty minutes before it stopped. On 20Jan2021, hemoglobin resulted 12.6, hematocrit was 3.9. The patient went to the hematologist the day before the report who said the patient was low on iron, hemoglobin and hematocrit were low, so he had to get an iron infusion the day of report for that (the patient went every three months and if his iron was low he got an infusion). The patient recovered from nose bled on 21Jan2021, the outcome of other events was unknown.

This patient received a Covid-19 vaccination on 1/28 at his post-acute skilled nursing facility. He began having fevers and low oxygenation the next day. He was brought to Hospital ED, tested positive for coronavirus, and was admitted to the hospital with Covid-19. I do not know what brand or lot vaccine the patient received. The SNF should have those records.